e
Magnesium (mg) 6.0
Iron (mg) 0.15
Iodine (µg) 5.0
Zinc (mg) 0.5
Copper (µg) 60.0
Manganese (µg) 5.0
Sodium (mg) 20.0 60.0.
Potassium (mg) 80.0 200.0.
Chloride (mg) 55.0 150.0.
a Stated per 100 kilocalories.
b The source of protein shall be at least
nutritionally equivalent to casein.
c Retinol equivalents.
d Required to be included in this amount only in
formulas which are not milk-based.
e Calcium to phosphorus ratio must be no less than 1.1
nor more than 2.0.
--------------------------------------------------------------------
-SOURCE-
(June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,
Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,
Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120;
Pub. L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)
-MISC1-
AMENDMENTS
1993 - Subsec. (h)(1). Pub. L. 103-80 substituted "(e)(1)(B) of
this section" for "(c)(1)(B) of this section," in concluding
provisions.
1986 - Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7),
added subsecs. (a) to (d) and struck out former subsecs. (a)
relating to adulteration and regulatory oversight, (b) relating to
notice to the Secretary by a manufacturer and requirements and
scope of that notice, (c) relating to additional notice
requirements for the manufacturer, and (d) relating to procedures
applicable to recalls by a manufacturer.
Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added
subsecs. (e) and (f) and redesignated former subsecs. (e) and (f)
as (g) and (h), respectively.
Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated
subsec. (e) as (g) and substituted "Such records shall be retained
for at least one year after the expiration of the shelf life of the
infant formula" for "No manufacturer shall be required under this
subsection to retain any record respecting the distribution of an
infant formula for a period of longer than 2 years from the date
the record was made". Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated
subsec. (f) as (h).
Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted
"(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".
Pub. L. 99-570, Sec. 4014(a)(5), which directed that "(d)(1)(B)"
be substituted for "(e)(1)(B)" in second sentence could not be
executed because "(e)(1)(B)" did not appear. See 1993 Amendment
note above.
Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted
"(a), (b), and (c)" for "(a) and (b)".
Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1),
redesignated subsec. (g) as (i), designated existing provisions as
par. (1), substituted "paragraph (2)" for "subsection (a)(2) of
this section", substituted a period for the colon after "as so
revised", and added par. (2).
EFFECTIVE DATE OF 1980 AMENDMENT
Section 6 of Pub. L. 96-359 provided that: "Section 412 of the
Federal Food, Drug, and Cosmetic Act (added by section 2) [this
section] shall apply with respect to infant formulas manufactured
on or after the 90th day after the date of the enactment of this
Act [Sept. 26, 1980]."
-End-
-CITE-
21 USC Sec. 350b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350b. New dietary ingredients
-STATUTE-
(a) In general
A dietary supplement which contains a new dietary ingredient
shall be deemed adulterated under section 342(f) of this title
unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients
which have been present in the food supply as an article used for
food in a form in which the food has not been chemically altered.
(2) There is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the
conditions recommended or suggested in the labeling of the
dietary supplement will reasonably be expected to be safe and, at
least 75 days before being introduced or delivered for
introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement
provides the Secretary with information, including any citation
to published articles, which is the basis on which the
manufacturer or distributor has concluded that a dietary
supplement containing such dietary ingredient will reasonably be
expected to be safe.
The Secretary shall keep confidential any information provided
under paragraph (2) for 90 days following its receipt. After the
expiration of such 90 days, the Secretary shall place such
information on public display, except matters in the information
which are trade secrets or otherwise confidential, commercial
information.
(b) Petition
Any person may file with the Secretary a petition proposing the
issuance of an order prescribing the conditions under which a new
dietary ingredient under its intended conditions of use will
reasonably be expected to be safe. The Secretary shall make a
decision on such petition within 180 days of the date the petition
is filed with the Secretary. For purposes of chapter 7 of title 5,
the decision of the Secretary shall be considered final agency
action.
(c) "New dietary ingredient" defined
For purposes of this section, the term "new dietary ingredient"
means a dietary ingredient that was not marketed in the United
States before October 15, 1994 and does not include any dietary
ingredient which was marketed in the United States before October
15, 1994.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec.
8, Oct. 25, 1994, 108 Stat. 4331.)
-End-
-CITE-
21 USC Sec. 350c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350c. Maintenance and inspection of records
-STATUTE-
(a) Records inspection
If the Secretary has a reasonable belief that an article of food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals, each person (excluding
farms and restaurants) who manufactures, processes, packs,
distributes, receives, holds, or imports such article shall, at the
request of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of appropriate
credentials and a written notice to such person, at reasonable
times and within reasonable limits and in a reasonable manner, to
have access to and copy all records relating to such article that
are needed to assist the Secretary in determining whether the food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals. The requirement under
the preceding sentence applies to all records relating to the
manufacture, processing, packing, distribution, receipt, holding,
or importation of such article maintained by or on behalf of such
person in any format (including paper and electronic formats) and
at any location.
(b) Regulations concerning recordkeeping
The Secretary, in consultation and coordination, as appropriate,
with other Federal departments and agencies with responsibilities
for regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for not
longer than two years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food, which records are needed by the
Secretary for inspection to allow the Secretary to identify the
immediate previous sources and the immediate subsequent recipients
of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans
or animals. The Secretary shall take into account the size of a
business in promulgating regulations under this section.
(c) Protection of sensitive information
The Secretary shall take appropriate measures to ensure that
there are in effect effective procedures to prevent the
unauthorized disclosure of any trade secret or confidential
information that is obtained by the Secretary pursuant to this
section.
(d) Limitations
This section shall not be construed -
(1) to limit the authority of the Secretary to inspect records
or to require establishment and maintenance of records under any
other provision of this chapter;
(2) to authorize the Secretary to impose any requirements with
respect to a food to the extent that it is within the exclusive
jurisdiction of the Secretary of Agriculture pursuant to the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.);
(3) to have any legal effect on section 552 of title 5 or
section 1905 of title 18; or
(4) to extend to recipes for food, financial data, pricing
data, personnel data, research data, or sales data (other than
shipment data regarding sales).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 414, as added Pub. L. 107-188, title
III, Sec. 306(a), June 12, 2002, 116 Stat. 669.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Meat Inspection Act, referred to in subsec. (d)(2),
is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L.
90-201, Dec. 15, 1967, 81 Stat. 584, and amended, which are
classified generally to subchapters I to IV (Sec. 601 et seq.) of
chapter 12 of this title. For complete classification of this Act
to the Code, see Short Title note set out under section 601 of this
title and Tables.
The Poultry Products Inspection Act, referred to in subsec.
(d)(2), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended,
which is classified generally to chapter 10 (Sec. 451 et seq.) of
this title. For complete classification of this Act to the Code,
see Short Title note set out under section 451 of this title and
Tables.
The Egg Products Inspection Act, referred to in subsec. (d)(2),
is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as amended, which
is classified generally to chapter 15 (Sec. 1031 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 1031 of this title and
Tables.
-MISC1-
EXPEDITED RULEMAKING
Pub. L. 107-188, title III, Sec. 306(d), June 12, 2002, 116 Stat.
670, provided that: "Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary shall
promulgate proposed and final regulations establishing
recordkeeping requirements under subsection 414(b) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by
subsection (a))."
-End-
-CITE-
21 USC Sec. 350d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350d. Registration of food facilities
-STATUTE-
(a) Registration
(1) In general
The Secretary shall by regulation require that any facility
engaged in manufacturing, processing, packing, or holding food
for consumption in the United States be registered with the
Secretary. To be registered -
(A) for a domestic facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary; and
(B) for a foreign facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary and shall include with the registration the name of
the United States agent for the facility.
(2) Registration
An entity (referred to in this section as the "registrant")
shall submit a registration under paragraph (1) to the Secretary
containing information necessary to notify the Secretary of the
name and address of each facility at which, and all trade names
under which, the registrant conducts business and, when
determined necessary by the Secretary through guidance, the
general food category (as identified under section 170.3 of title
21, Code of Federal Regulations) of any food manufactured,
processed, packed, or held at such facility. The registrant shall
notify the Secretary in a timely manner of changes to such
information.
(3) Procedure
Upon receipt of a completed registration described in paragraph
(1), the Secretary shall notify the registrant of the receipt of
such registration and assign a registration number to each
registered facility.
(4) List
The Secretary shall compile and maintain an up-to-date list of
facilities that are registered under this section. Such list and
any registration documents submitted pursuant to this subsection
shall not be subject to disclosure under section 552 of title 5.
Information derived from such list or registration documents
shall not be subject to disclosure under section 552 of title 5
to the extent that it discloses the identity or location of a
specific registered person.
(b) Facility
For purposes of this section:
(1) The term "facility" includes any factory, warehouse, or
establishment (including a factory, warehouse, or establishment
of an importer) that manufactures, processes, packs, or holds
food. Such term does not include farms; restaurants; other retail
food establishments; nonprofit food establishments in which food
is prepared for or served directly to the consumer; or fishing
vessels (except such vessels engaged in processing as defined in
section 123.3(k) of title 21, Code of Federal Regulations).
(2) The term "domestic facility" means a facility located in
any of the States or Territories.
(3)(A) The term "foreign facility" means a facility that
manufacturers, processes, packs, or holds food, but only if food
from such facility is exported to the United States without
further processing or packaging outside the United States.
(B) A food may not be considered to have undergone further
processing or packaging for purposes of subparagraph (A) solely
on the basis that labeling was added or that any similar activity
of a de minimis nature was carried out with respect to the food.
(c) Rule of construction
Nothing in this section shall be construed to authorize the
Secretary to require an application, review, or licensing process.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title
III, Sec. 305(a), June 12, 2002, 116 Stat. 667.)
-MISC1-
REGULATIONS
Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat.
669, provided that: "Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary of Health and
Human Services shall promulgate proposed and final regulations for
the requirement of registration under section 415 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by
subsection (a) of this section). Such requirement of registration
takes effect -
"(1) upon the effective date of such final regulations; or
"(2) upon the expiration of such 18-month period if the final
regulations have not been made effective as of the expiration of
such period, subject to compliance with the final regulations
when the final regulations are made effective."
ELECTRONIC FILING
Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat.
668, provided that: "For the purpose of reducing paperwork and
reporting burdens, the Secretary of Health and Human Services may
provide for, and encourage the use of, electronic methods of
submitting to the Secretary registrations required pursuant to this
section [enacting this section, amending sections 331 and 381 of
this title, and enacting provisions set out as a note under this
section]. In providing for the electronic submission of such
registrations, the Secretary shall ensure adequate authentication
protocols are used to enable identification of the registrant and
validation of the data as appropriate."
-End-
-CITE-
21 USC Sec. 350e 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350e. Sanitary transportation practices
-STATUTE-
(a) Definitions
In this section:
(1) Bulk vehicle
The term "bulk vehicle" includes a tank truck, hopper truck,
rail tank car, hopper car, cargo tank, portable tank, freight
container, or hopper bin, and any other vehicle in which food is
shipped in bulk, with the food coming into direct contact with
the vehicle.
(2) Transportation
The term "transportation" means any movement in commerce by
motor vehicle or rail vehicle.
(b) Regulations
The Secretary shall by regulation require shippers, carriers by
motor vehicle or rail vehicle, receivers, and other persons engaged
in the transportation of food to use sanitary transportation
practices prescribed by the Secretary to ensure that food is not
transported under conditions that may render the food adulterated.
(c) Contents
The regulations under subsection (b) of this section shall -
(1) prescribe such practices as the Secretary determines to be
appropriate relating to -
(A) sanitation;
(B) packaging, isolation, and other protective measures;
(C) limitations on the use of vehicles;
(D) information to be disclosed -
(i) to a carrier by a person arranging for the transport of
food; and
(ii) to a manufacturer or other person that -
(I) arranges for the transportation of food by a carrier;
or
(II) furnishes a tank vehicle or bulk vehicle for the
transportation of food; and
(E) recordkeeping; and
(2) include -
(A) a list of nonfood products that the Secretary determines
may, if shipped in a bulk vehicle, render adulterated food that
is subsequently transported in the same vehicle; and
(B) a list of nonfood products that the Secretary determines
may, if shipped in a motor vehicle or rail vehicle (other than
a tank vehicle or bulk vehicle), render adulterated food that
is simultaneously or subsequently transported in the same
vehicle.
(d) Waivers
(1) In general
The Secretary may waive any requirement under this section,
with respect to any class of persons, vehicles, food, or nonfood
products, if the Secretary determines that the waiver -
(A) will not result in the transportation of food under
conditions that would be unsafe for human or animal health; and
(B) will not be contrary to the public interest.
(2) Publication
The Secretary shall publish in the Federal Register any waiver
and the reasons for the waiver.
(e) Preemption
(1) In general
A requirement of a State or political subdivision of a State
that concerns the transportation of food is preempted if -
(A) complying with a requirement of the State or political
subdivision and a requirement of this section, or a regulation
prescribed under this section, is not possible; or
(B) the requirement of the State or political subdivision as
applied or enforced is an obstacle to accomplishing and
carrying out this section or a regulation prescribed under this
section.
(2) Applicability
This subsection applies to transportation that occurs on or
after the effective date of the regulations promulgated under
subsection (b) of this section.
(f) Assistance of other agencies
The Secretary of Transportation, the Secretary of Agriculture,
the Administrator of the Environmental Protection Agency, and the
heads of other Federal agencies, as appropriate, shall provide
assistance on request, to the extent resources are available, to
the Secretary for the purposes of carrying out this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 416, as added Pub. L. 109-59, title
VII, Sec. 7202(b), Aug. 10, 2005, 119 Stat. 1911.)
-MISC1-
EFFECTIVE DATE
Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109-
59, set out as an Effective Date of 2005 Amendment note under
section 331 of this title.
-End-
-CITE-
21 USC SUBCHAPTER V - DRUGS AND DEVICES 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
-HEAD-
SUBCHAPTER V - DRUGS AND DEVICES
-End-
-CITE-
21 USC Part A - Drugs and Devices 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
PART A - DRUGS AND DEVICES
-End-
-CITE-
21 USC Sec. 351 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 351. Adulterated drugs and devices
-STATUTE-
A drug or device shall be deemed to be adulterated -
(a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture
(1) If it consists in whole or in part of any filthy, putrid, or
decomposed substance; or (2)(A) if it has been prepared, packed, or
held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered
injurious to health; or (B) if it is a drug and the methods used
in, or the facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good
manufacturing practice to assure that such drug meets the
requirements of this chapter as to safety and has the identity and
strength, and meets the quality and purity characteristics, which
it purports or is represented to possess; or (C) if it is a
compounded positron emission tomography drug and the methods used
in, or the facilities and controls used for, its compounding,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with the positron emission
tomography compounding standards and the official monographs of the
United States Pharmacopoeia to assure that such drug meets the
requirements of this chapter as to safety and has the identity and
strength, and meets the quality and purity characteristics, that it
purports or is represented to possess; or (3) if its container is
composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or (4)
if (A) it bears or contains, for purposes of coloring only, a color
additive which is unsafe within the meaning of section 379e(a) of
this title, or (B) it is a color additive the intended use of which
in or on drugs or devices is for purposes of coloring only and is
unsafe within the meaning of section 379e(a) of this title; or (5)
if it is a new animal drug which is unsafe within the meaning of
section 360b of this title; or (6) if it is an animal feed bearing
or containing a new animal drug, and such animal feed is unsafe
within the meaning of section 360b of this title.
(b) Strength, quality, or purity differing from official compendium
If it purports to be or is represented as a drug the name of
which is recognized in an official compendium, and its strength
differs from, or its quality or purity falls below, the standard
set forth in such compendium. Such determination as to strength,
quality, or purity shall be made in accordance with the tests or
methods of assay set forth in such compendium, except that whenever
tests or methods of assay have not been prescribed in such
compendium, or such tests or methods of assay as are prescribed
are, in the judgment of the Secretary, insufficient for the making
of such determination, the Secretary shall bring such fact to the
attention of the appropriate body charged with the revision of such
compendium, and if such body fails within a reasonable time to
prescribe tests or methods of assay which, in the judgment of the
Secretary, are sufficient for purposes of this paragraph, then the
Secretary shall promulgate regulations prescribing appropriate
tests or methods of assay in accordance with which such
determination as to strength, quality, or purity shall be made. No
drug defined in an official compendium shall be deemed to be
adulterated under this paragraph because it differs from the
standard of strength, quality, or purity therefor set forth in such
compendium, if its difference in strength, quality, or purity from
such standard is plainly stated on its label. Whenever a drug is
recognized in both the United States Pharmacopoeia and the
Homoeopathic Pharmacopoeia of the United States it shall be subject
to the requirements of the United States Pharmacopoeia unless it is
labeled and offered for sale as a homoeopathic drug, in which case
it shall be subject to the provisions of the Homoeopathic
Pharmacopoeia of the United States and not to those of the United
States Pharmacopoeia.
(c) Misrepresentation of strength, etc., where drug is unrecognized
in compendium
If it is not subject to the provisions of paragraph (b) of this
section and its strength differs from, or its purity or quality
falls below, that which it purports or is represented to possess.
(d) Mixture with or substitution of another substance
If it is a drug and any substance has been (1) mixed or packed
therewith so as to reduce its quality or strength or (2)
substituted wholly or in part therefor.
(e) Devices not in conformity with performance standards
(1) If it is, or purports to be or is represented as, a device
which is subject to a performance standard established under
section 360d of this title unless such device is in all respects in
conformity with such standard.
(2) If it is declared to be, purports to be, or is represented
as, a device that is in conformity with any standard recognized
under section 360d(c) of this title unless such device is in all
respects in conformity with such standard.
(f) Certain class III devices
(1) If it is a class III device -
(A)(i) which is required by a regulation promulgated under
subsection (b) of section 360e of this title to have an approval
under such section of an application for premarket approval and
which is not exempt from section 360e of this title under section
360j(g) of this title, and
(ii)(I) for which an application for premarket approval or a
notice of completion of a product development protocol was not
filed with the Secretary within the ninety-day period beginning
on the date of the promulgation of such regulation, or
(II) for which such an application was filed and approval of
the application has been denied, suspended, or withdrawn, or such
a notice was filed and has been declared not completed or the
approval of the device under the protocol has been withdrawn;
(B)(i) which was classified under section 360c(f) of this title
into class III, which under section 360e(a) of this title is
required to have in effect an approved application for premarket
approval, and which is not exempt from section 360e of this title
under section 360j(g) of this title, and
(ii) which has an application which has been suspended or is
otherwise not in effect; or
(C) which was classified under section 360j(l) of this title
into class III, which under such section is required to have in
effect an approved application under section 360e of this title,
and which has an application which has been suspended or is
otherwise not in effect.
(2)(A) In the case of a device classified under section 360c(f)
of this title into class III and intended solely for
investigational use, paragraph (!1) (1)(B) shall not apply with
respect to such device during the period ending on the ninetieth
day after the date of the promulgation of the regulations
prescribing the procedures and conditions required by section
360j(g)(2) of this title.
(B) In the case of a device subject to a regulation promulgated
under subsection (b) of section 360e of this title, paragraph (!1)
(1) shall not apply with respect to such device during the period
ending -
(i) on the last day of the thirtieth calendar month beginning
after the month in which the classification of the device in
class III became effective under section 360c of this title, or
(ii) on the ninetieth day after the date of the promulgation of
such regulation,
whichever occurs later.
(g) Banned devices
If it is a banned device.
(h) Manufacture, packing, storage, or installation of device not in
conformity with applicable requirements or conditions
If it is a device and the methods used in, or the facilities or
controls used for, its manufacture, packing, storage, or
installation are not in conformity with applicable requirements
under section 360j(f)(1) of this title or an applicable condition
prescribed by an order under section 360j(f)(2) of this title.
(i) Failure to comply with requirements under which device was
exempted for investigational use
If it is a device for which an exemption has been granted under
section 360j(g) of this title for investigational use and the
person who was granted such exemption or any investigator who uses
such device under such exemption fails to comply with a requirement
prescribed by or under such section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 501, 52 Stat. 1049; Pub. L. 86-618,
title I, Sec. 102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L. 87-
781, title I, Sec. 101, Oct. 10, 1962, 76 Stat. 780; Pub. L. 90-
399, Sec. 101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94-295,
Secs. 3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L. 101-
629, Sec. 9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102-571,
title I, Sec. 107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105-
115, title I, Sec. 121(b)(1), title II, Sec. 204(c), Nov. 21,
1997, 111 Stat. 2320, 2336.)
-MISC1-
AMENDMENTS
1997 - Par. (a)(2)(C). Pub. L. 105-115, Sec. 121(b)(1), inserted
"; or (C) if it is a compounded positron emission tomography drug
and the methods used in, or the facilities and controls used for,
its compounding, processing, packing, or holding do not conform to
or are not operated or administered in conformity with the positron
emission tomography compounding standards and the official
monographs of the United States Pharmacopoeia to assure that such
drug meets the requirements of this chapter as to safety and has
the identity and strength, and meets the quality and purity
characteristics, that it purports or is represented to possess;"
before "or (3)".
Par. (e). Pub. L. 105-115, Sec. 204(c), designated existing
provisions as subpar. (1) and added subpar. (2).
1992 - Par. (a)(4). Pub. L. 102-571 substituted "379e(a)" for
"376(a)" in cls. (A) and (B).
1990 - Par. (f)(1). Pub. L. 101-629, Sec. 9(b), which directed
the amendment of subpars. (A) to (C) of par. (f), was executed by
making the amendments in cls. (A) to (C) of subpar. (1) of par. (f)
as follows to reflect the probable intent of Congress: in cl.
(A)(ii)(II), substituted ", suspended, or withdrawn" for "or
withdrawn"; in cl. (B)(ii), substituted "which has an application
which has been suspended or is otherwise not in effect" for "which
does not have such an application in effect"; and in cl. (C),
substituted "which has an application which has been suspended or
is otherwise not in effect" for "which does not have such an
application in effect".
1976 - Par. (a). Pub. L. 94-295, Sec. 9(b)(1), substituted "(3)
if its" for "(3) if it is a drug and its" in cl. (3), substituted
"(4) if (A) it bears or contains" for "(4) if (A) it is a drug
which bears or contains" in cl. (4)(A), and substituted "drugs or
devices" for "drugs" in cl. (4)(B).
Pars. (e) to (i). Pub. L. 94-295, Sec. 3(d), added pars. (e) to
(i).
1968 - Par. (a). Pub. L. 90-399 added cls. (5) and (6).
1962 - Par. (a). Pub. L. 87-781 designated existing provisions of
cl. (2) as (A) and added (B).
1960 - Par. (a). Pub. L. 86-618 substituted provisions in cl. (4)
relating to unsafe color additives for provisions which related to
a coal-tar color other than one from a batch that has been
certified in accordance with regulations as provided by section 354
of this title.
EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
Section 121(b)(2) of Pub. L. 105-115 provided that: "Section
501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) shall not apply 4 years after the date of enactment
of this Act [Nov. 21, 1997] or 2 years after the date on which the
Secretary of Health and Human Services establishes the requirements
described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L.
105-115, set out as a note under section 355 of this title],
whichever is later."
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as an Effective Date of 1997 Amendment note under
section 321 of this title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch.
242, 53 Stat. 853, set out as an Effective Date; Postponement in
Certain Cases note under section 301 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-FOOTNOTE-
(!1) So in original. Probably should be "subparagraph".
-End-
-CITE-
21 USC Sec. 352 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 352. Misbranded drugs and devices
-STATUTE-
A drug or device shall be deemed to be misbranded -
(a) False or misleading label
If its labeling is false or misleading in any particular. Health
care economic information provided to a formulary committee, or
other similar entity, in the course of the committee or the entity
carrying out its responsibilities for the selection of drugs for
managed care or other similar organizations, shall not be
considered to be false or misleading under this paragraph if the
health care economic information directly relates to an indication
approved under section 355 of this title or under section 262(a) of
title 42 for such drug and is based on competent and reliable
scientific evidence. The requirements set forth in section 355(a)
of this title or in section 262(a) of title 42 shall not apply to
health care economic information provided to such a committee or
entity in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic
information presented pursuant to this paragraph shall be made
available to the Secretary upon request. In this paragraph, the
term "health care economic information" means any analysis that
identifies, measures, or compares the economic consequences,
including the costs of the represented health outcomes, of the use
of a drug to the use of another drug, to another health care
intervention, or to no intervention.
(b) Package form; contents of label
If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count: Provided,
That under clause (2) of this paragraph reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
(c) Prominence of information on label
If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling)
and in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997,
111 Stat. 2327
(e) Designation of drugs or devices by established names
(1)(A) If it is a drug, unless its label bears, to the exclusion
of any other nonproprietary name (except the applicable systematic
chemical name or the chemical formula) -
(i) the established name (as defined in subparagraph (3)) of
the drug, if there is such a name;
(ii) the established name and quantity or, if determined to be
appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of any
alcohol, and also including whether active or not the established
name and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether, chloroform,
acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
mercury, ouabain, strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained
therein, except that the requirement for stating the quantity of
the active ingredients, other than the quantity of those
specifically named in this subclause, shall not apply to
nonprescription drugs not intended for human use; and
(iii) the established name of each inactive ingredient listed
in alphabetical order on the outside container of the retail
package and, if determined to be appropriate by the Secretary, on
the immediate container, as prescribed in regulation promulgated
by the Secretary, except that nothing in this subclause shall be
deemed to require that any trade secret be divulged, and except
that the requirements of this subclause with respect to
alphabetical order shall apply only to nonprescription drugs that
are not also cosmetics and that this subclause shall not apply to
nonprescription drugs not intended for human use.
(B) For any prescription drug the established name of such drug
or ingredient, as the case may be, on such label (and on any
labeling on which a name for such drug or ingredient is used) shall
be printed prominently and in type at least half as large as that
used thereon for any proprietary name or designation for such drug
or ingredient, except that to the extent that compliance with the
requirements of subclause (ii) or (iii) of clause (A) or this
clause is impracticable, exemptions shall be established by
regulations promulgated by the Secretary.
(2) If it is a device and it has an established name, unless its
label bears, to the exclusion of any other nonproprietary name, its
established name (as defined in subparagraph (4)) prominently
printed in type at least half as large as that used thereon for any
proprietary name or designation for such device, except that to the
extent compliance with the requirements of this subparagraph is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary.
(3) As used in subparagraph (1), the term "established name",
with respect to a drug or ingredient thereof, means (A) the
applicable official name designated pursuant to section 358 of this
title, or (B), if there is no such name and such drug, or such
ingredient, is an article recognized in an official compendium,
then the official title thereof in such compendium, or (C) if
neither clause (A) nor clause (B) of this subparagraph applies,
then the common or usual name, if any, of such drug or of such
ingredient, except that where clause (B) of this subparagraph
applies to an article recognized in the United States Pharmacopeia
and in the Homoeopathic Pharmacopoeia under different official
titles, the official title used in the United States Pharmacopeia
shall apply unless it is labeled and offered for sale as a
homoeopathic drug, in which case the official title used in the
Homoeopathic Pharmacopoeia shall apply.
(4) As used in subparagraph (2), the term "established name" with
respect to a device means (A) the applicable official name of the
device designated pursuant to section 358 of this title, (B) if
there is no such name and such device is an article recognized in
an official compendium, then the official title thereof in such
compendium, or (C) if neither clause (A) nor clause (B) of this
subparagraph applies, then any common or usual name of such device.
(f) Directions for use and warnings on label
Unless its labeling bears (1) adequate directions for use; and
(2) such adequate warnings against use in those pathological
conditions or by children where its use may be dangerous to health,
or against unsafe dosage or methods or duration of administration
or application, in such manner and form, as are necessary for the
protection of users, except that where any requirement of clause
(1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary
shall promulgate regulations exempting such drug or device from
such requirement. Required labeling for prescription devices
intended for use in health care facilities or by a health care
professional and required labeling for in vitro diagnostic devices
intended for use by health care professionals or in blood
establishments may be made available solely by electronic means,
provided that the labeling complies with all applicable
requirements of law, and that the manufacturer affords such users
the opportunity to request the labeling in paper form, and after
such request, promptly provides the requested information without
additional cost.
(g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug
If it purports to be a drug the name of which is recognized in an
official compendium, unless it is packaged and labeled as
prescribed therein. The method of packing may be modified with the
consent of the Secretary. Whenever a drug is recognized in both the
United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of
the United States, it shall be subject to the requirements of the
United States Pharmacopoeia with respect to packaging and labeling
unless it is labeled and offered for sale as a homoeopathic drug,
in which case it shall be subject to the provisions of the
Homoeopathic Pharmacopoeia of the United States, and not those of
the United States Pharmacopoeia, except that in the event of
inconsistency between the requirements of this paragraph and those
of paragraph (e) as to the name by which the drug or its
ingredients shall be designated, the requirements of paragraph (e)
shall prevail.
(h) Deteriorative drugs; packing and labeling
If it has been found by the Secretary to be a drug liable to
deterioration, unless it is packaged in such form and manner, and
its label bears a statement of such precautions, as the Secretary
shall by regulations require as necessary for the protection of the
public health. No such regulation shall be established for any drug
recognized in an official compendium until the Secretary shall have
informed the appropriate body charged with the revision of such
compendium of the need for such packaging or labeling requirements
and such body shall have failed within a reasonable time to
prescribe such requirements.
(i) Drug; misleading container; imitation; offer for sale under
another name
(1) If it is a drug and its container is so made, formed, or
filled as to be misleading; or (2) if it is an imitation of another
drug; or (3) if it is offered for sale under the name of another
drug.
(j) Health-endangering when used as prescribed
If it is dangerous to health when used in the dosage or manner,
or with the frequency or duration prescribed, recommended, or
suggested in the labeling thereof.
(k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),
(b)(2)(D), Nov. 21, 1997, 111 Stat. 2325
(m) Color additives; packing and labeling
If it is a color additive the intended use of which is for the
purpose of coloring only, unless its packaging and labeling are in
conformity with such packaging and labeling requirements applicable
to such color additive, as may be contained in regulations issued
under section 379e of this title.
(n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and
effectiveness; prior approval; false advertising; labeling;
construction of the Convention on Psychotropic Substances
In the case of any prescription drug distributed or offered for
sale in any State, unless the manufacturer, packer, or distributor
thereof includes in all advertisements and other descriptive
printed matter issued or caused to be issued by the manufacturer,
packer, or distributor with respect to that drug a true statement
of (1) the established name as defined in paragraph (e) of this
section, printed prominently and in type at least half as large as
that used for any trade or brand name thereof, (2) the formula
showing quantitatively each ingredient of such drug to the extent
required for labels under paragraph (e) of this section, and (3)
such other information in brief summary relating to side effects,
contraindications, and effectiveness as shall be required in
regulations which shall be issued by the Secretary in accordance
with the procedure specified in section 371(e) of this title,
except that (A) except in extraordinary circumstances, no
regulation issued under this paragraph shall require prior approval
by the Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the effective
date of regulations issued under this paragraph applicable to
advertisements of prescription drugs, shall with respect to the
matters specified in this paragraph or covered by such regulations,
be subject to the provisions of sections 52 to 57 of title 15. This
paragraph (n) shall not be applicable to any printed matter which
the Secretary determines to be labeling as defined in section
321(m) of this title. Nothing in the Convention on Psychotropic
Substances, signed at Vienna, Austria, on February 21, 1971, shall
be construed to prevent drug price communications to consumers.
(o) Drugs or devices from nonregistered establishments
If it was manufactured, prepared, propagated, compounded, or
processed in an establishment in any State not duly registered
under section 360 of this title, if it was not included in a list
required by section 360(j) of this title, if a notice or other
information respecting it was not provided as required by such
section or section 360(k) of this title, or if it does not bear
such symbols from the uniform system for identification of devices
prescribed under section 360(e) of this title as the Secretary by
regulation requires.
(p) Packaging or labeling of drugs in violation of regulations
If it is a drug and its packaging or labeling is in violation of
an applicable regulation issued pursuant to section 1472 or 1473 of
title 15.
(q) Restricted devices using false or misleading advertising or
used in violation of regulations
In the case of any restricted device distributed or offered for
sale in any State, if (1) its advertising is false or misleading in
any particular, or (2) it is sold, distributed, or used in
violation of regulations prescribed under section 360j(e) of this
title.
(r) Restricted devices not carrying requisite accompanying
statements in advertisements and other descriptive printed matter
In the case of any restricted device distributed or offered for
sale in any State, unless the manufacturer, packer, or distributor
thereof includes in all advertisements and other descriptive
printed matter issued or caused to be issued by the manufacturer,
packer, or distributor with respect to that device (1) a true
statement of the device's established name as defined in subsection
(e) of this section, printed prominently and in type at least half
as large as that used for any trade or brand name thereof, and (2)
a brief statement of the intended uses of the device and relevant
warnings, precautions, side effects, and contraindications and, in
the case of specific devices made subject to a finding by the
Secretary after notice and opportunity for comment that such action
is necessary to protect the public health, a full description of
the components of such device or the formula showing quantitatively
each ingredient of such device to the extent required in
regulations which shall be issued by the Secretary after an
opportunity for a hearing. Except in extraordinary circumstances,
no regulation issued under this paragraph shall require prior
approval by the Secretary of the content of any advertisement and
no advertisement of a restricted device, published after the
effective date of this paragraph shall, with respect to the matters
specified in this paragraph or covered by regulations issued
hereunder, be subject to the provisions of sections 52 through 55
of title 15. This paragraph shall not be applicable to any printed
matter which the Secretary determines to be labeling as defined in
section 321(m) of this title.
(s) Devices subject to performance standards not bearing requisite
labeling
If it is a device subject to a performance standard established
under section 360d of this title, unless it bears such labeling as
may be prescribed in such performance standard.
(t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or
information
If it is a device and there was a failure or refusal (1) to
comply with any requirement prescribed under section 360h of this
title respecting the device, (2) to furnish any material or
information required by or under section 360i of this title
respecting the device, or (3) to comply with a requirement under
section 360l of this title.
(u) Identification of manufacturer
(1) Subject to paragraph (2), if it is a reprocessed single-use
device, unless it, or an attachment thereto, prominently and
conspicuously bears the name of the manufacturer of the reprocessed
device, a generally recognized abbreviation of such name, or a
unique and generally recognized symbol identifying such
manufacturer.
(2) If the original device or an attachment thereto does not
prominently and conspicuously bear the name of the manufacturer of
the original device, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying such
manufacturer, a reprocessed device may satisfy the requirements of
paragraph (1) through the use of a detachable label on the
packaging that identifies the manufacturer and is intended to be
affixed to the medical record of a patient.
(v) Reprocessed single-use devices
If it is a reprocessed single-use device, unless all labeling of
the device prominently and conspicuously bears the statement
"Reprocessed device for single use. Reprocessed by __." The name of
the manufacturer of the reprocessed device shall be placed in the
space identifying the person responsible for reprocessing.
(w) New animal drugs
If it is a new animal drug -
(1) that is conditionally approved under section 360ccc of this
title and its labeling does not conform with the approved
application or section 360ccc(f) of this title, or that is not
conditionally approved under section 360ccc of this title and its
label bears the statement set forth in section 360ccc(f)(1)(A) of
this title; or
(2) that is indexed under section 360ccc-1 of this title and
its labeling does not conform with the index listing under
section 360ccc-1(e) of this title or 360ccc-1(h) of this title,
or that has not been indexed under section 360ccc-1 of this title
and its label bears the statement set forth in section 360ccc-
1(h) of this title.
(x) Nonprescription drugs
If it is a nonprescription drug (as defined in section 379aa of
this title) that is marketed in the United States, unless the label
of such drug includes a domestic address or domestic phone number
through which the responsible person (as described in section 379aa
of this title) may receive a report of a serious adverse event (as
defined in section 379aa of this title) with such drug.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,
ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55
Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,
1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,
63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.
86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.
L. 87-781, title I, Secs. 105(c), 112(a), (b), 131(a), title III,
Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-
399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,
Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,
renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
95 Stat. 716; Pub. L. 94-295, Secs. 3(e), 4(b)(2), 5(a), 9(b)(2),
May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.
111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),
June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.
107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),
Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),
Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,
title II, Sec. 206, title III, Secs. 301(a), 302(a)(1), Oct. 26,
2002, 116 Stat. 1613, 1616; Pub. L. 108-214, Sec. 2(b)(2)(B), Apr.
1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, Sec.
102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, Sec.
2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109-462, Sec. 2(d),
Dec. 22, 2006, 120 Stat. 3472.)
-MISC1-
AMENDMENTS
2006 - Par. (x). Pub. L. 109-462 added par. (x).
2005 - Par. (u). Pub. L. 109-43 amended par. (u) generally. Prior
to amendment, par. (u) read as follows: "If it is a device, unless
it, or an attachment thereto, prominently and conspicuously bears
the name of the manufacturer of the device, a generally recognized
abbreviation of such name, or a unique and generally recognized
symbol identifying such manufacturer, except that the Secretary may
waive any requirement under this paragraph for the device if the
Secretary determines that compliance with the requirement is not
feasible for the device or would compromise the provision of
reasonable assurance of the safety or effectiveness of the device."
2004 - Par. (f). Pub. L. 108-214, in last sentence, inserted "or
by a health care professional and required labeling for in vitro
diagnostic devices intended for use by health care professionals or
in blood establishments" after "in health care facilities",
inserted comma after "means", substituted "requirements of law, and
that the manufacturer affords such users the opportunity" for
"requirements of law and, that the manufacturer affords health care
facilities the opportunity", and struck out "the health care
facility" after "promptly provides".
Par. (w). Pub. L. 108-282 added par. (w).
2002 - Par. (f). Pub. L. 107-250, Sec. 206, inserted at end
"Required labeling for prescription devices intended for use in
health care facilities may be made available solely by electronic
means provided that the labeling complies with all applicable
requirements of law and, that the manufacturer affords health care
facilities the opportunity to request the labeling in paper form,
and after such request, promptly provides the health care facility
the requested information without additional cost."
Par. (u). Pub. L. 107-250, Sec. 301(a), which directed amendment
of section by adding par. (u) at end, was executed by adding par.
(u) before par. (v) to reflect the probable intent of Congress.
Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).
1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), inserted at end
"Health care economic information provided to a formulary
committee, or other similar entity, in the course of the committee
or the entity carrying out its responsibilities for the selection
of drugs for managed care or other similar organizations, shall not
be considered to be false or misleading under this paragraph if the
health care economic information directly relates to an indication
approved under section 355 of this title or under section 262(a) of
title 42 for such drug and is based on competent and reliable
scientific evidence. The requirements set forth in section 355(a)
of this title or in section 262(a) of title 42 shall not apply to
health care economic information provided to such a committee or
entity in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic
information presented pursuant to this paragraph shall be made
available to the Secretary upon request. In this paragraph, the
term 'health care economic information' means any analysis that
identifies, measures, or compares the economic consequences,
including the costs of the represented health outcomes, of the use
of a drug to the use of another drug, to another health care
intervention, or to no intervention."
Par. (d). Pub. L. 105-115, Sec. 126(b), struck out par. (d) which
read as follows: "If it is for use by man and contains any quantity
of the narcotic or hypnotic substance alpha eucaine, barbituric
acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
peyote, or sulphonmethane; or any chemical derivative of such
substance, which derivative has been by the Secretary, after
investigation, found to be, and by regulations designated as, habit
forming; unless its label bears the name and quantity or proportion
of such substance or derivative and in juxtaposition therewith the
statement 'Warning - May be habit forming.' "
Par. (e)(1). Pub. L. 105-115, Sec. 412(c), amended subpar. (1)
generally. Prior to amendment, subpar. (1) read as follows: "If it
is a drug, unless (A) its label bears, to the exclusion of any
other nonproprietary name (except the applicable systematic
chemical name or the chemical formula), (i) the established name
(as defined in subparagraph (3)) of the drug, if such there be, and
(ii), in case it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the quantity, kind, and proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilid,
acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury
ouabain strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein; Provided,
That the requirement for stating the quantity of the active
ingredients, other than the quantity of those specifically named in
this paragraph, shall apply only to prescription drugs; and (B) for
any prescription drug the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling
on which a name for such drug or ingredient is used) is printed
prominently and in type at least half as large as that used thereon
for any proprietary name or designation for such drug or
ingredient: Provided, That to the extent that compliance with the
requirements of clause (A)(ii) or clause (B) of this subparagraph
is impracticable, exemptions shall be established by regulations
promulgated by the Secretary."
Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), struck out par. (k)
which read as follows: "If it is, or purports to be, or is
represented as a drug composed wholly or partly of insulin, unless
(1) it is from a batch with respect to which a certificate or
release has been issued pursuant to section 356 of this title, and
(2) such certificate or release is in effect with respect to such
drug."
Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)
which read as follows: "If it is, or purports to be, or is
represented as a drug (except a drug for use in animals other than
man) composed wholly or partly of any kind of penicillin,
streptomycin, chlortetracycline, chloramphenicol, bacitracin, or
any other antibiotic drug, or any derivative thereof, unless (1) it
is from a batch with respect to which a certificate or release has
been issued pursuant to section 357 of this title, and (2) such
certificate or release is in effect with respect to such drug:
Provided, That this paragraph shall not apply to any drug or class
of drugs exempted by regulations promulgated under section 357(c)
or (d) of this title."
1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted "of
such ingredient, except that" for "of such ingredient: Provided,
That".
Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted "users,
except that where" for "users: Provided, That where".
Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted "prescribed
therein. The method" for "prescribed therein: Provided, That the
method" and "Pharmacopoeia, except that" for "Pharmacopoeia:
Provided further, That,".
Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted ", except
that (A)" for ": Provided, That (A)".
1992 - Par. (m). Pub. L. 102-571 substituted "379e" for "376".
Par. (t)(3). Pub. L. 102-300 added cl. (3).
1978 - Par. (n). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), substituted
"subparagraph (3)" for "subparagraph (2)" in subpar. (1), added
subpar. (2), redesignated former subpar. (2) as (3) and in subpar.
(3) as so redesignated substituted "subparagraph (1)" for "this
paragraph (e)", and added subpar. (4).
Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted "dosage or
manner," for "dosage,".
Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted "the intended
use of which is for" for "the intended use of which in or on drugs
is for".
Par. (o). Pub. L. 94-295, Sec. 4(b)(2), substituted "If it was
manufactured" for "If it is a drug and was manufactured" and
inserted ", if it was not included in a list required by section
360(j) of this title, if a notice or other information respecting
it was not provided as required by such section or section 360(k)
of this title, or if it does not bear such symbols from the uniform
system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires".
Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)
to (t).
1970 - Par. (p). Pub. L. 91-601 added par. (p).
1968 - Par. (l). Pub. L. 90-399 inserted "(except a drug for use
in animals other than man)" after "represented as a drug".
1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), designated existing
provisions as subpar. (1), substituted ", unless (A) its label
bears, to the exclusion of any other nonproprietary name (except
the applicable systematic chemical name or the chemical formula),
(i) the established name (as defined in subparagraph (2) of this
subsection) of the drug, if such there be, and (ii), in case it is
fabricated from two or more ingredients, the established name and
quantity" for "and is not designated solely by a name recognized in
an official compendium unless its label bears (1) the common or
usual name of the drug, if such there be; and (2), in case it is
fabricated from two or more ingredients, the common or usual name",
and "the established name" for "the name", provided that the
requirement for stating the quantity of active ingredients, other
than those specified in this par., applies only to prescription
drugs, and that the established name of a drug on a label is to be
printed prominently and in type at least half as large as used for
any proprietary designation, and added subpar. (2) defining
"established name".
Par. (g). Pub. L. 87-781, Sec. 112(b), provided that if there is
an inconsistency between the provisions of this par. and those of
par. (e), as to the name of a drug, the requirements of par. (e)
should prevail.
Par. (l). Pub. L. 87-781, Sec. 105(c), substituted "bacitracin,
or any other antibiotic drug" for "or bacitracin."
Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).
Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).
1960 - Par. (m). Pub. L. 86-618 added par. (m).
1953 - Par. (l). Act Aug. 5, 1953, substituted
"chlortetracycline" for "aureomycin".
1949 - Par. (l). Act July 13, 1949, inserted ", aureomycin,
chloramphenicol, or bacitracin" after "streptomycin".
1947 - Par. (l). Act Mar. 10, 1947, inserted "or streptomycin"
after "penicillin".
1945 - Par. (l). Act July 6, 1945, added par. (l).
1941 - Par. (k). Act Dec. 22, 1941, added par. (k).
1939 - Par. (d). Act June 29, 1939, substituted "name, and
quality or proportion" for "name, quantity, and percentage".
EFFECTIVE DATES OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 2(e)(1), (2), Dec. 22, 2006, 120 Stat.
3472, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by this section [enacting section 379aa of this
title and amending this section and section 331 of this title]
shall take effect 1 year after the date of enactment of this Act
[Dec. 22, 2006].
"(2) Misbranding. - Section 502(x) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall
apply to any nonprescription drug (as defined in such section
502(x)) labeled on or after the date that is 1 year after the date
of enactment of this Act [Dec. 22, 2006]."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.
1616, as amended by Pub. L. 108-214, Sec. 2(c)(1), Apr. 1, 2004,
118 Stat. 575; Pub. L. 109-43, Sec. 2(d), Aug. 1, 2005, 119 Stat.
441, provided that: "Section 502(u) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the
Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])
-
"(1) shall be effective -
"(A) with respect to devices described under paragraph (1) of
such section, 12 months after the date of enactment of the
Medical Device User Fee Stabilization Act of 2005 [Aug. 1,
2005], or the date on which the original device first bears the
name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, whichever is
later; and
"(B) with respect to devices described under paragraph (2) of
such section 502(u), 12 months after such date of enactment;
and
"(2) shall apply only to devices reprocessed and introduced or
delivered for introduction in interstate commerce after such
applicable effective date."
Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116
Stat. 1616, provided that: "The amendment made by paragraph (1)
[amending this section] takes effect 15 months after the date of
the enactment of this Act [Oct. 26, 2002], and only applies to
devices introduced or delivered for introduction into interstate
commerce after such effective date."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-
115 effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Section 112(c) of Pub. L. 87-781 provided that: "This section
[amending this section] shall take effect on the first day of the
seventh calendar month following the month in which this Act is
enacted [October 1962]."
Section 131(b) of Pub. L. 87-781 provided that: "No drug which
was being commercially distributed prior to the date of enactment
of this Act [Oct. 10, 1962] shall be deemed to be misbranded under
paragraph (n) of section 502 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until
the earlier of the following dates: (1) the first day of the
seventh month following the month in which this Act is enacted; or
(2) the effective date of regulations first issued under clause (3)
of such paragraph (n) in accordance with the procedure specified in
section 701(e) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 371(e)]."
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such
paragraphs effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain
labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
an Effective Date: Postponement in Certain Cases note under section
301 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
GUIDANCE; MISBRANDED DEVICES
Pub. L. 109-43, Sec. 2(c)(2), Aug. 1, 2005, 119 Stat. 441,
provided that: "Not later than 180 days after the date of enactment
of this Act [Aug. 1, 2005], the Secretary of Health and Human
Services shall issue guidance to identify circumstances in which
the name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, is not 'prominent
and conspicuous', as used in section 502(u) of Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1))."
STUDY ON MAKING PRESCRIPTION PHARMACEUTICAL INFORMATION ACCESSIBLE
FOR BLIND AND VISUALLY-IMPAIRED INDIVIDUALS
Pub. L. 108-173, title I, Sec. 107(f), Dec. 8, 2003, 117 Stat.
2171, directed the Secretary of Health and Human Services to
undertake a study of how to make prescription pharmaceutical
information, including drug labels and usage instructions,
accessible to blind and visually-impaired individuals, and to
submit a report to Congress not later than 18 months after Dec. 8,
2003.
STUDY AND REPORT
Section 114(b) of Pub. L. 105-115 provided that: "The Comptroller
General of the United States shall conduct a study of the
implementation of the provisions added by the amendment made by
subsection (a) [amending this section]. Not later than 4 years and
6 months after the date of enactment of this Act [Nov. 21, 1997],
the Comptroller General of the United States shall prepare and
submit to Congress a report containing the findings of the study."
COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF
POLICY
Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,
provided that: "The Congress finds and declares that there is a
substantial traffic in counterfeit drugs simulating the brand or
other identifying mark or device of the manufacturer of the genuine
article; that such traffic poses a serious hazard to the health of
innocent consumers of such drugs because of the lack of proper
qualifications, facilities, and manufacturing controls on the part
of the counterfeiter, whose operations are clandestine; that, while
such drugs are deemed misbranded within the meaning of section
502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
352(i)], the controls for the suppression of the traffic in such
drugs are inadequate because of the difficulty of determining the
place of interstate origin of such drugs and, if that place is
discovered, the fact that the implements for counterfeiting are not
subject to seizure, and that these factors require enactment of
additional controls with respect to such drugs without regard to
their interstate or intrastate origins."
Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.
89-74, set out as an Effective Date of 1965 Amendment note under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 353 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 353. Exemptions and consideration for certain drugs, devices,
and biological products
-STATUTE-
(a) Regulations for goods to be processed, labeled, or repacked
elsewhere
The Secretary is directed to promulgate regulations exempting
from any labeling or packaging requirement of this chapter drugs
and devices which are, in accordance with the practice of the
trade, to be processed, labeled, or repacked in substantial
quantities at establishments other than those where originally
processed or packed, on condition that such drugs and devices are
not adulterated or misbranded under the provisions of this chapter
upon removal from such processing, labeling, or repacking
establishment.
(b) Prescription by physician; exemption from labeling and
prescription requirements; misbranded drugs; compliance with
narcotic and marihuana laws
(1) A drug intended for use by man which -
(A) because of its toxicity or other potentiality for harmful
effect, or the method of its use, or the collateral measures
necessary to its use, is not safe for use except under the
supervision of a practitioner licensed by law to administer such
drug; or
(B) is limited by an approved application under section 355 of
this title to use under the professional supervision of a
practitioner licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a
practitioner licensed by law to administer such drug, or (ii) upon
an oral prescription of such practitioner which is reduced promptly
to writing and filed by the pharmacist, or (iii) by refilling any
such written or oral prescription if such refilling is authorized
by the prescriber either in the original prescription or by oral
order which is reduced promptly to writing and filed by the
pharmacist. The act of dispensing a drug contrary to the provisions
of this paragraph shall be deemed to be an act which results in the
drug being misbranded while held for sale.
(2) Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such
drug shall be exempt from the requirements of section 352 of this
title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the
packaging requirements of paragraphs (g), (h), and (p), if the drug
bears a label containing the name and address of the dispenser, the
serial number and date of the prescription or of its filling, the
name of the prescriber, and, if stated in the prescription, the
name of the patient, and the directions for use and cautionary
statements, if any, contained in such prescription. This exemption
shall not apply to any drug dispensed in the course of the conduct
of a business of dispensing drugs pursuant to diagnosis by mail, or
to a drug dispensed in violation of paragraph (1) of this
subsection.
(3) The Secretary may by regulation remove drugs subject to
section 355 of this title from the requirements of paragraph (1) of
this subsection when such requirements are not necessary for the
protection of the public health.
(4)(A) A drug that is subject to paragraph (1) shall be deemed to
be misbranded if at any time prior to dispensing the label of the
drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed
to be misbranded if at any time prior to dispensing the label of
the drug bears the symbol described in subparagraph (A).
(5) Nothing in this subsection shall be construed to relieve any
person from any requirement prescribed by or under authority of law
with respect to drugs now included or which may hereafter be
included within the classifications stated in sections 4721, 6001,
and 6151 of title 26, or to marihuana as defined in section 4761 of
title 26.
(c) Sales restrictions
(1) No person may sell, purchase, or trade or offer to sell,
purchase, or trade any drug sample. For purposes of this paragraph
and subsection (d) of this section, the term "drug sample" means a
unit of a drug, subject to subsection (b) of this section, which is
not intended to be sold and is intended to promote the sale of the
drug. Nothing in this paragraph shall subject an officer or
executive of a drug manufacturer or distributor to criminal
liability solely because of a sale, purchase, trade, or offer to
sell, purchase, or trade in violation of this paragraph by other
employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade, offer to sell,
purchase, or trade, or counterfeit any coupon. For purposes of this
paragraph, the term "coupon" means a form which may be redeemed, at
no cost or at a reduced cost, for a drug which is prescribed in
accordance with subsection (b) of this section.
(3)(A) No person may sell, purchase, or trade, or offer to sell,
purchase, or trade, any drug -
(i) which is subject to subsection (b) of this section, and
(ii)(I) which was purchased by a public or private hospital or
other health care entity, or
(II) which was donated or supplied at a reduced price to a
charitable organization described in section 501(c)(3) of title
26.
(B) Subparagraph (A) does not apply to -
(i) the purchase or other acquisition by a hospital or other
health care entity which is a member of a group purchasing
organization of a drug for its own use from the group purchasing
organization or from other hospitals or health care entities
which are members of such organization,
(ii) the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug by an organization described in
subparagraph (A)(ii)(II) to a nonprofit affiliate of the
organization to the extent otherwise permitted by law,
(iii) a sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care
entities which are under common control,
(iv) a sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons, or
(v) a sale, purchase, or trade of a drug, an offer to sell,
purchase, or trade a drug, or the dispensing of a drug pursuant
to a prescription executed in accordance with subsection (b) of
this section.
For purposes of this paragraph, the term "entity" does not include
a wholesale distributor of drugs or a retail pharmacy licensed
under State law and the term "emergency medical reasons" includes
transfers of a drug between health care entities or from a health
care entity to a retail pharmacy undertaken to alleviate temporary
shortages of the drug arising from delays in or interruptions of
regular distribution schedules.
(d) Distribution of drug samples
(1) Except as provided in paragraphs (2) and (3), no person may
distribute any drug sample. For purposes of this subsection, the
term "distribute" does not include the providing of a drug sample
to a patient by a -
(A) practitioner licensed to prescribe such drug,
(B) health care professional acting at the direction and under
the supervision of such a practitioner, or
(C) pharmacy of a hospital or of another health care entity
that is acting at the direction of such a practitioner and that
received such sample pursuant to paragraph (2) or (3).
(2)(A) The manufacturer or authorized distributor of record of a
drug subject to subsection (b) of this section may, in accordance
with this paragraph, distribute drug samples by mail or common
carrier to practitioners licensed to prescribe such drugs or, at
the request of a licensed practitioner, to pharmacies of hospitals
or other health care entities. Such a distribution of drug samples
may only be made -
(i) in response to a written request for drug samples made on a
form which meets the requirements of subparagraph (B), and
(ii) under a system which requires the recipient of the drug
sample to execute a written receipt for the drug sample upon its
delivery and the return of the receipt to the manufacturer or
authorized distributor of record.
(B) A written request for a drug sample required by subparagraph
(A)(i) shall contain -
(i) the name, address, professional designation, and signature
of the practitioner making the request,
(ii) the identity of the drug sample requested and the quantity
requested,
(iii) the name of the manufacturer of the drug sample
requested, and
(iv) the date of the request.
(C) Each drug manufacturer or authorized distributor of record
which makes distributions by mail or common carrier under this
paragraph shall maintain, for a period of 3 years, the request
forms submitted for such distributions and the receipts submitted
for such distributions and shall maintain a record of distributions
of drug samples which identifies the drugs distributed and the
recipients of the distributions. Forms, receipts, and records
required to be maintained under this subparagraph shall be made
available by the drug manufacturer or authorized distributor of
record to Federal and State officials engaged in the regulation of
drugs and in the enforcement of laws applicable to drugs.
(3) The manufacturer or authorized distributor of record of a
drug subject to subsection (b) of this section may, by means other
than mail or common carrier, distribute drug samples only if the
manufacturer or authorized distributor of record makes the
distributions in accordance with subparagraph (A) and carries out
the activities described in subparagraphs (B) through (F) as
follows:
(A) Drug samples may only be distributed -
(i) to practitioners licensed to prescribe such drugs if they
make a written request for the drug samples, or
(ii) at the written request of such a licensed practitioner,
to pharmacies of hospitals or other health care entities.
A written request for drug samples shall be made on a form which
contains the practitioner's name, address, and professional
designation, the identity of the drug sample requested, the
quantity of drug samples requested, the name of the manufacturer
or authorized distributor of record of the drug sample, the date
of the request and signature of the practitioner making the
request.
(B) Drug manufacturers or authorized distributors of record
shall store drug samples under conditions that will maintain
their stability, integrity, and effectiveness and will assure
that the drug samples will be free of contamination,
deterioration, and adulteration.
(C) Drug manufacturers or authorized distributors of record
shall conduct, at least annually, a complete and accurate
inventory of all drug samples in the possession of
representatives of the manufacturer or authorized distributor of
record. Drug manufacturers or authorized distributors of record
shall maintain lists of the names and address of each of their
representatives who distribute drug samples and of the sites
where drug samples are stored. Drug manufacturers or authorized
distributors of record shall maintain records for at least 3
years of all drug samples distributed, destroyed, or returned to
the manufacturer or authorized distributor of record, of all
inventories maintained under this subparagraph, of all thefts or
significant losses of drug samples, and of all requests made
under subparagraph (A) for drug samples. Records and lists
maintained under this subparagraph shall be made available by the
drug manufacturer or authorized distributor of record to the
Secretary upon request.
(D) Drug manufacturers or authorized distributors of record
shall notify the Secretary of any significant loss of drug
samples and any known theft of drug samples.
(E) Drug manufacturers or authorized distributors of record
shall report to the Secretary any conviction of their
representatives for violations of subsection (c)(1) of this
section or a State law because of the sale, purchase, or trade of
a drug sample or the offer to sell, purchase, or trade a drug
sample.
(F) Drug manufacturers or authorized distributors of record
shall provide to the Secretary the name and telephone number of
the individual responsible for responding to a request for
information respecting drug samples.
(e) Wholesale distributors; guidelines for licensing; definitions
(1)(A) Each person who is engaged in the wholesale distribution
of a drug subject to subsection (b) of this section and who is not
the manufacturer or an authorized distributor of record of such
drug shall, before each wholesale distribution of such drug
(including each distribution to an authorized distributor of record
or to a retail pharmacy), provide to the person who receives the
drug a statement (in such form and containing such information as
the Secretary may require) identifying each prior sale, purchase,
or trade of such drug (including the date of the transaction and
the names and addresses of all parties to the transaction).
(B) Each manufacturer of a drug subject to subsection (b) of this
section shall maintain at its corporate offices a current list of
the authorized distributors of record of such drug.
(2)(A) No person may engage in the wholesale distribution in
interstate commerce of drugs subject to subsection (b) of this
section in a State unless such person is licensed by the State in
accordance with the guidelines issued under subparagraph (B).
(B) The Secretary shall by regulation issue guidelines
establishing minimum standards, terms, and conditions for the
licensing of persons to make wholesale distributions in interstate
commerce of drugs subject to subsection (b) of this section. Such
guidelines shall prescribe requirements for the storage and
handling of such drugs and for the establishment and maintenance of
records of the distributions of such drugs.
(3) For the purposes of this subsection and subsection (d) of
this section -
(A) the term "authorized distributors of record" means those
distributors with whom a manufacturer has established an ongoing
relationship to distribute such manufacturer's products, and
(B) the term "wholesale distribution" means distribution of
drugs subject to subsection (b) of this section to other than the
consumer or patient but does not include intracompany sales and
does not include distributions of drugs described in subsection
(c)(3)(B) of this section.
(f) Veterinary prescription drugs
(1)(A) A drug intended for use by animals other than man, other
than a veterinary feed directive drug intended for use in animal
feed or an animal feed bearing or containing a veterinary feed
directive drug, which -
(i) because of its toxicity or other potentiality for harmful
effect, or the method of its use, or the collateral measures
necessary for its use, is not safe for animal use except under
the professional supervision of a licensed veterinarian, or
(ii) is limited by an approved application under subsection (b)
of section 360b of this title, a conditionally-approved
application under section 360ccc of this title, or an index
listing under section 360ccc-1 of this title to use under the
professional supervision of a licensed veterinarian,
shall be dispensed only by or upon the lawful written or oral order
of a licensed veterinarian in the course of the veterinarian's
professional practice.
(B) For purposes of subparagraph (A), an order is lawful if the
order -
(i) is a prescription or other order authorized by law,
(ii) is, if an oral order, promptly reduced to writing by the
person lawfully filling the order, and filed by that person, and
(iii) is refilled only if authorized in the original order or
in a subsequent oral order promptly reduced to writing by the
person lawfully filling the order, and filed by that person.
(C) The act of dispensing a drug contrary to the provisions of
this paragraph shall be deemed to be an act which results in the
drug being misbranded while held for sale.
(2) Any drug when dispensed in accordance with paragraph (1) of
this subsection -
(A) shall be exempt from the requirements of section 352 of
this title, except subsections (a), (g), (h), (i)(2), (i)(3), and
(p) of such section, and
(B) shall be exempt from the packaging requirements of
subsections (g), (h), and (p) of such section, if -
(i) when dispensed by a licensed veterinarian, the drug bears
a label containing the name and address of the practitioner and
any directions for use and cautionary statements specified by
the practitioner, or
(ii) when dispensed by filling the lawful order of a licensed
veterinarian, the drug bears a label containing the name and
address of the dispenser, the serial number and date of the
order or of its filling, the name of the licensed veterinarian,
and the directions for use and cautionary statements, if any,
contained in such order.
The preceding sentence shall not apply to any drug dispensed in the
course of the conduct of a business of dispensing drugs pursuant to
diagnosis by mail.
(3) The Secretary may by regulation exempt drugs for animals
other than man subject to section 360b, 360ccc, or 360ccc-1 of this
title from the requirements of paragraph (1) when such requirements
are not necessary for the protection of the public health.
(4) A drug which is subject to paragraph (1) shall be deemed to
be misbranded if at any time prior to dispensing its label fails to
bear the statement "Caution: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.". A drug to which
paragraph (1) does not apply shall be deemed to be misbranded if at
any time prior to dispensing its label bears the statement
specified in the preceding sentence.
(g) Regulation of combination products
(1) The Secretary shall in accordance with this subsection assign
an agency center to regulate products that constitute a combination
of a drug, device, or biological product. The Secretary shall
determine the primary mode of action of the combination product. If
the Secretary determines that the primary mode of action is that of
-
(A) a drug (other than a biological product), the agency center
charged with premarket review of drugs shall have primary
jurisdiction,
(B) a device, the agency center charged with premarket review
of devices shall have primary jurisdiction, or
(C) a biological product, the agency center charged with
premarket review of biological products shall have primary
jurisdiction.
(2) Nothing in this subsection shall prevent the Secretary from
using any agency resources of the Food and Drug Administration
necessary to ensure adequate review of the safety, effectiveness,
or substantial equivalence of an article.
(3) The Secretary shall promulgate regulations to implement
market clearance procedures in accordance with paragraphs (1) and
(2) not later than 1 year after November 28, 1990.
(4)(A) Not later than 60 days after October 26, 2002, the
Secretary shall establish within the Office of the Commissioner of
Food and Drugs an office to ensure the prompt assignment of
combination products to agency centers, the timely and effective
premarket review of such products, and consistent and appropriate
postmarket regulation of like products subject to the same
statutory requirements to the extent permitted by law.
Additionally, the office shall, in determining whether a product is
to be designated a combination product, consult with the component
within the Office of the Commissioner of Food and Drugs that is
responsible for such determinations. Such office (referred to in
this paragraph as the "Office") shall have appropriate scientific
and medical expertise, and shall be headed by a director.
(B) In carrying out this subsection, the Office shall, for each
combination product, promptly assign an agency center with primary
jurisdiction in accordance with paragraph (1) for the premarket
review of such product.
(C)(i) In carrying out this subsection, the Office shall ensure
timely and effective premarket reviews by overseeing the timeliness
of and coordinating reviews involving more than one agency center.
(ii) In order to ensure the timeliness of the premarket review of
a combination product, the agency center with primary jurisdiction
for the product, and the consulting agency center, shall be
responsible to the Office with respect to the timeliness of the
premarket review.
(D) In carrying out this subsection, the Office shall ensure the
consistency and appropriateness of postmarket regulation of like
products subject to the same statutory requirements to the extent
permitted by law.
(E)(i) Any dispute regarding the timeliness of the premarket
review of a combination product may be presented to the Office for
resolution, unless the dispute is clearly premature.
(ii) During the review process, any dispute regarding the
substance of the premarket review may be presented to the
Commissioner of Food and Drugs after first being considered by the
agency center with primary jurisdiction of the premarket review,
under the scientific dispute resolution procedures for such center.
The Commissioner of Food and Drugs shall consult with the Director
of the Office in resolving the substantive dispute.
(F) The Secretary, acting through the Office, shall review each
agreement, guidance, or practice of the Secretary that is specific
to the assignment of combination products to agency centers and
shall determine whether the agreement, guidance, or practice is
consistent with the requirements of this subsection. In carrying
out such review, the Secretary shall consult with stakeholders and
the directors of the agency centers. After such consultation, the
Secretary shall determine whether to continue in effect, modify,
revise, or eliminate such agreement, guidance, or practice, and
shall publish in the Federal Register a notice of the availability
of such modified or revised agreement, guidance or practice.
Nothing in this paragraph shall be construed as preventing the
Secretary from following each agreement, guidance, or practice
until continued, modified, revised, or eliminated.
(G) Not later than one year after October 26, 2002, and annually
thereafter, the Secretary shall report to the appropriate
committees of Congress on the activities and impact of the Office.
The report shall include provisions -
(i) describing the numbers and types of combination products
under review and the timeliness in days of such assignments,
reviews, and dispute resolutions;
(ii) identifying the number of premarket reviews of such
products that involved a consulting agency center; and
(iii) describing improvements in the consistency of postmarket
regulation of combination products.
(H) Nothing in this paragraph shall be construed to limit the
regulatory authority of any agency center.
(5) As used in this subsection:
(A) The term "agency center" means a center or alternative
organizational component of the Food and Drug Administration.
(B) The term "biological product" has the meaning given the
term in section 262(i) of title 42.
(C) The term "market clearance" includes -
(i) approval of an application under section 355, 357,(!1)
360e, or 360j(g) of this title,
(ii) a finding of substantial equivalence under this part,
and
(iii) approval of a biologics license application under
subsection (a) of section 262 of title 42.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,
ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.
104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),
formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
Pub. L. 100-293, Secs. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.
100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.
101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-
108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,
Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Secs.
2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,
Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,
Secs. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,
2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116
Stat. 1611; Pub. L. 108-282, title I, Sec. 102(b)(5)(F), Aug. 2,
2004, 118 Stat. 903.)
-REFTEXT-
REFERENCES IN TEXT
Section 357 of this title, referred to in subsec. (g)(5)(C)(i),
was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
1997, 111 Stat. 2325.
-COD-
CODIFICATION
In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26"
and "section 4761 of title 26" substituted for "section 3220 of the
Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the
Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on
authority of section 7852(b) of Title 26, Internal Revenue Code.
-MISC1-
AMENDMENTS
2004 - Subsec. (f)(1)(A)(ii). Pub. L. 108-282, Sec.
102(b)(5)(F)(i), substituted "360b of this title, a conditionally-
approved application under section 360ccc of this title, or an
index listing under section 360ccc-1 of this title" for "360b of
this title".
Subsec. (f)(3). Pub. L. 108-282, Sec. 102(b)(5)(F)(ii),
substituted "section 360b, 360ccc, or 360ccc-1" for "section 360b".
2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),
substituted "shall in accordance with this subsection assign an
agency center" for "shall designate a component of the Food and
Drug Administration" in first sentence of introductory provisions.
Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),
substituted "the agency center charged" for "the persons charged".
Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).
Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated
par. (4) as (5), added subpar. (A), and redesignated former
subpars. (A) and (B) as (B) and (C), respectively.
1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),
redesignated subpars. (B) and (C) as (A) and (B), respectively, and
struck out former subpar. (A), which read as follows: "is a habit-
forming drug to which section 352(d) of this title applies; or".
Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out
reference to section 352(d) of this title before "355".
Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)
generally. Prior to amendment, par. (4) read as follows: "A drug
which is subject to paragraph (1) of this subsection shall be
deemed to be misbranded if at any time prior to dispensing its
label fails to bear the statement 'Caution: Federal law prohibits
dispensing without prescription'. A drug to which paragraph (1) of
this subsection does not apply shall be deemed to be misbranded if
at any time prior to dispensing its label bears the caution
statement quoted in the preceding sentence."
Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted
"section 262(i) of title 42" for "section 262(a) of title 42".
Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),
substituted "biologics license application under subsection (a)"
for "product or establishment license under subsection (a) or (d)".
1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted ", other than
a veterinary feed directive drug intended for use in animal feed or
an animal feed bearing or containing a veterinary feed directive
drug," after "other than man" in introductory provisions.
1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Except as provided in paragraphs (2) and (3), no representative of
a drug manufacturer or distributor may distribute any drug sample."
Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted
"authorized distributor of record" for "distributor" wherever
appearing.
Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted
"authorized distributor of record" for "distributor" and
"authorized distributors of record" for "distributors" wherever
appearing.
Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)
generally. Prior to amendment, par. (1) read as follows: "Each
person who is engaged in the wholesale distribution of drugs
subject to subsection (b) of this section and who is not an
authorized distributor of record of such drugs shall provide to
each wholesale distributor of such drugs a statement identifying
each sale of the drug (including the date of the sale) before the
sale to such wholesale distributor. Each manufacturer shall
maintain at its corporate offices a current list of such authorized
distributors."
Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily
inserted "or has registered with the Secretary in accordance with
paragraph (3)". See Termination Date of 1992 Amendment note below.
Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily
added par. (3). Former par. (3) redesignated (4). See Termination
Date of 1992 Amendment note below.
Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted "and
subsection (d) of this section" after "For the purposes of this
subsection".
Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.
(3) as (4). See Termination Date of 1992 Amendment note below.
Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the
substitution of "an order" for "and order", could not be executed
because "and order" did not appear in subpar. (B).
Subsec. (g)(3). Pub. L. 102-300 substituted "clearance" for
"approval".
1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated
subsec. (c), relating to veterinary prescription drugs, as (f).
Former subsec. (f) redesignated (g).
Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made
technical amendment to reference to subsection (b) of this section
involving corresponding provision of original act.
Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical
amendment to reference to subsection (c)(1) of this section
involving corresponding provision of original act.
Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
(f), relating to regulation of combination products, as (g).
Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating
to veterinary prescription drugs, as (f).
Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
(f), relating to regulation of combination products, as (g).
1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted "Exemptions
and consideration for certain drugs, devices, and biological
products" for "Exemptions in case of drugs and devices" in section
catchline.
Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).
1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
veterinary prescription drugs.
Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales
restrictions.
Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).
Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).
1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from
packaging requirements of subsec. (p) of section 352 of this title.
1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted "approved"
for "effective".
1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)
generally to protect the public from abuses in the sale of potent
prescription drugs, and to relieve retail pharmacists and the
public from unnecessary restrictions on the dispensation of drugs
that are safe to use without supervision of a doctor.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
TERMINATION DATE OF 1992 AMENDMENT
Section 2(d) of Pub. L. 102-353 provided that: "Effective
September 14, 1994, the amendments made by subsections (a) and (b)
[amending this section] shall no longer be in effect."
EFFECTIVE DATE OF 1988 AMENDMENT
Section 8 of Pub. L. 100-293 provided that:
"(a) General Rule. - Except as provided in subsection (b), this
Act and the amendments made by this Act [amending this section and
sections 331, 333, and 381 of this title and enacting provisions
set out as notes under this section and section 301 of this title]
shall take effect upon the expiration of 90 days after the date of
the enactment of this Act [Apr. 22, 1988].
"(b) Exception. -
"(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take
effect upon the expiration of 180 days after the date of the
enactment of this Act [Apr. 22, 1988].
"(2) The Secretary of Health and Human Services shall by
regulation issue the guidelines required by section 503(e)(2)(B)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
353(e)(2)(B)] (as added by section 6 of this Act) not later than
180 days after the date of the enactment of this Act. Section
503(e)(2)(A) of such Act shall take effect upon the expiration of
2 years after the date such regulations are promulgated and take
effect."
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1951 AMENDMENT
Amendment by act Oct. 26, 1951, effective six months after Oct.
26, 1951, see section 3 of act Oct. 26, 1951, set out as a note
under section 333 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
EFFECTIVE MEDICATION GUIDES
Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.
1593, provided that:
"(a) In General. - Not later than 30 days after the date of
enactment of this Act [Aug. 6, 1996], the Secretary of the
Department of Health and Human Services shall request that national
organizations representing health care professionals, consumer
organizations, voluntary health agencies, the pharmaceutical
industry, drug wholesalers, patient drug information database
companies, and other relevant parties collaborate to develop a long-
range comprehensive action plan to achieve goals consistent with
the goals of the proposed rule of the Food and Drug Administration
on 'Prescription Drug Product Labeling: Medication Guide
Requirements' (60 Fed. Reg. 44182; relating to the provision of
oral and written prescription information to consumers).
"(b) Goals. - Goals consistent with the proposed rule described
in subsection (a) are the distribution of useful written
information to 75 percent of individuals receiving new precriptions
[sic] by the year 2000 and to 95 percent by the year 2006.
"(c) Plan. - The plan described in subsection (a) shall -
"(1) identify the plan goals;
"(2) assess the effectiveness of the current private-sector
approaches used to provide oral and written prescription
information to consumers;
"(3) develop guidelines for providing effective oral and
written prescription information consistent with the findings of
any such assessment;
"(4) contain elements necessary to ensure the transmittal of
useful information to the consuming public, including being
scientifically accurate, non-promotional in tone and content,
sufficiently specific and comprehensive as to adequately inform
consumers about the use of the product, and in an understandable,
legible format that is readily comprehensible and not confusing
to consumers expected to use the product.[;]
"(5) develop a mechanism to assess periodically the quality of
the oral and written prescription information and the frequency
with which the information is provided to consumers; and
"(6) provide for compliance with relevant State board
regulations.
"(d) Limitation on the Authority of the Secretary. - The
Secretary of the Department of Health and Human Services shall have
no authority to implement the proposed rule described in subsection
(a), or to develop any similar regulation, policy statement, or
other guideline specifying a uniform content or format for written
information voluntarily provided to consumers about prescription
drugs if, (1) not later than 120 days after the date of enactment
of this Act [Aug. 6, 1996], the national organizations described in
subsection (a) develop and submit to the Secretary for Health and
Human Services a comprehensive, long-range action plan (as
described in subsection (a)) which shall be acceptable to the
Secretary of Health and Human Services; (2) the aforementioned plan
is submitted to the Secretary of Health and Human Services for
review and acceptance: Provided, That the Secretary shall give due
consideration to the submitted plan and that any such acceptance
shall not be arbitrarily withheld; and (3) the implementation of
(a) a plan accepted by the Secretary commences within 30 days of
the Secretary's acceptance of such plan, or (b) the plan submitted
to the Secretary commences within 60 days of the submission of such
plan if the Secretary fails to take any action on the plan within
30 days of the submission of the plan. The Secretary shall accept,
reject or suggest modifications to the plan submitted within 30
days of its submission. The Secretary may confer with and assist
private parties in the development of the plan described in
subsections (a) and (b).
"(e) Secretary Review. - Not later than January 1, 2001, the
Secretary of the Department of Health and Human Services shall
review the status of private-sector initiatives designed to achieve
the goals of the plan described in subsection (a), and if such
goals are not achieved, the limitation in subsection (d) shall not
apply, and the Secretary shall seek public comment on other
initiatives that may be carried out to meet such goals."
CONGRESSIONAL FINDINGS
Section 2 of Pub. L. 100-293 provided that: "The Congress finds
the following:
"(1) American consumers cannot purchase prescription drugs with
the certainty that the products are safe and effective.
"(2) The integrity of the distribution system for prescription
drugs is insufficient to prevent the introduction and eventual
retail sale of substandard, ineffective, or even counterfeit
drugs.
"(3) The existence and operation of a wholesale submarket,
commonly known as the 'diversion market', prevents effective
control over or even routine knowledge of the true sources of
prescription drugs in a significant number of cases.
"(4) Large amounts of drugs are being reimported to the United
States as American goods returned. These imports are a health and
safety risk to American consumers because they may have become
subpotent or adulterated during foreign handling and shipping.
"(5) The ready market for prescription drug reimports has been
the catalyst for a continuing series of frauds against American
manufacturers and has provided the cover for the importation of
foreign counterfeit drugs.
"(6) The existing system of providing drug samples to
physicians through manufacturer's representatives has been abused
for decades and has resulted in the sale to consumers of
misbranded, expired, and adulterated pharmaceuticals.
"(7) The bulk resale of below wholesale priced prescription
drugs by health care entities, for ultimate sale at retail, helps
fuel the diversion market and is an unfair form of competition to
wholesalers and retailers that must pay otherwise prevailing
market prices.
"(8) The effect of these several practices and conditions is to
create an unacceptable risk that counterfeit, adulterated,
misbranded, subpotent, or expired drugs will be sold to American
consumers."
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 353a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 353a. Pharmacy compounding
-STATUTE-
(a) In general
Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not
apply to a drug product if the drug product is compounded for an
identified individual patient based on the unsolicited receipt of a
valid prescription order or a notation, approved by the prescribing
practitioner, on the prescription order that a compounded product
is necessary for the identified patient, if the drug product meets
the requirements of this section, and if the compounding -
(1) is by -
(A) a licensed pharmacist in a State licensed pharmacy or a
Federal facility, or
(B) a licensed physician,
on the prescription order for such individual patient made by a
licensed physician or other licensed practitioner authorized by
State law to prescribe drugs; or
(2)(A) is by a licensed pharmacist or licensed physician in
limited quantities before the receipt of a valid prescription
order for such individual patient; and
(B) is based on a history of the licensed pharmacist or
licensed physician receiving valid prescription orders for the
compounding of the drug product, which orders have been generated
solely within an established relationship between -
(i) the licensed pharmacist or licensed physician; and
(ii)(I) such individual patient for whom the prescription
order will be provided; or
(II) the physician or other licensed practitioner who will
write such prescription order.
(b) Compounded drug
(1) Licensed pharmacist and licensed physician
A drug product may be compounded under subsection (a) of this
section if the licensed pharmacist or licensed physician -
(A) compounds the drug product using bulk drug substances, as
defined in regulations of the Secretary published at section
207.3(a)(4) of title 21 of the Code of Federal Regulations -
(i) that -
(I) comply with the standards of an applicable United
States Pharmacopoeia or National Formulary monograph, if a
monograph exists, and the United States Pharmacopoeia
chapter on pharmacy compounding;
(II) if such a monograph does not exist, are drug
substances that are components of drugs approved by the
Secretary; or
(III) if such a monograph does not exist and the drug
substance is not a component of a drug approved by the
Secretary, that appear on a list developed by the Secretary
through regulations issued by the Secretary under
subsection (d) of this section;
(ii) that are manufactured by an establishment that is
registered under section 360 of this title (including a
foreign establishment that is registered under section 360(i)
of this title); and
(iii) that are accompanied by valid certificates of
analysis for each bulk drug substance;
(B) compounds the drug product using ingredients (other than
bulk drug substances) that comply with the standards of an
applicable United States Pharmacopoeia or National Formulary
monograph, if a monograph exists, and the United States
Pharmacopoeia chapter on pharmacy compounding;
(C) does not compound a drug product that appears on a list
published by the Secretary in the Federal Register of drug
products that have been withdrawn or removed from the market
because such drug products or components of such drug products
have been found to be unsafe or not effective; and
(D) does not compound regularly or in inordinate amounts (as
defined by the Secretary) any drug products that are
essentially copies of a commercially available drug product.
(2) Definition
For purposes of paragraph (1)(D), the term "essentially a copy
of a commercially available drug product" does not include a drug
product in which there is a change, made for an identified
individual patient, which produces for that patient a significant
difference, as determined by the prescribing practitioner,
between the compounded drug and the comparable commercially
available drug product.
(3) Drug product
A drug product may be compounded under subsection (a) only if -
(A) such drug product is not a drug product identified by the
Secretary by regulation as a drug product that presents
demonstrable difficulties for compounding that reasonably
demonstrate an adverse effect on the safety or effectiveness of
that drug product; and
(B) such drug product is compounded in a State -
(i) that has entered into a memorandum of understanding
with the Secretary which addresses the distribution of
inordinate amounts of compounded drug products interstate and
provides for appropriate investigation by a State agency of
complaints relating to compounded drug products distributed
outside such State; or
(ii) that has not entered into the memorandum of
understanding described in clause (i) and the licensed
pharmacist, licensed pharmacy, or licensed physician
distributes (or causes to be distributed) compounded drug
products out of the State in which they are compounded in
quantities that do not exceed 5 percent of the total
prescription orders dispensed or distributed by such pharmacy
or physician.
The Secretary shall, in consultation with the National
Association of Boards of Pharmacy, develop a standard memorandum
of understanding for use by the States in complying with
subparagraph (B)(i).
(c) Advertising and promotion
A drug may be compounded under subsection (a) of this section
only if the pharmacy, licensed pharmacist, or licensed physician
does not advertise or promote the compounding of any particular
drug, class of drug, or type of drug. The pharmacy, licensed
pharmacist, or licensed physician may advertise and promote the
compounding service provided by the licensed pharmacist or licensed
physician.
(d) Regulations
(1) In general
The Secretary shall issue regulations to implement this
section. Before issuing regulations to implement subsections
(b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) of this section, the
Secretary shall convene and consult an advisory committee on
compounding unless the Secretary determines that the issuance of
such regulations before consultation is necessary to protect the
public health. The advisory committee shall include
representatives from the National Association of Boards of
Pharmacy, the United States Pharmacopoeia, pharmacy, physician,
and consumer organizations, and other experts selected by the
Secretary.
(2) Limiting compounding
The Secretary, in consultation with the United States
Pharmacopoeia Convention, Incorporated, shall promulgate
regulations identifying drug substances that may be used in
compounding under subsection (b)(1)(A)(i)(III) of this section
for which a monograph does not exist or which are not components
of drug products approved by the Secretary. The Secretary shall
include in the regulation the criteria for such substances, which
shall include historical use, reports in peer reviewed medical
literature, or other criteria the Secretary may identify.
(e) Application
This section shall not apply to -
(1) compounded positron emission tomography drugs as defined in
section 321(ii) of this title; or
(2) radiopharmaceuticals.
(f) "Compounding" defined
As used in this section, the term "compounding" does not include
mixing, reconstituting, or other such acts that are performed in
accordance with directions contained in approved labeling provided
by the product's manufacturer and other manufacturer directions
consistent with that labeling.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 503A, as added Pub. L. 105-115, title
I, Sec. 127(a), Nov. 21, 1997, 111 Stat. 2328.)
-MISC1-
EFFECTIVE DATE
Section 127(b) of Pub. L. 105-115 provided that: "Section 503A of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by
subsection (a), shall take effect upon the expiration of the 1-year
period beginning on the date of the enactment of this Act [Nov. 21,
1997]."
-End-
-CITE-
21 USC Sec. 354 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 354. Veterinary feed directive drugs
-STATUTE-
(a) Lawful veterinary feed directive requirement
(1) A drug intended for use in or on animal feed which is limited
by an approved application filed pursuant to section 360b(b) of
this title, a conditionally-approved application filed pursuant to
section 360ccc of this title, or an index listing pursuant to
section 360ccc-1 of this title to use under the professional
supervision of a licensed veterinarian is a veterinary feed
directive drug. Any animal feed bearing or containing a veterinary
feed directive drug shall be fed to animals only by or upon a
lawful veterinary feed directive issued by a licensed veterinarian
in the course of the veterinarian's professional practice. When
labeled, distributed, held, and used in accordance with this
section, a veterinary feed directive drug and any animal feed
bearing or containing a veterinary feed directive drug shall be
exempt from section 352(f) of this title.
(2) A veterinary feed directive is lawful if it -
(A) contains such information as the Secretary may by general
regulation or by order require; and
(B) is in compliance with the conditions and indications for
use of the drug set forth in the notice published pursuant to
section 360b(i) of this title, or the index listing pursuant to
section 360ccc-1(e) of this title.
(3)(A) Any persons involved in the distribution or use of animal
feed bearing or containing a veterinary feed directive drug and the
licensed veterinarian issuing the veterinary feed directive shall
maintain a copy of the veterinary feed directive applicable to each
such feed, except in the case of a person distributing such feed to
another person for further distribution. Such person distributing
the feed shall maintain a written acknowledgment from the person to
whom the feed is shipped stating that that person shall not ship or
move such feed to an animal production facility without a
veterinary feed directive or ship such feed to another person for
further distribution unless that person has provided the same
written acknowledgment to its immediate supplier.
(B) Every person required under subparagraph (A) to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
(C) Any person who distributes animal feed bearing or containing
a veterinary feed directive drug shall upon first engaging in such
distribution notify the Secretary of that person's name and place
of business. The failure to provide such notification shall be
deemed to be an act which results in the drug being misbranded.
(b) Labeling and advertising
A veterinary feed directive drug and any feed bearing or
containing a veterinary feed directive drug shall be deemed to be
misbranded if their labeling fails to bear such cautionary
statement and such other information as the Secretary may by
general regulation or by order prescribe, or their advertising
fails to conform to the conditions and indications for use
published pursuant to section 360b(i) of this title, or the index
listing pursuant to section 360ccc-1(e) of this title or fails to
contain the general cautionary statement prescribed by the
Secretary.
(c) Nonprescription status
Neither a drug subject to this section, nor animal feed bearing
or containing such a drug, shall be deemed to be a prescription
article under any Federal or State law.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 504, as added Pub. L. 104-250, Sec.
5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108-282, title
I, Sec. 102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)
-MISC1-
PRIOR PROVISIONS
A prior section 354, act June 25, 1938, ch. 675, Sec. 504, 52
Stat. 1052, which directed Secretary to promulgate regulations for
listing of coal-tar colors, was repealed effective July 12, 1960,
subject to provisions of section 203 of Pub. L. 86-618, by Pub. L.
86-618, title I, Sec. 103(a)(2), title II, Sec. 202, July 12, 1960,
74 Stat. 398, 404.
AMENDMENTS
2004 - Subsec. (a)(1). Pub. L. 108-282, Sec. 102(b)(5)(G),
substituted "360b(b) of this title, a conditionally-approved
application filed pursuant to section 360ccc of this title, or an
index listing pursuant to section 360ccc-1 of this title" for
"360b(b) of this title".
Subsecs. (a)(2)(B), (b). Pub. L. 108-282, Sec. 102(b)(5)(H),
substituted "360b(i) of this title, or the index listing pursuant
to section 360ccc-1(e) of this title" for "360b(i) of this title".
-End-
-CITE-
21 USC Sec. 355 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 355. New drugs
-STATUTE-
(a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of an
application filed pursuant to subsection (b) or (j) of this section
is effective with respect to such drug.
(b) Filing application; contents
(1) Any person may file with the Secretary an application with
respect to any drug subject to the provisions of subsection (a) of
this section. Such person shall submit to the Secretary as a part
of the application (A) full reports of investigations which have
been made to show whether or not such drug is safe for use and
whether such drug is effective in use; (B) a full list of the
articles used as components of such drug; (C) a full statement of
the composition of such drug; (D) a full description of the methods
used in, and the facilities and controls used for, the manufacture,
processing, and packing of such drug; (E) such samples of such drug
and of the articles used as components thereof as the Secretary may
require; (F) specimens of the labeling proposed to be used for such
drug, and (G) any assessments required under section 355c of this
title. The applicant shall file with the application the patent
number and the expiration date of any patent which claims the drug
for which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person not
licensed by the owner engaged in the manufacture, use, or sale of
the drug. If an application is filed under this subsection for a
drug and a patent which claims such drug or a method of using such
drug is issued after the filing date but before approval of the
application, the applicant shall amend the application to include
the information required by the preceding sentence. Upon approval
of the application, the Secretary shall publish information
submitted under the two preceding sentences. The Secretary shall,
in consultation with the Director of the National Institutes of
Health and with representatives of the drug manufacturing industry,
review and develop guidance, as appropriate, on the inclusion of
women and minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug for
which the investigations described in clause (A) of such paragraph
and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted shall also
include -
(A) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims
the drug for which such investigations were conducted or which
claims a use for such drug for which the applicant is seeking
approval under this subsection and for which information is
required to be filed under paragraph (1) or subsection (c) of
this section -
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted; and
(B) if with respect to the drug for which investigations
described in paragraph (1)(A) were conducted information was
filed under paragraph (1) or subsection (c) of this section for a
method of use patent which does not claim a use for which the
applicant is seeking approval under this subsection, a statement
that the method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed. -
(A) Agreement to give notice. - An applicant that makes a
certification described in paragraph (2)(A)(iv) shall include in
the application a statement that the applicant will give notice
as required by this paragraph.
(B) Timing of notice. - An applicant that makes a certification
described in paragraph (2)(A)(iv) shall give notice as required
under this paragraph -
(i) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice with
which the Secretary informs the applicant that the application
has been filed; or
(ii) if the certification is in an amendment or supplement to
the application, at the time at which the applicant submits the
amendment or supplement, regardless of whether the applicant
has already given notice with respect to another such
certification contained in the application or in an amendment
or supplement to the application.
(C) Recipients of notice. - An applicant required under this
paragraph to give notice shall give notice to -
(i) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application under this
subsection for the drug that is claimed by the patent or a use
of which is claimed by the patent (or a representative of the
holder designated to receive such a notice).
(D) Contents of notice. - A notice required under this
paragraph shall -
(i) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification; and
(ii) include a detailed statement of the factual and legal
basis of the opinion of the applicant that the patent is
invalid or will not be infringed.
(4)(A) An applicant may not amend or supplement an application
referred to in paragraph (2) to seek approval of a drug that is a
different drug than the drug identified in the application as
submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3) of this
section prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1) or under section
262 of title 42, which shall relate to promptness in conducting the
review, technical excellence, lack of bias and conflict of
interest, and knowledge of regulatory and scientific standards, and
which shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection or
section 262 of title 42 if the sponsor or applicant makes a
reasonable written request for a meeting for the purpose of
reaching agreement on the design and size of clinical trials
intended to form the primary basis of an effectiveness claim. The
sponsor or applicant shall provide information necessary for
discussion and agreement on the design and size of the clinical
trials. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant upon
request.
(C) Any agreement regarding the parameters of the design and size
of clinical trials of a new drug under this paragraph that is
reached between the Secretary and a sponsor or applicant shall be
reduced to writing and made part of the administrative record by
the Secretary. Such agreement shall not be changed after the
testing begins, except -
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that
a substantial scientific issue essential to determining the
safety or effectiveness of the drug has been identified after the
testing has begun.
(D) A decision under subparagraph (C)(ii) by the director shall
be in writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director and
the sponsor or applicant will be present and at which the director
will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing division
why such decision should be modified.
(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary
to assure the marketing of a safe and effective drug.
(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval
of a drug under this subsection or section 262 of title 42
(including all scientific and medical matters, chemistry,
manufacturing, and controls).
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
(1) Within one hundred and eighty days after the filing of an
application under subsection (b) of this section, or such
additional period as may be agreed upon by the Secretary and the
applicant, the Secretary shall either -
(A) approve the application if he then finds that none of the
grounds for denying approval specified in subsection (d) of this
section applies, or
(B) give the applicant notice of an opportunity for a hearing
before the Secretary under subsection (d) of this section on the
question whether such application is approvable. If the applicant
elects to accept the opportunity for hearing by written request
within thirty days after such notice, such hearing shall commence
not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited basis
and the Secretary's order thereon shall be issued within ninety
days after the date fixed by the Secretary for filing final
briefs.
(2) If the patent information described in subsection (b) of this
section could not be filed with the submission of an application
under subsection (b) of this section because the application was
filed before the patent information was required under subsection
(b) of this section or a patent was issued after the application
was approved under such subsection, the holder of an approved
application shall file with the Secretary the patent number and the
expiration date of any patent which claims the drug for which the
application was submitted or which claims a method of using such
drug and with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug. If the holder
of an approved application could not file patent information under
subsection (b) of this section because it was not required at the
time the application was approved, the holder shall file such
information under this subsection not later than thirty days after
September 24, 1984, and if the holder of an approved application
could not file patent information under subsection (b) of this
section because no patent had been issued when an application was
filed or approved, the holder shall file such information under
this subsection not later than thirty days after the date the
patent involved is issued. Upon the submission of patent
information under this subsection, the Secretary shall publish it.
(3) The approval of an application filed under subsection (b) of
this section which contains a certification required by paragraph
(2) of such subsection shall be made effective on the last
applicable date determined by applying the following to each
certification made under subsection (b)(2)(A) of this section:
(A) If the applicant only made a certification described in
clause (i) or (ii) of subsection (b)(2)(A) of this section or in
both such clauses, the approval may be made effective
immediately.
(B) If the applicant made a certification described in clause
(iii) of subsection (b)(2)(A) of this section, the approval may
be made effective on the date certified under clause (iii).
(C) If the applicant made a certification described in clause
(iv) of subsection (b)(2)(A) of this section, the approval shall
be made effective immediately unless, before the expiration of 45
days after the date on which the notice described in subsection
(b)(3) of this section is received, an action is brought for
infringement of the patent that is the subject of the
certification and for which information was submitted to the
Secretary under paragraph (2) or subsection (b)(1) of this
section before the date on which the application (excluding an
amendment or supplement to the application) was submitted. If
such an action is brought before the expiration of such days, the
approval may be made effective upon the expiration of the thirty-
month period beginning on the date of the receipt of the notice
provided under subsection (b)(3) of this section or such shorter
or longer period as the court may order because either party to
the action failed to reasonably cooperate in expediting the
action, except that -
(i) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no cause
of action for patent infringement or invalidity), the approval
shall be made effective on -
(I) the date on which the court enters judgment reflecting
the decision; or
(II) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;
(ii) if before the expiration of such period the district
court decides that the patent has been infringed -
(I) if the judgment of the district court is appealed, the
approval shall be made effective on -
(aa) the date on which the court of appeals decides that
the patent is invalid or not infringed (including any
substantive determination that there is no cause of action
for patent infringement or invalidity); or
(bb) the date of a settlement order or consent decree
signed and entered by the court of appeals stating that the
patent that is the subject of the certification is invalid
or not infringed; or
(II) if the judgment of the district court is not appealed
or is affirmed, the approval shall be made effective on the
date specified by the district court in a court order under
section 271(e)(4)(A) of title 35;
(iii) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug
until the court decides the issues of patent validity and
infringement and if the court decides that such patent is
invalid or not infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period the court grants
a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug
until the court decides the issues of patent validity and
infringement and if the court decides that such patent has been
infringed, the approval shall be made effective as provided in
clause (ii).
In such an action, each of the parties shall reasonably cooperate
in expediting the action.
(D) Civil action to obtain patent certainty. -
(i) Declaratory judgment absent infringement action. -
(I) In general. - No action may be brought under section
2201 of title 28 by an applicant referred to in subsection
(b)(2) of this section for a declaratory judgment with
respect to a patent which is the subject of the certification
referred to in subparagraph (C) unless -
(aa) the 45-day period referred to in such subparagraph
has expired;
(bb) neither the owner of such patent nor the holder of
the approved application under subsection (b) of this
section for the drug that is claimed by the patent or a use
of which is claimed by the patent brought a civil action
against the applicant for infringement of the patent before
the expiration of such period; and
(cc) in any case in which the notice provided under
paragraph (2)(B) relates to noninfringement, the notice was
accompanied by a document described in subclause (III).
(II) Filing of civil action. - If the conditions described
in items (aa), (bb), and as applicable, (cc) of subclause (I)
have been met, the applicant referred to in such subclause
may, in accordance with section 2201 of title 28, bring a
civil action under such section against the owner or holder
referred to in such subclause (but not against any owner or
holder that has brought such a civil action against the
applicant, unless that civil action was dismissed without
prejudice) for a declaratory judgment that the patent is
invalid or will not be infringed by the drug for which the
applicant seeks approval, except that such civil action may
be brought for a declaratory judgment that the patent will
not be infringed only in a case in which the condition
described in subclause (I)(cc) is applicable. A civil action
referred to in this subclause shall be brought in the
judicial district where the defendant has its principal place
of business or a regular and established place of business.
(III) Offer of confidential access to application. - For
purposes of subclause (I)(cc), the document described in this
subclause is a document providing an offer of confidential
access to the application that is in the custody of the
applicant referred to in subsection (b)(2) of this section
for the purpose of determining whether an action referred to
in subparagraph (C) should be brought. The document providing
the offer of confidential access shall contain such
restrictions as to persons entitled to access, and on the use
and disposition of any information accessed, as would apply
had a protective order been entered for the purpose of
protecting trade secrets and other confidential business
information. A request for access to an application under an
offer of confidential access shall be considered acceptance
of the offer of confidential access with the restrictions as
to persons entitled to access, and on the use and disposition
of any information accessed, contained in the offer of
confidential access, and those restrictions and other terms
of the offer of confidential access shall be considered terms
of an enforceable contract. Any person provided an offer of
confidential access shall review the application for the sole
and limited purpose of evaluating possible infringement of
the patent that is the subject of the certification under
subsection (b)(2)(A)(iv) of this section and for no other
purpose, and may not disclose information of no relevance to
any issue of patent infringement to any person other than a
person provided an offer of confidential access. Further, the
application may be redacted by the applicant to remove any
information of no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action. -
(I) In general. - If an owner of the patent or the holder
of the approved application under subsection (b) of this
section for the drug that is claimed by the patent or a use
of which is claimed by the patent brings a patent
infringement action against the applicant, the applicant may
assert a counterclaim seeking an order requiring the holder
to correct or delete the patent information submitted by the
holder under subsection (b) of this section or this
subsection on the ground that the patent does not claim
either -
(aa) the drug for which the application was approved; or
(bb) an approved method of using the drug.
(II) No independent cause of action. - Subclause (I) does
not authorize the assertion of a claim described in subclause
(I) in any civil action or proceeding other than a
counterclaim described in subclause (I).
(iii) No damages. - An applicant shall not be entitled to
damages in a civil action under clause (i) or a counterclaim
under clause (ii).
(E)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b) of this section, was approved
during the period beginning January 1, 1982, and ending on
September 24, 1984, the Secretary may not make the approval of
another application for a drug for which the investigations
described in clause (A) of subsection (b)(1) of this section and
relied upon by the applicant for approval of the application were
not conducted by or for the applicant and for which the applicant
has not obtained a right of reference or use from the person by
or for whom the investigations were conducted effective before
the expiration of ten years from the date of the approval of the
application previously approved under subsection (b) of this
section.
(ii) If an application submitted under subsection (b) of this
section for a drug, no active ingredient (including any ester or
salt of the active ingredient) of which has been approved in any
other application under subsection (b) of this section, is
approved after September 24, 1984, no application which refers to
the drug for which the subsection (b) application was submitted
and for which the investigations described in clause (A) of
subsection (b)(1) of this section and relied upon by the
applicant for approval of the application were not conducted by
or for the applicant and for which the applicant has not obtained
a right of reference or use from the person by or for whom the
investigations were conducted may be submitted under subsection
(b) of this section before the expiration of five years from the
date of the approval of the application under subsection (b) of
this section, except that such an application may be submitted
under subsection (b) of this section after the expiration of four
years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity
or noninfringement described in clause (iv) of subsection
(b)(2)(A) of this section. The approval of such an application
shall be made effective in accordance with this paragraph except
that, if an action for patent infringement is commenced during
the one-year period beginning forty-eight months after the date
of the approval of the subsection (b) application, the thirty-
month period referred to in subparagraph (C) shall be extended
by such amount of time (if any) which is required for seven and
one-half years to have elapsed from the date of approval of the
subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient) that has
been approved in another application approved under subsection
(b) of this section, is approved after September 24, 1984, and if
such application contains reports of new clinical investigations
(other than bioavailability studies) essential to the approval of
the application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under subsection (b) of this section for the conditions of
approval of such drug in the approved subsection (b) application
effective before the expiration of three years from the date of
the approval of the application under subsection (b) of this
section if the investigations described in clause (A) of
subsection (b)(1) of this section and relied upon by the
applicant for approval of the application were not conducted by
or for the applicant and if the applicant has not obtained a
right of reference or use from the person by or for whom the
investigations were conducted.
(iv) If a supplement to an application approved under
subsection (b) of this section is approved after September 24,
1984, and the supplement contains reports of new clinical
investigations (other than bioavailabilty (!1) studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not make
the approval of an application submitted under subsection (b) of
this section for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b) of this section
if the investigations described in clause (A) of subsection
(b)(1) of this section and relied upon by the applicant for
approval of the application were not conducted by or for the
applicant and if the applicant has not obtained a right of
reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an application)
submitted under subsection (b) of this section for a drug, which
includes an active ingredient (including any ester or salt of the
active ingredient) that has been approved in another application
under subsection (b) of this section, was approved during the
period beginning January 1, 1982, and ending on September 24,
1984, the Secretary may not make the approval of an application
submitted under this subsection and for which the investigations
described in clause (A) of subsection (b)(1) of this section and
relied upon by the applicant for approval of the application were
not conducted by or for the applicant and for which the applicant
has not obtained a right of reference or use from the person by
or for whom the investigations were conducted and which refers to
the drug for which the subsection (b) application was submitted
effective before the expiration of two years from September 24,
1984.
(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a
full scale production facility is necessary to ensure the safety or
effectiveness of the drug.
(d) Grounds for refusing application; approval of application;
"substantial evidence" defined
If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that
(1) the investigations, reports of which are required to be
submitted to the Secretary pursuant to subsection (b) of this
section, do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof; (2) the results of such tests show that
such drug is unsafe for use under such conditions or do not show
that such drug is safe for use under such conditions; (3) the
methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to
preserve its identity, strength, quality, and purity; (4) upon the
basis of the information submitted to him as part of the
application, or upon the basis of any other information before him
with respect to such drug, he has insufficient information to
determine whether such drug is safe for use under such conditions;
or (5) evaluated on the basis of the information submitted to him
as part of the application and any other information before him
with respect to such drug, there is a lack of substantial evidence
that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof; or (6) the application
failed to contain the patent information prescribed by subsection
(b) of this section; or (7) based on a fair evaluation of all
material facts, such labeling is false or misleading in any
particular; he shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing, the
Secretary finds that clauses (1) through (6) do not apply, he shall
issue an order approving the application. As used in this
subsection and subsection (e) of this section, the term
"substantial evidence" means evidence consisting of adequate and
well-controlled investigations, including clinical investigations,
by experts qualified by scientific training and experience to
evaluate the effectiveness of the drug involved, on the basis of
which it could fairly and responsibly be concluded by such experts
that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from one
adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to public health
The Secretary shall, after due notice and opportunity for hearing
to the applicant, withdraw approval of an application with respect
to any drug under this section if the Secretary finds (1) that
clinical or other experience, tests, or other scientific data show
that such drug is unsafe for use under the conditions of use upon
the basis of which the application was approved; (2) that new
evidence of clinical experience, not contained in such application
or not available to the Secretary until after such application was
approved, or tests by new methods, or tests by methods not deemed
reasonably applicable when such application was approved, evaluated
together with the evidence available to the Secretary when the
application was approved, shows that such drug is not shown to be
safe for use under the conditions of use upon the basis of which
the application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the application
was approved, that there is a lack of substantial evidence that the
drug will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or suggested
in the labeling thereof; or (4) the patent information prescribed
by subsection (c) of this section was not filed within thirty days
after the receipt of written notice from the Secretary specifying
the failure to file such information; or (5) that the application
contains any untrue statement of a material fact: Provided, That if
the Secretary (or in his absence the officer acting as Secretary)
finds that there is an imminent hazard to the public health, he may
suspend the approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the
authority conferred by this proviso to suspend the approval of an
application shall not be delegated. The Secretary may also, after
due notice and opportunity for hearing to the applicant, withdraw
the approval of an application submitted under subsection (b) or
(j) of this section with respect to any drug under this section if
the Secretary finds (1) that the applicant has failed to establish
a system for maintaining required records, or has repeatedly or
deliberately failed to maintain such records or to make required
reports, in accordance with a regulation or order under subsection
(k) of this section or to comply with the notice requirements of
section 360(k)(2) of this title, or the applicant has refused to
permit access to, or copying or verification of, such records as
required by paragraph (2) of such subsection; or (2) that on the
basis of new information before him, evaluated together with the
evidence before him when the application was approved, the methods
used in, or the facilities and controls used for, the manufacture,
processing, and packing of such drug are inadequate to assure and
preserve its identity, strength, quality, and purity and were not
made adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of; or
(3) that on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, the labeling of such drug, based on a fair evaluation of
all material facts, is false or misleading in any particular and
was not corrected within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of. Any
order under this subsection shall state the findings upon which it
is based.
(f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d) or (e) of this
section refusing, withdrawing, or suspending approval of an
application and shall approve such application or reinstate such
approval, as may be appropriate.
(g) Service of orders
Orders of the Secretary issued under this section shall be served
(1) in person by any officer or employee of the department
designated by the Secretary or (2) by mailing the order by
registered mail or by certified mail addressed to the applicant or
respondent at his last-known address in the records of the
Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application under
this section. Such appeal shall be taken by filing in the United
States court of appeals for the circuit wherein such applicant
resides or has his principal place of business, or in the United
States Court of Appeals for the District of Columbia Circuit,
within sixty days after the entry of such order, a written petition
praying that the order of the Secretary be set aside. A copy of
such petition shall be forthwith transmitted by the clerk of the
court to the Secretary, or any officer designated by him for that
purpose, and thereupon the Secretary shall certify and file in the
court the record upon which the order complained of was entered, as
provided in section 2112 of title 28. Upon the filing of such
petition such court shall have exclusive jurisdiction to affirm or
set aside such order, except that until the filing of the record
the Secretary may modify or set aside his order. No objection to
the order of the Secretary shall be considered by the court unless
such objection shall have been urged before the Secretary or unless
there were reasonable grounds for failure so to do. The finding of
the Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show to
the satisfaction of the court that such additional evidence is
material and that there were reasonable grounds for failure to
adduce such evidence in the proceeding before the Secretary, the
court may order such additional evidence to be taken before the
Secretary and to be adduced upon the hearing in such manner and
upon such terms and conditions as to the court may seem proper. The
Secretary may modify his findings as to the facts by reason of the
additional evidence so taken, and he shall file with the court such
modified findings which, if supported by substantial evidence,
shall be conclusive, and his recommendation, if any, for the
setting aside of the original order. The judgment of the court
affirming or setting aside any such order of the Secretary shall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification as provided in section 1254 of
title 28. The commencement of proceedings under this subsection
shall not, unless specifically ordered by the court to the
contrary, operate as a stay of the Secretary's order.
(i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary
(1) The Secretary shall promulgate regulations for exempting from
the operation of the foregoing subsections of this section drugs
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs. Such regulations may, within the discretion
of the Secretary, among other conditions relating to the protection
of the public health, provide for conditioning such exemption upon -
(A) the submission to the Secretary, before any clinical
testing of a new drug is undertaken, of reports, by the
manufacturer or the sponsor of the investigation of such drug, of
preclinical tests (including tests on animals) of such drug
adequate to justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the investigation of a
new drug proposed to be distributed to investigators for clinical
testing obtaining a signed agreement from each of such
investigators that patients to whom the drug is administered will
be under his personal supervision, or under the supervision of
investigators responsible to him, and that he will not supply
such drug to any other investigator, or to clinics, for
administration to human beings;
(C) the establishment and maintenance of such records, and the
making of such reports to the Secretary, by the manufacturer or
the sponsor of the investigation of such drug, of data (including
but not limited to analytical reports by investigators) obtained
as the result of such investigational use of such drug, as the
Secretary finds will enable him to evaluate the safety and
effectiveness of such drug in the event of the filing of an
application pursuant to subsection (b) of this section; and
(D) the submission to the Secretary by the manufacturer or the
sponsor of the investigation of a new drug of a statement of
intent regarding whether the manufacturer or sponsor has plans
for assessing pediatric safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a new
drug may begin 30 days after the Secretary has received from the
manufacturer or sponsor of the investigation a submission
containing such information about the drug and the clinical
investigation, including -
(A) information on design of the investigation and adequate
reports of basic information, certified by the applicant to be
accurate reports, necessary to assess the safety of the drug for
use in clinical investigation; and
(B) adequate information on the chemistry and manufacturing of
the drug, controls available for the drug, and primary data
tabulations from animal or human studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in
this paragraph as a "clinical hold") if the Secretary makes a
determination described in subparagraph (B). The Secretary shall
specify the basis for the clinical hold, including the specific
information available to the Secretary which served as the basis
for such clinical hold, and confirm such determination in writing.
(B) For purposes of subparagraph (A), a determination described
in this subparagraph with respect to a clinical hold is that -
(i) the drug involved represents an unreasonable risk to the
safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the
clinical investigators, information about the drug, the design of
the clinical investigation, the condition for which the drug is
to be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such other reasons
as the Secretary may by regulation establish (including reasons
established by regulation before November 21, 1997).
(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a
decision, in writing and specifying the reasons therefor, within 30
days after receipt of such request. Any such request shall include
sufficient information to support the removal of such clinical
hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer or
sponsor that they will inform any human beings to whom such drugs,
or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are being
used for investigational purposes and will obtain the consent of
such human beings or their representatives, except where it is not
feasible or it is contrary to the best interests of such human
beings. Nothing in this subsection shall be construed to require
any clinical investigator to submit directly to the Secretary
reports on the investigational use of drugs.
(j) Abbreviated new drug applications
(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall contain -
(i) information to show that the conditions of use prescribed,
recommended, or suggested in the labeling proposed for the new
drug have been previously approved for a drug listed under
paragraph (7) (hereinafter in this subsection referred to as a
"listed drug");
(ii)(I) if the listed drug referred to in clause (i) has only
one active ingredient, information to show that the active
ingredient of the new drug is the same as that of the listed
drug;
(II) if the listed drug referred to in clause (i) has more than
one active ingredient, information to show that the active
ingredients of the new drug are the same as those of the listed
drug, or
(III) if the listed drug referred to in clause (i) has more
than one active ingredient and if one of the active ingredients
of the new drug is different and the application is filed
pursuant to the approval of a petition filed under subparagraph
(C), information to show that the other active ingredients of the
new drug are the same as the active ingredients of the listed
drug, information to show that the different active ingredient is
an active ingredient of a listed drug or of a drug which does not
meet the requirements of section 321(p) of this title, and such
other information respecting the different active ingredient with
respect to which the petition was filed as the Secretary may
require;
(iii) information to show that the route of administration, the
dosage form, and the strength of the new drug are the same as
those of the listed drug referred to in clause (i) or, if the
route of administration, the dosage form, or the strength of the
new drug is different and the application is filed pursuant to
the approval of a petition filed under subparagraph (C), such
information respecting the route of administration, dosage form,
or strength with respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is bioequivalent to
the listed drug referred to in clause (i), except that if the
application is filed pursuant to the approval of a petition filed
under subparagraph (C), information to show that the active
ingredients of the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred to in
clause (i) and the new drug can be expected to have the same
therapeutic effect as the listed drug when administered to
patients for a condition of use referred to in clause (i);
(v) information to show that the labeling proposed for the new
drug is the same as the labeling approved for the listed drug
referred to in clause (i) except for changes required because of
differences approved under a petition filed under subparagraph
(C) or because the new drug and the listed drug are produced or
distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F) of
subsection (b)(1) of this section;
(vii) a certification, in the opinion of the applicant and to
the best of his knowledge, with respect to each patent which
claims the listed drug referred to in clause (i) or which claims
a use for such listed drug for which the applicant is seeking
approval under this subsection and for which information is
required to be filed under subsection (b) or (c) of this section -
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted; and
(viii) if with respect to the listed drug referred to in clause
(i) information was filed under subsection (b) or (c) of this
section for a method of use patent which does not claim a use for
which the applicant is seeking approval under this subsection, a
statement that the method of use patent does not claim such a
use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed. -
(i) Agreement to give notice. - An applicant that makes a
certification described in subparagraph (A)(vii)(IV) shall
include in the application a statement that the applicant will
give notice as required by this subparagraph.
(ii) Timing of notice. - An applicant that makes a
certification described in subparagraph (A)(vii)(IV) shall give
notice as required under this subparagraph -
(I) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice with
which the Secretary informs the applicant that the application
has been filed; or
(II) if the certification is in an amendment or supplement to
the application, at the time at which the applicant submits the
amendment or supplement, regardless of whether the applicant
has already given notice with respect to another such
certification contained in the application or in an amendment
or supplement to the application.
(iii) Recipients of notice. - An applicant required under this
subparagraph to give notice shall give notice to -
(I) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application under subsection
(b) of this section for the drug that is claimed by the patent
or a use of which is claimed by the patent (or a representative
of the holder designated to receive such a notice).
(iv) Contents of notice. - A notice required under this
subparagraph shall -
(I) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification; and
(II) include a detailed statement of the factual and legal
basis of the opinion of the applicant that the patent is
invalid or will not be infringed.
(C) If a person wants to submit an abbreviated application for a
new drug which has a different active ingredient or whose route of
administration, dosage form, or strength differ from that of a
listed drug, such person shall submit a petition to the Secretary
seeking permission to file such an application. The Secretary shall
approve or disapprove a petition submitted under this subparagraph
within ninety days of the date the petition is submitted. The
Secretary shall approve such a petition unless the Secretary finds -
(i) that investigations must be conducted to show the safety
and effectiveness of the drug or of any of its active
ingredients, the route of administration, the dosage form, or
strength which differ from the listed drug; or
(ii) that any drug with a different active ingredient may not
be adequately evaluated for approval as safe and effective on the
basis of the information required to be submitted in an
abbreviated application.
(D)(i) An applicant may not amend or supplement an application to
seek approval of a drug referring to a different listed drug from
the listed drug identified in the application as submitted to the
Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant from
amending or supplementing the application to seek approval of a
different strength.
(iii) Within 60 days after December 8, 2003, the Secretary shall
issue guidance defining the term "listed drug" for purposes of this
subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals who
review applications submitted under paragraph (1), which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and knowledge of
regulatory and scientific standards, and which shall apply equally
to all individuals who review such applications.
(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection if
the sponsor or applicant makes a reasonable written request for a
meeting for the purpose of reaching agreement on the design and
size of bioavailability and bioequivalence studies needed for
approval of such application. The sponsor or applicant shall
provide information necessary for discussion and agreement on the
design and size of such studies. Minutes of any such meeting shall
be prepared by the Secretary and made available to the sponsor or
applicant.
(C) Any agreement regarding the parameters of design and size of
bioavailability and bioequivalence studies of a drug under this
paragraph that is reached between the Secretary and a sponsor or
applicant shall be reduced to writing and made part of the
administrative record by the Secretary. Such agreement shall not be
changed after the testing begins, except -
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing division, that
a substantial scientific issue essential to determining the
safety or effectiveness of the drug has been identified after the
testing has begun.
(D) A decision under subparagraph (C)(ii) by the director shall
be in writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director and
the sponsor or applicant will be present and at which the director
will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing division
why such decision should be modified.
(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary
to assure the marketing of a safe and effective drug.
(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval
of a drug under this subsection (including scientific matters,
chemistry, manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds -
(A) the methods used in, or the facilities and controls used
for, the manufacture, processing, and packing of the drug are
inadequate to assure and preserve its identity, strength,
quality, and purity;
(B) information submitted with the application is insufficient
to show that each of the proposed conditions of use have been
previously approved for the listed drug referred to in the
application;
(C)(i) if the listed drug has only one active ingredient,
information submitted with the application is insufficient to
show that the active ingredient is the same as that of the listed
drug;
(ii) if the listed drug has more than one active ingredient,
information submitted with the application is insufficient to
show that the active ingredients are the same as the active
ingredients of the listed drug, or
(iii) if the listed drug has more than one active ingredient
and if the application is for a drug which has an active
ingredient different from the listed drug, information submitted
with the application is insufficient to show -
(I) that the other active ingredients are the same as the
active ingredients of the listed drug, or
(II) that the different active ingredient is an active
ingredient of a listed drug or a drug which does not meet the
requirements of section 321(p) of this title,
or no petition to file an application for the drug with the
different ingredient was approved under paragraph (2)(C);
(D)(i) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is the same
as the route of administration, dosage form, or strength of the
listed drug referred to in the application, information submitted
in the application is insufficient to show that the route of
administration, dosage form, or strength is the same as that of
the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is different
from that of the listed drug referred to in the application, no
petition to file an application for the drug with the different
route of administration, dosage form, or strength was approved
under paragraph (2)(C);
(E) if the application was filed pursuant to the approval of a
petition under paragraph (2)(C), the application did not contain
the information required by the Secretary respecting the active
ingredient, route of administration, dosage form, or strength
which is not the same;
(F) information submitted in the application is insufficient to
show that the drug is bioequivalent to the listed drug referred
to in the application or, if the application was filed pursuant
to a petition approved under paragraph (2)(C), information
submitted in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the listed drug
referred to in paragraph (2)(A)(i) and that the new drug can be
expected to have the same therapeutic effect as the listed drug
when administered to patients for a condition of use referred to
in such paragraph;
(G) information submitted in the application is insufficient to
show that the labeling proposed for the drug is the same as the
labeling approved for the listed drug referred to in the
application except for changes required because of differences
approved under a petition filed under paragraph (2)(C) or because
the drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any other
information available to the Secretary shows that (i) the
inactive ingredients of the drug are unsafe for use under the
conditions prescribed, recommended, or suggested in the labeling
proposed for the drug, or (ii) the composition of the drug is
unsafe under such conditions because of the type or quantity of
inactive ingredients included or the manner in which the inactive
ingredients are included;
(I) the approval under subsection (c) of this section of the
listed drug referred to in the application under this subsection
has been withdrawn or suspended for grounds described in the
first sentence of subsection (e) of this section, the Secretary
has published a notice of opportunity for hearing to withdraw
approval of the listed drug under subsection (c) of this section
for grounds described in the first sentence of subsection (e) of
this section, the approval under this subsection of the listed
drug referred to in the application under this subsection has
been withdrawn or suspended under paragraph (6), or the Secretary
has determined that the listed drug has been withdrawn from sale
for safety or effectiveness reasons;
(J) the application does not meet any other requirement of
paragraph (2)(A); or
(K) the application contains an untrue statement of material
fact.
(5)(A) Within one hundred and eighty days of the initial receipt
of an application under paragraph (2) or within such additional
period as may be agreed upon by the Secretary and the applicant,
the Secretary shall approve or disapprove the application.
(B) The approval of an application submitted under paragraph (2)
shall be made effective on the last applicable date determined by
applying the following to each certification made under paragraph
(2)(A)(vii):
(i) If the applicant only made a certification described in
subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
subclauses, the approval may be made effective immediately.
(ii) If the applicant made a certification described in
subclause (III) of paragraph (2)(A)(vii), the approval may be
made effective on the date certified under subclause (III).
(iii) If the applicant made a certification described in
subclause (IV) of paragraph (2)(A)(vii), the approval shall be
made effective immediately unless, before the expiration of 45
days after the date on which the notice described in paragraph
(2)(B) is received, an action is brought for infringement of the
patent that is the subject of the certification and for which
information was submitted to the Secretary under subsection
(b)(1) or (c)(2) of this section before the date on which the
application (excluding an amendment or supplement to the
application), which the Secretary later determines to be
substantially complete, was submitted. If such an action is
brought before the expiration of such days, the approval shall be
made effective upon the expiration of the thirty-month period
beginning on the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as the court
may order because either party to the action failed to reasonably
cooperate in expediting the action, except that -
(I) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no cause
of action for patent infringement or invalidity), the approval
shall be made effective on -
(aa) the date on which the court enters judgment reflecting
the decision; or
(bb) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;
(II) if before the expiration of such period the district
court decides that the patent has been infringed -
(aa) if the judgment of the district court is appealed, the
approval shall be made effective on -
(AA) the date on which the court of appeals decides that
the patent is invalid or not infringed (including any
substantive determination that there is no cause of action
for patent infringement or invalidity); or
(BB) the date of a settlement order or consent decree
signed and entered by the court of appeals stating that the
patent that is the subject of the certification is invalid
or not infringed; or
(bb) if the judgment of the district court is not appealed
or is affirmed, the approval shall be made effective on the
date specified by the district court in a court order under
section 271(e)(4)(A) of title 35;
(III) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug
until the court decides the issues of patent validity and
infringement and if the court decides that such patent is
invalid or not infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period the court grants
a preliminary injunction prohibiting the applicant from
engaging in the commercial manufacture or sale of the drug
until the court decides the issues of patent validity and
infringement and if the court decides that such patent has been
infringed, the approval shall be made effective as provided in
subclause (II).
In such an action, each of the parties shall reasonably cooperate
in expediting the action.
(iv) 180-day exclusivity period. -
(I) Effectiveness of application. - Subject to subparagraph
(D), if the application contains a certification described in
paragraph (2)(A)(vii)(IV) and is for a drug for which a first
applicant has submitted an application containing such a
certification, the application shall be made effective on the
date that is 180 days after the date of the first commercial
marketing of the drug (including the commercial marketing of
the listed drug) by any first applicant.
(II) Definitions. - In this paragraph:
(aa) 180-day exclusivity period. - The term "180-day
exclusivity period" means the 180-day period ending on the
day before the date on which an application submitted by an
applicant other than a first applicant could become effective
under this clause.
(bb) First applicant. - As used in this subsection, the
term "first applicant" means an applicant that, on the first
day on which a substantially complete application containing
a certification described in paragraph (2)(A)(vii)(IV) is
submitted for approval of a drug, submits a substantially
complete application that contains and lawfully maintains a
certification described in paragraph (2)(A)(vii)(IV) for the
drug.
(cc) Substantially complete application. - As used in this
subsection, the term "substantially complete application"
means an application under this subsection that on its face
is sufficiently complete to permit a substantive review and
contains all the information required by paragraph (2)(A).
(dd) Tentative approval. -
(AA) In general. - The term "tentative approval" means
notification to an applicant by the Secretary that an
application under this subsection meets the requirements of
paragraph (2)(A), but cannot receive effective approval
because the application does not meet the requirements of
this subparagraph, there is a period of exclusivity for the
listed drug under subparagraph (F) or section 355a of this
title, or there is a 7-year period of exclusivity for the
listed drug under section 360cc of this title.
(BB) Limitation. - A drug that is granted tentative
approval by the Secretary is not an approved drug and shall
not have an effective approval until the Secretary issues
an approval after any necessary additional review of the
application.
(C) Civil action to obtain patent certainty. -
(i) Declaratory judgment absent infringement action. -
(I) In general. - No action may be brought under section 2201
of title 28 by an applicant under paragraph (2) for a
declaratory judgment with respect to a patent which is the
subject of the certification referred to in subparagraph
(B)(iii) unless -
(aa) the 45-day period referred to in such subparagraph has
expired;
(bb) neither the owner of such patent nor the holder of the
approved application under subsection (b) of this section for
the drug that is claimed by the patent or a use of which is
claimed by the patent brought a civil action against the
applicant for infringement of the patent before the
expiration of such period; and
(cc) in any case in which the notice provided under
paragraph (2)(B) relates to noninfringement, the notice was
accompanied by a document described in subclause (III).
(II) Filing of civil action. - If the conditions described in
items (aa), (bb), and as applicable, (cc) of subclause (I) have
been met, the applicant referred to in such subclause may, in
accordance with section 2201 of title 28, bring a civil action
under such section against the owner or holder referred to in
such subclause (but not against any owner or holder that has
brought such a civil action against the applicant, unless that
civil action was dismissed without prejudice) for a declaratory
judgment that the patent is invalid or will not be infringed by
the drug for which the applicant seeks approval, except that
such civil action may be brought for a declaratory judgment
that the patent will not be infringed only in a case in which
the condition described in subclause (I)(cc) is applicable. A
civil action referred to in this subclause shall be brought in
the judicial district where the defendant has its principal
place of business or a regular and established place of
business.
(III) Offer of confidential access to application. - For
purposes of subclause (I)(cc), the document described in this
subclause is a document providing an offer of confidential
access to the application that is in the custody of the
applicant under paragraph (2) for the purpose of determining
whether an action referred to in subparagraph (B)(iii) should
be brought. The document providing the offer of confidential
access shall contain such restrictions as to persons entitled
to access, and on the use and disposition of any information
accessed, as would apply had a protective order been entered
for the purpose of protecting trade secrets and other
confidential business information. A request for access to an
application under an offer of confidential access shall be
considered acceptance of the offer of confidential access with
the restrictions as to persons entitled to access, and on the
use and disposition of any information accessed, contained in
the offer of confidential access, and those restrictions and
other terms of the offer of confidential access shall be
considered terms of an enforceable contract. Any person
provided an offer of confidential access shall review the
application for the sole and limited purpose of evaluating
possible infringement of the patent that is the subject of the
certification under paragraph (2)(A)(vii)(IV) and for no other
purpose, and may not disclose information of no relevance to
any issue of patent infringement to any person other than a
person provided an offer of confidential access. Further, the
application may be redacted by the applicant to remove any
information of no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action. -
(I) In general. - If an owner of the patent or the holder of
the approved application under subsection (b) of this section
for the drug that is claimed by the patent or a use of which is
claimed by the patent brings a patent infringement action
against the applicant, the applicant may assert a counterclaim
seeking an order requiring the holder to correct or delete the
patent information submitted by the holder under subsection (b)
or (c) of this section on the ground that the patent does not
claim either -
(aa) the drug for which the application was approved; or
(bb) an approved method of using the drug.
(II) No independent cause of action. - Subclause (I) does not
authorize the assertion of a claim described in subclause (I)
in any civil action or proceeding other than a counterclaim
described in subclause (I).
(iii) No damages. - An applicant shall not be entitled to
damages in a civil action under clause (i) or a counterclaim
under clause (ii).
(D) Forfeiture of 180-day exclusivity period. -
(i) Definition of forfeiture event. - In this subparagraph, the
term "forfeiture event", with respect to an application under
this subsection, means the occurrence of any of the following:
(I) Failure to market. - The first applicant fails to market
the drug by the later of -
(aa) the earlier of the date that is -
(AA) 75 days after the date on which the approval of the
application of the first applicant is made effective under
subparagraph (B)(iii); or
(BB) 30 months after the date of submission of the
application of the first applicant; or
(bb) with respect to the first applicant or any other
applicant (which other applicant has received tentative
approval), the date that is 75 days after the date as of
which, as to each of the patents with respect to which the
first applicant submitted and lawfully maintained a
certification qualifying the first applicant for the 180-day
exclusivity period under subparagraph (B)(iv), at least 1 of
the following has occurred:
(AA) In an infringement action brought against that
applicant with respect to the patent or in a declaratory
judgment action brought by that applicant with respect to
the patent, a court enters a final decision from which no
appeal (other than a petition to the Supreme Court for a
writ of certiorari) has been or can be taken that the
patent is invalid or not infringed.
(BB) In an infringement action or a declaratory judgment
action described in subitem (AA), a court signs a
settlement order or consent decree that enters a final
judgment that includes a finding that the patent is invalid
or not infringed.
(CC) The patent information submitted under subsection
(b) or (c) of this section is withdrawn by the holder of
the application approved under subsection (b) of this
section.
(II) Withdrawal of application. - The first applicant
withdraws the application or the Secretary considers the
application to have been withdrawn as a result of a
determination by the Secretary that the application does not
meet the requirements for approval under paragraph (4).
(III) Amendment of certification. - The first applicant
amends or withdraws the certification for all of the patents
with respect to which that applicant submitted a certification
qualifying the applicant for the 180-day exclusivity period.
(IV) Failure to obtain tentative approval. - The first
applicant fails to obtain tentative approval of the application
within 30 months after the date on which the application is
filed, unless the failure is caused by a change in or a review
of the requirements for approval of the application imposed
after the date on which the application is filed.
(V) Agreement with another applicant, the listed drug
application holder, or a patent owner. - The first applicant
enters into an agreement with another applicant under this
subsection for the drug, the holder of the application for the
listed drug, or an owner of the patent that is the subject of
the certification under paragraph (2)(A)(vii)(IV), the Federal
Trade Commission or the Attorney General files a complaint, and
there is a final decision of the Federal Trade Commission or
the court with regard to the complaint from which no appeal
(other than a petition to the Supreme Court for a writ of
certiorari) has been or can be taken that the agreement has
violated the antitrust laws (as defined in section 12 of title
15, except that the term includes section 45 of title 15 to the
extent that that section applies to unfair methods of
competition).
(VI) Expiration of all patents. - All of the patents as to
which the applicant submitted a certification qualifying it for
the 180-day exclusivity period have expired.
(ii) Forfeiture. - The 180-day exclusivity period described in
subparagraph (B)(iv) shall be forfeited by a first applicant if a
forfeiture event occurs with respect to that first applicant.
(iii) Subsequent applicant. - If all first applicants forfeit
the 180-day exclusivity period under clause (ii) -
(I) approval of any application containing a certification
described in paragraph (2)(A)(vii)(IV) shall be made effective
in accordance with subparagraph (B)(iii); and
(II) no applicant shall be eligible for a 180-day exclusivity
period.
(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such
application is approvable. If the applicant elects to accept the
opportunity for hearing by written request within thirty days after
such notice, such hearing shall commence not more than ninety days
after the expiration of such thirty days unless the Secretary and
the applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order thereon
shall be issued within ninety days after the date fixed by the
Secretary for filing final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b) of this section, was approved
during the period beginning January 1, 1982, and ending on
September 24, 1984, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted
effective before the expiration of ten years from the date of the
approval of the application under subsection (b) of this section.
(ii) If an application submitted under subsection (b) of this
section for a drug, no active ingredient (including any ester or
salt of the active ingredient) of which has been approved in any
other application under subsection (b) of this section, is approved
after September 24, 1984, no application may be submitted under
this subsection which refers to the drug for which the subsection
(b) application was submitted before the expiration of five years
from the date of the approval of the application under subsection
(b) of this section, except that such an application may be
submitted under this subsection after the expiration of four years
from the date of the approval of the subsection (b) application if
it contains a certification of patent invalidity or noninfringement
described in subclause (IV) of paragraph (2)(A)(vii). The approval
of such an application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent infringement
is commenced during the one-year period beginning forty-eight
months after the date of the approval of the subsection (b)
application, the thirty-month period referred to in subparagraph
(B)(iii) shall be extended by such amount of time (if any) which is
required for seven and one-half years to have elapsed from the date
of approval of the subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient (including
any ester or salt of the active ingredient) that has been approved
in another application approved under subsection (b) of this
section, is approved after September 24, 1984, and if such
application contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval of the
application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under this subsection for the conditions of approval of such drug
in the subsection (b) application effective before the expiration
of three years from the date of the approval of the application
under subsection (b) of this section for such drug.
(iv) If a supplement to an application approved under subsection
(b) of this section is approved after September 24, 1984, and the
supplement contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval of the
supplement and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of an
application submitted under this subsection for a change approved
in the supplement effective before the expiration of three years
from the date of the approval of the supplement under subsection
(b) of this section.
(v) If an application (or supplement to an application) submitted
under subsection (b) of this section for a drug, which includes an
active ingredient (including any ester or salt of the active
ingredient) that has been approved in another application under
subsection (b) of this section, was approved during the period
beginning January 1, 1982, and ending on September 24, 1984, the
Secretary may not make the approval of an application submitted
under this subsection which refers to the drug for which the
subsection (b) application was submitted or which refers to a
change approved in a supplement to the subsection (b) application
effective before the expiration of two years from September 24,
1984.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was withdrawn
or suspended for grounds described in the first sentence of
subsection (e) of this section or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has been
withdrawn from sale for safety or effectiveness reasons, the
approval of the drug under this subsection shall be withdrawn or
suspended -
(A) for the same period as the withdrawal or suspension under
subsection (e) of this section or this paragraph, or
(B) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
(7)(A)(i) Within sixty days of September 24, 1984, the Secretary
shall publish and make available to the public -
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved for safety
and effectiveness under subsection (c) of this section before
September 24, 1984;
(II) the date of approval if the drug is approved after 1981
and the number of the application which was approved; and
(III) whether in vitro or in vivo bioequivalence studies, or
both such studies, are required for applications filed under this
subsection which will refer to the drug published.
(ii) Every thirty days after the publication of the first list
under clause (i) the Secretary shall revise the list to include
each drug which has been approved for safety and effectiveness
under subsection (c) of this section or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (b) or
(c) of this section respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions made
under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under subsection
(c) of this section or approved under this subsection shall, for
purposes of this subsection, be considered to have been published
under subparagraph (A) on the date of its approval or September 24,
1984, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) of this
section or was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale for
safety or effectiveness reasons, it may not be published in the
list under subparagraph (A) or, if the withdrawal or suspension
occurred after its publication in such list, it shall be
immediately removed from such list -
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(8) For purposes of this subsection:
(A)(i) The term "bioavailability" means the rate and extent to
which the active ingredient or therapeutic ingredient is absorbed
from a drug and becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed into the
bloodstream, the Secretary may assess bioavailability by
scientifically valid measurements intended to reflect the rate
and extent to which the active ingredient or therapeutic
ingredient becomes available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to a listed
drug if -
(i) the rate and extent of absorption of the drug do not show
a significant difference from the rate and extent of absorption
of the listed drug when administered at the same molar dose of
the therapeutic ingredient under similar experimental
conditions in either a single dose or multiple doses; or
(ii) the extent of absorption of the drug does not show a
significant difference from the extent of absorption of the
listed drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in
either a single dose or multiple doses and the difference from
the listed drug in the rate of absorption of the drug is
intentional, is reflected in its proposed labeling, is not
essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.
(C) For a drug that is not intended to be absorbed into the
bloodstream, the Secretary may establish alternative,
scientifically valid methods to show bioequivalence if the
alternative methods are expected to detect a significant
difference between the drug and the listed drug in safety and
therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of -
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the chemistry
of the application was assigned and the date of such assignment,
and
(D) the name of each person to whom the bioequivalence review
for such application was assigned and the date of such
assignment.
The information the Secretary is required to maintain under this
paragraph with respect to an application submitted under this
subsection shall be made available to the public after the approval
of such application.
(k) Records and reports; required information; regulations and
orders; access to records
(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) of this section is in
effect, the applicant shall establish and maintain such records,
and make such reports to the Secretary, of data relating to
clinical experience and other data or information, received or
otherwise obtained by such applicant with respect to such drug, as
the Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the Secretary
to determine, or facilitate a determination, whether there is or
may be ground for invoking subsection (e) of this section.
Regulations and orders issued under this subsection and under
subsection (i) of this section shall have due regard for the
professional ethics of the medical profession and the interests of
patients and shall provide, where the Secretary deems it to be
appropriate, for the examination, upon request, by the persons to
whom such regulations or orders are applicable, of similar
information received or otherwise obtained by the Secretary.
(2) Every person required under this section to maintain records,
and every person in charge or custody thereof, shall, upon request
of an officer or employee designated by the Secretary, permit such
officer or employee at all reasonable times to have access to and
copy and verify such records.
(l) Public disclosure of safety and effectiveness data
Safety and effectiveness data and information which has been
submitted in an application under subsection (b) of this section
for a drug and which has not previously been disclosed to the
public shall be made available to the public, upon request, unless
extraordinary circumstances are shown -
(1) if no work is being or will be undertaken to have the
application approved,
(2) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(3) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(4) if the Secretary has determined that such drug is not a new
drug, or
(5) upon the effective date of the approval of the first
application under subsection (j) of this section which refers to
such drug or upon the date upon which the approval of an
application under subsection (j) of this section which refers to
such drug could be made effective if such an application had been
submitted.
(m) "Patent" defined
For purposes of this section, the term "patent" means a patent
issued by the United States Patent and Trademark Office.
(n) Scientific advisory panels
(1) For the purpose of providing expert scientific advice and
recommendations to the Secretary regarding a clinical investigation
of a drug or the approval for marketing of a drug under this
section or section 262 of title 42, the Secretary shall establish
panels of experts or use panels of experts established before
November 21, 1997, or both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 394 of this title to a director of
a center or successor entity within the Food and Drug
Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall consist of
-
(A) members who are qualified by training and experience to
evaluate the safety and effectiveness of the drugs to be referred
to the panel and who, to the extent feasible, possess skill and
experience in the development, manufacture, or utilization of
such drugs;
(B) members with diverse expertise in such fields as clinical
and administrative medicine, pharmacy, pharmacology,
pharmacoeconomics, biological and physical sciences, and other
related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing industry
not directly affected by the matter to be brought before the
panel; and
(D) two or more members who are specialists or have other
expertise in the particular disease or condition for which the
drug under review is proposed to be indicated.
Scientific, trade, and consumer organizations shall be afforded an
opportunity to nominate individuals for appointment to the panels.
No individual who is in the regular full-time employ of the United
States and engaged in the administration of this chapter may be a
voting member of any panel. The Secretary shall designate one of
the members of each panel to serve as chairman thereof.
(4) Each member of a panel shall publicly disclose all conflicts
of interest that member may have with the work to be undertaken by
the panel. No member of a panel may vote on any matter where the
member or the immediate family of such member could gain
financially from the advice given to the Secretary. The Secretary
may grant a waiver of any conflict of interest requirement upon
public disclosure of such conflict of interest if such waiver is
necessary to afford the panel essential expertise, except that the
Secretary may not grant a waiver for a member of a panel when the
member's own scientific work is involved.
(5) The Secretary shall, as appropriate, provide education and
training to each new panel member before such member participates
in a panel's activities, including education regarding requirements
under this chapter and related regulations of the Secretary, and
the administrative processes and procedures related to panel
meetings.
(6) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or
otherwise engaged in its business, shall be entitled to receive
compensation for each day so engaged, including traveltime, at
rates to be fixed by the Secretary, but not to exceed the daily
equivalent of the rate in effect for positions classified above
grade GS-15 of the General Schedule. While serving away from their
homes or regular places of business, panel members may be allowed
travel expenses (including per diem in lieu of subsistence) as
authorized by section 5703 of title 5, for persons in the
Government service employed intermittently.
(7) The Secretary shall ensure that scientific advisory panels
meet regularly and at appropriate intervals so that any matter to
be reviewed by such a panel can be presented to the panel not more
than 60 days after the matter is ready for such review. Meetings of
the panel may be held using electronic communication to convene the
meetings.
(8) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and Drug
Administration official responsible for the matter shall review the
conclusions and recommendations of the panel, and notify the
affected persons of the final decision on the matter, or of the
reasons that no such decision has been reached. Each such final
decision shall be documented including the rationale for the
decision.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,
Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,
Secs. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76
Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972,
86 Stat. 562; Pub. L. 98-417, title I, Secs. 101, 102(a)-(b)(5),
103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L.
102-282, Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec.
3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315,
2316, 2318, 2324; Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title
IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584;
Pub. L. 107-109, Sec. 15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub.
L. 108-155, Sec. 2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
173, title XI, Secs. 1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003,
117 Stat. 2448, 2452, 2457, 2460.)
-REFTEXT-
REFERENCES IN TEXT
The General Schedule, referred to in subsec. (n)(6), is set out
under section 5332 of Title 5, Government Organization and
Employees.
-MISC1-
AMENDMENTS
2003 - Subsec. (b)(1). Pub. L. 108-155, in second sentence,
substituted "(F)" for "and (F)" and inserted ", and (G) any
assessments required under section 355c of this title" before
period at end.
Subsec. (b)(3). Pub. L. 108-173, Sec. 1101(b)(1)(A), added par.
(3) and struck out former par. (3) which, in subpar. (A), required
an applicant making a certification under par. (2)(A)(iv) to
include statement that applicant will give notice to each owner of
the patent which is the subject of the certification and to the
holder of the approved application, in subpar. (B), directed that
notice state that an application has been submitted and include a
detailed statement of the applicant's opinion that the patent is
not valid or will not be infringed, and, in subpar. (C), provided
that if an application is amended, notice shall be given when the
amended application is submitted.
Subsec. (b)(4), (5). Pub. L. 108-173, Sec. 1101(b)(1)(B), added
par. (4) and redesignated former par. (4) as (5).
Subsec. (c)(3). Pub. L. 108-173, Sec. 1101(b)(2)(A), substituted
"by applying the following to each certification made under
subsection (b)(2)(A) of this section" for "under the following" in
introductory provisions.
Subsec. (c)(3)(C). Pub. L. 108-173, Sec. 1101(b)(2)(B)(iii),
which directed the substitution of "subsection (b)(3) of this
section" for "paragraph (3)(B)" in third sentence, could not be
executed because such words do not appear. See note below.
Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(VI), in concluding
provisions, struck out "Until the expiration of forty-five days
from the date the notice made under paragraph (3)(B) is received,
no action may be brought under section 2201 of title 28 for a
declaratory judgment with respect to the patent. Any action brought
under such section 2201 shall be brought in the judicial district
where the defendant has its principal place of business or a
regular and established place of business." after "expediting the
action."
Pub. L. 108-173, Sec. 1101(b)(2)(B)(i), (ii)(I), in first
sentence of introductory provisions, substituted "unless, before
the expiration of 45 days after the date on which the notice
described in subsection (b)(3) of this section is received, an
action is brought for infringement of the patent that is the
subject of the certification and for which information was
submitted to the Secretary under paragraph (2) or subsection (b)(1)
of this section before the date on which the application (excluding
an amendment or supplement to the application) was submitted" for
"unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-
five days from the date the notice provided under paragraph (3)(B)
is received" and, in second sentence of introductory provisions,
substituted "subsection (b)(3) of this section" for "paragraph
(3)(B)".
Subsec. (c)(3)(C)(i). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i)
which read as follows: "if before the expiration of such period the
court decides that such patent is invalid or not infringed, the
approval may be made effective on the date of the court decision,".
Subsec. (c)(3)(C)(ii). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl.
(ii) which read as follows: "if before the expiration of such
period the court decides that such patent has been infringed, the
approval may be made effective on such date as the court orders
under section 271(e)(4)(A) of title 35, or".
Subsec. (c)(3)(C)(iii). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or"
for "on the date of such court decision."
Subsec. (c)(3)(C)(iv). Pub. L. 108-173, Sec.
1101(b)(2)(B)(ii)(V), added cl. (iv).
Subsec. (c)(3)(D), (E). Pub. L. 108-173, Sec. 1101(b)(2)(C), (D),
added subpar. (D) and redesignated former subpar. (D) as (E).
Subsec. (j)(2)(B). Pub. L. 108-173, Sec. 1101(a)(1)(A), added
subpar. (B) and struck out former subpar. (B) which, in cl. (i),
required that an applicant making a certification under subpar.
(A)(vii)(IV) include in the application a statement that notice
would be given to each owner of the patent and the holder of the
approved application, in cl. (ii), required that notice would state
that an application had been submitted and that it would include a
detailed statement of the basis of the applicant's opinion, and, in
cl. (iii), directed that notice of an amended application be given
when the amended application had been submitted.
Subsec. (j)(2)(D). Pub. L. 108-173, Sec. 1101(a)(1)(B), added
subpar. (D).
Subsec. (j)(5)(B). Pub. L. 108-173, Sec. 1101(a)(2)(A)(i),
substituted "by applying the following to each certification made
under paragraph (2)(A)(vii)" for "under the following" in
introductory provisions.
Subsec. (j)(5)(B)(iii). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second
sentence of subsec. (j)(5)(B)(iii) by striking "Until the
expiration" and all that follows in the matter after and below
subclause (IV), was executed by striking "Until the expiration of
forty-five days from the date the notice made under paragraph
(2)(B)(i) is received, no action may be brought under section 2201
of title 28, for a declaratory judgment with respect to the patent.
Any action brought under section 2201 shall be brought in the
judicial district where the defendant has its principal place of
business or a regular and established place of business." after
"expediting the action." in concluding provisions, to reflect the
probable intent of Congress.
Pub. L. 108-173, Sec. 1101(a)(2)(A)(ii)(I), in introductory
provisions, substituted "unless, before the expiration of 45 days
after the date on which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the patent that
is the subject of the certification and for which information was
submitted to the Secretary under subsection (b)(1) or (c)(2) of
this section before the date on which the application (excluding an
amendment or supplement to the application), which the Secretary
later determines to be substantially complete, was submitted" for
"unless an action is brought for infringement of a patent which is
the subject of the certification before the expiration of forty-
five days from the date the notice provided under paragraph
(2)(B)(i) is received".
Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former
subcl. (I) which read as follows: "if before the expiration of such
period the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date of the
court decision,".
Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former
subcl. (II) which read as follows: "if before the expiration of
such period the court decides that such patent has been infringed,
the approval shall be made effective on such date as the court
orders under section 271(e)(4)(A) of title 35, or".
Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause
(I); or" for "on the date of such court decision."
Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173, Sec.
1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
Subsec. (j)(5)(B)(iv). Pub. L. 108-173, Sec. 1102(a)(1), added
cl. (iv) and struck out former cl. (iv) which read as follows: "If
the application contains a certification described in subclause
(IV) of paragraph (2)(A)(vii) and is for a drug for which a
previous application has been submitted under this subsection
continuing such a certification, the application shall be made
effective not earlier than one hundred and eighty days after -
"(I) the date the Secretary receives notice from the applicant
under the previous application of the first commercial marketing
of the drug under the previous application, or
"(II) the date of a decision of a court in an action described
in clause (iii) holding the patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier."
Subsec. (j)(5)(C). Pub. L. 108-173, Sec. 1101(a)(2)(B), (C),
added subpar. (C). Former subpar. (C) redesignated (E).
Subsec. (j)(5)(D). Pub. L. 108-173, Sec. 1102(a)(2), added
subpar. (D).
Pub. L. 108-173, Sec. 1101(a)(2)(B), redesignated subpar. (D) as
(F).
Subsec. (j)(5)(E), (F). Pub. L. 108-173, Sec. 1101(a)(2)(B),
redesignated subpars. (C) and (D) as (E) and (F), respectively.
Subsec. (j)(8)(A). Pub. L. 108-173, Sec. 1103(a)(1), added
subpar. (A) and struck out former subpar. (A) which read as
follows: "The term 'bioavailability' means the rate and extent to
which the active ingredient or therapeutic ingredient is absorbed
from a drug and becomes available at the site of drug action."
Subsec. (j)(8)(C). Pub. L. 108-173, Sec. 1103(a)(2), added
subpar. (C).
2002 - Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).
1999 - Subsec. (m). Pub. L. 106-113 substituted "United States
Patent and Trademark Office" for "Patent and Trademark Office of
the Department of Commerce".
1997 - Subsec. (b)(1). Pub. L. 105-115, Sec. 115(b), inserted at
end "The Secretary shall, in consultation with the Director of the
National Institutes of Health and with representatives of the drug
manufacturing industry, review and develop guidance, as
appropriate, on the inclusion of women and minorities in clinical
trials required by clause (A)."
Subsec. (b)(4). Pub. L. 105-115, Sec. 119(a), added par. (4).
Subsec. (c)(4). Pub. L. 105-115, Sec. 124(a), added par. (4).
Subsec. (d). Pub. L. 105-115, Sec. 115(a), inserted at end "If
the Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence."
Subsec. (i). Pub. L. 105-115, Sec. 117, inserted "(1)" after
"(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C),
respectively, of par. (1), added pars. (2) to (4), and struck out
closing provisions which read as follows: "Such regulations shall
provide that such exemption shall be conditioned upon the
manufacturer, or the sponsor of the investigation, requiring that
experts using such drugs for investigational purposes certify to
such manufacturer or sponsor that they will inform any human beings
to whom such drugs, or any controls used in connection therewith,
are being administered, or their representatives, that such drugs
are being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except where
they deem it not feasible or, in their professional judgment,
contrary to the best interests of such human beings. Nothing in
this subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs."
Subsec. (j)(2)(A)(i). Pub. L. 105-115, Sec. 119(b)(2)(A),
substituted "paragraph (7)" for "paragraph (6)".
Subsec. (j)(3). Pub. L. 105-115, Sec. 119(b)(1)(B), added par.
(3). Former par. (3) redesignated (4).
Subsec. (j)(4). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(B),
redesignated par. (3) as (4) and in introductory provisions
substituted "paragraph (5)" for "paragraph (4)". Former par. (4)
redesignated (5).
Subsec. (j)(4)(I). Pub. L. 105-115, Sec. 119(b)(2)(C),
substituted "paragraph (6)" for "paragraph (5)".
Subsec. (j)(5), (6). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (4) and (5) as (5) and (6), respectively. Former
par. (6) redesignated (7).
Subsec. (j)(7). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(D),
redesignated par. (6) as (7) and in subpar. (C) substituted
"paragraph (6)" for "paragraph (5)" in two places. Former par. (7)
redesignated (8).
Subsec. (j)(8), (9). Pub. L. 105-115, Sec. 119(b)(1)(A),
redesignated pars. (7) and (8) as (8) and (9), respectively.
Subsec. (n). Pub. L. 105-115, Sec. 120, added subsec. (n).
1993 - Subsec. (j)(6)(A)(ii). Pub. L. 103-80, Sec. 3(n)(1)(A),
substituted "Secretary" for "Secretry".
Subsec. (j)(6)(A)(iii). Pub. L. 103-80, Sec. 3(n)(1)(B), inserted
comma after "published by the Secretary".
Subsec. (k)(1). Pub. L. 103-80, Sec. 3(n)(2), substituted
"section. Regulations" for "section: Provided, however, That
regulations".
1992 - Subsec. (j)(8). Pub. L. 102-282 added par. (8).
1984 - Subsec. (a). Pub. L. 98-417, Sec. 102(b)(1), inserted "or
(j)" after "subsection (b)".
Subsec. (b). Pub. L. 98-417, Secs. 102(a)(1), 103(a), designated
existing provisions of subsec. (b) as par. (1) thereof and
redesignated existing cls. (1) through (6) of such par. (1) as cls.
(A) through (F) thereof, respectively, inserted requirement that
the applicant file with the application the patent number and the
expiration date of any patent which claims the drug for which the
applicant submitted the application or which claims a method of
using such drug and with respect to which a claim of patent
infringement could reasonably by asserted if a person not licensed
by the owner engaged in the manufacture, use, or sale of the drug,
that the applicant amend the application to include such
information if an application is filed under this subsection for a
drug and a patent which claims such drug or a method of using such
drug is issued after the filing date but before approval of the
application, and that upon approval of the application, the
Secretary publish the information submitted, and added pars. (2)
and (3).
Subsec. (c). Pub. L. 98-417, Secs. 102(a)(2), (b)(2), 103(b),
designated existing provisions of subsec. (c) as par. (1) thereof
and in par. (1) as so designated substituted "subsection (b) of
this section" for "this subsection" and redesignated former pars.
(1) and (2) as subpars. (A) and (B), respectively, and added pars.
(2) and (3).
Subsec. (d)(6), (7). Pub. L. 98-417, Sec. 102(a)(3)(A), added cl.
(6) relating to the failure of the application to contain the
patent information prescribed by subsec. (b) of this section, and
redesignated former cl. (6) as (7).
Subsec. (e). Pub. L. 98-417, Sec. 102(a)(3)(B), in first
sentence, added a new cl. (4) relating to the failure to file the
patent information prescribed by subsec. (c) of this section within
30 days after the receipt of written notice from the Secretary
specifying the failure to file such information, and redesignated
former cl. (4) as (5).
Pub. L. 98-417, Sec. 102(b)(3), (4), in second sentence, inserted
in provisions preceding cl. (1) "submitted under subsection (b) or
(j) of this section" and in cl. (1) substituted "under subsection
(k) of this section or to comply with the notice requirements of
section 360(k)(2) of this title" for "under subsection (j) of this
section or to comply with the notice requirements of section
360(j)(2) of this title".
Subsecs. (j), (k). Pub. L. 98-417, Sec. 101, added subsec. (j)
and redesignated former subsec. (j) as (k).
Subsec. (k)(1). Pub. L. 98-417, Sec. 102(b)(5), substituted
"under subsection (b) or (j) of this section" for "pursuant to this
section".
Subsecs. (l), (m). Pub. L. 98-417, Sec. 104, added subsecs. (l)
and (m).
1972 - Subsec. (e). Pub. L. 92-387 inserted "or to comply with
the notice requirements of section 360(j)(2) of this title" in cl.
(1) of second sentence relating to the maintenance of records.
1962 - Subsec. (a). Pub. L. 87-781, Sec. 104(a), inserted "an
approval of" before "an application".
Subsec. (b). Pub. L. 87-781, Sec. 102(b), inserted "and whether
such drug is effective in use" after "is safe for use".
Subsec. (c). Pub. L. 87-781, Sec. 104(b), substituted provisions
requiring the Secretary, within 180 days after filing an
application, or such additional period as the Secretary and the
applicant agree upon, to either approve the application, if meeting
the requirements of subsec. (d) of this section, or give notice of
opportunity for hearing on question of whether such application is
approvable, and providing that if applicant requests hearing in
writing within 30 days, the hearing shall begin within 90 days
after expiration of said 30 days, unless the Secretary and
applicant agree otherwise, that such hearing shall be expedited,
and that the Secretary's order shall be issued within 90 days after
date for filing final briefs, for provisions which had an
application become effective on the sixtieth day after filing
thereof unless prior thereto the Secretary postponed the date by
written notice to such time, but not more than 180 days after
filing, as the Secretary deemed necessary to study and investigate
the application.
Subsec. (d). Pub. L. 87-781, Sec. 102(c), inserted references to
subsec. (c), added cls. (5) and (6), provided that if after notice
and opportunity for hearing, the Secretary finds that cls. (1) to
(6) do not apply, he shall approve the application, and defined
"substantial evidence" as used in this subsection and subsec. (e)
of this section.
Subsec. (e). Pub. L. 87-781, Sec. 102(d), amended subsec. (e)
generally, and among other changes, directed the Secretary to
withdraw approval of an application if by tests, other scientific
data or experience, or new evidence of clinical experience not
contained in the application or available at the time of its
approval, the drug is shown to be unsafe, or on the basis of new
information, there is shown a lack of substantial evidence that the
drug has the effect it is represented to have, and provided that if
the Secretary, or acting Secretary, finds there is an imminent
hazard to the public health, he may suspend approval immediately,
notify the applicant, and give him opportunity for an expedited
hearing, that the Secretary may withdraw approval if the applicant
fails to establish a system for maintaining required records, or
has repeatedly or deliberately failed to maintain records and make
reports, or has refused access to, or copying or verification of
such records, or if the Secretary finds on new evidence that the
methods, facilities and controls in the manufacturing, processing,
and packing are inadequate to assure and preserve the drugs'
identity, strength, quality and purity, and were not made adequate
within a reasonable time after receipt of written notice thereof,
or finds on new evidence, that the labeling is false or misleading
and was not corrected within a reasonable time after receipt of
written notice thereof.
Subsec. (f). Pub. L. 87-781, Sec. 104(c), substituted provisions
requiring the Secretary to revoke any previous order under subsecs.
(d) or (e) of this section refusing, withdrawing, or suspending
approval of an application and to approve such application or
reinstate such approval, for provisions which required him to
revoke an order refusing effectiveness to an application.
Subsec. (h). Pub. L. 87-781, Sec. 104(d)(1), (2), inserted "as
provided in section 2112 of title 28", and "except that until the
filing of the record the Secretary may modify or set aside his
order", substituted "or withdrawing approval of an application
under this section" for "to permit the application to become
effective, or suspending the effectiveness of the application",
"United States court of appeals for the circuit" for "district
court of the United States within any district", "Court of Appeals
for the District of Columbia Circuit" for "District Court for the
District of Columbia", "transmitted by the clerk of the court to"
for "served upon", and "by the Supreme Court of the United States
upon certiorari or certification as provided in section 1254 of
title 28" for "as provided in sections 225, 346, and 347 of title
28, as amended, and in section 7, as amended, of the Act entitled
'An Act to establish a Court of Appeals for the District of
Columbia', approved February 9, 1893", and eliminated "upon" before
"any officer designated", "a transcript of" before "the record" and
"and decree" before "of the court affirming".
Subsec. (i). Pub. L. 87-781, Sec. 103(b), inserted "the foregoing
subsections of" after "operation of", and "and effectiveness" after
"safety", and provided that the regulations may condition
exemptions upon the submission of reports of preclinical tests to
justify the proposed clinical testing, upon the obtaining by the
manufacturer or sponsor of the investigation of a new drug of a
signed agreement from each of the investigators that patients to
whom the drug is administered will be under his supervision or
under investigators responsible to him, and that he will not supply
such drug to any other investigator, or to clinics, for
administration to human beings, or upon the establishment and
maintenance of records and reports of data obtained by the
investigational use of such drug, as the Secretary finds will
enable him to evaluate the safety and effectiveness of such drug,
and provided that the regulations shall condition an exemption upon
the manufacturer or sponsor of the investigation requiring that
experts using such drugs certify that they will inform humans to
whom such drugs or any controls connected therewith are
administered, or their representatives, and will obtain the consent
of such people where feasible and not contrary to the best
interests of such people, and that reports on the investigational
use of drugs are not required to be submitted directly to the
Secretary.
Subsec. (j). Pub. L. 87-781, Sec. 103(a), added subsec. (j).
1960 - Subsec. (g). Pub. L. 86-507 inserted "or by certified
mail" after "registered mail".
EFFECTIVE DATE OF 2003 AMENDMENTS
Pub. L. 108-173, title XI, Sec. 1101(c), Dec. 8, 2003, 117 Stat.
2456, provided that:
"(1) In general. - Except as provided in paragraphs (2) and (3),
the amendments made by subsections (a) and (b) [amending this
section] apply to any proceeding under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or
after the date of the enactment of this Act [Dec. 8, 2003]
regardless of the date on which the proceeding was commenced or is
commenced.
"(2) Notice of opinion that patent is invalid or will not be
infringed. - The amendments made by subsections (a)(1) and (b)(1)
apply with respect to any certification under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after
August 18, 2003, in an application filed under subsection (b) or
(j) of that section or in an amendment or supplement to an
application filed under subsection (b) or (j) of that section.
"(3) Effective date of approval. - The amendments made by
subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to
any patent information submitted under subsection (b)(1) or (c)(2)
of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) on or after August 18, 2003."
Pub. L. 108-173, title XI, Sec. 1102(b), Dec. 8, 2003, 117 Stat.
2460, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendment made by subsection (a) [amending this section] shall be
effective only with respect to an application filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) after the date of the enactment of this Act [Dec. 8, 2003]
for a listed drug for which no certification under section
505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
enactment of this Act.
"(2) Collusive agreements. - If a forfeiture event described in
section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an
applicant, the applicant shall forfeit the 180-day period under
section 505(j)(5)(B)(iv) of that Act without regard to when the
first certification under section 505(j)(2)(A)(vii)(IV) of that Act
for the listed drug was made.
"(3) Decision of a court when the 180-day exclusivity period has
not been triggered. - With respect to an application filed before,
on, or after the date of the enactment of this Act [Dec. 8, 2003]
for a listed drug for which a certification under section
505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
enactment of this Act and for which neither of the events described
in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act
(as in effect on the day before the date of the enactment of this
Act) has occurred on or before the date of the enactment of this
Act, the term 'decision of a court' as used in clause (iv) of
section 505(j)(5)(B) of that Act means a final decision of a court
from which no appeal (other than a petition to the Supreme Court
for a writ of certiorari) has been or can be taken."
Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of this title.
EFFECTIVE DATE OF 1999 AMENDMENT
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
113, set out as a note under section 1 of Title 35, Patents.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1984 AMENDMENT
Section 105 of Pub. L. 98-417 provided that:
"(a) The Secretary of Health and Human Services shall promulgate,
in accordance with the notice and comment requirements of section
553 of title 5, United States Code, such regulations as may be
necessary for the administration of section 505 of the Federal
Food, Drug, and Cosmetic Act [this section], as amended by sections
101, 102, and 103 of this Act, within one year of the date of
enactment of this Act [Sept. 24, 1984].
"(b) During the period beginning sixty days after the date of the
enactment of this Act [Sept. 24, 1984], and ending on the date
regulations promulgated under subsection (a) take effect,
abbreviated new drug applications may be submitted in accordance
with the provisions of section 314.2 of title 21 of the Code of
Federal Regulations and shall be considered as suitable for any
drug which has been approved for safety and effectiveness under
section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec.
(c) of this section] before the date of the enactment of this Act.
If any such provision is inconsistent with the requirements of
section 505(j) of the Federal Food, Drug, and Cosmetic Act, the
Secretary shall consider the application under the applicable
requirements of such section. The Secretary of Health and Human
Services may not approve such an abbreviated new drug application
which is filed for a drug which is described in sections
505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and
Cosmetic Act, except in accordance with such section."
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
out as a note under section 360 of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282
Amendment by Pub. L. 102-282 not to preclude any other civil,
criminal, or administrative remedy provided under Federal or State
law, including any private right of action against any person for
the same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
EFFECT OF AMENDMENT BY PUB. L. 108-173 ON ABBREVIATED NEW DRUG
APPLICATIONS
Pub. L. 108-173, title XI, Sec. 1103(b), Dec. 8, 2003, 117 Stat.
2461, provided that: "The amendment made by subsection (a)
[amending this section] does not alter the standards for approval
of drugs under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j))."
FEDERAL TRADE COMMISSION REVIEW
Pub. L. 108-173, title XI, subtitle B, Dec. 8, 2003, 117 Stat.
2461, provided that:
"SEC. 1111. DEFINITIONS.
"In this subtitle:
"(1) ANDA. - The term 'ANDA' means an abbreviated drug
application, as defined under section 201(aa) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
"(2) Assistant attorney general. - The term 'Assistant Attorney
General' means the Assistant Attorney General in charge of the
Antitrust Division of the Department of Justice.
"(3) Brand name drug. - The term 'brand name drug' means a drug
for which an application is approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)],
including an application referred to in section 505(b)(2) of such
Act [21 U.S.C. 355(b)(2)].
"(4) Brand name drug company. - The term 'brand name drug
company' means the party that holds the approved application
referred to in paragraph (3) for a brand name drug that is a
listed drug in an ANDA, or a party that is the owner of a patent
for which information is submitted for such drug under subsection
(b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 355(b), (c)].
"(5) Commission. - The term 'Commission' means the Federal
Trade Commission.
"(6) Generic drug. - The term 'generic drug' means a drug for
which an application under section 505(j) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.
"(7) Generic drug applicant. - The term 'generic drug
applicant' means a person who has filed or received approval for
an ANDA under section 505(j) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 355(j)].
"(8) Listed drug. - The term 'listed drug' means a brand name
drug that is listed under section 505(j)(7) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].
"SEC. 1112. NOTIFICATION OF AGREEMENTS.
"(a) Agreement With Brand Name Drug Company. -
"(1) Requirement. - A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] and a brand name drug company
that enter into an agreement described in paragraph (2) shall
each file the agreement in accordance with subsection (c). The
agreement shall be filed prior to the date of the first
commercial marketing of the generic drug that is the subject of
the ANDA.
"(2) Subject matter of agreement. - An agreement described in
this paragraph between a generic drug applicant and a brand name
drug company is an agreement regarding -
"(A) the manufacture, marketing or sale of the brand name
drug that is the listed drug in the ANDA involved;
"(B) the manufacture, marketing, or sale of the generic drug
for which the ANDA was submitted; or
"(C) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to
any other ANDA based on the same brand name drug.
"(b) Agreement With Another Generic Drug Applicant. -
"(1) Requirement. - A generic drug applicant that has submitted
an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug
and another generic drug applicant that has submitted an ANDA
containing such a certification for the same listed drug shall
each file the agreement in accordance with subsection (c). The
agreement shall be filed prior to the date of the first
commercial marketing of either of the generic drugs for which
such ANDAs were submitted.
"(2) Subject matter of agreement. - An agreement described in
this paragraph between two generic drug applicants is an
agreement regarding the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which
the agreement is concerned.
"(c) Filing. -
"(1) Agreement. - The parties that are required in subsection
(a) or (b) to file an agreement in accordance with this
subsection shall file with the Assistant Attorney General and the
Commission the text of any such agreement, except that such
parties are not required to file an agreement that solely
concerns -
"(A) purchase orders for raw material supplies;
"(B) equipment and facility contracts;
"(C) employment or consulting contracts; or
"(D) packaging and labeling contracts.
"(2) Other agreements. - The parties that are required in
subsection (a) or (b) to file an agreement in accordance with
this subsection shall file with the Assistant Attorney General
and the Commission the text of any agreements between the parties
that are not described in such subsections and are contingent
upon, provide a contingent condition for, or are otherwise
related to an agreement that is required in subsection (a) or (b)
to be filed in accordance with this subsection.
"(3) Description. - In the event that any agreement required in
subsection (a) or (b) to be filed in accordance with this
subsection has not been reduced to text, each of the parties
involved shall file written descriptions of such agreement that
are sufficient to disclose all the terms and conditions of the
agreement.
"SEC. 1113. FILING DEADLINES.
"Any filing required under section 1112 shall be filed with the
Assistant Attorney General and the Commission not later than 10
business days after the date the agreements are executed.
"SEC. 1114. DISCLOSURE EXEMPTION.
"Any information or documentary material filed with the Assistant
Attorney General or the Commission pursuant to this subtitle shall
be exempt from disclosure under section 552 of title 5, United
States Code, and no such information or documentary material may be
made public, except as may be relevant to any administrative or
judicial action or proceeding. Nothing in this section is intended
to prevent disclosure to either body of the Congress or to any duly
authorized committee or subcommittee of the Congress.
"SEC. 1115. ENFORCEMENT.
"(a) Civil Penalty. - Any brand name drug company or generic drug
applicant which fails to comply with any provision of this subtitle
shall be liable for a civil penalty of not more than $11,000, for
each day during which such entity is in violation of this subtitle.
Such penalty may be recovered in a civil action brought by the
United States, or brought by the Commission in accordance with the
procedures established in section 16(a)(1) of the Federal Trade
Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).
"(b) Compliance and Equitable Relief. - If any brand name drug
company or generic drug applicant fails to comply with any
provision of this subtitle, the United States district court may
order compliance, and may grant such other equitable relief as the
court in its discretion determines necessary or appropriate, upon
application of the Assistant Attorney General or the Commission.
"SEC. 1116. RULEMAKING.
"The Commission, with the concurrence of the Assistant Attorney
General and by rule in accordance with section 553 of title 5,
United States Code, consistent with the purposes of this subtitle -
"(1) may define the terms used in this subtitle;
"(2) may exempt classes of persons or agreements from the
requirements of this subtitle; and
"(3) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this subtitle.
"SEC. 1117. SAVINGS CLAUSE.
"Any action taken by the Assistant Attorney General or the
Commission, or any failure of the Assistant Attorney General or the
Commission to take action, under this subtitle shall not at any
time bar any proceeding or any action with respect to any agreement
between a brand name drug company and a generic drug applicant, or
any agreement between generic drug applicants, under any other
provision of law, nor shall any filing under this subtitle
constitute or create a presumption of any violation of any
competition laws.
"SEC. 1118. EFFECTIVE DATE.
"This subtitle shall -
"(1) take effect 30 days after the date of the enactment of
this Act [Dec. 8, 2003]; and
"(2) shall apply to agreements described in section 1112 that
are entered into 30 days after the date of the enactment of this
Act."
REPORT ON PATIENT ACCESS TO NEW THERAPEUTIC AGENTS FOR PEDIATRIC
CANCER
Pub. L. 107-109, Sec. 15(d), Jan. 4, 2002, 115 Stat. 1421,
provided that: "Not later than January 31, 2003, the Secretary of
Health and Human Services, acting through the Commissioner of Food
and Drugs and in consultation with the Director of the National
Institutes of Health, shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report on
patient access to new therapeutic agents for pediatric cancer,
including access to single patient use of new therapeutic agents."
DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS
Section 118 of Pub. L. 105-115 provided that: "Within 12 months
after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall issue guidance that describes
when abbreviated study reports may be submitted, in lieu of full
reports, with a new drug application under section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a
biologics license application under section 351 of the Public
Health Service Act (42 U.S.C. 262) for certain types of studies.
Such guidance shall describe the kinds of studies for which
abbreviated reports are appropriate and the appropriate abbreviated
report formats."
REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD
MANUFACTURING PRACTICES FOR POSITRON EMISSION TECHNOLOGY
Section 121(c) of Pub. L. 105-115 provided that:
"(1) Procedures and requirements. -
"(A) In general. - In order to take account of the special
characteristics of positron emission tomography drugs and the
special techniques and processes required to produce these drugs,
not later than 2 years after the date of enactment of this Act
[Nov. 21, 1997], the Secretary of Health and Human Services shall
establish -
"(i) appropriate procedures for the approval of positron
emission tomography drugs pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
"(ii) appropriate current good manufacturing practice
requirements for such drugs.
"(B) Considerations and consultation. - In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account of
any relevant differences between not-for-profit institutions that
compound the drugs for their patients and commercial
manufacturers of the drugs. Prior to establishing the procedures
and requirements, the Secretary of Health and Human Services
shall consult with patient advocacy groups, professional
associations, manufacturers, and physicians and scientists
licensed to make or use positron emission tomography drugs.
"(2) Submission of new drug applications and abbreviated new drug
applications. -
"(A) In general. - Except as provided in subparagraph (B), the
Secretary of Health and Human Services shall not require the
submission of new drug applications or abbreviated new drug
applications under subsection (b) or (j) of section 505 (21
U.S.C. 355), for compounded positron emission tomography drugs
that are not adulterated drugs described in section 501(a)(2)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(C)) (as amended by subsection (b)), for a period of 4
years after the date of enactment of this Act [Nov. 21, 1997], or
for 2 years after the date on which the Secretary establishes
procedures and requirements under paragraph (1), whichever is
longer.
"(B) Exception. - Nothing in this Act [see Short Title of 1997
Amendment note set out under section 301 of this title] shall
prohibit the voluntary submission of such applications or the
review of such applications by the Secretary of Health and Human
Services. Nothing in this Act shall constitute an exemption for a
positron emission tomography drug from the requirements of
regulations issued under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i))."
"COMPOUNDED POSITRON EMISSION TOPOGRAPHY DRUG" DEFINED
Section 121(e) of Pub. L. 105-115 provided that: "As used in this
section [amending sections 321 and 351 of this title and enacting
provisions set out as notes under this section and section 351 of
this title], the term 'compounded positron emission tomography
drug' has the meaning given the term in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
REQUIREMENTS FOR RADIOPHARMACEUTICALS
Section 122 of Pub. L. 105-115 provided that:
"(a) Requirements. -
"(1) Regulations. -
"(A) Proposed regulations. - Not later than 180 days after
the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services, after consultation with
patient advocacy groups, associations, physicians licensed to
use radiopharmaceuticals, and the regulated industry, shall
issue proposed regulations governing the approval of
radiopharmaceuticals. The regulations shall provide that the
determination of the safety and effectiveness of such a
radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C. 262) shall include
consideration of the proposed use of the radiopharmaceutical in
the practice of medicine, the pharmacological and toxicological
activity of the radiopharmaceutical (including any carrier or
ligand component of the radiopharmaceutical), and the estimated
absorbed radiation dose of the radiopharmaceutical.
"(B) Final regulations. - Not later than 18 months after the
date of enactment of this Act, the Secretary shall promulgate
final regulations governing the approval of the
radiopharmaceuticals.
"(2) Special rule. - In the case of a radiopharmaceutical, the
indications for which such radiopharmaceutical is approved for
marketing may, in appropriate cases, refer to manifestations of
disease (such as biochemical, physiological, anatomic, or
pathological processes) common to, or present in, one or more
disease states.
"(b) Definition. - In this section, the term
'radiopharmaceutical' means -
"(1) an article -
"(A) that is intended for use in the diagnosis or monitoring
of a disease or a manifestation of a disease in humans; and
"(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
"(2) any nonradioactive reagent kit or nuclide generator that
is intended to be used in the preparation of any such article."
SPECIAL RULE
Section 123(f) of Pub. L. 105-115 provided that: "The Secretary
of Health and Human Services shall take measures to minimize
differences in the review and approval of products required to have
approved biologics license applications under section 351 of the
Public Health Service Act (42 U.S.C. 262) and products required to
have approved new drug applications under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))."
TRANSITION
Section 125(d) of Pub. L. 105-115 provided that:
"(1) In general. - An application that was approved by the
Secretary of Health and Human Services before the date of the
enactment of this Act [Nov. 21, 1997] for the marketing of an
antibiotic drug under section 507 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 357), as in effect on the day before the
date of the enactment of this Act, shall, on and after such date of
enactment, be considered to be an application that was submitted
and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and
approved for safety and effectiveness under section 505(c) of such
Act (21 U.S.C. 355(c)), except that if such application for
marketing was in the form of an abbreviated application, the
application shall be considered to have been filed and approved
under section 505(j) of such Act (21 U.S.C. 355(j)).
"(2) Exception. - The following subsections of section 505 (21
U.S.C. 355) shall not apply to any application for marketing in
which the drug that is the subject of the application contains an
antibiotic drug and the antibiotic drug was the subject of any
application for marketing received by the Secretary of Health and
Human Services under section 507 of such Act (21 U.S.C. 357) before
the date of the enactment of this Act [Nov. 21, 1997]:
"(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
(j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
"(ii) The third and fourth sentences of subsection (b)(1)
(regarding the filing and publication of patent information); and
"(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
the investigations relied upon by the applicant for approval of
the application were not conducted by or for the applicant and
for which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted.
"(3) Publication. - For purposes of this section, the Secretary
is authorized to make available to the public the established name
of each antibiotic drug that was the subject of any application for
marketing received by the Secretary for Health and Human Services
under section 507 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 357) before the date of enactment of this Act [Nov. 21,
1997]."
TERMINATION OF ADVISORY PANELS
Advisory panels established after Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period beginning on the
date of their establishment, unless, in the case of a panel
established by the President or an officer of the Federal
Government, such panel is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of a panel
established by Congress, its duration is otherwise provided for by
law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 770, 776, set out in the Appendix to Title 5, Government
Organization and Employees.
APPEALS TAKEN PRIOR TO OCTOBER 10, 1962
Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec.
(h) of this section inapplicable to any appeal taken prior to Oct.
10, 1962.
-FOOTNOTE-
(!1) So in original. Probably should be "bioavailability".
-End-
-CITE-
21 USC Sec. 355a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 355a. Pediatric studies of drugs
-STATUTE-
(a) Definitions
As used in this section, the term "pediatric studies" or
"studies" means at least one clinical investigation (that, at the
Secretary's discretion, may include pharmacokinetic studies) in
pediatric age groups (including neonates in appropriate cases) in
which a drug is anticipated to be used.
(b) Market exclusivity for new drugs
If, prior to approval of an application that is submitted under
section 355(b)(1) of this title, the Secretary determines that
information relating to the use of a new drug in the pediatric
population may produce health benefits in that population, the
Secretary makes a written request for pediatric studies (which
shall include a timeframe for completing such studies), and such
studies are completed within any such timeframe and the reports
thereof submitted in accordance with subsection (d)(2) of this
section or accepted in accordance with subsection (d)(3) of this
section -
(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
section 355 of this title, and in subsection (j)(5)(F)(ii) of
such section, is deemed to be five years and six months rather
than five years, and the references in subsections (c)(3)(D)(ii)
and (j)(5)(F)(ii) of such section to four years, to forty-eight
months, and to seven and one-half years are deemed to be four and
one-half years, fifty-four months, and eight years, respectively;
or
(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and
(iv) of subsection (j)(5)(F) of such section, is deemed to be
three years and six months rather than three years; and
(B) if the drug is designated under section 360bb of this title
for a rare disease or condition, the period referred to in
section 360cc(a) of this title is deemed to be seven years and
six months rather than seven years; and
(2)(A) if the drug is the subject of -
(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
of section 355 of this title and for which pediatric studies
were submitted prior to the expiration of the patent (including
any patent extensions); or
(ii) a listed patent for which a certification has been
submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 355 of this title,
the period during which an application may not be approved under
section 355(c)(3) of this title or section 355(j)(5)(B) of this
title shall be extended by a period of six months after the date
the patent expires (including any patent extensions); or
(B) if the drug is the subject of a listed patent for which a
certification has been submitted under subsection (b)(2)(A)(iv)
or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 355(c)(3) of this title or section
355(j)(5)(B) of this title shall be extended by a period of six
months after the date the patent expires (including any patent
extensions).
(c) Market exclusivity for already-marketed drugs
If the Secretary determines that information relating to the use
of an approved drug in the pediatric population may produce health
benefits in that population and makes a written request to the
holder of an approved application under section 355(b)(1) of this
title for pediatric studies (which shall include a timeframe for
completing such studies), the holder agrees to the request, the
studies are completed within any such timeframe, and the reports
thereof are submitted in accordance with subsection (d)(2) of this
section or accepted in accordance with subsection (d)(3) of this
section -
(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
section 355 of this title, and in subsection (j)(5)(F)(ii) of
such section, is deemed to be five years and six months rather
than five years, and the references in subsections (c)(3)(D)(ii)
and (j)(5)(F)(ii) of such section to four years, to forty-eight
months, and to seven and one-half years are deemed to be four and
one-half years, fifty-four months, and eight years, respectively;
or
(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and
(iv) of subsection (j)(5)(F) of such section, is deemed to be
three years and six months rather than three years; and
(B) if the drug is designated under section 360bb of this title
for a rare disease or condition, the period referred to in
section 360cc(a) of this title is deemed to be seven years and
six months rather than seven years; and
(2)(A) if the drug is the subject of -
(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
of section 355 of this title and for which pediatric studies
were submitted prior to the expiration of the patent (including
any patent extensions); or
(ii) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 355 of this title,
the period during which an application may not be approved under
section 355(c)(3) of this title or section 355(j)(5)(B) of this
title shall be extended by a period of six months after the date
the patent expires (including any patent extensions); or
(B) if the drug is the subject of a listed patent for which a
certification has been submitted under subsection (b)(2)(A)(iv)
or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 355(c)(3) of this title or section
355(j)(5)(B) of this title shall be extended by a period of six
months after the date the patent expires (including any patent
extensions).
(d) Conduct of pediatric studies
(1) Agreement for studies
The Secretary may, pursuant to a written request from the
Secretary under subsection (b) or (c) of this section, after
consultation with -
(A) the sponsor of an application for an investigational new
drug under section 355(i) of this title;
(B) the sponsor of an application for a new drug under
section 355(b)(1) of this title; or
(C) the holder of an approved application for a drug under
section 355(b)(1) of this title,
agree with the sponsor or holder for the conduct of pediatric
studies for such drug. Such agreement shall be in writing and
shall include a timeframe for such studies.
(2) Written protocols to meet the studies requirement
If the sponsor or holder and the Secretary agree upon written
protocols for the studies, the studies requirement of subsection
(b) or (c) of this section is satisfied upon the completion of
the studies and submission of the reports thereof in accordance
with the original written request and the written agreement
referred to in paragraph (1). In reaching an agreement regarding
written protocols, the Secretary shall take into account adequate
representation of children of ethnic and racial minorities. Not
later than 60 days after the submission of the report of the
studies, the Secretary shall determine if such studies were or
were not conducted in accordance with the original written
request and the written agreement and reported in accordance with
the requirements of the Secretary for filing and so notify the
sponsor or holder.
(3) Other methods to meet the studies requirement
If the sponsor or holder and the Secretary have not agreed in
writing on the protocols for the studies, the studies requirement
of subsection (b) or (c) of this section is satisfied when such
studies have been completed and the reports accepted by the
Secretary. Not later than 90 days after the submission of the
reports of the studies, the Secretary shall accept or reject such
reports and so notify the sponsor or holder. The Secretary's only
responsibility in accepting or rejecting the reports shall be to
determine, within the 90 days, whether the studies fairly respond
to the written request, have been conducted in accordance with
commonly accepted scientific principles and protocols, and have
been reported in accordance with the requirements of the
Secretary for filing.
(4) Written request to holders of approved applications for drugs
that have market exclusivity
(A) Request and response
If the Secretary makes a written request for pediatric
studies (including neonates, as appropriate) under subsection
(c) of this section to the holder of an application approved
under section 355(b)(1) of this title, the holder, not later
than 180 days after receiving the written request, shall
respond to the Secretary as to the intention of the holder to
act on the request by -
(i) indicating when the pediatric studies will be
initiated, if the holder agrees to the request; or
(ii) indicating that the holder does not agree to the
request.
(B) No agreement to request
(i) Referral
If the holder does not agree to a written request within
the time period specified in subparagraph (A), and if the
Secretary determines that there is a continuing need for
information relating to the use of the drug in the pediatric
population (including neonates, as appropriate), the
Secretary shall refer the drug to the Foundation for the
National Institutes of Health established under section 290b
of title 42 (referred to in this paragraph as the
"Foundation") for the conduct of the pediatric studies
described in the written request.
(ii) Public notice
The Secretary shall give public notice of the name of the
drug, the name of the manufacturer, and the indications to be
studied made in a referral under clause (i).
(C) Lack of funds
On referral of a drug under subparagraph (B)(i), the
Foundation shall issue a proposal to award a grant to conduct
the requested studies unless the Foundation certifies to the
Secretary, within a timeframe that the Secretary determines is
appropriate through guidance, that the Foundation does not have
funds available under section 290b(j)(9)(B)(i) (!1) of title 42
to conduct the requested studies. If the Foundation so
certifies, the Secretary shall refer the drug for inclusion on
the list established under section 284m of title 42 for the
conduct of the studies.
(D) Effect of subsection
Nothing in this subsection (including with respect to
referrals from the Secretary to the Foundation) alters or
amends section 331(j) of this title or section 552 of title 5
or section 1905 of title 18.
(E) No requirement to refer
Nothing in this subsection shall be construed to require that
every declined written request shall be referred to the
Foundation.
(F) Written requests under subsection (b)
For drugs under subsection (b) of this section for which
written requests have not been accepted, if the Secretary
determines that there is a continuing need for information
relating to the use of the drug in the pediatric population
(including neonates, as appropriate), the Secretary shall issue
a written request under subsection (c) of this section after
the date of approval of the drug.
(e) Delay of effective date for certain application
If the Secretary determines that the acceptance or approval of an
application under section 355(b)(2) or 355(j) of this title for a
new drug may occur after submission of reports of pediatric studies
under this section, which were submitted prior to the expiration of
the patent (including any patent extension) or the applicable
period under clauses (ii) through (iv) of section 355(c)(3)(D) of
this title or clauses (ii) through (iv) of section 355(j)(5)(F) of
this title, but before the Secretary has determined whether the
requirements of subsection (d) of this section have been satisfied,
the Secretary shall delay the acceptance or approval under section
355(b)(2) or 355(j) of this title until the determination under
subsection (d) of this section is made, but any such delay shall
not exceed 90 days. In the event that requirements of this section
are satisfied, the applicable six-month period under subsection (b)
or (c) of this section shall be deemed to have been running during
the period of delay.
(f) Notice of determinations on studies requirement
The Secretary shall publish a notice of any determination that
the requirements of subsection (d) of this section have been met
and that submissions and approvals under subsection (b)(2) or (j)
of section 355 of this title for a drug will be subject to the
provisions of this section.
(g) Limitations
A drug to which the six-month period under subsection (b) or (c)
of this section has already been applied -
(1) may receive an additional six-month period under subsection
(c)(1)(A)(ii) of this section for a supplemental application if
all other requirements under this section are satisfied, except
that such a drug may not receive any additional such period under
subsection (c)(2) of this section; and
(2) may not receive any additional such period under subsection
(c)(1)(B) of this section.
(h) Relationship to pediatric research requirements
Notwithstanding any other provision of law, if any pediatric
study is required by a provision of law (including a regulation)
other than this section and such study meets the completeness,
timeliness, and other requirements of this section, such study
shall be deemed to satisfy the requirement for market exclusivity
pursuant to this section.
(i) Labeling supplements
(1) Priority status for pediatric supplements
Any supplement to an application under section 355 of this
title proposing a labeling change pursuant to a report on a
pediatric study under this section -
(A) shall be considered to be a priority supplement; and
(B) shall be subject to the performance goals established by
the Commissioner for priority drugs.
(2) Dispute resolution
(A) Request for labeling change and failure to agree
If the Commissioner determines that an application with
respect to which a pediatric study is conducted under this
section is approvable and that the only open issue for final
action on the application is the reaching of an agreement
between the sponsor of the application and the Commissioner on
appropriate changes to the labeling for the drug that is the
subject of the application, not later than 180 days after the
date of submission of the application -
(i) the Commissioner shall request that the sponsor of the
application make any labeling change that the Commissioner
determines to be appropriate; and
(ii) if the sponsor of the application does not agree to
make a labeling change requested by the Commissioner, the
Commissioner shall refer the matter to the Pediatric Advisory
Committee.
(B) Action by the Pediatric Advisory Committee
Not later than 90 days after receiving a referral under
subparagraph (A)(ii), the Pediatric Advisory Committee shall -
(i) review the pediatric study reports; and
(ii) make a recommendation to the Commissioner concerning
appropriate labeling changes, if any.
(C) Consideration of recommendations
The Commissioner shall consider the recommendations of the
Pediatric Advisory Committee and, if appropriate, not later
than 30 days after receiving the recommendation, make a request
to the sponsor of the application to make any labeling change
that the Commissioner determines to be appropriate.
(D) Misbranding
If the sponsor of the application, within 30 days after
receiving a request under subparagraph (C), does not agree to
make a labeling change requested by the Commissioner, the
Commissioner may deem the drug that is the subject of the
application to be misbranded.
(E) No effect on authority
Nothing in this subsection limits the authority of the United
States to bring an enforcement action under this chapter when a
drug lacks appropriate pediatric labeling. Neither course of
action (the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding sentence) shall
preclude, delay, or serve as the basis to stay the other course
of action.
(j) Dissemination of pediatric information
(1) In general
Not later than 180 days after the date of submission of a
report on a pediatric study under this section, the Commissioner
shall make available to the public a summary of the medical and
clinical pharmacology reviews of pediatric studies conducted for
the supplement, including by publication in the Federal Register.
(2) Effect of subsection
Nothing in this subsection alters or amends section 331(j) of
this title or section 552 of title 5 or section 1905 of title 18.
(k) Clarification of interaction of market exclusivity under this
section and market exclusivity awarded to an applicant for
approval of a drug under section 355(j) of this title
If a 180-day period under section 355(j)(5)(B)(iv) of this title
overlaps with a 6-month exclusivity period under this section, so
that the applicant for approval of a drug under section 355(j) of
this title entitled to the 180-day period under that section loses
a portion of the 180-day period to which the applicant is entitled
for the drug, the 180-day period shall be extended from -
(1) the date on which the 180-day period would have expired by
the number of days of the overlap, if the 180-day period would,
but for the application of this subsection, expire after the 6-
month exclusivity period; or
(2) the date on which the 6-month exclusivity period expires,
by the number of days of the overlap if the 180-day period would,
but for the application of this subsection, expire during the six-
month exclusivity period.
(l) Prompt approval of drugs under section 355(j) of this title
when pediatric information is added to labeling
(1) General rule
A drug for which an application has been submitted or approved
under section 355(j) of this title shall not be considered
ineligible for approval under that section or misbranded under
section 352 of this title on the basis that the labeling of the
drug omits a pediatric indication or any other aspect of labeling
pertaining to pediatric use when the omitted indication or other
aspect is protected by patent or by exclusivity under clause
(iii) or (iv) of section 355(j)(5)(F) of this title.
(2) Labeling
Notwithstanding clauses (iii) and (iv) of section 355(j)(5)(F)
of this title, the Secretary may require that the labeling of a
drug approved under section 355(j) of this title that omits a
pediatric indication or other aspect of labeling as described in
paragraph (1) include -
(A) a statement that, because of marketing exclusivity for a
manufacturer -
(i) the drug is not labeled for pediatric use; or
(ii) in the case of a drug for which there is an additional
pediatric use not referred to in paragraph (1), the drug is
not labeled for the pediatric use under paragraph (1); and
(B) a statement of any appropriate pediatric
contraindications, warnings, or precautions that the Secretary
considers necessary.
(3) Preservation of pediatric exclusivity and other provisions
This subsection does not affect -
(A) the availability or scope of exclusivity under this
section;
(B) the availability or scope of exclusivity under section
355 of this title for pediatric formulations;
(C) the question of the eligibility for approval of any
application under section 355(j) of this title that omits any
other conditions of approval entitled to exclusivity under
clause (iii) or (iv) of section 355(j)(5)(F) of this title; or
(D) except as expressly provided in paragraphs (1) and (2),
the operation of section 355 of this title.
(m) Report
The Secretary shall conduct a study and report to Congress not
later than January 1, 2001, based on the experience under the
program established under this section. The study and report shall
examine all relevant issues, including -
(1) the effectiveness of the program in improving information
about important pediatric uses for approved drugs;
(2) the adequacy of the incentive provided under this section;
(3) the economic impact of the program on taxpayers and
consumers, including the impact of the lack of lower cost generic
drugs on patients, including on lower income patients; and
(4) any suggestions for modification that the Secretary
determines to be appropriate.
(n) Sunset
A drug may not receive any 6-month period under subsection (b) or
(c) of this section unless -
(1) on or before October 1, 2007, the Secretary makes a written
request for pediatric studies of the drug;
(2) on or before October 1, 2007, an application for the drug
is accepted for filing under section 355(b) of this title; and
(3) all requirements of this section are met.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 505A, as added Pub. L. 105-115, title
I, Sec. 111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107-
109, Secs. 2, 4, 5(b)(2), 7-11(a), 18(a), 19, Jan. 4, 2002, 115
Stat. 1408, 1411, 1413-1415, 1423, 1424; Pub. L. 108-155, Secs.
2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
173, title XI, Sec. 1104, Dec. 8, 2003, 117 Stat. 2461.)
-REFTEXT-
REFERENCES IN TEXT
Section 290b(j)(9)(B)(i) of title 42, referred to in subsec.
(d)(4)(C), was in the original "section 499(j)(9)(B)(i)" and was
translated as meaning section 499(j)(9)(B)(i) of the Public Health
Service Act to reflect the probable intent of Congress because
there is no section 499 of the Federal Food, Drug, and Cosmetic Act
and section 499 of the Public Health Service Act relates to the
establishment and duties of the National Foundation for Biomedical
Research.
-MISC1-
AMENDMENTS
2003 - Subsec. (b)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1),
substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
Subsec. (b)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
"(j)(5)(F)" for "(j)(5)(D)".
Subsec. (b)(2). Pub. L. 108-155, Sec. 3(a), substituted
"355(j)(5)(B)" for "355(j)(4)(B)" in two places.
Subsec. (c)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1), substituted
"(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
Subsec. (c)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
"(j)(5)(F)" for "(j)(5)(D)".
Subsec. (c)(2). Pub. L. 108-155, Sec. 3(a), substituted
"355(j)(5)(B)" for "355(j)(4)(B)" in two places.
Subsec. (e). Pub. L. 108-173, Sec. 1104(3), substituted
"355(j)(5)(F)" for "355(j)(5)(D)".
Subsec. (h). Pub. L. 108-155, Sec. 2(b)(2), substituted
"pediatric research requirements" for "regulations" in heading and
"by a provision of law (including a regulation) other than this
section" for "pursuant to regulations promulgated by the Secretary"
in text.
Subsec. (i)(2). Pub. L. 108-155, Sec. 3(b)(1), struck out
"Advisory Subcommittee of the Anti-Infective Drugs" before
"Advisory Committee" wherever appearing.
Subsec. (l). Pub. L. 108-173, Sec. 1104(3), substituted
"355(j)(5)(F)" for "355(j)(5)(D)" wherever appearing.
2002 - Subsec. (a). Pub. L. 107-109, Sec. 19(2), (3),
redesignated subsec. (g) as (a). Former subsec. (a) redesignated
(b).
Subsec. (a)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
Subsec. (b). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (a) as (b).
Pub. L. 107-109, Sec. 2(1), struck out heading and text of
subsec. (b). Text read as follows: "Not later than 180 days after
November 21, 1997, the Secretary, after consultation with experts
in pediatric research shall develop, prioritize, and publish an
initial list of approved drugs for which additional pediatric
information may produce health benefits in the pediatric
population. The Secretary shall annually update the list."
Subsec. (c). Pub. L. 107-109, Sec. 2(2), in introductory
provisions, inserted "determines that information relating to the
use of an approved drug in the pediatric population may produce
health benefits in that population and" after "the Secretary" and
struck out "concerning a drug identified in the list described in
subsection (b) of this section" after "such studies)".
Subsec. (c)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
Subsec. (d)(1). Pub. L. 107-109, Sec. 19(4), substituted
"subsection (b) or (c)" for "subsection (a) or (c)" in introductory
provisions.
Subsec. (d)(2). Pub. L. 107-109, Secs. 18(a), 19(4), substituted
"subsection (b) or (c)" for "subsection (a) or (c)" and inserted
"In reaching an agreement regarding written protocols, the
Secretary shall take into account adequate representation of
children of ethnic and racial minorities." after first sentence.
Subsec. (d)(3). Pub. L. 107-109, Sec. 19(4), substituted
"subsection (b) or (c)" for "subsection (a) or (c)".
Subsec. (d)(4). Pub. L. 107-109, Sec. 4, added par. (4).
Subsec. (e). Pub. L. 107-109, Sec. 19(1)(C), (4), substituted
"section 355(j)(5)(D)" for "section 355(j)(4)(D)" and "subsection
(b) or (c)" for "subsection (a) or (c)".
Subsec. (g). Pub. L. 107-109, Sec. 19(2), (3), (5), redesignated
subsec. (h) as (g) and substituted "subsection (b) or (c)" for
"subsection (a) or (b)" in introductory provisions. Former subsec.
(g) redesignated (a).
Pub. L. 107-109, Sec. 7, inserted "(including neonates in
appropriate cases)" after "pediatric age groups".
Subsec. (h). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (i) as (h). Former subsec. (h) redesignated (g).
Subsec. (i). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (l) as (i). Former subsec. (i) redesignated (h).
Subsec. (j). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (m) as (j). Former subsec. (j) redesignated (n).
Pub. L. 107-109, Sec. 8, added subsec. (j) and struck out heading
and text of former subsec. (j). Text read as follows: "A drug may
not receive any six-month period under subsection (a) or (c) of
this section unless the application for the drug under section
355(b)(1) of this title is submitted on or before January 1, 2002.
After January 1, 2002, a drug shall receive a six-month period
under subsection (c) of this section if -
"(1) the drug was in commercial distribution as of November 21,
1997;
"(2) the drug was included by the Secretary on the list under
subsection (b) of this section as of January 1, 2002;
"(3) the Secretary determines that there is a continuing need
for information relating to the use of the drug in the pediatric
population and that the drug may provide health benefits in that
population; and
"(4) all requirements of this section are met."
Subsec. (k). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (n) as (k). Former subsec. (k) redesignated (m).
Subsec. (l). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (o) as (l). Former subsec. (l) redesignated (i).
Pub. L. 107-109, Sec. 5(b)(2), added subsec. (l).
Subsec. (m). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (k) as (m). Former subsec. (m) redesignated (j).
Pub. L. 107-109, Sec. 9, added subsec. (m).
Subsec. (n). Pub. L. 107-109, Sec. 19(4), which directed
substitution of "subsection (b) or (c)" for "subsection (a) or (c)"
in subsec. (m), was executed by making the substitution in
introductory provisions of subsec. (n), to reflect the probable
intent of Congress.
Pub. L. 107-109, Sec. 19(2), (3), redesignated subsec. (j) as
(n). Former subsec. (n) redesignated (k).
Pub. L. 107-109, Sec. 10, added subsec. (n).
Subsec. (o). Pub. L. 107-109, Sec. 19(2), (3), redesignated
subsec. (o) as (l).
Pub. L. 107-109, Sec. 11(a), added subsec. (o).
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of this title.
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-109, Sec. 11(b), Jan. 4, 2002, 115 Stat. 1416,
provided that: "The amendment made by subsection (a) [amending this
section] takes effect on the date of enactment of this Act [Jan. 4,
2002], including with respect to applications under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that
are approved or pending on that date."
REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM
Pub. L. 107-109, Sec. 16, Jan. 4, 2002, 115 Stat. 1421, as
amended by Pub. L. 108-155, Sec. 3(b)(4), Dec. 3, 2003, 117 Stat.
1942, provided that: "Not later than October 1, 2006, the
Comptroller General of the United States, in consultation with the
Secretary of Health and Human Services, shall submit to Congress a
report that addresses the following issues, using publicly
available data or data otherwise available to the Government that
may be used and disclosed under applicable law:
"(1) The effectiveness of section 505A of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355a] and section 409I of the
Public Health Service Act [42 U.S.C. 284m] (as added by this Act)
in ensuring that medicines used by children are tested and
properly labeled, including -
"(A) the number and importance of drugs for children that are
being tested as a result of this legislation and the importance
for children, health care providers, parents, and others of
labeling changes made as a result of such testing;
"(B) the number and importance of drugs for children that are
not being tested for their use notwithstanding the provisions
of this legislation, and possible reasons for the lack of
testing; and
"(C) the number of drugs for which testing is being done,
exclusivity granted, and labeling changes required, including
the date pediatric exclusivity is granted and the date labeling
changes are made and which labeling changes required the use of
the dispute resolution process established pursuant to the
amendments made by this Act [see Short Title of 2002 Amendment
note set out under section 301 of this title], together with a
description of the outcomes of such process, including a
description of the disputes and the recommendations of the
Pediatric Advisory Committee.
"(2) The economic impact of section 505A of the Federal Food,
Drug, and Cosmetic Act and section 409I of the Public Health
Service Act (as added by this Act), including an estimate of -
"(A) the costs to taxpayers in the form of higher
expenditures by medicaid and other Government programs;
"(B) sales for each drug during the 6-month period for which
exclusivity is granted, as attributable to such exclusivity;
"(C) costs to consumers and private insurers as a result of
any delay in the availability of lower cost generic equivalents
of drugs tested and granted exclusivity under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and loss of
revenue by the generic drug industry and retail pharmacies as a
result of any such delay; and
"(D) the benefits to the government, to private insurers, and
to consumers resulting from decreased health care costs,
including -
"(i) decreased hospitalizations and fewer medical errors,
due to more appropriate and more effective use of medications
in children as a result of testing and re-labeling because of
the amendments made by this Act;
"(ii) direct and indirect benefits associated with fewer
physician visits not related to hospitalization;
"(iii) benefits to children from missing less time at
school and being less affected by chronic illnesses, thereby
allowing a better quality of life;
"(iv) benefits to consumers from lower health insurance
premiums due to lower treatment costs and hospitalization
rates; and
"(v) benefits to employers from reduced need for employees
to care for family members.
"(3) The nature and type of studies in children for each drug
granted exclusivity under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), including -
"(A) a description of the complexity of the studies;
"(B) the number of study sites necessary to obtain
appropriate data;
"(C) the number of children involved in any clinical studies;
and
"(D) the estimated cost of each of the studies.
"(4) Any recommendations for modifications to the programs
established under section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
Health Service Act [42 U.S.C. 284m] (as added by section 3) that
the Secretary determines to be appropriate, including a detailed
rationale for each recommendation.
"(5) The increased private and Government-funded pediatric
research capability associated with this Act and the amendments
made by this Act.
"(6) The number of written requests and additional letters of
recommendation that the Secretary issues.
"(7) The prioritized list of off-patent drugs for which the
Secretary issues written requests.
"(8)(A) The efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
"(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of studies ethical and safe."
STUDY BY GENERAL ACCOUNTING OFFICE
Pub. L. 107-109, Sec. 18(b), Jan. 4, 2002, 115 Stat. 1423,
required the Comptroller General, not later than Jan. 10, 2003, to
conduct a study relating to the representation of children of
ethnic and racial minorities in studies under section 355a of this
title and to submit a report to Congress describing the findings of
the study.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 355b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 355b. Adverse-event reporting
-STATUTE-
(a) Toll-free number in labeling
Not later than one year after January 4, 2002, the Secretary of
Health and Human Services shall promulgate a final rule requiring
that the labeling of each drug for which an application is approved
under section 505 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355] (regardless of the date on which approved) include the
toll-free number maintained by the Secretary for the purpose of
receiving reports of adverse events regarding drugs and a statement
that such number is to be used for reporting purposes only, not to
receive medical advice. With respect to the final rule:
(1) The rule shall provide for the implementation of such
labeling requirement in a manner that the Secretary considers to
be most likely to reach the broadest consumer audience.
(2) In promulgating the rule, the Secretary shall seek to
minimize the cost of the rule on the pharmacy profession.
(3) The rule shall take effect not later than 60 days after the
date on which the rule is promulgated.
(b) Drugs with pediatric market exclusivity
(1) In general
During the one year beginning on the date on which a drug
receives a period of market exclusivity under 505A (!1) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report
of an adverse event regarding the drug that the Secretary of
Health and Human Services receives shall be referred to the
Office of Pediatric Therapeutics established under section 393a
of this title. In considering the report, the Director of such
Office shall provide for the review of the report by the
Pediatric Advisory Committee, including obtaining any
recommendations of such subcommittee (!2) regarding whether the
Secretary should take action under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.
(2) Rule of construction
Paragraph (1) may not be construed as restricting the authority
of the Secretary of Health and Human Services to continue
carrying out the activities described in such paragraph regarding
a drug after the one-year period described in such paragraph
regarding the drug has expired.
-SOURCE-
(Pub. L. 107-109, Sec. 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L.
108-155, Sec. 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to this chapter. For complete
classification of this Act to the Code, see section 301 of this
title and Tables.
-COD-
CODIFICATION
Section was enacted as part of the Best Pharmaceuticals for
Children Act, and not as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-MISC1-
AMENDMENTS
2003 - Subsec. (b)(1). Pub. L. 108-155 struck out "Advisory
Subcommittee of the Anti-Infective Drugs" before "Advisory
Committee".
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
otherwise provided, see section 4 of Pub. L. 108-155, set out as an
Effective Date note under section 355c of this title.
-FOOTNOTE-
(!1) So in original. Probably should be preceded by "section".
(!2) So in original. Probably should be "Committee".
-End-
-CITE-
21 USC Sec. 355c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 355c. Research into pediatric uses for drugs and biological
products
-STATUTE-
(a) New drugs and biological products
(1) In general
A person that submits an application (or supplement to an
application) -
(A) under section 355 of this title for a new active
ingredient, new indication, new dosage form, new dosing
regimen, or new route of administration; or
(B) under section 262 of title 42 for a new active
ingredient, new indication, new dosage form, new dosing
regimen, or new route of administration;
shall submit with the application the assessments described in
paragraph (2).
(2) Assessments
(A) In general
The assessments referred to in paragraph (1) shall contain
data, gathered using appropriate formulations for each age
group for which the assessment is required, that are adequate -
(i) to assess the safety and effectiveness of the drug or
the biological product for the claimed indications in all
relevant pediatric subpopulations; and
(ii) to support dosing and administration for each
pediatric subpopulation for which the drug or the biological
product is safe and effective.
(B) Similar course of disease or similar effect of drug or
biological product
(i) In general
If the course of the disease and the effects of the drug
are sufficiently similar in adults and pediatric patients,
the Secretary may conclude that pediatric effectiveness can
be extrapolated from adequate and well-controlled studies in
adults, usually supplemented with other information obtained
in pediatric patients, such as pharmacokinetic studies.
(ii) Extrapolation between age groups
A study may not be needed in each pediatric age group if
data from one age group can be extrapolated to another age
group.
(3) Deferral
On the initiative of the Secretary or at the request of the
applicant, the Secretary may defer submission of some or all
assessments required under paragraph (1) until a specified date
after approval of the drug or issuance of the license for a
biological product if -
(A) the Secretary finds that -
(i) the drug or biological product is ready for approval
for use in adults before pediatric studies are complete;
(ii) pediatric studies should be delayed until additional
safety or effectiveness data have been collected; or
(iii) there is another appropriate reason for deferral; and
(B) the applicant submits to the Secretary -
(i) certification of the grounds for deferring the
assessments;
(ii) a description of the planned or ongoing studies; and
(iii) evidence that the studies are being conducted or will
be conducted with due diligence and at the earliest possible
time.
(4) Waivers
(A) Full waiver
On the initiative of the Secretary or at the request of an
applicant, the Secretary shall grant a full waiver, as
appropriate, of the requirement to submit assessments for a
drug or biological product under this subsection if the
applicant certifies and the Secretary finds that -
(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
is so small or the patients are geographically dispersed);
(ii) there is evidence strongly suggesting that the drug or
biological product would be ineffective or unsafe in all
pediatric age groups; or
(iii) the drug or biological product -
(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients; and
(II) is not likely to be used in a substantial number of
pediatric patients.
(B) Partial waiver
On the initiative of the Secretary or at the request of an
applicant, the Secretary shall grant a partial waiver, as
appropriate, of the requirement to submit assessments for a
drug or biological product under this subsection with respect
to a specific pediatric age group if the applicant certifies
and the Secretary finds that -
(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
(ii) there is evidence strongly suggesting that the drug or
biological product would be ineffective or unsafe in that age
group;
(iii) the drug or biological product -
(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
(II) is not likely to be used by a substantial number of
pediatric patients in that age group; or
(iv) the applicant can demonstrate that reasonable attempts
to produce a pediatric formulation necessary for that age
group have failed.
(C) Pediatric formulation not possible
If a waiver is granted on the ground that it is not possible
to develop a pediatric formulation, the waiver shall cover only
the pediatric groups requiring that formulation.
(D) Labeling requirement
If the Secretary grants a full or partial waiver because
there is evidence that a drug or biological product would be
ineffective or unsafe in pediatric populations, the information
shall be included in the labeling for the drug or biological
product.
(b) Marketed drugs and biological products
(1) In general
After providing notice in the form of a letter and an
opportunity for written response and a meeting, which may include
an advisory committee meeting, the Secretary may (by order in the
form of a letter) require the holder of an approved application
for a drug under section 355 of this title or the holder of a
license for a biological product under section 262 of title 42 to
submit by a specified date the assessments described in
subsection (a)(2) of this section if the Secretary finds that -
(A)(i) the drug or biological product is used for a
substantial number of pediatric patients for the labeled
indications; and
(ii) the absence of adequate labeling could pose significant
risks to pediatric patients; or
(B)(i) there is reason to believe that the drug or biological
product would represent a meaningful therapeutic benefit over
existing therapies for pediatric patients for one or more of
the claimed indications; and
(ii) the absence of adequate labeling could pose significant
risks to pediatric patients.
(2) Waivers
(A) Full waiver
At the request of an applicant, the Secretary shall grant a
full waiver, as appropriate, of the requirement to submit
assessments under this subsection if the applicant certifies
and the Secretary finds that -
(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed); or
(ii) there is evidence strongly suggesting that the drug or
biological product would be ineffective or unsafe in all
pediatric age groups.
(B) Partial waiver
At the request of an applicant, the Secretary shall grant a
partial waiver, as appropriate, of the requirement to submit
assessments under this subsection with respect to a specific
pediatric age group if the applicant certifies and the
Secretary finds that -
(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
(ii) there is evidence strongly suggesting that the drug or
biological product would be ineffective or unsafe in that age
group;
(iii)(I) the drug or biological product -
(aa) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
(bb) is not likely to be used in a substantial number of
pediatric patients in that age group; and
(II) the absence of adequate labeling could not pose
significant risks to pediatric patients; or
(iv) the applicant can demonstrate that reasonable attempts
to produce a pediatric formulation necessary for that age
group have failed.
(C) Pediatric formulation not possible
If a waiver is granted on the ground that it is not possible
to develop a pediatric formulation, the waiver shall cover only
the pediatric groups requiring that formulation.
(D) Labeling requirement
If the Secretary grants a full or partial waiver because
there is evidence that a drug or biological product would be
ineffective or unsafe in pediatric populations, the information
shall be included in the labeling for the drug or biological
product.
(3) Relationship to other pediatric provisions
(A) No assessment without written request
No assessment may be required under paragraph (1) for a drug
subject to an approved application under section 355 of this
title unless -
(i) the Secretary has issued a written request for a
related pediatric study under section 355a(c) of this title
or section 284m of title 42;
(ii)(I) if the request was made under section 355a(c) of
this title -
(aa) the recipient of the written request does not agree
to the request; or
(bb) the Secretary does not receive a response as
specified under section 355a(d)(4)(A) of this title; or
(II) if the request was made under section 284m of title 42
-
(aa) the recipient of the written request does not agree
to the request; or
(bb) the Secretary does not receive a response as
specified under section 284m(c)(2) of title 42; and
(iii)(I) the Secretary certifies under subparagraph (B)
that there are insufficient funds under sections 284m and
290b of title 42 to conduct the study; or
(II) the Secretary publishes in the Federal Register a
certification that certifies that -
(aa) no contract or grant has been awarded under section
284m or 290b of title 42; and
(bb) not less than 270 days have passed since the date of
a certification under subparagraph (B) that there are
sufficient funds to conduct the study.
(B) No agreement to request
Not later than 60 days after determining that no holder will
agree to the written request (including a determination that
the Secretary has not received a response specified under
section 355a(d) of this title or section 284m of title 42,(!1)
the Secretary shall certify whether the Secretary has
sufficient funds to conduct the study under section 284m or
290b of title 42, taking into account the prioritization under
section 284m of title 42.
(c) Meaningful therapeutic benefit
For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I)
of subsection (a) of this section and paragraphs (1)(B)(i) and
(2)(B)(iii)(I)(aa) of subsection (b) of this section, a drug or
biological product shall be considered to represent a meaningful
therapeutic benefit over existing therapies if the Secretary
estimates that -
(1) if approved, the drug or biological product would represent
a significant improvement in the treatment, diagnosis, or
prevention of a disease, compared with marketed products
adequately labeled for that use in the relevant pediatric
population; or
(2) the drug or biological product is in a class of products or
for an indication for which there is a need for additional
options.
(d) Submission of assessments
If a person fails to submit an assessment described in subsection
(a)(2) of this section, or a request for approval of a pediatric
formulation described in subsection (a) or (b) of this section, in
accordance with applicable provisions of subsections (a) and (b) of
this section -
(1) the drug or biological product that is the subject of the
assessment or request may be considered misbranded solely because
of that failure and subject to relevant enforcement action
(except that the drug or biological product shall not be subject
to action under section 333 of this title); but
(2) the failure to submit the assessment or request shall not
be the basis for a proceeding -
(A) to withdraw approval for a drug under section 355(e) of
this title; or
(B) to revoke the license for a biological product under
section 262 of title 42.
(e) Meetings
Before and during the investigational process for a new drug or
biological product, the Secretary shall meet at appropriate times
with the sponsor of the new drug or biological product to discuss -
(1) information that the sponsor submits on plans and timelines
for pediatric studies; or
(2) any planned request by the sponsor for waiver or deferral
of pediatric studies.
(f) Scope of authority
Nothing in this section provides to the Secretary any authority
to require a pediatric assessment of any drug or biological
product, or any assessment regarding other populations or uses of a
drug or biological product, other than the pediatric assessments
described in this section.
(g) Orphan drugs
Unless the Secretary requires otherwise by regulation, this
section does not apply to any drug for an indication for which
orphan designation has been granted under section 360bb of this
title.
(h) Integration with other pediatric studies
The authority under this section shall remain in effect so long
as an application subject to this section may be accepted for
filing by the Secretary on or before the date specified in section
355a(n) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 505B, as added Pub. L. 108-155, Sec.
2(a), Dec. 3, 2003, 117 Stat. 1936.)
-MISC1-
EFFECTIVE DATE
Pub. L. 108-155, Sec. 4, Dec. 3, 2003, 117 Stat. 1942, provided
that:
"(a) In General. - Subject to subsection (b), this Act [enacting
this section, amending sections 355, 355a, and 355b of this title
and sections 262 and 284m of Title 42, The Public Health and
Welfare, enacting provisions set out as a note under section 301 of
this title, and amending provisions set out as notes under section
355a of this title and section 284m of Title 42] and the amendments
made by this Act take effect on the date of enactment of this Act
[Dec. 3, 2003].
"(b) Applicability to New Drugs and Biological Products. -
"(1) In general. - Subsection (a) of section 505B of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)] (as
added by section 2) shall apply to an application described in
paragraph (1) of that subsection submitted to the Secretary of
Health and Human Services on or after April 1, 1999.
"(2) Waivers and deferrals. -
"(A) Waiver or deferral granted. - If, with respect to an
application submitted to the Secretary of Health and Human
Services between April 1, 1999, and the date of enactment of
this Act [Dec. 3, 2003], a waiver or deferral of pediatric
assessments was granted under regulations of the Secretary then
in effect, the waiver or deferral shall be a waiver or deferral
under subsection (a) of section 505B of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 355c(a)], except that any date
specified in such a deferral shall be extended by the number of
days that is equal to the number of days between October 17,
2002, and the date of enactment of this Act.
"(B) Waiver and deferral not granted. - If, with respect to
an application submitted to the Secretary of Health and Human
Services between April 1, 1999, and the date of enactment of
this Act [Dec. 3, 2003], neither a waiver nor deferral of
pediatric assessments was granted under regulations of the
Secretary then in effect, the person that submitted the
application shall be required to submit assessments under
subsection (a)(2) of section 505B of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 355c(a)(2)] on the date that is the
later of -
"(i) the date that is 1 year after the date of enactment of
this Act; or
"(ii) such date as the Secretary may specify under
subsection (a)(3) of that section;
unless the Secretary grants a waiver under subsection (a)(4) of
that section.
"(c) No Limitation of Authority. - Neither the lack of guidance
or regulations to implement this Act or the amendments made by this
Act nor the pendency of the process for issuing guidance or
regulations shall limit the authority of the Secretary of Health
and Human Services under, or defer any requirement under, this Act
or those amendments."
-FOOTNOTE-
(!1) So in original. A closing parenthesis probably should precede
the comma.
-End-
-CITE-
21 USC Sec. 356 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 356. Fast track products
-STATUTE-
(a) Designation of drug as fast track product
(1) In general
The Secretary shall, at the request of the sponsor of a new
drug, facilitate the development and expedite the review of such
drug if it is intended for the treatment of a serious or life-
threatening condition and it demonstrates the potential to
address unmet medical needs for such a condition. (In this
section, such a drug is referred to as a "fast track product".)
(2) Request for designation
The sponsor of a new drug may request the Secretary to
designate the drug as a fast track product. A request for the
designation may be made concurrently with, or at any time after,
submission of an application for the investigation of the drug
under section 355(i) of this title or section 262(a)(3) of title
42.
(3) Designation
Within 60 calendar days after the receipt of a request under
paragraph (2), the Secretary shall determine whether the drug
that is the subject of the request meets the criteria described
in paragraph (1). If the Secretary finds that the drug meets the
criteria, the Secretary shall designate the drug as a fast track
product and shall take such actions as are appropriate to
expedite the development and review of the application for
approval of such product.
(b) Approval of application for fast track product
(1) In general
The Secretary may approve an application for approval of a fast
track product under section 355(c) of this title or section 262
of title 42 upon a determination that the product has an effect
on a clinical endpoint or on a surrogate endpoint that is
reasonably likely to predict clinical benefit.
(2) Limitation
Approval of a fast track product under this subsection may be
subject to the requirements -
(A) that the sponsor conduct appropriate post-approval
studies to validate the surrogate endpoint or otherwise confirm
the effect on the clinical endpoint; and
(B) that the sponsor submit copies of all promotional
materials related to the fast track product during the
preapproval review period and, following approval and for such
period thereafter as the Secretary determines to be
appropriate, at least 30 days prior to dissemination of the
materials.
(3) Expedited withdrawal of approval
The Secretary may withdraw approval of a fast track product
using expedited procedures (as prescribed by the Secretary in
regulations which shall include an opportunity for an informal
hearing) if -
(A) the sponsor fails to conduct any required post-approval
study of the fast track drug with due diligence;
(B) a post-approval study of the fast track product fails to
verify clinical benefit of the product;
(C) other evidence demonstrates that the fast track product
is not safe or effective under the conditions of use; or
(D) the sponsor disseminates false or misleading promotional
materials with respect to the product.
(c) Review of incomplete applications for approval of fast track
product
(1) In general
If the Secretary determines, after preliminary evaluation of
clinical data submitted by the sponsor, that a fast track product
may be effective, the Secretary shall evaluate for filing, and
may commence review of portions of, an application for the
approval of the product before the sponsor submits a complete
application. The Secretary shall commence such review only if the
applicant -
(A) provides a schedule for submission of information
necessary to make the application complete; and
(B) pays any fee that may be required under section 379h of
this title.
(2) Exception
Any time period for review of human drug applications that has
been agreed to by the Secretary and that has been set forth in
goals identified in letters of the Secretary (relating to the use
of fees collected under section 379h of this title to expedite
the drug development process and the review of human drug
applications) shall not apply to an application submitted under
paragraph (1) until the date on which the application is
complete.
(d) Awareness efforts
The Secretary shall -
(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of this
section applicable to fast track products; and
(2) establish a program to encourage the development of
surrogate endpoints that are reasonably likely to predict
clinical benefit for serious or life-threatening conditions for
which there exist significant unmet medical needs.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 506, as added Pub. L. 105-115, title
I, Sec. 112(a), Nov. 21, 1997, 111 Stat. 2309.)
-MISC1-
PRIOR PROVISIONS
A prior section 356, act June 25, 1938, ch. 675, Sec. 506, as
added Dec. 22, 1941, ch. 613, Sec. 3, 55 Stat. 851; amended Pub. L.
102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-
80, Sec. 3(o), Aug. 13, 1993, 107 Stat. 777, related to
certification of drugs containing insulin, prior to repeal by Pub.
L. 105-115, title I, Sec. 125(a)(1), Nov. 21, 1997, 111 Stat. 2325.
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
GUIDANCE
Section 112(b) of Pub. L. 105-115 provided that: "Within 1 year
after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services shall issue guidance for
fast track products (as defined in section 506(a)(1) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes
the policies and procedures that pertain to section 506 of such
Act."
-End-
-CITE-
21 USC Sec. 356-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 356-1. Accelerated approval of priority countermeasures
-STATUTE-
(a) In general
The Secretary of Health and Human Services may designate a
priority countermeasure as a fast-track product pursuant to section
356 of this title or as a device granted review priority pursuant
to section 360e(d)(5) of this title. Such a designation may be made
prior to the submission of -
(1) a request for designation by the sponsor or applicant; or
(2) an application for the investigation of the drug under
section 355(i) of this title or section 262(a)(3) of title 42.
Nothing in this subsection shall be construed to prohibit a sponsor
or applicant from declining such a designation.
(b) Use of animal trials
A drug for which approval is sought under section 355(b) of this
title or section 262 of title 42 on the basis of evidence of
effectiveness that is derived from animal studies pursuant to
section 123 (!1) may be designated as a fast track product for
purposes of this section.
(c) Priority review of drugs and biological products
A priority countermeasure that is a drug or biological product
shall be considered a priority drug or biological product for
purposes of performance goals for priority drugs or biological
products agreed to by the Commissioner of Food and Drugs.
(d) Definitions
For purposes of this title: (!1)
(1) The term "priority countermeasure" has the meaning given
such term in section 247d-6(h)(4) of title 42.
(2) The term "priority drugs or biological products" means a
drug or biological product that is the subject of a drug or
biologics application referred to in section 101(4) of the Food
and Drug Administration Modernization Act of 1997.
-SOURCE-
(Pub. L. 107-188, title I, Sec. 122, June 12, 2002, 116 Stat. 613.)
-REFTEXT-
REFERENCES IN TEXT
Section 123, referred to in subsec. (b), is section 123 of Pub.
L. 107-188, title I, June 12, 2002, 116 Stat. 613, which is not
classified to the Code.
This title, referred to in subsec. (d), is title I of Pub. L. 107-
188, June 12, 2002, 116 Stat. 596, which enacted this section,
section 669a of Title 29, Labor, and sections 244, 245, 247d-3a,
247d-3b, 247d-7a to 247d-7d, 300hh, 300hh-11 to 300hh-13, 1320b-5,
and 7257d of Title 42, The Public Health and Welfare, amended
sections 247d to 247d-6, 264, 266, 290hh-1, and 5196b of Title 42,
and enacted provisions set out as notes preceding section 8101 of
Title 38, Veterans' Benefits, and under sections 201, 244, 247d,
247d-6, 300hh, 300hh-12, and 1320b-5 of Title 42. For complete
classification of this title to the Code, see Tables.
Section 101(4) of the Food and Drug Administration Modernization
Act of 1997, referred to in subsec. (d)(2), is section 101(4) of
Pub. L. 105-115, which is set out as a note under section 379g of
this title.
-COD-
CODIFICATION
Section was enacted as part of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, and not as part
of the Federal Food, Drug, and Cosmetic Act which comprises this
chapter.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 356a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 356a. Manufacturing changes
-STATUTE-
(a) In general
With respect to a drug for which there is in effect an approved
application under section 355 or 360b of this title or a license
under section 262 of title 42, a change from the manufacturing
process approved pursuant to such application or license may be
made, and the drug as made with the change may be distributed, if -
(1) the holder of the approved application or license (referred
to in this section as a "holder") has validated the effects of
the change in accordance with subsection (b) of this section; and
(2)(A) in the case of a major manufacturing change, the holder
has complied with the requirements of subsection (c) of this
section; or
(B) in the case of a change that is not a major manufacturing
change, the holder complies with the applicable requirements of
subsection (d) of this section.
(b) Validation of effects of changes
For purposes of subsection (a)(1) of this section, a drug made
with a manufacturing change (whether a major manufacturing change
or otherwise) may be distributed only if, before distribution of
the drug as so made, the holder involved validates the effects of
the change on the identity, strength, quality, purity, and potency
of the drug as the identity, strength, quality, purity, and potency
may relate to the safety or effectiveness of the drug.
(c) Major manufacturing changes
(1) Requirement of supplemental application
For purposes of subsection (a)(2)(A) of this section, a drug
made with a major manufacturing change may be distributed only
if, before the distribution of the drug as so made, the holder
involved submits to the Secretary a supplemental application for
such change and the Secretary approves the application. The
application shall contain such information as the Secretary
determines to be appropriate, and shall include the information
developed under subsection (b) of this section by the holder in
validating the effects of the change.
(2) Changes qualifying as major changes
For purposes of subsection (a)(2)(A) of this section, a major
manufacturing change is a manufacturing change that is determined
by the Secretary to have substantial potential to adversely
affect the identity, strength, quality, purity, or potency of the
drug as they may relate to the safety or effectiveness of a drug.
Such a change includes a change that -
(A) is made in the qualitative or quantitative formulation of
the drug involved or in the specifications in the approved
application or license referred to in subsection (a) of this
section for the drug (unless exempted by the Secretary by
regulation or guidance from the requirements of this
subsection);
(B) is determined by the Secretary by regulation or guidance
to require completion of an appropriate clinical study
demonstrating equivalence of the drug to the drug as
manufactured without the change; or
(C) is another type of change determined by the Secretary by
regulation or guidance to have a substantial potential to
adversely affect the safety or effectiveness of the drug.
(d) Other manufacturing changes
(1) In general
For purposes of subsection (a)(2)(B) of this section, the
Secretary may regulate drugs made with manufacturing changes that
are not major manufacturing changes as follows:
(A) The Secretary may in accordance with paragraph (2)
authorize holders to distribute such drugs without submitting a
supplemental application for such changes.
(B) The Secretary may in accordance with paragraph (3)
require that, prior to the distribution of such drugs, holders
submit to the Secretary supplemental applications for such
changes.
(C) The Secretary may establish categories of such changes
and designate categories to which subparagraph (A) applies and
categories to which subparagraph (B) applies.
(2) Changes not requiring supplemental application
(A) Submission of report
A holder making a manufacturing change to which paragraph
(1)(A) applies shall submit to the Secretary a report on the
change, which shall contain such information as the Secretary
determines to be appropriate, and which shall include the
information developed under subsection (b) of this section by
the holder in validating the effects of the change. The report
shall be submitted by such date as the Secretary may specify.
(B) Authority regarding annual reports
In the case of a holder that during a single year makes more
than one manufacturing change to which paragraph (1)(A)
applies, the Secretary may in carrying out subparagraph (A)
authorize the holder to comply with such subparagraph by
submitting a single report for the year that provides the
information required in such subparagraph for all the changes
made by the holder during the year.
(3) Changes requiring supplemental application
(A) Submission of supplemental application
The supplemental application required under paragraph (1)(B)
for a manufacturing change shall contain such information as
the Secretary determines to be appropriate, which shall include
the information developed under subsection (b) of this section
by the holder in validating the effects of the change.
(B) Authority for distribution
In the case of a manufacturing change to which paragraph
(1)(B) applies:
(i) The holder involved may commence distribution of the
drug involved 30 days after the Secretary receives the
supplemental application under such paragraph, unless the
Secretary notifies the holder within such 30-day period that
prior approval of the application is required before
distribution may be commenced.
(ii) The Secretary may designate a category of such changes
for the purpose of providing that, in the case of a change
that is in such category, the holder involved may commence
distribution of the drug involved upon the receipt by the
Secretary of a supplemental application for the change.
(iii) If the Secretary disapproves the supplemental
application, the Secretary may order the manufacturer to
cease the distribution of the drugs that have been made with
the manufacturing change.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 506A, as added Pub. L. 105-115, title
I, Sec. 116(a), Nov. 21, 1997, 111 Stat. 2313.)
-MISC1-
EFFECTIVE DATE
Section 116(b) of Pub. L. 105-115 provided that: "The amendment
made by subsection (a) [enacting this section] takes effect upon
the effective date of regulations promulgated by the Secretary of
Health and Human Services to implement such amendment, or upon the
expiration of the 24-month period beginning on the date of the
enactment of this Act [Nov. 21, 1997], whichever occurs first."
-End-
-CITE-
21 USC Sec. 356b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 356b. Reports of postmarketing studies
-STATUTE-
(a) Submission
(1) In general
A sponsor of a drug that has entered into an agreement with the
Secretary to conduct a postmarketing study of a drug shall submit
to the Secretary, within 1 year after the approval of such drug
and annually thereafter until the study is completed or
terminated, a report of the progress of the study or the reasons
for the failure of the sponsor to conduct the study. The report
shall be submitted in such form as is prescribed by the Secretary
in regulations issued by the Secretary.
(2) Agreements prior to effective date
Any agreement entered into between the Secretary and a sponsor
of a drug, prior to November 21, 1997, to conduct a postmarketing
study of a drug shall be subject to the requirements of paragraph
(1). An initial report for such an agreement shall be submitted
within 6 months after the date of the issuance of the regulations
under paragraph (1).
(b) Consideration of information as public information
Any information pertaining to a report described in subsection
(a) of this section shall be considered to be public information to
the extent that the information is necessary -
(1) to identify the sponsor; and
(2) to establish the status of a study described in subsection
(a) of this section and the reasons, if any, for any failure to
carry out the study.
(c) Status of studies and reports
The Secretary shall annually develop and publish in the Federal
Register a report that provides information on the status of the
postmarketing studies -
(1) that sponsors have entered into agreements to conduct; and
(2) for which reports have been submitted under subsection
(a)(1) of this section.
(d) Disclosure
If a sponsor fails to complete an agreed upon study required by
this section by its original or otherwise negotiated deadline, the
Secretary shall publish a statement on the Internet site of the
Food and Drug Administration stating that the study was not
completed and, if the reasons for such failure to complete the
study were not satisfactory to the Secretary, a statement that such
reasons were not satisfactory to the Secretary.
(e) Notification
With respect to studies of the type required under section
356(b)(2)(A) of this title or under section 314.510 or 601.41 of
title 21, Code of Federal Regulations, as each of such sections was
in effect on the day before the effective date of this subsection,
the Secretary may require that a sponsor who, for reasons not
satisfactory to the Secretary, fails to complete by its deadline a
study under any of such sections of such type for a drug or
biological product (including such a study conducted after such
effective date) notify practitioners who prescribe such drug or
biological product of the failure to complete such study and the
questions of clinical benefit, and, where appropriate, questions of
safety, that remain unanswered as a result of the failure to
complete such study. Nothing in this subsection shall be construed
as altering the requirements of the types of studies required under
section 356(b)(2)(A) of this title or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as so in effect,
or as prohibiting the Secretary from modifying such sections of
title 21 of such Code to provide for studies in addition to those
of such type.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 506B, as added Pub. L. 105-115, title
I, Sec. 130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107-
188, title V, Sec. 506, June 12, 2002, 116 Stat. 693.)
-REFTEXT-
REFERENCES IN TEXT
The effective date of this subsection, referred to in subsec.
(e), is Oct. 1, 2002, see Effective Date of 2002 Amendment note set
out below.
-MISC1-
AMENDMENTS
2002 - Subsecs. (d), (e). Pub. L. 107-188 added subsecs. (d) and
(e).
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-188, title V, Sec. 508, June 12, 2002, 116 Stat. 694,
provided that: "The amendments made by this subtitle [subtitle A
(Secs. 501-509) of title V of Pub. L. 107-188, amending this
section and sections 379g and 379h of this title] shall take effect
October 1, 2002."
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
REPORT TO CONGRESSIONAL COMMITTEES
Pub. L. 105-115, title I, Sec. 130(b), Nov. 21, 1997, 111 Stat.
2331, provided that not later than Oct. 1, 2001, the Secretary was
to submit to Congress a report containing a summary of the reports
submitted under section 356b of this title and an evaluation and
legislative recommendations relating to postmarketing studies of
drugs.
-End-
-CITE-
21 USC Sec. 356c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 356c. Discontinuance of life saving product
-STATUTE-
(a) In general
A manufacturer that is the sole manufacturer of a drug -
(1) that is -
(A) life-supporting;
(B) life-sustaining; or
(C) intended for use in the prevention of a debilitating
disease or condition;
(2) for which an application has been approved under section
355(b) or 355(j) of this title; and
(3) that is not a product that was originally derived from
human tissue and was replaced by a recombinant product,
shall notify the Secretary of a discontinuance of the manufacture
of the drug at least 6 months prior to the date of the
discontinuance.
(b) Reduction in notification period
The notification period required under subsection (a) of this
section for a manufacturer may be reduced if the manufacturer
certifies to the Secretary that good cause exists for the
reduction, such as a situation in which -
(1) a public health problem may result from continuation of the
manufacturing for the 6-month period;
(2) a biomaterials shortage prevents the continuation of the
manufacturing for the 6-month period;
(3) a liability problem may exist for the manufacturer if the
manufacturing is continued for the 6-month period;
(4) continuation of the manufacturing for the 6-month period
may cause substantial economic hardship for the manufacturer;
(5) the manufacturer has filed for bankruptcy under chapter 7
or 11 of title 11; or
(6) the manufacturer can continue the distribution of the drug
involved for 6 months.
(c) Distribution
To the maximum extent practicable, the Secretary shall distribute
information on the discontinuation of the drugs described in
subsection (a) of this section to appropriate physician and patient
organizations.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 506C, as added Pub. L. 105-115, title
I, Sec. 131(a), Nov. 21, 1997, 111 Stat. 2332.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 357 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 357. Repealed.
-MISC1-
Sec. 357. Repealed. Pub. L. 105-115, title I, Sec. 125(b)(1), Nov.
21, 1997, 111 Stat. 2325.
Section, act June 25, 1938, ch. 675, Sec. 507, as added July 6,
1945, ch. 281, Sec. 3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16,
Sec. 3, 61 Stat. 12; July 13, 1949, ch. 305, Sec. 2, 63 Stat. 409;
Aug. 5, 1953, ch. 334, Sec. 2, 67 Stat. 389; Pub. L. 87-781, title
I, Secs. 105(a), (b), (d)-(f), 106(a), (b), Oct. 10, 1962, 76 Stat.
785, 786, 787; Pub. L. 90-399, Sec. 105(b), July 13, 1968, 82 Stat.
352; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
Pub. L. 103-80, Sec. 3(p), Aug. 13, 1993, 107 Stat. 777, related to
certification of drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other
antibiotic drug.
-End-
-CITE-
21 USC Sec. 358 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 358. Authority to designate official names
-STATUTE-
(a) Necessity or desirability; use in official compendiums;
infringement of trademarks
The Secretary may designate an official name for any drug or
device if he determines that such action is necessary or desirable
in the interest of usefulness and simplicity. Any official name
designated under this section for any drug or device shall be the
only official name of that drug or device used in any official
compendium published after such name has been prescribed or for any
other purpose of this chapter. In no event, however, shall the
Secretary establish an official name so as to infringe a valid
trademark.
(b) Review of names in official compendiums
Within a reasonable time after October 10, 1962, and at such
other times as he may deem necessary, the Secretary shall cause a
review to be made of the official names by which drugs are
identified in the official United States Pharmacopoeia, the
official Homoeopathic Pharmacopoeia of the United States, and the
official National Formulary, and all supplements thereto, and at
such times as he may deem necessary shall cause a review to be made
of the official names by which devices are identified in any
official compendium (and all supplements thereto) to determine
whether revision of any of those names is necessary or desirable in
the interest of usefulness and simplicity.
(c) Determinations of complexity, usefulness, multiplicity, or lack
of name; designation by Secretary
Whenever he determines after any such review that (1) any such
official name is unduly complex or is not useful for any other
reason, (2) two or more official names have been applied to a
single drug or device, or to two or more drugs which are identical
in chemical structure and pharmacological action and which are
substantially identical in strength, quality, and purity, or to two
or more devices which are substantially equivalent in design and
purpose or (3) no official name has been applied to a medically
useful drug or device, he shall transmit in writing to the compiler
of each official compendium in which that drug or drugs or device
are identified and recognized his request for the recommendation of
a single official name for such drug or drugs or device which will
have usefulness and simplicity. Whenever such a single official
name has not been recommended within one hundred and eighty days
after such request, or the Secretary determines that any name so
recommended is not useful for any reason, he shall designate a
single official name for such drug or drugs or device. Whenever he
determines that the name so recommended is useful, he shall
designate that name as the official name of such drug or drugs or
device. Such designation shall be made as a regulation upon public
notice and in accordance with the procedure set forth in section
553 of title 5.
(d) Revised official names; compilation, publication, and public
distribution of listings
After each such review, and at such other times as the Secretary
may determine to be necessary or desirable, the Secretary shall
cause to be compiled, published, and publicly distributed a list
which shall list all revised official names of drugs or devices
designated under this section and shall contain such descriptive
and explanatory matter as the Secretary may determine to be
required for the effective use of those names.
(e) Request by compiler of official compendium for designation of
name
Upon a request in writing by any compiler of an official
compendium that the Secretary exercise the authority granted to him
under subsection (a) of this section, he shall upon public notice
and in accordance with the procedure set forth in section 553 of
title 5 designate the official name of the drug or device for which
the request is made.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 508, as added Pub. L. 87-781, title
I, Sec. 111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94-
295, Sec. 5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103-80, Sec.
3(q), Aug. 13, 1993, 107 Stat. 777.)
-MISC1-
AMENDMENTS
1993 - Subsecs. (c), (e). Pub. L. 103-80 substituted reference to
section 553 of title 5 for "section 4 of the Administrative
Procedure Act (5 U.S.C. 1003)".
1976 - Subsec. (a). Pub. L. 94-295 substituted "drug or device"
for "drug" wherever appearing.
Subsec. (b). Pub. L. 94-295 substituted "National Formulary, and
all supplements thereto, and at such times as he may deem necessary
shall cause a review to be made of the official names by which
devices are identified in any official compendium (and all
supplements thereto)" for "National Formulary, and all supplements
thereto,".
Subsec. (c)(2). Pub. L. 94-295 inserted "or device" after "single
drug", and "or to two or more devices which are substantially
equivalent in design and purpose" after "purity,".
Subsec. (c)(3). Pub. L. 94-295 inserted "or device" after "useful
drug" and after "drug or drugs" wherever appearing.
Subsec. (d). Pub. L. 94-295 inserted "or devices" after "drugs".
Subsec. (e). Pub. L. 94-295 substituted "drug or device" for
"drug".
EFFECTIVE DATE
Section 111(b) of Pub. L. 87-781 provided that: "This section
[enacting this section] shall take effect on the date of its
enactment [Oct. 10, 1962]."
-End-
-CITE-
21 USC Sec. 359 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 359. Nonapplicability of subchapter to cosmetics
-STATUTE-
This subchapter, as amended by the Drug Amendments of 1962, shall
not apply to any cosmetic unless such cosmetic is also a drug or
device or component thereof.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 509, as added Pub. L. 87-781, title
I, Sec. 113, Oct. 10, 1962, 76 Stat. 791.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, as amended by the Drug Amendments of 1962,
referred to in text, means the amendment of this subchapter by Pub.
L. 87-781 which enacted sections 358 to 360 of this title, amended
sections 351 to 353, 355, and 357 of this title, and enacted
provisions set out as notes under sections 352, 355, 358, and 360
of this title.
The Drug Amendments of 1962, referred to in text, is Pub. L. 87-
781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete
classification of this Act to the Code, see Short Title of 1962
Amendment note set out under section 301 of this title and Tables.
-End-
-CITE-
21 USC Sec. 360 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360. Registration of producers of drugs or devices
-STATUTE-
(a) Definitions
As used in this section -
(1) the term "manufacture, preparation, propagation,
compounding, or processing" shall include repackaging or
otherwise changing the container, wrapper, or labeling of any
drug package or device package in furtherance of the distribution
of the drug or device from the original place of manufacture to
the person who makes final delivery or sale to the ultimate
consumer or user; and
(2) the term "name" shall include in the case of a partnership
the name of each partner and, in the case of a corporation, the
name of each corporate officer and director, and the State of
incorporation.
(b) Annual registration
On or before December 31 of each year every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug or
drugs or a device or devices shall register with the Secretary his
name, places of business, and all such establishments.
(c) New producers
Every person upon first engaging in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs or a
device or devices in any establishment which he owns or operates in
any State shall immediately register with the Secretary his name,
place of business, and such establishment.
(d) Additional establishments
Every person duly registered in accordance with the foregoing
subsections of this section shall immediately register with the
Secretary any additional establishment which he owns or operates in
any State and in which he begins the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs or a
device or devices.
(e) Registration number; uniform system for identification of
devices intended for human use
The Secretary may assign a registration number to any person or
any establishment registered in accordance with this section. The
Secretary may also assign a listing number to each drug or class of
drugs listed under subsection (j) of this section. Any number
assigned pursuant to the preceding sentence shall be the same as
that assigned pursuant to the National Drug Code. The Secretary may
by regulation prescribe a uniform system for the identification of
devices intended for human use and may require that persons who are
required to list such devices pursuant to subsection (j) of this
section shall list such devices in accordance with such system.
(f) Availability of registrations for inspection
The Secretary shall make available for inspection, to any person
so requesting, any registration filed pursuant to this section;
except that any list submitted pursuant to paragraph (3) of
subsection (j) of this section and the information accompanying any
list or notice filed under paragraph (1) or (2) of that subsection
shall be exempt from such inspection unless the Secretary finds
that such an exemption would be inconsistent with protection of the
public health.
(g) Exclusions from application of section
The foregoing subsections of this section shall not apply to -
(1) pharmacies which maintain establishments in conformance
with any applicable local laws regulating the practice of
pharmacy and medicine and which are regularly engaged in
dispensing prescription drugs or devices, upon prescriptions of
practitioners licensed to administer such drugs or devices to
patients under the care of such practitioners in the course of
their professional practice, and which do not manufacture,
prepare, propagate, compound, or process drugs or devices for
sale other than in the regular course of their business of
dispensing or selling drugs or devices at retail;
(2) practitioners licensed by law to prescribe or administer
drugs or devices and who manufacture, prepare, propagate,
compound, or process drugs or devices solely for use in the
course of their professional practice;
(3) persons who manufacture, prepare, propagate, compound, or
process drugs or devices solely for use in research, teaching, or
chemical analysis and not for sale;
(4) any distributor who acts as a wholesale distributor of
devices, and who does not manufacture, repackage, process, or
relabel a device; or
(5) such other classes of persons as the Secretary may by
regulation exempt from the application of this section upon a
finding that registration by such classes of persons in
accordance with this section is not necessary for the protection
of the public health.
In this subsection, the term "wholesale distributor" means any
person (other than the manufacturer or the initial importer) who
distributes a device from the original place of manufacture to the
person who makes the final delivery or sale of the device to the
ultimate consumer or user.
(h) Inspection of premises
Every establishment in any State registered with the Secretary
pursuant to this section shall be subject to inspection pursuant to
section 374 of this title and every such establishment engaged in
the manufacture, propagation, compounding, or processing of a drug
or drugs or of a device or devices classified in class II or III
shall be so inspected by one or more officers or employees duly
designated by the Secretary, or by persons accredited to conduct
inspections under section 374(g) of this title, at least once in
the two-year period beginning with the date of registration of such
establishment pursuant to this section and at least once in every
successive two-year period thereafter.
(i) Registration of foreign establishments
(1) On or before December 31 of each year, any establishment
within any foreign country engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or a device that
is imported or offered for import into the United States shall,
through electronic means in accordance with the criteria of the
Secretary, register with the Secretary the name and place of
business of the establishment, the name of the United States agent
for the establishment, the name of each importer of such drug or
device in the United States that is known to the establishment, and
the name of each person who imports or offers for import such drug
or device to the United States for purposes of importation.
(2) The establishment shall also provide the information required
by subsection (j) of this section.
(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that
adequate and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by an
establishment described in paragraph (1), if imported or offered
for import into the United States, shall be refused admission on
any of the grounds set forth in section 381(a) of this title.
(j) Filing of lists of drugs and devices manufactured, prepared,
propagated and compounded by registrants; statements;
accompanying disclosures
(1) Every person who registers with the Secretary under
subsection (b), (c), (d), or (i) of this section shall, at the time
of registration under any such subsection, file with the Secretary
a list of all drugs and a list of all devices and a brief statement
of the basis for believing that each device included in the list is
a device rather than a drug (with each drug and device in each list
listed by its established name (as defined in section 352(e) of
this title) and by any proprietary name) which are being
manufactured, prepared, propagated, compounded, or processed by him
for commercial distribution and which he has not included in any
list of drugs or devices filed by him with the Secretary under this
paragraph or paragraph (2) before such time of registration. Such
list shall be prepared in such form and manner as the Secretary may
prescribe and shall be accompanied by -
(A) in the case of a drug contained in the applicable list and
subject to section 355 or 360b of this title, or a device
intended for human use contained in the applicable list with
respect to which a performance standard has been established
under section 360d of this title or which is subject to section
360e of this title, a reference to the authority for the
marketing of such drug or device and a copy of all labeling for
such drug or device;
(B) in the case of any other drug or device contained in an
applicable list -
(i) which drug is subject to section 353(b)(1) of this title,
or which device is a restricted device, a copy of all labeling
for such drug or device, a representative sampling of
advertisements for such drug or device, and, upon request made
by the Secretary for good cause, a copy of all advertisements
for a particular drug product or device, or
(ii) which drug is not subject to section 353(b)(1) of this
title or which device is not a restricted device, the label and
package insert for such drug or device and a representative
sampling of any other labeling for such drug or device;
(C) in the case of any drug contained in an applicable list
which is described in subparagraph (B), a quantitative listing of
its active ingredient or ingredients, except that with respect to
a particular drug product the Secretary may require the
submission of a quantitative listing of all ingredients if he
finds that such submission is necessary to carry out the purposes
of this chapter; and
(D) if the registrant filing a list has determined that a
particular drug product or device contained in such list is not
subject to section 355 or 360b of this title, or the particular
device contained in such list is not subject to a performance
standard established under section 360d of this title or to
section 360e of this title or is not a restricted device a brief
statement of the basis upon which the registrant made such
determination if the Secretary requests such a statement with
respect to that particular drug product or device.
(2) Each person who registers with the Secretary under this
section shall report to the Secretary once during the month of June
of each year and once during the month of December of each year the
following information:
(A) A list of each drug or device introduced by the registrant
for commercial distribution which has not been included in any
list previously filed by him with the Secretary under this
subparagraph or paragraph (1) of this subsection. A list under
this subparagraph shall list a drug or device by its established
name (as defined in section 352(e) of this title), and by any
proprietary name it may have and shall be accompanied by the
other information required by paragraph (1).
(B) If since the date the registrant last made a report under
this paragraph (or if he has not made a report under this
paragraph, since February 1, 1973) he has discontinued the
manufacture, preparation, propagation, compounding, or processing
for commercial distribution of a drug or device included in a
list filed by him under subparagraph (A) or paragraph (1); notice
of such discontinuance, the date of such discontinuance, and the
identity (by established name (as defined in section 352(e) of
this title) and by any proprietary name) of such drug or device.
(C) If since the date the registrant reported pursuant to
subparagraph (B) a notice of discontinuance he has resumed the
manufacture, preparation, propagation, compounding, or processing
for commercial distribution of the drug or device with respect to
which such notice of discontinuance was reported; notice of such
resumption, the date of such resumption, the identity of such
drug or device (each by established name (as defined in section
352(e) of this title) and by any proprietary name), and the other
information required by paragraph (1), unless the registrant has
previously reported such resumption to the Secretary pursuant to
this subparagraph.
(D) Any material change in any information previously submitted
pursuant to this paragraph or paragraph (1).
(3) The Secretary may also require each registrant under this
section to submit a list of each drug product which (A) the
registrant is manufacturing, preparing, propagating, compounding,
or processing for commercial distribution, and (B) contains a
particular ingredient. The Secretary may not require the submission
of such a list unless he has made a finding that the submission of
such a list is necessary to carry out the purposes of this chapter.
(k) Report preceding introduction of devices into interstate
commerce
Each person who is required to register under this section and
who proposes to begin the introduction or delivery for introduction
into interstate commerce for commercial distribution of a device
intended for human use shall, at least ninety days before making
such introduction or delivery, report to the Secretary or person
who is accredited under section 360m(a) of this title (in such form
and manner as the Secretary shall by regulation prescribe) -
(1) the class in which the device is classified under section
360c of this title or if such person determines that the device
is not classified under such section, a statement of that
determination and the basis for such person's determination that
the device is or is not so classified, and
(2) action taken by such person to comply with requirements
under section 360d or 360e of this title which are applicable to
the device.
(l) Exemption from reporting requirements
A report under subsection (k) of this section is not required for
a device intended for human use that is exempted from the
requirements of this subsection under subsection (m) of this
section or is within a type that has been classified into class I
under section 360c of this title. The exception established in the
preceding sentence does not apply to any class I device that is
intended for a use which is of substantial importance in preventing
impairment of human health, or to any class I device that presents
a potential unreasonable risk of illness or injury.
(m) List of exempt class II devices; determination by Secretary;
publication in Federal Register
(1) Not later than 60 days after November 21, 1997, the Secretary
shall publish in the Federal Register a list of each type of class
II device that does not require a report under subsection (k) of
this section to provide reasonable assurance of safety and
effectiveness. Each type of class II device identified by the
Secretary as not requiring the report shall be exempt from the
requirement to provide a report under subsection (k) of this
section as of the date of the publication of the list in the
Federal Register. The Secretary shall publish such list on the
Internet site of the Food and Drug Administration. The list so
published shall be updated not later than 30 days after each
revision of the list by the Secretary.
(2) Beginning on the date that is 1 day after the date of the
publication of a list under this subsection, the Secretary may
exempt a class II device from the requirement to submit a report
under subsection (k) of this section, upon the Secretary's own
initiative or a petition of an interested person, if the Secretary
determines that such report is not necessary to assure the safety
and effectiveness of the device. The Secretary shall publish in the
Federal Register notice of the intent of the Secretary to exempt
the device, or of the petition, and provide a 30-day period for
public comment. Within 120 days after the issuance of the notice in
the Federal Register, the Secretary shall publish an order in the
Federal Register that sets forth the final determination of the
Secretary regarding the exemption of the device that was the
subject of the notice. If the Secretary fails to respond to a
petition within 180 days of receiving it, the petition shall be
deemed to be granted.
(n) Review of report; time for determination by Secretary
The Secretary shall review the report required in subsection (k)
of this section and make a determination under section 360c(f)(1)
of this title not later than 90 days after receiving the report.
(o) Reprocessed single-use devices
(1) With respect to reprocessed single-use devices for which
reports are required under subsection (k) of this section:
(A) The Secretary shall identify such devices or types of
devices for which reports under such subsection must, in order to
ensure that the device is substantially equivalent to a predicate
device, include validation data, the types of which shall be
specified by the Secretary, regarding cleaning and sterilization,
and functional performance demonstrating that the single-use
device will remain substantially equivalent to its predicate
device after the maximum number of times the device is
reprocessed as intended by the person submitting the premarket
notification. Within six months after October 26, 2002, the
Secretary shall publish in the Federal Register a list of the
types so identified, and shall revise the list as appropriate.
Reports under subsection (k) of this section for devices or types
of devices within a type included on the list are, upon
publication of the list, required to include such validation
data.
(B) In the case of each report under subsection (k) of this
section that was submitted to the Secretary before the
publication of the initial list under subparagraph (A), or any
revision thereof, and was for a device or type of device included
on such list, the person who submitted the report under
subsection (k) of this section shall submit validation data as
described in subparagraph (A) to the Secretary not later than
nine months after the publication of the list. During such nine-
month period, the Secretary may not take any action under this
chapter against such device solely on the basis that the
validation data for the device have not been submitted to the
Secretary. After the submission of the validation data to the
Secretary, the Secretary may not determine that the device is
misbranded under section 352(o) of this title or adulterated
under section 351(f)(1)(B) of this title, or take action against
the device under section 331(p) of this title for failure to
provide any information required by subsection (k) of this
section until (i) the review is terminated by withdrawal of the
submission of the report under subsection (k) of this section;
(ii) the Secretary finds the data to be acceptable and issues a
letter; or (iii) the Secretary determines that the device is not
substantially equivalent to a predicate device. Upon a
determination that a device is not substantially equivalent to a
predicate device, or if such submission is withdrawn, the device
can no longer be legally marketed.
(C) In the case of a report under subsection (k) of this
section for a device identified under subparagraph (A) that is of
a type for which the Secretary has not previously received a
report under such subsection, the Secretary may, in advance of
revising the list under subparagraph (A) to include such type,
require that the report include the validation data specified in
subparagraph (A).
(D) Section 352(o) of this title applies with respect to the
failure of a report under subsection (k) of this section to
include validation data required under subparagraph (A).
(2) With respect to critical or semi-critical reprocessed single-
use devices that, under subsection (l) or (m) of this section, are
exempt from the requirement of submitting reports under subsection
(k) of this section:
(A) The Secretary shall identify such devices or types of
devices for which such exemptions should be terminated in order
to provide a reasonable assurance of the safety and effectiveness
of the devices. The Secretary shall publish in the Federal
Register a list of the devices or types of devices so identified,
and shall revise the list as appropriate. The exemption for each
device or type included on the list is terminated upon the
publication of the list. For each report under subsection (k) of
this section submitted pursuant to this subparagraph the
Secretary shall require the validation data described in
paragraph (1)(A).
(B) For each device or type of device included on the list
under subparagraph (A), a report under subsection (k) of this
section shall be submitted to the Secretary not later than 15
months after the publication of the initial list, or a revision
of the list, whichever terminates the exemption for the device.
During such 15-month period, the Secretary may not take any
action under this chapter against such device solely on the basis
that such report has not been submitted to the Secretary. After
the submission of the report to the Secretary the Secretary may
not determine that the device is misbranded under section 352(o)
of this title or adulterated under section 351(f)(1)(B) of this
title, or take action against the device under section 331(p) of
this title for failure to provide any information required by
subsection (k) of this section until (i) the review is terminated
by withdrawal of the submission; (ii) the Secretary determines by
order that the device is substantially equivalent to a predicate
device; or (iii) the Secretary determines by order that the
device is not substantially equivalent to a predicate device.
Upon a determination that a device is not substantially
equivalent to a predicate device, the device can no longer be
legally marketed.
(C) In the case of semi-critical devices, the initial list
under subparagraph (A) shall be published not later than 18
months after the effective date of this subsection. In the case
of critical devices, the initial list under such subparagraph
shall be published not later than six months after such effective
date.
(D) Section 352(o) of this title applies with respect to the
failure to submit a report under subsection (k) of this section
that is required pursuant to subparagraph (A), including a
failure of the report to include validation data required in such
subparagraph.
(E) The termination under subparagraph (A) of an exemption
under subsection (l) or (m) of this section for a critical or
semi-critical reprocessed single-use device does not terminate
the exemption under subsection (l) or (m) of this section for the
original device.
(p) Electronic registration
Registrations under subsections (b), (c), (d), and (i) of this
section (including the submission of updated information) shall be
submitted to the Secretary by electronic means, upon a finding by
the Secretary that the electronic receipt of such registrations is
feasible, unless the Secretary grants a request for waiver of such
requirement because use of electronic means is not reasonable for
the person requesting such waiver.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 510, as added Pub. L. 87-781, title
III, Sec. 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89-74,
Sec. 4, July 15, 1965, 79 Stat. 231; Pub. L. 91-513, title II, Sec.
701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92-387, Secs. 3, 4(a)-
(c), Aug. 16, 1972, 86 Stat. 560-562; Pub. L. 94-295, Sec. 4(a),
May 28, 1976, 90 Stat. 579; Pub. L. 105-115, title I, Sec.
125(a)(2)(C), title II, Secs. 206(a), 209(a), 213(b), title IV,
Sec. 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379;
Pub. L. 107-188, title III, Sec. 321(a), June 12, 2002, 116 Stat.
675; Pub. L. 107-250, title II, Secs. 201(e), 207, 211, title III,
Sec. 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub.
L. 108-214, Sec. 2(c)(2), Apr. 1, 2004, 118 Stat. 576.)
-REFTEXT-
REFERENCES IN TEXT
The effective date of this subsection, referred to in subsec.
(o)(2)(C), probably means the date of the enactment of Pub. L. 107-
250, which enacted subsec. (o) of this section and was approved
Oct. 26, 2002.
-MISC1-
AMENDMENTS
2004 - Subsec. (o)(1)(B), (2)(B). Pub. L. 108-214, Sec.
2(c)(2)(A), (B)(i), substituted "or adulterated" for ",
adulterated".
Subsec. (o)(2)(E). Pub. L. 108-214, Sec. 2(c)(2)(B)(ii),
substituted "semi-critical" for "semicritical".
2002 - Subsec. (h). Pub. L. 107-250, Sec. 201(e), inserted ", or
by persons accredited to conduct inspections under section 374(g)
of this title," after "duly designated by the Secretary".
Subsec. (i)(1). Pub. L. 107-188, Sec. 321(a)(1), substituted "On
or before December 31 of each year, any establishment" for "Any
establishment" and "shall, through electronic means in accordance
with the criteria of the Secretary, register with the Secretary the
name and place of business of the establishment, the name of the
United States agent for the establishment, the name of each
importer of such drug or device in the United States that is known
to the establishment, and the name of each person who imports or
offers for import such drug or device to the United States for
purposes of importation" for "shall register with the Secretary the
name and place of business of the establishment and the name of the
United States agent for the establishment".
Subsec. (j)(1). Pub. L. 107-188, Sec. 321(a)(2), substituted
"subsection (b), (c), (d), or (i)" for "subsection (b), (c), or
(d)" in first sentence.
Subsec. (m)(1). Pub. L. 107-250, Sec. 211, inserted at end "The
Secretary shall publish such list on the Internet site of the Food
and Drug Administration. The list so published shall be updated not
later than 30 days after each revision of the list by the
Secretary."
Subsec. (o). Pub. L. 107-250, Sec. 302(b), added subsec. (o).
Subsec. (p). Pub. L. 107-250, Sec. 207, added subsec. (p).
1997 - Subsec. (g). Pub. L. 105-115, Sec. 213(b)(3), inserted at
end "In this subsection, the term 'wholesale distributor' means any
person (other than the manufacturer or the initial importer) who
distributes a device from the original place of manufacture to the
person who makes the final delivery or sale of the device to the
ultimate consumer or user."
Subsec. (g)(4), (5). Pub. L. 105-115, Sec. 213(b)(1), (2), added
par. (4) and redesignated former par. (4) as (5).
Subsec. (i). Pub. L. 105-115, Sec. 417, amended subsec. (i)
generally. Prior to amendment, subsec. (i) read as follows: "Any
establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing
of a drug or drugs, or a device or devices, shall be permitted to
register under this section pursuant to regulations promulgated by
the Secretary. Such regulations shall require such establishment to
provide the information required by subsection (j) of this section
and shall require such establishment to provide the information
required by subsection (j) of this section in the case of a device
or devices and shall include provisions for registration of any
such establishment upon condition that adequate and effective means
are available, by arrangement with the government of such foreign
country or otherwise, to enable the Secretary to determine from
time to time whether drugs or devices manufactured, prepared,
propagated, compounded, or processed in such establishment, if
imported or offered for import into the United States, shall be
refused admission on any of the grounds set forth in section 381(a)
of this title."
Subsec. (j)(1)(A), (D). Pub. L. 105-115, Sec. 125(a)(2)(C),
struck out ", 356, 357," before "or 360b of this title".
Subsec. (k). Pub. L. 105-115, Sec. 206(a)(1), inserted "or person
who is accredited under section 360m(a) of this title" after
"report to the Secretary".
Subsecs. (l), (m). Pub. L. 105-115, Sec. 206(a)(2), added
subsecs. (l) and (m).
Subsec. (n). Pub. L. 105-115, Sec. 209(a), added subsec. (n).
1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 4(a)(2), substituted
"drug package or device package" for "drug package", "distribution
of the drug or device" for "distribution of the drug", and
"ultimate consumer or user" for "ultimate consumer".
Subsecs. (b) to (d). Pub. L. 94-295, Sec. 4(a)(3), inserted "or a
device or devices" after "drug or drugs".
Subsec. (e). Pub. L. 94-295, Sec. 4(a)(4), authorized the
Secretary to prescribe by regulation a uniform system for the
identification of devices intended for human use and authorized
him, in addition, to require that persons who are required to list
devices pursuant to subsec. (j) also list such devices in
accordance with the system.
Subsec. (g)(1) to (3). Pub. L. 94-295, Sec. 4(a)(5), substituted
"drugs or devices" for "drugs".
Subsec. (h). Pub. L. 94-295, Sec. 4(a)(6), inserted reference to
establishments engaged in the manufacture, propagation,
compounding, or processing of a drug or drugs or of a device or
devices classified in class II or III.
Subsec. (i). Pub. L. 94-295, Sec. 4(a)(7), inserted reference to
devices and inserted requirement that regulations require
establishments to provide the information required by subsection
(j) of this section in the case of a device or devices.
Subsec. (j)(1). Pub. L. 94-295, Sec. 4(a)(8)(A), in introductory
provisions substituted "a list of all drugs and a list of all
devices and a brief statement of the basis for believing that each
device included in the list is a device rather than a drug (with
each drug and device in each list listed by its established name"
for "a list of all drugs (by established name" and "drugs or
devices filed" for "drugs filed".
Subsec. (j)(1)(A). Pub. L. 94-295, Sec. 4(a)(8)(B), substituted
"the applicable list" for "such list", inserted "or a device
intended for human use contained in the applicable list with
respect to which a performance standard has been established under
section 360d of this title or which is subject to section 360e of
this title," after "360b of this title,", and substituted "such
drug or device" for "such drug" wherever appearing.
Subsec. (j)(1)(B). Pub. L. 94-295, Sec. 4(a)(8)(C), in
introductory provisions substituted "drug or device contained in an
applicable list" for "drug contained in such list".
Subsec. (j)(1)(B)(i). Pub. L. 94-295, Sec. 4(a)(8)(D),
substituted "which drug is subject to section 353(b)(1) of this
title, or which device is a restricted device, a copy of all
labeling for such drug or device, a representative sampling of
advertisements for such drug or device, and, upon request made by
the Secretary for good cause, a copy of all advertisements for a
particular drug product or device, or" for "which is subject to
section 353(b)(1) of this title, a copy of all labeling for such
drug, a representative sampling of advertisements for such drug,
and, upon request made by the Secretary for good cause, a copy of
all advertisements for a particular drug product, or".
Subsec. (j)(1)(B)(ii). Pub. L. 94-295, Sec. 4(a)(8)(E),
substituted "which drug is not subject to section 353(b)(1) of this
title or which device is not a restricted device, the label and
package insert for such drug or device and a representative
sampling of any other labeling for such drug or device" for "which
is not subject to section 353(b)(1) of this title, the label and
package insert for such drug and a representative sampling of any
other labeling for such drug".
Subsec. (j)(1)(C). Pub. L. 94-295, Sec. 4(a)(8)(F), substituted
"an applicable list" for "such list".
Subsec. (j)(1)(D). Pub. L. 94-295, Sec. 4(a)(8)(G), substituted
"a list" for "the list", inserted "or the particular device
contained in such list is not subject to a performance standard
established under section 360d of this title or to section 360e of
this title or is not a restricted device" after "or 360b of this
title,", and substituted "particular drug product or device" for
"particular drug product" wherever appearing.
Subsec. (j)(2). Pub. L. 94-295, Sec. 4(a)(8)(H), substituted
"drug or device" for "drug" in subpars. (A), (B), and (C), and
substituted "(each by established name" for "(by established name"
in subpar. (C).
Subsec. (k). Pub. L. 94-295, Sec. 4(a)(9), added subsec. (k).
1972 - Subsec. (e). Pub. L. 92-387, Sec. 4(a), inserted provision
that the Secretary may assign a listing number to each drug or
class of drugs listed under subsec. (j).
Subsec. (f). Pub. L. 92-387, Sec. 4(b), inserted exception that
the list submitted under subsec. (j)(3) and information submitted
under subsec. (j)(1), (2) shall be exempt from inspection unless
the Secretary determines otherwise.
Subsec. (i). Pub. L. 92-387, Sec. 4(c), inserted provision that
the regulations shall require such establishment to provide the
information required by subsec. (j).
Subsec. (j). Pub. L. 92-387, Sec. 3, added subsec. (j).
1970 - Subsec. (a). Pub. L. 91-513 struck out provisions defining
the wholesaling, jobbing, or distributing of depressant or
stimulant drugs.
Subsec. (b). Pub. L. 91-513 struck out provisions covering
establishments engaged in the wholesaling, jobbing, or distributing
of depressant or stimulant drugs and the inclusion of the fact of
such activity in the annual registration.
Subsec. (c). Pub. L. 91-513 struck out provisions covering new
registrations of persons first engaging in the wholesaling,
jobbing, or distributing of depressant or stimulant drugs and the
inclusion of the fact of such activity in the registration.
Subsec. (d). Pub. L. 91-513 struck out number designation "(1)"
preceding first sentence, struck out portion of such redesignated
provisions covering the wholesaling, jobbing, or distributing of
depressant or stimulant drugs, and struck out par. (2) covering the
filing of supplemental registration whenever a person not
previously engaged or involved with depressant or stimulant drugs
goes into the manufacturing, preparation, or processing thereof.
1965 - Pub. L. 89-74, Sec. 4(e), included certain wholesalers in
section catchline.
Subsec. (a)(2), (3). Pub. L. 89-74, Sec. 4(a), added par. (2) and
redesignated former par. (2) as (3).
Subsecs. (b), (c). Pub. L. 89-74, Sec. 4(b), (c), inserted "or in
the wholesaling, jobbing, or distributing of any depressant or
stimulant drug" after "drug or drugs" and inserted requirement that
establishment indicate activity in depressant or stimulant drugs at
time of registration.
Subsec. (d). Pub. L. 89-74 Sec. 4(d), designated existing
provisions as par. (1), inserted "or the wholesaling, jobbing, or
distributing of any depressant or stimulant drug" and the
requirement that the additional establishment indicate activity in
depressant or stimulant drugs at time of registration, and added
par. (2).
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107-188 effective upon the expiration of the
180-day period beginning June 12, 2002, see section 321(c) of Pub.
L. 107-188, set out as a note under section 331 of this title.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L.
105-115 effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Section 5 of Pub. L. 92-387 provided that: "The amendments made
by this Act [amending this section and sections 331 and 335 of this
title and enacting provisions set out below] shall take effect on
the first day of the sixth month beginning after the date of
enactment of this Act [Aug. 16, 1972]."
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to
registration with Secretary of names, places of business,
establishments, and other prescribed information prior to Feb. 1,
1966, see section 11 of Pub. L. 89-74, set out as a note under
section 321 of this title.
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for any violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
to be continued and brought to final determination in accord with
laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
CONGRESSIONAL DECLARATION OF NEED FOR REGISTRATION AND INSPECTION
OF DRUG ESTABLISHMENTS
Section 301 of Pub. L. 87-781 provided that: "The Congress hereby
finds and declares that in order to make regulation of interstate
commerce in drugs effective, it is necessary to provide for
registration and inspection of all establishments in which drugs
are manufactured, prepared, propagated, compounded, or processed;
that the products of all such establishments are likely to enter
the channels of interstate commerce and directly affect such
commerce; and that the regulation of interstate commerce in drugs
without provision for registration and inspection of establishments
that may be engaged only in intrastate commerce in such drugs would
discriminate against and depress interstate commerce in such drugs,
and adversely burden, obstruct, and affect such interstate
commerce."
DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972
Section 2 of Pub. L. 92-387 provided that: "The Federal
Government which is responsible for regulating drugs has no ready
means of determining what drugs are actually being manufactured or
packed by establishments registered under the Federal Food, Drug,
and Cosmetic Act [this chapter] except by periodic inspection of
such registered establishments. Knowledge of which particular drugs
are being manufactured or packed by each registered establishment
would substantially assist in the enforcement of Federal laws
requiring that such drugs be pure, safe, effective, and properly
labeled. Information on the discontinuance of a particular drug
could serve to alleviate the burden of reviewing and implementing
enforcement actions against drugs which, although commercially
discontinued, remain active for regulatory purposes. Information on
the type and number of different drugs being manufactured or packed
by drug establishments could permit more effective and timely
regulation by the agencies of the Federal Government responsible
for regulating drugs, including identification of which drugs in
interstate commerce are subject to section 505 or 507 [section 355
or 357 of this title], or to other provisions of the Federal Food,
Drug, and Cosmetic Act."
REGISTRATION OF CERTAIN PERSONS OWNING OR OPERATING DRUG
ESTABLISHMENTS PRIOR TO OCT. 10, 1962
Section 303 of Pub. L. 87-781 provided that any person who, on
the day immediately preceding Oct. 10, 1962, owned or operated an
establishment which manufactured or processed drugs, registered
before the first day of the seventh month following October, 1962,
would be deemed to be registered in accordance with subsec. (b) of
this section for the calendar year 1962 and if registered within
this period and effected in 1963, be deemed in compliance for that
calendar year.
-End-
-CITE-
21 USC Sec. 360a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360a. Repealed.
-MISC1-
Sec. 360a. Repealed. Pub. L. 91-513, title II, Sec. 701(a), Oct.
27, 1970, 84 Stat. 1281.
Section, act June 25, 1938, ch. 675, Sec. 511, as added July 15,
1965, Pub. L. 89-74, Sec. 3(b), 79 Stat. 227; amended Oct. 24,
1968, Pub. L. 90-639, Sec. 2(a), 82 Stat. 1361, regulated the
manufacture, compounding, and processing of depressant and
stimulant drugs and their sale, delivery, disposal, possession, and
recordkeeping activities connected therewith. See section 801 et
seq. of this title.
EFFECTIVE DATE OF REPEAL
Repeal by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
SAVINGS PROVISION
Repeal not to affect or abate any prosecutions for violation of
law or any civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of such repeal, and all
administrative proceedings pending before the Bureau of Narcotics
and Dangerous Drugs [now Drug Enforcement Administration] on Oct.
27, 1970, to be continued and brought to final determination in
accord with laws and regulations in effect prior to Oct. 27, 1970,
see section 702 of Pub. L. 91-513, set out as a note under section
321 of this title.
-End-
-CITE-
21 USC Sec. 360b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360b. New animal drugs
-STATUTE-
(a) Unsafe new animal drugs and animal feed containing such drugs;
conditions of safety; exemption of drugs for research; import
tolerances
(1) A new animal drug shall, with respect to any particular use
or intended use of such drug, be deemed unsafe for purposes of
section 351(a)(5) of this title and section 342(a)(2)(C)(ii) of
this title unless -
(A) there is in effect an approval of an application filed
pursuant to subsection (b) of this section with respect to such
use or intended use of such drug, and such drug, its labeling,
and such use conform to such approved application;
(B) there is in effect a conditional approval of an application
filed pursuant to section 360ccc of this title with respect to
such use or intended use of such drug, and such drug, its
labeling, and such use conform to such conditionally approved
application; or
(C) there is in effect an index listing pursuant to section
360ccc-1 of this title with respect to such use or intended use
of such drug in a minor species, and such drug, its labeling, and
such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes in
the event of removal from the establishment of a manufacturer,
packer, or distributor of such drug for use in the manufacture of
animal feed in any State unless at the time of such removal such
manufacturer, packer, or distributor has an unrevoked written
statement from the consignee of such drug, or notice from the
Secretary, to the effect that, with respect to the use of such drug
in animal feed, such consignee (i) holds a license issued under
subsection (m) of this section and has in its possession current
approved labeling for such drug in animal feed; or (ii) will, if
the consignee is not a user of the drug, ship such drug only to a
holder of a license issued under subsection (m) of this section.
(2) An animal feed bearing or containing a new animal drug shall,
with respect to any particular use or intended use of such animal
feed be deemed unsafe for purposes of section 351(a)(6) of this
title unless -
(A) there is in effect -
(i) an approval of an application filed pursuant to
subsection (b) of this section with respect to such drug, as
used in such animal feed, and such animal feed and its
labeling, distribution, holding, and use conform to such
approved application;
(ii) a conditional approval of an application filed pursuant
to section 360ccc of this title with respect to such drug, as
used in such animal feed, and such animal feed and its
labeling, distribution, holding, and use conform to such
conditionally approved application; or
(iii) an index listing pursuant to section 360ccc-1 of this
title with respect to such drug, as used in such animal feed,
and such animal feed and its labeling, distribution, holding,
and use conform to such index listing; and
(B) such animal feed is manufactured at a site for which there
is in effect a license issued pursuant to subsection (m)(1) of
this section to manufacture such animal feed.
(3) A new animal drug or an animal feed bearing or containing a
new animal drug shall not be deemed unsafe for the purposes of
section 351(a)(5) or (6) of this title if such article is for
investigational use and conforms to the terms of an exemption in
effect with respect thereto under subsection (j) of this section.
(4)(A) Except as provided in subparagraph (B), if an approval of
an application filed under subsection (b) of this section is in
effect with respect to a particular use or intended use of a new
animal drug, the drug shall not be deemed unsafe for the purposes
of paragraph (1) and shall be exempt from the requirements of
section 352(f) of this title with respect to a different use or
intended use of the drug, other than a use in or on animal feed, if
such use or intended use -
(i) is by or on the lawful written or oral order of a licensed
veterinarian within the context of a veterinarian-client-patient
relationship, as defined by the Secretary; and
(ii) is in compliance with regulations promulgated by the
Secretary that establish the conditions for such different use or
intended use.
The regulations promulgated by the Secretary under clause (ii) may
prohibit particular uses of an animal drug and shall not permit
such different use of an animal drug if the labeling of another
animal drug that contains the same active ingredient and which is
in the same dosage form and concentration provides for such
different use.
(B) If the Secretary finds that there is a reasonable probability
that a use of an animal drug authorized under subparagraph (A) may
present a risk to the public health, the Secretary may -
(i) establish a safe level for a residue of an animal drug when
it is used for such different use authorized by subparagraph (A);
and
(ii) require the development of a practical, analytical method
for the detection of residues of such drug above the safe level
established under clause (i).
The use of an animal drug that results in residues exceeding a safe
level established under clause (i) shall be considered an unsafe
use of such drug under paragraph (1). Safe levels may be
established under clause (i) either by regulation or order.
(C) The Secretary may by general regulation provide access to the
records of veterinarians to ascertain any use or intended use
authorized under subparagraph (A) that the Secretary has determined
may present a risk to the public health.
(D) If the Secretary finds, after affording an opportunity for
public comment, that a use of an animal drug authorized under
subparagraph (A) presents a risk to the public health or that an
analytical method required under subparagraph (B) has not been
developed and submitted to the Secretary, the Secretary may, by
order, prohibit any such use.
(5) If the approval of an application filed under section 355 of
this title is in effect, the drug under such application shall not
be deemed unsafe for purposes of paragraph (1) and shall be exempt
from the requirements of section 352(f) of this title with respect
to a use or intended use of the drug in animals if such use or
intended use -
(A) is by or on the lawful written or oral order of a licensed
veterinarian within the context of a veterinarian-client-patient
relationship, as defined by the Secretary; and
(B) is in compliance with regulations promulgated by the
Secretary that establish the conditions for the use or intended
use of the drug in animals.
(6) For purposes of section 342(a)(2)(D) (!1) of this title, a
use or intended use of a new animal drug shall not be deemed unsafe
under this section if the Secretary establishes a tolerance for
such drug and any edible portion of any animal imported into the
United States does not contain residues exceeding such tolerance.
In establishing such tolerance, the Secretary shall rely on data
sufficient to demonstrate that a proposed tolerance is safe based
on similar food safety criteria used by the Secretary to establish
tolerances for applications for new animal drugs filed under
subsection (b)(1) of this section. The Secretary may consider and
rely on data submitted by the drug manufacturer, including data
submitted to appropriate regulatory authorities in any country
where the new animal drug is lawfully used or data available from a
relevant international organization, to the extent such data are
not inconsistent with the criteria used by the Secretary to
establish a tolerance for applications for new animal drugs filed
under subsection (b)(1) of this section. For purposes of this
paragraph, "relevant international organization" means the Codex
Alimenterius (!2) Commission or other international organization
deemed appropriate by the Secretary. The Secretary may, under
procedures specified by regulation, revoke a tolerance established
under this paragraph if information demonstrates that the use of
the new animal drug under actual use conditions results in food
being imported into the United States with residues exceeding the
tolerance or if scientific evidence shows the tolerance to be
unsafe.
(b) Filing application for uses of new animal drug; contents;
patent information; abbreviated application; presubmission
conference
(1) Any person may file with the Secretary an application with
respect to any intended use or uses of a new animal drug. Such
person shall submit to the Secretary as a part of the application
(A) full reports of investigations which have been made to show
whether or not such drug is safe and effective for use; (B) a full
list of the articles used as components of such drug; (C) a full
statement of the composition of such drug; (D) a full description
of the methods used in, and the facilities and controls used for,
the manufacture, processing, and packing of such drug; (E) such
samples of such drug and of the articles used as components
thereof, of any animal feed for use in or on which such drug is
intended, and of the edible portions or products (before or after
slaughter) of animals to which such drug (directly or in or on
animal feed) is intended to be administered, as the Secretary may
require; (F) specimens of the labeling proposed to be used for such
drug, or in case such drug is intended for use in animal feed,
proposed labeling appropriate for such use, and specimens of the
labeling for the drug to be manufactured, packed, or distributed by
the applicant; (G) a description of practicable methods for
determining the quantity, if any, of such drug in or on food, and
any substance formed in or on food, because of its use; and (H) the
proposed tolerance or withdrawal period or other use restrictions
for such drug if any tolerance or withdrawal period or other use
restrictions are required in order to assure that the proposed use
of such drug will be safe. The applicant shall file with the
application the patent number and the expiration date of any patent
which claims the new animal drug for which the applicant filed the
application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug. If an application is filed
under this subsection for a drug and a patent which claims such
drug or a method of using such drug is issued after the filing date
but before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the Secretary
shall publish information submitted under the two preceding
sentences.
(2) Any person may file with the Secretary an abbreviated
application for the approval of a new animal drug. An abbreviated
application shall contain the information required by subsection
(n) of this section.
(3) Any person intending to file an application under paragraph
(1), section 360ccc of this title, or a request for an
investigational exemption under subsection (j) of this section
shall be entitled to one or more conferences prior to such
submission to reach an agreement acceptable to the Secretary
establishing a submission or an investigational requirement, which
may include a requirement for a field investigation. A decision
establishing a submission or an investigational requirement shall
bind the Secretary and the applicant or requestor unless (A) the
Secretary and the applicant or requestor mutually agree to modify
the requirement, or (B) the Secretary by written order determines
that a substantiated scientific requirement essential to the
determination of safety or effectiveness of the animal drug
involved has appeared after the conference. No later than 25
calendar days after each such conference, the Secretary shall
provide a written order setting forth a scientific justification
specific to the animal drug and intended uses under consideration
if the agreement referred to in the first sentence requires more
than one field investigation as being essential to provide
substantial evidence of effectiveness for the intended uses of the
drug. Nothing in this paragraph shall be construed as compelling
the Secretary to require a field investigation.
(c) Period for submission and approval of application; period for
notice and expedition of hearing; period for issuance of order;
abbreviated applications; withdrawal periods; effective date of
approval; relationship to other applications; withdrawal or
suspension of approval; bioequivalence; filing of additional
patent information
(1) Within one hundred and eighty days after the filing of an
application pursuant to subsection (b) of this section, or such
additional period as may be agreed upon by the Secretary and the
applicant, the Secretary shall either (A) issue an order approving
the application if he then finds that none of the grounds for
denying approval specified in subsection (d) of this section
applies, or (B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) of this section
on the question whether such application is approvable. If the
applicant elects to accept the opportunity for a hearing by written
request within thirty days after such notice, such hearing shall
commence not more than ninety days after the expiration of such
thirty days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing final
briefs.
(2)(A) Subject to subparagraph (C), the Secretary shall approve
an abbreviated application for a drug unless the Secretary finds -
(i) the methods used in, or the facilities and controls used
for, the manufacture, processing, and packing of the drug are
inadequate to assure and preserve its identity, strength,
quality, and purity;
(ii) the conditions of use prescribed, recommended, or
suggested in the proposed labeling are not reasonably certain to
be followed in practice or, except as provided in subparagraph
(B), information submitted with the application is insufficient
to show that each of the proposed conditions of use or similar
limitations (whether in the labeling or published pursuant to
subsection (i) of this section) have been previously approved for
the approved new animal drug referred to in the application;
(iii) information submitted with the application is
insufficient to show that the active ingredients are the same as
those of the approved new animal drug referred to in the
application;
(iv)(I) if the application is for a drug whose active
ingredients, route of administration, dosage form, strength, or
use with other animal drugs in animal feed is the same as the
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed of the
approved new animal drug referred to in the application,
information submitted in the application is insufficient to show
that the active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed is
the same as that of the approved new animal drug, or
(II) if the application is for a drug whose active ingredients,
route of administration, dosage form, strength, or use with other
animal drugs in animal feed is different from that of the
approved new animal drug referred to in the application, no
petition to file an application for the drug with the different
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed was
approved under subsection (n)(3) of this section;
(v) if the application was filed pursuant to the approval of a
petition under subsection (n)(3) of this section, the application
did not contain the information required by the Secretary
respecting the active ingredients, route of administration,
dosage form, strength, or use with other animal drugs in animal
feed which is not the same;
(vi) information submitted in the application is insufficient
to show that the drug is bioequivalent to the approved new animal
drug referred to in the application, or if the application is
filed under a petition approved pursuant to subsection (n)(3) of
this section, information submitted in the application is
insufficient to show that the active ingredients of the new
animal drug are of the same pharmacological or therapeutic class
as the pharmacological or therapeutic class of the approved new
animal drug and that the new animal drug can be expected to have
the same therapeutic effect as the approved new animal drug when
used in accordance with the labeling;
(vii) information submitted in the application is insufficient
to show that the labeling proposed for the drug is the same as
the labeling approved for the approved new animal drug referred
to in the application except for changes required because of
differences approved under a petition filed under subsection
(n)(3) of this section, because of a different withdrawal period,
or because the drug and the approved new animal drug are produced
or distributed by different manufacturers;
(viii) information submitted in the application or any other
information available to the Secretary shows that (I) the
inactive ingredients of the drug are unsafe for use under the
conditions prescribed, recommended, or suggested in the labeling
proposed for the drug, (II) the composition of the drug is unsafe
under such conditions because of the type or quantity of inactive
ingredients included or the manner in which the inactive
ingredients are included, or (III) in the case of a drug for food
producing animals, the inactive ingredients of the drug or its
composition may be unsafe with respect to human food safety;
(ix) the approval under subsection (b)(1) of this section of
the approved new animal drug referred to in the application filed
under subsection (b)(2) of this section has been withdrawn or
suspended for grounds described in paragraph (1) of subsection
(e) of this section, the Secretary has published a notice of a
hearing to withdraw approval of the approved new animal drug for
such grounds, the approval under this paragraph of the new animal
drug for which the application under subsection (b)(2) of this
section was filed has been withdrawn or suspended under
subparagraph (G) for such grounds, or the Secretary has
determined that the approved new animal drug has been withdrawn
from sale for safety or effectiveness reasons;
(x) the application does not meet any other requirement of
subsection (n) of this section; or
(xi) the application contains an untrue statement of material
fact.
(B) If the Secretary finds that a new animal drug for which an
application is submitted under subsection (b)(2) of this section is
bioequivalent to the approved new animal drug referred to in such
application and that residues of the new animal drug are consistent
with the tolerances established for such approved new animal drug
but at a withdrawal period which is different than the withdrawal
period approved for such approved new animal drug, the Secretary
may establish, on the basis of information submitted, such
different withdrawal period as the withdrawal period for the new
animal drug for purposes of the approval of such application for
such drug.
(C) Within 180 days of the initial receipt of an application
under subsection (b)(2) of this section or within such additional
period as may be agreed upon by the Secretary and the applicant,
the Secretary shall approve or disapprove the application.
(D) The approval of an application filed under subsection (b)(2)
of this section shall be made effective on the last applicable date
determined under the following:
(i) If the applicant only made a certification described in
clause (i) or (ii) of subsection (n)(1)(G) of this section or in
both such clauses, the approval may be made effective
immediately.
(ii) If the applicant made a certification described in clause
(iii) of subsection (n)(1)(G) of this section, the approval may
be made effective on the date certified under clause (iii).
(iii) If the applicant made a certification described in clause
(iv) of subsection (n)(1)(G) of this section, the approval shall
be made effective immediately unless an action is brought for
infringement of a patent which is the subject of the
certification before the expiration of 45 days from the date the
notice provided under subsection (n)(2)(B)(i) of this section is
received. If such an action is brought before the expiration of
such days, the approval shall be made effective upon the
expiration of the 30 month period beginning on the date of the
receipt of the notice provided under subsection (n)(2)(B) of this
section or such shorter or longer period as the court may order
because either party to the action failed to reasonably cooperate
in expediting the action, except that if before the expiration of
such period -
(I) the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date of
the court decision,
(II) the court decides that such patent has been infringed,
the approval shall be made effective on such date as the court
orders under section 271(e)(4)(A) of title 35, or
(III) the court grants a preliminary injunction prohibiting
the applicant from engaging in the commercial manufacture or
sale of the drug until the court decides the issues of patent
validity and infringement and if the court decides that such
patent is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate
in expediting the action. Until the expiration of 45 days from
the date the notice made under subsection (n)(2)(B) of this
section is received, no action may be brought under section 2201
of title 28 for a declaratory judgment with respect to the
patent. Any action brought under section 2201 of title 28 shall
be brought in the judicial district where the defendant has its
principal place of business or a regular and established place of
business.
(iv) If the application contains a certification described in
clause (iv) of subsection (n)(1)(G) of this section and is for a
drug for which a previous application has been filed under this
subsection containing such a certification, the application shall
be made effective not earlier than 180 days after -
(I) the date the Secretary receives notice from the applicant
under the previous application of the first commercial
marketing of the drug under the previous application, or
(II) the date of a decision of a court in an action described
in subclause (III) (!3) holding the patent which is the subject
of the certification to be invalid or not infringed,
whichever is earlier.
(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such
application is approvable. If the applicant elects to accept the
opportunity for hearing by written request within 30 days after
such notice, such hearing shall commence not more than 90 days
after the expiration of such 30 days unless the Secretary and the
applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order thereon
shall be issued within 90 days after the date fixed by the
Secretary for filing final briefs.
(F)(i) If an application submitted under subsection (b)(1) of
this section for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been approved in any
other application under subsection (b)(1) of this section, is
approved after November 16, 1988, no application may be submitted
under subsection (b)(2) of this section which refers to the drug
for which the subsection (b)(1) application was submitted before
the expiration of 5 years from the date of the approval of the
application under subsection (b)(1) of this section, except that
such an application may be submitted under subsection (b)(2) of
this section after the expiration of 4 years from the date of the
approval of the subsection (b)(1) application if it contains a
certification of patent invalidity or noninfringement described in
clause (iv) of subsection (n)(1)(G) of this section. The approval
of such an application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent infringement
is commenced during the one-year period beginning 48 months after
the date of the approval of the subsection (b) application, the 30
month period referred to in subparagraph (D)(iii) shall be extended
by such amount of time (if any) which is required for seven and one-
half years to have elapsed from the date of approval of the
subsection (b) application.
(ii) If an application submitted under subsection (b)(1) of this
section for a drug, which includes an active ingredient (including
any ester or salt of the active ingredient) that has been approved
in another application approved under such subsection, is approved
after November 16, 1988, and if such application contains
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety, or, in the case of food producing
animals, human food safety studies (other than bioequivalence
studies or residue depletion studies, except residue depletion
studies for minor uses or minor species) required for the approval
of the application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted
under subsection (b)(2) of this section for the conditions of
approval of such drug in the subsection (b)(1) application
effective before the expiration of 3 years from the date of the
approval of the application under subsection (b)(1) of this section
for such drug.
(iii) If a supplement to an application approved under subsection
(b)(1) of this section is approved after November 16, 1988, and the
supplement contains substantial evidence of the effectiveness of
the drug involved, any studies of animal safety, or, in the case of
food producing animals, human food safety studies (other than
bioequivalence studies or residue depletion studies, except residue
depletion studies for minor uses or minor species) required for the
approval of the supplement and conducted or sponsored by the person
submitting the supplement, the Secretary may not make the approval
of an application submitted under subsection (b)(2) of this section
for a change approved in the supplement effective before the
expiration of 3 years from the date of the approval of the
supplement.
(iv) An applicant under subsection (b)(1) of this section who
comes within the provisions of clause (i) of this subparagraph as a
result of an application which seeks approval for a use solely in
non-food producing animals, may elect, within 10 days of receiving
such approval, to waive clause (i) of this subparagraph, in which
event the limitation on approval of applications submitted under
subsection (b)(2) of this section set forth in clause (ii) of this
subparagraph shall be applicable to the subsection (b)(1)
application.
(v) If an application (including any supplement to a new animal
drug application) submitted under subsection (b)(1) of this section
for a new animal drug for a food-producing animal use, which
includes an active ingredient (including any ester or salt of the
active ingredient) which has been the subject of a waiver under
clause (iv) is approved after November 16, 1988, and if the
application contains substantial evidence of the effectiveness of
the drug involved, any studies of animal safety, or human food
safety studies (other than bioequivalence studies or residue
depletion studies, except residue depletion studies for minor uses
or minor species) required for the new approval of the application
and conducted or sponsored by the applicant, the Secretary may not
make the approval of an application (including any supplement to
such application) submitted under subsection (b)(2) of this section
for the new conditions of approval of such drug in the subsection
(b)(1) application effective before the expiration of five years
from the date of approval of the application under subsection
(b)(1) of this section for such drug. The provisions of this
paragraph shall apply only to the first approval for a food-
producing animal use for the same applicant after the waiver under
clause (iv).
(G) If an approved application submitted under subsection (b)(2)
of this section for a new animal drug refers to a drug the approval
of which was withdrawn or suspended for grounds described in
paragraph (1) or (2) of subsection (e) of this section or was
withdrawn or suspended under this subparagraph or which, as
determined by the Secretary, has been withdrawn from sale for
safety or effectiveness reasons, the approval of the drug under
this paragraph shall be withdrawn or suspended -
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or this subparagraph, or
(ii) if the approved new animal drug has been withdrawn from
sale, for the period of withdrawal from sale or, if earlier, the
period ending on the date the Secretary determines that the
withdrawal from sale is not for safety or effectiveness reasons.
(H) For purposes of this paragraph:
(i) The term "bioequivalence" means the rate and extent to
which the active ingredient or therapeutic ingredient is absorbed
from a new animal drug and becomes available at the site of drug
action.
(ii) A new animal drug shall be considered to be bioequivalent
to the approved new animal drug referred to in its application
under subsection (n) of this section if -
(I) the rate and extent of absorption of the drug do not show
a significant difference from the rate and extent of absorption
of the approved new animal drug referred to in the application
when administered at the same dose of the active ingredient
under similar experimental conditions in either a single dose
or multiple doses;
(II) the extent of absorption of the drug does not show a
significant difference from the extent of absorption of the
approved new animal drug referred to in the application when
administered at the same dose of the active ingredient under
similar experimental conditions in either a single dose or
multiple doses and the difference from the approved new animal
drug in the rate of absorption of the drug is intentional, is
reflected in its proposed labeling, is not essential to the
attainment of effective drug concentrations in use, and is
considered scientifically insignificant for the drug in
attaining the intended purposes of its use and preserving human
food safety; or
(III) in any case in which the Secretary determines that the
measurement of the rate and extent of absorption or excretion
of the new animal drug in biological fluids is inappropriate or
impractical, an appropriate acute pharmacological effects test
or other test of the new animal drug and, when deemed
scientifically necessary, of the approved new animal drug
referred to in the application in the species to be tested or
in an appropriate animal model does not show a significant
difference between the new animal drug and such approved new
animal drug when administered at the same dose under similar
experimental conditions.
If the approved new animal drug referred to in the application
for a new animal drug under subsection (n) of this section is
approved for use in more than one animal species, the
bioequivalency information described in subclauses (I), (II), and
(III) shall be obtained for one species, or if the Secretary
deems appropriate based on scientific principles, shall be
obtained for more than one species. The Secretary may prescribe
the dose to be used in determining bioequivalency under subclause
(I), (II), or (III). To assure that the residues of the new
animal drug will be consistent with the established tolerances
for the approved new animal drug referred to in the application
under subsection (b)(2) of this section upon the expiration of
the withdrawal period contained in the application for the new
animal drug, the Secretary shall require bioequivalency data or
residue depletion studies of the new animal drug or such other
data or studies as the Secretary considers appropriate based on
scientific principles. If the Secretary requires one or more
residue studies under the preceding sentence, the Secretary may
not require that the assay methodology used to determine the
withdrawal period of the new animal drug be more rigorous than
the methodology used to determine the withdrawal period for the
approved new animal drug referred to in the application. If such
studies are required and if the approved new animal drug,
referred to in the application for the new animal drug for which
such studies are required, is approved for use in more than one
animal species, such studies shall be conducted for one species,
or if the Secretary deems appropriate based on scientific
principles, shall be conducted for more than one species.
(3) If the patent information described in subsection (b)(1) of
this section could not be filed with the submission of an
application under subsection (b)(1) of this section because the
application was filed before the patent information was required
under subsection (b)(1) of this section or a patent was issued
after the application was approved under such subsection, the
holder of an approved application shall file with the Secretary the
patent number and the expiration date of any patent which claims
the new animal drug for which the application was filed or which
claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted if a
person not licensed by the owner engaged in the manufacture, use,
or sale of the drug. If the holder of an approved application could
not file patent information under subsection (b)(1) of this section
because it was not required at the time the application was
approved, the holder shall file such information under this
subsection not later than 30 days after November 16, 1988, and if
the holder of an approved application could not file patent
information under subsection (b)(1) of this section because no
patent had been issued when an application was filed or approved,
the holder shall file such information under this subsection not
later than 30 days after the date the patent involved is issued.
Upon the submission of patent information under this subsection,
the Secretary shall publish it.
(4) A drug manufactured in a pilot or other small facility may be
used to demonstrate the safety and effectiveness of the drug and to
obtain approval for the drug prior to manufacture of the drug in a
larger facility, unless the Secretary makes a determination that a
full scale production facility is necessary to ensure the safety or
effectiveness of the drug.
(d) Grounds for refusing application; approval of application;
factors; "substantial evidence" defined; combination drugs
(1) If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that
-
(A) the investigations, reports of which are required to be
submitted to the Secretary pursuant to subsection (b) of this
section, do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof;
(B) the results of such tests show that such drug is unsafe for
use under such conditions or do not show that such drug is safe
for use under such conditions;
(C) the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity;
(D) upon the basis of the information submitted to him as part
of the application, or upon the basis of any other information
before him with respect to such drug, he has insufficient
information to determine whether such drug is safe for use under
such conditions;
(E) evaluated on the basis of the information submitted to him
as part of the application and any other information before him
with respect to such drug, there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
(F) upon the basis of information submitted to the Secretary as
part of the application or any other information before the
Secretary with respect to such drug, any use prescribed,
recommended, or suggested in labeling proposed for such drug will
result in a residue of such drug in excess of a tolerance found
by the Secretary to be safe for such drug;
(G) the application failed to contain the patent information
prescribed by subsection (b)(1) of this section;
(H) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; or
(I) such drug induces cancer when ingested by man or animal or,
after tests which are appropriate for the evaluation of the
safety of such drug, induces cancer in man or animal, except that
the foregoing provisions of this subparagraph shall not apply
with respect to such drug if the Secretary finds that, under the
conditions of use specified in proposed labeling and reasonably
certain to be followed in practice (i) such drug will not
adversely affect the animals for which it is intended, and (ii)
no residue of such drug will be found (by methods of examination
prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (c), (d), and (h)
of this section), in any edible portion of such animals after
slaughter or in any food yielded by or derived from the living
animals;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearings, the Secretary finds
that subparagraphs (A) through (I) do not apply, he shall issue an
order approving the application.
(2) In determining whether such drug is safe for use under the
conditions prescribed, recommended, or suggested in the proposed
labeling thereof, the Secretary shall consider, among other
relevant factors, (A) the probable consumption of such drug and of
any substance formed in or on food because of the use of such drug,
(B) the cumulative effect on man or animal of such drug, taking
into account any chemically or pharmacologically related substance,
(C) safety factors which in the opinion of experts, qualified by
scientific training and experience to evaluate the safety of such
drugs, are appropriate for the use of animal experimentation data,
and (D) whether the conditions of use prescribed, recommended, or
suggested in the proposed labeling are reasonably certain to be
followed in practice. Any order issued under this subsection
refusing to approve an application shall state the findings upon
which it is based.
(3) As used in this section, the term "substantial evidence"
means evidence consisting of one or more adequate and well
controlled investigations, such as -
(A) a study in a target species;
(B) a study in laboratory animals;
(C) any field investigation that may be required under this
section and that meets the requirements of subsection (b)(3) of
this section if a presubmission conference is requested by the
applicant;
(D) a bioequivalence study; or
(E) an in vitro study;
by experts qualified by scientific training and experience to
evaluate the effectiveness of the drug involved, on the basis of
which it could fairly and reasonably be concluded by such experts
that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.
(4) In a case in which an animal drug contains more than one
active ingredient, or the labeling of the drug prescribes,
recommends, or suggests use of the drug in combination with one or
more other animal drugs, and the active ingredients or drugs
intended for use in the combination have previously been separately
approved pursuant to an application submitted under subsection
(b)(1) of this section for particular uses and conditions of use
for which they are intended for use in the combination -
(A) the Secretary shall not issue an order under paragraph
(1)(A), (1)(B), or (1)(D) refusing to approve the application for
such combination on human food safety grounds unless the
Secretary finds that the application fails to establish that -
(i) none of the active ingredients or drugs intended for use
in the combination, respectively, at the longest withdrawal
time of any of the active ingredients or drugs in the
combination, respectively, exceeds its established tolerance;
or
(ii) none of the active ingredients or drugs in the
combination interferes with the methods of analysis for another
of the active ingredients or drugs in the combination,
respectively;
(B) the Secretary shall not issue an order under paragraph
(1)(A), (1)(B), or (1)(D) refusing to approve the application for
such combination on target animal safety grounds unless the
Secretary finds that -
(i)(I) there is a substantiated scientific issue, specific to
one or more of the active ingredients or animal drugs in the
combination, that cannot adequately be evaluated based on
information contained in the application for the combination
(including any investigations, studies, or tests for which the
applicant has a right of reference or use from the person by or
for whom the investigations, studies, or tests were conducted);
or
(II) there is a scientific issue raised by target animal
observations contained in studies submitted to the Secretary as
part of the application; and
(ii) based on the Secretary's evaluation of the information
contained in the application with respect to the issues
identified in clauses (i)(I) and (II), paragraph (1)(A), (B),
or (D) apply;
(C) except in the case of a combination that contains a
nontopical antibacterial ingredient or animal drug, the Secretary
shall not issue an order under paragraph (1)(E) refusing to
approve an application for a combination animal drug intended for
use other than in animal feed or drinking water unless the
Secretary finds that the application fails to demonstrate that -
(i) there is substantial evidence that any active ingredient
or animal drug intended only for the same use as another active
ingredient or animal drug in the combination makes a
contribution to labeled effectiveness;
(ii) each active ingredient or animal drug intended for at
least one use that is different from all other active
ingredients or animal drugs used in the combination provides
appropriate concurrent use for the intended target population;
or
(iii) where based on scientific information the Secretary has
reason to believe the active ingredients or animal drugs may be
physically incompatible or have disparate dosing regimens, such
active ingredients or animal drugs are physically compatible or
do not have disparate dosing regimens; and
(D) the Secretary shall not issue an order under paragraph
(1)(E) refusing to approve an application for a combination
animal drug intended for use in animal feed or drinking water
unless the Secretary finds that the application fails to
demonstrate that -
(i) there is substantial evidence that any active ingredient
or animal drug intended only for the same use as another active
ingredient or animal drug in the combination makes a
contribution to the labeled effectiveness;
(ii) each of the active ingredients or animal drugs intended
for at least one use that is different from all other active
ingredients or animal drugs used in the combination provides
appropriate concurrent use for the intended target population;
(iii) where a combination contains more than one nontopical
antibacterial ingredient or animal drug, there is substantial
evidence that each of the nontopical antibacterial ingredients
or animal drugs makes a contribution to the labeled
effectiveness, except that for purposes of this clause,
antibacterial ingredient or animal drug does not include the
ionophore or arsenical classes of animal drugs; or
(iv) where based on scientific information the Secretary has
reason to believe the active ingredients or animal drugs
intended for use in drinking water may be physically
incompatible, such active ingredients or animal drugs intended
for use in drinking water are physically compatible.
(5) In reviewing an application that proposes a change to add an
intended use for a minor use or a minor species to an approved new
animal drug application, the Secretary shall reevaluate only the
relevant information in the approved application to determine
whether the application for the minor use or minor species can be
approved. A decision to approve the application for the minor use
or minor species is not, implicitly or explicitly, a reaffirmation
of the approval of the original application.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals
(1) The Secretary shall, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing approval of an
application filed pursuant to subsection (b) of this section with
respect to any new animal drug if the Secretary finds -
(A) that experience or scientific data show that such drug is
unsafe for use under the conditions of use upon the basis of
which the application was approved or the condition of use
authorized under subsection (a)(4)(A) of this section;
(B) that new evidence not contained in such application or not
available to the Secretary until after such application was
approved, or tests by new methods, or tests by methods not deemed
reasonably applicable when such application was approved,
evaluated together with the evidence available to the Secretary
when the application was approved, shows that such drug is not
shown to be safe for use under the conditions of use upon the
basis of which the application was approved or that subparagraph
(I) of paragraph (1) of subsection (d) of this section applies to
such drug;
(C) on the basis of new information before him with respect to
such drug, evaluated together with the evidence available to him
when the application was approved, that there is a lack of
substantial evidence that such drug will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof;
(D) the patent information prescribed by subsection (c)(3) of
this section was not filed within 30 days after the receipt of
written notice from the Secretary specifying the failure to file
such information;
(E) that the application contains any untrue statement of a
material fact; or
(F) that the applicant has made any changes from the standpoint
of safety or effectiveness beyond the variations provided for in
the application unless he has supplemented the application by
filing with the Secretary adequate information respecting all
such changes and unless there is in effect an approval of the
supplemental application. The supplemental application shall be
treated in the same manner as the original application.
If the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the health of
man or of the animals for which such drug is intended, he may
suspend the approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the
authority conferred by this sentence to suspend the approval of an
application shall not be delegated.
(2) The Secretary may also, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing the approval
of an application with respect to any new animal drug under this
section if the Secretary finds -
(A) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately
failed to maintain such records or to make required reports in
accordance with a regulation or order under subsection (1) of
this section, or the applicant has refused to permit access to,
or copying or verification of, such records as required by
paragraph (2) of such subsection;
(B) that on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of such drug
are inadequate to assure and preserve its identity, strength,
quality, and purity and were not made adequate within a
reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or
(C) that on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, the labeling of such drug, based on a fair evaluation
of all material facts, is false or misleading in any particular
and was not corrected within a reasonable time after receipt of
written notice from the Secretary specifying the matter
complained of.
(3) Any order under this subsection shall state the findings upon
which it is based.
(f) Revocation of order refusing, withdrawing or suspending
approval of application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d), (e), or (m) of this
section, or section 360ccc(c), (d), or (e) of this title refusing,
withdrawing, or suspending approval of an application and shall
approve such application or reinstate such approval, as may be
appropriate.
(g) Service of orders
Orders of the Secretary issued under this section, or section
360ccc of this title (other than orders issuing, amending, or
repealing regulations) shall be served (1) in person by any officer
or employee of the department designated by the Secretary or (2) by
mailing the order by registered mail or by certified mail addressed
to the applicant or respondent at his last known address in the
records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application filed
under subsection (b) or (m) of this section. The provisions of
subsection (h) of section 355 of this title shall govern any such
appeal.
(i) Publication in Federal Register; effective date and revocation
or suspension of regulation
When a new animal drug application filed pursuant to subsection
(b) of this section or section 360ccc of this title is approved,
the Secretary shall by notice, which upon publication shall be
effective as a regulation, publish in the Federal Register the name
and address of the applicant and the conditions and indications of
use of the new animal drug covered by such application, including
any tolerance and withdrawal period or other use restrictions and,
if such new animal drug is intended for use in animal feed,
appropriate purposes and conditions of use (including special
labeling requirements and any requirement that an animal feed
bearing or containing the new animal drug be limited to use under
the professional supervision of a licensed veterinarian) applicable
to any animal feed for use in which such drug is approved, and such
other information, upon the basis of which such application was
approved, as the Secretary deems necessary to assure the safe and
effective use of such drug. Upon withdrawal of approval of such new
animal drug application or upon its suspension or upon failure to
renew a conditional approval under section 360ccc of this title,
the Secretary shall forthwith revoke or suspend, as the case may
be, the regulation published pursuant to this subsection (i)
insofar as it is based on the approval of such application.
(j) Exemption of drugs for research; discretionary and mandatory
conditions
To the extent consistent with the public health, the Secretary
shall promulgate regulations for exempting from the operation of
this section new animal drugs, and animal feeds bearing or
containing new animal drugs, intended solely for investigational
use by experts qualified by scientific training and experience to
investigate the safety and effectiveness of animal drugs. Such
regulations may, in the discretion of the Secretary, among other
conditions relating to the protection of the public health, provide
for conditioning such exemption upon the establishment and
maintenance of such records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the investigation
of such article, of data (including but not limited to analytical
reports by investigators) obtained as a result of such
investigational use of such article, as the Secretary finds will
enable him to evaluate the safety and effectiveness of such article
in the event of the filing of an application pursuant to this
section. Such regulations, among other things, shall set forth the
conditions (if any) upon which animals treated with such articles,
and any products of such animals (before or after slaughter), may
be marketed for food use.
(k) Food containing new animal drug considered unadulterated while
approval of application for such drug is effective
While approval of an application for a new animal drug is
effective, a food shall not, by reason of bearing or containing
such drug or any substance formed in or on the food because of its
use in accordance with such application (including the conditions
and indications of use prescribed pursuant to subsection (i) of
this section), be considered adulterated within the meaning of
clause (1) of section 342(a) of this title.
(l) Records and reports; required information; regulations and
orders; examination of data; access to records
(1) In the case of any new animal drug for which an approval of
an application filed pursuant to subsection (b) of this section or
section 360ccc of this title is in effect, the applicant shall
establish and maintain such records, and make such reports to the
Secretary, of data relating to experience, including experience
with uses authorized under subsection (a)(4)(A) of this section,
and other data or information, received or otherwise obtained by
such applicant with respect to such drug, or with respect to animal
feeds bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such application,
prescribe on the basis of a finding that such records and reports
are necessary in order to enable the Secretary to determine, or
facilitate a determination, whether there is or may be ground for
invoking subsection (e) or subsection (m)(4) of this section. Such
regulation or order shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the persons
to whom such regulation or order is applicable, of similar
information received or otherwise obtained by the Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
(m) Feed mill licenses
(1) Any person may file with the Secretary an application for a
license to manufacture animal feeds bearing or containing new
animal drugs. Such person shall submit to the Secretary as part of
the application (A) a full statement of the business name and
address of the specific facility at which the manufacturing is to
take place and the facility's registration number, (B) the name and
signature of the responsible individual or individuals for that
facility, (C) a certification that the animal feeds bearing or
containing new animal drugs are manufactured and labeled in
accordance with the applicable regulations published pursuant to
subsection (i) of this section or for indexed new animal drugs in
accordance with the index listing published pursuant to section
360ccc-1(e)(2) of this title and the labeling requirements set
forth in section 360ccc-1(h) of this title, and (D) a certification
that the methods used in, and the facilities and controls used for,
manufacturing, processing, packaging, and holding such animal feeds
are in conformity with current good manufacturing practice as
described in section 351(a)(2)(B) of this title.
(2) Within 90 days after the filing of an application pursuant to
paragraph (1), or such additional period as may be agreed upon by
the Secretary and the applicant, the Secretary shall (A) issue an
order approving the application if the Secretary then finds that
none of the grounds for denying approval specified in paragraph (3)
applies, or (B) give the applicant notice of an opportunity for a
hearing before the Secretary under paragraph (3) on the question
whether such application is approvable. The procedure governing
such a hearing shall be the procedure set forth in the last two
sentences of subsection (c)(1) of this section.
(3) If the Secretary, after due notice to the applicant in
accordance with paragraph (2) and giving the applicant an
opportunity for a hearing in accordance with such paragraph, finds,
on the basis of information submitted to the Secretary as part of
the application, on the basis of a preapproval inspection, or on
the basis of any other information before the Secretary -
(A) that the application is incomplete, false, or misleading in
any particular;
(B) that the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such animal
feed are inadequate to preserve the identity, strength, quality,
and purity of the new animal drug therein; or
(C) that the facility manufactures animal feeds bearing or
containing new animal drugs in a manner that does not accord with
the specifications for manufacture or labels animal feeds bearing
or containing new animal drugs in a manner that does not accord
with the conditions or indications of use that are published
pursuant to subsection (i) of this section or an index listing
pursuant to section 360ccc-1(e) of this title,
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing, the
Secretary finds that subparagraphs (A) through (C) do not apply,
the Secretary shall issue an order approving the application. An
order under this subsection approving an application for a license
to manufacture animal feeds bearing or containing new animal drugs
shall permit a facility to manufacture only those animal feeds
bearing or containing new animal drugs for which there are in
effect regulations pursuant to subsection (i) of this section or an
index listing pursuant to section 360ccc-1(e) of this title
relating to the use of such drugs in or on such animal feed.
(4)(A) The Secretary shall, after due notice and opportunity for
hearing to the applicant, revoke a license to manufacture animal
feeds bearing or containing new animal drugs under this subsection
if the Secretary finds -
(i) that the application for such license contains any untrue
statement of a material fact; or
(ii) that the applicant has made changes that would cause the
application to contain any untrue statements of material fact or
that would affect the safety or effectiveness of the animal feeds
manufactured at the facility unless the applicant has
supplemented the application by filing with the Secretary
adequate information respecting all such changes and unless there
is in effect an approval of the supplemental application.
If the Secretary (or in the Secretary's absence the officer acting
as the Secretary) finds that there is an imminent hazard to the
health of humans or of the animals for which such animal feed is
intended, the Secretary may suspend the license immediately, and
give the applicant prompt notice of the action and afford the
applicant the opportunity for an expedited hearing under this
subsection; but the authority conferred by this sentence shall not
be delegated.
(B) The Secretary may also, after due notice and opportunity for
hearing to the applicant, revoke a license to manufacture animal
feed under this subsection if the Secretary finds -
(i) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately
failed to maintain such records or to make required reports in
accordance with a regulation or order under paragraph (5)(A) of
this subsection or section 354(a)(3)(A) of this title, or the
applicant has refused to permit access to, or copying or
verification of, such records as required by subparagraph (B) of
such paragraph or section 354(a)(3)(B) of this title;
(ii) that on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when
such license was issued, the methods used in, or the facilities
and controls used for, the manufacture, processing, packing, and
holding of such animal feed are inadequate to assure and preserve
the identity, strength, quality, and purity of the new animal
drug therein, and were not made adequate within a reasonable time
after receipt of written notice from the Secretary, specifying
the matter complained of;
(iii) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when such license was issued, the labeling of any
animal feeds, based on a fair evaluation of all material facts,
is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or
(iv) that on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when
such license was issued, the facility has manufactured,
processed, packed, or held animal feed bearing or containing a
new animal drug adulterated under section 351(a)(6) of this title
and the facility did not discontinue the manufacture, processing,
packing, or holding of such animal feed within a reasonable time
after receipt of written notice from the Secretary specifying the
matter complained of.
(C) The Secretary may also revoke a license to manufacture animal
feeds under this subsection if an applicant gives notice to the
Secretary of intention to discontinue the manufacture of all animal
feed covered under this subsection and waives an opportunity for a
hearing on the matter.
(D) Any order under this paragraph shall state the findings upon
which it is based.
(5) When a license to manufacture animal feeds bearing or
containing new animal drugs has been issued -
(A) the applicant shall establish and maintain such records,
and make such reports to the Secretary, or (at the option of the
Secretary) to the appropriate person or persons holding an
approved application filed under subsection (b) of this section,
as the Secretary may by general regulation, or by order with
respect to such application, prescribe on the basis of a finding
that such records and reports are necessary in order to enable
the Secretary to determine, or facilitate a determination,
whether there is or may be ground for invoking subsection (e) of
this section or paragraph (4); and
(B) every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(6) To the extent consistent with the public health, the
Secretary may promulgate regulations for exempting from the
operation of this subsection facilities that manufacture, process,
pack, or hold animal feeds bearing or containing new animal drugs.
(n) Abbreviated applications for new animal drugs; contents,
filing, etc.; lists of approved drugs
(1) An abbreviated application for a new animal drug shall
contain -
(A)(i) except as provided in clause (ii), information to show
that the conditions of use or similar limitations (whether in the
labeling or published pursuant to subsection (i) of this section)
prescribed, recommended, or suggested in the labeling proposed
for the new animal drug have been previously approved for a new
animal drug listed under paragraph (4) (hereinafter in this
subsection referred to as an "approved new animal drug"), and
(ii) information to show that the withdrawal period at which
residues of the new animal drug will be consistent with the
tolerances established for the approved new animal drug is the
same as the withdrawal period previously established for the
approved new animal drug or, if the withdrawal period is proposed
to be different, information showing that the residues of the new
animal drug at the proposed different withdrawal period will be
consistent with the tolerances established for the approved new
animal drug;
(B)(i) information to show that the active ingredients of the
new animal drug are the same as those of the approved new animal
drug, and
(ii) if the approved new animal drug has more than one active
ingredient, and if one of the active ingredients of the new
animal drug is different from one of the active ingredients of
the approved new animal drug and the application is filed
pursuant to the approval of a petition filed under paragraph (3) -
(I) information to show that the other active ingredients of
the new animal drug are the same as the active ingredients of
the approved new animal drug,
(II) information to show either that the different active
ingredient is an active ingredient of another approved new
animal drug or of an animal drug which does not meet the
requirements of section 321(v) of this title, and
(III) such other information respecting the different active
ingredients as the Secretary may require;
(C)(i) if the approved new animal drug is permitted to be used
with one or more animal drugs in animal feed, information to show
that the proposed uses of the new animal drug with other animal
drugs in animal feed are the same as the uses of the approved new
animal drug, and
(ii) if the approved new animal drug is permitted to be used
with one or more other animal drugs in animal feed, and one of
the other animal drugs proposed for use with the new animal drug
in animal feed is different from one of the other animal drugs
permitted to be used in animal feed with the approved new animal
drug, and the application is filed pursuant to the approval of a
petition filed under paragraph (3) -
(I) information to show either that the different animal drug
proposed for use with the approved new animal drug in animal
feed is an approved new animal drug permitted to be used in
animal feed or does not meet the requirements of section 321(v)
of this title when used with another animal drug in animal
feed,
(II) information to show that other animal drugs proposed for
use with the new animal drug in animal feed are the same as the
other animal drugs permitted to be used with the approved new
animal drug, and
(III) such other information respecting the different animal
drug or combination with respect to which the petition was
filed as the Secretary may require,
(D) information to show that the route of administration, the
dosage form, and the strength of the new animal drug are the same
as those of the approved new animal drug or, if the route of
administration, the dosage form, or the strength of the new
animal drug is different and the application is filed pursuant to
the approval of a petition filed under paragraph (3), such
information respecting the route of administration, dosage form,
or strength with respect to which the petition was filed as the
Secretary may require;
(E) information to show that the new animal drug is
bioequivalent to the approved new animal drug, except that if the
application is filed pursuant to the approval of a petition filed
under paragraph (3) for the purposes described in subparagraph
(B) or (C), information to show that the active ingredients of
the new animal drug are of the same pharmacological or
therapeutic class as the pharmacological or therapeutic class of
the approved new animal drug and that the new animal drug can be
expected to have the same therapeutic effect as the approved new
animal drug when used in accordance with the labeling;
(F) information to show that the labeling proposed for the new
animal drug is the same as the labeling approved for the approved
new animal drug except for changes required because of
differences approved under a petition filed under paragraph (3),
because of a different withdrawal period, or because the new
animal drug and the approved new animal drug are produced or
distributed by different manufacturers;
(G) the items specified in clauses (B) through (F) of
subsection (b)(1) of this section;
(H) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims
the approved new animal drug or which claims a use for such
approved new animal drug for which the applicant is seeking
approval under this subsection and for which information is
required to be filed under subsection (b)(1) or (c)(3) of this
section -
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new animal drug for which
the application is filed; and
(I) if with respect to the approved new animal drug information
was filed under subsection (b)(1) or (c)(3) of this section for a
method of use patent which does not claim a use for which the
applicant is seeking approval of an application under subsection
(c)(2) of this section, a statement that the method of use patent
does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by subparagraphs
(A) through (I).
(2)(A) An applicant who makes a certification described in
paragraph (1)(G)(iv) shall include in the application a statement
that the applicant will give the notice required by subparagraph
(B) to -
(i) each owner of the patent which is the subject of the
certification or the representative of such owner designated to
receive such notice, and
(ii) the holder of the approved application under subsection
(c)(1) of this section for the drug which is claimed by the
patent or a use of which is claimed by the patent or the
representative of such holder designated to receive such notice.
(B) The notice referred to in subparagraph (A) shall state that
an application, which contains data from bioequivalence studies,
has been filed under this subsection for the drug with respect to
which the certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of such drug before the
expiration of the patent referred to in the certification. Such
notice shall include a detailed statement of the factual and legal
basis of the applicant's opinion that the patent is not valid or
will not be infringed.
(C) If an application is amended to include a certification
described in paragraph (1)(G)(iv), the notice required by
subparagraph (B) shall be given when the amended application is
filed.
(3) If a person wants to submit an abbreviated application for a
new animal drug -
(A) whose active ingredients, route of administration, dosage
form, or strength differ from that of an approved new animal
drug, or
(B) whose use with other animal drugs in animal feed differs
from that of an approved new animal drug,
such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve
a petition for a new animal drug unless the Secretary finds that -
(C) investigations must be conducted to show the safety and
effectiveness, in animals to be treated with the drug, of the
active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed which
differ from the approved new animal drug, or
(D) investigations must be conducted to show the safety for
human consumption of any residues in food resulting from the
proposed active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed for
the new animal drug which is different from the active
ingredients, route of administration, dosage form, strength, or
use with other animal drugs in animal feed of the approved new
animal drug.
The Secretary shall approve or disapprove a petition submitted
under this paragraph within 90 days of the date the petition is
submitted.
(4)(A)(i) Within 60 days of November 16, 1988, the Secretary
shall publish and make available to the public a list in
alphabetical order of the official and proprietary name of each new
animal drug which has been approved for safety and effectiveness
before November 16, 1988.
(ii) Every 30 days after the publication of the first list under
clause (i) the Secretary shall revise the list to include each new
animal drug which has been approved for safety and effectiveness
under subsection (c) of this section during the 30 day period.
(iii) When patent information submitted under subsection (b)(1)
or (c)(3) of this section respecting a new animal drug included on
the list is to be published by the Secretary, the Secretary shall,
in revisions made under clause (ii), include such information for
such drug.
(B) A new animal drug approved for safety and effectiveness
before November 16, 1988, or approved for safety and effectiveness
under subsection (c) of this section shall, for purposes of this
subsection, be considered to have been published under subparagraph
(A) on the date of its approval or November 16, 1988, whichever is
later.
(C) If the approval of a new animal drug was withdrawn or
suspended under subsection (c)(2)(G) of this section or for grounds
described in subsection (e) of this section or if the Secretary
determines that a drug has been withdrawn from sale for safety or
effectiveness reasons, it may not be published in the list under
subparagraph (A) or, if the withdrawal or suspension occurred after
its publication in such list, it shall be immediately removed from
such list -
(i) for the same period as the withdrawal or suspension under
subsection (c)(2)(G) or (e) of this section, or
(ii) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(5) If an application contains the information required by
clauses (A), (G), and (H) of subsection (b)(1) of this section and
such information -
(A) is relied on by the applicant for the approval of the
application, and
(B) is not information derived either from investigations,
studies, or tests conducted by or for the applicant or for which
the applicant had obtained a right of reference or use from the
person by or for whom the investigations, studies, or tests were
conducted,
such application shall be considered to be an application filed
under subsection (b)(2) of this section.
(o) "Patent" defined
For purposes of this section, the term "patent" means a patent
issued by the United States Patent and Trademark Office.
(p) Safety and effectiveness data
(1) Safety and effectiveness data and information which has been
submitted in an application filed under subsection (b)(1) of this
section or section 360ccc(a) of this title for a drug and which has
not previously been disclosed to the public shall be made available
to the public, upon request, unless extraordinary circumstances are
shown -
(A) if no work is being or will be undertaken to have the
application approved,
(B) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(C) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(D) if the Secretary has determined that such drug is not a new
drug, or
(E) upon the effective date of the approval of the first
application filed under subsection (b)(2) of this section which
refers to such drug or upon the date upon which the approval of
an application filed under subsection (b)(2) of this section
which refers to such drug could be made effective if such an
application had been filed.
(2) Any request for data and information pursuant to paragraph
(1) shall include a verified statement by the person making the
request that any data or information received under such paragraph
shall not be disclosed by such person to any other person -
(A) for the purpose of, or as part of a plan, scheme, or device
for, obtaining the right to make, use, or market, or making,
using, or marketing, outside the United States, the drug
identified in the application filed under subsection (b)(1) of
this section or section 360ccc(a) of this title, and
(B) without obtaining from any person to whom the data and
information are disclosed an identical verified statement, a copy
of which is to be provided by such person to the Secretary, which
meets the requirements of this paragraph.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 512, as added Pub. L. 90-399, Sec.
101(b), July 13, 1968, 82 Stat. 343; amended Pub. L. 100-670, title
I, Secs. 101, 102, 104, 107(a)(2), Nov. 16, 1988, 102 Stat. 3971,
3981, 3982, 3984; Pub. L. 102-108, Sec. 2(e), Aug. 17, 1991, 105
Stat. 550; Pub. L. 103-80, Sec. 3(r), Aug. 13, 1993, 107 Stat. 777;
Pub. L. 103-396, Sec. 2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat.
4153, 4154; Pub. L. 104-250, Secs. 2(a)-(d), 3-5(c), 6(a), (b),
Oct. 9, 1996, 110 Stat. 3151-3153, 3155-3157; Pub. L. 105-115,
title I, Sec. 124(b), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 105-
277, div. A, Sec. 101(a) [title VII, Sec. 737], Oct. 21, 1998, 112
Stat. 2681, 2681-30; Pub. L. 106-113, div. B, Sec. 1000(a)(9)
[title IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-
584; Pub. L. 108-282, title I, Sec. 102(b)(2), (3), (5)(I)-(S),
Aug. 2, 2004, 118 Stat. 892, 903, 904.)
-REFTEXT-
REFERENCES IN TEXT
Section 342(a)(2) of this title, referred to in subsec. (a)(6),
was amended by Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996,
110 Stat. 1514, and, as so amended, no longer contains a subcl.
(D). See section 342(a)(2)(C)(ii) of this title.
-MISC1-
AMENDMENTS
2004 - Subsec. (a)(1), (2). Pub. L. 108-282, Sec. 102(b)(5)(I),
added pars. (1) and (2) and struck out former pars. (1) and (2)
which deemed as unsafe new animal drugs and animal feed bearing or
containing a new animal drug which did not have in effect certain
approvals.
Subsec. (b)(3). Pub. L. 108-282, Sec. 102(b)(5)(J), substituted
"under paragraph (1), section 360ccc of this title, or a request
for an investigational exemption under subsection (j)" for "under
paragraph (1) or a request for an investigational exemption under
subsection (j)".
Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108-282, Sec.
102(b)(2), substituted "(other than bioequivalence studies or
residue depletion studies, except residue depletion studies for
minor uses or minor species)" for "(other than bioequivalence or
residue studies)".
Subsec. (d)(4). Pub. L. 108-282, Sec. 102(b)(5)(K), substituted
"have previously been separately approved pursuant to an
application submitted under subsection (b)(1) of this section" for
"have previously been separately approved" in introductory
provisions.
Subsec. (d)(5). Pub. L. 108-282, Sec. 102(b)(3), added par. (5).
Subsec. (f). Pub. L. 108-282, Sec. 102(b)(5)(L), substituted
"subsection (d), (e), or (m) of this section, or section 360ccc(c),
(d), or (e) of this title" for "subsection (d), (e), or (m) of this
section".
Subsec. (g). Pub. L. 108-282, Sec. 102(b)(5)(M), substituted
"this section, or section 360ccc of this title" for "this section".
Subsec. (i). Pub. L. 108-282, Sec. 102(b)(5)(N), substituted
"subsection (b) of this section or section 360ccc of this title"
for "subsection (b) of this section" and inserted "or upon failure
to renew a conditional approval under section 360ccc of this title"
after "or upon its suspension".
Subsec. (l)(1). Pub. L. 108-282, Sec. 102(b)(5)(O), substituted
"subsection (b) of this section or section 360ccc of this title"
for "subsection (b) of this section".
Subsec. (m)(1)(C). Pub. L. 108-282, Sec. 102(b)(5)(P),
substituted "applicable regulations published pursuant to
subsection (i) of this section or for indexed new animal drugs in
accordance with the index listing published pursuant to section
360ccc-1(e)(2) of this title and the labeling requirements set
forth in section 360ccc-1(h) of this title" for "applicable
regulations published pursuant to subsection (i) of this section".
Subsec. (m)(3). Pub. L. 108-282, Sec. 102(b)(5)(Q), inserted "or
an index listing pursuant to section 360ccc-1(e) of this title"
after "subsection (i) of this section" in subpar. (C) and
concluding provisions.
Subsec. (p)(1), (2)(A). Pub. L. 108-282, Sec. 102(b)(5)(R), (S),
substituted "subsection (b)(1) of this section or section 360ccc(a)
of this title" for "subsection (b)(1) of this section".
1999 - Subsec. (o). Pub. L. 106-113 substituted "United States
Patent and Trademark Office" for "Patent and Trademark Office of
the Department of Commerce".
1998 - Subsec. (d)(4)(D)(iii). Pub. L. 105-277 inserted before
semicolon ", except that for purposes of this clause, antibacterial
ingredient or animal drug does not include the ionophore or
arsenical classes of animal drugs".
1997 - Subsec. (c)(4). Pub. L. 105-115 added par. (4).
1996 - Subsec. (a)(1). Pub. L. 104-250, Sec. 6(a), amended par.
(1) generally. Prior to amendment, par. (1) read as follows: "A new
animal drug shall, with respect to any particular use or intended
use of such drug, be deemed unsafe for the purposes of section
351(a)(5) and section 342(a)(2)(D) of this title unless -
"(A) there is in effect an approval of an application filed
pursuant to subsection (b) of this section with respect to such
use or intended use of such drug, and
"(B) such drug, its labeling, and such use conform to such
approved application.
A new animal drug shall also be deemed unsafe for such purposes in
the event of removal from the establishment of a manufacturer,
packer, or distributor of such drug for use in the manufacture of
animal feed in any State unless at the time of such removal such
manufacturer, packer, or distributor has an unrevoked written
statement from the consignee of such drug, or notice from the
Secretary, to the effect that, with respect to the use of such drug
in animal feed, such consignee -
"(i) is the holder of an approved application under subsection
(m) of this section; or
"(ii) will, if the consignee is not a user of the drug, ship
such drug only to a holder of an approved application under
subsection (m) of this section."
Subsec. (a)(2). Pub. L. 104-250, Sec. 6(a), amended par. (2)
generally. Prior to amendment, par. (2) read as follows: "An animal
feed bearing or containing a new animal drug shall, with respect to
any particular use or intended use of such animal feed, be deemed
unsafe for the purposes of section 351(a)(6) of this title unless -
"(A) there is in effect an approval of an application filed
pursuant to subsection (b) of this section with respect to such
drugs, as used in such animal feed,
"(B) there is in effect an approval of an application pursuant
to subsection (m)(1) of this section with respect to such animal
feed, and
"(C) such animal feed, its labeling, and such use conform to
the conditions and indications of use published pursuant to
subsection (i) of this section and to the application with
respect thereto approved under subsection (m) of this section."
Subsec. (a)(6). Pub. L. 104-250, Sec. 4, added par. (6).
Subsec. (b)(3). Pub. L. 104-250, Sec. 2(d), added par. (3).
Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104-250, Sec. 2(b)(1),
substituted "substantial evidence of the effectiveness of the drug
involved, any studies of animal safety, or," for "reports of new
clinical or field investigations (other than bioequivalence or
residue studies) and," and "required for the approval" for
"essential to the approval".
Subsec. (c)(2)(F)(v). Pub. L. 104-250, Sec. 2(b)(2), substituted
"clause (iv)" for "subparagraph (B)(iv)" in two places,
"substantial evidence of the effectiveness of the drug involved,
any studies of animal safety," for "reports of clinical or field
investigations" and "required for the new approval" for "essential
to the new approval".
Subsec. (d)(1)(F). Pub. L. 104-250, Sec. 3, amended subpar. (F)
generally. Prior to amendment, subpar. (F) read as follows: "upon
the basis of the information submitted to him as part of the
application or any other information before him with respect to
such drug, the tolerance limitation proposed, if any, exceeds that
reasonably required to accomplish the physical or other technical
effect for which the drug is intended;".
Subsec. (d)(3). Pub. L. 104-250, Sec. 2(a), amended par. (3)
generally. Prior to amendment, par. (3) read as follows: "As used
in this subsection and subsection (e) of this section, the term
'substantial evidence' means evidence consisting of adequate and
well-controlled investigations, including field investigation, by
experts qualified by scientific training and experience to evaluate
the effectiveness of the drug involved, on the basis of which it
could fairly and reasonably be concluded by such experts that the
drug will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or suggested
in the labeling or proposed labeling thereof."
Subsec. (d)(4). Pub. L. 104-250, Sec. 2(c), added par. (4).
Subsec. (i). Pub. L. 104-250, Sec. 5(c), inserted "and any
requirement that an animal feed bearing or containing the new
animal drug be limited to use under the professional supervision of
a licensed veterinarian" after "(including special labeling
requirements".
Subsec. (m). Pub. L. 104-250, Sec. 6(b), amended subsec. (m)
generally, substituting provisions relating to application for feed
mill licenses, including approval, refusal, revocation, and
suspension of such licenses, and provisions for record and
reporting requirements for, as well as exemption from, such
licenses, for provisions relating to application for uses of animal
feed containing new animal drug, including required contents,
approval, refusal, and withdrawal of approval or suspension of such
usage applications, and provisions for record and reporting
requirements of such usage applications.
1994 - Subsec. (a)(4), (5). Pub. L. 103-396, Sec. 2(a), added
pars. (4) and (5).
Subsec. (e)(1)(A). Pub. L. 103-396, Sec. 2(b)(2), inserted before
semicolon at end "or the condition of use authorized under
subsection (a)(4)(A) of this section".
Subsec. (l)(1). Pub. L. 103-396, Sec. 2(b)(3), substituted
"relating to experience, including experience with uses authorized
under subsection (a)(4)(A) of this section," for "relating to
experience".
1993 - Subsec. (c)(2)(A)(ii). Pub. L. 103-80, Sec. 3(r)(1),
inserted "in" after "except as provided".
Subsec. (c)(2)(F)(i). Pub. L. 103-80, Sec. 3(r)(2), substituted
"subparagraph (D)(iii)" for "subparagraph (C)(iii)".
Subsec. (c)(2)(H)(ii). Pub. L. 103-80, Sec. 3(r)(3), substituted
"subclauses" for "subclause" after "bioequivalency information
described in" in concluding provisions.
Subsec. (d)(1). Pub. L. 103-80, Sec. 3(r)(4), substituted
"subparagraphs (A) through (I)" for "subparagraphs (A) through (G)"
in concluding provisions.
Subsec. (n)(1). Pub. L. 103-80, Sec. 3(r)(5), substituted
"section 321(v) of this title" for "section 321(w) of this title"
in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted "through
(I)" for "through (H)" in concluding provisions.
1991 - Subsec. (e)(1)(B). Pub. L. 102-108 substituted "(I)" for
"(H)".
1988 - Subsec. (a)(1)(C). Pub. L. 100-670, Sec. 107(a)(2), struck
out subpar. (C) which read as follows: "in the case of a new animal
drug subject to subsection (n) of this section and not exempted
therefrom by regulations it is from a batch with respect to which a
certificate or release issued pursuant to subsection (n) of this
section is in effect with respect to such drug."
Subsec. (b). Pub. L. 100-670, Secs. 101(a), 102(a), designated
existing provisions as par. (1), redesignated cls. (1) to (8) as
cls. (A) to (H), respectively, added par. (2), and inserted
provisions at end of par. (1) which require applicant to file with
application, patent number and expiration date of any patent which
claims new animal drug, to amend application to include such
information if patent which claims such drug or method of using
such drug is issued after filing date but before approval of
application, and to publish such information upon approval.
Subsec. (c). Pub. L. 100-670, Secs. 101(c), 102(b)(1), designated
existing provisions as par. (1), redesignated cls. (1) and (2) as
cls. (A) and (B), respectively, and added pars. (2) and (3).
Subsec. (d)(1). Pub. L. 100-670, Sec. 102(b)(3), substituted
"(G)" for "(H)" in last sentence.
Subsec. (d)(1)(G) to (I). Pub. L. 100-670, Sec. 102(b)(2), added
subpar. (G) and redesignated former subpars. (G) and (H) as (H) and
(I), respectively.
Subsec. (e)(1)(D) to (F). Pub. L. 100-670, Sec. 102(b)(4), added
subpar. (D) and redesignated former subpars. (D) and (E) as (E) and
(F), respectively.
Subsecs. (n) to (p). Pub. L. 100-670, Sec. 101(b), added subsecs.
(n) to (p) and struck out former subsec. (n) which related to
certification of new drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, or bacitracin, and release
prior to certification.
EFFECTIVE DATE OF 1999 AMENDMENT
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
113, set out as a note under section 1 of Title 35, Patents.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Section 2(d) of Pub. L. 103-396 provided that: "The amendments
made by this section [amending this section and section 331 of this
title] shall take effect upon the adoption of the final regulations
under subsection (c) [set out below]." [Final regulations were
dated Oct. 22, 1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61
F.R. 57732, and effective Dec. 9, 1996.]
EFFECTIVE DATE OF 1988 AMENDMENT
Section 108 of Pub. L. 100-670 provided that: "The Secretary of
Health and Human Services may not make an approval of an
application submitted under section 512(b)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before
January 1, 1991."
EFFECTIVE DATE AND TRANSITIONAL PROVISIONS
Pub. L. 90-399, Sec. 108, July 13, 1968, 82 Stat. 353, as amended
by Pub. L. 108-282, title I, Sec. 102(b)(5)(T), Aug. 2, 2004, 118
Stat. 905, provided that:
"(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections [see Short Title of 1968 Amendment
note set out under section 301 of this title] shall take effect on
the first day of the thirteenth calendar month which begins after
the date of enactment of this Act [July 13, 1968].
"(b)(1) As used in this subsection, the term 'effective date'
means the effective date specified in subsection (a) of this
section; the term 'basic Act' means the Federal Food, Drug, and
Cosmetic Act [this chapter]; and other terms used both in this
section and the basic Act shall have the same meaning as they have,
or had, at the time referred to in the context, under the basic
Act.
"(2) Any approval, prior to the effective date, of a new animal
drug or of an animal feed bearing or containing a new animal drug,
whether granted by approval of a new-drug application, master file,
antibiotic regulation, or food additive regulations, shall continue
in effect, and shall be subject to change in accordance with the
provisions of the basic Act as amended by this Act [see Short Title
of 1968 Amendment note set out under section 301 of this title].
"(3) In the case of any drug (other than a drug subject to
section 512(n) of the basic Act as amended by this Act) [subsection
(n) of this section] intended for use in animals other than man
which, on October 9, 1962, (A) was commercially used or sold in the
United States, (B) was not a new drug as defined by section 201(p)
of the basic Act [section 321(p) of this title] as then in force,
and (C) was not covered by an effective application under section
505 of that Act [section 355 of this title], the words
'effectiveness' and 'effective' contained in section 201(v) to the
basic Act [sic] [section 321(v) of this title] shall not apply to
such drug when intended solely for use under conditions prescribed,
recommended, or suggested in labeling with respect to such drug on
that day.
"(4) Regulations providing for fees (and advance deposits to
cover fees) which on the day preceding the effective date
applicable under subsection (a) of this section were in effect
pursuant to section 507 of the basic Act [section 357 of this
title] shall, except as the Secretary may otherwise prescribe, be
deemed to apply also under section 512(n) of the basic Act
[subsection (n) of this section], and appropriations of fees (and
of advance deposits to cover fees) available for the purposes
specified in such section 507 [section 357 of this title] as in
effect prior to the effective date shall also be available for the
purposes specified in section 512(n) [subsection (n) of this
section], including preparatory work or proceedings prior to that
date."
REGULATIONS
Section 2(e) of Pub. L. 104-250 provided that:
"(1) In general. - Not later than 6 months after the date of
enactment of this Act [Oct. 9, 1996], the Secretary of Health and
Human Services shall issue proposed regulations implementing the
amendments made by this Act as described in paragraph (2)(A) of
this subsection, and not later than 18 months after the date of
enactment of this Act, the Secretary shall issue final regulations
implementing such amendments. Not later than 12 months after the
date of enactment of this Act, the Secretary shall issue proposed
regulations implementing the other amendments made by this Act as
described in paragraphs (2)(B) and (2)(C) of this subsection, and
not later than 24 months after the date of enactment of this Act,
the Secretary shall issue final regulations implementing such
amendments.
"(2) Contents. - In issuing regulations implementing the
amendments made by this Act [see Short Title of 1996 Amendments
note set out under section 301 of this title], and in taking an
action to review an application for approval of a new animal drug
under section 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b), or a request for an investigational exemption for a
new animal drug under subsection (j) of such section, that is
pending or has been submitted prior to the effective date of the
regulations, the Secretary shall -
"(A) further define the term 'adequate and well controlled', as
used in subsection (d)(3) of section 512 of such Act, to require
that field investigations be designed and conducted in a
scientifically sound manner, taking into account practical
conditions in the field and differences between field conditions
and laboratory conditions;
"(B) further define the term 'substantial evidence', as defined
in subsection (d)(3) of such section, in a manner that encourages
the submission of applications and supplemental applications; and
"(C) take into account the proposals contained in the citizen
petition (FDA Docket No. 91P-0434/CP) jointly submitted by the
American Veterinary Medical Association and the Animal Health
Institute, dated October 21, 1991.
Until the regulations required by subparagraph (A) are issued,
nothing in the regulations published at 21 C.F.R. 514.111(a)(5)
(April 1, 1996) shall be construed to compel the Secretary of
Health and Human Services to require a field investigation under
section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(d)(1)(E)) or to apply any of its provisions in a
manner inconsistent with the considerations for scientifically
sound field investigations set forth in subparagraph (A)."
Section 2(c) of Pub. L. 103-396 provided that: "Not later than 2
years after the date of the enactment of this Act [Oct. 22, 1994],
the Secretary of Health and Human Services shall promulgate
regulations to implement paragraphs (4)(A) and (5) of section
512(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360b(a)(4)(A), (5)] (as amended by subsection (a))."
Section 103 of Pub. L. 100-670 provided that:
"(a) General Rule. - The Secretary of Health and Human Services
shall promulgate, in accordance with the notice and comment
requirements of section 553 of title 5, United States Code, such
regulations as may be necessary for the administration of section
512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b],
as amended by sections 101 through 103 of this title, within one
year of the date of enactment of this Act [Nov. 16, 1988].
"(b) Transition. - During the period beginning 60 days after the
date of enactment of this Act [Nov. 16, 1988] and ending on the
date regulations promulgated under subsection (a) take effect,
abbreviated new animal drug applications may be submitted in
accordance with the provisions of section 314.55 and part 320 of
title 21 of the Code of Federal Regulations and shall be considered
as suitable for any drug which has been approved for safety and
effectiveness under section 512(c) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 360b(c)] before the date of enactment of
this Act. If any such provision of section 314.55 or part 320 is
inconsistent with the requirements of section 512 of the Federal
Food, Drug, and Cosmetic Act (as amended by this title), the
Secretary shall consider the application under the applicable
requirements of section 512 (as so amended)."
DRUGS INTENDED FOR MINOR SPECIES AND MINOR USES
Section 2(f) of Pub. L. 104-250 provided that: "The Secretary of
Health and Human Services shall consider legislative and regulatory
options for facilitating the approval under section 512 of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b] of animal
drugs intended for minor species and for minor uses and, within 18
months after the date of enactment of this Act [Oct. 9, 1996],
announce proposals for legislative or regulatory change to the
approval process under such section for animal drugs intended for
use in minor species or for minor uses."
TRANSITIONAL PROVISION REGARDING IMPLEMENTATION OF PUB. L. 104-250;
APPROVED MEDICATED FEED APPLICATION DEEMED LICENSE
Section 6(c) of Pub. L. 104-250 provided that: "A person engaged
in the manufacture of animal feeds bearing or containing new animal
drugs who holds at least one approved medicated feed application
for an animal feed bearing or containing new animal drugs, the
manufacture of which was not otherwise exempt from the requirement
for an approved medicated feed application on the date of the
enactment of this Act [Oct. 9, 1996], shall be deemed to hold a
license for the manufacturing site identified in the approved
medicated feed application. The revocation of license provisions of
section 512(m)(4) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360b(m)(4)], as amended by this Act, shall apply to such
licenses. Such license shall expire within 18 months from the date
of enactment of this Act unless the person submits to the Secretary
a completed license application for the manufacturing site
accompanied by a copy of an approved medicated feed application for
such site, which license application shall be deemed to be approved
upon receipt by the Secretary."
DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY
Section 106 of Pub. L. 100-670 provided that: "Notwithstanding
section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360b(b)(2)], the Secretary of Health and Human Services may
not approve an abbreviated application submitted under such section
for a new animal drug which is primarily manufactured using
recombinant DNA, recombinant RNA, hybridoma technology, or other
processes involving site specific genetic manipulation techniques."
-FOOTNOTE-
(!1) See References in Text note below.
(!2) So in original. Probably should be "Alimentarius".
(!3) So in original. Probably should be "clause (iii)(III)".
-End-
-CITE-
21 USC Sec. 360c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360c. Classification of devices intended for human use
-STATUTE-
(a) Classes of devices
(1) There are established the following classes of devices
intended for human use:
(A) Class I, General Controls. -
(i) A device for which the controls authorized by or under
section 351, 352, 360, 360f, 360h, 360i, or 360j of this title
or any combination of such sections are sufficient to provide
reasonable assurance of the safety and effectiveness of the
device.
(ii) A device for which insufficient information exists to
determine that the controls referred to in clause (i) are
sufficient to provide reasonable assurance of the safety and
effectiveness of the device or to establish special controls to
provide such assurance, but because it -
(I) is not purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health, and
(II) does not present a potential unreasonable risk of
illness or injury,
is to be regulated by the controls referred to in clause (i).
(B) Class II, Special Controls. - A device which cannot be
classified as a class I device because the general controls by
themselves are insufficient to provide reasonable assurance of
the safety and effectiveness of the device, and for which there
is sufficient information to establish special controls to
provide such assurance, including the promulgation of performance
standards, postmarket surveillance, patient registries,
development and dissemination of guidelines (including guidelines
for the submission of clinical data in premarket notification
submissions in accordance with section 360(k) of this title),
recommendations, and other appropriate actions as the Secretary
deems necessary to provide such assurance. For a device that is
purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall examine and identify
the special controls, if any, that are necessary to provide
adequate assurance of safety and effectiveness and describe how
such controls provide such assurance.
(C) Class III, Premarket Approval. - A device which because -
(i) it (I) cannot be classified as a class I device because
insufficient information exists to determine that the
application of general controls are sufficient to provide
reasonable assurance of the safety and effectiveness of the
device, and (II) cannot be classified as a class II device
because insufficient information exists to determine that the
special controls described in subparagraph (B) would provide
reasonable assurance of its safety and effectiveness, and
(ii)(I) is purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health, or
(II) presents a potential unreasonable risk of illness or
injury,
is to be subject, in accordance with section 360e of this title,
to premarket approval to provide reasonable assurance of its
safety and effectiveness.
If there is not sufficient information to establish a performance
standard for a device to provide reasonable assurance of its safety
and effectiveness, the Secretary may conduct such activities as may
be necessary to develop or obtain such information.
(2) For purposes of this section and sections 360d and 360e of
this title, the safety and effectiveness of a device are to be
determined -
(A) with respect to the persons for whose use the device is
represented or intended,
(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the device, and
(C) weighing any probable benefit to health from the use of the
device against any probable risk of injury or illness from such
use.
(3)(A) Except as authorized by subparagraph (B), the
effectiveness of a device is, for purposes of this section and
sections 360d and 360e of this title, to be determined, in
accordance with regulations promulgated by the Secretary, on the
basis of well-controlled investigations, including 1 or more
clinical investigations where appropriate, by experts qualified by
training and experience to evaluate the effectiveness of the
device, from which investigations it can fairly and responsibly be
concluded by qualified experts that the device will have the effect
it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the
device.
(B) If the Secretary determines that there exists valid
scientific evidence (other than evidence derived from
investigations described in subparagraph (A)) -
(i) which is sufficient to determine the effectiveness of a
device, and
(ii) from which it can fairly and responsibly be concluded by
qualified experts that the device will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the
device,
then, for purposes of this section and sections 360d and 360e of
this title, the Secretary may authorize the effectiveness of the
device to be determined on the basis of such evidence.
(C) In making a determination of a reasonable assurance of the
effectiveness of a device for which an application under section
360e of this title has been submitted, the Secretary shall consider
whether the extent of data that otherwise would be required for
approval of the application with respect to effectiveness can be
reduced through reliance on postmarket controls.
(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 360e of this
title, shall meet with such person to determine the type of valid
scientific evidence (within the meaning of subparagraphs (A) and
(B)) that will be necessary to demonstrate for purposes of approval
of an application the effectiveness of a device for the conditions
of use proposed by such person. The written request shall include a
detailed description of the device, a detailed description of the
proposed conditions of use of the device, a proposed plan for
determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device. Within 30 days after such
meeting, the Secretary shall specify in writing the type of valid
scientific evidence that will provide a reasonable assurance that a
device is effective under the conditions of use proposed by such
person.
(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for
demonstrating a reasonable assurance of device effectiveness shall
be specified as result of a determination by the Secretary that
such data are necessary to establish device effectiveness. The
Secretary shall consider, in consultation with the applicant, the
least burdensome appropriate means of evaluating device
effectiveness that would have a reasonable likelihood of resulting
in approval.
(iii) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i) and
(ii) shall be binding upon the Secretary, unless such determination
by the Secretary could be contrary to the public health.
(b) Classification panels
(1) For purposes of -
(A) determining which devices intended for human use should be
subject to the requirements of general controls, performance
standards, or premarket approval, and
(B) providing notice to the manufacturers and importers of such
devices to enable them to prepare for the application of such
requirements to devices manufactured or imported by them,
the Secretary shall classify all such devices (other than devices
classified by subsection (f) of this section) into the classes
established by subsection (a) of this section. For the purpose of
securing recommendations with respect to the classification of
devices, the Secretary shall establish panels of experts or use
panels of experts established before May 28, 1976, or both. Section
14 of the Federal Advisory Committee Act shall not apply to the
duration of a panel established under this paragraph.
(2) The Secretary shall appoint to each panel established under
paragraph (1) persons who are qualified by training and experience
to evaluate the safety and effectiveness of the devices to be
referred to the panel and who, to the extent feasible, possess
skill in the use of, or experience in the development, manufacture,
or utilization of, such devices. The Secretary shall make
appointments to each panel so that each panel shall consist of
members with adequately diversified expertise in such fields as
clinical and administrative medicine, engineering, biological and
physical sciences, and other related professions. In addition, each
panel shall include as nonvoting members a representative of
consumer interests and a representative of interests of the device
manufacturing industry. Scientific, trade, and consumer
organizations shall be afforded an opportunity to nominate
individuals for appointment to the panels. No individual who is in
the regular full-time employ of the United States and engaged in
the administration of this chapter may be a member of any panel.
The Secretary shall designate one of the members of each panel to
serve as chairman thereof.
(3) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or
otherwise engaged in its business, shall be entitled to receive
compensation at rates to be fixed by the Secretary, but not at
rates exceeding the daily equivalent of the rate in effect for
grade GS-18 of the General Schedule, for each day so engaged,
including traveltime; and while so serving away from their homes or
regular places of business each member may be allowed travel
expenses (including per diem in lieu of subsistence) as authorized
by section 5703 of title 5, for persons in the Government service
employed intermittently.
(4) The Secretary shall furnish each panel with adequate clerical
and other necessary assistance.
(5) Classification panels covering each type of device shall be
scheduled to meet at such times as may be appropriate for the
Secretary to meet applicable statutory deadlines.
(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have -
(i) the same access to data and information submitted to a
classification panel (except for data and information that are
not available for public disclosure under section 552 of title 5)
as the Secretary;
(ii) the opportunity to submit, for review by a classification
panel, information that is based on the data or information
provided in the application submitted under section 360e of this
title by the person, which information shall be submitted to the
Secretary for prompt transmittal to the classification panel; and
(iii) the same opportunity as the Secretary to participate in
meetings of the panel.
(B) Any meetings of a classification panel shall provide adequate
time for initial presentations and for response to any differing
views by persons whose devices are specifically the subject of a
classification panel review, and shall encourage free and open
participation by all interested persons.
(7) After receiving from a classification panel the conclusions
and recommendations of the panel on a matter that the panel has
reviewed, the Secretary shall review the conclusions and
recommendations, shall make a final decision on the matter in
accordance with section 360e(d)(2) of this title, and shall notify
the affected persons of the decision in writing and, if the
decision differs from the conclusions and recommendations of the
panel, shall include the reasons for the difference.
(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements of
the Federal Advisory Committee Act.
(c) Classification panel organization and operation
(1) The Secretary shall organize the panels according to the
various fields of clinical medicine and fundamental sciences in
which devices intended for human use are used. The Secretary shall
refer a device to be classified under this section to an
appropriate panel established or authorized to be used under
subsection (b) of this section for its review and for its
recommendation respecting the classification of the device. The
Secretary shall by regulation prescribe the procedure to be
followed by the panels in making their reviews and recommendations.
In making their reviews of devices, the panels, to the maximum
extent practicable, shall provide an opportunity for interested
persons to submit data and views on the classification of the
devices.
(2)(A) Upon completion of a panel's review of a device referred
to it under paragraph (1), the panel shall, subject to
subparagraphs (B) and (C), submit to the Secretary its
recommendation for the classification of the device. Any such
recommendation shall (i) contain (I) a summary of the reasons for
the recommendation, (II) a summary of the data upon which the
recommendation is based, and (III) an identification of the risks
to health (if any) presented by the device with respect to which
the recommendation is made, and (ii) to the extent practicable,
include a recommendation for the assignment of a priority for the
application of the requirements of section 360d or 360e of this
title to a device recommended to be classified in class II or class
III.
(B) A recommendation of a panel for the classification of a
device in class I shall include a recommendation as to whether the
device should be exempted from the requirements of section 360,
360i, or 360j(f) of this title.
(C) In the case of a device which has been referred under
paragraph (1) to a panel, and which -
(i) is intended to be implanted in the human body or is
purported or represented to be for a use in supporting or
sustaining human life, and
(ii)(I) has been introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28,
1976, or
(II) is within a type of device which was so introduced or
delivered before such date and is substantially equivalent to
another device within that type,
such panel shall recommend to the Secretary that the device be
classified in class III unless the panel determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. If a
panel does not recommend that such a device be classified in class
III, it shall in its recommendation to the Secretary for the
classification of the device set forth the reasons for not
recommending classification of the device in such class.
(3) The panels shall submit to the Secretary within one year of
the date funds are first appropriated for the implementation of
this section their recommendations respecting all devices of a type
introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976.
(d) Panel recommendation; publication; priorities
(1) Upon receipt of a recommendation from a panel respecting a
device, the Secretary shall publish in the Federal Register the
panel's recommendation and a proposed regulation classifying such
device and shall provide interested persons an opportunity to
submit comments on such recommendation and the proposed regulation.
After reviewing such comments, the Secretary shall, subject to
paragraph (2), by regulation classify such device.
(2)(A) A regulation under paragraph (1) classifying a device in
class I shall prescribe which, if any, of the requirements of
section 360, 360i, or 360j(f) of this title shall not apply to the
device. A regulation which makes a requirement of section 360,
360i, or 360j(f) of this title inapplicable to a device shall be
accompanied by a statement of the reasons of the Secretary for
making such requirement inapplicable.
(B) A device described in subsection (c)(2)(C) of this section
shall be classified in class III unless the Secretary determines
that classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. A
proposed regulation under paragraph (1) classifying such a device
in a class other than class III shall be accompanied by a full
statement of the reasons of the Secretary (and supporting
documentation and data) for not classifying such device in such
class and an identification of the risks to health (if any)
presented by such device.
(3) In the case of devices classified in class II and devices
classified under this subsection in class III and described in
section 360e(b)(1) of this title the Secretary may establish
priorities which, in his discretion, shall be used in applying
sections 360d and 360e of this title, as appropriate, to such
devices.
(e) Classification changes
(1) Based on new information respecting a device, the Secretary
may, upon his own initiative or upon petition of an interested
person, by regulation (A) change such device's classification, and
(B) revoke, because of the change in classification, any regulation
or requirement in effect under section 360d or 360e of this title
with respect to such device. In the promulgation of such a
regulation respecting a device's classification, the Secretary may
secure from the panel to which the device was last referred
pursuant to subsection (c) of this section a recommendation
respecting the proposed change in the device's classification and
shall publish in the Federal Register any recommendation submitted
to the Secretary by the panel respecting such change. A regulation
under this subsection changing the classification of a device from
class III to class II may provide that such classification shall
not take effect until the effective date of a performance standard
established under section 360d of this title for such device.
(2) By regulation promulgated under paragraph (1), the Secretary
may change the classification of a device from class III -
(A) to class II if the Secretary determines that special
controls would provide reasonable assurance of the safety and
effectiveness of the device and that general controls would not
provide reasonable assurance of the safety and effectiveness of
the device, or
(B) to class I if the Secretary determines that general
controls would provide reasonable assurance of the safety and
effectiveness of the device.
(f) Initial classification and reclassification of certain devices
(1) Any device intended for human use which was not introduced or
delivered for introduction into interstate commerce for commercial
distribution before May 28, 1976, is classified in class III unless
-
(A) the device -
(i) is within a type of device (I) which was introduced or
delivered for introduction into interstate commerce for
commercial distribution before such date and which is to be
classified pursuant to subsection (b) of this section, or (II)
which was not so introduced or delivered before such date and
has been classified in class I or II, and
(ii) is substantially equivalent to another device within
such type, or
(B) the Secretary in response to a petition submitted under
paragraph (3) has classified such device in class I or II.
A device classified in class III under this paragraph shall be
classified in that class until the effective date of an order of
the Secretary under paragraph (2) or (3) classifying the device in
class I or II.
(2)(A) Any person who submits a report under section 360(k) of
this title for a type of device that has not been previously
classified under this chapter, and that is classified into class
III under paragraph (1), may request, within 30 days after
receiving written notice of such a classification, the Secretary to
classify the device under the criteria set forth in subparagraphs
(A) through (C) of subsection (a)(1) of this section. The person
may, in the request, recommend to the Secretary a classification
for the device. Any such request shall describe the device and
provide detailed information and reasons for the recommended
classification.
(B)(i) Not later than 60 days after the date of the submission of
the request under subparagraph (A), the Secretary shall by written
order classify the device involved. Such classification shall be
the initial classification of the device for purposes of paragraph
(1) and any device classified under this paragraph shall be a
predicate device for determining substantial equivalence under
paragraph (1).
(ii) A device that remains in class III under this subparagraph
shall be deemed to be adulterated within the meaning of section
351(f)(1)(B) of this title until approved under section 360e of
this title or exempted from such approval under section 360j(g) of
this title.
(C) Within 30 days after the issuance of an order classifying a
device under this paragraph, the Secretary shall publish a notice
in the Federal Register announcing such classification.
(3)(A) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device classified
under paragraph (1) may petition the Secretary (in such form and
manner as he shall prescribe) for the issuance of an order
classifying the device in class I or class II. Within thirty days
of the filing of such a petition, the Secretary shall notify the
petitioner of any deficiencies in the petition which prevent the
Secretary from making a decision on the petition.
(B)(i) Upon determining that a petition does not contain any
deficiency which prevents the Secretary from making a decision on
the petition, the Secretary may for good cause shown refer the
petition to an appropriate panel established or authorized to be
used under subsection (b) of this section. A panel to which such a
petition has been referred shall not later than ninety days after
the referral of the petition make a recommendation to the Secretary
respecting approval or denial of the petition. Any such
recommendation shall contain (I) a summary of the reasons for the
recommendation, (II) a summary of the data upon which the
recommendation is based, and (III) an identification of the risks
to health (if any) presented by the device with respect to which
the petition was filed. In the case of a petition for a device
which is intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or
sustaining human life, the panel shall recommend that the petition
be denied unless the panel determines that the classification in
class III of the device is not necessary to provide reasonable
assurance of its safety and effectiveness. If the panel recommends
that such petition be approved, it shall in its recommendation to
the Secretary set forth its reasons for such recommendation.
(ii) The requirements of paragraphs (1) and (2) of subsection (c)
of this section (relating to opportunities for submission of data
and views and recommendations respecting priorities and exemptions
from sections 360, 360i, and 360j(f) of this title) shall apply
with respect to consideration by panels of petitions submitted
under subparagraph (A).
(C)(i) Within ninety days from the date the Secretary receives
the recommendation of a panel respecting a petition (but not later
than 210 days after the filing of such petition) the Secretary
shall by order deny or approve the petition. If the Secretary
approves the petition, the Secretary shall order the classification
of the device into class I or class II in accordance with the
criteria prescribed by subsection (a)(1)(A) or (a)(1)(B) of this
section. In the case of a petition for a device which is intended
to be implanted in the human body or which is purported or
represented to be for a use in supporting or sustaining human life,
the Secretary shall deny the petition unless the Secretary
determines that the classification in class III of the device is
not necessary to provide reasonable assurance of its safety and
effectiveness. An order approving such petition shall be
accompanied by a full statement of the reasons of the Secretary
(and supporting documentation and data) for approving the petition
and an identification of the risks to health (if any) presented by
the device to which such order applies.
(ii) The requirements of paragraphs (1) and (2)(A) of subsection
(d) of this section (relating to publication of recommendations,
opportunity for submission of comments, and exemption from sections
360, 360i, and 360j(f) of this title) shall apply with respect to
action by the Secretary on petitions submitted under subparagraph
(A).
(4) If a manufacturer reports to the Secretary under section
360(k) of this title that a device is substantially equivalent to
another device -
(A) which the Secretary has classified as a class III device
under subsection (b) of this section,
(B) which was introduced or delivered for introduction into
interstate commerce for commercial distribution before December
1, 1990, and
(C) for which no final regulation requiring premarket approval
has been promulgated under section 360e(b) of this title,
the manufacturer shall certify to the Secretary that the
manufacturer has conducted a reasonable search of all information
known or otherwise available to the manufacturer respecting such
other device and has included in the report under section 360(k) of
this title a summary of and a citation to all adverse safety and
effectiveness data respecting such other device and respecting the
device for which the section 360(k) report is being made and which
has not been submitted to the Secretary under section 360i of this
title. The Secretary may require the manufacturer to submit the
adverse safety and effectiveness data described in the report.
(5) The Secretary may not withhold a determination of the initial
classification of a device under paragraph (1) because of a failure
to comply with any provision of this chapter unrelated to a
substantial equivalence decision, including a finding that the
facility in which the device is manufactured is not in compliance
with good manufacturing requirements as set forth in regulations of
the Secretary under section 360j(f) of this title (other than a
finding that there is a substantial likelihood that the failure to
comply with such regulations will potentially present a serious
risk to human health).
(g) Information
Within sixty days of the receipt of a written request of any
person for information respecting the class in which a device has
been classified or the requirements applicable to a device under
this chapter, the Secretary shall provide such person a written
statement of the classification (if any) of such device and the
requirements of this chapter applicable to the device.
(h) Definitions
For purposes of this section and sections 351, 360, 360d, 360e,
360f, 360i, and 360j of this title
(1) a reference to "general controls" is a reference to the
controls authorized by or under sections 351, 352, 360, 360f,
360h, 360i, and 360j of this title,
(2) a reference to "class I", "class II", or "class III" is a
reference to a class of medical devices described in subparagraph
(A), (B), or (C) of subsection (a)(1) of this section, and
(3) a reference to a "panel under section 360c of this title"
is a reference to a panel established or authorized to be used
under this section.
(i) Substantial equivalence
(1)(A) For purposes of determinations of substantial equivalence
under subsection (f) of this section and section 360j(l) of this
title, the term "substantially equivalent" or "substantial
equivalence" means, with respect to a device being compared to a
predicate device, that the device has the same intended use as the
predicate device and that the Secretary by order has found that the
device -
(i) has the same technological characteristics as the predicate
device, or
(ii)(I) has different technological characteristics and the
information submitted that the device is substantially equivalent
to the predicate device contains information, including
appropriate clinical or scientific data if deemed necessary by
the Secretary or a person accredited under section 360m of this
title, that demonstrates that the device is as safe and effective
as a legally marketed device, and (II) does not raise different
questions of safety and effectiveness than the predicate device.
(B) For purposes of subparagraph (A), the term "different
technological characteristics" means, with respect to a device
being compared to a predicate device, that there is a significant
change in the materials, design, energy source, or other features
of the device from those of the predicate device.
(C) To facilitate reviews of reports submitted to the Secretary
under section 360(k) of this title, the Secretary shall consider
the extent to which reliance on postmarket controls may expedite
the classification of devices under subsection (f)(1) of this
section.
(D) Whenever the Secretary requests information to demonstrate
that devices with differing technological characteristics are
substantially equivalent, the Secretary shall only request
information that is necessary to making substantial equivalence
determinations. In making such request, the Secretary shall
consider the least burdensome means of demonstrating substantial
equivalence and request information accordingly.
(E)(i) Any determination by the Secretary of the intended use of
a device shall be based upon the proposed labeling submitted in a
report for the device under section 360(k) of this title. However,
when determining that a device can be found substantially
equivalent to a legally marketed device, the director of the
organizational unit responsible for regulating devices (in this
subparagraph referred to as the "Director") may require a statement
in labeling that provides appropriate information regarding a use
of the device not identified in the proposed labeling if, after
providing an opportunity for consultation with the person who
submitted such report, the Director determines and states in
writing -
(I) that there is a reasonable likelihood that the device will
be used for an intended use not identified in the proposed
labeling for the device; and
(II) that such use could cause harm.
(ii) Such determination shall -
(I) be provided to the person who submitted the report within
10 days from the date of the notification of the Director's
concerns regarding the proposed labeling;
(II) specify the limitations on the use of the device not
included in the proposed labeling; and
(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the labeling for
such device conforms to the limitations specified in subclause
(II).
(iii) The responsibilities of the Director under this
subparagraph may not be delegated.
(F) Not later than 270 days after November 21, 1997, the
Secretary shall issue guidance specifying the general principles
that the Secretary will consider in determining when a specific
intended use of a device is not reasonably included within a
general use of such device for purposes of a determination of
substantial equivalence under subsection (f) of this section or
section 360j(l) of this title.
(2) A device may not be found to be substantially equivalent to a
predicate device that has been removed from the market at the
initiative of the Secretary or that has been determined to be
misbranded or adulterated by a judicial order.
(3)(A) As part of a submission under section 360(k) of this title
respecting a device, the person required to file a premarket
notification under such section shall provide an adequate summary
of any information respecting safety and effectiveness or state
that such information will be made available upon request by any
person.
(B) Any summary under subparagraph (A) respecting a device shall
contain detailed information regarding data concerning adverse
health effects and shall be made available to the public by the
Secretary within 30 days of the issuance of a determination that
such device is substantially equivalent to another device.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 513, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 540; amended Pub. L. 101-629, Secs. 4(a),
5(a)-(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515,
4517, 4518, 4523, 4528; Pub. L. 102-300, Sec. 6(e), June 16, 1992,
106 Stat. 240; Pub. L. 103-80, Sec. 3(s), Aug. 13, 1993, 107 Stat.
778; Pub. L. 105-115, title II, Secs. 205(a), (b), 206(b), (c),
207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340,
2350; Pub. L. 107-250, title II, Sec. 208, Oct. 26, 2002, 116 Stat.
1613.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in subsec.
(b)(1), (8), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5, Government
Organization and Employees.
-MISC1-
AMENDMENTS
2002 - Subsec. (i)(1)(E)(iv). Pub. L. 107-250 struck out cl. (iv)
which read as follows: "This subparagraph has no legal effect after
the expiration of the five-year period beginning on November 21,
1997."
1997 - Subsec. (a)(3)(A). Pub. L. 105-115, Sec. 217, substituted
"1 or more clinical investigations" for "clinical investigations".
Subsec. (a)(3)(C), (D). Pub. L. 105-115, Sec. 205(a), added
subpars. (C) and (D).
Subsec. (b)(5) to (8). Pub. L. 105-115, Sec. 208, added pars. (5)
to (8).
Subsec. (f)(1). Pub. L. 105-115, Sec. 207(1)(B), substituted
"paragraph (2) or (3)" for "paragraph (2)" in closing provisions.
Subsec. (f)(1)(B). Pub. L. 105-115, Sec. 207(1)(A), substituted
"paragraph (3)" for "paragraph (2)".
Subsec. (f)(2) to (4). Pub. L. 105-115, Sec. 207(2), (3), added
par. (2) and redesignated former pars. (2) and (3) as (3) and (4),
respectively.
Subsec. (f)(5). Pub. L. 105-115, Sec. 206(b), added par. (5).
Subsec. (i)(1)(A)(ii). Pub. L. 105-115, Sec. 206(c)(1),
substituted "appropriate clinical or scientific data" for "clinical
data", inserted "or a person accredited under section 360m of this
title" after "Secretary", and substituted "effectiveness" for
"efficacy".
Subsec. (i)(1)(C) to (E). Pub. L. 105-115, Sec. 205(b), added
subpars. (C) to (E).
Subsec. (i)(1)(F). Pub. L. 105-115, Sec. 206(c)(2), added subpar.
(F).
1993 - Subsec. (b)(3). Pub. L. 103-80 substituted "5703" for
"5703(b)".
1992 - Subsec. (f)(3). Pub. L. 102-300 redesignated clauses (i)
to (iii) as subpars. (A) to (C), respectively, and substituted "the
section 360(k) report" for "the 360(k) report" in closing
provisions.
1990 - Subsec. (a)(1)(A)(ii). Pub. L. 101-629, Sec. 5(a)(1),
substituted "or to establish special controls" for "or to establish
a performance standard".
Subsec. (a)(1)(B). Pub. L. 101-629, Sec. 5(a)(2), amended subpar.
(B) generally. Prior to amendment, subpar. (B) read as follows:
"Class II, Performance Standards. - A device which cannot be
classified as a class I device because the controls authorized by
or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
title by themselves are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, for which
there is sufficient information to establish a performance standard
to provide such assurance, and for which it is therefore necessary
to establish for the device a performance standard under section
360d of this title to provide reasonable assurance of its safety
and effectiveness."
Subsec. (a)(1)(C)(i). Pub. L. 101-629, Sec. 5(a)(3), amended cl.
(i) generally. Prior to amendment, cl. (i) read as follows: "it (I)
cannot be classified as a class I device because insufficient
information exists to determine that the controls authorized by or
under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
title are sufficient to provide reasonable assurance of the safety
and effectiveness of the device and (II) cannot be classified as a
class II device because insufficient information exists for the
establishment of a performance standard to provide reasonable
assurance of its safety and effectiveness, and".
Subsec. (e). Pub. L. 101-629, Sec. 5(b), designated existing
provisions as par. (1), redesignated cls. (1) and (2) as (A) and
(B), respectively, and added par. (2).
Subsec. (f). Pub. L. 101-629, Sec. 5(c)(3), inserted "and
reclassification" before "of" in heading.
Subsec. (f)(2)(A). Pub. L. 101-629, Sec. 5(c)(1), substituted
"The Secretary may initiate the reclassification of a device
classified into class III under paragraph (1) of this subsection or
the manufacturer" for "The manufacturer".
Subsec. (f)(2)(B)(i). Pub. L. 101-629, Sec. 18(a), substituted
"the Secretary may for good cause shown" for "the Secretary shall".
Subsec. (f)(3). Pub. L. 101-629, Sec. 4(a), added par. (3).
Subsec. (i). Pub. L. 101-629, Sec. 12(a), added subsec. (i).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
SHORT TITLE OF 1976 AMENDMENT
Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
that: "This Act [enacting sections 360c to 360k, 379, and 379a of
this title and section 3512 of Title 42, The Public Health and
Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
374, 379e, and 381 of this title and section 55 of Title 15,
Commerce and Trade] may be cited as the 'Medical Device Amendments
of 1976'."
REGULATIONS
Section 12(b) of Pub. L. 101-629 provided that: "Within 12 months
of the date of the enactment of this Act [Nov. 28, 1990], the
Secretary of Health and Human Services shall issue regulations
establishing the requirements of the summaries under section
513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360c(i)(3)], as added by the amendment made by subsection (a)."
DAILY WEAR SOFT OR DAILY WEAR NONHYDROPHILIC PLASTIC CONTACT LENSES
Section 4(b)(3) of Pub. L. 101-629 provided that:
"(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health
and Human Services shall not retain any daily wear soft or daily
wear nonhydrophilic plastic contact lens in class III under such
Act [this chapter] unless the Secretary finds that it meets the
criteria set forth in section 513(a)(1)(C) of such Act [21 U.S.C.
360c(a)(1)(C)]. The finding and the grounds for the finding shall
be published in the Federal Register. For any such lens, the
Secretary shall make the determination respecting reclassification
required in section 520(l)(5)(B) of such Act within 24 months of
the date of the enactment of this paragraph [Nov. 28, 1990].
"(B) The Secretary of Health and Human Services may by notice
published in the Federal Register extend the two-year period
prescribed by subparagraph (A) for a lens for an additional period
not to exceed one year.
"(C)(i) Before classifying a lens in class II pursuant to
subparagraph (A), the Secretary of Health and Human Services shall
pursuant to section 513(a)(1)(B) of such Act assure that
appropriate regulatory safeguards are in effect which provide
reasonable assurance of the safety and effectiveness of such lens,
including clinical and preclinical data if deemed necessary by the
Secretary.
"(ii) Prior to classifying a lens in class I pursuant to
subparagraph (A), the Secretary shall assure that appropriate
regulatory safeguards are in effect which provide reasonable
assurance of the safety and effectiveness of such lens, including
clinical and preclinical data if deemed necessary by the Secretary.
"(D) Notwithstanding section 520(l)(5) of such Act, if the
Secretary of Health and Human Services has not made the finding and
published the finding required by subparagraph (A) within 36 months
of the date of the enactment of this subparagraph [Nov. 28, 1990],
the Secretary shall issue an order placing the lens in class II.
"(E) Any person adversely affected by a final regulation under
this paragraph revising the classification of a lens may challenge
the revision of the classification of such lens only by filing a
petition under section 513(e) for a classification change."
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
-End-
-CITE-
21 USC Sec. 360d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360d. Performance standards
-STATUTE-
(a) Reasonable assurance of safe and effective performance;
periodic evaluation
(1) The special controls required by section 360c(a)(1)(B) of
this title shall include performance standards for a class II
device if the Secretary determines that a performance standard is
necessary to provide reasonable assurance of the safety and
effectiveness of the device. A class III device may also be
considered a class II device for purposes of establishing a
standard for the device under subsection (b) of this section if the
device has been reclassified as a class II device under a
regulation under section 360c(e) of this title but such regulation
provides that the reclassification is not to take effect until the
effective date of such a standard for the device.
(2) A performance standard established under subsection (b) of
this section for a device -
(A) shall include provisions to provide reasonable assurance of
its safe and effective performance;
(B) shall, where necessary to provide reasonable assurance of
its safe and effective performance, include -
(i) provisions respecting the construction, components,
ingredients, and properties of the device and its compatibility
with power systems and connections to such systems,
(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the device or, if it is
determined that no other more practicable means are available
to the Secretary to assure the conformity of the device to the
standard, provisions for the testing (on a sample basis or, if
necessary, on an individual basis) by the Secretary or by
another person at the direction of the Secretary,
(iii) provisions for the measurement of the performance
characteristics of the device,
(iv) provisions requiring that the results of each or of
certain of the tests of the device required to be made under
clause (ii) show that the device is in conformity with the
portions of the standard for which the test or tests were
required, and
(v) a provision requiring that the sale and distribution of
the device be restricted but only to the extent that the sale
and distribution of a device may be restricted under a
regulation under section 360j(e) of this title; and
(C) shall, where appropriate, require the use and prescribe the
form and content of labeling for the proper installation,
maintenance, operation, and use of the device.
(3) The Secretary shall provide for periodic evaluation of
performance standards established under subsection (b) of this
section to determine if such standards should be changed to reflect
new medical, scientific, or other technological data.
(4) In carrying out his duties under this subsection and
subsection (b) of this section, the Secretary shall, to the maximum
extent practicable -
(A) use personnel, facilities, and other technical support
available in other Federal agencies,
(B) consult with other Federal agencies concerned with standard-
setting and other nationally or internationally recognized
standard-setting entities, and
(C) invite appropriate participation, through joint or other
conferences, workshops, or other means, by informed persons
representative of scientific, professional, industry, or consumer
organizations who in his judgment can make a significant
contribution.
(b) Establishment of a standard
(1)(A) The Secretary shall publish in the Federal Register a
notice of proposed rulemaking for the establishment, amendment, or
revocation of any performance standard for a device.
(B) A notice of proposed rulemaking for the establishment or
amendment of a performance standard for a device shall -
(i) set forth a finding with supporting justification that the
performance standard is appropriate and necessary to provide
reasonable assurance of the safety and effectiveness of the
device,
(ii) set forth proposed findings with respect to the risk of
illness or injury that the performance standard is intended to
reduce or eliminate,
(iii) invite interested persons to submit to the Secretary,
within 30 days of the publication of the notice, requests for
changes in the classification of the device pursuant to section
360c(e) of this title based on new information relevant to the
classification, and
(iv) invite interested persons to submit an existing
performance standard for the device, including a draft or
proposed performance standard, for consideration by the
Secretary.
(C) A notice of proposed rulemaking for the revocation of a
performance standard shall set forth a finding with supporting
justification that the performance standard is no longer necessary
to provide reasonable assurance of the safety and effectiveness of
a device.
(D) The Secretary shall provide for a comment period of not less
than 60 days.
(2) If, after publication of a notice in accordance with
paragraph (1), the Secretary receives a request for a change in the
classification of the device, the Secretary shall, within 60 days
of the publication of the notice, after consultation with the
appropriate panel under section 360c of this title, either deny the
request or give notice of an intent to initiate such change under
section 360c(e) of this title.
(3)(A) After the expiration of the period for comment on a notice
of proposed rulemaking published under paragraph (1) respecting a
performance standard and after consideration of such comments and
any report from an advisory committee under paragraph (5), the
Secretary shall (i) promulgate a regulation establishing a
performance standard and publish in the Federal Register findings
on the matters referred to in paragraph (1), or (ii) publish a
notice terminating the proceeding for the development of the
standard together with the reasons for such termination. If a
notice of termination is published, the Secretary shall (unless
such notice is issued because the device is a banned device under
section 360f of this title) initiate a proceeding under section
360c(e) of this title to reclassify the device subject to the
proceeding terminated by such notice.
(B) A regulation establishing a performance standard shall set
forth the date or dates upon which the standard shall take effect,
but no such regulation may take effect before one year after the
date of its publication unless (i) the Secretary determines that an
earlier effective date is necessary for the protection of the
public health and safety, or (ii) such standard has been
established for a device which, effective upon the effective date
of the standard, has been reclassified from class III to class II.
Such date or dates shall be established so as to minimize,
consistent with the public health and safety, economic loss to, and
disruption or dislocation of, domestic and international trade.
(4)(A) The Secretary, upon his own initiative or upon petition of
an interested person may by regulation, promulgated in accordance
with the requirements of paragraphs (1), (2), and (3)(B) of this
subsection, amend or revoke a performance standard.
(B) The Secretary may declare a proposed amendment of a
performance standard to be effective on and after its publication
in the Federal Register and until the effective date of any final
action taken on such amendment if he determines that making it so
effective is in the public interest. A proposed amendment of a
performance standard made so effective under the preceding sentence
may not prohibit, during the period in which it is so effective,
the introduction or delivery for introduction into interstate
commerce of a device which conforms to such standard without the
change or changes provided by such proposed amendment.
(5)(A) The Secretary -
(i) may on his own initiative refer a proposed regulation for
the establishment, amendment, or revocation of a performance
standard, or
(ii) shall, upon the request of an interested person which
demonstrates good cause for referral and which is made before the
expiration of the period for submission of comments on such
proposed regulation refer such proposed regulation,
to an advisory committee of experts, established pursuant to
subparagraph (B), for a report and recommendation with respect to
any matter involved in the proposed regulation which requires the
exercise of scientific judgment. If a proposed regulation is
referred under this subparagraph to an advisory committee, the
Secretary shall provide the advisory committee with the data and
information on which such proposed regulation is based. The
advisory committee shall, within sixty days of the referral of a
proposed regulation and after independent study of the data and
information furnished to it by the Secretary and other data and
information before it, submit to the Secretary a report and
recommendation respecting such regulation, together with all
underlying data and information and a statement of the reason or
basis for the recommendation. A copy of such report and
recommendation shall be made public by the Secretary.
(B) The Secretary shall establish advisory committees (which may
not be panels under section 360c of this title) to receive
referrals under subparagraph (A). The Secretary shall appoint as
members of any such advisory committee persons qualified in the
subject matter to be referred to the committee and of appropriately
diversified professional background, except that the Secretary may
not appoint to such a committee any individual who is in the
regular full-time employ of the United States and engaged in the
administration of this chapter. Each such committee shall include
as nonvoting members a representative of consumer interests and a
representative of interests of the device manufacturing industry.
Members of an advisory committee who are not officers or employees
of the United States, while attending conferences or meetings of
their committee or otherwise serving at the request of the
Secretary, shall be entitled to receive compensation at rates to be
fixed by the Secretary, which rates may not exceed the daily
equivalent of the rate in effect for grade GS-18 of the General
Schedule, for each day (including traveltime) they are so engaged;
and while so serving away from their homes or regular places of
business each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of title
5 for persons in the Government service employed intermittently.
The Secretary shall designate one of the members of each advisory
committee to serve as chairman thereof. The Secretary shall furnish
each advisory committee with clerical and other assistance, and
shall by regulation prescribe the procedures to be followed by each
such committee in acting on referrals made under subparagraph (A).
(c) Recognition of standard
(1)(A) In addition to establishing a performance standard under
this section, the Secretary shall, by publication in the Federal
Register, recognize all or part of an appropriate standard
established by a nationally or internationally recognized standard
development organization for which a person may submit a
declaration of conformity in order to meet a premarket submission
requirement or other requirement under this chapter to which such
standard is applicable.
(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements described
in such subparagraph, the person shall provide a declaration of
conformity to the Secretary that certifies that the device is in
conformity with such standard. A person may elect to use data, or
information, other than data required by a standard recognized
under subparagraph (A) to meet any requirement regarding devices
under this chapter.
(2) The Secretary may withdraw such recognition of a standard
through publication of a notice in the Federal Register if the
Secretary determines that the standard is no longer appropriate for
meeting a requirement regarding devices under this chapter.
(3)(A) Subject to subparagraph (B), the Secretary shall accept a
declaration of conformity that a device is in conformity with a
standard recognized under paragraph (1) unless the Secretary finds -
(i) that the data or information submitted to support such
declaration does not demonstrate that the device is in conformity
with the standard identified in the declaration of conformity; or
(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under
review.
(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under paragraph
(1).
(C) A person making a declaration of conformity with respect to a
standard recognized under paragraph (1) shall maintain the data and
information demonstrating conformity of the device to the standard
for a period of two years after the date of the classification or
approval of the device by the Secretary or a period equal to the
expected design life of the device, whichever is longer.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 514, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 546; amended Pub. L. 94-460, title III, Sec.
304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101-629, Secs. 6(a),
(b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102-
300, Sec. 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103-80, Sec.
4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105-115, title II,
Sec. 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 204(d)(1),
substituted "under subsection (b) of this section" for "under this
section".
Subsec. (a)(2). Pub. L. 105-115, Sec. 204(d)(2), substituted
"under subsection (b) of this section" for "under this section" in
introductory provisions.
Subsec. (a)(3). Pub. L. 105-115, Sec. 204(d)(3), substituted
"under subsection (b) of this section" for "under this section".
Subsec. (a)(4). Pub. L. 105-115, Sec. 204(d)(4), substituted
"this subsection and subsection (b) of this section" for "this
section" in introductory provisions.
Subsec. (c). Pub. L. 105-115, Sec. 204(a), added subsec. (c).
1993 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103-80 amended
directory language of Pub. L. 101-619, Sec. 18(b), identical to
amendment by Pub. L. 102-300, Sec. 6(g)(1). See 1992 and 1990
Amendment notes below.
1992 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102-300 made
technical corrections to directory language of Pub. L. 101-629,
Sec. 18(b)(1), (2). See 1990 Amendment note below.
1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 6(a)(1), substituted
"The special controls required by section 360c(a)(1)(B) of this
title shall include performance standards for a class II device if
the Secretary determines that a performance standard is necessary
to provide reasonable assurance of the safety and effectiveness of
the device." for "The Secretary may by regulation, promulgated in
accordance with this section, establish a performance standard for
a class II device."
Subsec. (b). Pub. L. 101-629, Sec. 6(a)(2), (3), redesignated
subsec. (g) as (b) and struck out former subsec. (b) which read as
follows:
"(1) A proceeding for the development of a performance standard
for a device shall be initiated by the Secretary by the publication
in the Federal Register of notice of the opportunity to submit to
the Secretary a request (within fifteen days of the date of the
publication of the notice) for a change in the classification of
the device based on new information relevant to its classification.
"(2) If, after publication of a notice pursuant to paragraph (1)
the Secretary receives a request for a change in the device's
classification, he shall, within sixty days of the publication of
such notice and after consultation with the appropriate panel under
section 360c of this title, by order published in the Federal
Register, either deny the request for change in classification or
give notice of his intent to initiate such a change under section
360c(e) of this title."
Subsec. (b)(1), (2). Pub. L. 101-629, Sec. 6(a)(4), amended pars.
(1) and (2) generally. Prior to amendment, pars. (1) and (2) read
as follows:
"(1)(A) After publication pursuant to subsection (c) of this
section of a notice respecting a performance standard for a device,
the Secretary shall either -
"(i) publish, in the Federal Register in a notice of proposed
rulemaking, a proposed performance standard for the device (I)
developed by an offeror under such notice and accepted by the
Secretary, (II) developed under subsection (c)(4) of this
section, (III) accepted by the Secretary under subsection (d) of
this section, or (IV) developed by him under subsection (f) of
this section, or
"(ii) issue a notice in the Federal Register that the
proceeding is terminated together with the reasons for such
termination.
"(B) If the Secretary issues under subparagraph (A)(ii) a notice
of termination of a proceeding to establish a performance standard
for a device, he shall (unless such notice is issued because the
device is a banned device under section 360f of this title)
initiate a proceeding under section 360c(e) of this title to
reclassify the device subject to the proceeding terminated by such
notice.
"(2) A notice of proposed rulemaking for the establishment of a
performance standard for a device published under paragraph
(1)(A)(i) shall set forth proposed findings with respect to the
degree of the risk of illness or injury designed to be eliminated
or reduced by the proposed standard and the benefit to the public
from the device."
Subsec. (b)(3)(A)(i). Pub. L. 101-629, Sec. 6(b)(1)(A),
substituted "paragraph (1)" for "paragraph (2)".
Subsec. (b)(4)(A). Pub. L. 101-629, Sec. 6(b)(1)(B), substituted
"paragraphs (1), (2), and (3)(B)" for "paragraphs (2) and (3)(B)".
Subsec. (b)(4)(B). Pub. L. 101-629, Sec. 18(b)(1), as amended by
Pub. L. 102-300, Sec. 6(g)(1), (2), and Pub. L. 103-80, Sec.
4(a)(1), struck out ", after affording all interested persons an
opportunity for an informal hearing," after "if he determines".
Subsec. (b)(5)(A)(ii). Pub. L. 101-629, Sec. 18(b)(2), as amended
by Pub. L. 102-300, Sec. 6(g)(1), (3), and Pub. L. 103-80, Sec.
4(a)(1), substituted "which demonstrates good cause for referral
and which is made before the expiration of the period for
submission of comments on such proposed regulation refer such
proposed regulation," for "unless the Secretary finds the request
to be without good cause or the request is made after the
expiration of the period for submission of comments on such
proposed regulation refer such proposed regulation,".
Subsecs. (c) to (f). Pub. L. 101-629, Sec. 6(a)(2), struck out
subsec. (c) relating to invitations for standards, subsec. (d)
relating to acceptance of certain existing standards, subsec. (e)
relating to acceptance of offers to develop standards, and subsec.
(f) relating to development of standards by the Secretary after
publication of notice inviting submissions or offers of standards.
Subsec. (g). Pub. L. 101-629, Sec. 6(a)(3), redesignated subsec.
(g) as (b).
1976 - Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5)
as (3) and (4), respectively. Section as originally enacted
contained no par. (3).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees in existence on Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period following Jan.
5, 1973, and advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year period
beginning on the date of their establishment, unless in the case of
a committee established by the President or an officer of the
Federal Government, such committee is renewed by appropriate action
prior to the expiration of such 2-year period, or in the case of a
committee established by Congress, its duration is otherwise
provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
-End-
-CITE-
21 USC Sec. 360e 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360e. Premarket approval
-STATUTE-
(a) General requirement
A class III device -
(1) which is subject to a regulation promulgated under
subsection (b) of this section; or
(2) which is a class III device because of section 360c(f) of
this title,
is required to have, unless exempt under section 360j(g) of this
title, an approval under this section of an application for
premarket approval or, as applicable, an approval under subsection
(c)(2) of this section of a report seeking premarket approval.
(b) Regulation to require premarket approval
(1) In the case of a class III device which -
(A) was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28,
1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is
substantially equivalent to another device within that type,
the Secretary shall by regulation, promulgated in accordance with
this subsection, require that such device have an approval under
this section of an application for premarket approval.
(2)(A) A proceeding for the promulgation of a regulation under
paragraph (1) respecting a device shall be initiated by the
publication in the Federal Register of a notice of proposed
rulemaking. Such notice shall contain -
(i) the proposed regulation;
(ii) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by
requiring the device to have an approved application for
premarket approval and the benefit to the public from use of the
device;
(iii) opportunity for the submission of comments on the
proposed regulation and the proposed findings; and
(iv) opportunity to request a change in the classification of
the device based on new information relevant to the
classification of the device.
(B) If, within fifteen days after publication of a notice under
subparagraph (A), the Secretary receives a request for a change in
the classification of a device, he shall, within sixty days of the
publication of such notice and after consultation with the
appropriate panel under section 360c of this title, by order
published in the Federal Register, either deny the request for
change in classification or give notice of his intent to initiate
such a change under section 360c(e) of this title.
(3) After the expiration of the period for comment on a proposed
regulation and proposed findings published under paragraph (2) and
after consideration of comments submitted on such proposed
regulation and findings, the Secretary shall (A) promulgate such
regulation and publish in the Federal Register findings on the
matters referred to in paragraph (2)(A)(ii), or (B) publish a
notice terminating the proceeding for the promulgation of the
regulation together with the reasons for such termination. If a
notice of termination is published, the Secretary shall (unless
such notice is issued because the device is a banned device under
section 360f of this title) initiate a proceeding under section
360c(e) of this title to reclassify the device subject to the
proceeding terminated by such notice.
(4) The Secretary, upon his own initiative or upon petition of an
interested person, may by regulation amend or revoke any regulation
promulgated under this subsection. A regulation to amend or revoke
a regulation under this subsection shall be promulgated in
accordance with the requirements prescribed by this subsection for
the promulgation of the regulation to be amended or revoked.
(c) Application for premarket approval
(1) Any person may file with the Secretary an application for
premarket approval for a class III device. Such an application for
a device shall contain -
(A) full reports of all information, published or known to or
which should reasonably be known to the applicant, concerning
investigations which have been made to show whether or not such
device is safe and effective;
(B) a full statement of the components, ingredients, and
properties and of the principle or principles of operation, of
such device;
(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing,
and, when relevant, packing and installation of, such device;
(D) an identifying reference to any performance standard under
section 360d of this title which would be applicable to any
aspect of such device if it were a class II device, and either
adequate information to show that such aspect of such device
fully meets such performance standard or adequate information to
justify any deviation from such standard;
(E) such samples of such device and of components thereof as
the Secretary may reasonably require, except that where the
submission of such samples is impracticable or unduly burdensome,
the requirement of this subparagraph may be met by the submission
of complete information concerning the location of one or more
such devices readily available for examination and testing;
(F) specimens of the labeling proposed to be used for such
device; and
(G) such other information relevant to the subject matter of
the application as the Secretary, with the concurrence of the
appropriate panel under section 360c of this title, may require.
(2)(A) Any person may file with the Secretary a report seeking
premarket approval for a class III device referred to in subsection
(a) of this section that is a reprocessed single-use device. Such a
report shall contain the following:
(i) The device name, including both the trade or proprietary
name and the common or usual name.
(ii) The establishment registration number of the owner or
operator submitting the report.
(iii) Actions taken to comply with performance standards under
section 360d of this title.
(iv) Proposed labels, labeling, and advertising sufficient to
describe the device, its intended use, and directions for use.
(v) Full reports of all information, published or known to or
which should be reasonably known to the applicant, concerning
investigations which have been made to show whether or not the
device is safe or effective.
(vi) A description of the device's components, ingredients, and
properties.
(vii) A full description of the methods used in, and the
facilities and controls used for, the reprocessing and packing of
the device.
(viii) Such samples of the device that the Secretary may
reasonably require.
(ix) A financial certification or disclosure statement or both,
as required by part 54 of title 21, Code of Federal Regulations.
(x) A statement that the applicant believes to the best of the
applicant's knowledge that all data and information submitted to
the Secretary are truthful and accurate and that no material fact
has been omitted in the report.
(xi) Any additional data and information, including information
of the type required in paragraph (1) for an application under
such paragraph, that the Secretary determines is necessary to
determine whether there is reasonable assurance of safety and
effectiveness for the reprocessed device.
(xii) Validation data described in section 360(o)(1)(A) of this
title that demonstrates that the reasonable assurance of the
safety or effectiveness of the device will remain after the
maximum number of times the device is reprocessed as intended by
the person submitting such report.
(B) In the case of a class III device referred to in subsection
(a) of this section that is a reprocessed single-use device:
(i) Subparagraph (A) of this paragraph applies in lieu of
paragraph (1).
(ii) Subject to clause (i), the provisions of this section
apply to a report under subparagraph (A) to the same extent and
in the same manner as such provisions apply to an application
under paragraph (1).
(iii) Each reference in other sections of this chapter to an
application under this section, other than such a reference in
section 379i or 379j of this title, shall be considered to be a
reference to a report under subparagraph (A).
(iv) Each reference in other sections of this chapter to a
device for which an application under this section has been
approved, or has been denied, suspended, or withdrawn, other than
such a reference in section 379i or 379j of this title, shall be
considered to be a reference to a device for which a report under
subparagraph (A) has been approved, or has been denied,
suspended, or withdrawn, respectively.
(3) Upon receipt of an application meeting the requirements set
forth in paragraph (1), the Secretary -
(A) may on the Secretary's own initiative, or
(B) shall, upon the request of an applicant unless the
Secretary finds that the information in the application which
would be reviewed by a panel substantially duplicates information
which has previously been reviewed by a panel appointed under
section 360c of this title,
refer such application to the appropriate panel under section 360c
of this title for study and for submission (within such period as
he may establish) of a report and recommendation respecting
approval of the application, together with all underlying data and
the reasons or basis for the recommendation. Where appropriate, the
Secretary shall ensure that such panel includes, or consults with,
one or more pediatric experts.
(4)(A) Prior to the submission of an application under this
subsection, the Secretary shall accept and review any portion of
the application that the applicant and the Secretary agree is
complete, ready, and appropriate for review, except that such
requirement does not apply, and the Secretary has discretion
whether to accept and review such portion, during any period in
which, under section 379j(g) of this title, the Secretary does not
have the authority to collect fees under section 379j(a) of this
title.
(B) Each portion of a submission reviewed under subparagraph (A)
and found acceptable by the Secretary shall not be further reviewed
after receipt of an application that satisfies the requirements of
paragraph (1), unless a significant issue of safety or
effectiveness provides the Secretary reason to review such accepted
portion.
(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the Secretary
shall, in writing, provide to the applicant a description of any
deficiencies in such portion and identify the information that is
required to correct these deficiencies, unless the applicant is no
longer pursuing the application.
(d) Action on application for premarket approval
(1)(A) As promptly as possible, but in no event later than one
hundred and eighty days after the receipt of an application under
subsection (c) of this section (except as provided in section
360j(l)(3)(D)(ii) of this title or unless, in accordance with
subparagraph (B)(i), an additional period as agreed upon by the
Secretary and the applicant), the Secretary, after considering the
report and recommendation submitted under paragraph (2) of such
subsection, shall -
(i) issue an order approving the application if he finds that
none of the grounds for denying approval specified in paragraph
(2) of this subsection applies; or
(ii) deny approval of the application if he finds (and sets
forth the basis for such finding as part of or accompanying such
denial) that one or more grounds for denial specified in
paragraph (2) of this subsection apply.
In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of use
included in the proposed labeling as the basis for determining
whether or not there is a reasonable assurance of safety and
effectiveness, if the proposed labeling is neither false nor
misleading. In determining whether or not such labeling is false or
misleading, the Secretary shall fairly evaluate all material facts
pertinent to the proposed labeling.
(B)(i) The Secretary may not enter into an agreement to extend
the period in which to take action with respect to an application
submitted for a device subject to a regulation promulgated under
subsection (b) of this section unless he finds that the continued
availability of the device is necessary for the public health.
(ii) An order approving an application for a device may require
as a condition to such approval that the sale and distribution of
the device be restricted but only to the extent that the sale and
distribution of a device may be restricted under a regulation under
section 360j(e) of this title.
(iii) The Secretary shall accept and review statistically valid
and reliable data and any other information from investigations
conducted under the authority of regulations required by section
360j(g) of this title to make a determination of whether there is a
reasonable assurance of safety and effectiveness of a device
subject to a pending application under this section if -
(I) the data or information is derived from investigations of
an earlier version of the device, the device has been modified
during or after the investigations (but prior to submission of an
application under subsection (c) of this section) and such a
modification of the device does not constitute a significant
change in the design or in the basic principles of operation of
the device that would invalidate the data or information; or
(II) the data or information relates to a device approved under
this section, is available for use under this chapter, and is
relevant to the design and intended use of the device for which
the application is pending.
(2) The Secretary shall deny approval of an application for a
device if, upon the basis of the information submitted to the
Secretary as part of the application and any other information
before him with respect to such device, the Secretary finds that -
(A) there is a lack of a showing of reasonable assurance that
such device is safe under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
(B) there is a lack of a showing of reasonable assurance that
the device is effective under the conditions of use prescribed,
recommended, or suggested in the proposed labeling thereof;
(C) the methods used in, or the facilities or controls used
for, the manufacture, processing, packing, or installation of
such device do not conform to the requirements of section 360j(f)
of this title;
(D) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular; or
(E) such device is not shown to conform in all respects to a
performance standard in effect under section 360d of this title
compliance with which is a condition to approval of the
application and there is a lack of adequate information to
justify the deviation from such standard.
Any denial of an application shall, insofar as the Secretary
determines to be practicable, be accompanied by a statement
informing the applicant of the measures required to place such
application in approvable form (which measures may include further
research by the applicant in accordance with one or more protocols
prescribed by the Secretary).
(3)(A)(i) The Secretary shall, upon the written request of an
applicant, meet with the applicant, not later than 100 days after
the receipt of an application that has been filed as complete under
subsection (c) of this section, to discuss the review status of the
application.
(ii) The Secretary shall, in writing and prior to the meeting,
provide to the applicant a description of any deficiencies in the
application that, at that point, have been identified by the
Secretary based on an interim review of the entire application and
identify the information that is required to correct those
deficiencies.
(iii) The Secretary shall notify the applicant promptly of -
(I) any additional deficiency identified in the application, or
(II) any additional information required to achieve completion
of the review and final action on the application,
that was not described as a deficiency in the written description
provided by the Secretary under clause (ii).
(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under this
paragraph.
(4) An applicant whose application has been denied approval may,
by petition filed on or before the thirtieth day after the date
upon which he receives notice of such denial, obtain review thereof
in accordance with either paragraph (1) or (2) of subsection (g) of
this section, and any interested person may obtain review, in
accordance with paragraph (1) or (2) of subsection (g) of this
section, of an order of the Secretary approving an application.
(5) In order to provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating human diseases or
conditions, the Secretary shall provide review priority for devices
-
(A) representing breakthrough technologies,
(B) for which no approved alternatives exist,
(C) which offer significant advantages over existing approved
alternatives, or
(D) the availability of which is in the best interest of the
patients.
(6)(A)(i) A supplemental application shall be required for any
change to a device subject to an approved application under this
subsection that affects safety or effectiveness, unless such change
is a modification in a manufacturing procedure or method of
manufacturing and the holder of the approved application submits a
written notice to the Secretary that describes in detail the
change, summarizes the data or information supporting the change,
and informs the Secretary that the change has been made under the
requirements of section 360j(f) of this title.
(ii) The holder of an approved application who submits a notice
under clause (i) with respect to a manufacturing change of a device
may distribute the device 30 days after the date on which the
Secretary receives the notice, unless the Secretary within such 30-
day period notifies the holder that the notice is not adequate and
describes such further information or action that is required for
acceptance of such change. If the Secretary notifies the holder
that a supplemental application is required, the Secretary shall
review the supplement within 135 days after the receipt of the
supplement. The time used by the Secretary to review the notice of
the manufacturing change shall be deducted from the 135-day review
period if the notice meets appropriate content requirements for
premarket approval supplements.
(B)(i) Subject to clause (ii), in reviewing a supplement to an
approved application, for an incremental change to the design of a
device that affects safety or effectiveness, the Secretary shall
approve such supplement if -
(I) nonclinical data demonstrate that the design modification
creates the intended additional capacity, function, or
performance of the device; and
(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device to
provide a reasonable assurance of safety and effectiveness.
(e) Withdrawal and temporary suspension of approval of application
(1) The Secretary shall, upon obtaining, where appropriate,
advice on scientific matters from a panel or panels under section
360c of this title, and after due notice and opportunity for
informal hearing to the holder of an approved application for a
device, issue an order withdrawing approval of the application if
the Secretary finds -
(A) that such device is unsafe or ineffective under the
conditions of use prescribed, recommended, or suggested in the
labeling thereof;
(B) on the basis of new information before him with respect to
such device, evaluated together with the evidence available to
him when the application was approved, that there is a lack of a
showing of reasonable assurance that the device is safe or
effective under the conditions of use prescribed, recommended, or
suggested in the labeling thereof;
(C) that the application contained or was accompanied by an
untrue statement of a material fact;
(D) that the applicant (i) has failed to establish a system for
maintaining records, or has repeatedly or deliberately failed to
maintain records or to make reports, required by an applicable
regulation under section 360i(a) of this title, (ii) has refused
to permit access to, or copying or verification of, such records
as required by section 374 of this title, or (iii) has not
complied with the requirements of section 360 of this title;
(E) on the basis of new information before him with respect to
such device, evaluated together with the evidence before him when
the application was approved, that the methods used in, or the
facilities and controls used for, the manufacture, processing,
packing, or installation of such device do not conform with the
requirements of section 360j(f) of this title and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from the
Secretary of nonconformity;
(F) on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, that the labeling of such device, based on a fair
evaluation of all material facts, is false or misleading in any
particular and was not corrected within a reasonable time after
receipt of written notice from the Secretary of such fact; or
(G) on the basis of new information before him, evaluated
together with the evidence before him when the application was
approved, that such device is not shown to conform in all
respects to a performance standard which is in effect under
section 360d of this title compliance with which was a condition
to approval of the application and that there is a lack of
adequate information to justify the deviation from such standard.
(2) The holder of an application subject to an order issued under
paragraph (1) withdrawing approval of the application may, by
petition filed on or before the thirtieth day after the date upon
which he receives notice of such withdrawal, obtain review thereof
in accordance with either paragraph (1) or (2) of subsection (g) of
this section.
(3) If, after providing an opportunity for an informal hearing,
the Secretary determines there is reasonable probability that the
continuation of distribution of a device under an approved
application would cause serious, adverse health consequences or
death, the Secretary shall by order temporarily suspend the
approval of the application approved under this section. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such application.
(f) Product development protocol
(1) In the case of a class III device which is required to have
an approval of an application submitted under subsection (c) of
this section, such device shall be considered as having such an
approval if a notice of completion of testing conducted in
accordance with a product development protocol approved under
paragraph (4) has been declared completed under paragraph (6).
(2) Any person may submit to the Secretary a proposed product
development protocol with respect to a device. Such a protocol
shall be accompanied by data supporting it. If, within thirty days
of the receipt of such a protocol, the Secretary determines that it
appears to be appropriate to apply the requirements of this
subsection to the device with respect to which the protocol is
submitted, the Secretary -
(A) may, at the initiative of the Secretary, refer the proposed
protocol to the appropriate panel under section 360c of this
title for its recommendation respecting approval of the protocol;
or
(B) shall so refer such protocol upon the request of the
submitter, unless the Secretary finds that the proposed protocol
and accompanying data which would be reviewed by such panel
substantially duplicate a product development protocol and
accompanying data which have previously been reviewed by such a
panel.
(3) A proposed product development protocol for a device may be
approved only if -
(A) the Secretary determines that it is appropriate to apply
the requirements of this subsection to the device in lieu of the
requirement of approval of an application submitted under
subsection (c) of this section; and
(B) the Secretary determines that the proposed protocol
provides -
(i) a description of the device and the changes which may be
made in the device,
(ii) a description of the preclinical trials (if any) of the
device and a specification of (I) the results from such trials
to be required before the commencement of clinical trials of
the device, and (II) any permissible variations in preclinical
trials and the results therefrom,
(iii) a description of the clinical trials (if any) of the
device and a specification of (I) the results from such trials
to be required before the filing of a notice of completion of
the requirements of the protocol, and (II) any permissible
variations in such trials and the results therefrom,
(iv) a description of the methods to be used in, and the
facilities and controls to be used for, the manufacture,
processing, and, when relevant, packing and installation of the
device,
(v) an identifying reference to any performance standard
under section 360d of this title to be applicable to any aspect
of such device,
(vi) if appropriate, specimens of the labeling proposed to be
used for such device,
(vii) such other information relevant to the subject matter
of the protocol as the Secretary, with the concurrence of the
appropriate panel or panels under section 360c of this title,
may require, and
(viii) a requirement for submission of progress reports and,
when completed, records of the trials conducted under the
protocol which records are adequate to show compliance with the
protocol.
(4) The Secretary shall approve or disapprove a proposed product
development protocol submitted under paragraph (2) within one
hundred and twenty days of its receipt unless an additional period
is agreed upon by the Secretary and the person who submitted the
protocol. Approval of a protocol or denial of approval of a
protocol is final agency action subject to judicial review under
chapter 7 of title 5.
(5) At any time after a product development protocol for a device
has been approved pursuant to paragraph (4), the person for whom
the protocol was approved may submit a notice of completion -
(A) stating (i) his determination that the requirements of the
protocol have been fulfilled and that, to the best of his
knowledge, there is no reason bearing on safety or effectiveness
why the notice of completion should not become effective, and
(ii) the data and other information upon which such determination
was made, and
(B) setting forth the results of the trials required by the
protocol and all the information required by subsection (c)(1) of
this section.
(6)(A) The Secretary may, after providing the person who has an
approved protocol and opportunity for an informal hearing and at
any time prior to receipt of notice of completion of such protocol,
issue a final order to revoke such protocol if he finds that -
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol
differ so substantially from the results required by the protocol
that further trials cannot be justified, or
(iii) the results of the trials conducted under the protocol or
available new information do not demonstrate that the device
tested under the protocol does not present an unreasonable risk
to health and safety.
(B) After the receipt of a notice of completion of an approved
protocol the Secretary shall, within the ninety-day period
beginning on the date such notice is received, by order either
declare the protocol completed or declare it not completed. An
order declaring a protocol not completed may take effect only after
the Secretary has provided the person who has the protocol
opportunity for an informal hearing on the order. Such an order may
be issued only if the Secretary finds -
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol
differ substantially from the results required by the protocol,
or
(iii) there is a lack of a showing of reasonable assurance of
the safety and effectiveness of the device under the conditions
of use prescribed, recommended, or suggested in the proposed
labeling thereof.
(C) A final order issued under subparagraph (A) or (B) shall be
in writing and shall contain the reasons to support the conclusions
thereof.
(7) At any time after a notice of completion has become
effective, the Secretary may issue an order (after due notice and
opportunity for an informal hearing to the person for whom the
notice is effective) revoking the approval of a device provided by
a notice of completion which has become effective as provided in
subparagraph (B) if he finds that any of the grounds listed in
subparagraphs (A) through (G) of subsection (e)(1) of this section
apply. Each reference in such subparagraphs to an application shall
be considered for purposes of this paragraph as a reference to a
protocol and the notice of completion of such protocol, and each
reference to the time when an application was approved shall be
considered for purposes of this paragraph as a reference to the
time when a notice of completion took effect.
(8) A person who has an approved protocol subject to an order
issued under paragraph (6)(A) revoking such protocol, a person who
has an approved protocol with respect to which an order under
paragraph (6)(B) was issued declaring that the protocol had not
been completed, or a person subject to an order issued under
paragraph (7) revoking the approval of a device may, by petition
filed on or before the thirtieth day after the date upon which he
receives notice of such order, obtain review thereof in accordance
with either paragraph (1) or (2) of subsection (g) of this section.
(g) Review
(1) Upon petition for review of -
(A) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection
(e) of this section withdrawing approval of an application, or
(B) an order under subsection (f)(6)(A) of this section
revoking an approved protocol, under subsection (f)(6)(B) of this
section declaring that an approved protocol has not been
completed, or under subsection (f)(7) of this section revoking
the approval of a device,
the Secretary shall, unless he finds the petition to be without
good cause or unless a petition for review of such order has been
submitted under paragraph (2), hold a hearing, in accordance with
section 554 of title 5, on the order. The panel or panels which
considered the application, protocol, or device subject to such
order shall designate a member to appear and testify at any such
hearing upon request of the Secretary, the petitioner, or the
officer conducting the hearing, but this requirement does not
preclude any other member of the panel or panels from appearing and
testifying at any such hearing. Upon completion of such hearing and
after considering the record established in such hearing, the
Secretary shall issue an order either affirming the order subject
to the hearing or reversing such order and, as appropriate,
approving or denying approval of the application, reinstating the
application's approval, approving the protocol, or placing in
effect a notice of completion.
(2)(A) Upon petition for review of -
(i) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection
(e) of this section withdrawing approval of an application, or
(ii) an order under subsection (f)(6)(A) of this section
revoking an approved protocol, under subsection (f)(6)(B) of this
section declaring that an approved protocol has not been
completed, or under subsection (f)(7) of this section revoking
the approval of a device,
the Secretary shall refer the application or protocol subject to
the order and the basis for the order to an advisory committee of
experts established pursuant to subparagraph (B) for a report and
recommendation with respect to the order. The advisory committee
shall, after independent study of the data and information
furnished to it by the Secretary and other data and information
before it, submit to the Secretary a report and recommendation,
together with all underlying data and information and a statement
of the reasons or basis for the recommendation. A copy of such
report shall be promptly supplied by the Secretary to any person
who petitioned for such referral to the advisory committee.
(B) The Secretary shall establish advisory committees (which may
not be panels under section 360c of this title) to receive
referrals under subparagraph (A). The Secretary shall appoint as
members of any such advisory committee persons qualified in the
subject matter to be referred to the committee and of appropriately
diversified professional backgrounds, except that the Secretary may
not appoint to such a committee any individual who is in the
regular full-time employ of the United States and engaged in the
administration of this chapter. Members of an advisory committee
(other than officers or employees of the United States), while
attending conferences or meetings of their committee or otherwise
serving at the request of the Secretary, shall be entitled to
receive compensation at rates to be fixed by the Secretary, which
rates may not exceed the daily equivalent for grade GS-18 of the
General Schedule for each day (including traveltime) they are so
engaged; and while so serving away from their homes or regular
places of business each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by section
5703 of title 5 for persons in the Government service employed
intermittently. The Secretary shall designate the chairman of an
advisory committee from its members. The Secretary shall furnish
each advisory committee with clerical and other assistance, and
shall by regulation prescribe the procedures to be followed by each
such committee in acting on referrals made under subparagraph (A).
(C) The Secretary shall make public the report and recommendation
made by an advisory committee with respect to an application and
shall by order, stating the reasons therefor, either affirm the
order referred to the advisory committee or reverse such order and,
if appropriate, approve or deny approval of the application,
reinstate the application's approval, approve the protocol, or
place in effect a notice of completion.
(h) Service of orders
Orders of the Secretary under this section shall be served (1) in
person by any officer or employee of the department designated by
the Secretary, or (2) by mailing the order by registered mail or
certified mail addressed to the applicant at his last known address
in the records of the Secretary.
(i) Revision
(1) Before December 1, 1995, the Secretary shall by order require
manufacturers of devices, which were introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, and which are subject to revision of
classification under paragraph (2), to submit to the Secretary a
summary of and citation to any information known or otherwise
available to the manufacturer respecting such devices, including
adverse safety or effectiveness information which has not been
submitted under section 360i of this title. The Secretary may
require the manufacturer to submit the adverse safety or
effectiveness data for which a summary and citation were submitted,
if such data are available to the manufacturer.
(2) After the issuance of an order under paragraph (1) but before
December 1, 1995, the Secretary shall publish a regulation in the
Federal Register for each device -
(A) which the Secretary has classified as a class III device,
and
(B) for which no final regulation has been promulgated under
subsection (b) of this section,
revising the classification of the device so that the device is
classified into class I or class II, unless the regulation requires
the device to remain in class III. In determining whether to revise
the classification of a device or to require a device to remain in
class III, the Secretary shall apply the criteria set forth in
section 360c(a) of this title. Before the publication of a
regulation requiring a device to remain in class III or revising
its classification, the Secretary shall publish a proposed
regulation respecting the classification of a device under this
paragraph and provide reasonable opportunity for the submission of
comments on any such regulation. No regulation requiring a device
to remain in class III or revising its classification may take
effect before the expiration of 90 days from the date of its
publication in the Federal Register as a proposed regulation.
(3) The Secretary shall, as promptly as is reasonably achievable,
but not later than 12 months after the effective date of the
regulation requiring a device to remain in class III, establish a
schedule for the promulgation of a subsection (b) of this section
regulation for each device which is subject to the regulation
requiring the device to remain in class III.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 515, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 552; amended Pub. L. 101-629, Secs. 4(b)(1),
9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103-
80, Sec. 3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115,
title II, Secs. 201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997,
111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107-250, title II, Secs.
209, 210, title III, Sec. 302(c), Oct. 26, 2002, 116 Stat. 1613,
1614, 1618; Pub. L. 108-214, Sec. 2(d)(1), Apr. 1, 2004, 118 Stat.
576.)
-MISC1-
AMENDMENTS
2004 - Subsec. (c)(3). Pub. L. 108-214, Sec. 2(d)(1)(B), amended
directory language of Pub. L. 107-250, Sec. 210. See 2002 Amendment
note below.
Pub. L. 108-214, Sec. 2(d)(1)(A)(i), redesignated par. (3)
relating to acceptance and review of any portion of the application
prior to submission as (4).
Subsec. (c)(4). Pub. L. 108-214, Sec. 2(d)(1)(A), redesignated
par. (3) relating to acceptance and review of any portion of the
application prior to submission as (4) and substituted "unless a
significant issue of safety" for "unless an issue of safety" in
subpar. (B).
2002 - Subsec. (a). Pub. L. 107-250, Sec. 302(c)(1), inserted
"or, as applicable, an approval under subsection (c)(2) of this
section of a report seeking premarket approval" before period in
concluding provisions.
Subsec. (c)(2). Pub. L. 107-250, Sec. 302(c)(2)(B), added par.
(2). Former par. (2) redesignated (3).
Subsec. (c)(3). Pub. L. 107-250, Sec. 302(c)(2)(A), redesignated
par. (2) relating to Secretary's referral of application to
appropriate panel as (3).
Pub. L. 107-250, Sec. 210, as amended by Pub. L. 108-214, Sec.
2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure
that such panel includes, or consults with, one or more pediatric
experts." at the end of the concluding provisions of par. (3) as
redesignated by Pub. L. 107-250, Sec. 302(c)(2)(A).
Pub. L. 107-250, Sec. 209, added par. (3) relating to acceptance
and review of any portion of the application prior to submission.
1997 - Subsec. (d)(1)(A). Pub. L. 105-115, Sec. 205(c)(1),
inserted at end "In making the determination whether to approve or
deny the application, the Secretary shall rely on the conditions of
use included in the proposed labeling as the basis for determining
whether or not there is a reasonable assurance of safety and
effectiveness, if the proposed labeling is neither false nor
misleading. In determining whether or not such labeling is false or
misleading, the Secretary shall fairly evaluate all material facts
pertinent to the proposed labeling."
Subsec. (d)(1)(B)(iii). Pub. L. 105-115, Sec. 201(b), added cl.
(iii).
Subsec. (d)(3), (4). Pub. L. 105-115, Sec. 202(1), 209(b), added
par. (3) and redesignated former par. (3) as (4).
Subsec. (d)(5). Pub. L. 105-115, Sec. 202(2), added par. (5).
Subsec. (d)(6). Pub. L. 105-115, Sec. 205(c)(2), added par. (6).
Subsec. (f)(2). Pub. L. 105-115, Sec. 216(b), substituted "the
Secretary - " and subpars. (A) and (B) for "he shall refer the
proposed protocol to the appropriate panel under section 360c of
this title for its recommendation respecting approval of the
protocol."
1993 - Subsec. (c)(2)(A). Pub. L. 103-80 struck out "refer such
application" after "own initiative".
1990 - Subsec. (c)(2). Pub. L. 101-629, Sec. 18(c), substituted
"the Secretary - " for "the Secretary shall" and added subpars. (A)
and (B).
Subsec. (e). Pub. L. 101-629, Sec. 9(a)(2), inserted "and
temporary suspension" after "Withdrawal" in heading.
Subsec. (e)(3). Pub. L. 101-629, Sec. 9(a)(1), added par. (3).
Subsec. (i). Pub. L. 101-629, Sec. 4(b)(1), added subsec. (i).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees in existence on Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period following Jan.
5, 1973, and advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year period
beginning on the date of their establishment, unless in the case of
a committee established by the President or an officer of the
Federal Government, such committee is renewed by appropriate action
prior to the expiration of such 2-year period, or in the case of a
committee established by Congress, its duration is otherwise
provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
REPORT ON CERTAIN DEVICES
Pub. L. 107-250, title II, Sec. 205, Oct. 26, 2002, 116 Stat.
1612, directed the Secretary of Health and Human Services, not
later than one year after Oct. 26, 2002, to report to the
appropriate committees of Congress on the timeliness and
effectiveness of device premarket reviews by centers other than the
Center for Devices and Radiological Health, including information
on the times required to log in and review original submissions and
supplements, times required to review manufacturers' replies to
submissions, times to approve or clear such devices, and
recommendations on improvement of performance and reassignment of
responsibility for regulating such devices.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
-End-
-CITE-
21 USC Sec. 360f 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360f. Banned devices
-STATUTE-
(a) General rule
Whenever the Secretary finds, on the basis of all available data
and information, that -
(1) a device intended for human use presents substantial
deception or an unreasonable and substantial risk of illness or
injury; and
(2) in the case of substantial deception or an unreasonable and
substantial risk of illness or injury which the Secretary
determined could be corrected or eliminated by labeling or change
in labeling and with respect to which the Secretary provided
written notice to the manufacturer specifying the deception or
risk of illness or injury, the labeling or change in labeling to
correct the deception or eliminate or reduce such risk, and the
period within which such labeling or change in labeling was to be
done, such labeling or change in labeling was not done within
such period;
he may initiate a proceeding to promulgate a regulation to make
such device a banned device.
(b) Special effective date
The Secretary may declare a proposed regulation under subsection
(a) of this section to be effective upon its publication in the
Federal Register and until the effective date of any final action
taken respecting such regulation if (1) he determines, on the basis
of all available data and information, that the deception or risk
of illness or injury associated with the use of the device which is
subject to the regulation presents an unreasonable, direct, and
substantial danger to the health of individuals, and (2) before the
date of the publication of such regulation, the Secretary notifies
the manufacturer of such device that such regulation is to be made
so effective. If the Secretary makes a proposed regulation so
effective, he shall, as expeditiously as possible, give interested
persons prompt notice of his action under this subsection, provide
reasonable opportunity for an informal hearing on the proposed
regulation, and either affirm, modify, or revoke such proposed
regulation.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 516, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 18(d),
Nov. 28, 1990, 104 Stat. 4529.)
-MISC1-
AMENDMENTS
1990 - Subsec. (a). Pub. L. 101-629 struck out "and after
consultation with the appropriate panel or panels under section
360c of this title" after "data and information" in introductory
provisions and struck out at end "The Secretary shall afford all
interested persons opportunity for an informal hearing on a
regulation proposed under this subsection."
-End-
-CITE-
21 USC Sec. 360g 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360g. Judicial review
-STATUTE-
(a) Petition; record
Not later than thirty days after -
(1) the promulgation of a regulation under section 360c of this
title classifying a device in class I or changing the
classification of a device to class I or an order under
subsection (f)(2) of such section reclassifying a device or
denying a petition for reclassification of a device,
(2) the promulgation of a regulation under section 360d of this
title establishing, amending, or revoking a performance standard
for a device,
(3) the issuance of an order under section 360d(b)(2) or
360e(b)(2)(B) of this title denying a request for
reclassification of a device,
(4) the promulgation of a regulation under paragraph (3) of
section 360e(b) of this title requiring a device to have an
approval of a premarket application, a regulation under paragraph
(4) of that section amending or revoking a regulation under
paragraph (3), or an order pursuant to section 360e(g)(1) or
360e(g)(2)(C) of this title,
(5) the promulgation of a regulation under section 360f of this
title (other than a proposed regulation made effective under
subsection (b) of such section upon the regulation's publication)
making a device a banned device,
(6) the issuance of an order under section 360j(f)(2) of this
title,
(7) an order under section 360j(g)(4) of this title
disapproving an application for an exemption of a device for
investigational use or an order under section 360j(g)(5) of this
title withdrawing such an exemption for a device,
(8) an order pursuant to section 360c(i) of this title, or
(9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of
this title,
any person adversely affected by such regulation or order may file
a petition with the United States Court of Appeals for the District
of Columbia or for the circuit wherein such person resides or has
his principal place of business for judicial review of such
regulation or order. A copy of the petition shall be transmitted by
the clerk of the court to the Secretary or other officer designated
by him for that purpose. The Secretary shall file in the court the
record of the proceedings on which the Secretary based his
regulation or order as provided in section 2112 of title 28. For
purposes of this section, the term "record" means all notices and
other matter published in the Federal Register with respect to the
regulation or order reviewed, all information submitted to the
Secretary with respect to such regulation or order, proceedings of
any panel or advisory committee with respect to such regulation or
order, any hearing held with respect to such regulation or order,
and any other information identified by the Secretary, in the
administrative proceeding held with respect to such regulation or
order, as being relevant to such regulation or order.
(b) Additional data, views, and arguments
If the petitioner applies to the court for leave to adduce
additional data, views, or arguments respecting the regulation or
order being reviewed and shows to the satisfaction of the court
that such additional data, views, or arguments are material and
that there were reasonable grounds for the petitioner's failure to
adduce such data, views, or arguments in the proceedings before the
Secretary, the court may order the Secretary to provide additional
opportunity for the oral presentation of data, views, or arguments
and for written submissions. The Secretary may modify his findings,
or make new findings by reason of the additional data, views, or
arguments so taken and shall file with the court such modified or
new findings, and his recommendation, if any, for the modification
or setting aside of the regulation or order being reviewed, with
the return of such additional data, views, or arguments.
(c) Standard for review
Upon the filing of the petition under subsection (a) of this
section for judicial review of a regulation or order, the court
shall have jurisdiction to review the regulation or order in
accordance with chapter 7 of title 5 and to grant appropriate
relief, including interim relief, as provided in such chapter. A
regulation described in paragraph (2) or (5) of subsection (a) of
this section and an order issued after the review provided by
section 360e(g) of this title shall not be affirmed if it is found
to be unsupported by substantial evidence on the record taken as a
whole.
(d) Finality of judgments
The judgment of the court affirming or setting aside, in whole or
in part, any regulation or order shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28.
(e) Remedies
The remedies provided for in this section shall be in addition to
and not in lieu of any other remedies provided by law.
(f) Statement of reasons
To facilitate judicial review under this section or under any
other provision of law of a regulation or order issued under
section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this
title each such regulation or order shall contain a statement of
the reasons for its issuance and the basis, in the record of the
proceedings held in connection with its issuance, for its issuance.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 517, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 13, Nov.
28, 1990, 104 Stat. 4524; Pub. L. 102-300, Sec. 6(f), June 16,
1992, 106 Stat. 240; Pub. L. 105-115, title II, Sec. 216(a)(2),
Nov. 21, 1997, 111 Stat. 2349.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a)(8). Pub. L. 105-115, Sec. 216(a)(2)(A),
inserted "or" at end.
Subsec. (a)(9). Pub. L. 105-115, Sec. 216(a)(2)(B), substituted
comma for ", or" at end.
Subsec. (a)(10). Pub. L. 105-115, Sec. 216(a)(2)(C), struck out
par. (10) which read as follows: "an order under section
360j(h)(4)(B) of this title,".
1992 - Subsec. (a)(10). Pub. L. 102-300 substituted
"360j(h)(4)(B)" for "360j(c)(4)(B)".
1990 - Subsec. (a)(8) to (10). Pub. L. 101-629 added pars. (8) to
(10).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
-End-
-CITE-
21 USC Sec. 360h 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360h. Notification and other remedies
-STATUTE-
(a) Notification
If the Secretary determines that -
(1) a device intended for human use which is introduced or
delivered for introduction into interstate commerce for
commercial distribution presents an unreasonable risk of
substantial harm to the public health, and
(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure
that adequate notification is provided in an appropriate form, by
the persons and means best suited under the circumstances involved,
to all health professionals who prescribe or use the device and to
any other person (including manufacturers, importers, distributors,
retailers, and device users) who should properly receive such
notification in order to eliminate such risk. An order under this
subsection shall require that the individuals subject to the risk
with respect to which the order is to be issued be included in the
persons to be notified of the risk unless the Secretary determines
that notice to such individuals would present a greater danger to
the health of such individuals than no such notification. If the
Secretary makes such a determination with respect to such
individuals, the order shall require that the health professionals
who prescribe or use the device provide for the notification of the
individuals whom the health professionals treated with the device
of the risk presented by the device and of any action which may be
taken by or on behalf of such individuals to eliminate or reduce
such risk. Before issuing an order under this subsection, the
Secretary shall consult with the persons who are to give notice
under the order.
(b) Repair, replacement, or refund
(1)(A) If, after affording opportunity for an informal hearing,
the Secretary determines that -
(i) a device intended for human use which is introduced or
delivered for introduction into interstate commerce for
commercial distribution presents an unreasonable risk of
substantial harm to the public health,
(ii) there are reasonable grounds to believe that the device
was not properly designed or manufactured with reference to the
state of the art as it existed at the time of its design or
manufacture,
(iii) there are reasonable grounds to believe that the
unreasonable risk was not caused by failure of a person other
than a manufacturer, importer, distributor, or retailer of the
device to exercise due care in the installation, maintenance,
repair, or use of the device, and
(iv) the notification authorized by subsection (a) of this
section would not by itself be sufficient to eliminate the
unreasonable risk and action described in paragraph (2) of this
subsection is necessary to eliminate such risk,
the Secretary may order the manufacturer, importer, or any
distributor of such device, or any combination of such persons, to
submit to him within a reasonable time a plan for taking one or
more of the actions described in paragraph (2). An order issued
under the preceding sentence which is directed to more than one
person shall specify which person may decide which action shall be
taken under such plan and the person specified shall be the person
who the Secretary determines bears the principal, ultimate
financial responsibility for action taken under the plan unless the
Secretary cannot determine who bears such responsibility or the
Secretary determines that the protection of the public health
requires that such decision be made by a person (including a device
user or health professional) other than the person he determines
bears such responsibility.
(B) The Secretary shall approve a plan submitted pursuant to an
order issued under subparagraph (A) unless he determines (after
affording opportunity for an informal hearing) that the action or
actions to be taken under the plan or the manner in which such
action or actions are to be taken under the plan will not assure
that the unreasonable risk with respect to which such order was
issued will be eliminated. If the Secretary disapproves a plan, he
shall order a revised plan to be submitted to him within a
reasonable time. If the Secretary determines (after affording
opportunity for an informal hearing) that the revised plan is
unsatisfactory or if no revised plan or no initial plan has been
submitted to the Secretary within the prescribed time, the
Secretary shall (i) prescribe a plan to be carried out by the
person or persons to whom the order issued under subparagraph (A)
was directed, or (ii) after affording an opportunity for an
informal hearing, by order prescribe a plan to be carried out by a
person who is a manufacturer, importer, distributor, or retailer of
the device with respect to which the order was issued but to whom
the order under subparagraph (A) was not directed.
(2) The actions which may be taken under a plan submitted under
an order issued under paragraph (1) are as follows:
(A) To repair the device so that it does not present the
unreasonable risk of substantial harm with respect to which the
order under paragraph (1) was issued.
(B) To replace the device with a like or equivalent device
which is in conformity with all applicable requirements of this
chapter.
(C) To refund the purchase price of the device (less a
reasonable allowance for use if such device has been in the
possession of the device user for one year or more -
(i) at the time of notification ordered under subsection (a)
of this section, or
(ii) at the time the device user receives actual notice of
the unreasonable risk with respect to which the order was
issued under paragraph (1),
whichever first occurs).
(3) No charge shall be made to any person (other than a
manufacturer, importer, distributor or retailer) for availing
himself of any remedy, described in paragraph (2) and provided
under an order issued under paragraph (1), and the person subject
to the order shall reimburse each person (other than a
manufacturer, importer, distributor, or retailer) who is entitled
to such a remedy for any reasonable and foreseeable expenses
actually incurred by such person in availing himself of such
remedy.
(c) Reimbursement
An order issued under subsection (b) of this section with respect
to a device may require any person who is a manufacturer, importer,
distributor, or retailer of the device to reimburse any other
person who is a manufacturer, importer, distributor, or retailer of
such device for such other person's expenses actually incurred in
connection with carrying out the order if the Secretary determines
such reimbursement is required for the protection of the public
health. Any such requirement shall not affect any rights or
obligations under any contract to which the person receiving
reimbursement or the person making such reimbursement is a party.
(d) Effect on other liability
Compliance with an order issued under this section shall not
relieve any person from liability under Federal or State law. In
awarding damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff in
such action of any remedy provided him under such order shall be
taken into account.
(e) Recall authority
(1) If the Secretary finds that there is a reasonable probability
that a device intended for human use would cause serious, adverse
health consequences or death, the Secretary shall issue an order
requiring the appropriate person (including the manufacturers,
importers, distributors, or retailers of the device) -
(A) to immediately cease distribution of such device, and
(B) to immediately notify health professionals and device user
facilities of the order and to instruct such professionals and
facilities to cease use of such device.
The order shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than 10
days after the date of the issuance of the order, on the actions
required by the order and on whether the order should be amended to
require a recall of such device. If, after providing an opportunity
for such a hearing, the Secretary determines that inadequate
grounds exist to support the actions required by the order, the
Secretary shall vacate the order.
(2)(A) If, after providing an opportunity for an informal hearing
under paragraph (1), the Secretary determines that the order should
be amended to include a recall of the device with respect to which
the order was issued, the Secretary shall, except as provided in
subparagraphs (B) and (C), amend the order to require a recall. The
Secretary shall specify a timetable in which the device recall will
occur and shall require periodic reports to the Secretary
describing the progress of the recall.
(B) An amended order under subparagraph (A) -
(i) shall -
(I) not include recall of a device from individuals, and
(II) not include recall of a device from device user
facilities if the Secretary determines that the risk of
recalling such device from the facilities presents a greater
health risk than the health risk of not recalling the device
from use, and
(ii) shall provide for notice to individuals subject to the
risks associated with the use of such device.
In providing the notice required by clause (ii), the Secretary may
use the assistance of health professionals who prescribed or used
such a device for individuals. If a significant number of such
individuals cannot be identified, the Secretary shall notify such
individuals pursuant to section 375(b) of this title.
(3) The remedy provided by this subsection shall be in addition
to remedies provided by subsections (a), (b), and (c) of this
section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 518, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 562; amended Pub. L. 101-629, Sec. 8, Nov.
28, 1990, 104 Stat. 4520; Pub. L. 102-300, Sec. 4, June 16, 1992,
106 Stat. 239.)
-MISC1-
AMENDMENTS
1992 - Subsec. (b)(1)(A)(ii). Pub. L. 102-300 substituted "or"
for "and" after "properly designed" and "time of its design".
1990 - Subsec. (e). Pub. L. 101-629 added subsec. (e).
-End-
-CITE-
21 USC Sec. 360i 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360i. Records and reports on devices
-STATUTE-
(a) General rule
Every person who is a manufacturer or importer of a device
intended for human use shall establish and maintain such records,
make such reports, and provide such information, as the Secretary
may by regulation reasonably require to assure that such device is
not adulterated or misbranded and to otherwise assure its safety
and effectiveness. Regulations prescribed under the preceding
sentence -
(1) shall require a device manufacturer or importer to report
to the Secretary whenever the manufacturer or importer receives
or otherwise becomes aware of information that reasonably
suggests that one of its marketed devices -
(A) may have caused or contributed to a death or serious
injury, or
(B) has malfunctioned and that such device or a similar
device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the
malfunction were to recur;
(2) shall define the term "serious injury" to mean an injury
that -
(A) is life threatening,
(B) results in permanent impairment of a body function or
permanent damage to a body structure, or
(C) necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent damage to
a body structure;
(3) shall require reporting of other significant adverse device
experiences as determined by the Secretary to be necessary to be
reported;
(4) shall not impose requirements unduly burdensome to a device
manufacturer or importer taking into account his cost of
complying with such requirements and the need for the protection
of the public health and the implementation of this chapter;
(5) which prescribe the procedure for making requests for
reports or information shall require that each request made under
such regulations for submission of a report or information to the
Secretary state the reason or purpose for such request and
identify to the fullest extent practicable such report or
information;
(6) which require submission of a report or information to the
Secretary shall state the reason or purpose for the submission of
such report or information and identify to the fullest extent
practicable such report or information;
(7) may not require that the identity of any patient be
disclosed in records, reports, or information required under this
subsection unless required for the medical welfare of an
individual, to determine the safety or effectiveness of a device,
or to verify a record, report, or information submitted under
this chapter; and
(8) may not require a manufacturer or importer of a class I
device to -
(A) maintain for such a device records respecting information
not in the possession of the manufacturer or importer, or
(B) to submit for such a device to the Secretary any report
or information -
(i) not in the possession of the manufacturer or importer,
or
(ii) on a periodic basis,
unless such report or information is necessary to determine if
the device should be reclassified or if the device is adulterated
or misbranded. and (!1)
In prescribing such regulations, the Secretary shall have due
regard for the professional ethics of the medical profession and
the interests of patients. The prohibitions of paragraph (7) of
this subsection continue to apply to records, reports, and
information concerning any individual who has been a patient,
irrespective of whether or when he ceases to be a patient. The
Secretary shall by regulation require distributors to keep records
and make such records available to the Secretary upon request.
Paragraphs (4) and (8) apply to distributors to the same extent and
in the same manner as such paragraphs apply to manufacturers and
importers.
(b) User reports
(1)(A) Whenever a device user facility receives or otherwise
becomes aware of information that reasonably suggests that a device
has or may have caused or contributed to the death of a patient of
the facility, the facility shall, as soon as practicable but not
later than 10 working days after becoming aware of the information,
report the information to the Secretary and, if the identity of the
manufacturer is known, to the manufacturer of the device. In the
case of deaths, the Secretary may by regulation prescribe a shorter
period for the reporting of such information.
(B) Whenever a device user facility receives or otherwise becomes
aware of -
(i) information that reasonably suggests that a device has or
may have caused or contributed to the serious illness of, or
serious injury to, a patient of the facility, or
(ii) other significant adverse device experiences as determined
by the Secretary by regulation to be necessary to be reported,
the facility shall, as soon as practicable but not later than 10
working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary
if the identity of the manufacturer is not known.
(C) Each device user facility shall submit to the Secretary on an
annual basis a summary of the reports made under subparagraphs (A)
and (B). Such summary shall be submitted on January 1 of each year.
The summary shall be in such form and contain such information from
such reports as the Secretary may require and shall include -
(i) sufficient information to identify the facility which made
the reports for which the summary is submitted,
(ii) in the case of any product which was the subject of a
report, the product name, serial number, and model number,
(iii) the name and the address of the manufacturer of such
device, and
(iv) a brief description of the event reported to the
manufacturer.
(D) For purposes of subparagraphs (A), (B), and (C), a device
user facility shall be treated as having received or otherwise
become aware of information with respect to a device of that
facility when medical personnel who are employed by or otherwise
formally affiliated with the facility receive or otherwise become
aware of information with respect to that device in the course of
their duties.
(2) The Secretary may not disclose the identity of a device user
facility which makes a report under paragraph (1) except in
connection with -
(A) an action brought to enforce section 331(q) of this title,
or
(B) a communication to a manufacturer of a device which is the
subject of a report under paragraph (1).
This paragraph does not prohibit the Secretary from disclosing the
identity of a device user facility making a report under paragraph
(1) or any information in such a report to employees of the
Department of Health and Human Services, to the Department of
Justice, or to the duly authorized committees and subcommittees of
the Congress.
(3) No report made under paragraph (1) by -
(A) a device user facility,
(B) an individual who is employed by or otherwise formally
affiliated with such a facility, or
(C) a physician who is not required to make such a report,
shall be admissible into evidence or otherwise used in any civil
action involving private parties unless the facility, individual,
or physician who made the report had knowledge of the falsity of
the information contained in the report.
(4) A report made under paragraph (1) does not affect any
obligation of a manufacturer who receives the report to file a
report as required under subsection (a) of this section.
(5) With respect to device user facilities:
(A) The Secretary shall by regulation plan and implement a
program under which the Secretary limits user reporting under
paragraphs (1) through (4) to a subset of user facilities that
constitutes a representative profile of user reports for device
deaths and serious illnesses or serious injuries.
(B) During the period of planning the program under
subparagraph (A), paragraphs (1) through (4) continue to apply.
(C) During the period in which the Secretary is providing for a
transition to the full implementation of the program, paragraphs
(1) through (4) apply except to the extent that the Secretary
determines otherwise.
(D) On and after the date on which the program is fully
implemented, paragraphs (1) through (4) do not apply to a user
facility unless the facility is included in the subset referred
to in subparagraph (A).
(E) Not later than 2 years after November 21, 1997, the
Secretary shall submit to the Committee on Commerce of the House
of Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the plan developed
by the Secretary under subparagraph (A) and the progress that has
been made toward the implementation of the plan.
(6) For purposes of this subsection:
(A) The term "device user facility" means a hospital,
ambulatory surgical facility, nursing home, or outpatient
treatment facility which is not a physician's office. The
Secretary may by regulation include an outpatient diagnostic
facility which is not a physician's office in such term.
(B) The terms "serious illness" and "serious injury" mean
illness or injury, respectively, that -
(i) is life threatening,
(ii) results in permanent impairment of a body function or
permanent damage to a body structure, or
(iii) necessitates medical or surgical intervention to
preclude permanent impairment of a body function or permanent
damage to a body structure.
(c) Persons exempt
Subsection (a) of this section shall not apply to -
(1) any practitioner who is licensed by law to prescribe or
administer devices intended for use in humans and who
manufactures or imports devices solely for use in the course of
his professional practice;
(2) any person who manufactures or imports devices intended for
use in humans solely for such person's use in research or
teaching and not for sale (including any person who uses a device
under an exemption granted under section 360j(g) of this title);
and
(3) any other class of persons as the Secretary may by
regulation exempt from subsection (a) of this section upon a
finding that compliance with the requirements of such subsection
by such class with respect to a device is not necessary to (A)
assure that a device is not adulterated or misbranded or (B)
otherwise to assure its safety and effectiveness.
(d) Repealed. Pub. L. 105-115, title II, Sec. 213(a)(2), Nov. 21,
1997, 111 Stat. 2347
(e) Device tracking
(1) The Secretary may by order require a manufacturer to adopt a
method of tracking a class II or class III device -
(A) the failure of which would be reasonably likely to have
serious adverse health consequences; or
(B) which is -
(i) intended to be implanted in the human body for more than
one year, or
(ii) a life sustaining or life supporting device used outside
a device user facility.
(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to
release, the patient's name, address, social security number, or
other identifying information for the purpose of tracking.
(f) Reports of removals and corrections
(1) Except as provided in paragraph (2), the Secretary shall by
regulation require a manufacturer or importer of a device to report
promptly to the Secretary any correction or removal of a device
undertaken by such manufacturer or importer if the removal or
correction was undertaken -
(A) to reduce a risk to health posed by the device, or
(B) to remedy a violation of this chapter caused by the device
which may present a risk to health.
A manufacturer or importer of a device who undertakes a correction
or removal of a device which is not required to be reported under
this paragraph shall keep a record of such correction or removal.
(2) No report of the corrective action or removal of a device may
be required under paragraph (1) if a report of the corrective
action or removal is required and has been submitted under
subsection (a) of this section.
(3) For purposes of paragraphs (1) and (2), the terms
"correction" and "removal" do not include routine servicing.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 519, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 564; amended Pub. L. 101-629, Secs. 2(a),
3(a)(1), (b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514,
4520; Pub. L. 102-300, Sec. 5(a), June 16, 1992, 106 Stat. 239;
Pub. L. 103-80, Sec. 3(u), Aug. 13, 1993, 107 Stat. 778; Pub. L.
105-115, title II, Secs. 211, 213(a), (c), Nov. 21, 1997, 111 Stat.
2345-2347.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a). Pub. L. 105-115, Sec. 213(a)(1)(A), (F), in
introductory provisions, substituted "manufacturer or importer" for
"manufacturer, importer, or distributor" and, in closing
provisions, inserted at end "The Secretary shall by regulation
require distributors to keep records and make such records
available to the Secretary upon request. Paragraphs (4) and (8)
apply to distributors to the same extent and in the same manner as
such paragraphs apply to manufacturers and importers."
Subsec. (a)(4). Pub. L. 105-115, Sec. 213(a)(1)(B), substituted
"manufacturer or importer" for "manufacturer, importer, or
distributor".
Subsec. (a)(7). Pub. L. 105-115, Sec. 213(a)(1)(C), inserted
"and" after semicolon at end.
Subsec. (a)(8). Pub. L. 105-115, Sec. 213(a)(1)(D), substituted
"manufacturer or importer" for "manufacturer, importer, or
distributor" wherever appearing and substituted period for
semicolon after "misbranded".
Subsec. (a)(9). Pub. L. 105-115, Sec. 213(a)(1)(E), struck out
par. (9) which read as follows: "shall require distributors who
submit such reports to submit copies of the reports to the
manufacturer of the device for which the report was made."
Subsec. (b)(1)(C). Pub. L. 105-115, Sec. 213(c)(1)(A), in
introductory provisions, substituted "on an annual basis" for "on a
semi-annual basis" and struck out "and July 1" after "January 1"
and struck out closing provisions which read as follows: "The
Secretary may by regulation alter the frequency and timing of
reports required by this subparagraph."
Subsec. (b)(2)(A). Pub. L. 105-115, Sec. 213(c)(1)(B)(i),
inserted "or" after comma at end.
Subsec. (b)(2)(B). Pub. L. 105-115, Sec. 213(c)(1)(B)(ii),
substituted period for ", or" at end.
Subsec. (b)(2)(C). Pub. L. 105-115, Sec. 213(c)(1)(B)(iii),
struck out subpar. (C) which read as follows: "a disclosure
required under subsection (a) of this section."
Subsec. (b)(5), (6). Pub. L. 105-115, Sec. 213(c)(2), added par.
(5) and redesignated former par. (5) as (6).
Subsec. (d). Pub. L. 105-115, Sec. 213(a)(2), struck out heading
and text of subsec. (d). Text read as follows: "Each manufacturer,
importer, and distributor required to make reports under subsection
(a) of this section shall submit to the Secretary annually a
statement certifying that -
"(1) the manufacturer, importer, or distributor did file a
certain number of such reports, or
"(2) the manufacturer, importer, or distributor did not file
any report under subsection (a) of this section."
Subsec. (e). Pub. L. 105-115, Sec. 211, amended heading and text
of subsec. (e) generally. Prior to amendment, text read as follows:
"Every person who registers under section 360 of this title and is
engaged in the manufacture of -
"(1) a device the failure of which would be reasonably likely
to have serious adverse health consequences and which is (A) a
permanently implantable device, or (B) a life sustaining or life
supporting device used outside a device user facility, or
"(2) any other device which the Secretary may designate,
shall adopt a method of device tracking."
Subsec. (f)(1). Pub. L. 105-115, Sec. 213(a)(3), substituted "or
importer" for ", importer, or distributor" wherever appearing.
1993 - Subsec. (a). Pub. L. 103-80 substituted "paragraph (7)"
for "paragraph (4)" in last sentence.
1992 - Subsec. (a). Pub. L. 102-300, Sec. 5(a)(1), added pars.
(1) to (3) and redesignated former pars. (1) to (6) as (4) to (9),
respectively.
Subsec. (b)(1)(A). Pub. L. 102-300, Sec. 5(a)(2)(A), substituted
"a device has or may have" for "there is a probability that a
device has".
Subsec. (b)(1)(B). Pub. L. 102-300, Sec. 5(a)(2)(A), (B),
substituted "a device has or may have" for "there is a probability
that a device has", designated existing provisions as cl. (i), and
added cl. (ii).
Subsec. (b)(5)(B)(iii). Pub. L. 102-300, Sec. 5(a)(2)(C), struck
out "immediate" before "medical".
1990 - Subsec. (a)(6). Pub. L. 101-629, Sec. 3(a)(1), added par.
(6).
Subsecs. (b), (c). Pub. L. 101-629, Sec. 2(a), added subsec. (b)
and redesignated former subsec. (b) as (c).
Subsecs. (d), (e). Pub. L. 101-629, Sec. 3(b)(1), added subsecs.
(d) and (e).
Subsec. (f). Pub. L. 101-629, Sec. 7, added subsec. (f).
-CHANGE-
CHANGE OF NAME
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
-MISC2-
EFFECTIVE DATE OF 1997 AMENDMENT
Section 211 of Pub. L. 105-115 provided in part that the
amendment made by that section is effective 90 days after Nov. 21,
1997.
Amendment by section 213(a), (c) of Pub. L. 105-115 effective 90
days after Nov. 21, 1997, except as otherwise provided, see section
501 of Pub. L. 105-115, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1992 AMENDMENT
Section 2(b) of Pub. L. 102-300 provided that: "The amendments
made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub.
L. 101-629, set out as notes below] shall take effect as of May 27,
1992 and any rule to implement section 519(e) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section
3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101-629,
set out as a note below] shall revert to its proposed status as of
such date."
Section 5(b) of Pub. L. 102-300 provided that: "The amendments
made by subsection (a) [amending this section] shall take effect -
"(1) 1 year after the date of the enactment of this Act [June
16, 1992]; or
"(2) on the effective date of regulations of the Secretary to
implement such amendments,
whichever occurs first."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 2(c) of Pub. L. 101-629 provided that: "Section 519(b) of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as
added by the amendment made by subsection (a), shall take effect -
"(1) upon the effective date of regulations promulgated under
subsection (b) [set out below], or
"(2) upon the expiration of 12 months from the date of the
enactment of this Act [Nov. 28, 1990],
whichever occurs first."
Section 3(a)(2) of Pub. L. 101-629 provided that: "Section
519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by
paragraph (1), shall take effect upon the effective date of final
regulations under subsection (c) [set out below]."
Section 3(b)(3) of Pub. L. 101-629, as amended by Pub. L. 102-
300, Sec. 2(a)(1), June 16, 1992, 106 Stat. 238, provided that:
"Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made
by paragraph (1), shall take effect upon the expiration of 9 months
after the issuance of final regulations under subsection (c) [set
out below]."
[For effective date of amendment by Pub. L. 102-300, see section
2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
Amendment note.]
REGULATIONS
Section 2(b) of Pub. L. 101-629 provided that: "The Secretary of
Health and Human Services shall promulgate regulations to implement
section 519(b) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360i(b)], as added by the amendment made by subsection (a)
(including a definition of the summary required by paragraph (1)(C)
of such section) not later than 12 months after the date of
enactment of this Act [Nov. 28, 1990]. In promulgating the
regulations, the Secretary shall minimize the administrative
burdens on device user facilities consistent with the need to
assure adequate information."
Section 3(c) of Pub. L. 101-629, as amended by Pub. L. 102-300,
Sec. 2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:
"(1)(A) Not later than 9 months after the date of the enactment
of this Act [Nov. 28, 1990], the Secretary of Health and Human
Services shall issue proposed regulations -
"(i) to require distributors of devices to establish and
maintain records and to make reports (including reports required
by part 803 of title 21 of the Code of Federal Regulations) under
section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360i(a)(6)], and
"(ii) to implement section 519(e) of such Act.
The Secretary may exempt from regulations described in clause (i)
classes of distributors of class I and class II devices from whom
reports are not necessary for the protection of the public health.
"(B) Regulations under subparagraph (A) shall -
"(i) require appropriate methods for maintenance of records to
ensure that patients who receive devices can be provided the
notification required by such Act [this chapter],
"(ii) require that manufacturers adopt effective methods of
tracking devices,
"(iii) take into account the position of distributors in the
device distribution process, and
"(iv) include such other requirements as the Secretary deems
necessary for the adoption of an effective user tracking program
under section 519(e) of such Act.
"(2) Not later than 18 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic
Act. If the Secretary does not promulgate such final regulations
upon the expiration of such 18 months, the Congress finds that
there is good cause for the proposed regulations to be considered
as the final regulations without response to comment because the
implementation of sections [sic] 519(a)(6) of such Act is essential
to protect the health of patients who use such devices.
Consequently, in such event, the proposed regulations issued under
paragraph (1) shall become final regulations as of the expiration
of such 18 months. There shall be promptly published in the Federal
Register notice of the new status of the proposed regulations.
"(3) Not later than November 28, 1992, the Secretary shall issue
final regulations to implement section 519(e) of the Federal Food,
Drug, and Cosmetic Act. If the Secretary does not promulgate such
final regulations by November 28, 1992, the Congress finds that
there is good cause for the proposed regulations to be considered
as the final regulations without response to comment because the
implementation of section 519(e) of such Act is essential to
protect the health of patients who use devices. In such event, the
proposed regulations issued under paragraph (1) shall become the
issued final regulations on November 29, 1992. There shall be
promptly published in the Federal Register notice of the new status
of the proposed regulations."
[For effective date of amendment by Pub. L. 102-300, see section
2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
Amendment note.]
INFORMATION CONCERNING REPORTING REQUIREMENTS FOR DEVICE USER
FACILITIES
Section 2(d) of Pub. L. 101-629 directed Secretary of Health and
Human Services, during the 18-month period beginning on Nov. 28,
1990, to inform device user facilities (as defined in 21 U.S.C.
360i(b)(5)(A)) and manufacturers and distributors of devices
respecting the requirements of 21 U.S.C. 360i(b), and, to the
extent practicable, provide persons subject to such requirements
assistance in the form of publications regarding such requirements.
STUDY OF REPORTING REQUIREMENTS; COMPLIANCE BY DEVICE USER
FACILITIES; ACTIONS BY MANUFACTURERS; COST EFFECTIVENESS;
RECOMMENDATIONS
Section 2(e) of Pub. L. 101-629 directed Comptroller General of
the United States, not more than 36 months after Nov. 28, 1990, to
conduct a study of compliance by device user facilities with the
requirements of 21 U.S.C. 360i(b), actions taken by manufacturers
of devices in response to reports made to them, cost effectiveness
of such requirements and their implementation, and any
recommendations for improvements to such requirements, with
Comptroller General to complete the study and submit a report on
the study not later than 45 months from Nov. 28, 1990, to
appropriate committees of Congress.
REPORT TO CONGRESS ON REPORTING REQUIREMENTS FOR DEVICE USER
FACILITIES
Section 2(f) of Pub. L. 101-629 directed Secretary of Health and
Human Services, not later than 36 months after Nov. 28, 1990, to
prepare and submit to appropriate committees of Congress a report
containing an evaluation of the requirements of 21 U.S.C. 360i(b),
consisting of an evaluation of the safety benefits of the
requirements, the burdens placed on the Food and Drug
Administration and on device user facilities by the requirements,
and the cost-effectiveness of the requirements and recommendations
for legislative reform.
-FOOTNOTE-
(!1) So in original. The word "and" probably should not appear.
-End-
-CITE-
21 USC Sec. 360j 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360j. General provisions respecting control of devices
intended for human use
-STATUTE-
(a) General rule
Any requirement authorized by or under section 351, 352, 360, or
360i of this title applicable to a device intended for human use
shall apply to such device until the applicability of the
requirement to the device has been changed by action taken under
section 360c, 360d, or 360e of this title or under subsection (g)
of this section, and any requirement established by or under
section 351, 352, 360, or 360i of this title which is inconsistent
with a requirement imposed on such device under section 360d or
360e of this title or under subsection (g) of this section shall
not apply to such device.
(b) Custom devices
Sections 360d and 360e of this title do not apply to any device
which, in order to comply with the order of an individual physician
or dentist (or any other specially qualified person designated
under regulations promulgated by the Secretary after an opportunity
for an oral hearing) necessarily deviates from an otherwise
applicable performance standard or requirement prescribed by or
under section 360e of this title if (1) the device is not generally
available in finished form for purchase or for dispensing upon
prescription and is not offered through labeling or advertising by
the manufacturer, importer, or distributor thereof for commercial
distribution, and (2) such device -
(A)(i) is intended for use by an individual patient named in
such order of such physician or dentist (or other specially
qualified person so designated) and is to be made in a specific
form for such patient, or
(ii) is intended to meet the special needs of such physician or
dentist (or other specially qualified person so designated) in
the course of the professional practice of such physician or
dentist (or other specially qualified person so designated), and
(B) is not generally available to or generally used by other
physicians or dentists (or other specially qualified persons so
designated).
(c) Trade secrets
Any information reported to or otherwise obtained by the
Secretary or his representative under section 360c, 360d, 360e,
360f, 360h, 360i, or 374 of this title or under subsection (f) or
(g) of this section which is exempt from disclosure pursuant to
subsection (a) of section 552 of title 5 by reason of subsection
(b)(4) of such section shall be considered confidential and shall
not be disclosed and may not be used by the Secretary as the basis
for the reclassification of a device from class III to class II or
class I or as the basis for the establishment or amendment of a
performance standard under section 360d of this title for a device
reclassified from class III to class II, except (1) in accordance
with subsection (h) of this section, and (2) that such information
may be disclosed to other officers or employees concerned with
carrying out this chapter or when relevant in any proceeding under
this chapter (other than section 360c or 360d of this title).
(d) Notices and findings
Each notice of proposed rulemaking under section 360c, 360d,
360e, 360f, 360h, or 360i of this title, or under this section, any
other notice which is published in the Federal Register with
respect to any other action taken under any such section and which
states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking under
any such section shall set forth -
(1) the manner in which interested persons may examine data and
other information on which the notice or findings is based, and
(2) the period within which interested persons may present
their comments on the notice or findings (including the need
therefor) orally or in writing, which period shall be at least
sixty days but may not exceed ninety days unless the time is
extended by the Secretary by a notice published in the Federal
Register stating good cause therefor.
(e) Restricted devices
(1) The Secretary may by regulation require that a device be
restricted to sale, distribution, or use -
(A) only upon the written or oral authorization of a
practitioner licensed by law to administer or use such device, or
(B) upon such other conditions as the Secretary may prescribe
in such regulation,
if, because of its potentiality for harmful effect or the
collateral measures necessary to its use, the Secretary determines
that there cannot otherwise be reasonable assurance of its safety
and effectiveness. No condition prescribed under subparagraph (B)
may restrict the use of a device to persons with specific training
or experience in its use or to persons for use in certain
facilities unless the Secretary determines that such a restriction
is required for the safe and effective use of the device. No such
condition may exclude a person from using a device solely because
the person does not have the training or experience to make him
eligible for certification by a certifying board recognized by the
American Board of Medical Specialties or has not been certified by
such a Board. A device subject to a regulation under this
subsection is a restricted device.
(2) The label of a restricted device shall bear such appropriate
statements of the restrictions required by a regulation under
paragraph (1) as the Secretary may in such regulation prescribe.
(f) Good manufacturing practice requirements
(1)(A) The Secretary may, in accordance with subparagraph (B),
prescribe regulations requiring that the methods used in, and the
facilities and controls used for, the manufacture, pre-production
design validation (including a process to assess the performance of
a device but not including an evaluation of the safety or
effectiveness of a device), packing, storage, and installation of a
device conform to current good manufacturing practice, as
prescribed in such regulations, to assure that the device will be
safe and effective and otherwise in compliance with this chapter.
(B) Before the Secretary may promulgate any regulation under
subparagraph (A) he shall -
(i) afford the advisory committee established under paragraph
(3) an opportunity to submit recommendations to him with respect
to the regulation proposed to be promulgated;
(ii) afford opportunity for an oral hearing; and
(iii) ensure that such regulation conforms, to the extent
practicable, with internationally recognized standards defining
quality systems, or parts of the standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable
time to make its recommendation with respect to proposed
regulations under subparagraph (A).
(2)(A) Any person subject to any requirement prescribed by
regulations under paragraph (1) may petition the Secretary for an
exemption or variance from such requirement. Such a petition shall
be submitted to the Secretary in such form and manner as he shall
prescribe and shall -
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the device will be safe and effective and
otherwise in compliance with this chapter,
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in, and
the facilities and controls proposed to be used for, the
manufacture, packing, storage, and installation of the device in
lieu of the methods, facilities, and controls prescribed by the
requirement, and
(iii) contain such other information as the Secretary shall
prescribe.
(B) The Secretary may refer to the advisory committee established
under paragraph (3) any petition submitted under subparagraph (A).
The advisory committee shall report its recommendations to the
Secretary with respect to a petition referred to it within sixty
days of the date of the petition's referral. Within sixty days
after -
(i) the date the petition was submitted to the Secretary under
subparagraph (A), or
(ii) if the petition was referred to an advisory committee, the
expiration of the sixty-day period beginning on the date the
petition was referred to the advisory committee,
whichever occurs later, the Secretary shall by order either deny
the petition or approve it.
(C) The Secretary may approve -
(i) a petition for an exemption for a device from a requirement
if he determines that compliance with such requirement is not
required to assure that the device will be safe and effective and
otherwise in compliance with this chapter, and
(ii) a petition for a variance for a device from a requirement
if he determines that the methods to be used in, and the
facilities and controls to be used for, the manufacture, packing,
storage, and installation of the device in lieu of the methods,
controls, and facilities prescribed by the requirement are
sufficient to assure that the device will be safe and effective
and otherwise in compliance with this chapter.
An order of the Secretary approving a petition for a variance shall
prescribe such conditions respecting the methods used in, and the
facilities and controls used for, the manufacture, packing,
storage, and installation of the device to be granted the variance
under the petition as may be necessary to assure that the device
will be safe and effective and otherwise in compliance with this
chapter.
(D) After the issuance of an order under subparagraph (B)
respecting a petition, the petitioner shall have an opportunity for
an informal hearing on such order.
(3) The Secretary shall establish an advisory committee for the
purpose of advising and making recommendations to him with respect
to regulations proposed to be promulgated under paragraph (1)(A)
and the approval or disapproval of petitions submitted under
paragraph (2). The advisory committee shall be composed of nine
members as follows:
(A) Three of the members shall be appointed from persons who
are officers or employees of any State or local government or of
the Federal Government.
(B) Two of the members shall be appointed from persons who are
representative of interests of the device manufacturing industry;
two of the members shall be appointed from persons who are
representative of the interests of physicians and other health
professionals; and two of the members shall be representative of
the interests of the general public.
Members of the advisory committee who are not officers or employees
of the United States, while attending conferences or meetings of
the committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which rates may not exceed the daily equivalent of the
rate in effect for grade GS-18 of the General Schedule, for each
day (including traveltime) they are so engaged; and while so
serving away from their homes or regular places of business each
member may be allowed travel expenses, including per diem in lieu
of subsistence, as authorized by section 5703 of title 5 for
persons in the Government service employed intermittently. The
Secretary shall designate one of the members of the advisory
committee to serve as its chairman. The Secretary shall furnish the
advisory committee with clerical and other assistance. Section 14
of the Federal Advisory Committee Act shall not apply with respect
to the duration of the advisory committee established under this
paragraph.
(g) Exemption for devices for investigational use
(1) It is the purpose of this subsection to encourage, to the
extent consistent with the protection of the public health and
safety and with ethical standards, the discovery and development of
useful devices intended for human use and to that end to maintain
optimum freedom for scientific investigators in their pursuit of
that purpose.
(2)(A) The Secretary shall, within the one hundred and twenty-day
period beginning on May 28, 1976, by regulation prescribe
procedures and conditions under which devices intended for human
use may upon application be granted an exemption from the
requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e
of this title or subsection (e) or (f) of this section or from any
combination of such requirements to permit the investigational use
of such devices by experts qualified by scientific training and
experience to investigate the safety and effectiveness of such
devices.
(B) The conditions prescribed pursuant to subparagraph (A) shall
include the following:
(i) A requirement that an application be submitted to the
Secretary before an exemption may be granted and that the
application be submitted in such form and manner as the Secretary
shall specify.
(ii) A requirement that the person applying for an exemption
for a device assure the establishment and maintenance of such
records, and the making of such reports to the Secretary of data
obtained as a result of the investigational use of the device
during the exemption, as the Secretary determines will enable him
to assure compliance with such conditions, review the progress of
the investigation, and evaluate the safety and effectiveness of
the device.
(iii) Such other requirements as the Secretary may determine to
be necessary for the protection of the public health and safety.
(C) Procedures and conditions prescribed pursuant to subparagraph
(A) for an exemption may appropriately vary depending on (i) the
scope and duration of clinical testing to be conducted under such
exemption, (ii) the number of human subjects that are to be
involved in such testing, (iii) the need to permit changes to be
made in the device subject to the exemption during testing
conducted in accordance with a clinical testing plan required under
paragraph (3)(A), and (iv) whether the clinical testing of such
device is for the purpose of developing data to obtain approval for
the commercial distribution of such device.
(3) Procedures and conditions prescribed pursuant to paragraph
(2)(A) shall require, as a condition to the exemption of any device
to be the subject of testing involving human subjects, that the
person applying for the exemption -
(A) submit a plan for any proposed clinical testing of the
device and a report of prior investigations of the device
(including, where appropriate, tests on animals) adequate to
justify the proposed clinical testing -
(i) to the local institutional review committee which has
been established in accordance with regulations of the
Secretary to supervise clinical testing of devices in the
facilities where the proposed clinical testing is to be
conducted, or
(ii) to the Secretary, if -
(I) no such committee exists, or
(II) the Secretary finds that the process of review by such
committee is inadequate (whether or not the plan for such
testing has been approved by such committee),
for review for adequacy to justify the commencement of such
testing; and, unless the plan and report are submitted to the
Secretary, submit to the Secretary a summary of the plan and a
report of prior investigations of the device (including, where
appropriate, tests on animals);
(B) promptly notify the Secretary (under such circumstances and
in such manner as the Secretary prescribes) of approval by a
local institutional review committee of any clinical testing plan
submitted to it in accordance with subparagraph (A);
(C) in the case of a device to be distributed to investigators
for testing, obtain signed agreements from each of such
investigators that any testing of the device involving human
subjects will be under such investigator's supervision and in
accordance with subparagraph (D) and submit such agreements to
the Secretary; and
(D) assure that informed consent will be obtained from each
human subject (or his representative) of proposed clinical
testing involving such device, except where subject to such
conditions as the Secretary may prescribe, the investigator
conducting or supervising the proposed clinical testing of the
device determines in writing that there exists a life threatening
situation involving the human subject of such testing which
necessitates the use of such device and it is not feasible to
obtain informed consent from the subject and there is not
sufficient time to obtain such consent from his representative.
The determination required by subparagraph (D) shall be concurred
in by a licensed physician who is not involved in the testing of
the human subject with respect to which such determination is made
unless immediate use of the device is required to save the life of
the human subject of such testing and there is not sufficient time
to obtain such concurrence.
(4)(A) An application, submitted in accordance with the
procedures prescribed by regulations under paragraph (2), for an
exemption for a device (other than an exemption from section 360f
of this title) shall be deemed approved on the thirtieth day after
the submission of the application to the Secretary unless on or
before such day the Secretary by order disapproves the application
and notifies the applicant of the disapproval of the application.
(B) The Secretary may disapprove an application only if he finds
that the investigation with respect to which the application is
submitted does not conform to procedures and conditions prescribed
under regulations under paragraph (2). Such a notification shall
contain the order of disapproval and a complete statement of the
reasons for the Secretary's disapproval of the application and
afford the applicant opportunity for an informal hearing on the
disapproval order.
(5) The Secretary may by order withdraw an exemption granted
under this subsection for a device if the Secretary determines that
the conditions applicable to the device under this subsection for
such exemption are not met. Such an order may be issued only after
opportunity for an informal hearing, except that such an order may
be issued before the provision of an opportunity for an informal
hearing if the Secretary determines that the continuation of
testing under the exemption with respect to which the order is to
be issued will result in an unreasonable risk to the public health.
(6)(A) Not later than 1 year after November 21, 1997, the
Secretary shall by regulation establish, with respect to a device
for which an exemption under this subsection is in effect,
procedures and conditions that, without requiring an additional
approval of an application for an exemption or the approval of a
supplement to such an application, permit -
(i) developmental changes in the device (including
manufacturing changes) that do not constitute a significant
change in design or in basic principles of operation and that are
made in response to information gathered during the course of an
investigation; and
(ii) changes or modifications to clinical protocols that do not
affect -
(I) the validity of data or information resulting from the
completion of an approved protocol, or the relationship of
likely patient risk to benefit relied upon to approve a
protocol;
(II) the scientific soundness of an investigational plan
submitted under paragraph (3)(A); or
(III) the rights, safety, or welfare of the human subjects
involved in the investigation.
(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be made
if -
(i) the sponsor of the investigation determines, on the basis
of credible information (as defined by the Secretary) that the
applicable conditions under subparagraph (A) are met; and
(ii) the sponsor submits to the Secretary, not later than 5
days after making the change or modification, a notice of the
change or modification.
(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any implantable
device, the Secretary shall ensure that the person has an
opportunity, prior to submitting an application to the Secretary or
to an institutional review committee, to submit to the Secretary,
for review, an investigational plan (including a clinical
protocol). If the applicant submits a written request for a meeting
with the Secretary regarding such review, the Secretary shall, not
later than 30 days after receiving the request, meet with the
applicant for the purpose of reaching agreement regarding the
investigational plan (including a clinical protocol). The written
request shall include a detailed description of the device, a
detailed description of the proposed conditions of use of the
device, a proposed plan (including a clinical protocol) for
determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device.
(B) Any agreement regarding the parameters of an investigational
plan (including a clinical protocol) that is reached between the
Secretary and a sponsor or applicant shall be reduced to writing
and made part of the administrative record by the Secretary. Any
such agreement shall not be changed, except -
(i) with the written agreement of the sponsor or applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which the
device involved is reviewed, that a substantial scientific issue
essential to determining the safety or effectiveness of the
device involved has been identified.
(C) A decision under subparagraph (B)(ii) by the director shall
be in writing, and may be made only after the Secretary has
provided to the sponsor or applicant an opportunity for a meeting
at which the director and the sponsor or applicant are present and
at which the director documents the scientific issue involved.
(h) Release of information respecting safety and effectiveness
(1) The Secretary shall promulgate regulations under which a
detailed summary of information respecting the safety and
effectiveness of a device which information was submitted to the
Secretary and which was the basis for -
(A) an order under section 360e(d)(1)(A) of this title
approving an application for premarket approval for the device or
denying approval of such an application or an order under section
360e(e) of this title withdrawing approval of such an application
for the device,
(B) an order under section 360e(f)(6)(A) of this title revoking
an approved protocol for the device, an order under section
360e(f)(6)(B) of this title declaring a protocol for the device
completed or not completed, or an order under section 360e(f)(7)
of this title revoking the approval of the device, or
(C) an order approving an application under subsection (g) of
this section for an exemption for the device from section 360f of
this title or an order disapproving, or withdrawing approval of,
an application for an exemption under such subsection for the
device,
shall be made available to the public upon issuance of the order.
Summaries of information made available pursuant to this paragraph
respecting a device shall include information respecting any
adverse effects on health of the device.
(2) The Secretary shall promulgate regulations under which each
advisory committee established under section 360e(g)(2)(B) of this
title shall make available to the public a detailed summary of
information respecting the safety and effectiveness of a device
which information was submitted to the advisory committee and which
was the basis for its recommendation to the Secretary made pursuant
to section 360e(g)(2)(A) of this title. A summary of information
upon which such a recommendation is based shall be made available
pursuant to this paragraph only after the issuance of the order
with respect to which the recommendation was made and each summary
shall include information respecting any adverse effect on health
of the device subject to such order.
(3) Except as provided in paragraph (4), any information
respecting a device which is made available pursuant to paragraph
(1) or (2) of this subsection (A) may not be used to establish the
safety or effectiveness of another device for purposes of this
chapter by any person other than the person who submitted the
information so made available, and (B) shall be made available
subject to subsection (c) of this section.
(4)(A) Any information contained in an application for premarket
approval filed with the Secretary pursuant to section 360e(c) of
this title (including information from clinical and preclinical
tests or studies that demonstrate the safety and effectiveness of a
device, but excluding descriptions of methods of manufacture and
product composition and other trade secrets) shall be available, 6
years after the application has been approved by the Secretary, for
use by the Secretary in -
(i) approving another device;
(ii) determining whether a product development protocol has
been completed, under section 360e of this title for another
device;
(iii) establishing a performance standard or special control
under this chapter; or
(iv) classifying or reclassifying another device under section
360c of this title and subsection (l)(2) of this section.
(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as the
evidentiary basis for the agency actions described in subparagraph
(A).
(i) Proceedings of advisory panels and committees
Each panel under section 360c of this title and each advisory
committee established under section 360d(b)(5)(B) or 360e(g) of
this title or under subsection (f) of this section shall make and
maintain a transcript of any proceeding of the panel or committee.
Each such panel and committee shall delete from any transcript made
pursuant to this subsection information which under subsection (c)
of this section is to be considered confidential.
(j) Traceability
Except as provided in section 360i(e) of this title, no
regulation under this chapter may impose on a type or class of
device requirements for the traceability of such type or class of
device unless such requirements are necessary to assure the
protection of the public health.
(k) Research and development
The Secretary may enter into contracts for research, testing, and
demonstrations respecting devices and may obtain devices for
research, testing, and demonstration purposes without regard to
section 3324(a) and (b) of title 31 and section 5 of title 41.
(l) Transitional provisions for devices considered as new drugs
(1) Any device intended for human use -
(A) for which on May 28, 1976 (hereinafter in this subsection
referred to as the "enactment date") an approval of an
application submitted under section 355(b) of this title was in
effect;
(B) for which such an application was filed on or before the
enactment date and with respect to which application no order of
approval or refusing to approve had been issued on such date
under subsection (c) or (d) of such section;
(C) for which on the enactment date an exemption under
subsection (i) of such section was in effect;
(D) which is within a type of device described in subparagraph
(A), (B), or (C) and is substantially equivalent to another
device within that type;
(E) which the Secretary in a notice published in the Federal
Register before the enactment date has declared to be a new drug
subject to section 355 of this title; or
(F) with respect to which on the enactment date an action is
pending in a United States court under section 332, 333, or 334
of this title for an alleged violation of a provision of section
331 of this title which enforces a requirement of section 355 of
this title or for an alleged violation of section 355(a) of this
title,
is classified in class III unless the Secretary in response to a
petition submitted under paragraph (2) has classified such device
in class I or II.
(2) The Secretary may initiate the reclassification of a device
classified into class III under paragraph (1) of this subsection or
the manufacturer or importer of a device classified under paragraph
(1) may petition the Secretary (in such form and manner as he shall
prescribe) for the issuance of an order classifying the device in
class I or class II. Within thirty days of the filing of such a
petition, the Secretary shall notify the petitioner of any
deficiencies in the petition which prevent the Secretary from
making a decision on the petition. Except as provided in paragraph
(3)(D)(ii), within one hundred and eighty days after the filing of
a petition under this paragraph, the Secretary shall, after
consultation with the appropriate panel under section 360c of this
title, by order either deny the petition or order the
classification, in accordance with the criteria prescribed by
section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title,
of the device in class I or class II.
(3)(A) In the case of a device which is described in paragraph
(1)(A) and which is in class III -
(i) such device shall on the enactment date be considered a
device with an approved application under section 360e of this
title, and
(ii) the requirements applicable to such device before the
enactment date under section 355 of this title shall continue to
apply to such device until changed by the Secretary as authorized
by this chapter.
(B) In the case of a device which is described in paragraph
(1)(B) and which is in class III, an application for such device
shall be considered as having been filed under section 360e of this
title on the enactment date. The period in which the Secretary
shall act on such application in accordance with section 360e(d)(1)
of this title shall be one hundred and eighty days from the
enactment date (or such greater period as the Secretary and the
applicant may agree upon after the Secretary has made the finding
required by section 360e(d)(1)(B)(i) of this title) less the number
of days in the period beginning on the date an application for such
device was filed under section 355 of this title and ending on the
enactment date. After the expiration of such period such device is
required, unless exempt under subsection (g) of this section, to
have in effect an approved application under section 360e of this
title.
(C) A device which is described in paragraph (1)(C) and which is
in class III shall be considered a new drug until the expiration of
the ninety-day period beginning on the date of the promulgation of
regulations under subsection (g) of this section. After the
expiration of such period such device is required, unless exempt
under subsection (g) of this section, to have in effect an approved
application under section 360e of this title.
(D)(i) Except as provided in clauses (ii) and (iii), a device
which is described in subparagraph (D), (E), or (F) of paragraph
(1) and which is in class III is required, unless exempt under
subsection (g) of this section, to have on and after sixty days
after the enactment date in effect an approved application under
section 360e of this title.
(ii) If -
(I) a petition is filed under paragraph (2) for a device
described in subparagraph (D), (E), or (F) of paragraph (1), or
(II) an application for premarket approval is filed under
section 360e of this title for such a device,
within the sixty-day period beginning on the enactment date (or
within such greater period as the Secretary, after making the
finding required under section 360e(d)(1)(B) of this title, and the
petitioner or applicant may agree upon), the Secretary shall act on
such petition or application in accordance with paragraph (2) or
section 360e of this title except that the period within which the
Secretary must act on the petition or application shall be within
the one hundred and twenty-day period beginning on the date the
petition or application is filed. If such a petition or application
is filed within such sixty-day (or greater) period, clause (i) of
this subparagraph shall not apply to such device before the
expiration of such one hundred and twenty-day period, or if such
petition is denied or such application is denied approval, before
the date of such denial, whichever occurs first.
(iii) In the case of a device which is described in subparagraph
(E) of paragraph (1), which the Secretary in a notice published in
the Federal Register after March 31, 1976, declared to be a new
drug subject to section 355 of this title, and which is in class
III -
(I) the device shall, after eighteen months after the enactment
date, have in effect an approved application under section 360e
of this title unless exempt under subsection (g) of this section,
and
(II) the Secretary may, during the period beginning one hundred
and eighty days after the enactment date and ending eighteen
months after such date, restrict the use of the device to
investigational use by experts qualified by scientific training
and experience to investigate the safety and effectiveness of
such device, and to investigational use in accordance with the
requirements applicable under regulations under subsection (g) of
this section to investigational use of devices granted an
exemption under such subsection.
If the requirements under subsection (g) of this section are made
applicable to the investigational use of such a device, they shall
be made applicable in such a manner that the device shall be made
reasonably available to physicians meeting appropriate
qualifications prescribed by the Secretary.
(4) Repealed. Pub. L. 105-115, title I, Sec. 125(b)(2)(E), Nov.
21, 1997, 111 Stat. 2325.
(5)(A) Before December 1, 1991, the Secretary shall by order
require manufacturers of devices described in paragraph (1), which
are subject to revision of classification under subparagraph (B),
to submit to the Secretary a summary of and citation to any
information known or otherwise available to the manufacturers
respecting the devices, including adverse safety or effectiveness
information which has not been submitted under section 360i of this
title. The Secretary may require a manufacturer to submit the
adverse safety or effectiveness data for which a summary and
citation were submitted, if such data are available to the
manufacturer.
(B) Except as provided in subparagraph (C), after the issuance of
an order under subparagraph (A) but before December 1, 1992, the
Secretary shall publish a regulation in the Federal Register for
each device which is classified in class III under paragraph (1)
revising the classification of the device so that the device is
classified into class I or class II, unless the regulation requires
the device to remain in class III. In determining whether to revise
the classification of a device or to require a device to remain in
class III, the Secretary shall apply the criteria set forth in
section 360c(a) of this title. Before the publication of a
regulation requiring a device to remain in class III or revising
its classification, the Secretary shall publish a proposed
regulation respecting the classification of a device under this
subparagraph and provide an opportunity for the submission of
comments on any such regulation. No regulation under this
subparagraph requiring a device to remain in class III or revising
its classification may take effect before the expiration of 90 days
from the date of the publication in the Federal Register of the
proposed regulation.
(C) The Secretary may by notice published in the Federal Register
extend the period prescribed by subparagraph (B) for a device for
an additional period not to exceed 1 year.
(m) Humanitarian device exemption
(1) To the extent consistent with the protection of the public
health and safety and with ethical standards, it is the purpose of
this subsection to encourage the discovery and use of devices
intended to benefit patients in the treatment and diagnosis of
diseases or conditions that affect fewer than 4,000 individuals in
the United States.
(2) The Secretary may grant a request for an exemption from the
effectiveness requirements of sections 360d and 360e of this title
for a device for which the Secretary finds that -
(A) the device is designed to treat or diagnose a disease or
condition that affects fewer than 4,000 individuals in the United
States,
(B) the device would not be available to a person with a
disease or condition referred to in subparagraph (A) unless the
Secretary grants such an exemption and there is no comparable
device, other than under this exemption, available to treat or
diagnose such disease or condition, and
(C) the device will not expose patients to an unreasonable or
significant risk of illness or injury and the probable benefit to
health from the use of the device outweighs the risk of injury or
illness from its use, taking into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The request shall be in the form of an application submitted to the
Secretary. Not later than 75 days after the date of the receipt of
the application, the Secretary shall issue an order approving or
denying the application.
(3) No person granted an exemption under paragraph (2) with
respect to a device may sell the device for an amount that exceeds
the costs of research and development, fabrication, and
distribution of the device.
(4) Devices granted an exemption under paragraph (2) may only be
used -
(A) in facilities that have established, in accordance with
regulations of the Secretary, a local institutional review
committee to supervise clinical testing of devices in the
facilities, and
(B) if, before the use of a device, an institutional review
committee approves the use in the treatment or diagnosis of a
disease or condition referred to in paragraph (2)(A), unless a
physician determines in an emergency situation that approval from
a local institutional review committee can not be obtained in
time to prevent serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician uses a
device without an approval from an institutional review committee,
the physician shall, after the use of the device, notify the
chairperson of the local institutional review committee of such
use. Such notification shall include the identification of the
patient involved, the date on which the device was used, and the
reason for the use.
(5) The Secretary may require a person granted an exemption under
paragraph (2) to demonstrate continued compliance with the
requirements of this subsection if the Secretary believes such
demonstration to be necessary to protect the public health or if
the Secretary has reason to believe that the criteria for the
exemption are no longer met.
(6) The Secretary may suspend or withdraw an exemption from the
effectiveness requirements of sections 360d and 360e of this title
for a humanitarian device only after providing notice and an
opportunity for an informal hearing.
(n) Regulation of contact lenses as devices
(1) All contact lenses shall be deemed to be devices under
section 321(h) of this title.
(2) Paragraph (1) shall not be construed as bearing on or being
relevant to the question of whether any product other than a
contact lens is a device as defined by section 321(h) of this title
or a drug as defined by section 321(g) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 520, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 565; amended Pub. L. 101-629, Secs. 3(b)(2),
4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990,
104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102-
571, title I, Sec. 107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
105-115, title I, Sec. 125(b)(2)(E), title II, Secs. 201(a), 203,
216(a)(1), title IV, Sec. 410(a), Nov. 21, 1997, 111 Stat. 2325,
2332, 2334, 2349, 2372; Pub. L. 109-96, Sec. 1, Nov. 9, 2005, 119
Stat. 2119.)
-REFTEXT-
REFERENCES IN TEXT
Section 14 of the Federal Advisory Committee Act, referred to in
subsec. (f)(3), is section 14 of Pub. L. 92-463, which is set out
in the Appendix to Title 5, Government Organization and Employees.
-COD-
CODIFICATION
In subsec. (k), "section 3324(a) and (b) of title 31" substituted
for reference to section 3648 of the Revised Statutes (31 U.S.C.
529) on authority of Pub. L. 97-258, Sec. 4(b), Sept. 13, 1982, 96
Stat. 1067, the first section of which enacted Title 31, Money and
Finance.
-MISC1-
AMENDMENTS
2005 - Subsec. (n). Pub. L. 109-96 added subsec. (n).
1997 - Subsec. (f)(1)(B)(iii). Pub. L. 105-115, Sec. 410(a),
added cl. (iii).
Subsec. (g)(6), (7). Pub. L. 105-115, Sec. 201(a), added pars.
(6) and (7).
Subsec. (h)(4). Pub. L. 105-115, Sec. 216(a)(1), amended par. (4)
generally. Prior to amendment, par. (4) related to premarket
approval of devices.
Subsec. (l). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out "or
antibiotic drugs" after "new drugs" in heading.
Subsec. (l)(4). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out
par. (4) which read as follows: "Any device intended for human use
which on the enactment date was subject to the requirements of
section 357 of this title shall be subject to such requirements as
follows:
"(A) In the case of such a device which is classified into
class I, such requirements shall apply to such device until the
effective date of the regulation classifying the device into such
class.
"(B) In the case of such a device which is classified into
class II, such requirements shall apply to such device until the
effective date of a performance standard applicable to the device
under section 360d of this title.
"(C) In the case of such a device which is classified into
class III, such requirements shall apply to such device until the
date on which the device is required to have in effect an
approved application under section 360e of this title."
Subsec. (m)(2). Pub. L. 105-115, Sec. 203(1), inserted at end
"The request shall be in the form of an application submitted to
the Secretary. Not later than 75 days after the date of the receipt
of the application, the Secretary shall issue an order approving or
denying the application."
Subsec. (m)(4). Pub. L. 105-115, Sec. 203(2)(B), inserted at end
"In a case described in subparagraph (B) in which a physician uses
a device without an approval from an institutional review
committee, the physician shall, after the use of the device, notify
the chairperson of the local institutional review committee of such
use. Such notification shall include the identification of the
patient involved, the date on which the device was used, and the
reason for the use."
Subsec. (m)(4)(B). Pub. L. 105-115, Sec. 203(2)(A), inserted
before period at end ", unless a physician determines in an
emergency situation that approval from a local institutional review
committee can not be obtained in time to prevent serious harm or
death to a patient".
Subsec. (m)(5). Pub. L. 105-115, Sec. 203(3), amended par. (5)
generally. Prior to amendment, par. (5) read as follows: "An
exemption under paragraph (2) shall be for a term of 18 months and
may only be initially granted in the 5-year period beginning on the
date regulations under paragraph (6) take effect. The Secretary may
extend such an exemption for a period of 18 months if the Secretary
is able to make the findings set forth in paragraph (2) and if the
applicant supplies information demonstrating compliance with
paragraph (3). An exemption may be extended more than once and may
be extended after the expiration of such 5-year period."
Subsec. (m)(6). Pub. L. 105-115, Sec. 203(4), amended par. (6)
generally. Prior to amendment, par. (6) read as follows: "Within
one year of November 28, 1990, the Secretary shall issue
regulations to implement this subsection."
1992 - Subsec. (g)(2)(A). Pub. L. 102-571 substituted "379e" for
"376".
1990 - Subsec. (c). Pub. L. 101-629, Sec. 11(1), substituted
"from class III to class II or class I" for "under section 360c of
this title from class III to class II" and inserted "(1) in
accordance with subsection (h) of this section, and (2)" after
"except".
Subsec. (f)(1)(A). Pub. L. 101-629, Sec. 18(e), inserted "pre-
production design validation (including a process to assess the
performance of a device but not including an evaluation of the
safety or effectiveness of a device)," after "manufacture,".
Subsec. (h)(3). Pub. L. 101-629, Sec. 11(2)(A), substituted
"Except as provided in paragraph (4), any" for "Any".
Subsec. (h)(4). Pub. L. 101-629, Sec. 11(2)(B), added par. (4).
Subsec. (i). Pub. L. 101-629, Sec. 6(b)(2), substituted "section
360d(b)(5)(B)" for "section 360d(g)(5)(B)".
Subsec. (j). Pub. L. 101-629, Sec. 3(b)(2), substituted "Except
as provided in section 360i(e) of this title, no" for "No".
Subsec. (l)(2). Pub. L. 101-629, Sec. 18(f), struck out "and
after affording the petitioner an opportunity for an informal
hearing" after "under this paragraph".
Pub. L. 101-629, Sec. 5(c)(2), substituted "The Secretary may
initiate the reclassification of a device classified into class III
under paragraph (1) of this subsection or the manufacturer" for
"The manufacturer".
Subsec. (l)(5). Pub. L. 101-629, Sec. 4(b)(2), added par. (5).
Subsec. (m). Pub. L. 101-629, Sec. 14(a), added subsec. (m).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of Pub.
L. 105-115 effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
a note under section 321 of this title.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 14(b) of Pub. L. 101-629 provided that: "Subsection (m)
of section 520 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 360j(m)], as added by the amendment made by subsection (a),
shall take effect on the effective date of the regulations issued
by the Secretary under paragraph (6) of such subsection."
GUIDANCE REGARDING PEDIATRIC DEVICES
Pub. L. 107-250, title II, Sec. 213, Oct. 26, 2002, 116 Stat.
1614, provided that: "Not later than 270 days after the date of the
enactment of this Act [Oct. 26, 2002], the Secretary of Health and
Human Services shall issue guidance on the following:
"(1) The type of information necessary to provide reasonable
assurance of the safety and effectiveness of medical devices
intended for use in pediatric populations.
"(2) Protections for pediatric subjects in clinical
investigations of the safety or effectiveness of such devices."
REPORT ON HUMANITARIAN DEVICE EXEMPTIONS
Section 14(c) of Pub. L. 101-629 directed Secretary of Health and
Human Services, within 4 years after issuance of regulations under
21 U.S.C. 360j(m)(6), to report to Congress on types of devices
exempted, an evaluation of effects of such section, and a
recommendation on extension of the section.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
-End-
-CITE-
21 USC Sec. 360k 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360k. State and local requirements respecting devices
-STATUTE-
(a) General rule
Except as provided in subsection (b) of this section, no State or
political subdivision of a State may establish or continue in
effect with respect to a device intended for human use any
requirement -
(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device
or to any other matter included in a requirement applicable to
the device under this chapter.
(b) Exempt requirements
Upon application of a State or a political subdivision thereof,
the Secretary may, by regulation promulgated after notice and
opportunity for an oral hearing, exempt from subsection (a) of this
section, under such conditions as may be prescribed in such
regulation, a requirement of such State or political subdivision
applicable to a device intended for human use if -
(1) the requirement is more stringent than a requirement under
this chapter which would be applicable to the device if an
exemption were not in effect under this subsection; or
(2) the requirement -
(A) is required by compelling local conditions, and
(B) compliance with the requirement would not cause the
device to be in violation of any applicable requirement under
this chapter.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 521, as added Pub. L. 94-295, Sec. 2,
May 28, 1976, 90 Stat. 574.)
-End-
-CITE-
21 USC Sec. 360l 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360l. Postmarket surveillance
-STATUTE-
(a) In general
The Secretary may by order require a manufacturer to conduct
postmarket surveillance for any device of the manufacturer which is
a class II or class III device the failure of which would be
reasonably likely to have serious adverse health consequences or
which is intended to be -
(1) implanted in the human body for more than one year, or
(2) a life sustaining or life supporting device used outside a
device user facility.
(b) Surveillance approval
Each manufacturer required to conduct a surveillance of a device
shall, within 30 days of receiving an order from the Secretary
prescribing that the manufacturer is required under this section to
conduct such surveillance, submit, for the approval of the
Secretary, a plan for the required surveillance. The Secretary,
within 60 days of the receipt of such plan, shall determine if the
person designated to conduct the surveillance has appropriate
qualifications and experience to undertake such surveillance and if
the plan will result in the collection of useful data that can
reveal unforeseen adverse events or other information necessary to
protect the public health. The Secretary, in consultation with the
manufacturer, may by order require a prospective surveillance
period of up to 36 months. Any determination by the Secretary that
a longer period is necessary shall be made by mutual agreement
between the Secretary and the manufacturer or, if no agreement can
be reached, after the completion of a dispute resolution process as
described in section 360bbb-1 of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 522, as added Pub. L. 101-629, Sec.
10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102-300, Sec.
3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105-115, title II, Sec.
212, Nov. 21, 1997, 111 Stat. 2346.)
-MISC1-
AMENDMENTS
1997 - Pub. L. 105-115 amended section generally, substituting
present provisions for former provisions which related to required
surveillance, discretionary surveillance, and surveillance
approval.
1992 - Subsec. (b). Pub. L. 102-300 substituted "(a)(1)" for
"(a)", inserted comma after "commerce", and inserted after first
sentence "Each manufacturer required to conduct a surveillance of a
device under subsection (a)(2) of this section shall, within 30
days after receiving notice that the manufacturer is required to
conduct such surveillance, submit, for the approval of the
Secretary, a protocol for the required surveillance."
EFFECTIVE DATE OF 1997 AMENDMENT
Section 212 of Pub. L. 105-115 provided in part that the
amendment made by that section is effective 90 days after Nov. 21,
1997.
STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING
PEDIATRIC POPULATIONS
Pub. L. 107-250, title II, Sec. 212, Oct. 26, 2002, 116 Stat.
1614, as amended by Pub. L. 108-214, Sec. 2(d)(3)(C), Apr. 1, 2004,
118 Stat. 577, provided that:
"(a) In General. - The Secretary of Health and Human Services
(referred to in this section as the 'Secretary') shall request the
Institute of Medicine to enter into an agreement with the Secretary
under which such Institute conducts a study for the purpose of
determining whether the system under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] for the postmarket
surveillance of medical devices provides adequate safeguards
regarding the use of devices in pediatric populations.
"(b) Certain Matters. - The Secretary shall ensure that
determinations made in the study under subsection (a) include
determinations of -
"(1) whether postmarket surveillance studies of implanted
medical devices are of long enough duration to evaluate the
impact of growth and development for the number of years that the
child will have the implant, and whether the studies are adequate
to evaluate how children's active lifestyles may affect the
failure rate and longevity of the implant; and
"(2) whether the postmarket surveillance by the Food and Drug
Administration of medical devices used in pediatric populations
is sufficient to provide adequate safeguards for such
populations, taking into account the Secretary's monitoring of
commitments made at the time of approval of medical devices and
the Secretary's monitoring and use of adverse reaction reports,
registries, and other postmarket surveillance activities.
"(c) Report to Congress. - The Secretary shall ensure that, not
later than four years after the date of the enactment of this Act
[Oct. 26, 2002], a report describing the findings of the study
under subsection (a) is submitted to the Congress. The report shall
include any recommendations of the Secretary for administrative or
legislative changes to the system of postmarket surveillance
referred to in such subsection."
-End-
-CITE-
21 USC Sec. 360m 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part A - Drugs and Devices
-HEAD-
Sec. 360m. Accredited persons
-STATUTE-
(a) In general
(1) Review and classification of devices
Not later than 1 year after November 21, 1997, the Secretary
shall, subject to paragraph (3), accredit persons for the purpose
of reviewing reports submitted under section 360(k) of this title
and making recommendations to the Secretary regarding the initial
classification of devices under section 360c(f)(1) of this title.
(2) Requirements regarding review
(A) In general
In making a recommendation to the Secretary under paragraph
(1), an accredited person shall notify the Secretary in writing
of the reasons for the recommendation.
(B) Time period for review
Not later than 30 days after the date on which the Secretary
is notified under subparagraph (A) by an accredited person with
respect to a recommendation of an initial classification of a
device, the Secretary shall make a determination with respect
to the initial classification.
(C) Special rule
The Secretary may change the initial classification under
section 360c(f)(1) of this title that is recommended under
paragraph (1) by an accredited person, and in such case shall
provide to such person, and the person who submitted the report
under section 360(k) of this title for the device, a statement
explaining in detail the reasons for the change.
(3) Certain devices
(A) In general
An accredited person may not be used to perform a review of -
(i) a class III device;
(ii) a class II device which is intended to be permanently
implantable or life sustaining or life supporting; or
(iii) a class II device which requires clinical data in the
report submitted under section 360(k) of this title for the
device, except that the number of class II devices to which
the Secretary applies this clause for a year, less the number
of such reports to which clauses (i) and (ii) apply, may not
exceed 6 percent of the number that is equal to the total
number of reports submitted to the Secretary under such
section for such year less the number of such reports to
which such clauses apply for such year.
(B) Adjustment
In determining for a year the ratio described in subparagraph
(A)(iii), the Secretary shall not include in the numerator
class III devices that the Secretary reclassified into class
II, and the Secretary shall include in the denominator class II
devices for which reports under section 360(k) of this title
were not required to be submitted by reason of the operation of
section 360(m) of this title.
(b) Accreditation
(1) Programs
The Secretary shall provide for such accreditation through
programs administered by the Food and Drug Administration, other
government agencies, or by other qualified nongovernment
organizations.
(2) Accreditation
(A) In general
Not later than 180 days after November 21, 1997, the
Secretary shall establish and publish in the Federal Register
criteria to accredit or deny accreditation to persons who
request to perform the duties specified in subsection (a) of
this section. The Secretary shall respond to a request for
accreditation within 60 days of the receipt of the request. The
accreditation of such person shall specify the particular
activities under subsection (a) of this section for which such
person is accredited.
(B) Withdrawal of accreditation
The Secretary may suspend or withdraw accreditation of any
person accredited under this paragraph, after providing notice
and an opportunity for an informal hearing, when such person is
substantially not in compliance with the requirements of this
section or poses a threat to public health or fails to act in a
manner that is consistent with the purposes of this section.
(C) Performance auditing
To ensure that persons accredited under this section will
continue to meet the standards of accreditation, the Secretary
shall -
(i) make onsite visits on a periodic basis to each
accredited person to audit the performance of such person;
and
(ii) take such additional measures as the Secretary
determines to be appropriate.
(D) Annual report
The Secretary shall include in the annual report required
under section 393(g) of this title the names of all accredited
persons and the particular activities under subsection (a) of
this section for which each such person is accredited and the
name of each accredited person whose accreditation has been
withdrawn during the year.
(3) Qualifications
An accredited person shall, at a minimum, meet the following
requirements:
(A) Such person may not be an employee of the Federal
Government.
(B) Such person shall be an independent organization which is
not owned or controlled by a manufacturer, supplier, or vendor
of devices and which has no organizational, material, or
financial affiliation with such a manufacturer, supplier, or
vendor.
(C) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
(D) Such person shall not engage in the design, manufacture,
promotion, or sale of devices.
(E) The operations of such person shall be in accordance with
generally accepted professional and ethical business practices
and shall agree in writing that as a minimum it will -
(i) certify that reported information accurately reflects
data reviewed;
(ii) limit work to that for which competence and capacity
are available;
(iii) treat information received, records, reports, and
recommendations as proprietary information;
(iv) promptly respond and attempt to resolve complaints
regarding its activities for which it is accredited; and
(v) protect against the use, in carrying out subsection (a)
of this section with respect to a device, of any officer or
employee of the person who has a financial conflict of
interest regarding the device, and annually make available to
the public disclosures of the extent to which the person, and
the officers and employees of the person, have maintained
compliance with requirements under this clause relating to
financial conflicts of interest.
(4) Selection of accredited persons
The Secretary shall provide each person who chooses to use an
accredited person to receive a section 360(k) of this title
report a panel of at least two or more accredited persons from
which the regulated person may select one for a specific
regulatory function.
(5) Compensation of accredited persons
Compensation for an accredited person shall be determined by
agreement between the accredited person and the person who
engages the services of the accredited person, and shall be paid
by the person who engages such services.
(c) Duration
The authority provided by this section terminates October 1,
2007.
(d) Report
Not later than January 10, 2007, the Secretary shall conduct a
study based on the experience under the program under this section
and submit to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report describing the findings of the
study. The objectives of the study shall include determining -
(1) the number of devices reviewed under this section;
(2) the number of devices reviewed under this section that were
ultimately cleared by the Secretary;
(3) the number of devices reviewed under this section that were
ultimately not cleared by the Secretary;
(4) the average time period for a review under this section
(including the time it takes for the Secretary to review a
recommendation of an accredited person under subsection (a) of
this section and determine the initial device classification);
(5) the average time period identified in paragraph (4)
compared to the average time period for review of devices solely
by the Secretary pursuant to section 360(k) of this title;
(6) if there is a difference in the average time period under
paragraph (4) and the average time period under paragraph (5),
the reasons for such difference;
(7) whether the quality of reviews under this section for
devices for which no guidance has been issued is qualitatively
inferior to reviews by the Secretary for devices for which no
guidance has been issued;
(8) whether the quality of reviews under this section of
devices for which no guidance has been issued is qualitatively
inferior to reviews under this section of devices for which
guidance has been issued;
(9) whether this section has in any way jeopardized or improved
the public health;
(10) any impact of this section on resources available to the
Secretary to review reports under section 360(k) of this title;
and
(11) any suggestions for continuation, modification (including
contraction or expansion of device eligibility), or termination
of this section that the Secretary determines to be appropriate.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 523, as added Pub. L. 105-115, title
II, Sec. 210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107-
250, title II, Sec. 202, Oct. 26, 2002, 116 Stat. 1609.)
-MISC1-
AMENDMENTS
2002 - Subsec. (c). Pub. L. 107-250, Sec. 202(1), substituted
"The authority provided by this section terminates October 1,
2007." for "The authority provided by this section terminates -
"(1) 5 years after the date on which the Secretary notifies
Congress that at least 2 persons accredited under subsection (b)
of this section are available to review at least 60 percent of
the submissions under section 360(k) of this title, or
"(2) 4 years after the date on which the Secretary notifies
Congress that the Secretary has made a determination described in
paragraph (2)(B) of subsection (a) of this section for at least
35 percent of the devices that are subject to review under
paragraph (1) of such subsection,
whichever occurs first."
Subsec. (d). Pub. L. 107-250, Sec. 202(2), added subsec. (d).
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
a note under section 321 of this title.
REPORTS ON PROGRAM OF ACCREDITATION
Pub. L. 105-115, title II, Sec. 210(d), Nov. 21, 1997, 111 Stat.
2345, provided that:
"(1) Comptroller general. -
"(A) Implementation of program. - Not later than 5 years after
the date of the enactment of this Act [Nov. 21, 1997], the
Comptroller General of the United States shall submit to the
Committee on Commerce [now Committee on Energy and Commerce] of
the House of Representatives and the Committee on Labor and Human
Resources [now Committee on Health, Education, Labor, and
Pensions] of the Senate a report describing the extent to which
the program of accreditation required by the amendment made by
subsection (a) [enacting this section] has been implemented.
"(B) Evaluation of program. - Not later than 6 months prior to
the date on which, pursuant to subsection (c) of section 523 of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as
added by subsection (a)), the authority provided under subsection
(a) of such section will terminate, the Comptroller General shall
submit to the Committee on Commerce [now Committee on Energy and
Commerce] of the House of Representatives and the Committee on
Labor and Human Resources [now Committee on Health, Education,
Labor, and Pensions] of the Senate a report describing the use of
accredited persons under such section 523, including an
evaluation of the extent to which such use assisted the Secretary
in carrying out the duties of the Secretary under such Act [21
U.S.C. 301 et seq.] with respect to devices, and the extent to
which such use promoted actions which are contrary to the
purposes of such Act.
"(2) Inclusion of certain devices within program. - Not later
than 3 years after the date of the enactment of this Act [Nov. 21,
1997], the Secretary of Health and Human Services shall submit to
the Committee on Commerce of the House of Representatives and the
Committee on Labor and Human Resources [now Committee on Health,
Education, Labor, and Pensions] of the Senate a report providing a
determination by the Secretary of whether, in the program of
accreditation established pursuant to the amendment made by
subsection (a), the limitation established in clause (iii) of
section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 360m(a)(3)(A)] (relating to class II devices for which
clinical data are required in reports under section 510(k) [21
U.S.C. 360(k)]) should be removed."
-End-
-CITE-
21 USC Part B - Drugs for Rare Diseases or Conditions 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
PART B - DRUGS FOR RARE DISEASES OR CONDITIONS
-End-
-CITE-
21 USC Sec. 360aa 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
Sec. 360aa. Recommendations for investigations of drugs for rare
diseases or conditions
-STATUTE-
(a) Request by sponsor; response by Secretary
The sponsor of a drug for a disease or condition which is rare in
the States may request the Secretary to provide written
recommendations for the non-clinical and clinical investigations
which must be conducted with the drug before -
(1) it may be approved for such disease or condition under
section 355 of this title, or
(2) if the drug is a biological product, it may be licensed for
such disease or condition under section 262 of title 42.
If the Secretary has reason to believe that a drug for which a
request is made under this section is a drug for a disease or
condition which is rare in the States, the Secretary shall provide
the person making the request written recommendations for the non-
clinical and clinical investigations which the Secretary believes,
on the basis of information available to the Secretary at the time
of the request under this section, would be necessary for approval
of such drug for such disease or condition under section 355 of
this title or licensing of such drug for such disease or condition
under section 262 of title 42.
(b) Regulations
The Secretary shall by regulation promulgate procedures for the
implementation of subsection (a) of this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 525, as added Pub. L. 97-414, Sec.
2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99-91, Sec.
3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105-115, title I,
Sec. 125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(G), struck
out ", certification of such drug for such disease or condition
under section 357 of this title," before "or licensing of such
drug" in closing provisions.
Subsec. (a)(1) to (3). Pub. L. 105-115, Sec. 125(b)(2)(F),
inserted "or" at end of par. (1), redesignated par. (3) as (2), and
struck out former par. (2), which read as follows: "if the drug is
an antibiotic, it may be certified for such disease or condition
under section 357 of this title, or".
1985 - Subsec. (a). Pub. L. 99-91 struck out "or" at end of par.
(1), inserted par. (2), redesignated former par. (2) as (3) and
struck out "before" after "product,", and in last sentence inserted
provisions relating to certification of such drug for disease or
condition under section 357 of this title and substituted
"licensing of such drug for such disease or condition under section
262 of title 42" for "licensing under section 262 of title 42 for
such disease or condition".
EFFECTIVE DATE OF 1985 AMENDMENT
Section 8 of Pub. L. 99-91 provided that:
"(a) General Rule. - Except as provided in subsection (b), this
Act and the amendments made by this Act [amending this section,
sections 360bb, 360cc, and 360ee of this title, and sections 295g-1
and 6022 of Title 42, The Public Health and Welfare, and enacting
provisions set out as notes under section 301 of this title and
section 236 of Title 42] shall take effect October 1, 1985.
"(b) Exception. - The amendments made by sections 2, 3, and 6(a)
[amending this section and sections 360bb and 360cc of this title]
shall take effect on the date of the enactment of this Act [Aug.
15, 1985]. The amendment made by section 6(b) [amending section
6022 of Title 42] shall take effect October 19, 1984. The
amendments made by section 7 [amending section 295g-1 of Title 42]
shall take effect October 1, 1984 and shall cease to be in effect
after September 30, 1985."
STUDY
Pub. L. 100-290, Sec. 3(d), Apr. 18, 1988, 102 Stat. 91, directed
Secretary of Health and Human Services to conduct a study to
determine whether the application of subchapter B of chapter V of
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq.
(relating to drugs for rare diseases and conditions), and 26 U.S.C.
28 (relating to tax credit) to medical devices or medical foods for
rare diseases or conditions or to both was needed to encourage
development of such devices and foods and report results of the
study to Congress not later than one year after Apr. 18, 1988.
CONGRESSIONAL FINDINGS
Section 1(b) of Pub. L. 97-414 provided that: "The Congress finds
that -
"(1) there are many diseases and conditions, such as
Huntington's disease, myoclonus, ALS (Lou Gehrig's disease),
Tourette syndrome, and muscular dystrophy which affect such small
numbers of individuals residing in the United States that the
diseases and conditions are considered rare in the United States;
"(2) adequate drugs for many of such diseases and conditions
have not been developed;
"(3) drugs for these diseases and conditions are commonly
referred to as 'orphan drugs';
"(4) because so few individuals are affected by any one rare
disease or condition, a pharmaceutical company which develops an
orphan drug may reasonably expect the drug to generate relatively
small sales in comparison to the cost of developing the drug and
consequently to incur a financial loss;
"(5) there is reason to believe that some promising orphan
drugs will not be developed unless changes are made in the
applicable Federal laws to reduce the costs of developing such
drugs and to provide financial incentives to develop such drugs;
and
"(6) it is in the public interest to provide such changes and
incentives for the development of orphan drugs."
-End-
-CITE-
21 USC Sec. 360bb 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
Sec. 360bb. Designation of drugs for rare diseases or conditions
-STATUTE-
(a) Request by sponsor; preconditions; "rare disease or condition"
defined
(1) The manufacturer or the sponsor of a drug may request the
Secretary to designate the drug as a drug for a rare disease or
condition. A request for designation of a drug shall be made before
the submission of an application under section 355(b) of this title
for the drug, or the submission of an application for licensing of
the drug under section 262 of title 42. If the Secretary finds that
a drug for which a request is submitted under this subsection is
being or will be investigated for a rare disease or condition and -
(A) if an application for such drug is approved under section
355 of this title, or
(B) if a license for such drug is issued under section 262 of
title 42,
the approval, certification, or license would be for use for such
disease or condition, the Secretary shall designate the drug as a
drug for such disease or condition. A request for a designation of
a drug under this subsection shall contain the consent of the
applicant to notice being given by the Secretary under subsection
(b) of this section respecting the designation of the drug.
(2) For purposes of paragraph (1), the term "rare disease or
condition" means any disease or condition which (A) affects less
than 200,000 persons in the United States, or (B) affects more than
200,000 in the United States and for which there is no reasonable
expectation that the cost of developing and making available in the
United States a drug for such disease or condition will be
recovered from sales in the United States of such drug.
Determinations under the preceding sentence with respect to any
drug shall be made on the basis of the facts and circumstances as
of the date the request for designation of the drug under this
subsection is made.
(b) Notification of discontinuance of drug or application as
condition
A designation of a drug under subsection (a) of this section
shall be subject to the condition that -
(1) if an application was approved for the drug under section
355(b) of this title or a license was issued for the drug under
section 262 of title 42, the manufacturer of the drug will notify
the Secretary of any discontinuance of the production of the drug
at least one year before discontinuance, and
(2) if an application has not been approved for the drug under
section 355(b) of this title or a license has not been issued for
the drug under section 262 of title 42 and if preclinical
investigations or investigations under section 355(i) of this
title are being conducted with the drug, the manufacturer or
sponsor of the drug will notify the Secretary of any decision to
discontinue active pursuit of approval of an application under
section 355(b) of this title or approval of a license under
section 262 of title 42.
(c) Notice to public
Notice respecting the designation of a drug under subsection (a)
of this section shall be made available to the public.
(d) Regulations
The Secretary shall by regulation promulgate procedures for the
implementation of subsection (a) of this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 526, as added Pub. L. 97-414, Sec.
2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, Sec.
4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 3(a)(2),
Aug. 15, 1985, 99 Stat. 387; Pub. L. 100-290, Sec. 2, Apr. 18,
1988, 102 Stat. 90; Pub. L. 105-115, title I, Sec. 125(b)(2)(H),
(I), Nov. 21, 1997, 111 Stat. 2326.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 125(b)(2)(H), struck
out "the submission of an application for certification of the drug
under section 357 of this title," before "or the submission of an
application for licensing of the drug" in introductory provisions,
inserted "or" at end of subpar. (A), redesignated subpar. (C) as
(B), and struck out former subpar. (B) which read as follows: "if a
certification for such drug is issued under section 357 of this
title, or".
Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(I)(i), struck out
", a certificate was issued for the drug under section 357 of this
title," before "or a license was issued".
Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(I)(ii), struck
out ", a certificate has not been issued for the drug under section
357 of this title," before "or a license has not been issued" and
", approval of an application for certification under section 357
of this title," before "or approval of a license".
1988 - Subsec. (a)(1). Pub. L. 100-290, Sec. 2(a), inserted after
first sentence "A request for designation of a drug shall be made
before the submission of an application under section 355(b) of
this title for the drug, the submission of an application for
certification of the drug under section 357 of this title, or the
submission of an application for licensing of the drug under
section 262 of title 42."
Subsecs. (b) to (d). Pub. L. 100-290, Sec. 2(b), added subsec.
(b) and redesignated former subsecs. (b) and (c) as (c) and (d),
respectively.
1985 - Subsec. (a)(1). Pub. L. 99-91 struck out "or" at end of
subpar. (A), struck out subpar. (B) and substituted subpars. (B)
and (C), and inserted ", certification," after "approval".
1984 - Subsec. (a)(2). Pub. L. 98-551 substituted "which (A)
affects less than 200,000 persons in the United States, or (B)
affects more than 200,000 in the United States and for which" for
"which occurs so infrequently in the United States that".
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
8(b) of Pub. L. 99-91, set out as a note under section 360aa of
this title.
-End-
-CITE-
21 USC Sec. 360cc 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
Sec. 360cc. Protection for drugs for rare diseases or conditions
-STATUTE-
(a) Exclusive approval, certification, or license
Except as provided in subsection (b) of this section, if the
Secretary -
(1) approves an application filed pursuant to section 355 of
this title, or
(2) issues a license under section 262 of title 42
for a drug designated under section 360bb of this title for a rare
disease or condition, the Secretary may not approve another
application under section 355 of this title or issue another
license under section 262 of title 42 for such drug for such
disease or condition for a person who is not the holder of such
approved application or of such license until the expiration of
seven years from the date of the approval of the approved
application or the issuance of the license. Section 355(c)(2) of
this title does not apply to the refusal to approve an application
under the preceding sentence.
(b) Exceptions
If an application filed pursuant to section 355 of this title is
approved for a drug designated under section 360bb of this title
for a rare disease or condition or if a license is issued under
section 262 of title 42 for such a drug, the Secretary may, during
the seven-year period beginning on the date of the application
approval or of the issuance of the license, approve another
application under section 355 of this title or issue a license
under section 262 of title 42, for such drug for such disease or
condition for a person who is not the holder of such approved
application or of such license if -
(1) the Secretary finds, after providing the holder notice and
opportunity for the submission of views, that in such period the
holder of the approved application or of the license cannot
assure the availability of sufficient quantities of the drug to
meet the needs of persons with the disease or condition for which
the drug was designated; or
(2) such holder provides the Secretary in writing the consent
of such holder for the approval of other applications or the
issuance of other licenses before the expiration of such seven-
year period.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 527, as added Pub. L. 97-414, Sec.
2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I,
Sec. 102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, Secs.
2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, Sec.
3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, Sec.
125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281,
Sec. 4, Nov. 6, 2002, 116 Stat. 1993.)
-MISC1-
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-281, in concluding provisions,
struck out ", of such certification," after "such approved
application" and ", the issuance of the certification," after
"approval of the approved application".
1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(J), struck
out ", issue another certification under section 357 of this
title," before "or issue another license" in closing provisions,
inserted "or" at end of par. (1), redesignated par. (3) as (2), and
struck out former par. (2) which read as follows: "issues a
certification under section 357 of this title, or".
Subsec. (b). Pub. L. 105-115, Sec. 125(b)(2)(K), in introductory
provisions, struck out ", if a certification is issued under
section 357 of this title for such a drug," after "rare disease or
condition", ", of the issuance of the certification under section
357 of this title," after "application approval", ", issue another
certification under section 357 of this title," after "application
under section 355 of this title", and ", of such certification,"
after "approved application".
Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
of the certification," after "holder of the approved application".
Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
issuance of other certifications," after "approval of other
applications".
1993 - Subsec. (b). Pub. L. 103-80 struck out extraneous comma
before "or issue a license under section 262" in introductory
provisions and substituted "the" for "The" at beginning of par.
(1).
1985 - Pub. L. 99-91, Sec. 2(3), struck out "unpatented" before
"drugs" in section catchline.
Subsec. (a). Pub. L. 99-91, Secs. 2(1), 3(a)(3)(A)-(D), struck
out "or" at end of par. (1), added par. (2), redesignated former
par. (2) as (3), struck out "and for which a United States Letter
of Patent may not be issued" after "rare disease or condition",
inserted in first sentence ", issue another certification under
section 357 of this title," after "section 355 of this title" the
second time it appeared, inserted ", of such certification," after
"holder of such approved application", and inserted ", the issuance
of the certification," after "approval of the approved
application".
Subsec. (b). Pub. L. 99-91, Secs. 2(2), 3(a)(3)(E)-(K), struck
out "and if a United States Letter of Patent may not be issued for
the drug" after "such a drug", substituted ", if a certification is
issued under section 357 of this title for such a drug, or if a
license" for "or a license", inserted ", of the issuance of the
certification under section 357 of this title," after "application
approval", struck out ", if the drug is a biological product,"
before "issue a license", inserted ", issue another certification
under section 357 of this title," after "section 355 of this
title", inserted ", of such certification," after "holder of such
approved application", inserted ", of such certification," after
"application" in par. (1), and inserted ", issuance of other
certifications," after "other applications" in par. (2).
1984 - Subsecs. (a), (b). Pub. L. 98-417 substituted "section
355" for "section 355(b)" wherever appearing.
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
8(b) of Pub. L. 99-91, set out as a note under section 360aa of
this title.
-End-
-CITE-
21 USC Sec. 360dd 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
Sec. 360dd. Open protocols for investigations of drugs for rare
diseases or conditions
-STATUTE-
If a drug is designated under section 360bb of this title as a
drug for a rare disease or condition and if notice of a claimed
exemption under section 355(i) of this title or regulations issued
thereunder is filed for such drug, the Secretary shall encourage
the sponsor of such drug to design protocols for clinical
investigations of the drug which may be conducted under the
exemption to permit the addition to the investigations of persons
with the disease or condition who need the drug to treat the
disease or condition and who cannot be satisfactorily treated by
available alternative drugs.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 528, as added Pub. L. 97-414, Sec.
2(a), Jan. 4, 1983, 96 Stat. 2051.)
-End-
-CITE-
21 USC Sec. 360ee 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part B - Drugs for Rare Diseases or Conditions
-HEAD-
Sec. 360ee. Grants and contracts for development of drugs for rare
diseases and conditions
-STATUTE-
(a) Authority of Secretary
The Secretary may make grants to and enter into contracts with
public and private entities and individuals to assist in (1)
defraying the costs of qualified testing expenses incurred in
connection with the development of drugs for rare diseases and
conditions, (2) defraying the costs of developing medical devices
for rare diseases or conditions, and (3) defraying the costs of
developing medical foods for rare diseases or conditions.
(b) Definitions
For purposes of subsection (a) of this section:
(1) The term "qualified testing" means -
(A) human clinical testing -
(i) which is carried out under an exemption for a drug for
a rare disease or condition under section 355(i) of this
title (or regulations issued under such section); and
(ii) which occurs after the date such drug is designated
under section 360bb of this title and before the date on
which an application with respect to such drug is submitted
under section 355(b) of this title or under section 262 of
title 42; and
(B) preclinical testing involving a drug for a rare disease
or condition which occurs after the date such drug is
designated under section 360bb of this title and before the
date on which an application with respect to such drug is
submitted under section 355(b) of this title or under section
262 of title 42.
(2) The term "rare disease or condition" means (1) in the case
of a drug, any disease or condition which (A) affects less than
200,000 persons in the United States, or (B) affects more than
200,000 in the United States and for which there is no reasonable
expectation that the cost of developing and making available in
the United States a drug for such disease or condition will be
recovered from sales in the United States of such drug, (2) in
the case of a medical device, any disease or condition that
occurs so infrequently in the United States that there is no
reasonable expectation that a medical device for such disease or
condition will be developed without assistance under subsection
(a) of this section, and (3) in the case of a medical food, any
disease or condition that occurs so infrequently in the United
States that there is no reasonable expectation that a medical
food for such disease or condition will be developed without
assistance under subsection (a) of this section. Determinations
under the preceding sentence with respect to any drug shall be
made on the basis of the facts and circumstances as of the date
the request for designation of the drug under section 360bb of
this title is made.
(3) The term "medical food" means a food which is formulated to
be consumed or administered enterally under the supervision of a
physician and which is intended for the specific dietary
management of a disease or condition for which distinctive
nutritional requirements, based on recognized scientific
principles, are established by medical evaluation.
(c) Authorization of appropriations
For grants and contracts under subsection (a) of this section,
there are authorized to be appropriated such sums as already have
been appropriated for fiscal year 2002, and $25,000,000 for each of
the fiscal years 2003 through 2006.
-SOURCE-
(Pub. L. 97-414, Sec. 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98-
551, Sec. 4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec.
5, Aug. 15, 1985, 99 Stat. 391; Pub. L. 100-290, Sec. 3(a)-(c),
Apr. 18, 1988, 102 Stat. 90, 91; Pub. L. 105-115, title I, Sec.
125(b)(2)(N), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281, Sec.
3, Nov. 6, 2002, 116 Stat. 1993.)
-COD-
CODIFICATION
Section was enacted as part of the Orphan Drug Act, and not as
part of the Federal Food, Drug, and Cosmetic Act which comprises
this chapter.
-MISC1-
AMENDMENTS
2002 - Subsec. (c). Pub. L. 107-281 amended subsec. (c)
generally. Prior to amendment, subsec. (c) read as follows: "For
grants and contracts under subsection (a) of this section there are
authorized to be appropriated $10,000,000 for fiscal year 1988,
$12,000,000 for fiscal year 1989, $14,000,000 for fiscal year
1990."
1997 - Subsec. (b)(1)(A)(ii), (B). Pub. L. 105-115 struck out "or
357" after "355(b)".
1988 - Subsec. (a). Pub. L. 100-290, Sec. 3(a)(1), (b)(1),
inserted "(1)" after "assist in" and added cls. (2) and (3).
Subsec. (b)(2). Pub. L. 100-290, Sec. 3(a)(2), (b)(2), inserted
"(1) in the case of a drug," after "means", added cls. (2) and (3),
and substituted "under section 360bb of this title" for "under this
subsection" in last sentence.
Subsec. (b)(3). Pub. L. 100-290, Sec. 3(b)(3), added par. (3).
Subsec. (c). Pub. L. 100-290, Sec. 3(c), amended subsec. (c)
generally. Prior to amendment, subsec. (c) read as follows: "For
grants and contracts under subsection (a) of this section there are
authorized to be appropriated $4,000,000 for fiscal year 1986,
$4,000,000 for fiscal year 1987, and $4,000,000 for fiscal year
1988."
1985 - Subsec. (a). Pub. L. 99-91, Sec. 5(a)(1), struck out
"clinical" before "testing".
Subsec. (b)(1). Pub. L. 99-91, Sec. 5(a)(2), substituted
provisions defining "qualified testing" for provisions defining
"qualified clinical testing".
Subsec. (c). Pub. L. 99-91, Sec. 5(b), substituted provisions
authorizing appropriations for fiscal years 1986 to 1988, for
provisions authorizing appropriations for fiscal years 1983 and the
two succeeding fiscal years.
1984 - Subsec. (b)(2). Pub. L. 98-551 substituted "which (A)
affects less than 200,000 persons in the United States, or (B)
affects more than 200,000 in the United States and for which" for
"which occurs so infrequently in the United States that".
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section
8(a) of Pub. L. 99-91, set out as a note under section 360aa of
this title.
FINDINGS AND PURPOSES
Pub. L. 107-281, Sec. 2, Nov. 6, 2002, 116 Stat. 1992, provided
that:
"(a) Findings. - Congress makes the following findings:
"(1) Rare diseases and disorders are those which affect small
patient populations, typically populations smaller than 200,000
individuals in the United States. Such diseases and conditions
include Huntington's disease, amyotrophic lateral sclerosis (Lou
Gehrig's disease), Tourette syndrome, Crohn's disease, cystic
fibrosis, cystinosis, and Duchenne muscular dystrophy.
"(2) For many years, the 25,000,000 Americans suffering from
the over 6,000 rare diseases and disorders were denied access to
effective medicines because prescription drug manufacturers could
rarely make a profit from marketing drugs for such small groups
of patients. The prescription drug industry did not adequately
fund research into such treatments. Despite the urgent health
need for these medicines, they came to be known as 'orphan drugs'
because no companies would commercialize them.
"(3) During the 1970s, an organization called the National
Organization for Rare Disorders (NORD) was founded to provide
services and to lobby on behalf of patients with rare diseases
and disorders. NORD was instrumental in pressing Congress for
legislation to encourage the development of orphan drugs.
"(4) The Orphan Drug Act [see Short Title of 1983 Amendments
note set out under section 301 of this title] created financial
incentives for the research and production of such orphan drugs.
New Federal programs at the National Institutes of Health and the
Food and Drug Administration encouraged clinical research and
commercial product development for products that target rare
diseases. An Orphan Products Board was established to promote the
development of drugs and devices for rare diseases or disorders.
"(5) Before 1983, some 38 orphan drugs had been developed.
Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more
than 220 new orphan drugs have been approved and marketed in the
United States and more than 800 additional drugs are in the
research pipeline.
"(6) Despite the tremendous success of the Orphan Drug Act,
rare diseases and disorders deserve greater emphasis in the
national biomedical research enterprise.
"(7) The Food and Drug Administration supports small clinical
trials through Orphan Products Research Grants. Such grants
embody successful partnerships of government and industry, and
have led to the development of at least 23 drugs and four medical
devices for rare diseases and disorders. Yet the appropriations
in fiscal year 2001 for such grants were less than in fiscal year
1995.
"(b) Purposes. - The purpose of this Act [see Short Title of 2002
Amendments note set out under section 301 of this title] is to
increase the national investment in the development of diagnostics
and treatments for patients with rare diseases and disorders."
-End-
-CITE-
21 USC Part C - Electronic Product Radiation Control 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
PART C - ELECTRONIC PRODUCT RADIATION CONTROL
-COD-
CODIFICATION
This part was classified to subpart 3 (Sec. 263c et seq.) of part
F of subchapter II of chapter 6A of Title 42, The Public Health and
Welfare, prior to its renumbering by Pub. L. 101-629, Sec.
19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103-
80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 779.
-End-
-CITE-
21 USC Sec. 360hh 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360hh. Definitions
-STATUTE-
As used in this part -
(1) the term "electronic product radiation" means -
(A) any ionizing or non-ionizing electromagnetic or
particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is
emitted from an electronic product as the result of the
operation of an electronic circuit in such product;
(2) the term "electronic product" means (A) any manufactured or
assembled product which, when in operation, (i) contains or acts
as part of an electronic circuit and (ii) emits (or in the
absence of effective shielding or other controls would emit)
electronic product radiation, or (B) any manufactured or
assembled article which is intended for use as a component, part,
or accessory of a product described in clause (A) and which when
in operation emits (or in the absence of effective shielding or
other controls would emit) such radiation;
(3) the term "manufacturer" means any person engaged in the
business of manufacturing, assembling, or importing of electronic
products;
(4) the term "commerce" means (A) commerce between any place in
any State and any place outside thereof; and (B) commerce wholly
within the District of Columbia; and
(5) the term "State" includes the District of Columbia, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the
Virgin Islands, Guam, and American Samoa.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 531, formerly act July 1, 1944, ch.
373, title III, Sec. 531, formerly Sec. 355, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94-
484, title IX, Sec. 905(b)(1), Oct. 12, 1976, 90 Stat. 2325;
renumbered Sec. 531 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
(3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.
4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263c of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263c of Title 42, The
Public Health and Welfare, as this section.
1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
for "this subpart" in introductory provisions.
1976 - Par. (5). Pub. L. 94-484 defined "State" to include
Northern Mariana Islands.
SHORT TITLE
For short title of Pub. L. 90-602, which enacted provisions now
comprising this part (Secs. 360hh to 360ss), as the "Radiation
Control for Health and Safety Act of 1968", see section 1 of Pub.
L. 90-602, set out as a Short Title of 1968 Amendments note under
section 301 of this title.
TRANSFER OF SUBPART; CONSTRUCTION
Section 19(c) of Pub. L. 101-629 provided that: "The transfer of
subpart 3 of part F of title III of the Public Health Service Act
[42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic
Act [this chapter] does not change the application of the
requirements of such subpart and such Act to electronic products
which were in effect on the date of the enactment of this Act [Nov.
28, 1990]."
-CROSS-
DEFINITION OF "SECRETARY" AND "DEPARTMENT"
Section 3 of Pub. L. 90-602, as amended Pub. L. 96-88, title V,
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "As used
in the amendments made by section 2 of this Act [enacting
provisions now comprising sections 360hh to 360ss of this title],
except when otherwise specified, the term 'Secretary' means the
Secretary of Health and Human Services, and the term 'Department'
means the Department of Health and Human Services."
-MISC2-
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Section 4 of Pub. L. 90-602 provided that: "The amendments made
by section 2 of this Act [enacting provisions now comprising
sections 360hh to 360ss of this title] shall not be construed as
superseding or limiting the functions, under any other provision of
law, of any officer or agency of the United States."
-End-
-CITE-
21 USC Sec. 360ii 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360ii. Program of control
-STATUTE-
(a) Establishment
The Secretary shall establish and carry out an electronic product
radiation control program designed to protect the public health and
safety from electronic product radiation. As a part of such
program, he shall -
(1) pursuant to section 360kk of this title, develop and
administer performance standards for electronic products;
(2) plan, conduct, coordinate, and support research,
development, training, and operational activities to minimize the
emissions of and the exposure of people to, unnecessary
electronic product radiation;
(3) maintain liaison with and receive information from other
Federal and State departments and agencies with related
interests, professional organizations, industry, industry and
labor associations, and other organizations on present and future
potential electronic product radiation;
(4) study and evaluate emissions of, and conditions of exposure
to, electronic product radiation and intense magnetic fields;
(5) develop, test, and evaluate the effectiveness of procedures
and techniques for minimizing exposure to electronic product
radiation; and
(6) consult and maintain liaison with the Secretary of
Commerce, the Secretary of Defense, the Secretary of Labor, the
Atomic Energy Commission, and other appropriate Federal
departments and agencies on (A) techniques, equipment, and
programs for testing and evaluating electronic product radiation,
and (B) the development of performance standards pursuant to
section 360kk of this title to control such radiation emissions.
(b) Powers of Secretary
In carrying out the purposes of subsection (a) of this section,
the Secretary is authorized to -
(1)(A) collect and make available, through publications and
other appropriate means, the results of, and other information
concerning, research and studies relating to the nature and
extent of the hazards and control of electronic product
radiation; and (B) make such recommendations relating to such
hazards and control as he considers appropriate;
(2) make grants to public and private agencies, organizations,
and institutions, and to individuals for the purposes stated in
paragraphs (2), (4), and (5) of subsection (a) of this section;
(3) contract with public or private agencies, institutions, and
organizations, and with individuals, without regard to section
3324 of title 31 and section 5 of title 41; and
(4) procure (by negotiation or otherwise) electronic products
for research and testing purposes, and sell or otherwise dispose
of such products.
(c) Record keeping
(1) Each recipient of assistance under this part pursuant to
grants or contracts entered into under other than competitive
bidding procedures shall keep such records as the Secretary shall
prescribe, including records which fully disclose the amount and
disposition by such recipient of the proceeds of such assistance,
the total cost of the project or undertaking in connection with
which such assistance is given or used, and the amount of that
portion of the cost of the project or undertaking supplied by other
sources, and such other records as will facilitate an effective
audit.
(2) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall have
access for the purpose of audit and examination to any books,
documents, papers, and records of the recipients that are pertinent
to the grants or contracts entered into under this part under other
than competitive bidding procedures.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 532, formerly act July 1, 1944, ch.
373, title III, Sec. 532, formerly Sec. 356, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered Sec. 532
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(A), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263d of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263d of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a)(1), (6). Pub. L. 101-629, Sec. 19(a)(2)(A)(i),
substituted "section 360kk" for "section 263f".
Subsec. (b)(3). Pub. L. 101-629, Sec. 19(a)(2)(A)(ii),
substituted reference to section 3324 of title 31 for reference to
section 3648 of the Revised Statutes (31 U.S.C. 529).
Subsec. (c)(1), (2). Pub. L. 101-629, Sec. 19(a)(1)(B),
substituted "this part" for "this subpart".
-TRANS-
TRANSFER OF FUNCTIONS
Atomic Energy Commission abolished and functions transferred by
sections 5814 and 5841 of Title 42, The Public Health and Welfare.
See also Transfer of Functions notes set out under those sections.
-MISC2-
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law or any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360jj 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360jj. Studies by Secretary
-STATUTE-
(a) Report to Congress
The Secretary shall conduct the following studies, and shall make
a report or reports of the results of such studies to the Congress
on or before January 1, 1970, and from time to time thereafter as
he may find necessary, together with such recommendations for
legislation as he may deem appropriate:
(1) A study of present State and Federal control of health
hazards from electronic product radiation and other types of
ionizing radiation, which study shall include, but not be limited
to -
(A) control of health hazards from radioactive materials other
than materials regulated under the Atomic Energy Act of 1954 [42
U.S.C. 2011 et seq.];
(B) any gaps and inconsistencies in present controls;
(C) the need for controlling the sale of certain used
electronic products, particularly antiquated X-ray equipment,
without upgrading such products to meet the standards for new
products or separate standards for used products;
(D) measures to assure consistent and effective control of the
aforementioned health hazards;
(E) measures to strengthen radiological health programs of
State governments; and
(F) the feasibility of authorizing the Secretary to enter into
arrangements with individual States or groups of States to define
their respective functions and responsibilities for the control
of electronic product radiation and other ionizing radiation;
(2) A study to determine the necessity for the development of
standards for the use of nonmedical electronic products for
commercial and industrial purposes; and
(3) A study of the development of practicable procedures for the
detection and measurement of electronic product radiation which may
be emitted from electronic products manufactured or imported prior
to the effective date of any applicable standard established
pursuant to this part.
(b) Participation of other Federal agencies
In carrying out these studies, the Secretary shall invite the
participation of other Federal departments and agencies having
related responsibilities and interests, State governments -
particularly those of States which regulate radioactive materials
under section 274 of the Atomic Energy Act of 1954, as amended [42
U.S.C. 2021], and interested professional, labor, and industrial
organizations. Upon request from congressional committees
interested in these studies, the Secretary shall keep these
committees currently informed as to the progress of the studies and
shall permit the committees to send observers to meetings of the
study groups.
(c) Organization of studies and participation
The Secretary or his designee shall organize the studies and the
participation of the invited participants as he deems best. Any
dissent from the findings and recommendations of the Secretary
shall be included in the report if so requested by the dissenter.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 533, formerly act July 1, 1944, ch.
373, title III, Sec. 533, formerly Sec. 357, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered Sec. 533
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
1993, 107 Stat. 779.)
-REFTEXT-
REFERENCES IN TEXT
The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A),
is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch.
1073, Sec. 1, 68 Stat. 921, and amended, which is classified
generally to chapter 23 (Sec. 2011 et seq.) of Title 42, The Public
Health and Welfare. For complete classification of this Act to the
Code, see Short Title note set out under section 2011 of Title 42
and Tables.
-COD-
CODIFICATION
Section was classified to section 263e of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263e of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B),
substituted "this part" for "this subpart".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360kk 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360kk. Performance standards for electronic products
-STATUTE-
(a) Promulgation of regulations
(1) The Secretary shall by regulation prescribe performance
standards for electronic products to control the emission of
electronic product radiation from such products if he determines
that such standards are necessary for the protection of the public
health and safety. Such standards may include provisions for the
testing of such products and the measurement of their electronic
product radiation emissions, may require the attachment of warning
signs and labels, and may require the provision of instructions for
the installation, operation, and use of such products. Such
standards may be prescribed from time to time whenever such
determinations are made, but the first of such standards shall be
prescribed prior to January 1, 1970. In the development of such
standards, the Secretary shall consult with Federal and State
departments and agencies having related responsibilities or
interests and with appropriate professional organizations and
interested persons, including representatives of industries and
labor organizations which would be affected by such standards, and
shall give consideration to -
(A) the latest available scientific and medical data in the
field of electronic product radiation;
(B) the standards currently recommended by (i) other Federal
agencies having responsibilities relating to the control and
measurement of electronic product radiation, and (ii) public or
private groups having an expertise in the field of electronic
product radiation;
(C) the reasonableness and technical feasibility of such
standards as applied to a particular electronic product;
(D) the adaptability of such standards to the need for
uniformity and reliability of testing and measuring procedures
and equipment; and
(E) in the case of a component, or accessory described in
paragraph (2)(B) of section 360hh of this title, the performance
of such article in the manufactured or assembled product for
which it is designed.
(2) The Secretary may prescribe different and individual
performance standards, to the extent appropriate and feasible, for
different electronic products so as to recognize their different
operating characteristics and uses.
(3) The performance standards prescribed under this section shall
not apply to any electronic product which is intended solely for
export if (A) such product and the outside of any shipping
container used in the export of such product are labeled or tagged
to show that such product is intended for export, and (B) such
product meets all the applicable requirements of the country to
which such product is intended for export.
(4) The Secretary may by regulation amend or revoke any
performance standard prescribed under this section.
(5) The Secretary may exempt from the provisions of this section
any electronic product intended for use by departments or agencies
of the United States provided such department or agency has
prescribed procurement specifications governing emissions of
electronic product radiation and provided further that such product
is of a type used solely or predominantly by departments or
agencies of the United States.
(b) Administrative procedure
The provisions of subchapter II of chapter 5 of title 5 (relating
to the administrative procedure for rulemaking), and of chapter 7
of title 5 (relating to judicial review), shall apply with respect
to any regulation prescribing, amending, or revoking any standard
prescribed under this section.
(c) Publication in Federal Register
Each regulation prescribing, amending, or revoking a standard
shall specify the date on which it shall take effect which, in the
case of any regulation prescribing, or amending any standard, may
not be sooner than one year or not later than two years after the
date on which such regulation is issued, unless the Secretary
finds, for good cause shown, that an earlier or later effective
date is in the public interest and publishes in the Federal
Register his reason for such finding, in which case such earlier or
later date shall apply.
(d) Judicial review
(1) In a case of actual controversy as to the validity of any
regulation issued under this section prescribing, amending, or
revoking a performance standard, any person who will be adversely
affected by such regulation when it is effective may at any time
prior to the sixtieth day after such regulation is issued file a
petition with the United States court of appeals for the circuit
wherein such person resides or has his principal place of business,
for a judicial review of such regulation. A copy of the petition
shall be forthwith transmitted by the clerk of the court to the
Secretary or other officer designated by him for that purpose. The
Secretary thereupon shall file in the court the record of the
proceedings on which the Secretary based the regulation, as
provided in section 2112 of title 28.
(2) If the petitioner applies to the court for leave to adduce
additional evidence, and shows to the satisfaction of the court
that such additional evidence is material and that there were
reasonable grounds for the failure to adduce such evidence in the
proceeding before the Secretary, the court may order such
additional evidence (and evidence in rebuttal thereof) to be taken
before the Secretary, and to be adduced upon the hearing, in such
manner and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings, or make new
findings, by reason of the additional evidence so taken, and he
shall file such modified or new findings, and his recommendations,
if any, for the modification or setting aside of his original
regulation, with the return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1)
of this subsection, the court shall have jurisdiction to review the
regulation in accordance with chapter 7 of title 5 and to grant
appropriate relief as provided in such chapter.
(4) The judgment of the court affirming or setting aside, in
whole or in part, any such regulation of the Secretary shall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification as provided in section 1254 of
title 28.
(5) Any action instituted under this subsection shall survive,
notwithstanding any change in the person occupying the office of
Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in
addition to and not in substitution for any other remedies provided
by law.
(e) Availability of record
A certified copy of the transcript of the record and
administrative proceedings under this section shall be furnished by
the Secretary to any interested party at his request, and payment
of the costs thereof, and shall be admissible in any criminal,
exclusion of imports, or other proceeding arising under or in
respect of this part irrespective of whether proceedings with
respect to the regulation have previously been initiated or become
final under this section.
(f) Technical Electronic Product Radiation Safety Standards
Committee
(1)(A) The Secretary shall establish a Technical Electronic
Product Radiation Safety Standards Committee (hereafter in this
part referred to as the "Committee") which he shall consult before
prescribing any standard under this section. The Committee shall be
appointed by the Secretary, after consultation with public and
private agencies concerned with the technical aspect of electronic
product radiation safety, and shall be composed of fifteen members
each of whom shall be technically qualified by training and
experience in one or more fields of science or engineering
applicable to electronic product radiation safety, as follows:
(i) Five members shall be selected from governmental agencies,
including State and Federal Governments;
(ii) Five members shall be selected from the affected
industries after consultation with industry representatives; and
(iii) Five members shall be selected from the general public,
of which at least one shall be a representative of organized
labor.
(B) The Committee may propose electronic product radiation safety
standards to the Secretary for his consideration. All proceedings
of the Committee shall be recorded and the record of each such
proceeding shall be available for public inspection.
(2) Payments to members of the Committee who are not officers or
employees of the United States pursuant to subsection (c) of
section 210 of title 42 shall not render members of the Committee
officers or employees of the United States for any purpose.
(g) Review and evaluation
The Secretary shall review and evaluate on a continuing basis
testing programs carried out by industry to assure the adequacy of
safeguards against hazardous electronic product radiation and to
assure that electronic products comply with standards prescribed
under this section.
(h) Product certification
Every manufacturer of an electronic product to which is
applicable a standard in effect under this section shall furnish to
the distributor or dealer at the time of delivery of such product,
in the form of a label or tag permanently affixed to such product
or in such manner as approved by the Secretary, the certification
that such product conforms to all applicable standards under this
section. Such certification shall be based upon a test, in
accordance with such standard, of the individual article to which
it is attached or upon a testing program which is in accord with
good manufacturing practice and which has not been disapproved by
the Secretary (in such manner as he shall prescribe by regulation)
on the grounds that it does not assure the adequacy of safeguards
against hazardous electronic product radiation or that it does not
assure that electronic products comply with the standards
prescribed under this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 534, formerly act July 1, 1944, ch.
373, title III, Sec. 534, formerly Sec. 358, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91-
515, title VI, Sec. 601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311;
renumbered Sec. 534 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
(2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-
80, Secs. 3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)
-COD-
CODIFICATION
Section was classified to section 263f of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80, Sec. 4(a)(2), amended directory language
of Pub. L. 101-629, Sec. 19(a)(4), which renumbered section 263f of
Title 42, The Public Health and Welfare, as this section.
Subsec. (f)(2). Pub. L. 103-80, Sec. 3(w), made technical
amendment to reference to section 210 of title 42 to reflect
correction of corresponding provision of original act.
1990 - Subsec. (a)(1)(E). Pub. L. 101-629, Sec. 19(a)(2)(B),
substituted "section 360hh" for "section 263c".
Subsecs. (e), (f)(1)(A). Pub. L. 101-629, Sec. 19(a)(1)(B),
substituted "this part" for "this subpart".
1970 - Subsec. (f)(2). Pub. L. 91-515 struck out provisions
related to payment of compensation and travel expenses of members
of the Committee who are not officers or employees of the United
States, and substituted "to members of the Committee who are not
officers or employees of the United States pursuant to subsection
(c) of section 210 of title 42" for "under this subsection".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360ll 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360ll. Notification of defects in and repair or replacement of
electronic products
-STATUTE-
(a) Notification; exemption
(1) Every manufacturer of electronic products who discovers that
an electronic product produced, assembled, or imported by him has a
defect which relates to the safety of use of such product by reason
of the emission of electronic product radiation, or that an
electronic product produced, assembled, or imported by him on or
after the effective date of an applicable standard prescribed
pursuant to section 360kk of this title fails to comply with such
standard, shall immediately notify the Secretary of such defect or
failure to comply if such product has left the place of manufacture
and shall (except as authorized by paragraph (2)) with reasonable
promptness furnish notification of such defect or failure to the
persons (where known to the manufacturer) specified in subsection
(b) of this section.
(2) If, in the opinion of such manufacturer, the defect or
failure to comply is not such as to create a significant risk of
injury, including genetic injury, to any person, he may, at the
time of giving notice to the Secretary of such defect or failure to
comply, apply to the Secretary for an exemption from the
requirement of notice to the persons specified in subsection (b) of
this section. If such application states reasonable grounds for
such exemption, the Secretary shall afford such manufacturer an
opportunity to present his views and evidence in support of the
application, the burden of proof being on the manufacturer. If,
after such presentation, the Secretary is satisfied that such
defect or failure to comply is not such as to create a significant
risk of injury, including genetic injury, to any person, he shall
exempt such manufacturer from the requirement of notice to the
persons specified in subsection (b) of this section and from the
requirements of repair or replacement imposed by subsection (f) of
this section.
(b) Method of notification
The notification (other than to the Secretary) required by
paragraph (1) of subsection (a) of this section shall be
accomplished -
(1) by certified mail to the first purchaser of such product
for purposes other than resale, and to any subsequent transferee
of such product; and
(2) by certified mail or other more expeditious means to the
dealers or distributors of such manufacturer to whom such product
was delivered.
(c) Requisite elements of notification
The notifications required by paragraph (1) of subsection (a) of
this section shall contain a clear description of such defect or
failure to comply with an applicable standard, an evaluation of the
hazard reasonably related to such defect or failure to comply, and
a statement of the measures to be taken to repair such defect. In
the case of a notification to a person referred to in subsection
(b) of this section, the notification shall also advise the person
of his rights under subsection (f) of this section.
(d) Copies to Secretary of communications by manufacturers to
dealers or distributors regarding defects
Every manufacturer of electronic products shall furnish to the
Secretary a true or representative copy of all notices, bulletins,
and other communications to the dealers or distributors of such
manufacturer or to purchasers (or subsequent transferees) of
electronic products of such manufacturer regarding any such defect
in such product or any such failure to comply with a standard
applicable to such product. The Secretary shall disclose to the
public so much of the information contained in such notice or other
information obtained under section 360nn of this title as he deems
will assist in carrying out the purposes of this part, but he shall
not disclose any information which contains or relates to a trade
secret or other matter referred to in section 1905 of title 18
unless he determines that it is necessary to carry out the purposes
of this part.
(e) Notice from Secretary to manufacturer of defects or failure to
comply with standards
If through testing, inspection, investigation, or research
carried out pursuant to this part, or examination of reports
submitted pursuant to section 360nn of this title, or otherwise,
the Secretary determines that any electronic product -
(1) does not comply with an applicable standard prescribed
pursuant to section 360kk of this title; or
(2) contains a defect which relates to the safety of use of
such product by reason of the emission of electronic product
radiation;
he shall immediately notify the manufacturer of such product of
such defect or failure to comply. The notice shall contain the
findings of the Secretary and shall include all information upon
which the findings are based. The Secretary shall afford such
manufacturer an opportunity to present his views and evidence in
support thereof, to establish that there is no failure of
compliance or that the alleged defect does not exist or does not
relate to safety of use of the product by reason of the emission of
such radiation hazard. If after such presentation by the
manufacturer the Secretary determines that such product does not
comply with an applicable standard prescribed pursuant to section
360kk of this title, or that it contains a defect which relates to
the safety of use of such product by reason of the emission of
electronic product radiation, the Secretary shall direct the
manufacturer to furnish the notification specified in subsection
(c) of this section to the persons specified in paragraphs (1) and
(2) of subsection (b) of this section (where known to the
manufacturer), unless the manufacturer has applied for an exemption
from the requirement of such notification on the ground specified
in paragraph (2) of subsection (a) of this section and the
Secretary is satisfied that such noncompliance or defect is not
such as to create a significant risk of injury, including genetic
injury, to any person.
(f) Correction of defects
If any electronic product is found under subsection (a) or (e) of
this section to fail to comply with an applicable standard
prescribed under this part or to have a defect which relates to the
safety of use of such product, and the notification specified in
subsection (c) of this section is required to be furnished on
account of such failure or defect, the manufacturer of such product
shall (1) without charge, bring such product into conformity with
such standard or remedy such defect and provide reimbursement for
any expenses for transportation of such product incurred in
connection with having such product brought into conformity or
having such defect remedied, (2) replace such product with a like
or equivalent product which complies with each applicable standard
prescribed under this part and which has no defect relating to the
safety of its use, or (3) make a refund of the cost of such
product. The manufacturer shall take the action required by this
subsection in such manner, and with respect to such persons, as the
Secretary by regulations shall prescribe.
(g) Effective date
This section shall not apply to any electronic product that was
manufactured before October 18, 1968.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 535, formerly act July 1, 1944, ch.
373, title III, Sec. 535, formerly Sec. 359, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered Sec. 535
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263g of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263g of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(C)(i),
substituted "section 360kk" for "section 263f".
Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C)(ii),
substituted "section 360nn" for "section 263i" and "this part" for
"this subpart" in two places.
Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C),
substituted "this part" for "this subpart" and "section 360nn" for
"section 263i" in introductory provisions and "section 360kk" for
"section 263f" in par. (1) and concluding provisions.
Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
part" for "this subpart" in two places.
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360mm 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360mm. Imports
-STATUTE-
(a) Refusal of admission to noncomplying electronic products
Any electronic product offered for importation into the United
States which fails to comply with an applicable standard prescribed
under this part, or to which is not affixed a certification in the
form of a label or tag in conformity with section 360kk(h) of this
title shall be refused admission into the United States. The
Secretary of the Treasury shall deliver to the Secretary of Health
and Human Services, upon the latter's request, samples of
electronic products which are being imported or offered for import
into the United States, giving notice thereof to the owner or
consignee, who may have a hearing before the Secretary of Health
and Human Services. If it appears from an examination of such
samples or otherwise that any electronic product fails to comply
with applicable standards prescribed pursuant to section 360kk of
this title, then, unless subsection (b) of this section applies and
is complied with, (1) such electronic product shall be refused
admission, and (2) the Secretary of the Treasury shall cause the
destruction of such electronic product unless such article is
exported, under regulations prescribed by the Secretary of the
Treasury, within 90 days after the date of notice of refusal of
admission or within such additional time as may be permitted by
such regulations.
(b) Bond
If it appears to the Secretary of Health and Human Services that
any electronic product refused admission pursuant to subsection (a)
of this section can be brought into compliance with applicable
standards prescribed pursuant to section 360kk of this title, final
determination as to admission of such electronic product may be
deferred upon filing of timely written application by the owner or
consignee and the execution by him of a good and sufficient bond
providing for the payment of such liquidated damages in the event
of default as the Secretary of Health and Human Services may by
regulation prescribe. If such application is filed and such bond is
executed the Secretary of Health and Human Services may, in
accordance with rules prescribed by him, permit the applicant to
perform such operations with respect to such electronic product as
may be specified in the notice of permission.
(c) Liability of owner or consignee for expenses connected with
refusal of admission
All expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection (a) of
this section and the supervision of operations provided for in
subsection (b) of this section, and all expenses in connection with
the storage, cartage, or labor with respect to any electronic
product refused admission pursuant to subsection (a) of this
section, shall be paid by the owner or consignee, and, in event of
default, shall constitute a lien against any future importations
made by such owner or consignee.
(d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic
product for importation into the United States to designate in
writing an agent upon whom service of all administrative and
judicial processes, notices, orders, decisions, and requirements
may be made for and on behalf of said manufacturer, and to file
such designation with the Secretary, which designation may from
time to time be changed by like writing, similarly filed. Service
of all administrative and judicial processes, notices, orders,
decisions, and requirements may be made upon said manufacturer by
service upon such designated agent at his office or usual place of
residence with like effect as if made personally upon said
manufacturer, and in default of such designation of such agent,
service of process, notice, order, requirement, or decision in any
proceeding before the Secretary or in any judicial proceeding for
enforcement of this part or any standards prescribed pursuant to
this part may be made by posting such process, notice, order,
requirement, or decision in the Office of the Secretary or in a
place designated by him by regulation.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 536, formerly act July 1, 1944, ch.
373, title III, Sec. 536, formerly Sec. 360, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered Sec. 536
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102-300, Sec. 6(b)(1),
June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec. 4(a)(2), Aug.
13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263h of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263h of Title 42, The
Public Health and Welfare, as this section.
1992 - Subsecs. (a), (b). Pub. L. 102-300 substituted "Health and
Human Services" for "Health, Education, and Welfare" wherever
appearing.
1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D),
substituted "this part" for "this subpart", "section 360kk(h)" for
"section 263f(h)", and "section 360kk" for "section 263f".
Subsec. (b). Pub. L. 101-629, Sec. 19(a)(2)(D), substituted
"section 360kk" for "section 263f".
Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
part" for "this subpart" in two places.
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360nn 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360nn. Inspection, records, and reports
-STATUTE-
(a) Inspection of premises
If the Secretary finds for good cause that the methods, tests, or
programs related to electronic product radiation safety in a
particular factory, warehouse, or establishment in which electronic
products are manufactured or held, may not be adequate or reliable,
officers or employees duly designated by the Secretary, upon
presenting appropriate credentials and a written notice to the
owner, operator, or agent in charge, are thereafter authorized (1)
to enter, at reasonable times, any area in such factory, warehouse,
or establishment in which the manufacturer's tests (or testing
programs) required by section 360kk(h) of this title are carried
out, and (2) to inspect, at reasonable times and within reasonable
limits and in a reasonable manner, the facilities and procedures
within such area which are related to electronic product radiation
safety. Each such inspection shall be commenced and completed with
reasonable promptness. In addition to other grounds upon which good
cause may be found for purposes of this subsection, good cause will
be considered to exist in any case where the manufacturer has
introduced into commerce any electronic product which does not
comply with an applicable standard prescribed under this part and
with respect to which no exemption from the notification
requirements has been granted by the Secretary under section
360ll(a)(2) or 360ll(e) of this title.
(b) Record keeping
Every manufacturer of electronic products shall establish and
maintain such records (including testing records), make such
reports, and provide such information, as the Secretary may
reasonably require to enable him to determine whether such
manufacturer has acted or is acting in compliance with this part
and standards prescribed pursuant to this part and shall, upon
request of an officer or employee duly designated by the Secretary,
permit such officer or employee to inspect appropriate books,
papers, records, and documents relevant to determining whether such
manufacturer has acted or is acting in compliance with standards
prescribed pursuant to this part.
(c) Disclosure of technical data
Every manufacturer of electronic products shall provide to the
Secretary such performance data and other technical data related to
safety as may be required to carry out the purposes of this part.
The Secretary is authorized to require the manufacturer to give
such notification of such performance and technical data at the
time of original purchase to the ultimate purchaser of the
electronic product, as he determines necessary to carry out the
purposes of this part after consulting with the affected industry.
(d) Public nature of reports
Accident and investigation reports made under this part by any
officer, employee, or agent of the Secretary shall be available for
use in any civil, criminal, or other judicial proceeding arising
out of such accident. Any such officer, employee, or agent may be
required to testify in such proceedings as to the facts developed
in such investigations. Any such report shall be made available to
the public in a manner which need not identify individuals. All
reports on research projects, demonstration projects, and other
related activities shall be public information.
(e) Trade secrets
The Secretary or his representative shall not disclose any
information reported to or otherwise obtained by him, pursuant to
subsection (a) or (b) of this section, which concerns any
information which contains or relates to a trade secret or other
matter referred to in section 1905 of title 18, except that such
information may be disclosed to other officers or employees of the
Department and of other agencies concerned with carrying out this
part or when relevant in any proceeding under this part. Nothing in
this section shall authorize the withholding of information by the
Secretary, or by any officers or employees under his control, from
the duly authorized committees of the Congress.
(f) Information required to identify and locate first purchasers of
electronic products
The Secretary may by regulation (1) require dealers and
distributors of electronic products, to which there are applicable
standards prescribed under this part and the retail prices of which
is not less than $50, to furnish manufacturers of such products
such information as may be necessary to identify and locate, for
purposes of section 360ll of this title, the first purchasers of
such products for purposes other than resale, and (2) require
manufacturers to preserve such information. Any regulation
establishing a requirement pursuant to clause (1) of the preceding
sentence shall (A) authorize such dealers and distributors to
elect, in lieu of immediately furnishing such information to the
manufacturer, to hold and preserve such information until advised
by the manufacturer or Secretary that such information is needed by
the manufacturer for purposes of section 360ll of this title, and
(B) provide that the dealer or distributor shall, upon making such
election, give prompt notice of such election (together with
information identifying the notifier and the product) to the
manufacturer and shall, when advised by the manufacturer or
Secretary, of the need therefor for the purposes of section 360ll
of this title, immediately furnish the manufacturer with the
required information. If a dealer or distributor discontinues the
dealing in or distribution of electronic products, he shall turn
the information over to the manufacturer. Any manufacturer
receiving information pursuant to this subsection concerning first
purchasers of products for purposes other than resale shall treat
it as confidential and may use it only if necessary for the purpose
of notifying persons pursuant to section 360ll(a) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 537, formerly act July 1, 1944, ch.
373, title III, Sec. 537, formerly Sec. 360A, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered Sec. 537
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263i of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263i of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E),
substituted "section 360kk(h)" for "section 263f(h)", "this part"
for "this subpart", and "section 360ll(a)(2) or 360ll(e)" for
"section 263g(a)(2) or 263g(e)".
Subsecs. (b) to (e). Pub. L. 101-629, Sec. 19(a)(1)(B),
substituted "this part" for "this subpart" wherever appearing.
Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E)(ii),
substituted "this part" for "this subpart", "section 360ll" for
"section 263g" in three places, and "section 360ll(a)" for "section
263g(a)".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360oo 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360oo. Prohibited acts
-STATUTE-
(a) It shall be unlawful -
(1) for any manufacturer to introduce, or to deliver for
introduction, into commerce, or to import into the United States,
any electronic product which does not comply with an applicable
standard prescribed pursuant to section 360kk of this title;
(2) for any person to fail to furnish any notification or other
material or information required by section 360ll or 360nn of
this title; or to fail to comply with the requirements of section
360ll(f) of this title;
(3) for any person to fail or to refuse to establish or
maintain records required by this part or to permit access by the
Secretary or any of his duly authorized representatives to, or
the copying of, such records, or to permit entry or inspection,
as required by or pursuant to section 360nn of this title;
(4) for any person to fail or to refuse to make any report
required pursuant to section 360nn(b) of this title or to furnish
or preserve any information required pursuant to section 360nn(f)
of this title; or
(5) for any person (A) to fail to issue a certification as
required by section 360kk(h) of this title, or (B) to issue such
a certification when such certification is not based upon a test
or testing program meeting the requirements of section 360kk(h)
of this title or when the issuer, in the exercise of due care,
would have reason to know that such certification is false or
misleading in a material respect.
(b) The Secretary may exempt any electronic product, or class
thereof, from all or part of subsection (a) of this section, upon
such conditions as he may find necessary to protect the public
health or welfare, for the purpose of research, investigations,
studies, demonstrations, or training, or for reasons of national
security.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 538, formerly act July 1, 1944, ch.
373, title III, Sec. 538, formerly Sec. 360B, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 538
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263j of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263j of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(F)(i),
substituted "section 360kk" for "section 263f".
Subsec. (a)(2). Pub. L. 101-629, Sec. 19(a)(2)(F)(ii), (iii),
substituted "section 360ll or 360nn" for "section 263g or 263i" and
"section 360ll(f)" for "section 263g(f)".
Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F)(iii),
substituted "this part" for "this subpart" and "section 360nn" for
"section 263i".
Subsec. (a)(4). Pub. L. 101-629, Sec. 19(a)(2)(F)(iii),
substituted "section 360nn(b)" for "section 263i(b)" and "section
360nn(f)" for "section 263i(f)".
Subsec. (a)(5). Pub. L. 101-629, Sec. 19(a)(2)(F)(i), substituted
"section 360kk(h)" for "section 263f(h)" in two places.
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360pp 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360pp. Enforcement
-STATUTE-
(a) Jurisdiction of courts
The district courts of the United States shall have jurisdiction,
for cause shown, to restrain violations of section 360oo of this
title and to restrain dealers and distributors of electronic
products from selling or otherwise disposing of electronic products
which do not conform to an applicable standard prescribed pursuant
to section 360kk of this title except when such products are
disposed of by returning them to the distributor or manufacturer
from whom they were obtained. The district courts of the United
States shall also have jurisdiction in accordance with section 1355
of title 28 to enforce the provisions of subsection (b) of this
section.
(b) Penalties
(1) Any person who violates section 360oo of this title shall be
subject to a civil penalty of not more than $1,000. For purposes of
this subsection, any such violation shall with respect to each
electronic product involved, or with respect to each act or
omission made unlawful by section 360oo of this title, constitute a
separate violation, except that the maximum civil penalty imposed
on any person under this subsection for any related series of
violations shall not exceed $300,000.
(2) Any such civil penalty may on application be remitted or
mitigated by the Secretary. In determining the amount of such
penalty, or whether it should be remitted or mitigated and in what
amount, the appropriateness of such penalty to the size of the
business of the person charged and the gravity of the violation
shall be considered. The amount of such penalty, when finally
determined, may be deducted from any sums owing by the United
States to the person charged.
(c) Venue; process
Actions under subsections (a) and (b) of this section may be
brought in the district court of the United States for the district
wherein any act or omission or transaction constituting the
violation occurred, or in such court for the district where the
defendant is found or transacts business, and process in such cases
may be served in any other district of which the defendant is an
inhabitant or wherever the defendant may be found.
(d) Warnings
Nothing in this part shall be construed as requiring the
Secretary to report for the institution of proceedings minor
violations of this part whenever he believes that the public
interest will be adequately served by a suitable written notice or
warning.
(e) Compliance with regulations
Except as provided in the first sentence of section 360ss of this
title, compliance with this part or any regulations issued
thereunder shall not relieve any person from liability at common
law or under statutory law.
(f) Additional remedies
The remedies provided for in this part shall be in addition to
and not in substitution for any other remedies provided by law.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 539, formerly act July 1, 1944, ch.
373, title III, Sec. 539, formerly Sec. 360C, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 539
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263k of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263k of Title 42, The
Public Health and Welfare, as this section.
1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(2)(G)(i), (ii),
substituted "section 360oo" for "section 263j" and "section 360kk"
for "section 263f".
Subsec. (b)(1). Pub. L. 101-629, Sec. 19(a)(2)(G)(ii),
substituted "section 360oo" for "section 263j" in two places.
Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
part" for "this subpart" in two places.
Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G)(iii),
substituted "section 360ss" for "section 263n" and "this part" for
"this subpart".
Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
part" for "this subpart".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360qq 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360qq. Repealed.
-MISC1-
Sec. 360qq. Repealed. Pub. L. 105-362, title VI, Sec. 601(a)(2)(A),
Nov. 10, 1998, 112 Stat. 3285.
Section, act June 25, 1938, ch. 675, Sec. 540, formerly act July
1, 1944, ch. 373, title III, Sec. 540, formerly Sec. 360D, as added
Pub. L. 90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered
Sec. 540 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779, related to annual report on
administration of electronic product radiation control program.
-End-
-CITE-
21 USC Sec. 360rr 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360rr. Federal-State cooperation
-STATUTE-
The Secretary is authorized (1) to accept from State and local
authorities engaged in activities related to health or safety or
consumer protection, on a reimbursable basis or otherwise, any
assistance in the administration and enforcement of this part which
he may request and which they may be able and willing to provide
and, if so agreed, may pay in advance or otherwise for the
reasonable cost of such assistance, and (2) he may, for the purpose
of conducting examinations, investigations, and inspections,
commission any officer or employee of any such authority as an
officer of the Department.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 541, formerly act July 1, 1944, ch.
373, title III, Sec. 541, formerly Sec. 360E, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 541
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263m of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263m of Title 42, The
Public Health and Welfare, as this section.
1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
for "this subpart".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Sec. 360ss 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part C - Electronic Product Radiation Control
-HEAD-
Sec. 360ss. State standards
-STATUTE-
Whenever any standard prescribed pursuant to section 360kk of
this title with respect to an aspect of performance of an
electronic product is in effect, no State or political subdivision
of a State shall have any authority either to establish, or to
continue in effect, any standard which is applicable to the same
aspect of performance of such product and which is not identical to
the Federal standard. Nothing in this part shall be construed to
prevent the Federal Government or the government of any State or
political subdivision thereof from establishing a requirement with
respect to emission of radiation from electronic products procured
for its own use if such requirement imposes a more restrictive
standard than that required to comply with the otherwise applicable
Federal standard.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 542, formerly act July 1, 1944, ch.
373, title III, Sec. 542, formerly Sec. 360F, as added Pub. L. 90-
602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 542
and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), (3), (4),
Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
Aug. 13, 1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was classified to section 263n of Title 42, The Public
Health and Welfare, prior to renumbering by Pub. L. 101-629.
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
629, Sec. 19(a)(4), which renumbered section 263n of Title 42, The
Public Health and Welfare, as this section.
1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), substituted
"section 360kk" for "section 263f" and "this part" for "this
subpart".
NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
Enactment of this section not to be construed to supersede or
limit the functions under any other provision of law of any officer
or agency of the United States, see section 4 of Pub. L. 90-602,
set out as a note under section 360hh of this title.
-End-
-CITE-
21 USC Part D - Dissemination of Treatment Information 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
PART D - DISSEMINATION OF TREATMENT INFORMATION
-STATAMEND-
TERMINATION OF PART
For termination of part by section 401(e) of Pub. L. 105-115, see
Effective and Termination Dates note set out under section 360aaa
of this title.
-End-
-CITE-
21 USC Sec. 360aaa 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa. Requirements for dissemination of treatment
information on drugs or devices
-STATUTE-
(a) In general
Notwithstanding sections 331(d), 352(f), and 355 of this title,
and section 262 of title 42, a manufacturer may disseminate to -
(1) a health care practitioner;
(2) a pharmacy benefit manager;
(3) a health insurance issuer;
(4) a group health plan; or
(5) a Federal or State governmental agency;
written information concerning the safety, effectiveness, or
benefit of a use not described in the approved labeling of a drug
or device if the manufacturer meets the requirements of subsection
(b) of this section.
(b) Specific requirements
A manufacturer may disseminate information under subsection (a)
of this section on a new use only if -
(1)(A) in the case of a drug, there is in effect for the drug
an application filed under subsection (b) or (j) of section 355
of this title or a biologics license issued under section 262 of
title 42; or
(B) in the case of a device, the device is being commercially
distributed in accordance with a regulation under subsection (d)
or (e) of section 360c of this title, an order under subsection
(f) of such section, or the approval of an application under
section 360e of this title;
(2) the information meets the requirements of section 360aaa-1
of this title;
(3) the information to be disseminated is not derived from
clinical research conducted by another manufacturer or if it was
derived from research conducted by another manufacturer, the
manufacturer disseminating the information has the permission of
such other manufacturer to make the dissemination;
(4) the manufacturer has, 60 days before such dissemination,
submitted to the Secretary -
(A) a copy of the information to be disseminated; and
(B) any clinical trial information the manufacturer has
relating to the safety or effectiveness of the new use, any
reports of clinical experience pertinent to the safety of the
new use, and a summary of such information;
(5) the manufacturer has complied with the requirements of
section 360aaa-3 of this title (relating to a supplemental
application for such use);
(6) the manufacturer includes along with the information to be
disseminated under this subsection -
(A) a prominently displayed statement that discloses -
(i) that the information concerns a use of a drug or device
that has not been approved or cleared by the Food and Drug
Administration;
(ii) if applicable, that the information is being
disseminated at the expense of the manufacturer;
(iii) if applicable, the name of any authors of the
information who are employees of, consultants to, or have
received compensation from, the manufacturer, or who have a
significant financial interest in the manufacturer;
(iv) the official labeling for the drug or device and all
updates with respect to the labeling;
(v) if applicable, a statement that there are products or
treatments that have been approved or cleared for the use
that is the subject of the information being disseminated
pursuant to subsection (a)(1) of this section; and
(vi) the identification of any person that has provided
funding for the conduct of a study relating to the new use of
a drug or device for which such information is being
disseminated; and
(B) a bibliography of other articles from a scientific
reference publication or scientific or medical journal that
have been previously published about the use of the drug or
device covered by the information disseminated (unless the
information already includes such bibliography).
(c) Additional information
If the Secretary determines, after providing notice of such
determination and an opportunity for a meeting with respect to such
determination, that the information submitted by a manufacturer
under subsection (b)(3)(B) of this section, with respect to the use
of a drug or device for which the manufacturer intends to
disseminate information, fails to provide data, analyses, or other
written matter that is objective and balanced, the Secretary may
require the manufacturer to disseminate -
(1) additional objective and scientifically sound information
that pertains to the safety or effectiveness of the use and is
necessary to provide objectivity and balance, including any
information that the manufacturer has submitted to the Secretary
or, where appropriate, a summary of such information or any other
information that the Secretary has authority to make available to
the public; and
(2) an objective statement of the Secretary, based on data or
other scientifically sound information available to the
Secretary, that bears on the safety or effectiveness of the new
use of the drug or device.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 551, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2356.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note below.
-MISC1-
EFFECTIVE AND TERMINATION DATES
Section 401(d) of Pub. L. 105-115 provided that: "The amendments
made by this section [enacting this part and amending section 331
of this title] shall take effect 1 year after the date of enactment
of this Act [Nov. 21, 1997], or upon the Secretary's issuance of
final regulations pursuant to subsection (c) [section 401(c) of
Pub. L. 105-115 set out below], whichever is sooner."
Section 401(e) of Pub. L. 105-115 provided that: "The amendments
made by this section [enacting this part and amending section 331
of this title] cease to be effective September 30, 2006, or 7 years
after the date on which the Secretary promulgates the regulations
described in subsection (c) [section 401(c) of Pub. L. 105-115 set
out below], whichever is later."
REGULATIONS
Section 401(c) of Pub. L. 105-115 provided that: "Not later than
1 year after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services shall promulgate regulations
to implement the amendments made by this section [enacting this
part and amending section 331 of this title]."
STUDIES AND REPORTS
Pub. L. 105-115, title IV, Sec. 401(f), Nov. 21, 1997, 111 Stat.
2364, provided that:
"(1) General accounting office [now Government Accountability
Office]. -
"(A) In general. - The Comptroller General of the United States
shall conduct a study to determine the impact of subchapter D of
chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
360aaa et seq.], as added by this section, on the resources of
the Department of Health and Human Services.
"(B) Report. - Not later than January 1, 2002, the Comptroller
General of the United States shall prepare and submit to the
Committee on Labor and Human Resources [now Committee on Health,
Education, Labor, and Pensions] of the Senate and the Committee
on Commerce [now Committee on Energy and Commerce] of the House
of Representatives a report of the results of the study.
"(2) Department of health and human services. -
"(A) In general. - In order to assist Congress in determining
whether the provisions of such subchapter should be extended
beyond the termination date specified in subsection (e) [section
401(e) of Pub. L. 105-115, set out above], the Secretary of
Health and Human Services shall, in accordance with subparagraph
(B), arrange for the conduct of a study of the scientific issues
raised as a result of the enactment of such subchapter including
issues relating to -
"(i) the effectiveness of such subchapter with respect to the
provision of useful scientific information to health care
practitioners;
"(ii) the quality of the information being disseminated
pursuant to the provisions of such subchapter;
"(iii) the quality and usefulness of the information
provided, in accordance with such subchapter, by the Secretary
or by the manufacturer at the request of the Secretary; and
"(iv) the impact of such subchapter on research in the area
of new uses, indications, or dosages, particularly the impact
on pediatric indications and rare diseases.
"(3) Procedure for study. -
"(A) In general. - The Secretary shall request the Institute of
Medicine of the National Academy of Sciences to conduct the study
required by paragraph (2), and to prepare and submit the report
required by subparagraph (B), under an arrangement by which the
actual expenses incurred by the Institute of Medicine in
conducting the study and preparing the report will be paid by the
Secretary. If the Institute of Medicine is unwilling to conduct
the study under such an arrangement, the Comptroller General of
the United States shall conduct such study.
"(B) Report. - Not later than September 30, 2005, the Institute
of Medicine or the Comptroller General of the United States, as
appropriate, shall prepare and submit to the Committee on Labor
and Human Resources [now Committee on Health, Education, Labor,
and Pensions] of the Senate, the Committee on Commerce [now
Committee on Energy and Commerce] of the House of
Representatives, and the Secretary a report of the results of the
study required by paragraph (2). The Secretary, after the receipt
of the report, shall make the report available to the public."
-End-
-CITE-
21 USC Sec. 360aaa-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-1. Information authorized to be disseminated
-STATUTE-
(a) Authorized information
A manufacturer may disseminate information under section 360aaa
of this title on a new use only if the information -
(1) is in the form of an unabridged -
(A) reprint or copy of an article, peer-reviewed by experts
qualified by scientific training or experience to evaluate the
safety or effectiveness of the drug or device involved, which
was published in a scientific or medical journal (as defined in
section 360aaa-5(5) of this title), which is about a clinical
investigation with respect to the drug or device, and which
would be considered to be scientifically sound by such experts;
or
(B) reference publication, described in subsection (b) of
this section, that includes information about a clinical
investigation with respect to the drug or device that would be
considered to be scientifically sound by experts qualified by
scientific training or experience to evaluate the safety or
effectiveness of the drug or device that is the subject of such
a clinical investigation; and
(2) is not false or misleading and would not pose a significant
risk to the public health.
(b) Reference publication
A reference publication referred to in subsection (a)(1)(B) of
this section is a publication that -
(1) has not been written, edited, excerpted, or published
specifically for, or at the request of, a manufacturer of a drug
or device;
(2) has not been edited or significantly influenced by such a
manufacturer;
(3) is not solely distributed through such a manufacturer but
is generally available in bookstores or other distribution
channels where medical textbooks are sold;
(4) does not focus on any particular drug or device of a
manufacturer that disseminates information under section 360aaa
of this title and does not have a primary focus on new uses of
drugs or devices that are marketed or under investigation by a
manufacturer supporting the dissemination of information; and
(5) presents materials that are not false or misleading.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 552, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2358.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Sec. 360aaa-2 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-2. Establishment of list of articles and publications
disseminated and list of providers that received articles and
reference publications
-STATUTE-
(a) In general
A manufacturer may disseminate information under section 360aaa
of this title on a new use only if the manufacturer prepares and
submits to the Secretary biannually -
(1) a list containing the titles of the articles and reference
publications relating to the new use of drugs or devices that
were disseminated by the manufacturer to a person described in
section 360aaa(a) of this title for the 6-month period preceding
the date on which the manufacturer submits the list to the
Secretary; and
(2) a list that identifies the categories of providers (as
described in section 360aaa(a) of this title) that received the
articles and reference publications for the 6-month period
described in paragraph (1).
(b) Records
A manufacturer that disseminates information under section 360aaa
of this title shall keep records that may be used by the
manufacturer when, pursuant to section 360aaa-4 of this title, such
manufacturer is required to take corrective action and shall be
made available to the Secretary, upon request, for purposes of
ensuring or taking corrective action pursuant to such section. Such
records, at the Secretary's discretion, may identify the recipient
of information provided pursuant to section 360aaa of this title or
the categories of such recipients.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 553, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Sec. 360aaa-3 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-3. Requirement regarding submission of supplemental
application for new use; exemption from requirement
-STATUTE-
(a) In general
A manufacturer may disseminate information under section 360aaa
of this title on a new use only if -
(1)(A) the manufacturer has submitted to the Secretary a
supplemental application for such use; or
(B) the manufacturer meets the condition described in
subsection (b) or (c) of this section (relating to a
certification that the manufacturer will submit such an
application); or
(2) there is in effect for the manufacturer an exemption under
subsection (d) of this section from the requirement of paragraph
(1).
(b) Certification on supplemental application; condition in case of
completed studies
For purposes of subsection (a)(1)(B) of this section, a
manufacturer may disseminate information on a new use if the
manufacturer has submitted to the Secretary an application
containing a certification that -
(1) the studies needed for the submission of a supplemental
application for the new use have been completed; and
(2) the supplemental application will be submitted to the
Secretary not later than 6 months after the date of the initial
dissemination of information under section 360aaa of this title.
(c) Certification on supplemental application; condition in case of
planned studies
(1) In general
For purposes of subsection (a)(1)(B) of this section, a
manufacturer may disseminate information on a new use if -
(A) the manufacturer has submitted to the Secretary an
application containing -
(i) a proposed protocol and schedule for conducting the
studies needed for the submission of a supplemental
application for the new use; and
(ii) a certification that the supplemental application will
be submitted to the Secretary not later than 36 months after
the date of the initial dissemination of information under
section 360aaa of this title (or, as applicable, not later
than such date as the Secretary may specify pursuant to an
extension under paragraph (3)); and
(B) the Secretary has determined that the proposed protocol
is adequate and that the schedule for completing such studies
is reasonable.
(2) Progress reports on studies
A manufacturer that submits to the Secretary an application
under paragraph (1) shall submit to the Secretary periodic
reports describing the status of the studies involved.
(3) Extension of time regarding planned studies
The period of 36 months authorized in paragraph (1)(A)(ii) for
the completion of studies may be extended by the Secretary if -
(A) the Secretary determines that the studies needed to
submit such an application cannot be completed and submitted
within 36 months; or
(B) the manufacturer involved submits to the Secretary a
written request for the extension and the Secretary determines
that the manufacturer has acted with due diligence to conduct
the studies in a timely manner, except that an extension under
this subparagraph may not be provided for more than 24
additional months.
(d) Exemption from requirement of supplemental application
(1) In general
For purposes of subsection (a)(2) of this section, a
manufacturer may disseminate information on a new use if -
(A) the manufacturer has submitted to the Secretary an
application for an exemption from meeting the requirement of
subsection (a)(1) of this section; and
(B)(i) the Secretary has approved the application in
accordance with paragraph (2); or
(ii) the application is deemed under paragraph (3)(A) to have
been approved (unless such approval is terminated pursuant to
paragraph (3)(B)).
(2) Conditions for approval
The Secretary may approve an application under paragraph (1)
for an exemption if the Secretary makes a determination described
in subparagraph (A) or (B), as follows:
(A) The Secretary makes a determination that, for reasons
defined by the Secretary, it would be economically prohibitive
with respect to such drug or device for the manufacturer to
incur the costs necessary for the submission of a supplemental
application. In making such determination, the Secretary shall
consider (in addition to any other considerations the Secretary
finds appropriate) -
(i) the lack of the availability under law of any period
during which the manufacturer would have exclusive marketing
rights with respect to the new use involved; and
(ii) the size of the population expected to benefit from
approval of the supplemental application.
(B) The Secretary makes a determination that, for reasons
defined by the Secretary, it would be unethical to conduct the
studies necessary for the supplemental application. In making
such determination, the Secretary shall consider (in addition
to any other considerations the Secretary finds appropriate)
whether the new use involved is the standard of medical care
for a health condition.
(3) Time for consideration of application; deemed approval
(A) In general
The Secretary shall approve or deny an application under
paragraph (1) for an exemption not later than 60 days after the
receipt of the application. If the Secretary does not comply
with the preceding sentence, the application is deemed to be
approved.
(B) Termination of deemed approval
If pursuant to a deemed approval under subparagraph (A) a
manufacturer disseminates written information under section
360aaa of this title on a new use, the Secretary may at any
time terminate such approval and under section 360aaa-4(b)(3)
of this title order the manufacturer to cease disseminating the
information.
(e) Requirements regarding applications
Applications under this section shall be submitted in the form
and manner prescribed by the Secretary.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 554, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Sec. 360aaa-4 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-4. Corrective actions; cessation of dissemination
-STATUTE-
(a) Postdissemination data regarding safety and effectiveness
(1) Corrective actions
With respect to data received by the Secretary after the
dissemination of information under section 360aaa of this title
by a manufacturer has begun (whether received pursuant to
paragraph (2) or otherwise), if the Secretary determines that the
data indicate that the new use involved may not be effective or
may present a significant risk to public health, the Secretary
shall, after consultation with the manufacturer, take such action
regarding the dissemination of the information as the Secretary
determines to be appropriate for the protection of the public
health, which may include ordering that the manufacturer cease
the dissemination of the information.
(2) Responsibilities of manufacturers to submit data
After a manufacturer disseminates information under section
360aaa of this title, the manufacturer shall submit to the
Secretary a notification of any additional knowledge of the
manufacturer on clinical research or other data that relate to
the safety or effectiveness of the new use involved. If the
manufacturer is in possession of the data, the notification shall
include the data. The Secretary shall by regulation establish the
scope of the responsibilities of manufacturers under this
paragraph, including such limits on the responsibilities as the
Secretary determines to be appropriate.
(b) Cessation of dissemination
(1) Failure of manufacturer to comply with requirements
The Secretary may order a manufacturer to cease the
dissemination of information pursuant to section 360aaa of this
title if the Secretary determines that the information being
disseminated does not comply with the requirements established in
this part. Such an order may be issued only after the Secretary
has provided notice to the manufacturer of the intent of the
Secretary to issue the order and (unless paragraph (2)(B)
applies) has provided an opportunity for a meeting with respect
to such intent. If the failure of the manufacturer constitutes a
minor violation of this part, the Secretary shall delay issuing
the order and provide to the manufacturer an opportunity to
correct the violation.
(2) Supplemental applications
The Secretary may order a manufacturer to cease the
dissemination of information pursuant to section 360aaa of this
title if -
(A) in the case of a manufacturer that has submitted a
supplemental application for a new use pursuant to section
360aaa-3(a)(1) of this title, the Secretary determines that the
supplemental application does not contain adequate information
for approval of the new use for which the application was
submitted;
(B) in the case of a manufacturer that has submitted a
certification under section 360aaa-3(b) of this title, the
manufacturer has not, within the 6-month period involved,
submitted the supplemental application referred to in the
certification; or
(C) in the case of a manufacturer that has submitted a
certification under section 360aaa-3(c) of this title but has
not yet submitted the supplemental application referred to in
the certification, the Secretary determines, after an informal
hearing, that the manufacturer is not acting with due diligence
to complete the studies involved.
(3) Termination of deemed approval of exemption regarding
supplemental applications
If under section 360aaa-3(d)(3) of this title the Secretary
terminates a deemed approval of an exemption, the Secretary may
order the manufacturer involved to cease disseminating the
information. A manufacturer shall comply with an order under the
preceding sentence not later than 60 days after the receipt of
the order.
(c) Corrective actions by manufacturers
(1) In general
In any case in which under this section the Secretary orders a
manufacturer to cease disseminating information, the Secretary
may order the manufacturer to take action to correct the
information that has been disseminated, except as provided in
paragraph (2).
(2) Termination of deemed approval of exemption regarding
supplemental applications
In the case of an order under subsection (b)(3) of this section
to cease disseminating information, the Secretary may not order
the manufacturer involved to take action to correct the
information that has been disseminated unless the Secretary
determines that the new use described in the information would
pose a significant risk to the public health.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 555, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2361.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Sec. 360aaa-5 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-5. Definitions
-STATUTE-
For purposes of this part:
(1) The term "health care practitioner" means a physician, or
other individual who is a provider of health care, who is
licensed under the law of a State to prescribe drugs or devices.
(2) The terms "health insurance issuer" and "group health plan"
have the meaning given such terms under section 300gg-91 of title
42.
(3) The term "manufacturer" means a person who manufactures a
drug or device, or who is licensed by such person to distribute
or market the drug or device.
(4) The term "new use" -
(A) with respect to a drug, means a use that is not included
in the labeling of the approved drug; and
(B) with respect to a device, means a use that is not
included in the labeling for the approved or cleared device.
(5) The term "scientific or medical journal" means a scientific
or medical publication -
(A) that is published by an organization -
(i) that has an editorial board;
(ii) that utilizes experts, who have demonstrated expertise
in the subject of an article under review by the organization
and who are independent of the organization, to review and
objectively select, reject, or provide comments about
proposed articles; and
(iii) that has a publicly stated policy, to which the
organization adheres, of full disclosure of any conflict of
interest or biases for all authors or contributors involved
with the journal or organization;
(B) whose articles are peer-reviewed and published in
accordance with the regular peer-review procedures of the
organization;
(C) that is generally recognized to be of national scope and
reputation;
(D) that is indexed in the Index Medicus of the National
Library of Medicine of the National Institutes of Health; and
(E) that is not in the form of a special supplement that has
been funded in whole or in part by one or more manufacturers.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 556, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2362.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Sec. 360aaa-6 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part D - Dissemination of Treatment Information
-HEAD-
Sec. 360aaa-6. Rules of construction
-STATUTE-
(a) Unsolicited request
Nothing in section 360aaa of this title shall be construed as
prohibiting a manufacturer from disseminating information in
response to an unsolicited request from a health care practitioner.
(b) Dissemination of information on drugs or devices not evidence
of intended use
Notwithstanding subsection (a), (f), or (o) of section 352 of
this title, or any other provision of law, the dissemination of
information relating to a new use of a drug or device, in
accordance with section 360aaa of this title, shall not be
construed by the Secretary as evidence of a new intended use of the
drug or device that is different from the intended use of the drug
or device set forth in the official labeling of the drug or device.
Such dissemination shall not be considered by the Secretary as
labeling, adulteration, or misbranding of the drug or device.
(c) Patent protection
Nothing in section 360aaa of this title shall affect patent
rights in any manner.
(d) Authorization for dissemination of articles and fees for
reprints of articles
Nothing in section 360aaa of this title shall be construed as
prohibiting an entity that publishes a scientific journal (as
defined in section 360aaa-5(5) of this title) from requiring
authorization from the entity to disseminate an article published
by such entity or charging fees for the purchase of reprints of
published articles from such entity.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 557, as added Pub. L. 105-115, title
IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2363.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 401(e) of Pub. L. 105-115,
see Effective and Termination Dates note set out under section
360aaa of this title.
-End-
-CITE-
21 USC Part E - General Provisions Relating to Drugs and
Devices 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES
-End-
-CITE-
21 USC Sec. 360bbb 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
Sec. 360bbb. Expanded access to unapproved therapies and
diagnostics
-STATUTE-
(a) Emergency situations
The Secretary may, under appropriate conditions determined by the
Secretary, authorize the shipment of investigational drugs or
investigational devices for the diagnosis, monitoring, or treatment
of a serious disease or condition in emergency situations.
(b) Individual patient access to investigational products intended
for serious diseases
Any person, acting through a physician licensed in accordance
with State law, may request from a manufacturer or distributor, and
any manufacturer or distributor may, after complying with the
provisions of this subsection, provide to such physician an
investigational drug or investigational device for the diagnosis,
monitoring, or treatment of a serious disease or condition if -
(1) the licensed physician determines that the person has no
comparable or satisfactory alternative therapy available to
diagnose, monitor, or treat the disease or condition involved,
and that the probable risk to the person from the investigational
drug or investigational device is not greater than the probable
risk from the disease or condition;
(2) the Secretary determines that there is sufficient evidence
of safety and effectiveness to support the use of the
investigational drug or investigational device in the case
described in paragraph (1);
(3) the Secretary determines that provision of the
investigational drug or investigational device will not interfere
with the initiation, conduct, or completion of clinical
investigations to support marketing approval; and
(4) the sponsor, or clinical investigator, of the
investigational drug or investigational device submits to the
Secretary a clinical protocol consistent with the provisions of
section 355(i) or 360j(g) of this title, including any
regulations promulgated under section 355(i) or 360j(g) of this
title, describing the use of the investigational drug or
investigational device in a single patient or a small group of
patients.
(c) Treatment investigational new drug applications and treatment
investigational device exemptions
Upon submission by a sponsor or a physician of a protocol
intended to provide widespread access to an investigational drug or
investigational device for eligible patients (referred to in this
subsection as an "expanded access protocol"), the Secretary shall
permit such investigational drug or investigational device to be
made available for expanded access under a treatment
investigational new drug application or treatment investigational
device exemption if the Secretary determines that -
(1) under the treatment investigational new drug application or
treatment investigational device exemption, the investigational
drug or investigational device is intended for use in the
diagnosis, monitoring, or treatment of a serious or immediately
life-threatening disease or condition;
(2) there is no comparable or satisfactory alternative therapy
available to diagnose, monitor, or treat that stage of disease or
condition in the population of patients to which the
investigational drug or investigational device is intended to be
administered;
(3)(A) the investigational drug or investigational device is
under investigation in a controlled clinical trial for the use
described in paragraph (1) under an investigational drug
application in effect under section 355(i) of this title or
investigational device exemption in effect under section 360j(g)
of this title; or
(B) all clinical trials necessary for approval of that use of
the investigational drug or investigational device have been
completed;
(4) the sponsor of the controlled clinical trials is actively
pursuing marketing approval of the investigational drug or
investigational device for the use described in paragraph (1)
with due diligence;
(5) in the case of an investigational drug or investigational
device described in paragraph (3)(A), the provision of the
investigational drug or investigational device will not interfere
with the enrollment of patients in ongoing clinical
investigations under section 355(i) or 360j(g) of this title;
(6) in the case of serious diseases, there is sufficient
evidence of safety and effectiveness to support the use described
in paragraph (1); and
(7) in the case of immediately life-threatening diseases, the
available scientific evidence, taken as a whole, provides a
reasonable basis to conclude that the investigational drug or
investigational device may be effective for its intended use and
would not expose patients to an unreasonable and significant risk
of illness or injury.
A protocol submitted under this subsection shall be subject to the
provisions of section 355(i) or 360j(g) of this title, including
regulations promulgated under section 355(i) or 360j(g) of this
title. The Secretary may inform national, State, and local medical
associations and societies, voluntary health associations, and
other appropriate persons about the availability of an
investigational drug or investigational device under expanded
access protocols submitted under this subsection. The information
provided by the Secretary, in accordance with the preceding
sentence, shall be the same type of information that is required by
section 282(i)(3) of title 42.
(d) Termination
The Secretary may, at any time, with respect to a sponsor,
physician, manufacturer, or distributor described in this section,
terminate expanded access provided under this section for an
investigational drug or investigational device if the requirements
under this section are no longer met.
(e) Definitions
In this section, the terms "investigational drug",
"investigational device", "treatment investigational new drug
application", and "treatment investigational device exemption"
shall have the meanings given the terms in regulations prescribed
by the Secretary.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 561, as added Pub. L. 105-115, title
IV, Sec. 402, Nov. 21, 1997, 111 Stat. 2365; amended Pub. L. 109-
482, title I, Sec. 102(f)(2), Jan. 15, 2007, 120 Stat. 3685.)
-MISC1-
AMENDMENTS
2007 - Subsec. (c). Pub. L. 109-482 substituted "section
282(i)(3)" for "section 282(j)(3)" in concluding provisions.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 109-482 applicable only with respect to
amounts appropriated for fiscal year 2007 or subsequent fiscal
years, see section 109 of Pub. L. 109-482, set out as a note under
section 281 of Title 42, The Public Health and Welfare.
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 360bbb-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
Sec. 360bbb-1. Dispute resolution
-STATUTE-
If, regarding an obligation concerning drugs or devices under
this Act or section 351 of the Public Health Service Act [42 U.S.C.
262], there is a scientific controversy between the Secretary and a
person who is a sponsor, applicant, or manufacturer and no specific
provision of the Act involved, including a regulation promulgated
under such Act, provides a right of review of the matter in
controversy, the Secretary shall, by regulation, establish a
procedure under which such sponsor, applicant, or manufacturer may
request a review of such controversy, including a review by an
appropriate scientific advisory panel described in section 355(n)
of this title or an advisory committee described in section
360e(g)(2)(B) of this title. Any such review shall take place in a
timely manner. The Secretary shall promulgate such regulations
within 1 year after November 21, 1997.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 562, as added Pub. L. 105-115, title
IV, Sec. 404, Nov. 21, 1997, 111 Stat. 2368.)
-REFTEXT-
REFERENCES IN TEXT
This Act, referred to in text, is the Federal Food, Drug, and
Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to this chapter. For
complete classification of this Act to the Code, see section 301 of
this title and Tables.
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 360bbb-2 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
Sec. 360bbb-2. Classification of products
-STATUTE-
(a) Request
A person who submits an application or submission (including a
petition, notification, and any other similar form of request)
under this chapter for a product, may submit a request to the
Secretary respecting the classification of the product as a drug,
biological product, device, or a combination product subject to
section 353(g) of this title or respecting the component of the
Food and Drug Administration that will regulate the product. In
submitting the request, the person shall recommend a classification
for the product, or a component to regulate the product, as
appropriate.
(b) Statement
Not later than 60 days after the receipt of the request described
in subsection (a) of this section, the Secretary shall determine
the classification of the product under subsection (a) of this
section, or the component of the Food and Drug Administration that
will regulate the product, and shall provide to the person a
written statement that identifies such classification or such
component, and the reasons for such determination. The Secretary
may not modify such statement except with the written consent of
the person, or for public health reasons based on scientific
evidence.
(c) Inaction of Secretary
If the Secretary does not provide the statement within the 60-day
period described in subsection (b) of this section, the
recommendation made by the person under subsection (a) of this
section shall be considered to be a final determination by the
Secretary of such classification of the product, or the component
of the Food and Drug Administration that will regulate the product,
as applicable, and may not be modified by the Secretary except with
the written consent of the person, or for public health reasons
based on scientific evidence.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 563, as added Pub. L. 105-115, title
IV, Sec. 416, Nov. 21, 1997, 111 Stat. 2378.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 360bbb-3 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
Sec. 360bbb-3. Authorization for medical products for use in
emergencies
-STATUTE-
(a) In general
(1) Emergency uses
Notwithstanding sections 355, 360(k), and 360e of this title
and section 262 of title 42, and subject to the provisions of
this section, the Secretary may authorize the introduction into
interstate commerce, during the effective period of a declaration
under subsection (b) of this section, of a drug, device, or
biological product intended for use in an actual or potential
emergency (referred to in this section as an "emergency use").
(2) Approval status of product
An authorization under paragraph (1) may authorize an emergency
use of a product that -
(A) is not approved, licensed, or cleared for commercial
distribution under a provision of law referred to in such
paragraph (referred to in this section as an "unapproved
product"); or
(B) is approved, licensed, or cleared under such a provision,
but which use is not under such provision an approved,
licensed, or cleared use of the product (referred to in this
section as an "unapproved use of an approved product").
(3) Relation to other uses
An emergency use authorized under paragraph (1) for a product
is in addition to any other use that is authorized for the
product under a provision of law referred to in such paragraph.
(4) Definitions
For purposes of this section:
(A) The term "biological product" has the meaning given such
term in section 262 of title 42.
(B) The term "emergency use" has the meaning indicated for
such term in paragraph (1).
(C) The term "product" means a drug, device, or biological
product.
(D) The term "unapproved product" has the meaning indicated
for such term in paragraph (2)(A).
(E) The term "unapproved use of an approved product" has the
meaning indicated for such term in paragraph (2)(B).
(b) Declaration of emergency
(1) In general
The Secretary may declare an emergency justifying the
authorization under this subsection for a product on the basis of
-
(A) a determination by the Secretary of Homeland Security
that there is a domestic emergency, or a significant potential
for a domestic emergency, involving a heightened risk of attack
with a specified biological, chemical, radiological, or nuclear
agent or agents;
(B) a determination by the Secretary of Defense that there is
a military emergency, or a significant potential for a military
emergency, involving a heightened risk to United States
military forces of attack with a specified biological,
chemical, radiological, or nuclear agent or agents; or
(C) a determination by the Secretary of a public health
emergency under section 247d of title 42 that affects, or has a
significant potential to affect, national security, and that
involves a specified biological, chemical, radiological, or
nuclear agent or agents, or a specified disease or condition
that may be attributable to such agent or agents.
(2) Termination of declaration
(A) In general
A declaration under this subsection shall terminate upon the
earlier of -
(i) a determination by the Secretary, in consultation as
appropriate with the Secretary of Homeland Security or the
Secretary of Defense, that the circumstances described in
paragraph (1) have ceased to exist; or
(ii) the expiration of the one-year period beginning on the
date on which the declaration is made.
(B) Renewal
Notwithstanding subparagraph (A), the Secretary may renew a
declaration under this subsection, and this paragraph shall
apply to any such renewal.
(C) Disposition of product
If an authorization under this section with respect to an
unapproved product ceases to be effective as a result of a
termination under subparagraph (A) of this paragraph, the
Secretary shall consult with the manufacturer of such product
with respect to the appropriate disposition of the product.
(3) Advance notice of termination
The Secretary shall provide advance notice that a declaration
under this subsection will be terminated. The period of advance
notice shall be a period reasonably determined to provide -
(A) in the case of an unapproved product, a sufficient period
for disposition of the product, including the return of such
product (except such quantities of product as are necessary to
provide for continued use consistent with subsection (f)(2) of
this section) to the manufacturer (in the case of a
manufacturer that chooses to have such product returned); and
(B) in the case of an unapproved use of an approved product,
a sufficient period for the disposition of any labeling, or any
information under subsection (e)(2)(B)(ii) of this section, as
the case may be, that was provided with respect to the
emergency use involved.
(4) Publication
The Secretary shall promptly publish in the Federal Register
each declaration, determination, advance notice of termination,
and renewal under this subsection.
(c) Criteria for issuance of authorization
The Secretary may issue an authorization under this section with
respect to the emergency use of a product only if, after
consultation with the Director of the National Institutes of Health
and the Director of the Centers for Disease Control and Prevention
(to the extent feasible and appropriate given the circumstances of
the emergency involved), the Secretary concludes -
(1) that an agent specified in a declaration under subsection
(b) of this section can cause a serious or life-threatening
disease or condition;
(2) that, based on the totality of scientific evidence
available to the Secretary, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to
believe that -
(A) the product may be effective in diagnosing, treating, or
preventing -
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition
caused by a product authorized under this section, approved
or cleared under this chapter, or licensed under section 262
of title 42, for diagnosing, treating, or preventing such a
disease or condition caused by such an agent; and
(B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product;
(3) that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or
treating such disease or condition; and
(4) that such other criteria as the Secretary may by regulation
prescribe are satisfied.
(d) Scope of authorization
An authorization of a product under this section shall state -
(1) each disease or condition that the product may be used to
diagnose, prevent, or treat within the scope of the
authorization;
(2) the Secretary's conclusions, made under subsection
(c)(2)(B) of this section, that the known and potential benefits
of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of
the product; and
(3) the Secretary's conclusions, made under subsection (c) of
this section, concerning the safety and potential effectiveness
of the product in diagnosing, preventing, or treating such
diseases or conditions, including an assessment of the available
scientific evidence.
(e) Conditions of authorization
(1) Unapproved product
(A) Required conditions
With respect to the emergency use of an unapproved product,
the Secretary, to the extent practicable given the
circumstances of the emergency, shall, for a person who carries
out any activity for which the authorization is issued,
establish such conditions on an authorization under this
section as the Secretary finds necessary or appropriate to
protect the public health, including the following:
(i) Appropriate conditions designed to ensure that health
care professionals administering the product are informed -
(I) that the Secretary has authorized the emergency use
of the product;
(II) of the significant known and potential benefits and
risks of the emergency use of the product, and of the
extent to which such benefits and risks are unknown; and
(III) of the alternatives to the product that are
available, and of their benefits and risks.
(ii) Appropriate conditions designed to ensure that
individuals to whom the product is administered are informed -
(I) that the Secretary has authorized the emergency use
of the product;
(II) of the significant known and potential benefits and
risks of such use, and of the extent to which such benefits
and risks are unknown; and
(III) of the option to accept or refuse administration of
the product, of the consequences, if any, of refusing
administration of the product, and of the alternatives to
the product that are available and of their benefits and
risks.
(iii) Appropriate conditions for the monitoring and
reporting of adverse events associated with the emergency use
of the product.
(iv) For manufacturers of the product, appropriate
conditions concerning recordkeeping and reporting, including
records access by the Secretary, with respect to the
emergency use of the product.
(B) Authority for additional conditions
With respect to the emergency use of an unapproved product,
the Secretary may, for a person who carries out any activity
for which the authorization is issued, establish such
conditions on an authorization under this section as the
Secretary finds necessary or appropriate to protect the public
health, including the following:
(i) Appropriate conditions on which entities may distribute
the product with respect to the emergency use of the product
(including limitation to distribution by government
entities), and on how distribution is to be performed.
(ii) Appropriate conditions on who may administer the
product with respect to the emergency use of the product, and
on the categories of individuals to whom, and the
circumstances under which, the product may be administered
with respect to such use.
(iii) Appropriate conditions with respect to the collection
and analysis of information, during the period when the
authorization is in effect, concerning the safety and
effectiveness of the product with respect to the emergency
use of such product.
(iv) For persons other than manufacturers of the product,
appropriate conditions concerning recordkeeping and
reporting, including records access by the Secretary, with
respect to the emergency use of the product.
(2) Unapproved use
With respect to the emergency use of a product that is an
unapproved use of an approved product:
(A) For a manufacturer of the product who carries out any
activity for which the authorization is issued, the Secretary
shall, to the extent practicable given the circumstances of the
emergency, establish conditions described in clauses (i) and
(ii) of paragraph (1)(A), and may establish conditions
described in clauses (iii) and (iv) of such paragraph.
(B)(i) If the authorization under this section regarding the
emergency use authorizes a change in the labeling of the
product, but the manufacturer of the product chooses not to
make such change, such authorization may not authorize
distributors of the product or any other person to alter or
obscure the labeling provided by the manufacturer.
(ii) In the circumstances described in clause (i), for a
person who does not manufacture the product and who chooses to
act under this clause, an authorization under this section
regarding the emergency use shall, to the extent practicable
given the circumstances of the emergency, authorize such person
to provide appropriate information with respect to such product
in addition to the labeling provided by the manufacturer,
subject to compliance with clause (i). While the authorization
under this section is effective, such additional information
shall not be considered labeling for purposes of section 352 of
this title.
(C) The Secretary may establish with respect to the
distribution and administration of the product for the
unapproved use conditions no more restrictive than those
established by the Secretary with respect to the distribution
and administration of the product for the approved use.
(3) Good manufacturing practice
With respect to the emergency use of a product for which an
authorization under this section is issued (whether an unapproved
product or an unapproved use of an approved product), the
Secretary may waive or limit, to the extent appropriate given the
circumstances of the emergency, requirements regarding current
good manufacturing practice otherwise applicable to the
manufacture, processing, packing, or holding of products subject
to regulation under this chapter, including such requirements
established under section 351 of this title.
(4) Advertising
The Secretary may establish conditions on advertisements and
other promotional descriptive printed matter that relate to the
emergency use of a product for which an authorization under this
section is issued (whether an unapproved product or an unapproved
use of an approved product), including, as appropriate -
(A) with respect to drugs and biological products,
requirements applicable to prescription drugs pursuant to
section 352(n) of this title; or
(B) with respect to devices, requirements applicable to
restricted devices pursuant to section 352(r) of this title.
(f) Duration of authorization
(1) In general
Except as provided in paragraph (2), an authorization under
this section shall be effective until the earlier of the
termination of the declaration under subsection (b) of this
section or a revocation under subsection (g) of this section.
(2) Continued use after end of effective period
Notwithstanding the termination of the declaration under
subsection (b) of this section or a revocation under subsection
(g) of this section, an authorization shall continue to be
effective to provide for continued use of an unapproved product
with respect to a patient to whom it was administered during the
period described by paragraph (1), to the extent found necessary
by such patient's attending physician.
(g) Revocation of authorization
(1) Review
The Secretary shall periodically review the circumstances and
the appropriateness of an authorization under this section.
(2) Revocation
The Secretary may revoke an authorization under this section if
the criteria under subsection (c) of this section for issuance of
such authorization are no longer met or other circumstances make
such revocation appropriate to protect the public health or
safety.
(h) Publication; confidential information
(1) Publication
The Secretary shall promptly publish in the Federal Register a
notice of each authorization, and each termination or revocation
of an authorization under this section, and an explanation of the
reasons therefor (which may include a summary of data or
information that has been submitted to the Secretary in an
application under section 355(i) of this title or section 360j(g)
of this title, even if such summary may indirectly reveal the
existence of such application).
(2) Confidential information
Nothing in this section alters or amends section 1905 of title
18 or section 552(b)(4) of title 5.
(i) Actions committed to agency discretion
Actions under the authority of this section by the Secretary, by
the Secretary of Defense, or by the Secretary of Homeland Security
are committed to agency discretion.
(j) Rules of construction
The following applies with respect to this section:
(1) Nothing in this section impairs the authority of the
President as Commander in Chief of the Armed Forces of the United
States under article II, section 2 of the United States
Constitution.
(2) Nothing in this section impairs the authority of the
Secretary of Defense with respect to the Department of Defense,
including the armed forces, under other provisions of Federal
law.
(3) Nothing in this section (including any exercise of
authority by a manufacturer under subsection (e)(2)) impairs the
authority of the United States to use or manage quantities of a
product that are owned or controlled by the United States
(including quantities in the stockpile maintained under section
247d-6b of title 42).
(k) Relation to other provisions
If a product is the subject of an authorization under this
section, the use of such product within the scope of the
authorization shall not be considered to constitute a clinical
investigation for purposes of section 355(i) of this title, section
360j(g) of this title, or any other provision of this chapter or
section 262 of title 42.
(l) Option to carry out authorized activities
Nothing in this section provides the Secretary any authority to
require any person to carry out any activity that becomes lawful
pursuant to an authorization under this section, and no person is
required to inform the Secretary that the person will not be
carrying out such activity, except that a manufacturer of a sole-
source unapproved product authorized for emergency use shall
report to the Secretary within a reasonable period of time after
the issuance by the Secretary of such authorization if such
manufacturer does not intend to carry out any activity under the
authorization. This section only has legal effect on a person who
carries out an activity for which an authorization under this
section is issued. This section does not modify or affect
activities carried out pursuant to other provisions of this chapter
or section 262 of title 42. Nothing in this subsection may be
construed as restricting the Secretary from imposing conditions on
persons who carry out any activity pursuant to an authorization
under this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 564, as added Pub. L. 108-136, div.
A, title XVI, Sec. 1603(a), Nov. 24, 2003, 117 Stat. 1684; amended
Pub. L. 108-276, Sec. 4(a), July 21, 2004, 118 Stat. 853.)
-MISC1-
AMENDMENTS
2004 - Pub. L. 108-276 amended section generally, substituting
provisions of subsecs. (a) to (l) for similar former provisions,
except for additional provisions in subsec. (b)(1) allowing
Secretary to authorize use of medical products in actual or
potential domestic and public health emergencies in addition to
actual or potential military emergencies.
-End-
-CITE-
21 USC Sec. 360bbb-4 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part E - General Provisions Relating to Drugs and Devices
-HEAD-
Sec. 360bbb-4. Technical assistance
-STATUTE-
The Secretary, in consultation with the Commissioner of Food and
Drugs, shall establish within the Food and Drug Administration a
team of experts on manufacturing and regulatory activities
(including compliance with current Good Manufacturing Practice) to
provide both off-site and on-site technical assistance to the
manufacturers of qualified countermeasures (as defined in section
247d-6a of title 42), security countermeasures (as defined in
section 247d-6b of title 42), or vaccines, at the request of such a
manufacturer and at the discretion of the Secretary, if the
Secretary determines that a shortage or potential shortage may
occur in the United States in the supply of such vaccines or
countermeasures and that the provision of such assistance would be
beneficial in helping alleviate or avert such shortage.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 565, as added Pub. L. 109-417, title
IV, Sec. 404, Dec. 19, 2006, 120 Stat. 2875.)
-End-
-CITE-
21 USC Part F - New Animal Drugs for Minor Use and Minor
Species 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part F - New Animal Drugs for Minor Use and Minor Species
-HEAD-
PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
-End-
-CITE-
21 USC Sec. 360ccc 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part F - New Animal Drugs for Minor Use and Minor Species
-HEAD-
Sec. 360ccc. Conditional approval of new animal drugs for minor use
and minor species
-STATUTE-
(a) Application requirements; contents; restrictions
(1) Except as provided in paragraph (3) of this section,(!1) any
person may file with the Secretary an application for conditional
approval of a new animal drug intended for a minor use or a minor
species. Such an application may not be a supplement to an
application approved under section 360b of this title. Such
application must comply in all respects with the provisions of
section 360b of this title except sections 360b(a)(4), 360b(b)(2),
360b(c)(1), 360b(c)(2), 360b(c)(3), 360b(d)(1), 360b(e), 360b(h),
and 360b(n) of this title unless otherwise stated in this section,
and any additional provisions of this section. New animal drugs are
subject to application of the same safety standards that would be
applied to such drugs under section 360b(d) of this title
(including, for antimicrobial new animal drugs, with respect to
antimicrobial resistance).
(2) The applicant shall submit to the Secretary as part of an
application for the conditional approval of a new animal drug -
(A) all information necessary to meet the requirements of
section 360b(b)(1) of this title except section 360b(b)(1)(A) of
this title;
(B) full reports of investigations which have been made to show
whether or not such drug is safe under section 360b(d) of this
title (including, for an antimicrobial new animal drug, with
respect to antimicrobial resistance) and there is a reasonable
expectation of effectiveness for use;
(C) data for establishing a conditional dose;
(D) projections of expected need and the justification for that
expectation based on the best information available;
(E) information regarding the quantity of drug expected to be
distributed on an annual basis to meet the expected need; and
(F) a commitment that the applicant will conduct additional
investigations to meet the requirements for the full
demonstration of effectiveness under section 360b(d)(1)(E) of
this title within 5 years.
(3) A person may not file an application under paragraph (1) if -
(A) the application seeks conditional approval of a new animal
drug that is contained in, or is a product of, a transgenic
animal.(!2)
(B) the person has previously filed an application for
conditional approval under paragraph (1) for the same drug in the
same dosage form for the same intended use whether or not
subsequently conditionally approved by the Secretary under
subsection (b) of this section, or
(C) the person obtained the application, or data or other
information contained therein, directly or indirectly from the
person who filed for conditional approval under paragraph (1) for
the same drug in the same dosage form for the same intended use
whether or not subsequently conditionally approved by the
Secretary under subsection (b) of this section.
(b) Order of approval or hearing
Within 180 days after the filing of an application pursuant to
subsection (a) of this section, or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary shall
either -
(1) issue an order, effective for one year, conditionally
approving the application if the Secretary finds that none of the
grounds for denying conditional approval, specified in subsection
(c) of this section applies and publish a Federal Register notice
of the conditional approval, or
(2) give the applicant notice of an opportunity for an informal
hearing on the question whether such application can be
conditionally approved.
(c) Order of approval or refusal after hearing
If the Secretary finds, after giving the applicant notice and an
opportunity for an informal hearing, that -
(1) any of the provisions of section 360b(d)(1)(A) through (D)
or (F) through (I) of this title are applicable;
(2) the information submitted to the Secretary as part of the
application and any other information before the Secretary with
respect to such drug, is insufficient to show that there is a
reasonable expectation that the drug will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the proposed labeling
thereof; or
(3) another person has received approval under section 360b of
this title for the same drug in the same dosage form for the same
intended use, and that person is able to assure the availability
of sufficient quantities of the drug to meet the needs for which
the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and opportunity for
an informal hearing, the Secretary finds that paragraphs (1)
through (3) do not apply, the Secretary shall issue an order
conditionally approving the application effective for one year and
publish a Federal Register notice of the conditional approval. Any
order issued under this subsection refusing to conditionally
approve an application shall state the findings upon which it is
based.
(d) Effective period; renewal; refusal of renewal
A conditional approval under this section is effective for a 1-
year period and is thereafter renewable by the Secretary annually
for up to 4 additional 1-year terms. A conditional approval shall
be in effect for no more than 5 years from the date of approval
under subsection (b)(1) or (c) of this section unless extended as
provided for in subsection (h) of this section. The following shall
also apply:
(1) No later than 90 days from the end of the 1-year period for
which the original or renewed conditional approval is effective,
the applicant may submit a request to renew a conditional
approval for an additional 1-year term.
(2) A conditional approval shall be deemed renewed at the end
of the 1-year period, or at the end of a 90-day extension that
the Secretary may, at the Secretary's discretion, grant by letter
in order to complete review of the renewal request, unless the
Secretary determines before the expiration of the 1-year period
or the 90-day extension that -
(A) the applicant failed to submit a timely renewal request;
(B) the request fails to contain sufficient information to
show that -
(i) the applicant is making sufficient progress toward
meeting approval requirements under section 360b(d)(1)(E) of
this title, and is likely to be able to fulfill those
requirements and obtain an approval under section 360b of
this title before the expiration of the 5-year maximum term
of the conditional approval;
(ii) the quantity of the drug that has been distributed is
consistent with the conditionally approved intended use and
conditions of use, unless there is adequate explanation that
ensures that the drug is only used for its intended purpose;
or
(iii) the same drug in the same dosage form for the same
intended use has not received approval under section 360b of
this title, or if such a drug has been approved, that the
holder of the approved application is unable to assure the
availability of sufficient quantities of the drug to meet the
needs for which the drug is intended; or
(C) any of the provisions of section 360b(e)(1)(A) through
(B) or (D) through (F) of this title are applicable.
(3) If the Secretary determines before the end of the 1-year
period or the 90-day extension, if granted, that a conditional
approval should not be renewed, the Secretary shall issue an
order refusing to renew the conditional approval, and such
conditional approval shall be deemed withdrawn and no longer in
effect. The Secretary shall thereafter provide an opportunity for
an informal hearing to the applicant on the issue whether the
conditional approval shall be reinstated.
(e) Withdrawal of conditional approval
(1) The Secretary shall issue an order withdrawing conditional
approval of an application filed pursuant to subsection (a) of this
section if the Secretary finds that another person has received
approval under section 360b of this title for the same drug in the
same dosage form for the same intended use and that person is able
to assure the availability of sufficient quantities of the drug to
meet the needs for which the drug is intended.
(2) The Secretary shall, after due notice and opportunity for an
informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection
(a) of this section if the Secretary finds that -
(A) any of the provisions of section 360b(e)(1)(A) through (B)
or (D) through (F) of this title are applicable; or
(B) on the basis of new information before the Secretary with
respect to such drug, evaluated together with the evidence
available to the Secretary when the application was conditionally
approved, that there is not a reasonable expectation that such
drug will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or suggested
in the labeling thereof.
(3) The Secretary may also, after due notice and opportunity for
an informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection
(a) of this section if the Secretary finds that any of the
provisions of section 360b(e)(2) of this title are applicable.
(f) Labeling
(1) The label and labeling of a new animal drug with a
conditional approval under this section shall -
(A) bear the statement, "conditionally approved by FDA pending
a full demonstration of effectiveness under application number";
and
(B) contain such other information as prescribed by the
Secretary.
(2) An intended use that is the subject of a conditional approval
under this section shall not be included in the same product label
with any intended use approved under section 360b of this title.
(g) Amendment of application
A conditionally approved new animal drug application may not be
amended or supplemented to add indications for use.
(h) Order of approval after conditional approval period termination
180 days prior to the termination date established under
subsection (d) of this section, an applicant shall have submitted
all the information necessary to support a complete new animal drug
application in accordance with section 360b(b)(1) of this title or
the conditional approval issued under this section is no longer in
effect. Following review of this information, the Secretary shall
either -
(1) issue an order approving the application under section
360b(c) of this title if the Secretary finds that none of the
grounds for denying approval specified in section 360b(d)(1) of
this title applies, or
(2) give the applicant an opportunity for a hearing before the
Secretary under section 360b(d) of this title on the question
whether such application can be approved.
Upon issuance of an order approving the application, product
labeling and administrative records of approval shall be modified
accordingly. If the Secretary has not issued an order under section
360b(c) of this title approving such application prior to the
termination date established under subsection (d) of this section,
the conditional approval issued under this section is no longer in
effect unless the Secretary grants an extension of an additional
180-day period so that the Secretary can complete review of the
application. The decision to grant an extension is committed to the
discretion of the Secretary and not subject to judicial review.
(i) Judicial review
The decision of the Secretary under subsection (c), (d), or (e)
of this section refusing or withdrawing conditional approval of an
application shall constitute final agency action subject to
judicial review.
(j) Definition
In this section and section 360ccc-1 of this title, the term
"transgenic animal" means an animal whose genome contains a
nucleotide sequence that has been intentionally modified in vitro,
and the progeny of such an animal; Provided that the term
"transgenic animal" does not include an animal of which the
nucleotide sequence of the genome has been modified solely by
selective breeding.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 571, as added Pub. L. 108-282, title
I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 892.)
-MISC1-
FINDINGS
Pub. L. 108-282, title I, Sec. 102(a), Aug. 2, 2004, 118 Stat.
891, provided that: "Congress makes the following findings:
"(1) There is a severe shortage of approved new animal drugs
for use in minor species.
"(2) There is a severe shortage of approved new animal drugs
for treating animal diseases and conditions that occur
infrequently or in limited geographic areas.
"(3) Because of the small market shares, low-profit margins
involved, and capital investment required, it is generally not
economically feasible for new animal drug applicants to pursue
approvals for these species, diseases, and conditions.
"(4) Because the populations for which such new animal drugs
are intended may be small and conditions of animal management may
vary widely, it is often difficult to design and conduct studies
to establish drug safety and effectiveness under traditional new
animal drug approval processes.
"(5) It is in the public interest and in the interest of animal
welfare to provide for special procedures to allow the lawful use
and marketing of certain new animal drugs for minor species and
minor uses that take into account these special circumstances and
that ensure that such drugs do not endanger animal or public
health.
"(6) Exclusive marketing rights for clinical testing expenses
have helped encourage the development of 'orphan' drugs for human
use, and comparable incentives should encourage the development
of new animal drugs for minor species and minor uses."
REGULATIONS
Pub. L. 108-282, title I, Sec. 102(b)(6), Aug. 2, 2004, 118 Stat.
905, provided that: "On the date of enactment of this Act [Aug. 2,
2004], the Secretary of Health and Human Services shall implement
sections 571 and 573 of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 360ccc, 360ccc-2] and subsequently publish implementing
regulations. Not later than 12 months after the date of enactment
of this Act, the Secretary shall issue proposed regulations to
implement section 573 of the Federal Food, Drug, and Cosmetic Act
(as added by this Act), and not later than 24 months after the date
of enactment of this Act, the Secretary shall issue final
regulations implementing section 573 of the Federal Food, Drug, and
Cosmetic Act. Not later than 18 months after the date of enactment
of this Act, the Secretary shall issue proposed regulations to
implement section 572 of the Federal Food, Drug, and Cosmetic Act
(as added by this Act) [21 U.S.C. 360ccc-1], and not later than 36
months after the date of enactment of this Act, the Secretary shall
issue final regulations implementing section 572 of the Federal
Food, Drug, and Cosmetic Act. Not later than 30 months after the
date of enactment of this Act, the Secretary shall issue proposed
regulations to implement section 571 of the Federal Food, Drug, and
Cosmetic Act (as added by this Act), and not later than 42 months
after the date of enactment of this Act, the Secretary shall issue
final regulations implementing section 571 of the Federal Food,
Drug, and Cosmetic Act. These timeframes shall be extended by 12
months for each fiscal year, in which the funds authorized to be
appropriated under subsection (i) [no subsection (i) of section 102
has been enacted] are not in fact appropriated."
-FOOTNOTE-
(!1) So in original. Probably should be "this subsection,".
(!2) So in original. The period probably should be a comma.
-End-
-CITE-
21 USC Sec. 360ccc-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part F - New Animal Drugs for Minor Use and Minor Species
-HEAD-
Sec. 360ccc-1. Index of legally marketed unapproved new animal
drugs for minor species
-STATUTE-
(a) Establishment and content
(1) The Secretary shall establish an index limited to -
(A) new animal drugs intended for use in a minor species for
which there is a reasonable certainty that the animal or edible
products from the animal will not be consumed by humans or food-
producing animals; and
(B) new animal drugs intended for use only in a hatchery, tank,
pond, or other similar contained man-made structure in an early,
non-food life stage of a food-producing minor species, where
safety for humans is demonstrated in accordance with the standard
of section 360b(d) of this title (including, for an antimicrobial
new animal drug, with respect to antimicrobial resistance).
(2) The index shall not include a new animal drug that is
contained in or a product of a transgenic animal.
(b) Conferences
Any person intending to file a request under this section shall
be entitled to one or more conferences to discuss the requirements
for indexing a new animal drug.
(c) Request for determination of eligibility for inclusion in index
(1) Any person may submit a request to the Secretary for a
determination whether a new animal drug may be eligible for
inclusion in the index. Such a request shall include -
(A) information regarding the need for the new animal drug, the
species for which the new animal drug is intended, the proposed
intended use and conditions of use, and anticipated annual
distribution;
(B) information to support the conclusion that the proposed use
meets the conditions of subparagraph (A) or (B) of subsection
(a)(1) of this section;
(C) information regarding the components and composition of the
new animal drug;
(D) a description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing
of such new animal drug;
(E) an environmental assessment that meets the requirements of
the National Environmental Policy Act of 1969 [42 U.S.C. 4321 et
seq.], as amended, and as defined in 21 CFR Part 25, as it
appears on August 2, 2004, and amended thereafter or information
to support a categorical exclusion from the requirement to
prepare an environmental assessment;
(F) information sufficient to support the conclusion that the
proposed use of the new animal drug is safe under section 360b(d)
of this title with respect to individuals exposed to the new
animal drug through its manufacture or use; and
(G) such other information as the Secretary may deem necessary
to make this eligibility determination.
(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on subsection
(a)(1)(A) of this section, or 180 days for a request submitted
based on subsection (a)(1)(B) of this section, the Secretary shall
grant or deny the request, and notify the person who requested such
determination of the Secretary's decision. The Secretary shall
grant the request if the Secretary finds that -
(A) the same drug in the same dosage form for the same intended
use is not approved or conditionally approved;
(B) the proposed use of the drug meets the conditions of
subparagraph (A) or (B) of subsection (a)(1) of this section, as
appropriate;
(C) the person requesting the determination has established
appropriate specifications for the manufacture and control of the
new animal drug and has demonstrated an understanding of the
requirements of current good manufacturing practices;
(D) the new animal drug will not significantly affect the human
environment; and
(E) the new animal drug is safe with respect to individuals
exposed to the new animal drug through its manufacture or use.
If the Secretary denies the request, the Secretary shall thereafter
provide due notice and an opportunity for an informal conference. A
decision of the Secretary to deny an eligibility request following
an informal conference shall constitute final agency action subject
to judicial review.
(d) Request for addition to index
(1) With respect to a new animal drug for which the Secretary has
made a determination of eligibility under subsection (c) of this
section, the person who made such a request may ask that the
Secretary add the new animal drug to the index established under
subsection (a) of this section. The request for addition to the
index shall include -
(A) a copy of the Secretary's determination of eligibility
issued under subsection (c) of this section;
(B) a written report that meets the requirements in subsection
(d)(2) of this section;
(C) a proposed index entry;
(D) facsimile labeling;
(E) anticipated annual distribution of the new animal drug;
(F) a written commitment to manufacture the new animal drug and
animal feeds bearing or containing such new animal drug according
to current good manufacturing practices;
(G) a written commitment to label, distribute, and promote the
new animal drug only in accordance with the index entry;
(H) upon specific request of the Secretary, information
submitted to the expert panel described in paragraph (3); and
(I) any additional requirements that the Secretary may
prescribe by general regulation or specific order.
(2) The report required in paragraph (1) shall -
(A) be authored by a qualified expert panel;
(B) include an evaluation of all available target animal safety
and effectiveness information, including anecdotal information;
(C) state the expert panel's opinion regarding whether the
benefits of using the new animal drug for the proposed use in a
minor species outweigh its risks to the target animal, taking
into account the harm being caused by the absence of an approved
or conditionally approved new animal drug for the minor species
in question;
(D) include information from which labeling can be written; and
(E) include a recommendation regarding whether the new animal
drug should be limited to use under the professional supervision
of a licensed veterinarian.
(3) A qualified expert panel, as used in this section, is a panel
that -
(A) is composed of experts qualified by scientific training and
experience to evaluate the target animal safety and effectiveness
of the new animal drug under consideration;
(B) operates external to FDA; and
(C) is not subject to the Federal Advisory Committee Act.
The Secretary shall define the criteria for selection of a
qualified expert panel and the procedures for the operation of the
panel by regulation.
(4) Within 180 days after the receipt of a request for listing a
new animal drug in the index, the Secretary shall grant or deny the
request. The Secretary shall grant the request if the request for
indexing continues to meet the eligibility criteria in subsection
(a) of this section and the Secretary finds, on the basis of the
report of the qualified expert panel and other information
available to the Secretary, that the benefits of using the new
animal drug for the proposed use in a minor species outweigh its
risks to the target animal, taking into account the harm caused by
the absence of an approved or conditionally-approved new animal
drug for the minor species in question. If the Secretary denies the
request, the Secretary shall thereafter provide due notice and the
opportunity for an informal conference. The decision of the
Secretary following an informal conference shall constitute final
agency action subject to judicial review.
(e) Index contents; publication
(1) The index established under subsection (a) of this section
shall include the following information for each listed drug -
(A) the name and address of the person who holds the index
listing;
(B) the name of the drug and the intended use and conditions of
use for which it is being indexed;
(C) product labeling; and
(D) conditions and any limitations that the Secretary deems
necessary regarding use of the drug.
(2) The Secretary shall publish the index, and revise it
periodically.
(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or labeling of
indexed products.
(f) Removal from index; suspended listing
(1) If the Secretary finds, after due notice to the person who
requested the index listing and an opportunity for an informal
conference, that -
(A) the expert panel failed to meet the requirements as set
forth by the Secretary by regulation;
(B) on the basis of new information before the Secretary,
evaluated together with the evidence available to the Secretary
when the new animal drug was listed in the index, the benefits of
using the new animal drug for the indexed use do not outweigh its
risks to the target animal;
(C) the conditions of subsection (c)(2) of this section are no
longer satisfied;
(D) the manufacture of the new animal drug is not in accordance
with current good manufacturing practices;
(E) the labeling, distribution, or promotion of the new animal
drug is not in accordance with the index entry;
(F) the conditions and limitations of use associated with the
index listing have not been followed; or
(G) the request for indexing contains any untrue statement of
material fact,
the Secretary shall remove the new animal drug from the index. The
decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
(2) If the Secretary finds that there is a reasonable probability
that the use of the drug would present a risk to the health of
humans or other animals, the Secretary may -
(A) suspend the listing of such drug immediately;
(B) give the person listed in the index prompt notice of the
Secretary's action; and
(C) afford that person the opportunity for an informal
conference.
The decision of the Secretary following an informal conference
shall constitute final agency action subject to judicial review.
(g) Regulations concerning exemptions for investigational use
For purposes of indexing new animal drugs under this section, to
the extent consistent with the public health, the Secretary shall
promulgate regulations for exempting from the operation of section
360b of this title minor species new animal drugs and animal feeds
bearing or containing new animal drugs intended solely for
investigational use by experts qualified by scientific training and
experience to investigate the safety and effectiveness of minor
species animal drugs. Such regulations may, at the discretion of
the Secretary, among other conditions relating to the protection of
the public health, provide for conditioning such exemption upon the
establishment and maintenance of such records, and the making of
such reports to the Secretary, by the manufacturer or the sponsor
of the investigation of such article, of data (including but not
limited to analytical reports by investigators) obtained as a
result of such investigational use of such article, as the
Secretary finds will enable the Secretary to evaluate the safety
and effectiveness of such article in the event of the filing of a
request for an index listing pursuant to this section.
(h) Labeling contents
The labeling of a new animal drug that is the subject of an index
listing shall state, prominently and conspicuously -
(1) "Not approved by fda. - Legally marketed as an FDA indexed
product. Extra-label use is prohibited.";
(2) except in the case of new animal drugs indexed for use in
an early life stage of a food-producing animal, "This product is
not to be used in animals intended for use as food for humans or
other animals."; and
(3) such other information as may be prescribed by the
Secretary in the index listing.
(i) Records and reports
(1) In the case of any new animal drug for which an index listing
pursuant to subsection (a) of this section is in effect, the person
who has an index listing shall establish and maintain such records,
and make such reports to the Secretary, of data relating to
experience, and other data or information, received or otherwise
obtained by such person with respect to such drug, or with respect
to animal feeds bearing or containing such drug, as the Secretary
may by general regulation, or by order with respect to such
listing, prescribe on the basis of a finding that such records and
reports are necessary in order to enable the Secretary to
determine, or facilitate a determination, whether there is or may
be ground for invoking subsection (f) of this section. Such
regulation or order shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the persons
to whom such regulation or order is applicable, of similar
information received or otherwise obtained by the Secretary.
(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
(j) Public disclosure of safety and effectiveness data
(1) Safety and effectiveness data and information which has been
submitted in support of a request for a new animal drug to be
indexed under this section and which has not been previously
disclosed to the public shall be made available to the public, upon
request, unless extraordinary circumstances are shown -
(A) if no work is being or will be undertaken to have the drug
indexed in accordance with the request,
(B) if the Secretary has determined that such drug cannot be
indexed and all legal appeals have been exhausted,
(C) if the indexing of such drug is terminated and all legal
appeals have been exhausted, or
(D) if the Secretary has determined that such drug is not a new
animal drug.
(2) Any request for data and information pursuant to paragraph
(1) shall include a verified statement by the person making the
request that any data or information received under such paragraph
shall not be disclosed by such person to any other person -
(A) for the purpose of, or as part of a plan, scheme, or device
for, obtaining the right to make, use, or market, or making,
using, or marketing, outside the United States, the drug
identified in the request for indexing; and
(B) without obtaining from any person to whom the data and
information are disclosed an identical verified statement, a copy
of which is to be provided by such person to the Secretary, which
meets the requirements of this paragraph.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 572, as added Pub. L. 108-282, title
I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 896.)
-REFTEXT-
REFERENCES IN TEXT
The National Environmental Policy Act of 1969, referred to in
subsec. (c)(1)(E), is Pub. L. 91-190, Jan. 1, 1970, 83 Stat. 852,
as amended, which is classified generally to chapter 55 (Sec. 4321
et seq.) of Title 42, The Public Health and Welfare. For complete
classification of this Act to the Code, see Short Title note set
out under section 4321 of Title 42 and Tables.
The Federal Advisory Committee Act, referred to in subsec.
(d)(3)(C), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
amended, which is set out in the Appendix to Title 5, Government
Organization and Employees.
-End-
-CITE-
21 USC Sec. 360ccc-2 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V - DRUGS AND DEVICES
Part F - New Animal Drugs for Minor Use and Minor Species
-HEAD-
Sec. 360ccc-2. Designated new animal drugs for minor use or minor
species
-STATUTE-
(a) Designation
(1) The manufacturer or the sponsor of a new animal drug for a
minor use or use in a minor species may request that the Secretary
declare that drug a "designated new animal drug". A request for
designation of a new animal drug shall be made before the
submission of an application under section 360b(b) of this title or
section 360ccc of this title for the new animal drug.
(2) The Secretary may declare a new animal drug a "designated new
animal drug" if -
(A) it is intended for a minor use or use in a minor species;
and
(B) the same drug in the same dosage form for the same intended
use is not approved under section 360b or 360ccc of this title or
designated under this section at the time the request is made.
(3) Regarding the termination of a designation -
(A) the sponsor of a new animal drug shall notify the Secretary
of any decision to discontinue active pursuit of approval under
section 360b or 360ccc of this title of an application for a
designated new animal drug. The Secretary shall terminate the
designation upon such notification;
(B) the Secretary may also terminate designation if the
Secretary independently determines that the sponsor is not
actively pursuing approval under section 360b or 360ccc of this
title with due diligence;
(C) the sponsor of an approved designated new animal drug shall
notify the Secretary of any discontinuance of the manufacture of
such new animal drug at least one year before discontinuance. The
Secretary shall terminate the designation upon such notification;
and
(D) the designation shall terminate upon the expiration of any
applicable exclusivity period under subsection (c) of this
section.
(4) Notice respecting the designation or termination of
designation of a new animal drug shall be made available to the
public.
(b) Grants and contracts for development of designated new animal
drugs
(1) The Secretary may make grants to and enter into contracts
with public and private entities and individuals to assist in
defraying the costs of qualified safety and effectiveness testing
expenses and manufacturing expenses incurred in connection with the
development of designated new animal drugs.
(2) For purposes of paragraph (1) of this section -
(A) The term "qualified safety and effectiveness testing" means
testing -
(i) which occurs after the date such new animal drug is
designated under this section and before the date on which an
application with respect to such drug is submitted under
section 360b of this title; and
(ii) which is carried out under an investigational exemption
under section 360b(j) of this title.
(B) The term "manufacturing expenses" means expenses incurred
in developing processes and procedures associated with
manufacture of the designated new animal drug which occur after
the new animal drug is designated under this section and before
the date on which an application with respect to such new animal
drug is submitted under section 360b or 360ccc of this title.
(c) Exclusivity for designated new animal drugs
(1) Except as provided in subsection (c)(2) of this section, if
the Secretary approves or conditionally approves an application for
a designated new animal drug, the Secretary may not approve or
conditionally approve another application submitted for such new
animal drug with the same intended use as the designated new animal
drug for another applicant before the expiration of seven years
from the date of approval or conditional approval of the
application.
(2) If an application filed pursuant to section 360b of this
title or section 360ccc of this title is approved for a designated
new animal drug, the Secretary may, during the 7-year exclusivity
period beginning on the date of the application approval or
conditional approval, approve or conditionally approve another
application under section 360b of this title or section 360ccc of
this title for such drug for such minor use or minor species for
another applicant if -
(A) the Secretary finds, after providing the holder of such an
approved application notice and opportunity for the submission of
views, that in the granted exclusivity period the holder of the
approved application cannot assure the availability of sufficient
quantities of the drug to meet the needs for which the drug was
designated; or
(B) such holder provides written consent to the Secretary for
the approval or conditional approval of other applications before
the expiration of such exclusivity period.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 573, as added Pub. L. 108-282, title
I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 900.)
-End-
-CITE-
21 USC SUBCHAPTER VI - COSMETICS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VI - COSMETICS
-HEAD-
SUBCHAPTER VI - COSMETICS
-End-
-CITE-
21 USC Sec. 361 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VI - COSMETICS
-HEAD-
Sec. 361. Adulterated cosmetics
-STATUTE-
A cosmetic shall be deemed to be adulterated -
(a) If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the
conditions of use prescribed in the labeling thereof, or under such
conditions of use as are customary or usual, except that this
provision shall not apply to coal-tar hair dye, the label of which
bears the following legend conspicuously displayed thereon:
"Caution - This product contains ingredients which may cause skin
irritation on certain individuals and a preliminary test according
to accompanying directions should first be made. This product must
not be used for dyeing the eyelashes or eyebrows; to do so may
cause blindness.", and the labeling of which bears adequate
directions for such preliminary testing. For the purposes of this
paragraph and paragraph (e) the term "hair dye" shall not include
eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or
decomposed substance.
(c) If it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health.
(e) If it is not a hair dye and it is, or it bears or contains, a
color additive which is unsafe within the meaning of section
379e(a) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 601, 52 Stat. 1054; Pub. L. 86-618,
title I, Sec. 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102-
571, title I, Sec. 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
103-80, Sec. 3(x), Aug. 13, 1993, 107 Stat. 778.)
-MISC1-
AMENDMENTS
1993 - Subsec. (a). Pub. L. 103-80 substituted "usual, except
that this" for "usual: Provided, That this".
1992 - Par. (e). Pub. L. 102-571 substituted "379e(a)" for
"376(a)".
1960 - Par. (e). Pub. L. 86-618 substituted "and it is, or it
bears or contains, a color additive which is unsafe within the
meaning of section 376(a) of this title" for "and it bears or
contains a coal-tar color other than one from a batch that has been
certified in accordance with regulations as provided by section 364
of this title".
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
53 Stat. 853, set out as an Effective Date; Postponement in Certain
Cases note under section 301 of this title.
EFFECTIVE DATE
Section effective twelve months after June 25, 1938, except par.
(a), which, with certain exceptions, became effective on June 25,
1938, see section 902(a) of act June 25, 1938, set out as a note
under section 301 of this title.
-End-
-CITE-
21 USC Sec. 362 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VI - COSMETICS
-HEAD-
Sec. 362. Misbranded cosmetics
-STATUTE-
A cosmetic shall be deemed to be misbranded -
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count: Provided,
That under clause (2) of this paragraph reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or
under authority of this chapter to appear on the label or labeling
is not prominently placed thereon with such conspicuousness (as
compared with other words, statements, designs, or devices, in the
labeling) and in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(d) If its container is so made, formed, or filled as to be
misleading.
(e) If it is a color additive, unless its packaging and labeling
are in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in
regulations issued under section 379e of this title. This paragraph
shall not apply to packages of color additives which, with respect
to their use for cosmetics, are marketed and intended for use only
in or on hair dyes (as defined in the last sentence of section
361(a) of this title).
(f) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 602, 52 Stat. 1054; Pub. L. 86-618,
title I, Sec. 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91-
601, Sec. 6(f), formerly Sec. 7(f), Dec. 30, 1970, 84 Stat. 1673,
renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
95 Stat. 716; Pub. L. 102-571, title I, Sec. 107(12), Oct. 29,
1992, 106 Stat. 4499.)
-MISC1-
AMENDMENTS
1992 - Par. (e). Pub. L. 102-571 substituted "379e" for "376".
1970 - Par. (f). Pub. L. 91-601 added par. (f).
1960 - Par. (e). Pub. L. 86-618 added par. (e).
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (b) effective Jan. 1, 1940, and such subsection effective
July 1, 1940, as provided by regulations for certain lithographed
labeling and containers bearing certain labeling, see act June 23,
1939, ch. 242, 53 Stat. 853, set out as an Effective Date;
Postponement in Certain Cases note under section 301 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 363 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VI - COSMETICS
-HEAD-
Sec. 363. Regulations making exemptions
-STATUTE-
The Secretary shall promulgate regulations exempting from any
labeling requirement of this chapter cosmetics which are, in
accordance with the practice of the trade, to be processed,
labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition
that such cosmetics are not adulterated or misbranded under the
provisions of this chapter upon removal from such processing,
labeling, or repacking establishment.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 603, 52 Stat. 1054.)
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 364 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VI - COSMETICS
-HEAD-
Sec. 364. Repealed.
-MISC1-
Sec. 364. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(3), July
12, 1960, 74 Stat. 398.
Section, act June 25, 1938, ch. 675, Sec. 604, 52 Stat. 1055,
directed Secretary to promulgate regulations for listing of coal-
tar colors for cosmetics. See section 379e of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective July 12, 1960, subject to the provisions of
section 203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618,
set out as an Effective Date of 1960 Amendment note under section
379e of this title.
-End-
-CITE-
21 USC SUBCHAPTER VII - GENERAL AUTHORITY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
-HEAD-
SUBCHAPTER VII - GENERAL AUTHORITY
-End-
-CITE-
21 USC Part A - General Administrative Provisions 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
PART A - GENERAL ADMINISTRATIVE PROVISIONS
-End-
-CITE-
21 USC Sec. 371 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 371. Regulations and hearings
-STATUTE-
(a) Authority to promulgate regulations
The authority to promulgate regulations for the efficient
enforcement of this chapter, except as otherwise provided in this
section, is vested in the Secretary.
(b) Regulations for imports and exports
The Secretary of the Treasury and the Secretary of Health and
Human Services shall jointly prescribe regulations for the
efficient enforcement of the provisions of section 381 of this
title, except as otherwise provided therein. Such regulations shall
be promulgated in such manner and take effect at such time, after
due notice, as the Secretary of Health and Human Services shall
determine.
(c) Conduct of hearings
Hearings authorized or required by this chapter shall be
conducted by the Secretary or such officer or employee as he may
designate for the purpose.
(d) Effectiveness of definitions and standards of identity
The definitions and standards of identity promulgated in
accordance with the provisions of this chapter shall be effective
for the purposes of the enforcement of this chapter,
notwithstanding such definitions and standards as may be contained
in other laws of the United States and regulations promulgated
thereunder.
(e) Procedure for establishment
(1) Any action for the issuance, amendment, or repeal of any
regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or
(h) of this title, and any action for the amendment or repeal of
any definition and standard of identity under section 341 of this
title for any dairy product (including products regulated under
parts 131, 133 and 135 of title 21, Code of Federal Regulations)
shall be begun by a proposal made (A) by the Secretary on his own
initiative, or (B) by petition of any interested person, showing
reasonable grounds therefor, filed with the Secretary. The
Secretary shall publish such proposal and shall afford all
interested persons an opportunity to present their views thereon,
orally or in writing. As soon as practicable thereafter, the
Secretary shall by order act upon such proposal and shall make such
order public. Except as provided in paragraph (2), the order shall
become effective at such time as may be specified therein, but not
prior to the day following the last day on which objections may be
filed under such paragraph.
(2) On or before the thirtieth day after the date on which an
order entered under paragraph (1) is made public, any person who
will be adversely affected by such order if placed in effect may
file objections thereto with the Secretary, specifying with
particularity the provisions of the order deemed objectionable,
stating the grounds therefor, and requesting a public hearing upon
such objections. Until final action upon such objections is taken
by the Secretary under paragraph (3), the filing of such objections
shall operate to stay the effectiveness of those provisions of the
order to which the objections are made. As soon as practicable
after the time for filing objections has expired the Secretary
shall publish a notice in the Federal Register specifying those
parts of the order which have been stayed by the filing of
objections and, if no objections have been filed, stating that
fact.
(3) As soon as practicable after such request for a public
hearing, the Secretary, after due notice, shall hold such a public
hearing for the purpose of receiving evidence relevant and material
to the issues raised by such objections. At the hearing, any
interested person may be heard in person or by representative. As
soon as practicable after completion of the hearing, the Secretary
shall by order act upon such objections and make such order public.
Such order shall be based only on substantial evidence of record at
such hearing and shall set forth, as part of the order, detailed
findings of fact on which the order is based. The Secretary shall
specify in the order the date on which it shall take effect, except
that it shall not be made to take effect prior to the ninetieth day
after its publication unless the Secretary finds that emergency
conditions exist necessitating an earlier effective date, in which
event the Secretary shall specify in the order his findings as to
such conditions.
(f) Review of order
(1) In a case of actual controversy as to the validity of any
order under subsection (e) of this section, any person who will be
adversely affected by such order if placed in effect may at any
time prior to the ninetieth day after such order is issued file a
petition with the United States court of appeals for the circuit
wherein such person resides or has his principal place of business,
for a judicial review of such order. A copy of the petition shall
be forthwith transmitted by the clerk of the court to the Secretary
or other officer designated by him for that purpose. The Secretary
thereupon shall file in the court the record of the proceedings on
which the Secretary based his order, as provided in section 2112 of
title 28.
(2) If the petitioner applies to the court for leave to adduce
additional evidence, and shows to the satisfaction of the court
that such additional evidence is material and that there were
reasonable grounds for the failure to adduce such evidence in the
proceeding before the Secretary, the court may order such
additional evidence (and evidence in rebuttal thereof) to be taken
before the Secretary, and to be adduced upon the hearing, in such
manner and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts, or
make new findings, by reason of the additional evidence so taken,
and he shall file such modified or new findings, and his
recommendation, if any, for the modification or setting aside of
his original order, with the return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1)
of this subsection, the court shall have jurisdiction to affirm the
order, or to set it aside in whole or in part, temporarily or
permanently. If the order of the Secretary refuses to issue, amend,
or repeal a regulation and such order is not in accordance with law
the court shall by its judgment order the Secretary to take action,
with respect to such regulation, in accordance with law. The
findings of the Secretary as to the facts, if supported by
substantial evidence, shall be conclusive.
(4) The judgment of the court affirming or setting aside, in
whole or in part, any such order of the Secretary shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in section 1254 of title
28.
(5) Any action instituted under this subsection shall survive
notwithstanding any change in the person occupying the office of
Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in
addition to and not in substitution for any other remedies provided
by law.
(g) Copies of records of hearings
A certified copy of the transcript of the record and proceedings
under subsection (e) of this section shall be furnished by the
Secretary to any interested party at his request, and payment of
the costs thereof, and shall be admissible in any criminal, libel
for condemnation, exclusion of imports, or other proceeding arising
under or in respect to this chapter, irrespective of whether
proceedings with respect to the order have previously been
instituted or become final under subsection (f) of this section.
(h) Guidance documents
(1)(A) The Secretary shall develop guidance documents with public
participation and ensure that information identifying the existence
of such documents and the documents themselves are made available
to the public both in written form and, as feasible, through
electronic means. Such documents shall not create or confer any
rights for or on any person, although they present the views of the
Secretary on matters under the jurisdiction of the Food and Drug
Administration.
(B) Although guidance documents shall not be binding on the
Secretary, the Secretary shall ensure that employees of the Food
and Drug Administration do not deviate from such guidances without
appropriate justification and supervisory concurrence. The
Secretary shall provide training to employees in how to develop and
use guidance documents and shall monitor the development and
issuance of such documents.
(C) For guidance documents that set forth initial interpretations
of a statute or regulation, changes in interpretation or policy
that are of more than a minor nature, complex scientific issues, or
highly controversial issues, the Secretary shall ensure public
participation prior to implementation of guidance documents, unless
the Secretary determines that such prior public participation is
not feasible or appropriate. In such cases, the Secretary shall
provide for public comment upon implementation and take such
comment into account.
(D) For guidance documents that set forth existing practices or
minor changes in policy, the Secretary shall provide for public
comment upon implementation.
(2) In developing guidance documents, the Secretary shall ensure
uniform nomenclature for such documents and uniform internal
procedures for approval of such documents. The Secretary shall
ensure that guidance documents and revisions of such documents are
properly dated and indicate the nonbinding nature of the documents.
The Secretary shall periodically review all guidance documents and,
where appropriate, revise such documents.
(3) The Secretary, acting through the Commissioner, shall
maintain electronically and update and publish periodically in the
Federal Register a list of guidance documents. All such documents
shall be made available to the public.
(4) The Secretary shall ensure that an effective appeals
mechanism is in place to address complaints that the Food and Drug
Administration is not developing and using guidance documents in
accordance with this subsection.
(5) Not later than July 1, 2000, the Secretary after evaluating
the effectiveness of the Good Guidance Practices document,
published in the Federal Register at 62 Fed. Reg. 8961, shall
promulgate a regulation consistent with this subsection specifying
the policies and procedures of the Food and Drug Administration for
the development, issuance, and use of guidance documents.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 701, 52 Stat. 1055; June 25, 1948,
ch. 646, Sec. 32, 62 Stat. 991; Apr. 15, 1954, ch. 143, Sec. 2, 68
Stat. 55; Aug. 1, 1956, ch. 861, Sec. 2, 70 Stat. 919; Pub. L. 85-
791, Sec. 21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86-618, title
I, Sec. 103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101-535,
Sec. 8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102-300, Sec.
6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Secs. 3(y),
(dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103-396,
Sec. 3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105-115, title
IV, Sec. 405, Nov. 21, 1997, 111 Stat. 2368.)
-MISC1-
AMENDMENTS
1997 - Subsec. (h). Pub. L. 105-115 added subsec. (h).
1994 - Subsec. (e)(1). Pub. L. 103-396 which directed the
amendment of par. (1) by striking out "or maple syrup (regulated
under section 168.140 of title 21, Code of Federal Regulations).",
was executed by striking out "or maple sirup (regulated under
section 168.140 of title 21, Code of Federal Regulations)" before
"shall be begun by a proposal", to reflect the probable intent of
Congress.
1993 - Subsec. (b). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture" in two places.
Subsec. (e)(1). Pub. L. 103-80, Sec. 4(c), made technical
correction to directory language of Pub. L. 101-535, Sec. 8. See
1990 Amendment note below.
Pub. L. 103-80, Sec. 3(y)(1), struck out period after second
reference to "Regulations)".
Subsec. (f)(4). Pub. L. 103-80, Sec. 3(y)(2), substituted
reference to section 1254 of title 28 for "sections 239 and 240 of
the Judicial Code, as amended".
1992 - Subsec. (b). Pub. L. 102-300, which directed the
substitution of "Health and Human Services" for "Health, Education,
and Welfare", could not be executed because such words did not
appear in the original statutory text. See 1993 Amendment note
above and Transfer of Functions note below.
1990 - Subsec. (e)(1). Pub. L. 101-535, Sec. 8, as amended by
Pub. L. 103-80, Sec. 4(c), substituted "Any action for the
issuance, amendment, or repeal of any regulation under section
343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and
any action for the amendment or repeal of any definition and
standard of identity under section 341 of this title for any dairy
product (including products regulated under parts 131, 133 and 135
of title 21, Code of Federal Regulations) or maple sirup (regulated
under section 168.140 of title 21, Code of Federal Regulations)"
for "Any action for the issuance, amendment, or repeal of any
regulation under section 341, 343(j), 344(a), 346, 351(b), or
352(d) or (h) of this title".
1960 - Subsec. (e). Pub. L. 86-618 substituted "section 341,
343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for
"section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h),
354 or 364 of this title".
1958 - Subsec. (f)(1). Pub. L. 85-791, Sec. 21(a), substituted
provisions requiring transmission of a copy of the petition by
clerk to Secretary, and filing of the record by Secretary, for
provisions which permitted service of summons and petition any
place in United States and required Secretary to certify and file
transcript of the proceedings and record upon service.
Subsec. (f)(3). Pub. L. 85-791, Sec. 21(b), inserted "Upon the
filing of the petition referred to in paragraph (1) of this
subsection".
1956 - Subsec. (e). Act Aug. 1, 1956, simplified procedures
governing prescribing of regulations under certain provisions of
this chapter.
1954 - Subsec. (e). Act Apr. 15, 1954, struck out reference to
section 341 of this title, before "343(j)", such section 341 now
containing its own provisions with respect to hearings regarding
the establishment of food standards.
-CHANGE-
CHANGE OF NAME
Circuit Court of Appeals of the United States changed to United
States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.
-MISC2-
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter the
authority of the Secretary of Health and Human Services and the
Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
et seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
SAVINGS PROVISION
Savings clause of act Aug. 1, 1956, see note set out under
section 341 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC3-
APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS
Section 403 of Pub. L. 105-115 provided that:
"(a) Standards. - Not later than 180 days after the date of
enactment of this Act [Nov. 21, 1997], the Secretary of Health and
Human Services shall publish in the Federal Register standards for
the prompt review of supplemental applications submitted for
approved articles under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) or section 351 of the Public Health Service
Act (42 U.S.C. 262).
"(b) Guidance to Industry. - Not later than 180 days after the
date of enactment of this Act [Nov. 21, 1997], the Secretary shall
issue final guidances to clarify the requirements for, and
facilitate the submission of data to support, the approval of
supplemental applications for the approved articles described in
subsection (a). The guidances shall -
"(1) clarify circumstances in which published matter may be the
basis for approval of a supplemental application;
"(2) specify data requirements that will avoid duplication of
previously submitted data by recognizing the availability of data
previously submitted in support of an original application; and
"(3) define supplemental applications that are eligible for
priority review.
"(c) Responsibilities of Centers. - The Secretary shall designate
an individual in each center within the Food and Drug
Administration (except the Center for Food Safety and Applied
Nutrition) to be responsible for -
"(1) encouraging the prompt review of supplemental applications
for approved articles; and
"(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.
"(d) Collaboration. - The Secretary shall implement programs and
policies that will foster collaboration between the Food and Drug
Administration, the National Institutes of Health, professional
medical and scientific societies, and other persons, to identify
published and unpublished studies that may support a supplemental
application, and to encourage sponsors to make supplemental
applications or conduct further research in support of a
supplemental application based, in whole or in part, on such
studies."
HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS
Provisions of this chapter in effect prior to Apr. 15, 1954, as
applicable with respect to hearings begun prior to such date under
subsection (e) of this section, regarding food standards, see
Savings Provisions note set out under section 341 of this title.
-End-
-CITE-
21 USC Sec. 372 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 372. Examinations and investigations
-STATUTE-
(a) Authority to conduct
(1) The Secretary is authorized to conduct examinations and
investigations for the purposes of this chapter through officers
and employees of the Department or through any health, food, or
drug officer or employee of any State, Territory, or political
subdivision thereof, duly commissioned by the Secretary as an
officer of the Department.
(2)(A) In addition to the authority established in paragraph (1),
the Secretary, pursuant to a memorandum of understanding between
the Secretary and the head of another Federal department or agency,
is authorized to conduct examinations and investigations for the
purposes of this chapter through the officers and employees of such
other department or agency, subject to subparagraph (B). Such a
memorandum shall include provisions to ensure adequate training of
such officers and employees to conduct the examinations and
investigations. The memorandum of understanding shall contain
provisions regarding reimbursement. Such provisions may, at the
sole discretion of the head of the other department or agency,
require reimbursement, in whole or in part, from the Secretary for
the examinations or investigations performed under this section by
the officers or employees of the other department or agency.
(B) A memorandum of understanding under subparagraph (A) between
the Secretary and another Federal department or agency is effective
only in the case of examinations or inspections at facilities or
other locations that are jointly regulated by the Secretary and
such department or agency.
(C) For any fiscal year in which the Secretary and the head of
another Federal department or agency carries out one or more
examinations or inspections under a memorandum of understanding
under subparagraph (A), the Secretary and the head of such
department or agency shall with respect to their respective
departments or agencies submit to the committees of jurisdiction
(authorizing and appropriating) in the House of Representatives and
the Senate a report that provides, for such year -
(i) the number of officers or employees that carried out one or
more programs, projects, or activities under such memorandum;
(ii) the number of additional articles that were inspected or
examined as a result of such memorandum; and
(iii) the number of additional examinations or investigations
that were carried out pursuant to such memorandum.
(3) In the case of food packed in the Commonwealth of Puerto Rico
or a Territory the Secretary shall attempt to make inspection of
such food at the first point of entry within the United States
when, in his opinion and with due regard to the enforcement of all
the provisions of this chapter, the facilities at his disposal will
permit of such inspection.
(4) For the purposes of this subsection, the term "United States"
means the States and the District of Columbia.
(b) Availability to owner of part of analysis samples
Where a sample of a food, drug, or cosmetic is collected for
analysis under this chapter the Secretary shall, upon request,
provide a part of such official sample for examination or analysis
by any person named on the label of the article, or the owner
thereof, or his attorney or agent; except that the Secretary is
authorized, by regulations, to make such reasonable exceptions
from, and impose such reasonable terms and conditions relating to,
the operation of this subsection as he finds necessary for the
proper administration of the provisions of this chapter.
(c) Records of other departments and agencies
For purposes of enforcement of this chapter, records of any
department or independent establishment in the executive branch of
the Government shall be open to inspection by any official of the
Department duly authorized by the Secretary to make such
inspection.
(d) Information on patents for drugs
The Secretary is authorized and directed, upon request from the
Under Secretary of Commerce for Intellectual Property and Director
of the United States Patent and Trademark Office, to furnish full
and complete information with respect to such questions relating to
drugs as the Director may submit concerning any patent application.
The Secretary is further authorized, upon receipt of any such
request, to conduct or cause to be conducted, such research as may
be required.
(e) Powers of enforcement personnel
Any officer or employee of the Department designated by the
Secretary to conduct examinations, investigations, or inspections
under this chapter relating to counterfeit drugs may, when so
authorized by the Secretary -
(1) carry firearms;
(2) execute and serve search warrants and arrest warrants;
(3) execute seizure by process issued pursuant to libel under
section 334 of this title;
(4) make arrests without warrant for offenses under this
chapter with respect to such drugs if the offense is committed in
his presence or, in the case of a felony, if he has probable
cause to believe that the person so arrested has committed, or is
committing, such offense; and
(5) make, prior to the institution of libel proceedings under
section 334(a)(2) of this title, seizures of drugs or containers
or of equipment, punches, dies, plates, stones, labeling, or
other things, if they are, or he has reasonable grounds to
believe that they are, subject to seizure and condemnation under
such section 334(a)(2). In the event of seizure pursuant to this
paragraph (5), libel proceedings under section 334(a)(2) of this
title shall be instituted promptly and the property seized be
placed under the jurisdiction of the court.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 702, 52 Stat. 1056; Pub. L. 87-781,
title III, Secs. 307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L.
89-74, Sec. 8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91-513,
title II, Sec. 701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102-
300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
Sec. 3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106-113, div.
B, Sec. 1000(a)(9) [title IV, Sec. 4732(b)(12)], Nov. 29, 1999, 113
Stat. 1536, 1501A-584; Pub. L. 107-188, title III, Sec. 314, June
12, 2002, 116 Stat. 674.)
-MISC1-
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-188 inserted "(1)" before "The
Secretary is authorized to conduct", added par. (2), inserted "(3)"
before "In the case of food packed", and substituted "(4) For the
purposes of this subsection," for "For the purposes of this
subsection".
1999 - Subsec. (d). Pub. L. 106-113, in first sentence,
substituted "Under Secretary of Commerce for Intellectual Property
and Director of the United States Patent and Trademark Office" for
"Commissioner of Patents" and "Director" for "Commissioner".
1993 - Subsec. (c). Pub. L. 103-80 struck out "of Agriculture"
after "Department".
1992 - Subsec. (c). Pub. L. 102-300, which directed the amendment
of subsec. (c) by striking out "of Health, Education, and Welfare",
could not be executed because such words did not appear in the
original statutory text. See 1993 Amendment note above and Transfer
of Functions note below.
1970 - Subsec. (e). Pub. L. 91-513 struck out reference to
depressant or stimulant drugs.
1965 - Subsec. (e). Pub. L. 89-74 added subsec. (e).
1962 - Subsec. (a). Pub. L. 87-781, Sec. 307(b), inserted "the
Commonwealth of Puerto Rico or" before "a Territory the Secretary".
Subsec. (d). Pub. L. 87-781, Sec. 308, added subsec. (d).
EFFECTIVE DATE OF 1999 AMENDMENT
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
113, set out as a note under section 1 of Title 35, Patents.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective July 15, 1965, see section
11 of Pub. L. 89-74, set out as a note under section 321 of this
title.
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for any violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
continued and brought to final determination in accord with laws
and regulations in effect prior to Oct. 27, 1970, see section 702
of Pub. L. 91-513, set out as a note under section 321 of this
title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see note set out under
section 41 of this title.
-End-
-CITE-
21 USC Sec. 372a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 372a. Transferred
-COD-
CODIFICATION
Section, act June 25, 1938, ch. 675, Sec. 702A, formerly June 30,
1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712, 48 Stat.
1204, and amended, which related to examination of sea food, was
renumbered section 706 of act June 25, 1938, by Pub. L. 102-571,
title I, Sec. 106(3), Oct. 29, 1992, 106 Stat. 4498, and
transferred to section 376 of this title.
-End-
-CITE-
21 USC Sec. 373 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 373. Records
-STATUTE-
(a) In general
For the purpose of enforcing the provisions of this chapter,
carriers engaged in interstate commerce, and persons receiving
food, drugs, devices, or cosmetics in interstate commerce or
holding such articles so received, shall, upon the request of an
officer or employee duly designated by the Secretary, permit such
officer or employee, at reasonable times, to have access to and to
copy all records showing the movement in interstate commerce of any
food, drug, device, or cosmetic, or the holding thereof during or
after such movement, and the quantity, shipper, and consignee
thereof; and it shall be unlawful for any such carrier or person to
fail to permit such access to and copying of any such record so
requested when such request is accompanied by a statement in
writing specifying the nature or kind of food, drug, device, or
cosmetic to which such request relates, except that evidence
obtained under this section, or any evidence which is directly or
indirectly derived from such evidence, shall not be used in a
criminal prosecution of the person from whom obtained, and except
that carriers shall not be subject to the other provisions of this
chapter by reason of their receipt, carriage, holding, or delivery
of food, drugs, devices, or cosmetics in the usual course of
business as carriers, except as provided in subsection (b) of this
section.
(b) Food transportation records
A shipper, carrier by motor vehicle or rail vehicle, receiver, or
other person subject to section 350e of this title shall, on
request of an officer or employee designated by the Secretary,
permit the officer or employee, at reasonable times, to have access
to and to copy all records that the Secretary requires to be kept
under section 350e(c)(1)(E) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 703, 52 Stat. 1057; Pub. L. 91-452,
title II, Sec. 230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103-80,
Sec. 3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109-59, title VII,
Sec. 7202(c), Aug. 10, 2005, 119 Stat. 1913.)
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-59 struck out "of interstate shipment" after
"Records" in section catchline, designated existing provisions as
subsec. (a), inserted subsec. heading, substituted "carriers,
except as provided in subsection (b) of this section" for
"carriers" before period at end, and added subsec. (b).
1993 - Pub. L. 103-80 substituted ", except that" for ":
Provided, That" and ", and except that" for ": Provided further,
That".
1970 - Pub. L. 91-452 inserted ", or any evidence which is
directly or indirectly derived from such evidence," after "under
this section".
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
7204 of Pub. L. 109-59, set out as a note under section 331 of this
title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-452 effective on sixtieth day following
Oct. 15, 1970, and not to affect any immunity to which any
individual is entitled under this section by reason of any
testimony given before sixtieth day following Oct. 15, 1970, see
section 260 of Pub. L. 91-452, set out as an Effective Date;
Savings Provision note under section 6001 of Title 18, Crimes and
Criminal Procedure.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 374 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 374. Inspection
-STATUTE-
(a) Right of agents to enter; scope of inspection; notice;
promptness; exclusions
(1) For purposes of enforcement of this chapter, officers or
employees duly designated by the Secretary, upon presenting
appropriate credentials and a written notice to the owner,
operator, or agent in charge, are authorized (A) to enter, at
reasonable times, any factory, warehouse, or establishment in which
food, drugs, devices, or cosmetics are manufactured, processed,
packed, or held, for introduction into interstate commerce or after
such introduction, or to enter any vehicle being used to transport
or hold such food, drugs, devices, or cosmetics in interstate
commerce; and (B) to inspect, at reasonable times and within
reasonable limits and in a reasonable manner, such factory,
warehouse, establishment, or vehicle and all pertinent equipment,
finished and unfinished materials, containers, and labeling
therein. In the case of any person (excluding farms and
restaurants) who manufactures, processes, packs, transports,
distributes, holds, or imports foods, the inspection shall extend
to all records and other information described in section 350c of
this title when the Secretary has a reasonable belief that an
article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals, subject
to the limitations established in section 350c(d) of this title. In
the case of any factory, warehouse, establishment, or consulting
laboratory in which prescription drugs, nonprescription drugs
intended for human use, or restricted devices are manufactured,
processed, packed, or held, the inspection shall extend to all
things therein (including records, files, papers, processes,
controls, and facilities) bearing on whether prescription drugs,
nonprescription drugs intended for human use, or restricted devices
which are adulterated or misbranded within the meaning of this
chapter, or which may not be manufactured, introduced into
interstate commerce, or sold, or offered for sale by reason of any
provision of this chapter, have been or are being manufactured,
processed, packed, transported, or held in any such place, or
otherwise bearing on violation of this chapter. No inspection
authorized by the preceding sentence or by paragraph (3) shall
extend to financial data, sales data other than shipment data,
pricing data, personnel data (other than data as to qualification
of technical and professional personnel performing functions
subject to this chapter), and research data (other than data
relating to new drugs, antibiotic drugs, and devices and subject to
reporting and inspection under regulations lawfully issued pursuant
to section 355(i) or (k) (!1) section 360i, or 360j(g) of this
title, and data relating to other drugs or devices which in the
case of a new drug would be subject to reporting or inspection
under lawful regulations issued pursuant to section 355(j) of this
title). A separate notice shall be given for each such inspection,
but a notice shall not be required for each entry made during the
period covered by the inspection. Each such inspection shall be
commenced and completed with reasonable promptness.
(2) The provisions of the third sentence of paragraph (1) shall
not apply to -
(A) pharmacies which maintain establishments in conformance
with any applicable local laws regulating the practice of
pharmacy and medicine and which are regularly engaged in
dispensing prescription drugs or devices, upon prescriptions of
practitioners licensed to administer such drugs or devices to
patients under the care of such practitioners in the course of
their professional practice, and which do not, either through a
subsidiary or otherwise, manufacture, prepare, propagate,
compound, or process drugs or devices for sale other than in the
regular course of their business of dispensing or selling drugs
or devices at retail;
(B) practitioners licensed by law to prescribe or administer
drugs, or prescribe or use devices, as the case may be, and who
manufacture, prepare, propagate, compound, or process drugs, or
manufacture or process devices, solely for use in the course of
their professional practice;
(C) persons who manufacture, prepare, propagate, compound, or
process drugs or manufacture or process devices, solely for use
in research, teaching, or chemical analysis and not for sale;
(D) such other classes of persons as the Secretary may by
regulation exempt from the application of this section upon a
finding that inspection as applied to such classes of persons in
accordance with this section is not necessary for the protection
of the public health.
(3) An officer or employee making an inspection under paragraph
(1) for purposes of enforcing the requirements of section 350a of
this title applicable to infant formulas shall be permitted, at all
reasonable times, to have access to and to copy and verify any
records -
(A) bearing on whether the infant formula manufactured or held
in the facility inspected meets the requirements of section 350a
of this title, or
(B) required to be maintained under section 350a of this title.
(b) Written report to owner; copy to Secretary
Upon completion of any such inspection of a factory, warehouse,
consulting laboratory, or other establishment, and prior to leaving
the premises, the officer or employee making the inspection shall
give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in
his judgment, indicate that any food, drug, device, or cosmetic in
such establishment (1) consists in whole or in part of any filthy,
putrid, or decomposed substance, or (2) has been prepared, packed,
or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered
injurious to health. A copy of such report shall be sent promptly
to the Secretary.
(c) Receipt for samples taken
If the officer or employee making any such inspection of a
factory, warehouse, or other establishment has obtained any sample
in the course of the inspection, upon completion of the inspection
and prior to leaving the premises he shall give to the owner,
operator, or agent in charge a receipt describing the samples
obtained.
(d) Analysis of samples furnished owner
Whenever in the course of any such inspection of a factory or
other establishment where food is manufactured, processed, or
packed, the officer or employee making the inspection obtains a
sample of any such food, and an analysis is made of such sample for
the purpose of ascertaining whether such food consists in whole or
in part of any filthy, putrid, or decomposed substance, or is
otherwise unfit for food, a copy of the results of such analysis
shall be furnished promptly to the owner, operator, or agent in
charge.
(e) Accessibility of records
Every person required under section 360i or 360j(g) of this title
to maintain records and every person who is in charge or custody of
such records shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at all
reasonable times to have access to, and to copy and verify, such
records.
(f) Recordkeeping
(1) An accredited person described in paragraph (3) shall
maintain records documenting the training qualifications of the
person and the employees of the person, the procedures used by the
person for handling confidential information, the compensation
arrangements made by the person, and the procedures used by the
person to identify and avoid conflicts of interest. Upon the
request of an officer or employee designated by the Secretary, the
person shall permit the officer or employee, at all reasonable
times, to have access to, to copy, and to verify, the records.
(2) Within 15 days after the receipt of a written request from
the Secretary to an accredited person described in paragraph (3)
for copies of records described in paragraph (1), the person shall
produce the copies of the records at the place designated by the
Secretary.
(3) For purposes of paragraphs (1) and (2), an accredited person
described in this paragraph is a person who -
(A) is accredited under subsection (g) of this section; or
(B) is accredited under section 360m of this title.
(g) Inspections by accredited persons
(1) Not later than one year after October 26, 2002, the Secretary
shall, subject to the provisions of this subsection, accredit
persons for the purpose of conducting inspections of establishments
that manufacture, prepare, propagate, compound, or process class II
or class III devices, which inspections are required under section
360(h) of this title or are inspections of such establishments
required to register under section 360(i) of this title. The owner
or operator of such an establishment that is eligible under
paragraph (6) may, from the list published under paragraph (4),
select an accredited person to conduct such inspections.
(2) Not later than 180 days after October 26, 2002, the Secretary
shall publish in the Federal Register criteria to accredit or deny
accreditation to persons who request to perform the duties
specified in paragraph (1). Thereafter, the Secretary shall inform
those requesting accreditation, within 60 days after the receipt of
such request, whether the request for accreditation is adequate for
review, and the Secretary shall promptly act on the request for
accreditation. Any resulting accreditation shall state that such
person is accredited to conduct inspections at device
establishments identified in paragraph (1). The accreditation of
such person shall specify the particular activities under this
subsection for which such person is accredited. In the first year
following the publication in the Federal Register of criteria to
accredit or deny accreditation to persons who request to perform
the duties specified in paragraph (1), the Secretary shall accredit
no more than 15 persons who request to perform duties specified in
paragraph (1).
(3) An accredited person shall, at a minimum, meet the following
requirements:
(A) Such person may not be an employee of the Federal
Government.
(B) Such person shall be an independent organization which is
not owned or controlled by a manufacturer, supplier, or vendor of
articles regulated under this chapter and which has no
organizational, material, or financial affiliation (including a
consultative affiliation) with such a manufacturer, supplier, or
vendor.
(C) Such person shall be a legally constituted entity permitted
to conduct the activities for which it seeks accreditation.
(D) Such person shall not engage in the design, manufacture,
promotion, or sale of articles regulated under this chapter.
(E) The operations of such person shall be in accordance with
generally accepted professional and ethical business practices,
and such person shall agree in writing that at a minimum the
person will -
(i) certify that reported information accurately reflects
data reviewed, inspection observations made, other matters that
relate to or may influence compliance with this chapter, and
recommendations made during an inspection or at an inspection's
closing meeting;
(ii) limit work to that for which competence and capacity are
available;
(iii) treat information received, records, reports, and
recommendations as confidential commercial or financial
information or trade secret information, except such
information may be made available to the Secretary;
(iv) promptly respond and attempt to resolve complaints
regarding its activities for which it is accredited; and
(v) protect against the use, in carrying out paragraph (1),
of any officer or employee of the accredited person who has a
financial conflict of interest regarding any product regulated
under this chapter, and annually make available to the public
disclosures of the extent to which the accredited person, and
the officers and employees of the person, have maintained
compliance with requirements under this clause relating to
financial conflicts of interest.
(4) The Secretary shall publish on the Internet site of the Food
and Drug Administration a list of persons who are accredited under
paragraph (2). Such list shall be updated to ensure that the
identity of each accredited person, and the particular activities
for which the person is accredited, is known to the public. The
updating of such list shall be no later than one month after the
accreditation of a person under this subsection or the suspension
or withdrawal of accreditation, or the modification of the
particular activities for which the person is accredited.
(5)(A) To ensure that persons accredited under this subsection
continue to meet the standards of accreditation, the Secretary
shall (i) audit the performance of such persons on a periodic basis
through the review of inspection reports and inspections by persons
designated by the Secretary to evaluate the compliance status of a
device establishment and the performance of accredited persons, and
(ii) take such additional measures as the Secretary determines to
be appropriate.
(B) The Secretary may withdraw accreditation of any person
accredited under paragraph (2), after providing notice and an
opportunity for an informal hearing, when such person is
substantially not in compliance with the standards of
accreditation, poses a threat to public health, fails to act in a
manner that is consistent with the purposes of this subsection, or
where the Secretary determines that there is a financial conflict
of interest in the relationship between the accredited person and
the owner or operator of a device establishment that the accredited
person has inspected under this subsection. The Secretary may
suspend the accreditation of such person during the pendency of the
process under the preceding sentence.
(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspections by persons accredited
under paragraph (2) if the following conditions are met:
(i) The Secretary classified the results of the most recent
inspection described in paragraph (1) as "no action indicated" or
"voluntary action indicated".
(ii) With respect to inspections to be conducted by an
accredited person during a 2-year period -
(I) the owner or operator of the establishment submits to the
Secretary a notice requesting clearance to use an accredited
person to conduct the inspection, and the Secretary provides
such clearance; and
(II) such notice identifies the accredited person whom the
establishment has selected to conduct the inspection, and the
Secretary agrees to the selected accredited person.
(iii) With respect to the devices that are manufactured,
prepared, propagated, compounded, or processed by the
establishment, at least one of such devices is marketed in the
United States, and 1 or both of the following additional
conditions are met:
(I) At least one of such devices is marketed, or is intended
to be marketed, in one or more foreign countries, one of which
countries certifies, accredits, or otherwise recognizes the
person (accredited under paragraph (2) and identified under
clause (ii)(II)) as a person authorized to conduct such
inspections of device establishments.
(II) The owner or operator of the establishment submits to
the Secretary a statement that the law of a country in which
such a device is marketed, or is intended to be marketed,
recognizes an inspection of the establishment by the Secretary
or by a person accredited under paragraph (2), and not later
than 30 days after receiving such statement, the Secretary
informs the owner or operator of the establishment that the
owner or operator may submit a notice requesting clearance
under clause (ii).
(iv)(I) In the case of an inspection to be conducted pursuant
to section 360(h) of this title, persons accredited under
paragraph (2) did not conduct inspections of the establishment
during the previous 4 years, except that the establishment may
petition the Secretary for a waiver of such condition. Such a
waiver may be granted only if the petition states a commercial
reason for the waiver; the Secretary determines that the public
health would be served by granting the waiver; and the Secretary
has conducted an inspection of the establishment during the four-
year period preceding the date on which the notice under clause
(ii) is submitted to the Secretary. Such a waiver is deemed to be
granted only if the Secretary has not determined that the public
health would not be served by granting the waiver; and the owner
or operator of the device establishment has requested in writing,
not later than 18 months following the most recent inspection of
such establishment by a person accredited under paragraph (2),
that the Secretary inspect the establishment and the Secretary
has not conducted an inspection within 30 months after the most
recent inspection. With respect to such a waiver that is granted
or deemed to be granted, no additional such waiver may be granted
or deemed to be granted until after the Secretary has conducted
an inspection of the establishment.
(II) In the case of an inspection to be conducted of a device
establishment required to register pursuant to section 360(i) of
this title, the Secretary periodically conducts inspections of
the establishment.
(B)(i) The Secretary shall respond to a notice under subparagraph
(A) from a device establishment not later than 30 days after the
Secretary receives the notice. Through such response, the Secretary
shall (I) provide clearance under such subparagraph, and agree to
the selection of an accredited person, or (II) make a request under
clause (ii). If the Secretary fails to respond to the notice within
such 30-day period, the establishment is deemed to have such
clearance, and to have the agreement of the Secretary for such
selection.
(ii) The request referred to in clause (i)(II) is -
(I) a request to the device establishment involved to submit to
the Secretary compliance data in accordance with clause (iii); or
(II) a request to the establishment, or to the accredited
person identified in the notice under subparagraph (A), for
information concerning the relationship between the establishment
and such accredited person, including information about the
number of inspections of the establishment, or other
establishments owned or operated by the owner or operator of the
establishment, that have been conducted by the accredited person.
The Secretary may make both such requests.
(iii) The compliance data to be submitted by a device
establishment under clause (ii) are data describing whether the
quality controls of the establishment have been sufficient for
ensuring consistent compliance with current good manufacturing
practice within the meaning of section 351(h) of this title and
with other applicable provisions of this chapter. Such data shall
include complete reports of inspectional findings regarding good
manufacturing practice or other quality control audits that, during
the preceding two-year period, were conducted at the establishment
by persons other than the owner or operator of the establishment,
together with all other relevant compliance data the Secretary
deems necessary. Data under the preceding sentence shall
demonstrate to the Secretary whether the establishment has
facilitated consistent compliance by promptly correcting any
compliance problems identified in such inspections.
(iv)(I) Not later than 60 days after receiving compliance data
under clause (iii) from a device establishment, the Secretary shall
provide or deny clearance under subparagraph (A). The Secretary may
deny clearance if the Secretary determines that the establishment
has failed to demonstrate consistent compliance for purposes of
clause (iii). The Secretary shall provide to the establishment a
statement of such reasons for such determination. If the Secretary
fails to provide such statement to the establishment within such 60-
day period, the establishment is deemed to have such clearance.
(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this chapter,
the Secretary may, after notice and a written response, notify the
establishment that the eligibility of the establishment for the
inspections by accredited persons has been suspended.
(v)(I) A request to an accredited person under clause (ii)(II)
may not seek any information that is not required to be maintained
by such person in records under subsection (f)(1) of this section.
Not later than 60 days after receiving the information sought by
the request, the Secretary shall agree to, or reject, the selection
of such person by the device establishment involved. The Secretary
may reject the selection if the Secretary provides to the
establishment a statement of the reasons for such rejection.
Reasons for the rejection may include that the establishment or the
accredited person, as the case may be, has failed to fully respond
to the request, or that the Secretary has concerns regarding the
relationship between the establishment and such accredited person.
If within such 60-day period the Secretary fails to agree to or
reject the selection in accordance with this subclause, the
Secretary is deemed to have agreed to the selection.
(II) If the Secretary rejects the selection of an accredited
person by a device establishment, the establishment may make an
additional selection of an accredited person by submitting to the
Secretary a notice that identifies the additional selection.
Clauses (i) and (ii), and subclause (I) of this clause, apply to
the selection of an accredited person through a notice under the
preceding sentence in the same manner and to the same extent as
such provisions apply to a selection of an accredited person
through a notice under subparagraph (A).
(vi) In the case of a device establishment that under clause (iv)
is denied clearance under subparagraph (A), or whose selection of
an accredited person is rejected under clause (v), the Secretary
shall designate a person to review the findings of the Secretary
under such clause if, during the 30-day period beginning on the
date on which the establishment receives the findings, the
establishment requests the review. The review shall commence not
later than 30 days after the establishment requests the review,
unless the Secretary and the establishment otherwise agree.
(C)(i) In the case of a device establishment for which the
Secretary classified the results of the most recent inspection of
the establishment by a person accredited under paragraph (2) as
"official action indicated", the establishment, if otherwise
eligible under subparagraph (A), is eligible for further
inspections by persons accredited under such paragraph if (I) the
Secretary issues a written statement to the owner or operator of
the establishment that the violations leading to such
classification have been resolved, and (II) the Secretary, either
upon the Secretary's own initiative or a petition of the owner or
operator of the establishment, notifies the establishment that it
has clearance to use an accredited person for the inspections. The
Secretary shall respond to such petition within 30 days after the
receipt of the petition.
(ii) If the Secretary denies a petition under clause (i), the
device establishment involved may, after the expiration of one year
after such denial, again petition the Secretary for a determination
of eligibility for inspection by persons accredited by the
Secretary under paragraph (2). If the Secretary denies such
petition, the Secretary shall provide the establishment with such
reasons for such denial within 60 days after the denial. If, as of
the expiration of 48 months after the receipt of the first
petition, the establishment has not been inspected by the
Secretary, the establishment is eligible for further inspections by
accredited persons.
(7)(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection observations
and shall present the observations to the device establishment's
designated representative and describe each observation.
Additionally, such accredited person shall prepare an inspection
report (including for inspections classified as "no action
indicated") in a form and manner consistent with such reports
prepared by employees and officials designated by the Secretary to
conduct inspections.
(B) At a minimum, an inspection report under subparagraph (A)
shall identify the persons responsible for good manufacturing
practice compliance at the inspected device establishment, the
dates of the inspection, the scope of the inspection, and shall
describe in detail each observation identified by the accredited
person, identify other matters that relate to or may influence
compliance with this chapter, and describe any recommendations
during the inspection or at the inspection's closing meeting.
(C) An inspection report under subparagraph (A) shall be sent to
the Secretary and to the designated representative of the inspected
device establishment at the same time, but under no circumstances
later than three weeks after the last day of the inspection. The
report to the Secretary shall be accompanied by all written
inspection observations previously provided to the designated
representative of the establishment.
(D) Any statement or representation made by an employee or agent
of a device establishment to a person accredited under paragraph
(2) to conduct inspections shall be subject to section 1001 of
title 18.
(E) If at any time during an inspection by an accredited person
the accredited person discovers a condition that could cause or
contribute to an unreasonable risk to the public health, the
accredited person shall immediately notify the Secretary of the
identification of the device establishment subject to inspection
and such condition.
(8) Compensation for an accredited person shall be determined by
agreement between the accredited person and the person who engages
the services of the accredited person, and shall be paid by the
person who engages such services.
(9) Nothing in this subsection affects the authority of the
Secretary to inspect any device establishment pursuant to this
chapter.
(10)(A) For fiscal year 2005 and each subsequent fiscal year, no
device establishment may be inspected during the fiscal year
involved by a person accredited under paragraph (2) if -
(i) of the amounts appropriated for salaries and expenses of
the Food and Drug Administration for the preceding fiscal year
(referred to in this subparagraph as the "first prior fiscal
year"), the amount obligated by the Secretary for inspections of
device establishments by the Secretary was less than the adjusted
base amount applicable to such first prior fiscal year; and
(ii) of the amounts appropriated for salaries and expenses of
the Food and Drug Administration for the fiscal year preceding
the first prior fiscal year (referred to in this subparagraph as
the "second prior fiscal year"), the amount obligated by the
Secretary for inspections of device establishments by the
Secretary was less than the adjusted base amount applicable to
such second prior fiscal year.
(B)(i) Subject to clause (ii), the Comptroller General of the
United States shall determine the amount that was obligated by the
Secretary for fiscal year 2002 for compliance activities of the
Food and Drug Administration with respect to devices (referred to
in this subparagraph as the "compliance budget"), and of such
amount, the amount that was obligated for inspections by the
Secretary of device establishments (referred to in this
subparagraph as the "inspection budget").
(ii) For purposes of determinations under clause (i), the
Comptroller General shall not include in the compliance budget or
the inspection budget any amounts obligated for inspections of
device establishments conducted as part of the process of reviewing
applications under section 360e of this title.
(iii) Not later than March 31, 2003, the Comptroller General
shall complete the determinations required in this subparagraph and
submit to the Secretary and the Congress a report describing the
findings made through such determinations.
(C) For purposes of this paragraph:
(i) The term "base amount" means the inspection budget
determined under subparagraph (B) for fiscal year 2002.
(ii) The term "adjusted base amount", in the case of
applicability to fiscal year 2003, means an amount equal to the
base amount increased by 5 percent.
(iii) The term "adjusted base amount", with respect to
applicability to fiscal year 2004 or any subsequent fiscal year,
means the adjusted based amount applicable to the preceding year
increased by 5 percent.
(11) The authority provided by this subsection terminates on
October 1, 2012.
(12) No later than four years after October 26, 2002, the
Comptroller General shall report to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor and Pensions of the Senate -
(A) the number of inspections conducted by accredited persons
pursuant to this subsection and the number of inspections
conducted by Federal employees pursuant to section 360(h) of this
title and of device establishments required to register under
section 360(i) of this title;
(B) the number of persons who sought accreditation under this
subsection, as well as the number of persons who were accredited
under this subsection;
(C) the reasons why persons who sought accreditation, but were
denied accreditation, were denied;
(D) the number of audits conducted by the Secretary of
accredited persons, the quality of inspections conducted by
accredited persons, whether accredited persons are meeting their
obligations under this chapter, and whether the number of audits
conducted is sufficient to permit these assessments;
(E) whether this subsection is achieving the goal of ensuring
more information about device establishment compliance is being
presented to the Secretary, and whether that information is of a
quality consistent with information obtained by the Secretary
pursuant to inspections conducted by Federal employees;
(F) whether this subsection is advancing efforts to allow
device establishments to rely upon third-party inspections for
purposes of compliance with the laws of foreign governments; and
(G) whether the Congress should continue, modify, or terminate
the program under this subsection.
(13) The Secretary shall include in the annual report required
under section 393(g) of this title the names of all accredited
persons and the particular activities under this subsection for
which each such person is accredited and the name of each
accredited person whose accreditation has been withdrawn during the
year.
(14) Notwithstanding any provision of this subsection, this
subsection does not have any legal effect on any agreement
described in section 383(b) of this title between the Secretary and
a foreign country.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 704, 52 Stat. 1057; Aug. 7, 1953, ch.
350, Sec. 1, 67 Stat. 476; Pub. L. 87-781, title II, Sec. 201(a),
(b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, Sec. 6, May
28, 1976, 90 Stat. 581; Pub. L. 96-359, Sec. 4, Sept. 26, 1980, 94
Stat. 1193; Pub. L. 103-80, Sec. 3(aa), Aug. 13, 1993, 107 Stat.
778; Pub. L. 105-115, title I, Sec. 125(b)(2)(L), title II, Sec.
210(b), title IV, Sec. 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344,
2375; Pub. L. 107-188, title III, Sec. 306(b), June 12, 2002, 116
Stat. 670; Pub. L. 107-250, title II, Sec. 201(a), (b), Oct. 26,
2002, 116 Stat. 1602, 1609; Pub. L. 108-214, Sec. 2(b)(1), Apr. 1,
2004, 118 Stat. 573.)
-MISC1-
AMENDMENTS
2004 - Subsec. (g)(1). Pub. L. 108-214, Sec. 2(b)(1)(A), in first
sentence, substituted "conducting inspections of establishments
that manufacture, prepare, propagate, compound, or process class II
or class III devices, which inspections are required under section
360(h) of this title or are inspections of such establishments
required to register under section 360(i) of this title." for
"conducting inspections of establishments that manufacture,
prepare, propagate, compound, or process class II or class III
devices that are required in section 360(h) of this title, or
inspections of such establishments required to register pursuant to
section 360(i) of this title."
Subsec. (g)(5)(B). Pub. L. 108-214, Sec. 2(b)(1)(B), in first
sentence, substituted "poses a threat to public health, fails to
act in a manner that is consistent with the purposes of this
subsection, or where the Secretary determines that there is a
financial conflict of interest in the relationship between the
accredited person and the owner or operator of a device
establishment that the accredited person has inspected under this
subsection." for "or poses a threat to public health or fails to
act in a manner that is consistent with the purposes of this
subsection."
Subsec. (g)(6)(A)(i). Pub. L. 108-214, Sec. 2(b)(1)(C)(i),
substituted "described in paragraph (1)" for "of the establishment
pursuant to subsection (h) or (i) of section 360 of this title".
Subsec. (g)(6)(A)(ii). Pub. L. 108-214, Sec. 2(b)(1)(C)(ii)(I),
substituted "inspections" for "each inspection" and inserted
"during a 2-year period" after "person" in introductory provisions.
Subsec. (g)(6)(A)(ii)(I). Pub. L. 108-214, Sec.
2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a
person".
Subsec. (g)(6)(A)(iii). Pub. L. 108-214, Sec. 2(b)(1)(C)(iii)(I),
substituted "and 1 or both of the following additional conditions
are met:" for "and the following additional conditions are met:" in
introductory provisions.
Subsec. (g)(6)(A)(iii)(I). Pub. L. 108-214, Sec.
2(b)(1)(C)(iii)(II), substituted "(accredited under paragraph (2)
and identified under clause (ii)(II)) as a person authorized to
conduct such inspections of device establishments." for "accredited
under paragraph (2) and identified under subclause (II) of this
clause."
Subsec. (g)(6)(A)(iii)(II). Pub. L. 108-214, Sec.
2(b)(1)(C)(iii)(III), inserted "or by a person accredited under
paragraph (2)" after "by the Secretary".
Subsec. (g)(6)(A)(iv)(I). Pub. L. 108-214, Sec. 2(b)(1)(C)(iv),
in first sentence, inserted "section" after "pursuant to" and
substituted "inspections of the establishment during the previous 4
years" for "the two immediately preceding inspections of the
establishment", in third sentence, struck out "the petition states
a commercial reason for the waiver;" after "granted only if" and
inserted "not" after "the Secretary has not determined that the
public health would", and, in last sentence, substituted "granted
or deemed to be granted until" for "granted until".
Subsec. (g)(6)(A)(iv)(II). Pub. L. 108-214, Sec. 2(b)(1)(C)(v),
inserted "of a device establishment required to register" after "to
be conducted" and "section" after "pursuant to".
Subsec. (g)(6)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(D), in
first sentence, substituted "and with other" for ", and data
otherwise describing whether the establishment has consistently
been in compliance with sections 351 and 352 of this title and
other" and, in second sentence, substituted "inspectional findings"
for "inspections" and inserted "relevant" after "together with all
other".
Subsec. (g)(6)(B)(iv). Pub. L. 108-214, Sec. 2(b)(1)(E),
designated existing provisions as subcl. (I) and added subcl. (II).
Subsec. (g)(6)(C)(ii). Pub. L. 108-214, Sec. 2(b)(1)(F), struck
out "in accordance with section 360(h) of this title, or has not
during such period been inspected pursuant to section 360(i) of
this title, as applicable" after "inspected by the Secretary".
Subsec. (g)(10)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(G),
substituted "a report" for "a reporting".
Subsec. (g)(12)(A). Pub. L. 108-214, Sec. 2(b)(1)(H)(i), added
subpar. (A) and struck out former subpar. (A) which read as
follows: "the number of inspections pursuant to subsections (h) and
(i) of section 360 of this title conducted by accredited persons
and the number of inspections pursuant to such subsections
conducted by Federal employees;".
Subsec. (g)(12)(E). Pub. L. 108-214, Sec. 2(b)(1)(H)(ii),
substituted "obtained by the Secretary pursuant to inspections
conducted by Federal employees;" for "obtained by the Secretary
pursuant to subsection (h) or (i) of section 360 of this title;".
2002 - Subsec. (a)(1). Pub. L. 107-188, Sec. 306(b)(1), inserted
after first sentence "In the case of any person (excluding farms
and restaurants) who manufactures, processes, packs, transports,
distributes, holds, or imports foods, the inspection shall extend
to all records and other information described in section 350c of
this title when the Secretary has a reasonable belief that an
article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals, subject
to the limitations established in section 350c(d) of this title."
Subsec. (a)(2). Pub. L. 107-188, Sec. 306(b)(2), substituted
"third sentence" for "second sentence" in introductory provisions.
Subsec. (f)(1). Pub. L. 107-250, Sec. 201(b)(1), in first
sentence, substituted "An accredited person described in paragraph
(3) shall maintain records" for "A person accredited under section
360m of this title to review reports made under section 360(k) of
this title and make recommendations of initial classifications of
devices to the Secretary shall maintain records".
Subsec. (f)(2). Pub. L. 107-250, Sec. 201(b)(2), substituted "an
accredited person described in paragraph (3)" for "a person
accredited under section 360m of this title".
Subsec. (f)(3). Pub. L. 107-250, Sec. 201(b)(3), added par. (3).
Subsec. (g). Pub. L. 107-250, Sec. 201(a), added subsec. (g).
1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 412(b), substituted
"prescription drugs, nonprescription drugs intended for human use,"
for "prescription drugs" in two places.
Pub. L. 105-115, Sec. 125(b)(2)(L), struck out ", section 357(d)
or (g)," before "section 360i".
Subsec. (f). Pub. L. 105-115, Sec. 210(b), added subsec. (f).
1993 - Subsec. (a)(1). Pub. L. 103-80 substituted a comma for
semicolon after "finished and unfinished materials" and "section
355(i) or (k)" for "section 355(i) or (j)".
1980 - Subsec. (a)(1). Pub. L. 96-359, Sec. 4(1), (2),
restructured first five sentences of former subsec. (a) as par. (1)
and, as so restructured, inserted reference to paragraph (3) and
substituted "(A)" and "(B)" for "(1)" and "(2)", respectively.
Subsec. (a)(2). Pub. L. 96-359, Sec. 4(3), redesignated sixth
sentence of former subsec. (a) as par. (2) and, as so redesignated,
substituted reference to second sentence of paragraph (1) for
reference to former second sentence of this subsection, and "(A)",
"(B)", "(C)", and "(D)", for "(1)", "(2)", "(3)", and "(4)",
respectively.
Subsec. (a)(3). Pub. L. 96-359, Sec. 4(4), added par. (3).
1976 - Subsec. (a). Pub. L. 94-295, Sec. 6(a)-(c), expanded
existing provisions to encompass medical devices by inserting
references to factories, warehouses, establishments, and consulting
laboratories in which restricted devices are manufactured,
processed, packed, or held, inspections relating to devices,
reporting and inspection regulations issued pursuant to sections
360i and 360j(g) of this title, and the manufacture and processing
of devices.
Subsec. (e). Pub. L. 94-295, Sec. 6(d), added subsec. (e).
1962 - Subsec. (a). Pub. L. 87-781, Sec. 201(a), extended the
inspection, where prescription drugs are manufactured, processed,
packed, or held, to all things bearing on whether adulterated or
misbranded drugs, or any which may not be manufactured, introduced
in interstate commerce, or sold or offered for sale under any
provision of this chapter, have been or are being manufactured,
processed, packed, transported or held in any such place, or
otherwise bearing on violation of this chapter, but excluded from
such inspection, data concerning finance, sales other than
shipment, pricing, personnel other than qualifications of technical
and professional personnel, research other than relating to new
drugs subject to reporting, provided that provisions of second
sentence of this subsection shall be inapplicable to pharmacies,
practitioners and other persons enumerated in pars. (1) to (4), and
struck out "are held" before "after such introduction".
Subsec. (b). Pub. L. 87-781, Sec. 201(b), inserted "consulting
laboratory" after "warehouse".
1953 - Act Aug. 7, 1953, designated existing provisions as
subsec. (a) and amended them by substituting provisions permitting
entry and inspection upon presentation of appropriate credentials
and a written notice to the owner, operator, or agent in charge for
provisions which authorized entry and inspection only after making
a request and obtaining permission from the owner, operator, or
custodian, and inserting provisions requiring a separate written
notice for each inspection but not for each entry made during the
period covered by the inspection, and directing that the inspection
shall be conducted within reasonable limits, in a reasonable manner
and completed with reasonable promptness, and added subsecs. (b) to
(d).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by sections 210(b) and 412(b) of Pub. L. 105-115
effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
203 of Pub. L. 87-781, set out as a note under section 332 of this
title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
AUTHORITY OF SECRETARY PRIOR TO OCTOBER 10, 1962
Section 201(d) of Pub. L. 87-781 provided that: "Nothing in the
amendments made by subsections (a) and (b) of this section
[amending this section] shall be construed to negate or derogate
from any authority of the Secretary existing prior to the enactment
of this Act [Oct. 10, 1962]."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 374a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 374a. Inspections relating to food allergens
-STATUTE-
The Secretary of Health and Human Services shall conduct
inspections consistent with the authority under section 374 of this
title of facilities in which foods are manufactured, processed,
packed, or held -
(1) to ensure that the entities operating the facilities comply
with practices to reduce or eliminate cross-contact of a food
with residues of major food allergens that are not intentional
ingredients of the food; and
(2) to ensure that major food allergens are properly labeled on
foods.
-SOURCE-
(Pub. L. 108-282, title II, Sec. 205, Aug. 2, 2004, 118 Stat. 909.)
-COD-
CODIFICATION
Section was enacted as a part of the Food Allergen Labeling and
Consumer Protection Act of 2004, and not as part of the Federal
Food, Drug, and Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC Sec. 375 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 375. Publicity
-STATUTE-
(a) Reports
The Secretary shall cause to be published from time to time
reports summarizing all judgments, decrees, and court orders which
have been rendered under this chapter, including the nature of the
charge and the disposition thereof.
(b) Information regarding certain goods
The Secretary may also cause to be disseminated information
regarding food, drugs, devices, or cosmetics in situations
involving, in the opinion of the Secretary, imminent danger to
health or gross deception of the consumer. Nothing in this section
shall be construed to prohibit the Secretary from collecting,
reporting, and illustrating the results of the investigations of
the Department.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 705, 52 Stat. 1057.)
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 376 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 376. Examination of sea food on request of packer; marking
food with results; fees; penalties
-STATUTE-
The Secretary, upon application of any packer of any sea food for
shipment or sale within the jurisdiction of this chapter, may, at
his discretion, designate inspectors to examine and inspect such
food and the production, packing, and labeling thereof. If on such
examination and inspection compliance is found with the provisions
of this chapter and regulations promulgated thereunder, the
applicant shall be authorized or required to mark the food as
provided by regulation to show such compliance. Services under this
section shall be rendered only upon payment by the applicant of
fees fixed by regulation in such amounts as may be necessary to
provide, equip, and maintain an adequate and efficient inspection
service. Receipts from such fees shall be covered into the Treasury
and shall be available to the Secretary for expenditures incurred
in carrying out the purposes of this section, including
expenditures for salaries of additional inspectors when necessary
to supplement the number of inspectors for whose salaries Congress
has appropriated. The Secretary is authorized to promulgate
regulations governing the sanitary and other conditions under which
the service herein provided shall be granted and maintained, and
for otherwise carrying out the purposes of this section. Any person
who forges, counterfeits, simulates, or falsely represents, or
without proper authority uses any mark, stamp, tag, label, or other
identification devices authorized or required by the provisions of
this section or regulations thereunder, shall be guilty of a
misdemeanor, and shall on conviction thereof be subject to
imprisonment for not more than one year or a fine of not less than
$1,000 nor more than $5,000, or both such imprisonment and fine.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 706, formerly Sec. 702A, formerly
June 30, 1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712,
48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June
25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059; renumbered Sec. 702A
of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat.
500; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
renumbered Sec. 706, Pub. L. 102-571, title I, Sec. 106(3), Oct.
29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(dd)(2), Aug. 13,
1993, 107 Stat. 779.)
-COD-
CODIFICATION
Section was formerly classified to section 372a of this title
prior to renumbering by Pub. L. 102-571.
Section, which formerly was not a part of the Federal Food, Drug,
and Cosmetic Act, originally was classified to section 14a of this
title. Section 902(a) of act June 25, 1938, set out as an Effective
Date note under section 301 of this title, provided that the
section should remain in force and effect and be applicable to the
provisions of this chapter. Act July 12, 1943, renumbered this
section as 702A of the Federal Food, Drug, and Cosmetic Act.
-MISC1-
PRIOR PROVISIONS
A prior section 376, act June 25, 1938, ch. 675, Sec. 706, 52
Stat. 1058, as amended, which related to listing and certification
of color additives for foods, drugs, devices, and cosmetics, was
renumbered section 721 of act June 25, 1938, by Pub. L. 102-571,
title I, Sec. 106(4), Oct. 29, 1992, 106 Stat. 4498, and
transferred to section 379e of this title.
AMENDMENTS
1993 - Pub. L. 103-80 struck out "of Agriculture" after
"Secretary" in two places.
1992 - Pub. L. 102-300, which directed the amendment of the
section by striking out "of Health, Education, and Welfare"
wherever appearing, could not be executed because such words did
not appear in the original statutory text. See 1993 Amendment note
above and Transfer of Functions note below.
-TRANS-
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 377 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 377. Revision of United States Pharmacopoeia; development of
analysis and mechanical and physical tests
-STATUTE-
The Secretary, in carrying into effect the provisions of this
chapter, is authorized on and after July 12, 1943, to cooperate
with associations and scientific societies in the revision of the
United States Pharmacopoeia and in the development of methods of
analysis and mechanical and physical tests necessary to carry out
the work of the Food and Drug Administration.
-SOURCE-
(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan
No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
-COD-
CODIFICATION
Section was enacted as part of the Labor-Federal Security
Appropriation Act, 1944, and not as part of the Federal Food, Drug,
and Cosmetic Act which comprises this chapter.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 378 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 378. Advertising of foods
-STATUTE-
(a) Determination of misbranding; notification of Federal Trade
Commission by Secretary; contents
(1) Except as provided in subsection (c) of this section, before
the Secretary may initiate any action under subchapter III of this
chapter -
(A) with respect to any food which the Secretary determines is
misbranded under section 343(a)(2) of this title because of its
advertising, or
(B) with respect to a food's advertising which the Secretary
determines causes the food to be so misbranded,
the Secretary shall, in accordance with paragraph (2), notify in
writing the Federal Trade Commission of the action the Secretary
proposes to take respecting such food or advertising.
(2) The notice required by paragraph (1) shall -
(A) contain (i) a description of the action the Secretary
proposes to take and of the advertising which the Secretary has
determined causes a food to be misbranded, (ii) a statement of
the reasons for the Secretary's determination that such
advertising has caused such food to be misbranded, and
(B) be accompanied by the records, documents, and other written
materials which the Secretary determines supports his
determination that such food is misbranded because of such
advertising.
(b) Action by Federal Trade Commission precluding action by
Secretary; exception
(1) If the Secretary notifies the Federal Trade Commission under
subsection (a) of this section of action proposed to be taken under
subchapter III of this chapter with respect to a food or food
advertising and the Commission notifies the Secretary in writing,
within the 30-day period beginning on the date of the receipt of
such notice, that -
(A) it has initiated under the Federal Trade Commission Act [15
U.S.C. 41 et seq.] an investigation of such advertising to
determine if it is prohibited by such Act or any order or rule
under such Act,
(B) it has commenced (or intends to commence) a civil action
under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with
respect to such advertising or the Attorney General has commenced
(or intends to commence) a civil action under section 5 [15
U.S.C. 45] with respect to such advertising,
(C) it has issued and served (or intends to issue and serve) a
complaint under section 5(b) of such Act [15 U.S.C. 45(b)]
respecting such advertising, or
(D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it
has made a certification to the Attorney General respecting such
advertising,
the Secretary may not, except as provided by paragraph (2),
initiate the action described in the Secretary's notice to the
Federal Trade Commission.
(2) If, before the expiration of the 60-day period beginning on
the date the Secretary receives a notice described in paragraph (1)
from the Federal Trade Commission in response to a notice of the
Secretary under subsection (a) of this section -
(A) the Commission or the Attorney General does not commence a
civil action described in subparagraph (B) of paragraph (1) of
this subsection respecting the advertising described in the
Secretary's notice,
(B) the Commission does not issue and serve a complaint
described in subparagraph (C) of such paragraph respecting such
advertising, or
(C) the Commission does not (as described in subparagraph (D)
of such paragraph) make a certification to the Attorney General
respecting such advertising, or, if the Commission does make such
a certification to the Attorney General respecting such
advertising, the Attorney General, before the expiration of such
period, does not cause appropriate criminal proceedings to be
brought against such advertising,
the Secretary may, after the expiration of such period, initiate
the action described in the notice to the Commission pursuant to
subsection (a) of this section. The Commission shall promptly
notify the Secretary of the commencement by the Commission of such
a civil action, the issuance and service by it of such a complaint,
or the causing by the Attorney General of criminal proceedings to
be brought against such advertising.
(c) Secretary's determination of imminent hazard to health as
suspending applicability of provisions
The requirements of subsections (a) and (b) of this section do
not apply with respect to action under subchapter III of this
chapter with respect to any food or food advertising if the
Secretary determines that such action is required to eliminate an
imminent hazard to health.
(d) Coordination of action by Secretary with Federal Trade
Commission
For the purpose of avoiding unnecessary duplication, the
Secretary shall coordinate any action taken under subchapter III of
this chapter because of advertising which the Secretary determines
causes a food to be misbranded with any action of the Federal Trade
Commission under the Federal Trade Commission Act [15 U.S.C. 41 et
seq.] with respect to such advertising.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 707, as added Pub. L. 94-278, title
V, Sec. 502(b), Apr. 22, 1976, 90 Stat. 412.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Trade Commission Act, referred to in subsecs. (b) and
(d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended,
which is classified generally to subchapter I (Sec. 41 et seq.) of
chapter 2 of Title 15, Commerce and Trade. For complete
classification of this Act to the Code, see section 58 of Title 15
and Tables.
-End-
-CITE-
21 USC Sec. 379 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 379. Confidential information
-STATUTE-
The Secretary may provide any information which is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5 by
reason of subsection (b)(4) of such section to a person other than
an officer or employee of the Department if the Secretary
determines such other person requires the information in connection
with an activity which is undertaken under contract with the
Secretary, which relates to the administration of this chapter, and
with respect to which the Secretary (or an officer or employee of
the Department) is not prohibited from using such information. The
Secretary shall require as a condition to the provision of
information under this section that the person receiving it take
such security precautions respecting the information as the
Secretary may by regulation prescribe.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 708, as added Pub. L. 94-295, Sec. 8,
May 28, 1976, 90 Stat. 582.)
-End-
-CITE-
21 USC Sec. 379a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 379a. Presumption of existence of jurisdiction
-STATUTE-
In any action to enforce the requirements of this chapter
respecting a device, food, drug, or cosmetic the connection with
interstate commerce required for jurisdiction in such action shall
be presumed to exist.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 709, as added Pub. L. 94-295, Sec. 8,
May 28, 1976, 90 Stat. 583; amended Pub. L. 105-115, title IV, Sec.
419, Nov. 21, 1997, 111 Stat. 2379.)
-MISC1-
AMENDMENTS
1997 - Pub. L. 105-115 substituted "a device, food, drug, or
cosmetic" for "a device".
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
-End-
-CITE-
21 USC Sec. 379b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 379b. Consolidated administrative and laboratory facility
-STATUTE-
(a) Authority
The Secretary, in consultation with the Administrator of the
General Services Administration, shall enter into contracts for the
design, construction, and operation of a consolidated Food and Drug
Administration administrative and laboratory facility.
(b) Awarding of contract
The Secretary shall solicit contract proposals under subsection
(a) of this section from interested parties. In awarding contracts
under such subsection, the Secretary shall review such proposals
and give priority to those alternatives that are the most cost
effective for the Federal Government and that allow for the use of
donated land, federally owned property, or lease-purchase
arrangements. A contract under this subsection shall not be entered
into unless such contract results in a net cost savings to the
Federal Government over the duration of the contract, as compared
to the Government purchase price including borrowing by the
Secretary of the Treasury.
(c) Donations
In carrying out this section, the Secretary shall have the power,
in connection with real property, buildings, and facilities, to
accept on behalf of the Food and Drug Administration gifts or
donations of services or property, real or personal, as the
Secretary determines to be necessary.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section
$100,000,000 for fiscal year 1991, and such sums as may be
necessary for each of the subsequent fiscal years, to remain
available until expended.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 710, as added Pub. L. 101-635, title
I, Sec. 101, Nov. 28, 1990, 104 Stat. 4583.)
-End-
-CITE-
21 USC Sec. 379c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 379c. Transferred
-COD-
CODIFICATION
Section, act June 25, 1938, ch. 675, Sec. 711, as added Nov. 28,
1990, Pub. L. 101-635, title II, Sec. 201, 104 Stat. 4584, which
related to recovery and retention of fees for freedom of
information requests, was renumbered section 731 of act June 25,
1938, by Pub. L. 102-571, title I, Sec. 106(6), Oct. 29, 1992, 106
Stat. 4499, and transferred to section 379f of this title.
-End-
-CITE-
21 USC Sec. 379d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part A - General Administrative Provisions
-HEAD-
Sec. 379d. Automation of Food and Drug Administration
-STATUTE-
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs,
shall automate appropriate activities of the Food and Drug
Administration to ensure timely review of activities regulated
under this chapter.
(b) Authorization of appropriations
There are authorized to be appropriated each fiscal year such
sums as are necessary to carry out this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 711, formerly Sec. 712, as added Pub.
L. 101-635, title IV, Sec. 401, Nov. 28, 1990, 104 Stat. 4585;
renumbered Sec. 711, Pub. L. 102-571, title I, Sec. 106(3), Oct.
29, 1992, 106 Stat. 4498.)
-MISC1-
PRIOR PROVISIONS
A prior section 711 of act June 25, 1938, was renumbered section
731 by Pub. L. 102-571 and is classified to section 379f of this
title.
-End-
-CITE-
21 USC Part B - Colors 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part B - Colors
-HEAD-
PART B - COLORS
-End-
-CITE-
21 USC Sec. 379e 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part B - Colors
-HEAD-
Sec. 379e. Listing and certification of color additives for foods,
drugs, devices, and cosmetics
-STATUTE-
(a) Unsafe color additives
A color additive shall, with respect to any particular use (for
which it is being used or intended to be used or is represented as
suitable) in or on food or drugs or devices or cosmetics, be deemed
unsafe for the purposes of the application of section 342(c),
351(a)(4), or 361(e) of this title, as the case may be, unless -
(1)(A) there is in effect, and such additive and such use are
in conformity with, a regulation issued under subsection (b) of
this section listing such additive for such use, including any
provision of such regulation prescribing the conditions under
which such additive may be safely used, and (B) such additive
either (i) is from a batch certified, in accordance with
regulations issued pursuant to subsection (c) of this section,
for such use, or (ii) has, with respect to such use, been
exempted by the Secretary from the requirement of certification;
or
(2) such additive and such use thereof conform to the terms of
an exemption which is in effect pursuant to subsection (f) of
this section.
While there are in effect regulations under subsections (b) and (c)
of this section relating to a color additive or an exemption
pursuant to subsection (f) of this section with respect to such
additive, an article shall not, by reason of bearing or containing
such additive in all respects in accordance with such regulations
or such exemption, be considered adulterated within the meaning of
clause (1) of section 342(a) of this title if such article is a
food, or within the meaning of section 361(a) of this title if such
article is a cosmetic other than a hair dye (as defined in the last
sentence of section 361(a) of this title). A color additive for use
in or on a device shall be subject to this section only if the
color additive comes in direct contact with the body of man or
other animals for a significant period of time. The Secretary may
by regulation designate the uses of color additives in or on
devices which are subject to this section.
(b) Listing of colors; regulations; issuance, amendment or repeal;
referral to advisory committee; report and recommendations;
appointment and compensation of advisory committee
(1) The Secretary shall, by regulation, provide for separately
listing color additives for use in or on food, color additives for
use in or on drugs, or devices, and color additives for use in or
on cosmetics, if and to the extent that such additives are suitable
and safe for any such use when employed in accordance with such
regulations.
(2)(A) Such regulations may list any color additive for use
generally in or on food, or in or on drugs or devices, or in or on
cosmetics, if the Secretary finds that such additive is suitable
and may safely be employed for such general use.
(B) If the data before the Secretary do not establish that the
additive satisfies the requirements for listing such additive on
the applicable list pursuant to subparagraph (A) of this paragraph,
or if the proposal is for listing such additive for a more limited
use or uses, such regulations may list such additive only for any
more limited use or uses for which it is suitable and may safely be
employed.
(3) Such regulations shall, to the extent deemed necessary by the
Secretary to assure the safety of the use or uses for which a
particular color additive is listed, prescribe the conditions under
which such additive may be safely employed for such use or uses
(including, but not limited to, specifications, hereafter in this
section referred to as tolerance limitations, as to the maximum
quantity or quantities which may be used or permitted to remain in
or on the article or articles in or on which it is used;
specifications as to the manner in which such additive may be added
to or used in or on such article or articles; and directions or
other labeling or packaging requirements for such additive).
(4) The Secretary shall not list a color additive under this
section for a proposed use unless the data before him establish
that such use, under the conditions of use specified in the
regulations, will be safe: Provided, however, That a color additive
shall be deemed to be suitable and safe for the purpose of listing
under this subsection for use generally in or on food, while there
is in effect a published finding of the Secretary declaring such
substance exempt from the term "food additive" because of its being
generally recognized by qualified experts as safe for its intended
use, as provided in section 321(s) of this title.
(5)(A) In determining, for the purposes of this section, whether
a proposed use of a color additive is safe, the Secretary shall
consider, among other relevant factors -
(i) the probable consumption of, or other relevant exposure
from, the additive and of any substance formed in or on food,
drugs or devices, or cosmetics because of the use of the
additive;
(ii) the cumulative effect, if any, of such additive in the
diet of man or animals, taking into account the same or any
chemically or pharmacologically related substance or substances
in such diet;
(iii) safety factors which, in the opinion of experts qualified
by scientific training and experience to evaluate the safety of
color additives for the use or uses for which the additive is
proposed to be listed, are generally recognized as appropriate
for the use of animal experimentation data; and
(iv) the availability of any needed practicable methods of
analysis for determining the identity and quantity of (I) the
pure dye and all intermediates and other impurities contained in
such color additive, (II) such additive in or on any article of
food, drug or device, or cosmetic, and (III) any substance formed
in or on such article because of the use of such additive.
(B) A color additive (i) shall be deemed unsafe, and shall not be
listed, for any use which will or may result in ingestion of all or
part of such additive, if the additive is found by the Secretary to
induce cancer when ingested by man or animal, or if it is found by
the Secretary, after tests which are appropriate for the evaluation
of the safety of additives for use in food, to induce cancer in man
or animal, and (ii) shall be deemed unsafe, and shall not be
listed, for any use which will not result in ingestion of any part
of such additive, if, after tests which are appropriate for the
evaluation of the safety of additives for such use, or after other
relevant exposure of man or animal to such additive, it is found by
the Secretary to induce cancer in man or animal: Provided, That
clause (i) of this subparagraph (B) shall not apply with respect to
the use of a color additive as an ingredient of feed for animals
which are raised for food production, if the Secretary finds that,
under the conditions of use and feeding specified in proposed
labeling and reasonably certain to be followed in practice, such
additive will not adversely affect the animals for which such feed
is intended, and that no residue of the additive will be found (by
methods of examination prescribed or approved by the Secretary by
regulations, which regulations shall not be subject to subsection
(d) of this section) in any edible portion of such animals after
slaughter or in any food yielded by or derived from the living
animal.
(C)(i) In any proceeding for the issuance, amendment, or repeal
of a regulation listing a color additive, whether commenced by a
proposal of the Secretary on his own initiative or by a proposal
contained in a petition, the petitioner, or any other person who
will be adversely affected by such proposal or by the Secretary's
order issued in accordance with paragraph (1) of section 371(e) of
this title if placed in effect, may request, within the time
specified in this subparagraph, that the petition or order thereon,
or the Secretary's proposal, be referred to an advisory committee
for a report and recommendations with respect to any matter arising
under subparagraph (B) of this paragraph, which is involved in such
proposal or order and which requires the exercise of scientific
judgment. Upon such request, or if the Secretary within such time
deems such a referral necessary, the Secretary shall forthwith
appoint an advisory committee under subparagraph (D) of this
paragraph and shall refer to it, together with all the data before
him, such matter arising under subparagraph (B) for study thereof
and for a report and recommendations on such matter. A person who
has filed a petition or who has requested the referral of a matter
to an advisory committee pursuant to this subparagraph (C), as well
as representatives of the Department, shall have the right to
consult with such advisory committee in connection with the matter
referred to it. The request for referral under this subparagraph,
or the Secretary's referral on his own initiative, may be made at
any time before, or within thirty days after, publication of an
order of the Secretary acting upon the petition or proposal.
(ii) Within sixty days after the date of such referral, or within
an additional thirty days if the committee deems such additional
time necessary, the committee shall, after independent study of the
data furnished to it by the Secretary and other data before it,
certify to the Secretary a report and recommendations, together
with all underlying data and a statement of the reasons or basis
for the recommendations. A copy of the foregoing shall be promptly
supplied by the Secretary to any person who has filed a petition,
or who has requested such referral to the advisory committee.
Within thirty days after such certification, and after giving due
consideration to all data then before him, including such report,
recommendations, underlying data, and statement, and to any prior
order issued by him in connection with such matter, the Secretary
shall by order confirm or modify any order theretofore issued or,
if no such prior order has been issued, shall by order act upon the
petition or other proposal.
(iii) Where -
(I) by reason of subparagraph (B) of this paragraph, the
Secretary has initiated a proposal to remove from listing a color
additive previously listed pursuant to this section; and
(II) a request has been made for referral of such proposal to
an advisory committee;
the Secretary may not act by order on such proposal until the
advisory committee has made a report and recommendations to him
under clause (ii) of this subparagraph and he has considered such
recommendations, unless the Secretary finds that emergency
conditions exist necessitating the issuance of an order
notwithstanding this clause.
(D) The advisory committee referred to in subparagraph (C) of
this paragraph shall be composed of experts selected by the
National Academy of Sciences, qualified in the subject matter
referred to the committee and of adequately diversified
professional background, except that in the event of the inability
or refusal of the National Academy of Sciences to act, the
Secretary shall select the members of the committee. The size of
the committee shall be determined by the Secretary. Members of any
advisory committee established under this chapter, while attending
conferences or meetings of their committees or otherwise serving at
the request of the Secretary, shall be entitled to receive
compensation at rates to be fixed by the Secretary but at rates not
exceeding the daily equivalent of the rate specified at the time of
such service for grade GS-18 of the General Schedule, including
traveltime; and while away from their homes or regular places of
business they may be allowed travel expenses, including per diem in
lieu of subsistence, as authorized by section 5703 of title 5 for
persons in the Government service employed intermittently. The
members shall not be subject to any other provisions of law
regarding the appointment and compensation of employees of the
United States. The Secretary shall furnish the committee with
adequate clerical and other assistance, and shall by rules and
regulations prescribe the procedure to be followed by the
committee.
(6) The Secretary shall not list a color additive under this
subsection for a proposed use if the data before him show that such
proposed use would promote deception of the consumer in violation
of this chapter or would otherwise result in misbranding or
adulteration within the meaning of this chapter.
(7) If, in the judgment of the Secretary, a tolerance limitation
is required in order to assure that a proposed use of a color
additive will be safe, the Secretary -
(A) shall not list the additive for such use if he finds that
the data before him do not establish that such additive, if used
within a safe tolerance limitation, would achieve the intended
physical or other technical effect; and
(B) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
intended physical or other technical effect.
(8) If, having regard to the aggregate quantity of color additive
likely to be consumed in the diet or to be applied to the human
body, the Secretary finds that the data before him fail to show
that it would be safe and otherwise permissible to list a color
additive (or pharmacologically related color additives) for all the
uses proposed therefor and at the levels of concentration proposed,
the Secretary shall, in determining for which use or uses such
additive (or such related additives) shall be or remain listed, or
how the aggregate allowable safe tolerance for such additive or
additives shall be allocated by him among the uses under
consideration, take into account, among other relevant factors (and
subject to the paramount criterion of safety), (A) the relative
marketability of the articles involved as affected by the proposed
uses of the color additive (or of such related additives) in or on
such articles, and the relative dependence of the industries
concerned on such uses; (B) the relative aggregate amounts of such
color additive which he estimates would be consumed in the diet or
applied to the human body by reason of the various uses and levels
of concentration proposed; and (C) the availability, if any, of
other color additives suitable and safe for one or more of the uses
proposed.
(c) Certification of colors
The Secretary shall further, by regulation, provide (1) for the
certification, with safe diluents or without diluents, of batches
of color additives listed pursuant to subsection (b) of this
section and conforming to the requirements for such additives
established by regulations under such subsection and this
subsection, and (2) for exemption from the requirement of
certification in the case of any such additive, or any listing or
use thereof, for which he finds such requirement not to be
necessary in the interest of the protection of the public health:
Provided, That, with respect to any use in or on food for which a
listed color additive is deemed to be safe by reason of the proviso
to paragraph (4) of subsection (b), the requirement of
certification shall be deemed not to be necessary in the interest
of public health protection.
(d) Procedure for issuance, amendment, or repeal of regulations
The provisions of section 371(e), (f), and (g) of this title
shall, subject to the provisions of subparagraph (C) of subsection
(b)(5) of this section, apply to and in all respects govern
proceedings for the issuance, amendment, or repeal of regulations
under subsection (b) or (c) of this section (including judicial
review of the Secretary's action in such proceedings) and the
admissibility of transcripts of the record of such proceedings in
other proceedings, except that -
(1) if the proceeding is commenced by the filing of a petition,
notice of the proposal made by the petition shall be published in
general terms by the Secretary within thirty days after such
filing, and the Secretary's order (required by paragraph (1) of
section 371(e) of this title) acting upon such proposal shall, in
the absence of prior referral (or request for referral) to an
advisory committee, be issued within ninety days after the date
of such filing, except that the Secretary may (prior to such
ninetieth day), by written notice to the petitioner, extend such
ninety-day period to such time (not more than one hundred and
eighty days after the date of filing of the petition) as the
Secretary deems necessary to enable him to study and investigate
the petition;
(2) any report, recommendations, underlying data, and reasons
certified to the Secretary by an advisory committee appointed
pursuant to subparagraph (D) of subsection (b)(5) of this
section, shall be made a part of the record of any hearing if
relevant and material, subject to the provisions of section
556(d) of title 5. The advisory committee shall designate a
member to appear and testify at any such hearing with respect to
the report and recommendations of such committee upon request of
the Secretary, the petitioner, or the officer conducting the
hearing, but this shall not preclude any other member of the
advisory committee from appearing and testifying at such hearing;
(3) the Secretary's order after public hearing (acting upon
objections filed to an order made prior to hearing) shall be
subject to the requirements of section 348(f)(2) of this title;
and
(4) the scope of judicial review of such order shall be in
accordance with the fourth sentence of paragraph (2), and with
the provisions of paragraph (3), of section 348(g) of this title.
(e) Fees
The admitting to listing and certification of color additives, in
accordance with regulations prescribed under this chapter, shall be
performed only upon payment of such fees, which shall be specified
in such regulations, as may be necessary to provide, maintain, and
equip an adequate service for such purposes.
(f) Exemptions
The Secretary shall by regulations (issued without regard to
subsection (d) of this section) provide for exempting from the
requirements of this section any color additive or any specific
type of use thereof, and any article of food, drug, or device, or
cosmetic bearing or containing such additive, intended solely for
investigational use by qualified experts when in his opinion such
exemption is consistent with the public health.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 721, formerly Sec. 706, 52 Stat.
1058; Pub. L. 86-618, title I, Sec. 103(b), July 12, 1960, 74 Stat.
399; Pub. L. 87-781, title I, Sec. 104(f)(2), Oct. 10, 1962, 76
Stat. 785; Pub. L. 91-515, title VI, Sec. 601(d)(2), Oct. 30, 1970,
84 Stat. 1311; Pub. L. 94-295, Sec. 9(a), May 28, 1976, 90 Stat.
583; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
renumbered Sec. 721, Pub. L. 102-571, title I, Sec. 106(4), Oct.
29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(bb), Aug. 13,
1993, 107 Stat. 778.)
-COD-
CODIFICATION
Section was formerly classified to section 376 of this title
prior to renumbering by Pub. L. 102-571.
In subsec. (d)(2), "section 556(d) of title 5" substituted for
"section 7(c) of the Administrative Procedure Act (5 U.S.C., sec.
1006(c))" on authority of Pub. L. 89-554, Sec. 7(b), Sept. 6, 1966,
80 Stat. 631, the first section of which enacted Title 5,
Government Organization and Employees.
-MISC1-
AMENDMENTS
1993 - Subsec. (b)(5)(D). Pub. L. 103-80 substituted "section
5703" for "section 5703(b)".
1992 - Subsec. (b)(5)(C)(i). Pub. L. 102-300 struck out "of
Health, Education, and Welfare" after "representatives of the
Department".
1976 - Subsec. (a). Pub. L. 94-295, Sec. 9(a)(2), (3), inserted
reference to devices and inserted provisions directing that color
additives for use in or on devices be subject to this section only
if the color additives come in direct contact with the body of man
or other animals for a significant period of time and authorizing
the Secretary to designate by regulation the uses of color
additives in or on devices which are subject to this section.
Subsec. (b). Pub. L. 94-295, Sec. 9(a)(1), (2), substituted "drug
or device" for "drug" and "drugs or devices" for "drugs" wherever
appearing.
Subsec. (f). Pub. L. 94-295, Sec. 9(a)(1), substituted "drug or
device" for "drug".
1970 - Subsec. (b)(5)(D). Pub. L. 91-515 substituted provisions
authorizing members of an advisory committee to receive
compensation at rates fixed by the Secretary, with a specific
maximum amount, and travel expenses, including per diem in lieu of
subsistence, as authorized by section 5703(b) of Title 5, for
provisions authorizing such members to receive as compensation a
reasonable per diem for time actually spent on committee work, and
necessary traveling and subsistence expenses while serving away
from their places of residence.
1962 - Subsec. (b)(5)(B). Pub. L. 87-781 provided that clause (i)
of this subparagraph shall not apply to a color additive in feed of
animals raised for food production, if under the conditions of use
specified in proposed labeling, and which conditions are reasonably
certain to be followed in practice, such additive will not
adversely affect the animals and no residue will be found in any
edible portion of such animal after slaughter or in any food from
the living animal.
1960 - Pub. L. 86-618 amended section generally. Prior to
amendment, section read as follows: "The admitting to listing and
certification of coal-tar colors, in accordance with regulations
prescribed under this chapter, shall be performed only upon payment
of such fees, which shall be specified in such regulations, as may
be necessary to provide, maintain, and equip an adequate service
for such purposes."
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1960 AMENDMENT, TRANSITIONAL PROVISIONS, AND
EFFECT ON OTHER LAWS
Title II of Pub. L. 86-618 provided that:
"Sec. 201. [Definitions.] As used in this title, the term 'basic
Act' means the Federal Food, Drug, and Cosmetic Act [this chapter];
the term 'enactment date' means the date of enactment of this Act
[July 12, 1960]; and other terms, insofar as also used in the basic
Act (whether before or after enactment of this Act) shall have the
same meaning as they have, or had when in effect, under the basic
Act.
"Sec. 202. [Effective Date.] This Act [amending this section and
sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
of this title and repealing sections 354 and 364 of this title]
shall, subject to the provisions of section 203, take effect on the
enactment date [July 12, 1960].
"Sec. 203. [Provisional Listings of Commercially Established
Colors.] (a)(1) The purpose of this section is to make possible, on
an interim basis for a reasonable period, through provisional
listings, the use of commercially established color additives to
the extent consistent with the public health, pending the
completion of the scientific investigations needed as a basis for
making determinations as to listing of such additives under the
basic Act as amended by this Act. A provisional listing (including
a deemed provisional listing) of a color additive under this
section for any use shall, unless sooner terminated or expiring
under the provisions of this section, expire (A) on the closing
date (as defined in paragraph (2) of this subsection) or (B) on the
effective date of a listing of such additive for such use under
section 706 [now 721] of the basic Act, [this section], whichever
date first occurs.
"(2) For the purposes of this section, the term 'closing date'
means (A) the last day of the two and one-half year period
beginning on the enactment date [July 12, 1960] or (B), with
respect to a particular provisional listing (or deemed provisional
listing) of a color additive or use thereof, such later closing
date as the Secretary may from time to time establish pursuant to
the authority of this paragraph. The Secretary may by regulation,
upon application of an interested person or on his own initiative,
from time to time postpone the original closing date with respect
to a provisional listing (or deemed provisional listing) under this
section of a specified color additive, or of a specified use or
uses of such additive, for such period or periods as he finds
necessary to carry out the purpose of this section, if in the
Secretary's judgment such action is consistent with the objective
of carrying to completion in good faith, as soon as reasonably
practicable, the scientific investigations necessary for making a
determination as to listing such additive, or such specified use or
uses thereof, under section 706 [now 721] of the basic Act [this
section]. The Secretary may terminate a postponement of the closing
date at any time if he finds that such postponement should not have
been granted, or that by reason of a change in circumstances the
basis for such postponement no longer exists, or that there has
been a failure to comply with a requirement for submission of
progress reports or with other conditions attached to such
postponement.
"(b) Subject to the other provisions of this section -
"(1) any color additive which, on the day preceding the
enactment date [July 12, 1960], was listed and certifiable for
any use or uses under section 406(b), 504, or 604 [section
346(b), 354, or 364 of this title], or under the third proviso of
section 402(c) [section 342(c) of this title], of the basic Act,
and of which a batch or batches had been certified for such use
or uses prior to the enactment date [July 12, 1960], and
"(2) any color additive which was commercially used or sold
prior to the enactment date [July 12, 1960] for any use or uses
in or on any food, drug, or cosmetic, and which either, (A), on
the day preceding the enactment date [July 12, 1960], was not a
material within the purview of any of the provisions of the basic
Act enumerated in paragraph (1) of this subsection, or (B) is the
color additive known as synthetic beta-carotene,
shall, beginning on the enactment date [July 12, 1960], be deemed
to be provisionally listed under this section as a color additive
for such use or uses.
"(c) Upon request of any person, the Secretary, by regulations
issued under subsection (d), shall without delay, if on the basis
of the data before him he deems such action consistent with the
protection of the public health, provisionally list a material as a
color additive for any use for which it was listed, and for which a
batch or batches of such material had been certified, under section
406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364
of this title] prior to the enactment date [July 12, 1960],
although such color was no longer listed and certifiable for such
use under such sections on the day preceding the enactment date.
Such provisional listing shall take effect on the date of
publication.
"(d)(1) The Secretary shall, by regulations issued or amended
from time to time under this section -
"(A) insofar as practicable promulgate and keep current a list
or lists of the color additives, and of the particular uses
thereof, which he finds are deemed provisionally listed under
subsection (b), and the presence of a color additive on such a
list with respect to a particular use shall, in any proceeding
under the basic Act, be conclusive evidence that such provisional
listing is in effect;
"(B) provide for the provisional listing of the color additives
and particular uses thereof specified in subsection (c);
"(C) provide, with respect to particular uses for which color
additives are or are deemed to be provisionally listed, such
temporary tolerance limitations (including such limitations at
zero level) and other conditions of use and labeling or packaging
requirements, if any, as in his judgment are necessary to protect
the public health pending listing under section 706 [now 721] of
the basic Act [this section];
"(D) provide for the certification of batches of such color
additives (with or without diluents) for the uses for which they
are so listed or deemed to be listed under this section, except
that such an additive which is a color additive deemed
provisionally listed under subsection (b)(2) of this section
shall be deemed exempt from the requirement of such certification
while not subject to a tolerance limitation; and
"(E) provide for the termination of a provisional listing (or
deemed provisional listing) of a color additive or particular use
thereof forthwith whenever in his judgment such action is
necessary to protect the public health.
"(2)(A) Except as provided in subparagraph (C) of this paragraph,
regulations under this section shall, from time to time, be issued,
amended, or repealed by the Secretary without regard to the
requirements of the basic Act [subsec. (e) of this section], but
for the purposes of the application of section 706(e) [now 721(e)]
of the basic Act (relating to fees) and of determining the
availability of appropriations of fees (and of advance deposits to
cover fees), proceedings, regulations, and certifications under
this section shall be deemed to be proceedings, regulations, and
certifications under such section 706 [now 721, this section].
Regulations providing for fees (and advance deposits to cover
fees), which on the day preceding the enactment date [July 12,
1960] were in effect pursuant to section 706 [now 721] of the basic
Act [this section], shall be deemed to be regulations under such
section 706 [now 721, this section] as amended by this Act, and
appropriations of fees (and advance deposits) available for the
purposes specified in such section 706 [now 721] as in effect prior
to the enactment date [July 12, 1960] shall be available for the
purposes specified in such section 706 [now 721, this section] as
so amended.
"(B) If the Secretary, by regulation -
"(i) has terminated a provisional listing (or deemed
provisional listing) of a color additive or particular use
thereof pursuant to paragraph (1)(E) of this subsection; or
"(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of
this subsection, initially established or rendered more
restrictive a tolerance limitation or other restriction or
requirement with respect to a provisional listing (or deemed
provisional listing) which listing had become effective prior to
such action,
any person adversely affected by such action may, prior to the
expiration of the period specified in clause (A) of subsection
(a)(2) of this section, file with the Secretary a petition for
amendment of such regulation so as to revoke or modify such action
of the Secretary, but the filing of such petition shall not operate
to stay or suspend the effectiveness of such action. Such petition
shall, in accordance with regulations, set forth the proposed
amendment and shall contain data (or refer to data which are before
the Secretary or of which he will take official notice), which show
that the revocation or modification proposed is consistent with the
protection of the public health. The Secretary shall, after
publishing such proposal and affording all interested persons an
opportunity to present their views thereon orally or in writing,
act upon such proposal by published order.
"(C) Any person adversely affected by an order entered under
subparagraph (B) of this paragraph may, within thirty days after
its publication, file objections thereto with the Secretary,
specifying with particularity the provisions of the order deemed
objectionable, stating reasonable grounds for such objections, and
requesting a public hearing upon such objections. The Secretary
shall hold a public hearing on such objections and shall, on the
basis of the evidence adduced at such hearing, act on such
objections by published order. Such order may reinstate a
terminated provisional listing, or increase or dispense with a
previously established temporary tolerance limitation, or make less
restrictive any other limitation established by him under paragraph
(1) or (3) of this subsection, only if in his judgment the evidence
so adduced shows that such action will be consistent with the
protection of the public health. An order entered under this
subparagraph shall be subject to judicial review in accordance with
section 701(f) of the basic Act [section 371(f) of this title]
except that the findings and order of the Secretary shall be
sustained only if based upon a fair evaluation of the entire record
at such hearing. No stay or suspension of such order shall be
ordered by the court pending conclusion of such judicial review.
"(D) On and after the enactment date [July 12, 1960],
regulations, provisional listings, and certifications (or
exemptions from certification) in effect under this section shall,
for the purpose of determining whether an article is adulterated or
misbranded within the meaning of the basic Act by reason of its
being, bearing, or containing a color additive, have the same
effect as would regulations, listings, and certifications (or
exemptions from certification) under section 706 [now 721] of the
basic Act [this section]. A regulation, provisional listing or
termination thereof, tolerance limitation, or certification or
exemption therefrom, under this section shall not be the basis for
any presumption or inference in any proceeding under section 706(b)
or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of
this section].
"(3) For the purpose of enabling the Secretary to carry out his
functions under paragraphs (1)(A) and (C) of this subsection with
respect to color additives deemed provisionally listed, he shall,
as soon as practicable after enactment of this Act [July 12, 1960],
afford by public notice a reasonable opportunity to interested
persons to submit data relevant thereto. If the data so submitted
or otherwise before him do not, in his judgment, establish a
reliable basis for including such a color additive or particular
use or uses thereof in a list or lists promulgated under paragraph
(1)(A), or for determining the prevailing level or levels of use
thereof prior to the enactment date [July 12, 1960] with a view to
prescribing a temporary tolerance or tolerances for such use or
uses under paragraph (1)(C), the Secretary shall establish a
temporary tolerance limitation at zero level for such use or uses
until such time as he finds that it would not be inconsistent with
the protection of the public health to increase or dispense with
such temporary tolerance limitation.
"Sec. 204. [Effect on Meat Inspection and Poultry Products
Inspection Acts.] Nothing in this Act [amending this section and
sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
of this title and repealing sections 354 and 364 of this title]
shall be construed to exempt any meat or meat food product, poultry
or poultry product, or any person from any requirement imposed by
or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat.
1260, as amended or extended (21 U.S.C. 71 and the following) [see
section 601 et seq. of this title] or the Poultry Products
Inspection Act (21 U.S.C. 451 and the following)."
EFFECTIVE DATE; ACCELERATION
This section was made "immediately effective" by act May 2, 1939,
ch. 107, title I, Sec. 1, 53 Stat. 631.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees in existence on Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period following Jan.
5, 1973, and advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year period
beginning on the date of their establishment, unless in the case of
a committee established by the President or an officer of the
Federal Government, such committee is renewed by appropriate action
prior to the expiration of such 2-year period, or in the case of a
committee established by Congress, its duration is otherwise
provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
-End-
-CITE-
21 USC Part C - Fees 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
-HEAD-
PART C - FEES
-End-
-CITE-
21 USC subpart 1 - freedom of information fees 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 1 - freedom of information fees
-HEAD-
SUBPART 1 - FREEDOM OF INFORMATION FEES
-End-
-CITE-
21 USC Sec. 379f 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 1 - freedom of information fees
-HEAD-
Sec. 379f. Recovery and retention of fees for freedom of
information requests
-STATUTE-
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs,
may -
(1) set and charge fees, in accordance with section
552(a)(4)(A) of title 5, to recover all reasonable costs incurred
in processing requests made under section 552 of title 5 for
records obtained or created under this chapter or any other
Federal law for which responsibility for administration has been
delegated to the Commissioner by the Secretary;
(2) retain all fees charged for such requests; and
(3) establish an accounting system and procedures to control
receipts and expenditures of fees received under this section.
(b) Use of fees
The Secretary and the Commissioner of Food and Drugs shall not
use fees received under this section for any purpose other than
funding the processing of requests described in subsection (a)(1)
of this section. Such fees shall not be used to reduce the amount
of funds made to carry out other provisions of this chapter.
(c) Waiver of fees
Nothing in this section shall supersede the right of a requester
to obtain a waiver of fees pursuant to section 552(a)(4)(A) of
title 5.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 731, formerly Sec. 711, as added Pub.
L. 101-635, title II, Sec. 201, Nov. 28, 1990, 104 Stat. 4584;
renumbered Sec. 731, Pub. L. 102-571, title I, Sec. 106(6), Oct.
29, 1992, 106 Stat. 4499.)
-COD-
CODIFICATION
Section was formerly classified to section 379c of this title
prior to renumbering by Pub. L. 102-571.
-End-
-CITE-
21 USC subpart 2 - fees relating to drugs 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 2 - fees relating to drugs
-HEAD-
SUBPART 2 - FEES RELATING TO DRUGS
-STATAMEND-
TERMINATION OF SUBPART
For termination of subpart by section 105 of Pub. L. 102-571, see
Termination Date note set out under section 379g of this title.
-End-
-CITE-
21 USC Sec. 379g 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 2 - fees relating to drugs
-HEAD-
Sec. 379g. Definitions
-STATUTE-
For purposes of this part:
(1) The term "human drug application" means an application for -
(A) approval of a new drug submitted under section 355(b)(1)
of this title,
(B) approval of a new drug submitted under section 355(b)(2)
of this title after September 30, 1992, which requests approval
of -
(i) a molecular entity which is an active ingredient
(including any salt or ester of an active ingredient), or
(ii) an indication for a use,
that had not been approved under an application submitted under
section 355(b) of this title, or
(C) licensure of a biological product under section 262 of
title 42.
Such term does not include a supplement to such an application,
does not include an application with respect to whole blood or a
blood component for transfusion, does not include an application
with respect to a bovine blood product for topical application
licensed before September 1, 1992, an allergenic extract product,
or an in vitro diagnostic biologic product licensed under section
262 of title 42, does not include an application with respect to
a large volume parenteral drug product approved before September
1, 1992, does not include an application for a licensure of a
biological product for further manufacturing use only, and does
not include an application or supplement submitted by a State or
Federal Government entity for a drug that is not distributed
commercially. Such term does include an application for
licensure, as described in subparagraph (C), of a large volume
biological product intended for single dose injection for
intravenous use or infusion.
(2) The term "supplement" means a request to the Secretary to
approve a change in a human drug application which has been
approved.
(3) The term "prescription drug product" means a specific
strength or potency of a drug in final dosage form -
(A) for which a human drug application has been approved,
(B) which may be dispensed only under prescription pursuant
to section 353(b) of this title, and
(C) which is on the list of products described in section
355(j)(7)(A) of this title or is on a list created and
maintained by the Secretary of products approved under human
drug applications under section 262 of title 42.
Such term does not include whole blood or a blood component for
transfusion, does not include a bovine blood product for topical
application licensed before September 1, 1992, an allergenic
extract product, or an in vitro diagnostic biologic product
licensed under section 262 of title 42. Such term does not
include a biological product that is licensed for further
manufacturing use only, and does not include a drug that is not
distributed commercially and is the subject of an application or
supplement submitted by a State or Federal Government entity.
Such term does include a large volume biological product intended
for single dose injection for intravenous use or infusion.
(4) The term "final dosage form" means, with respect to a
prescription drug product, a finished dosage form which is
approved for administration to a patient without substantial
further manufacturing.
(5) The term "prescription drug establishment" means a foreign
or domestic place of business which is at one general physical
location consisting of one or more buildings all of which are
within five miles of each other and at which one or more
prescription drug products are manufactured in final dosage form.
For purposes of this paragraph, the term "manufactured" does not
include packaging.
(6) The term "process for the review of human drug
applications" means the following activities of the Secretary
with respect to the review of human drug applications and
supplements:
(A) The activities necessary for the review of human drug
applications and supplements.
(B) The issuance of action letters which approve human drug
applications or which set forth in detail the specific
deficiencies in such applications and, where appropriate, the
actions necessary to place such applications in condition for
approval.
(C) The inspection of prescription drug establishments and
other facilities undertaken as part of the Secretary's review
of pending human drug applications and supplements.
(D) Activities necessary for the review of applications for
licensure of establishments subject to section 262 of title 42
and for the release of lots of biologics under such section.
(E) Monitoring of research conducted in connection with the
review of human drug applications.
(F) In the case of drugs approved after October 1, 2002,
under human drug applications or supplements: collecting,
developing, and reviewing safety information on the drugs,
including adverse event reports, during a period of time after
approval of such applications or supplements, not to exceed
three years.
(7) The term "costs of resources allocated for the process for
the review of human drug applications" means the expenses
incurred in connection with the process for the review of human
drug applications for -
(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such
officers, employees, and committees and to contracts with such
contractors,
(B) management of information, and the acquisition,
maintenance, and repair of computer resources,
(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other necessary
materials and supplies, and
(D) collecting fees under section 379h of this title and
accounting for resources allocated for the review of human drug
applications and supplements.
(8) The term "adjustment factor" applicable to a fiscal year is
the Consumer Price Index for all urban consumers (all items;
United States city average) for April of the preceding fiscal
year divided by such Index for April 1997.
(9) The term "affiliate" means a business entity that has a
relationship with a second business entity if, directly or
indirectly -
(A) one business entity controls, or has the power to
control, the other business entity; or
(B) a third party controls, or has power to control, both of
the business entities.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 735, as added Pub. L. 102-571, title
I, Sec. 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105-
115, title I, Secs. 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat.
2298, 2326; Pub. L. 107-188, title V, Sec. 503, June 12, 2002, 116
Stat. 688.)
-STATAMEND-
AMENDMENT OF SECTION
For termination of amendment by section 509 of Pub. L. 107-188,
see Effective and Termination Dates of 2002 Amendments note below.
For termination of amendment by section 107 of Pub. L. 105-115,
see Effective and Termination Dates of 1997 Amendment note below.
TERMINATION OF SECTION
For termination of section by section 105 of Pub. L. 102-571, see
Termination Date note below.
-MISC1-
AMENDMENTS
2002 - Par. (1). Pub. L. 107-188, Secs. 503(1), 509, temporarily
substituted "licensure, as described in subparagraph (C)" for
"licensure, as described in subparagraph (D)" in concluding
provisions. See Effective and Termination Dates of 2002 Amendment
note below.
Par. (3). Pub. L. 107-188, Secs. 503(2)(D), 509, which directed
the temporary amendment of concluding provisions of par. (3) by
striking "section 262 of title 42" and all that follows through
"biological product" and inserting "section 262 of title 42. Such
term does not include a biological product", was executed by
striking language ending with "biological product" the first time
appearing, thereby making the substitution for "section 262 of
title 42, does not include a large volume parenteral drug product
approved before September 1, 1992, does not include a biological
product", to reflect the probable intent of Congress. See Effective
and Termination Dates of 2002 Amendment note below.
Par. (3)(C). Pub. L. 107-188, Secs. 503(2)(A)-(C), 509,
temporarily added subpar. (C). See Effective and Termination Dates
of 2002 Amendment note below.
Par. (6)(F). Pub. L. 107-188, Secs. 503(3), 509, temporarily
added subpar. (F). See Effective and Termination Dates of 2002
Amendment note below.
Par. (8). Pub. L. 107-188, Secs. 503(4), 509, temporarily struck
out designations of subpars. (A) and (B) and text of subpar. (B)
and concluding provisions, substituting definition of "adjustment
factor" as the Consumer Price Index for definition of Index as the
lower of the Consumer Price Index or the total of discretionary
budget authority provided for programs in the domestic category for
the immediately preceding fiscal year divided by such budget
authority for fiscal year 1997. See Effective and Termination Dates
of 2002 Amendment note below.
1997 - Par. (1). Pub. L. 105-115, Secs. 102(1), 107, in closing
provisions, temporarily struck out "and" before "does not include
an application" and substituted "September 1, 1992, does not
include an application for a licensure of a biological product for
further manufacturing use only, and does not include an application
or supplement submitted by a State or Federal Government entity for
a drug that is not distributed commercially. Such term does include
an application for licensure, as described in subparagraph (D), of
a large volume biological product intended for single dose
injection for intravenous use or infusion" for "September 1, 1992"
before period at end. See Effective and Termination Dates of 1997
Amendment note below.
Par. (1)(B) to (D). Pub. L. 105-115, Sec. 125(b)(2)(M), inserted
"or" at end of subpar. (B), redesignated subpar. (D) as (C), and
struck out former subpar. (C) which read as follows: "initial
certification or initial approval of an antibiotic drug under
section 357 of this title, or".
Par. (3). Pub. L. 105-115, Secs. 102(2), 107, in closing
provisions, temporarily struck out "and" before "does not include a
large volume parenteral drug" and substituted "September 1, 1992,
does not include a biological product that is licensed for further
manufacturing use only, and does not include a drug that is not
distributed commercially and is the subject of an application or
supplement submitted by a State or Federal Government entity. Such
term does include a large volume biological product intended for
single dose injection for intravenous use or infusion" for
"September 1, 1992" before period at end. See Effective and
Termination Dates of 1997 Amendment note below.
Par. (4). Pub. L. 105-115, Secs. 102(3), 107, temporarily
substituted "without substantial further manufacturing" for
"without further manufacturing". See Effective and Termination
Dates of 1997 Amendment note below.
Par. (5). Pub. L. 105-115, Secs. 102(4), 107, temporarily amended
first sentence generally. Prior to amendment, first sentence read
as follows: "The term 'prescription drug establishment' means a
foreign or domestic place of business which is -
"(A) at one general physical location consisting of one or more
buildings all of which are within 5 miles of each other, at which
one or more prescription drug products are manufactured in final
dosage form, and
"(B) under the management of a person that is listed as the
applicant in a human drug application for a prescription drug
product with respect to at least one such product."
See Effective and Termination Dates of 1997 Amendment note below.
Par. (7)(A). Pub. L. 105-115, Secs. 102(5), 107, temporarily
substituted "contractors of the Food and Drug Administration," for
"employees under contract with the Food and Drug Administration who
work in facilities owned or leased for the Food and Drug
Administration," and "and committees and to contracts with such
contractors," for "and committees,". See Effective and Termination
Dates of 1997 Amendment note below.
Par. (8)(A). Pub. L. 105-115, Secs. 102(6)(A), 107, temporarily
substituted "April of the preceding fiscal year" for "August of the
preceding fiscal year" and "April 1997" for "August 1992". See
Effective and Termination Dates of 1997 Amendment note below.
Par. (8)(B). Pub. L. 105-115, Secs. 102(6)(B), 107, temporarily
substituted "section 254(c)" for "section 254(d)", "fiscal year
1997" for "fiscal year 1992", and "105th Congress, 1st Session" for
"102d Congress, 2d Session". See Effective and Termination Dates of
1997 Amendment note below.
Par. (9). Pub. L. 105-115, Secs. 102(7), 107, temporarily added
par. (9). See Effective and Termination Dates of 1997 Amendment
note below.
EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT
Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
508 of Pub. L. 107-188, set out as an Effective Date of 2002
Amendment note under section 356b of this title.
Pub. L. 107-188, title V, Sec. 509, June 12, 2002, 116 Stat. 694,
provided that: "The amendments made by sections 503 and 504
[amending this section and section 379h of this title] cease to be
effective October 1, 2007, and section 505 [enacting provisions set
out as a note below] ceases to be effective 120 days after such
date."
EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
Section 106 of title I of Pub. L. 105-115 provided that: "The
amendments made by this subtitle [subtitle A (Secs. 101-107) of
title I of Pub. L. 105-115, amending this section and section 379h
of this title] shall take effect October 1, 1997."
Section 107 of Pub. L. 105-115 provided that: "The amendments
made by sections 102 and 103 [amending this section and section
379h of this title] cease to be effective October 1, 2002, and
section 104 [enacting provisions formerly set out as a note below]
ceases to be effective 120 days after such date."
TERMINATION DATE
Section 105 of Pub. L. 102-571 provided that: "The amendments
made by section 103 [enacting this subpart] shall not be in effect
after October 1, 1997 and section 104 [enacting provisions set out
as a note below] shall not be in effect after 120 days after such
date."
SAVINGS PROVISION
Pub. L. 107-188, title V, Sec. 507, June 12, 2002, 116 Stat. 694,
provided that: "Notwithstanding section 107 of the Food and Drug
Administration Modernization Act of 1997 [section 107 of Pub. L.
105-115, set out as an Effective and Termination Dates of 1997
Amendment note above], and notwithstanding the amendments made by
this subtitle [subtitle A (Secs. 501-509) of title V of Pub. L. 107-
188, amending this section and sections 356b and 379h of this
title], part 2 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act [this subpart], as in effect on the day
before the date of the enactment of this Act [June 12, 2002],
continues to be in effect with respect to human drug applications
and supplements (as defined in such part as of such day) that, on
or after October 1, 1997, but before October 1, 2002, were accepted
by the Food and Drug Administration for filing and with respect to
assessing and collecting any fee required by such Act for a fiscal
year prior to fiscal year 2003."
Section 105 of Pub. L. 105-115 provided that: "Notwithstanding
section 105 of the Prescription Drug User Fee Act of 1992 [section
105 of Pub. L. 102-571, set out above], the Secretary shall retain
the authority to assess and collect any fee required by part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act [this subpart] for a human drug application or supplement
accepted for filing prior to October 1, 1997, and to assess and
collect any product or establishment fee required by such Act for a
fiscal year prior to fiscal year 1998."
ACCOUNTABILITY AND REPORTS
Pub. L. 107-188, title V, Sec. 505, June 12, 2002, 116 Stat. 692,
provided that:
"(a) Public Accountability. -
"(1) Consultation. - In developing recommendations to the
Congress for the goals and plans for meeting the goals for the
process for the review of human drug applications for the fiscal
years after fiscal year 2007, and for the reauthorization of
sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 379g, 379h], the Secretary of Health and Human
Services (referred to in this section as the 'Secretary') shall
consult with the Committee on Energy and Commerce of the House of
Representatives, the Committee on Health, Education, Labor, and
Pensions of the Senate, appropriate scientific and academic
experts, health care professionals, representatives of patient
and consumer advocacy groups, and the regulated industry.
"(2) Recommendations. - The Secretary shall publish in the
Federal Register recommendations under paragraph (1), after
negotiations with the regulated industry; shall present such
recommendations to the congressional committees specified in such
paragraph; shall hold a meeting at which the public may present
its views on such recommendations; and shall provide for a period
of 30 days for the public to provide written comments on such
recommendations.
"(b) Performance Report. - Beginning with fiscal year 2003, not
later than 60 days after the end of each fiscal year during which
fees are collected under part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.),
the Secretary of Health and Human Services shall prepare and submit
to the President, the Committee on Energy and Commerce of the House
of Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of the
Food and Drug Administration in achieving the goals identified in
the letters described in section 502(4) [section 502(4) of Pub. L.
107-188, set out below] during such fiscal year and the future
plans of the Food and Drug Administration for meeting the goals.
"(c) Fiscal Report. - Beginning with fiscal year 2003, not later
than 120 days after the end of each fiscal year during which fees
are collected under the part described in subsection (b), the
Secretary of Health and Human Services shall prepare and submit to
the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report on the implementation of the
authority for such fees during such fiscal year and the use, by the
Food and Drug Administration, of the fees collected during such
fiscal year for which the report is made."
[Section 505 of Pub. L. 107-188, set out above, ceases to be
effective 120 days after Oct. 1, 2007, see Effective and
Termination Dates of 2002 Amendment note above.]
CONGRESSIONAL FINDINGS CONCERNING FEES RELATING TO DRUGS
Pub. L. 107-188, title V, Sec. 502, June 12, 2002, 116 Stat. 687,
provided that: "The Congress finds that -
"(1) prompt approval of safe and effective new drugs and other
therapies is critical to the improvement of the public health so
that patients may enjoy the benefits provided by these therapies
to treat and prevent illness and disease;
"(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for the review of human drug applications and the assurance of
drug safety;
"(3) the provisions added by the Prescription Drug User Fee Act
of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
Short Title of 1992 Amendment note under section 301 of this
title], as amended by the Food and Drug Administration
Modernization Act of 1997 [see Short Title of 1997 Amendment note
set out under section 301 of this title], have been successful in
substantially reducing review times for human drug applications
and should be -
"(A) reauthorized for an additional 5 years, with certain
technical improvements; and
"(B) carried out by the Food and Drug Administration with new
commitments to implement more ambitious and comprehensive
improvements in regulatory processes of the Food and Drug
Administration, including -
"(i) strengthening and improving the review and monitoring
of drug safety;
"(ii) considering greater interaction between the agency
and sponsors during the review of drugs and biologics
intended to treat serious diseases and life-threatening
diseases; and
"(iii) developing principles for improving first-cycle
reviews; and
"(4) the fees authorized by amendments made in this subtitle
[subtitle A (Secs. 501-509) of title V of Pub. L. 107-188,
amending this section and sections 356b and 379h of this title]
will be dedicated towards expediting the drug development process
and the process for the review of human drug applications as set
forth in the goals identified for purposes of part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act [this subpart], in the letters from the Secretary of
Health and Human Services to the chairman of the Committee on
Energy and Commerce of the House of Representatives and the
chairman of the Committee on Health, Education, Labor and
Pensions of the Senate, as set forth in the Congressional
Record."
Pub. L. 105-115, title I, Sec. 101, Nov. 21, 1997, 111 Stat.
2298, provided that: "Congress finds that -
"(1) prompt approval of safe and effective new drugs and other
therapies is critical to the improvement of the public health so
that patients may enjoy the benefits provided by these therapies
to treat and prevent illness and disease;
"(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for review of human drug applications;
"(3) the provisions added by the Prescription Drug User Fee Act
of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
Short Title of 1992 Amendment note under section 301 of this
title] have been successful in substantially reducing review
times for human drug applications and should be -
"(A) reauthorized for an additional 5 years, with certain
technical improvements; and
"(B) carried out by the Food and Drug Administration with new
commitments to implement more ambitious and comprehensive
improvements in regulatory processes of the Food and Drug
Administration; and
"(4) the fees authorized by amendments made in this subtitle
[subtitle A (Secs. 101-107) of title I of Pub. L. 105-115,
amending this section and section 379h of this title] will be
dedicated toward expediting the drug development process and the
review of human drug applications as set forth in the goals
identified, for purposes of part 2 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act [this subpart], in
the letters from the Secretary of Health and Human Services to
the chairman of the Committee on Commerce of the House of
Representatives and the chairman of the Committee on Labor and
Human Resources [now Committee on Health, Education, Labor, and
Pensions] of the Senate, as set forth in the Congressional
Record."
ANNUAL REPORTS
Pub. L. 105-115, title I, Sec. 104, Nov. 21, 1997, 111 Stat.
2304, which directed the Secretary of Health and Human Services to
prepare and submit to Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources of
the Senate, within 60 days after the end of each fiscal year during
which fees are collected under this subpart, a report stating the
Food and Drug Administration's progress in achieving the goals
identified in the letters described in section 101(4) of Pub. L.
105-115, set out above, during such fiscal year and the
Administration's future plans for meeting the goals, and within 120
days after the end of each fiscal year during which fees are
collected, to prepare and submit a report on the implementation of
the authority for such fees during such fiscal year and on the use
the Administration made of the fees collected during such fiscal
year, ceased to be effective 120 days after Oct. 1, 2002. See
section 107 of Pub. L. 105-115, set out as an Effective and
Termination Dates of 1997 Amendment note above.
CONGRESSIONAL FINDINGS CONCERNING PRESCRIPTION DRUG USER FEES
Section 102 of title I of Pub. L. 102-571 provided that: "The
Congress finds that -
"(1) prompt approval of safe and effective new drugs is
critical to the improvement of the public health so that patients
may enjoy the benefits provided by these therapies to treat and
prevent illness and disease;
"(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for review of human drug applications; and
"(3) the fees authorized by this title [see Short Title of 1992
Amendment note, set out under section 301 of this title] will be
dedicated toward expediting the review of human drug applications
as set forth in the goals identified in the letters of September
14, 1992, and September 21, 1992, from the Commissioner of Food
and Drugs to the Chairman of the Energy and Commerce Committee of
the House of Representatives and the Chairman of the Labor and
Human Resources Committee of the Senate, as set forth at 138
Cong. Rec. H9099-H9100 (daily ed. September 22, 1992)."
ANNUAL REPORTS
Pub. L. 102-571, title I, Sec. 104, Oct. 29, 1992, 106 Stat.
4498, which provided that the Secretary of Health and Human
Services submit to Committee on Energy and Commerce of the House of
Representatives and Committee on Labor and Human Resources of the
Senate, within 60 days after the end of each fiscal year during
which fees were collected under this subpart, a report stating the
Food and Drug Administration's progress in achieving the goals
identified in section 102(3) of Pub. L. 102-571, set out as a note
above, during such fiscal year and that agency's future plans for
meeting such goals, and within 120 days after the end of each
fiscal year during which such fees were collected, a report on the
implementation of the authority for such fees during such fiscal
year and on the use the Food and Drug Administration made of the
fees collected during such fiscal year, ceased to be in effect 120
days after Oct. 1, 1997. See Termination Date note above.
ANIMAL DRUG USER FEE STUDY
Section 108 of Pub. L. 102-571 directed Secretary, in
consultation with manufacturers of animal drug products and other
interested persons, to undertake study to evaluate whether, and
under what conditions, to impose user fees to supplement
appropriated funds in order to improve process of reviewing
applications (including abbreviated and supplemental applications)
for new animal drugs under section 360b of this title, and further
provided for submission of study to Congress no later than Jan. 4,
1994.
-End-
-CITE-
21 USC Sec. 379h 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 2 - fees relating to drugs
-HEAD-
Sec. 379h. Authority to assess and use drug fees
-STATUTE-
(a) Types of fees
Beginning in fiscal year 2003, the Secretary shall assess and
collect fees in accordance with this section as follows:
(1) Human drug application and supplement fee
(A) In general
Each person that submits, on or after September 1, 1992, a
human drug application or a supplement shall be subject to a
fee as follows:
(i) A fee established under subsection (c)(4) of this
section for a human drug application for which clinical data
(other than bioavailability or bioequivalence studies) with
respect to safety or effectiveness are required for approval.
(ii) A fee established under subsection (c)(4) of this
section for a human drug application for which clinical data
with respect to safety or effectiveness are not required or a
supplement for which clinical data (other than
bioavailability or bioequivalence studies) with respect to
safety or effectiveness are required. Such fee shall be half
of the amount of the fee established under clause (i).
(B) Payment
The fee required by subparagraph (A) shall be due upon
submission of the application or supplement.
(C) Exception for previously filed application or supplement
If a human drug application or supplement was submitted by a
person that paid the fee for such application or supplement,
was accepted for filing, and was not approved or was withdrawn
(without a waiver), the submission of a human drug application
or a supplement for the same product by the same person (or the
person's licensee, assignee, or successor) shall not be subject
to a fee under subparagraph (A).
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under
subparagraph (B) for any application or supplement which is
refused for filing.
(E) Exception for designated orphan drug or indication
A human drug application for a prescription drug product that
has been designated as a drug for a rare disease or condition
pursuant to section 360bb of this title shall not be subject to
a fee under subparagraph (A), unless the human drug application
includes an indication for other than a rare disease or
condition. A supplement proposing to include a new indication
for a rare disease or condition in a human drug application
shall not be subject to a fee under subparagraph (A), if the
drug has been designated pursuant to section 360bb of this
title as a drug for a rare disease or condition with regard to
the indication proposed in such supplement.
(F) Refund of fee if application withdrawn
If an application or supplement is withdrawn after the
application or supplement was filed, the Secretary may refund
the fee or a portion of the fee if no substantial work was
performed on the application or supplement after the
application or supplement was filed. The Secretary shall have
the sole discretion to refund a fee or a portion of the fee
under this subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall not be
reviewable.
(2) Prescription drug establishment fee
(A) In general
Except as provided in subparagraph (B), each person that -
(i) is named as the applicant in a human drug application;
and
(ii) after September 1, 1992, had pending before the
Secretary a human drug application or supplement,
shall be assessed an annual fee established under subsection
(c)(4) of this section for each prescription drug establishment
listed in its approved human drug application as an
establishment that manufactures the prescription drug product
named in the application. The annual establishment fee shall be
assessed in each fiscal year in which the prescription drug
product named in the application is assessed a fee under
paragraph (3) unless the prescription drug establishment listed
in the application does not engage in the manufacture of the
prescription drug product during the fiscal year. The
establishment fee shall be payable on or before October 1 of
each year. Each such establishment shall be assessed only one
fee per establishment, notwithstanding the number of
prescription drug products manufactured at the establishment.
In the event an establishment is listed in a human drug
application by more than one applicant, the establishment fee
for the fiscal year shall be divided equally and assessed among
the applicants whose prescription drug products are
manufactured by the establishment during the fiscal year and
assessed product fees under paragraph (3).
(B) Exception
If, during the fiscal year, an applicant initiates or causes
to be initiated the manufacture of a prescription drug product
at an establishment listed in its human drug application -
(i) that did not manufacture the product in the previous
fiscal year; and
(ii) for which the full establishment fee has been assessed
in the fiscal year at a time before manufacture of the
prescription drug product was begun;
the applicant will not be assessed a share of the establishment
fee for the fiscal year in which the manufacture of the product
began.
(3) Prescription drug product fee
(A) In general
Except as provided in subparagraph (B), each person who is
named as the applicant in a human drug application, and who,
after September 1, 1992, had pending before the Secretary a
human drug application or supplement, shall pay for each such
prescription drug product the annual fee established under
subsection (c)(4) of this section. Such fee shall be payable on
or before October 1 of each year. Such fee shall be paid only
once for each product for a fiscal year in which the fee is
payable.
(B) Exception
A prescription drug product shall not be assessed a fee under
subparagraph (A) if such product is identified on the list
compiled under section 355(j)(7)(A) of this title with a
potency described in terms of per 100 mL, or if such product is
the same product as another product approved under an
application filed under section 355(b) or 355(j) of this title,
under an abbreviated application filed under section 357 of
this title (as in effect on the day before November 21, 1997),
or under an abbreviated new drug application pursuant to
regulations in effect prior to the implementation of the Drug
Price Competition and Patent Term Restoration Act of 1984.
(b) Fee revenue amounts
Except as provided in subsections (c), (d), (f), and (g) of this
section, fees under subsection (a) of this section shall be
established to generate the following revenue amounts:
Type of Fee Revenue: Application/Supplement
Fiscal Year 2003: $74,300,000
Fiscal Year 2004: $77,000,000
Fiscal Year 2005: $84,000,000
Fiscal Year 2006: $86,434,000
Fiscal Year 2007: $86,434,000
Type of Fee Revenue: Establishment
Fiscal Year 2003: $74,300,000
Fiscal Year 2004: $77,000,000
Fiscal Year 2005: $84,000,000
Fiscal Year 2006: $86,433,000
Fiscal Year 2007: $86,433,000
Type of Fee Revenue: Product
Fiscal Year 2003: $74,300,000
Fiscal Year 2004: $77,000,000
Fiscal Year 2005: $84,000,000
Fiscal Year 2006: $86,433,000
Fiscal Year 2007: $86,433,000
Type of Fee Revenue: Total Fee Revenue
Fiscal Year 2003: $222,900,000
Fiscal Year 2004: $231,000,000
Fiscal Year 2005: $252,000,000
Fiscal Year 2006: $259,300,000
Fiscal Year 2007: $259,300,000
--------------------------------------------------------------------
If, after June 12, 2002, legislation is enacted requiring the
Secretary to fund additional costs of the retirement of Federal
personnel, fee revenue amounts shall be increased in each year by
the amount necessary to fully fund the portion of such additional
costs that are attributable to the process for the review of human
drug applications.
(c) Adjustments
(1) Inflation adjustment
The revenues established in subsection (b) of this section
shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year to reflect the greater of -
(A) the total percentage change that occurred in the Consumer
Price Index for all urban consumers (all items; U.S. city
average) for the 12 month period ending June 30 preceding the
fiscal year for which fees are being established, or
(B) the total percentage change for the previous fiscal year
in basic pay under the General Schedule in accordance with
section 5332 of title 5, as adjusted by any locality-based
comparability payment pursuant to section 5304 of such title
for Federal employees stationed in the District of Columbia.
The adjustment made each fiscal year by this subsection will be
added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2003 under this subsection.
(2) Workload adjustment
Beginning with fiscal year 2004, after the fee revenues
established in subsection (b) of this section are adjusted for a
fiscal year for inflation in accordance with paragraph (1), the
fee revenues shall be adjusted further for such fiscal year to
reflect changes in the workload of the Secretary for the process
for the review of human drug applications. With respect to such
adjustment:
(A) The adjustment shall be determined by the Secretary based
on a weighted average of the change in the total number of
human drug applications, commercial investigational new drug
applications, efficacy supplements, and manufacturing
supplements submitted to the Secretary. The Secretary shall
publish in the Federal Register the fee revenues and fees
resulting from the adjustment and the supporting methodologies.
(B) Under no circumstances shall the adjustment result in fee
revenues for a fiscal year that are less than the fee revenues
for the fiscal year established in subsection (b) of this
section, as adjusted for inflation under paragraph (1).
(3) Final year adjustment
For fiscal year 2007, the Secretary may, in addition to
adjustments under paragraphs (1) and (2), further increase the
fee revenues and fees established in subsection (b) of this
section if such an adjustment is necessary to provide for not
more than three months of operating reserves of carryover user
fees for the process for the review of human drug applications
for the first three months of fiscal year 2008. If such an
adjustment is necessary, the rationale for the amount of the
increase shall be contained in the annual notice establishing fee
revenues and fees for fiscal year 2007. If the Secretary has
carryover balances for such process in excess of three months of
such operating reserves, the adjustment under this paragraph
shall not be made.
(4) Annual fee setting
The Secretary shall, 60 days before the start of each fiscal
year that begins after September 30, 2002, establish, for the
next fiscal year, application, product, and establishment fees
under subsection (a) of this section, based on the revenue
amounts established under subsection (b) of this section and the
adjustments provided under this subsection.
(5) Limit
The total amount of fees charged, as adjusted under this
subsection, for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for the process for
the review of human drug applications.
(d) Fee waiver or reduction
(1) In general
The Secretary shall grant a waiver from or a reduction of one
or more fees assessed under subsection (a) of this section where
the Secretary finds that -
(A) such waiver or reduction is necessary to protect the
public health,
(B) the assessment of the fee would present a significant
barrier to innovation because of limited resources available to
such person or other circumstances,
(C) the fees to be paid by such person will exceed the
anticipated present and future costs incurred by the Secretary
in conducting the process for the review of human drug
applications for such person, or
(D) the applicant involved is a small business submitting its
first human drug application to the Secretary for review.
(2) Use of standard costs
In making the finding in paragraph (1)(C), the Secretary may
use standard costs.
(3) Rules relating to small businesses
(A) "Small business" defined
In paragraph (1)(D), the term "small business" means an
entity that has fewer than 500 employees, including employees
of affiliates.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(D) the
application fee for the first human drug application that a
small business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is granted such
a waiver, the small business or its affiliate shall pay -
(i) application fees for all subsequent human drug
applications submitted to the Secretary for review in the
same manner as an entity that does not qualify as a small
business; and
(ii) all supplement fees for all supplements to human drug
applications submitted to the Secretary for review in the
same manner as an entity that does not qualify as a small
business.
(e) Effect of failure to pay fees
A human drug application or supplement submitted by a person
subject to fees under subsection (a) of this section shall be
considered incomplete and shall not be accepted for filing by the
Secretary until all fees owed by such person have been paid.
(f) Limitations
(1) In general
Fees under subsection (a) of this section shall be refunded for
a fiscal year beginning after fiscal year 1997 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of fees
appropriated for such fiscal year) are equal to or greater than
the amount of appropriations for the salaries and expenses of the
Food and Drug Administration for the fiscal year 1997 (excluding
the amount of fees appropriated for such fiscal year) multiplied
by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) of
this section during any portion of a fiscal year because of
paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
human drug applications and supplements, prescription drug
establishments, and prescription drug products at any time in
such fiscal year notwithstanding the provisions of subsection (a)
of this section relating to the date fees are to be paid.
(g) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) of this section shall be
collected and available for obligation only to the extent and in
the amount provided in advance in appropriations Acts. Such fees
are authorized to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account for
salaries and expenses with such fiscal year limitation. The sums
transferred shall be available solely for the process for the
review of human drug applications.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section -
(i) shall be retained in each fiscal year in an amount not
to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation, for such fiscal
year, and
(ii) shall only be collected and available to defray
increases in the costs of the resources allocated for the
process for the review of human drug applications (including
increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process) over such costs,
excluding costs paid from fees collected under this section,
for fiscal year 1997 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the
requirements of subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated for the process
for the review of human drug applications -
(i) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified
in subparagraph (A)(ii), and fees assessed for the fiscal
year following the subsequent fiscal year are decreased by
the amount in excess of 3 percent by which such costs fell
below the level specified in such subparagraph; and
(II) such costs are not more than 5 percent below the level
specified in such subparagraph.
(3) Authorization of appropriations
There are authorized to be appropriated for fees under this
section -
(A) $222,900,000 for fiscal year 2003;
(B) $231,000,000 for fiscal year 2004;
(C) $252,000,000 for fiscal year 2005;
(D) $259,300,000 for fiscal year 2006; and
(E) $259,300,000 for fiscal year 2007;
as adjusted to reflect adjustments in the total fee revenues made
under this section and changes in the total amounts collected by
application, supplement, establishment, and product fees.
(4) Offset
Any amount of fees collected for a fiscal year under this
section that exceeds the amount of fees specified in
appropriation Acts for such fiscal year shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected
under this section pursuant to appropriation Acts for a
subsequent fiscal year.
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee
assessed under subsection (a) of this section within 30 days after
it is due, such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 of title
31.
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under
subsection (d) of this section, or for a refund of any fee
collected in accordance with subsection (a) of this section, a
person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee
is due.
(j) Construction
This section may not be construed to require that the number of
full-time equivalent positions in the Department of Health and
Human Services, for officers, employers, and advisory committees
not engaged in the process of the review of human drug
applications, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 736, as added Pub. L. 102-571, title
I, Sec. 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105-
115, title I, Sec. 103(a)-(g), Nov. 21, 1997, 111 Stat. 2299-2304;
Pub. L. 107-109, Sec. 5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L.
107-188, title V, Sec. 504, June 12, 2002, 116 Stat. 689.)
-STATAMEND-
AMENDMENT OF SECTION
For termination of amendment by section 509 of Pub. L. 107-188,
see Effective and Termination Dates of 2002 Amendments note below.
For termination of amendment by section 107 of Pub. L. 105-115,
see Effective and Termination Dates of 1997 Amendment note below.
TERMINATION OF SECTION
For termination of section by section 105 of Pub. L. 102-571, see
Termination Date note below.
-REFTEXT-
REFERENCES IN TEXT
Section 357 of this title, referred to in subsec. (a)(3)(B), was
repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
1997, 111 Stat. 2325.
The Drug Price Competition and Patent Term Restoration Act of
1984, referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept.
24, 1984, 98 Stat. 1585. For complete classification of this Act to
the Code, see Short Title of 1984 Amendment note set out under
section 301 of this title and Tables.
-MISC1-
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-188, Secs. 504(a)(1), 509,
temporarily substituted "fiscal year 2003" for "fiscal year 1998"
in introductory provisions. See Effective and Termination Dates of
2002 Amendment note below.
Subsec. (a)(1)(A)(i). Pub. L. 107-188, Secs. 504(a)(2)(A), 509,
temporarily substituted "under subsection (c)(4)" for "in
subsection (b)". See Effective and Termination Dates of 2002
Amendment note below.
Subsec. (a)(1)(A)(ii). Pub. L. 107-188, Secs. 504(a)(2), 509,
temporarily substituted "under subsection (c)(4)" for "in
subsection (b)" and inserted "Such fee shall be half of the amount
of the fee established under clause (i)." at end. See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (a)(1)(F), (G). Pub. L. 107-109 redesignated subpar. (G)
as (F) and struck out heading and text of former subpar. (F). Text
read as follows: "A supplement to a human drug application
proposing to include a new indication for use in pediatric
populations shall not be assessed a fee under subparagraph (A)."
Subsec. (a)(2)(A). Pub. L. 107-188, Secs. 504(a)(3), 509, in
concluding provisions, temporarily substituted "under subsection
(c)(4)" for "in subsection (b)" and "payable on or before October
1" for "payable on or before January 31". See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (a)(3)(A). Pub. L. 107-188, Secs. 504(a)(4)(A), 509,
temporarily amended heading and text of subpar. (A) generally.
Prior to amendment, text read as follows: "Except as provided in
subparagraph (B), each person -
"(i) who is named as the applicant in a human drug application
for a prescription drug product which has been submitted for
listing under section 360 of this title, and
"(ii) who, after September 1, 1992, had pending before the
Secretary a human drug application or supplement,
shall pay for each such prescription drug product the annual fee
established in subsection (b) of this section. Such fee shall be
payable for the fiscal year in which the product is first submitted
for listing under section 360 of this title, or is submitted for
relisting under section 360 of this title if the product has been
withdrawn from listing and relisted. After such fee is paid for
that fiscal year, such fee shall be payable on or before January 31
of each year. Such fee shall be paid only once for each product for
a fiscal year in which the fee is payable." See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (a)(3)(B). Pub. L. 107-188, Secs. 504(a)(4)(B), 509,
temporarily substituted "A prescription drug product shall not be
assessed a fee under subparagraph (A) if such product is identified
on the list compiled under section 355(j)(7)(A) of this title with
a potency described in terms of per 100 mL, or if such product is
the same product as another product approved under an application
filed under section 355(b)" for "The listing of a prescription drug
product under section 360 of this title shall not require the
person who listed such product to pay the fee prescribed by
subparagraph (A) if such product is the same product as a product
approved under an application filed under section 355(b)(2)". See
Effective and Termination Dates of 2002 Amendment note below.
Subsec. (b). Pub. L. 107-188, Secs. 504(b), 509, temporarily
amended heading and text of subsec. (b) generally, substituting
"Fee revenue amounts" for "Fee amounts" in heading and substituting
fee schedules for fiscal years 2003 to 2007 for fee provisions
relating to fiscal years 1998 to 2002. See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (c)(1). Pub. L. 107-188, Secs. 504(c)(1)(A), (D), 509,
temporarily substituted "revenues" for "fees and total fee
revenues" in introductory provisions and "fiscal year 2003" for
"fiscal year 1997" in concluding provisions. See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (c)(1)(A). Pub. L. 107-188, Secs. 504(c)(1)(B), 509,
temporarily struck out "during the preceding fiscal year" before
"in the Consumer Price Index" and substituted "for the 12 month
period ending June 30 preceding the fiscal year for which fees are
being established, or" for ", or". See Effective and Termination
Dates of 2002 Amendment note below.
Subsec. (c)(1)(B). Pub. L. 107-188, Secs. 504(c)(1)(C), 509,
temporarily substituted "for the previous fiscal year" for "for
such fiscal year". See Effective and Termination Dates of 2002
Amendment note below.
Subsec. (c)(2) to (5). Pub. L. 107-188, Secs. 504(c)(2)-(4), 509,
temporarily added pars. (2) and (3), redesignated former pars. (2)
and (3) as (4) and (5), respectively, and amended heading and text
of par. (4) generally. Prior to amendment, text of par. (4) read as
follows: "Subject to the amount appropriated for a fiscal year
under subsection (g) of this section, the Secretary shall, within
60 days after the end of each fiscal year beginning after September
30, 1997, adjust the establishment and product fees described in
subsection (b) of this section for the fiscal year in which the
adjustment occurs so that the revenues collected from each of the
categories of fees described in paragraphs (2) and (3) of
subsection (b) of this section shall be set to be equal to the
revenues collected from the category of application and supplement
fees described in paragraph (1) of subsection (b) of this section."
See Effective and Termination Dates of 2002 Amendment note below.
Subsec. (d)(1)(C) to (E). Pub. L. 107-188, Secs. 504(d)(1), 509,
temporarily inserted "or" at end of subpar. (C), redesignated
subpar. (E) as (D), and struck out former subpar. (D) which read as
follows: "assessment of the fee for an application or a supplement
filed under section 355(b)(1) of this title pertaining to a drug
containing an active ingredient would be inequitable because an
application for a product containing the same active ingredient
filed by another person under section 355(b)(2) of this title could
not be assessed fees under subsection (a)(1) of this section, or".
See Effective and Termination Dates of 2002 Amendment note below.
Subsec. (d)(3)(A), (B). Pub. L. 107-188, Secs. 504(d)(2), 509,
temporarily substituted "paragraph (1)(D)" for "paragraph (1)(E)".
See Effective and Termination Dates of 2002 Amendment note below.
Subsec. (f). Pub. L. 107-188, Secs. 504(e)(1), 509, temporarily
substituted "Limitations" for "Assessment of fees" in heading. See
Effective and Termination Dates of 2002 Amendment note below.
Subsec. (f)(1). Pub. L. 107-188, Secs. 504(e)(2), 509,
temporarily substituted "In general" for "Limitation" in heading
and "Fees under subsection (a) of this section shall be refunded
for a fiscal year beginning" for "Fees may not be assessed under
subsection (a) of this section for a fiscal year beginning" in
text. See Effective and Termination Dates of 2002 Amendment note
below.
Subsec. (g)(1). Pub. L. 107-188, Secs. 504(f)(1), 509, which
directed the temporary amendment of par. (1) by striking "Fees
collected for a fiscal year" and all that follows through "fiscal
year limitation." and inserting "Fees authorized under subsection
(a) of this section shall be collected and available for obligation
only to the extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain available
until expended.", was executed by striking language ending with
"fiscal year limitation." the first time appearing, thereby making
the substitution for "Fees collected for a fiscal year pursuant to
subsection (a) of this section shall be credited to the
appropriation account for salaries and expenses of the Food and
Drug Administration and shall be available in accordance with
appropriation Acts until expended without fiscal year limitation.",
to reflect the probable intent of Congress. See Effective and
Termination Dates of 2002 Amendment note below.
Subsec. (g)(2). Pub. L. 107-188, Secs. 504(f)(2), 509,
temporarily amended par. (2) by designating existing provisions as
subpar. (A), inserting subpar. (A) heading, adding subpar. (B),
redesignating former subpars. (A) and (B) as cls. (i) and (ii),
respectively, of subpar. (A), substituting "shall be retained in
each fiscal year in an amount not to exceed the amount specified"
for "shall be collected in each fiscal year in an amount equal to
the amount specified" in cl. (i), and realigning margin of cl.
(ii). See Effective and Termination Dates of 2002 Amendment note
below.
Subsec. (g)(3)(A) to (E). Pub. L. 107-188, Secs. 504(f)(3), 509,
temporarily added subpars. (A) to (E) and struck out former
subpars. (A) to (E) which read as follows:
"(A) $106,800,000 for fiscal year 1998;
"(B) $109,200,000 for fiscal year 1999;
"(C) $109,200,000 for fiscal year 2000;
"(D) $114,000,000 for fiscal year 2001; and
"(E) $110,100,000 for fiscal year 2002,".
See Effective and Termination Dates of 2002 Amendment note below.
1997 - Subsec. (a). Pub. L. 105-115, Secs. 103(a)(1), 107,
temporarily substituted "Beginning in fiscal year 1998" for
"Beginning in fiscal year 1993" in introductory provisions. See
Effective and Termination Dates of 1997 Amendment note below.
Subsec. (a)(1)(B). Pub. L. 105-115, Secs. 103(a)(2)(A), 107,
temporarily amended heading and text of subpar. (B) generally.
Prior to amendment, text read as follows:
"(i) First payment. - 50 percent of the fee required by
subparagraph (A) shall be due upon submission of the application or
supplement.
"(ii) Final payment. - The remaining 50 percent of the fee
required by subparagraph (A) shall be due upon -
"(I) the expiration of 30 days from the date the Secretary
sends to the applicant a letter designated by the Secretary as an
action letter described in section 379g(6)(B) of this title, or
"(II) the withdrawal of the application or supplement after it
is filed unless the Secretary waives the fee or a portion of the
fee because no substantial work was performed on such application
or supplement after it was filed.
The designation under subclause (I) or the waiver under subclause
(II) shall be solely in the discretion of the Secretary and shall
not be reviewable." See Effective and Termination Dates of 1997
Amendment note below.
Subsec. (a)(1)(D). Pub. L. 105-115, Secs. 103(a)(2)(B), 107,
temporarily substituted "refused" for "not accepted" in heading and
"75 percent" for "50 percent", "subparagraph (B)" for "subparagraph
(B)(i)", and "refused" for "not accepted" in text. See Effective
and Termination Dates of 1997 Amendment note below.
Subsec. (a)(1)(E) to (G). Pub. L. 105-115, Secs. 103(a)(2)(C),
107, temporarily added subpars. (E) to (G). See Effective and
Termination Dates of 1997 Amendment note below.
Subsec. (a)(2). Pub. L. 105-115, Secs. 103(a)(3), 107,
temporarily reenacted heading without change and amended text
generally. Prior to amendment, text read as follows: "Each person
that -
"(A) owns a prescription drug establishment, at which is
manufactured at least 1 prescription drug product which is not
the, or not the same as a, product approved under an application
filed under section 355(b)(2) or 355(j) of this title, and
"(B) after September 1, 1992, had pending before the Secretary
a human drug application or supplement,
shall be subject to the annual fee established in subsection (b) of
this section for each such establishment, payable on or before
January 31 of each year." See Effective and Termination Dates of
1997 Amendment note below.
Subsec. (a)(3)(A). Pub. L. 105-115, Secs. 103(a)(4)(A), 107,
temporarily substituted, in cl. (i), "has been submitted for
listing" for "is listed" and, in closing provisions, "Such fee
shall be payable for the fiscal year in which the product is first
submitted for listing under section 360 of this title, or is
submitted for relisting under section 360 of this title if the
product has been withdrawn from listing and relisted. After such
fee is paid for that fiscal year, such fee shall be payable on or
before January 31 of each year. Such fee shall be paid only once
for each product for a fiscal year in which the fee is payable."
for "Such fee shall be payable at the time of the first such
listing of such product in each calendar year. Such fee shall be
paid only once each year for each listed prescription drug product
irrespective of the number of times such product is listed under
section 360 of this title." See Effective and Termination Dates of
1997 Amendment note below.
Subsec. (a)(3)(B). Pub. L. 105-115, Secs. 103(a)(4)(B), 107,
temporarily substituted "355(j) of this title, under an abbreviated
application filed under section 357 of this title (as in effect on
the day before November 21, 1997), or under an abbreviated new drug
application pursuant to regulations in effect prior to the
implementation of the Drug Price Competition and Patent Term
Restoration Act of 1984." for "355(j) of this title.". See
Effective and Termination Dates of 1997 Amendment note below.
Subsec. (b). Pub. L. 105-115, Secs. 103(b), 107, temporarily
amended subsec. (b) generally. Prior to amendment, subsec. (b)
related to fee amounts, including a schedule of fees in par. (1)
and fee exceptions for certain small businesses in par. (2). See
Effective and Termination Dates of 1997 Amendment note below.
Subsec. (c). Pub. L. 105-115, Secs. 103(c)(1), 107, temporarily
substituted "Adjustments" for "Increases and adjustments" in
heading. See Effective and Termination Dates of 1997 Amendment note
below.
Subsec. (c)(1). Pub. L. 105-115, Secs. 103(c)(2), 107,
temporarily substituted "Inflation adjustment" for "Revenue
increase" in heading, "The fees and total fee revenues established
in subsection (b) of this section shall be adjusted by the
Secretary" for "The total fee revenues established by the schedule
in subsection (b)(1) of this section shall be increased by the
Secretary" in introductory provisions, and "change" for "increase"
after "total percentage" in subpars. (A) and (B), and inserted at
end "The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 1997 under this subsection." See
Effective and Termination Dates of 1997 Amendment note below.
Subsec. (c)(2). Pub. L. 105-115, Secs. 103(c)(3), 107,
temporarily substituted "September 30, 1997, adjust the
establishment and product fees described in subsection (b) of this
section for the fiscal year in which the adjustment occurs so that
the revenues collected from each of the categories of fees
described in paragraphs (2) and (3) of subsection (b) of this
section shall be set to be equal to the revenues collected from the
category of application and supplement fees described in paragraph
(1) of subsection (b) of this section." for "October 1, 1992,
adjust the fees established by the schedule in subsection (b)(1) of
this section for the following fiscal year to achieve the total fee
revenues, as may be increased under paragraph (1). Such fees shall
be adjusted under this paragraph to maintain the proportions
established in such schedule." See Effective and Termination Dates
of 1997 Amendment note below.
Subsec. (c)(3). Pub. L. 105-115, Secs. 103(c)(4), 107,
temporarily substituted "this subsection" for "paragraph (2)". See
Effective and Termination Dates of 1997 Amendment note below.
Subsec. (d). Pub. L. 105-115, Secs. 103(d), 107, temporarily
struck out introductory provisions which read "The Secretary shall
grant a waiver from or a reduction of 1 or more fees under
subsection (a) of this section where the Secretary finds that - "
and closing provisions which read "In making the finding in
paragraph (3), the Secretary may use standard costs.", inserted
designation, heading, and introductory provisions of par. (1),
redesignated former pars. (1) to (4) as subpars. (A) to (D),
respectively, of par. (1), and added pars. (1)(E), (2), and (3).
See Effective and Termination Dates of 1997 Amendment note below.
Subsec. (f)(1). Pub. L. 105-115, Secs. 103(e), 107, temporarily
substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal
year 1997 (excluding the amount of fees appropriated for such
fiscal year)" for "fiscal year 1992". See Effective and Termination
Dates of 1997 Amendment note below.
Subsec. (g)(1). Pub. L. 105-115, Secs. 103(f)(1), 107,
temporarily inserted at end "Such sums as may be necessary may be
transferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the process for the review of human drug applications."
See Effective and Termination Dates of 1997 Amendment note below.
Subsec. (g)(2)(A). Pub. L. 105-115, Secs. 103(f)(2)(A), 107,
temporarily substituted "Acts, or otherwise made available for
obligation," for "Acts". See Effective and Termination Dates of
1997 Amendment note below.
Subsec. (g)(2)(B). Pub. L. 105-115, Secs. 103(f)(2)(B), 107,
temporarily substituted "over such costs, excluding costs paid from
fees collected under this section, for fiscal year 1997" for "over
such costs for fiscal year 1992". See Effective and Termination
Dates of 1997 Amendment note below.
Subsec. (g)(3), (4). Pub. L. 105-115, Secs. 103(f)(3), 107,
temporarily added pars. (3) and (4) and struck out heading and text
of former par. (3). Text read as follows: "There are authorized to
be appropriated for fees under this section -
"(A) $36,000,000 for fiscal year 1993,
"(B) $54,000,000 for fiscal year 1994,
"(C) $75,000,000 for fiscal year 1995,
"(D) $78,000,000 for fiscal year 1996, and
"(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made
under subsection (c)(1) of this section." See Effective and
Termination Dates of 1997 Amendment note below.
Subsecs. (i), (j). Pub. L. 105-115, Secs. 103(g), 107,
temporarily added subsec. (i) and redesignated former subsec. (i)
as (j). See Effective and Termination Dates of 1997 Amendment note
below.
EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT
Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
508 of Pub. L. 107-188, set out as an Effective Date of 2002
Amendment note under section 356b of this title.
Amendment by Pub. L. 107-188 to cease to be effective Oct. 1,
2007, see section 509 of Pub. L. 107-188, set out as a note under
section 379g of this title.
EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective Oct. 1, 1997, and ceases
to be effective Oct. 1, 2002, see sections 106 and 107 of Pub. L.
105-115, set out as notes under section 379g of this title.
TERMINATION DATE
Section not in effect after Oct. 1, 1997, see section 105 of Pub.
L. 102-571, set out as a note under section 379g of this title.
SPECIAL RULE FOR WAIVERS AND REFUNDS
Section 103(h) of Pub. L. 105-115 provided that: "Any requests
for waivers or refunds for fees assessed under section 736 of the
Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the
date of enactment of this Act [Nov. 21, 1997] shall be submitted in
writing to the Secretary of Health and Human Services within 1 year
after the date of enactment of this Act. Any requests for waivers
or refunds pertaining to a fee for a human drug application or
supplement accepted for filing prior to October 1, 1997 or to a
product or establishment fee required by such Act for a fiscal year
prior to fiscal year 1998, shall be evaluated according to the
terms of the Prescription Drug User Fee Act of 1992 [see section
101(a) of Pub. L. 102-571, set out as a Short Title of 1992
Amendment note under section 301 of this title] (as in effect on
September 30, 1997) and part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.]
(as in effect on September 30, 1997). The term "person" in such
Acts shall continue to include an affiliate thereof."
-End-
-CITE-
21 USC subpart 3 - fees relating to devices 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 3 - fees relating to devices
-HEAD-
SUBPART 3 - FEES RELATING TO DEVICES
-STATAMEND-
TERMINATION OF SUBPART
For termination of subpart by section 107 of Pub. L. 107-250, see
Effective and Termination Dates note set out under section 379i of
this title.
-End-
-CITE-
21 USC Sec. 379i 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 3 - fees relating to devices
-HEAD-
Sec. 379i. Definitions
-STATUTE-
For purposes of this part:
(1) The term "premarket application" means -
(A) an application for approval of a device submitted under
section 360e(c) of this title or section 262 of title 42; or
(B) a product development protocol described in section
360e(f) of this title.
Such term does not include a supplement, a premarket report, or a
premarket notification submission.
(2) The term "premarket report" means a report submitted under
section 360e(c)(2) of this title.
(3) The term "premarket notification submission" means a report
submitted under section 360(k) of this title.
(4)(A) The term "supplement", with respect to a panel-track
supplement, a 180-day supplement, a real-time supplement, or an
efficacy supplement, means a request to the Secretary to approve
a change in a device for which -
(i) an application or report has been approved under section
360e(d) of this title, or an application has been approved
under section 262 of title 42; or
(ii) a notice of completion has become effective under
section 360e(f) of this title.
(B) The term "panel-track supplement" means a supplement to an
approved premarket application or premarket report under section
360e of this title that requests a significant change in design
or performance of the device, or a new indication for use of the
device, and for which substantial clinical data are necessary to
provide a reasonable assurance of safety and effectiveness.
(C) The term "180-day supplement" means a supplement to an
approved premarket application or premarket report under section
360e of this title that is not a panel-track supplement and
requests a significant change in components, materials, design,
specification, software, color additives, or labeling.
(D) The term "real-time supplement" means a supplement to an
approved premarket application or premarket report under section
360e of this title that requests a minor change to the device,
such as a minor change to the design of the device, software,
sterilization, or labeling, and for which the applicant has
requested and the agency has granted a meeting or similar forum
to jointly review and determine the status of the supplement.
(E) The term "efficacy supplement" means a supplement to an
approved premarket application under section 262 of title 42 that
requires substantive clinical data.
(5) The term "process for the review of device applications"
means the following activities of the Secretary with respect to
the review of premarket applications, premarket reports,
supplements, and premarket notification submissions:
(A) The activities necessary for the review of premarket
applications, premarket reports, supplements, and premarket
notification submissions.
(B) The issuance of action letters that allow the marketing
of devices or which set forth in detail the specific
deficiencies in such applications, reports, supplements, or
submissions and, where appropriate, the actions necessary to
place them in condition for approval.
(C) The inspection of manufacturing establishments and other
facilities undertaken as part of the Secretary's review of
pending premarket applications, premarket reports, and
supplements.
(D) Monitoring of research conducted in connection with the
review of such applications, reports, supplements, and
submissions.
(E) Review of device applications subject to section 262 of
title 42 for an investigational new drug application under
section 355(i) of this title or for an investigational device
exemption under section 360j(g) of this title and activities
conducted in anticipation of the submission of such
applications under section 355(i) or 360j(g) of this title.
(F) The development of guidance, policy documents, or
regulations to improve the process for the review of premarket
applications, premarket reports, supplements, and premarket
notification submissions.
(G) The development of voluntary test methods, consensus
standards, or mandatory performance standards under section
360d of this title in connection with the review of such
applications, reports, supplements, or submissions and related
activities.
(H) The provision of technical assistance to device
manufacturers in connection with the submission of such
applications, reports, supplements, or submissions.
(I) Any activity undertaken under section 360c or 360e(i) of
this title in connection with the initial classification or
reclassification of a device or under section 360e(b) of this
title in connection with any requirement for approval of a
device.
(J) Evaluation of postmarket studies required as a condition
of an approval of a premarket application or premarket report
under section 360e of this title or a premarket application
under section 262 of title 42.
(K) Compiling, developing, and reviewing information on
relevant devices to identify safety and effectiveness issues
for devices subject to premarket applications, premarket
reports, supplements, or premarket notification submissions.
(6) The term "costs of resources allocated for the process for
the review of device applications" means the expenses incurred in
connection with the process for the review of device applications
for -
(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such
officers, employees, and committees and to contracts with such
contractors;
(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees and accounting for resources allocated
for the review of premarket applications, premarket reports,
supplements, and submissions.
(7) The term "adjustment factor" applicable to a fiscal year is
the Consumer Price Index for all urban consumers (all items;
United States city average) for April of the preceding fiscal
year divided by such Index for April 2002.
(8) The term "affiliate" means a business entity that has a
relationship with a second business entity (whether domestic or
international) if, directly or indirectly -
(A) one business entity controls, or has the power to
control, the other business entity; or
(B) a third party controls, or has power to control, both of
the business entities.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 737, as added Pub. L. 107-250, title
I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108-
214, Sec. 2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 107 of Pub. L. 107-250, see
Effective and Termination Dates note set out below.
-MISC1-
AMENDMENTS
2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
correction to directory language of Pub. L. 107-250, Sec. 102(a),
which enacted this section.
Par. (4)(B). Pub. L. 108-214, Sec. 2(a)(1)(A), substituted "and
for which substantial clinical data are necessary to provide a
reasonable assurance of safety and effectiveness" for "and for
which clinical data are generally necessary to provide a reasonable
assurance of safety and effectiveness".
Par. (4)(D). Pub. L. 108-214, Sec. 2(a)(1)(B), struck out
"manufacturing," after "software,".
Par. (5)(J). Pub. L. 108-214, Sec. 2(a)(1)(C), substituted "a
premarket application or premarket report under section 360e of
this title or a premarket application under section 262 of title
42." for "a premarket application under section 360e of this title
or section 262 of title 42."
Par. (8). Pub. L. 108-214, Sec. 2(a)(1)(D), substituted "The term
'affiliate' means a business entity that has a relationship with a
second business entity (whether domestic or international)" for
"The term 'affiliate' means a business entity that has a
relationship with a second business entity".
EFFECTIVE AND TERMINATION DATES
Pub. L. 107-250, title I, Sec. 106, Oct. 26, 2002, 116 Stat.
1602, provided that: "The amendments made by this title [enacting
this subpart] shall take effect on the date of the enactment of
this Act [Oct. 26, 2002], except that fees shall be assessed for
all premarket applications, premarket reports, supplements, and
premarket notification submissions received on or after October 1,
2002, regardless of the date of enactment."
Pub. L. 107-250, title I, Sec. 107, Oct. 26, 2002, 116 Stat.
1602, provided that: "The amendments made by this title [enacting
this subpart] cease to be effective October 1, 2007, except that
section 103 [set out as a note below] with respect to annual
reports ceases to be effective January 31, 2008."
FINDINGS
Pub. L. 107-250, title I, Sec. 101, Oct. 26, 2002, 116 Stat.
1589, provided that: "The Congress finds that -
"(1) prompt approval and clearance of safe and effective
devices is critical to the improvement of the public health so
that patients may enjoy the benefits of devices to diagnose,
treat, and prevent disease;
"(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources of
the Food and Drug Administration that are devoted to the process
for the review of devices and the assurance of device safety and
effectiveness so that statutorily mandated deadlines may be met;
and
"(3) the fees authorized by this title [enacting this subpart
and provisions set out as notes under this section and section
379j of this title] will be dedicated to meeting the goals
identified in the letters from the Secretary of Health and Human
Services to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate, as set forth in the Congressional
Record."
ANNUAL REPORTS
Pub. L. 107-250, title I, Sec. 103, Oct. 26, 2002, 116 Stat.
1600, as amended by Pub. L. 109-43, Sec. 2(b), Aug. 1, 2005, 119
Stat. 441, provided that:
"(a) In General. - Beginning with fiscal year 2003, the Secretary
shall prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor and Pensions of the Senate a report concerning -
"(1) the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 101(3) [set out as a note above] during such fiscal year
and the future plans of the Food and Drug Administration for
meeting the goals, not later than 60 days after the end of each
fiscal year during which fees are collected under this part
[title I of Pub. L. 107-250 does not contain parts]; and
"(2) the implementation of the authority for such fees during
such fiscal year, and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year,
not later than 120 days after the end of each fiscal year during
which fees are collected under the medical device user-fee
program established under the amendment made by section 102
[enacting this subpart].
"(b) Additional Information. - For fiscal years 2006 and 2007,
the report described under subsection (a)(2) shall include -
"(1) information on the number of different types of
applications and notifications, and the total amount of fees paid
for each such type of application or notification, from
businesses with gross receipts or sales from $0 to $100,000,000,
with such businesses categorized in $10,000,000 intervals; and
"(2) a certification by the Secretary that the amounts
appropriated for salaries and expenses of the Food and Drug
Administration for such fiscal year and obligated by the
Secretary for the performance of any function relating to devices
that is not for the process for the review of device
applications, as defined in paragraph (5) of section 737 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not
less than such amounts for fiscal year 2002 multiplied by the
adjustment factor, as defined in paragraph (7) of such section
737."
[Section 103 of Pub. L. 107-250, set out above, ceases to be
effective Jan. 31, 2008, see Effective and Termination Dates note
above.]
STUDY
Pub. L. 107-250, title I, Sec. 104(b), Oct. 26, 2002, 116 Stat.
1601, directed the Secretary of Health and Human Services to
conduct a study for the purpose of making certain determinations
regarding the medical device user-fee program established under the
amendment made by section 102 of Pub. L. 107-250 and to submit a
report to Congress by Jan. 10, 2007.
CONSULTATION
Pub. L. 107-250, title I, Sec. 105, Oct. 26, 2002, 116 Stat.
1601, provided that:
"(a) In General. - In developing recommendations to the Congress
for the goals and plans for meeting the goals for the process for
the review of medical device applications for fiscal years after
fiscal year 2007, and for the reauthorization of sections 737 and
738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i,
379j], the Secretary of Health and Human Services (referred to in
this section as the 'Secretary') shall consult with the Committee
on Energy and Commerce of the House of Representatives, the
Committee on Health, Education, Labor, and Pensions of the Senate,
appropriate scientific and academic experts, health care
professionals, representatives of patient and consumer advocacy
groups, and the regulated industry.
"(b) Recommendations. - The Secretary shall publish in the
Federal Register recommendations under subsection (a), after
negotiations with the regulated industry; shall present such
recommendations to the congressional committees specified in such
paragraph; shall hold a meeting at which the public may present its
views on such recommendations; and shall provide for a period of 30
days for the public to provide written comments on such
recommendations."
-End-
-CITE-
21 USC Sec. 379j 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 3 - fees relating to devices
-HEAD-
Sec. 379j. Authority to assess and use device fees
-STATUTE-
(a) Types of fees
(1) In general
Beginning on October 26, 2002, the Secretary shall assess and
collect fees in accordance with this section.
(2) Premarket application, premarket report, supplement, and
submission fee
(A) In general
Except as provided in subparagraph (B) and subsections (d)
and (e) of this section, each person who submits any of the
following, on or after October 1, 2002, shall be subject to a
fee established under subsection (c)(1) of this section for the
fiscal year involved in accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee equal to the fee that
applies under clause (i).
(iii) For a panel track supplement, a fee equal to the fee
that applies under clause (i).
(iv) For a 180-day supplement, a fee equal to 21.5 percent
of the fee that applies under clause (i).
(v) For a real-time supplement, a fee equal to 7.2 percent
of the fee that applies under clause (i).
(vi) For an efficacy supplement, a fee equal to the fee
that applies under clause (i).
(vii) For a premarket notification submission, a fee equal
to 1.42 percent of the fee that applies under clause (i),
subject to any adjustment under subsection (e)(2)(C)(ii) of
this section.
(B) Exceptions
(i) Humanitarian device exemption
An application under section 360j(m) of this title is not
subject to any fee under subparagraph (A).
(ii) Further manufacturing use
No fee shall be required under subparagraph (A) for the
submission of a premarket application under section 262 of
title 42 for a product licensed for further manufacturing use
only.
(iii) State or Federal Government sponsors
No fee shall be required under subparagraph (A) for a
premarket application, premarket report, supplement, or
premarket notification submission submitted by a State or
Federal Government entity unless the device involved is to be
distributed commercially.
(iv) Premarket notifications by third parties
No fee shall be required under subparagraph (A) for a
premarket notification submission reviewed by an accredited
person pursuant to section 360m of this title.
(v) Pediatric conditions of use
(I) In general
No fee shall be required under subparagraph (A) for a
premarket application, premarket report, or premarket
notification submission if the proposed conditions of use
for the device involved are solely for a pediatric
population. No fee shall be required under such
subparagraph for a supplement if the sole purpose of the
supplement is to propose conditions of use for a pediatric
population.
(II) Subsequent proposal of adult conditions of use
In the case of a person who submits a premarket
application or premarket report for which, under subclause
(I), a fee under subparagraph (A) is not required, any
supplement to such application that proposes conditions of
use for any adult population is subject to the fee that
applies under such subparagraph for a premarket
application.
(C) Payment
The fee required by subparagraph (A) shall be due upon
submission of the premarket application, premarket report,
supplement, or premarket notification submission except that
invoices for applications submitted between October 1, 2002,
and October 26, 2002, shall be payable on October 30, 2002.
Applicants submitting portions of applications pursuant to
section 360e(c)(3) (!1) of this title shall pay such fees upon
submission of the first portion of such applications. The fees
credited to fiscal year 2003 under this section shall include
all fees payable from October 1, 2002, through September 30,
2003.
(D) Refunds
(i) Application refused for filing
The Secretary shall refund 75 percent of the fee paid under
subparagraph (A) for any application, report, or supplement
that is refused for filing.
(ii) Application withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under
subparagraph (A) for any application, report, or supplement
that is withdrawn prior to the filing decision of the
Secretary.
(iii) Application withdrawn before first action
After receipt of a request for a refund of the fee paid
under subparagraph (A) for a premarket application, premarket
report, or supplement that is withdrawn after filing but
before a first action, the Secretary may return some or all
of the fee. The amount of refund, if any, shall be based on
the level of effort already expended on the review of such
application, report, or supplement. The Secretary shall have
sole discretion to refund a fee or portion of the fee under
this subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall not be
reviewable.
(b) Fee revenue amounts
Except as provided in subsections (c), (d), (e), (g), and (h) of
this section, the fees under subsection (a) of this section shall
be established to generate the following revenue amounts:
$25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004;
and $29,785,000 in fiscal year 2005. If legislation is enacted
after October 26, 2002, requiring the Secretary to fund additional
costs of the retirement of Federal personnel, fee revenue amounts
under this subsection shall be increased in each year by the amount
necessary to fully fund the portion of such additional costs that
are attributable to the process for the review of device
applications.
(c) Annual fee setting
(1) In general
The Secretary shall, 60 days before the start of each fiscal
year after September 30, 2002, publish in the Federal Register
fees under subsection (a) of this section. The fees established
for fiscal year 2006 shall be based on a premarket application
fee of $259,600, and the fees established for fiscal year 2007
shall be based on a premarket application fee of $281,600.
(2) Limit
The total amount of fees charged, as adjusted under this
subsection, for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for the process for
the review of device applications.
(3) Supplement
(A) In general
For fiscal years 2006 and 2007, the Secretary may use
unobligated carryover balances from fees collected in previous
fiscal years to ensure that sufficient fee revenues are
available in that fiscal year, so long as the Secretary
maintains unobligated carryover balances of not less than 1
month of operating reserves for the first month of fiscal year
2008.
(B) Notice to Congress
Not later than 14 days before the Secretary anticipates the
use of funds described in subparagraph (A), the Secretary shall
provide notice to the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives.
(d) Small businesses; fee waiver and fee reduction regarding
premarket approval fees
(1) In general
The Secretary shall grant a waiver of the fee required under
subsection (a) of this section for one premarket application, or
one premarket report, where the Secretary finds that the
applicant involved is a small business submitting its first
premarket application to the Secretary, or its first premarket
report, respectively, for review. For the purposes of this
paragraph, the term "small business" means an entity that
reported $30,000,000 or less of gross receipts or sales in its
most recent Federal income tax return for a taxable year,
including such returns of all of its affiliates, partners, and
parent firms. In addition, for subsequent premarket applications,
premarket reports, and supplements where the Secretary finds that
the applicant involved is a small business, the fees specified in
clauses (i) through (vi) of subsection (a)(2)(A) of this section
may be paid at a reduced rate in accordance with paragraph
(2)(C).
(2) Rules relating to premarket approval fees
(A) Definition
For purposes of this paragraph, the term "small business"
means an entity that reported $100,000,000 or less of gross
receipts or sales in its most recent Federal income tax
return for a taxable year, including such returns of all of
its affiliates, partners, and parent firms.
(B) Evidence of qualification
An applicant shall pay the higher fees established by the
Secretary each year unless the applicant submits evidence that
it qualifies for a waiver of the fee or the lower fee rate. The
applicant shall support its claim that it meets the definition
under subparagraph (A) by submission of a copy of its most
recent Federal income tax return for a taxable year, and a copy
of such returns of its affiliates, partners, and parent firms,
which show an amount of gross sales or receipts that is less
than the maximum established in subparagraph (A). The
applicant, and each of such affiliates, partners, and parent
firms, shall certify that the information provided is a true
and accurate copy of the actual tax forms they submitted to the
Internal Revenue Service. If no tax forms are submitted for
affiliates, partners, or parent firms, the applicant shall
certify that the applicant has no affiliates, partners, or
parent firms, respectively.
(C) Reduced fees
Where the Secretary finds that the applicant involved meets
the definition under subparagraph (A), the fees established
under subsection (c)(1) of this section may be paid at a
reduced rate of 38 percent of the fee established under such
subsection for a premarket application, a premarket report, or
a supplement.
(D) Request for fee waiver or reduction
An applicant seeking a fee waiver or reduction under this
subsection shall submit supporting information to the Secretary
at least 60 days before the fee is required pursuant to
subsection (a) of this section. The decision of the Secretary
regarding whether an entity qualifies for such a waiver or
reduction is not reviewable.
(e) Small businesses; fee reduction regarding premarket
notification submissions
(1) In general
For fiscal year 2004 and each subsequent fiscal year, where the
Secretary finds that the applicant involved is a small business,
the fee specified in subsection (a)(2)(A)(vii) of this section
may be paid at a reduced rate in accordance with paragraph
(2)(C).
(2) Rules relating to premarket notification submissions
(A) Definition
For purposes of this subsection, the term "small business"
means an entity that reported $100,000,000 or less of gross
receipts or sales in its most recent Federal income tax return
for a taxable year, including such returns of all of its
affiliates, partners, and parent firms.
(B) Evidence of qualification
An applicant shall pay the higher fees established by the
Secretary each year unless the applicant submits evidence that
it qualifies for the lower fee rate. The applicant shall
support its claim that it meets the definition under
subparagraph (A) by submission of a copy of its most recent
Federal income tax return for a taxable year, and a copy of
such returns of its affiliates, partners, and parent firms,
which show an amount of gross sales or receipts that is less
than the maximum established in subparagraph (A). The
applicant, and each of such affiliates, partners, and parent
firms, shall certify that the information provided is a true
and accurate copy of the actual tax forms they submitted to the
Internal Revenue Service. If no tax forms are submitted for
affiliates, partners, or parent firms, the applicant shall
certify that the applicant has no affiliates, partners, or
parent firms, respectively.
(C) Reduced fees
(i) In general
For fiscal year 2004 and each subsequent fiscal year, where
the Secretary finds that the applicant involved meets the
definition under subparagraph (A), the fee for a premarket
notification submission may be paid at 80 percent of the fee
that applies under subsection (a)(2)(A)(vii) of this section,
as adjusted under clause (ii) and as established under
subsection (c)(1) of this section.
(ii) Adjustment per fee revenue amount
For fiscal year 2004 and each subsequent fiscal year, the
Secretary, in setting the revenue amount under subsection
(c)(1) of this section for premarket notification
submissions, shall determine the revenue amount that would
apply if all such submissions for the fiscal year involved
paid a fee equal to 1.42 percent of the amount that applies
under subsection (a)(2)(A)(i) of this section for premarket
applications, and shall adjust the fee under subsection
(a)(2)(A)(vii) of this section for premarket notification
submissions such that the reduced fees collected under clause
(i) of this subparagraph, when added to fees for such
submissions that are not paid at the reduced rate, will equal
such revenue amount for the fiscal year.
(D) Request for reduction
An applicant seeking a fee reduction under this subsection
shall submit supporting information to the Secretary at least
60 days before the fee is required pursuant to subsection (a)
of this section. The decision of the Secretary regarding
whether an entity qualifies for such a reduction is not
reviewable.
(f) Effect of failure to pay fees
A premarket application, premarket report, supplement, or
premarket notification submission submitted by a person subject to
fees under subsection (a) of this section shall be considered
incomplete and shall not be accepted by the Secretary until all
fees owed by such person have been paid.
(g) Conditions
(1) Performance goals through fiscal year 2005; termination of
program after fiscal year 2005
With respect to the amount that, under the salaries and
expenses account of the Food and Drug Administration, is
appropriated for a fiscal year for devices and radiological
products:
(A)(i) For each of the fiscal years 2003 and 2004, the
Secretary is expected to meet all of the goals identified for
the fiscal year involved in any letter referred to in section
101(3) of the Medical Device User Fee and Modernization Act of
2002 (referred to in this paragraph as "performance goals") if
the amount so appropriated for such fiscal year, excluding the
amount of fees appropriated for such fiscal year, is equal to
or greater than $205,720,000 multiplied by the adjustment
factor applicable to the fiscal year.
(ii) For each of the fiscal years 2003 and 2004, if the
amount so appropriated for the fiscal year involved, excluding
the amount of fees appropriated for such fiscal year, is less
than the amount that applies under clause (i) for such fiscal
year, the following applies:
(I) The Secretary is expected to meet such goals to the
extent practicable, taking into account the amounts that are
available to the Secretary for such purpose, whether from
fees under subsection (a) of this section or otherwise.
(II) The Comptroller General of the United States shall
submit to the Congress a report describing whether and to
what extent the Secretary is meeting the performance goals
identified for such fiscal year, and whether the Secretary
will be able to meet all performance goals identified for
fiscal year 2005. A report under the preceding sentence shall
be submitted to the Congress not later than July 1 of the
fiscal year with which the report is concerned.
(B)(i) For fiscal year 2005, the Secretary is expected to
meet all of the performance goals identified for the fiscal
year if the amount so appropriated for such fiscal year,
excluding the amount of fees appropriated for such fiscal year,
is equal to or greater than $205,720,000 multiplied by the
adjustment factor applicable to the fiscal year.
(ii) For fiscal year 2005, if the amount so appropriated for
such fiscal year, excluding the amount of fees appropriated for
such fiscal year, is more than 1 percent less than the amount
that applies under clause (i), the following applies:
(I) The Secretary is expected to meet such goals to the
extent practicable, taking into account the amounts that are
available to the Secretary for such purpose, whether from
fees under subsection (a) of this section or otherwise.
(II) The Comptroller General of the United States shall
submit to the Congress a report describing whether and to
what extent the Secretary is meeting the performance goals
identified for such fiscal year, and whether the Secretary
will be able to meet all performance goals identified for
fiscal year 2006. The report under the preceding sentence
shall be submitted to the Congress not later than July 1,
2005.
(C) For fiscal year 2006, fees may not be assessed under
subsection (a) of this section for the fiscal year, and the
Secretary is not expected to meet any performance goals
identified for the fiscal year, if the total of the amounts so
appropriated for fiscal years 2005 and 2006, excluding the
amount of fees appropriated for such fiscal years, is more than
1 percent less than the sum of -
(i) $205,720,000 multiplied by the adjustment factor
applicable to fiscal year 2006; and
(ii) an amount equal to the amount that applies for
purposes of subparagraph (B)(i).
(D) For fiscal year 2007, fees may not be assessed under
subsection (a) of this section for the fiscal year, and the
Secretary is not expected to meet any performance goals
identified for the fiscal year, if -
(i) the amount so appropriated for the fiscal year,
excluding the amount of fees appropriated for the fiscal
year, is more than 1 percent less than $205,720,000
multiplied by the adjustment factor applicable to fiscal year
2007; or
(ii) pursuant to subparagraph (C), fees were not assessed
under subsection (a) of this section for fiscal year 2006.
(2) Authority
If the Secretary does not assess fees under subsection (a) of
this section during any portion of a fiscal year because of
subparagraph (C) or (D) of paragraph (1) and if at a later date
in such fiscal year the Secretary may assess such fees, the
Secretary may assess and collect such fees, without any
modification in the rate for premarket applications, supplements,
premarket reports, and premarket notification submissions, and at
any time in such fiscal year, notwithstanding the provisions of
subsection (a) of this section relating to the date fees are to
be paid.
(h) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) of this section shall be
collected and available for obligation only to the extent and in
the amount provided in advance in appropriation Acts. Such fees
are authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal
year limitation. The sums transferred shall be available solely
for the process for the review of device applications.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section -
(i) shall be retained in each fiscal year in an amount not
to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation, for such fiscal
year, and
(ii) shall only be collected and available to defray
increases in the costs of the resources allocated for the
process for the review of device applications (including
increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process) over such costs,
excluding costs paid from fees collected under this section,
for fiscal year 2002 multiplied by the adjustment factor.
(B) Compliance
(i) In general
The Secretary shall be considered to have met the
requirements of subparagraph (A)(ii) in any fiscal year if
the costs funded by appropriations and allocated for the
process for the review of device applications -
(I) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
(II)(aa) are more than 3 percent below the level
specified in subparagraph (A)(ii), and fees assessed for a
subsequent fiscal year are decreased by the amount in
excess of 3 percent by which such costs fell below the
level specified in such subparagraph; and
(bb) such costs are not more than 5 percent below the
level specified in such subparagraph.
(ii) More than 5 percent
To the extent such costs are more than 5 percent below the
specified level in subparagraph (A)(ii), fees may not be
collected under this section for that fiscal year.
(3) Authorization of appropriations
There are authorized to be appropriated for fees under this
section -
(A) $25,125,000 for fiscal year 2003;
(B) $27,255,000 for fiscal year 2004;
(C) $29,785,000 for fiscal year 2005; and
(D) such sums as may be necessary for each of fiscal years
2006 and 2007.(!2)
as adjusted to reflect adjustments in the total fee revenues made
under this section and changes in the total amounts collected by
application fees.
(4) Offset
Any amount of fees collected for a fiscal year under this
section that exceeds the amount of fees specified in
appropriation Acts for such fiscal year shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected
under this section pursuant to appropriation Acts for a
subsequent fiscal year.
(i) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee
assessed under subsection (a) of this section within 30 days after
it is due, such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 of title
31.
(j) Written requests for refunds
To qualify for consideration for a refund under subsection
(a)(2)(D) of this section, a person shall submit to the Secretary a
written request for such refund not later than 180 days after such
fee is due.
(k) Construction
This section may not be construed to require that the number of
full-time equivalent positions in the Department of Health and
Human Services, for officers, employees, and advisory committees
not engaged in the process of the review of device applications, be
reduced to offset the number of officers, employees, and advisory
committees so engaged.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 738, as added Pub. L. 107-250, title
I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108-
214, Sec. 2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat.
572, 576, 577; Pub. L. 109-43, Sec. 2(a), Aug. 1, 2005, 119 Stat.
439.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 107 of Pub. L. 107-250, see
Effective and Termination Dates note set out under section 379i of
this title.
-REFTEXT-
REFERENCES IN TEXT
Section 360e(c)(3) of this title, referred to in subsec.
(a)(2)(C), which related to submission of portions of applications,
was redesignated section 360e(c)(4) of this title by Pub. L. 108-
214, Sec. 2(d)(1)(A)(i), Apr. 1, 2004, 118 Stat. 576.
Section 101(3) of the Medical Device User Fee and Modernization
Act of 2002, referred to in subsec. (g)(1)(A)(i), is section 101(3)
of Pub. L. 107-250, which is set out as a note under section 379i
of this title.
-MISC1-
AMENDMENTS
2005 - Subsec. (a)(2)(A). Pub. L. 109-43, Sec. 2(a)(7),
substituted "subsection (c)(1)" for "subsection (c)(5)".
Subsec. (b). Pub. L. 109-43, Sec. 2(a)(1), inserted "and" after
"2004;" and substituted "2005" for "2005; $32,615,000 in fiscal
year 2006, and $35,000,000 in fiscal year 2007".
Subsec. (c). Pub. L. 109-43, Sec. 2(a)(2)(A), substituted "Annual
fee setting" for "Adjustments" in heading.
Subsec. (c)(1). Pub. L. 109-43, Sec. 2(a)(2)(B)-(D), redesignated
par. (5) as (1), substituted "In general" for "Annual fee setting"
in heading, "publish in the Federal Register fees under subsection
(a) of this section. The fees" for "establish, for the next fiscal
year, and publish in the Federal Register, fees under subsection
(a) of this section, based on the revenue amounts established under
subsection (b) of this section and the adjustment provided under
this subsection and subsection (e)(2)(C)(ii) of this section,
except that the fees", "2006" for "2003", and "$259,600, and the
fees established for fiscal year 2007 shall be based on a premarket
application fee of $281,600." for "$154,000." in text, and struck
out former par. (1) which required an annual inflation adjustment
of the revenues established in subsec. (b).
Subsec. (c)(2). Pub. L. 109-43, Sec. 2(a)(2)(B), (C),
redesignated par. (6) as (2) and struck out former par. (2) which
required an annual adjustment of the fee revenues established in
subsec. (b) to reflect changes in the workload of the Secretary for
the process for the review of device applications.
Subsec. (c)(3). Pub. L. 109-43, Sec. 2(a)(2)(B), (E), added par.
(3) and struck out former par. (3) which required an annual
compensating adjustment of the fee revenues established in subsec.
(b).
Subsec. (c)(4). Pub. L. 109-43, Sec. 2(a)(2)(B), struck out par.
(4) which provided for a fiscal year 2007 adjustment of the fee
revenues established in subsec. (b) to provide for operating
reserves of carryover user fees.
Subsec. (c)(5), (6). Pub. L. 109-43, Sec. 2(a)(2)(C),
redesignated pars. (5) and (6) as (1) and (2), respectively.
Subsec. (d)(1). Pub. L. 109-43, Sec. 2(a)(3)(A), inserted after
first sentence "For the purposes of this paragraph, the term 'small
business' means an entity that reported $30,000,000 or less of
gross receipts or sales in its most recent Federal income tax
return for a taxable year, including such returns of all of its
affiliates, partners, and parent firms."
Subsec. (d)(2)(A). Pub. L. 109-43, Sec. 2(a)(3)(B), struck out
cl. (i) designation and heading before "For purposes", substituted
"paragraph," for "subsection," and "$100,000,000" for
"$30,000,000", and struck out heading and text of clause (ii). Text
read as follows: "The Secretary may adjust the $30,000,000
threshold established in clause (i) if the Secretary has evidence
from actual experience that this threshold results in a reduction
in revenues from premarket applications, premarket reports, and
supplements that is 16 percent or more than would occur without
small business exemptions and lower fee rates. To adjust this
threshold, the Secretary shall publish a notice in the Federal
Register setting out the rationale for the adjustment, and the new
threshold."
Subsec. (d)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
"subsection (c)(1)" for "subsection (c)(5)".
Subsec. (e)(2)(A). Pub. L. 109-43, Sec. 2(a)(4), substituted
"$100,000,000" for "$30,000,000".
Subsec. (e)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
"subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).
Subsec. (g)(1)(B)(i). Pub. L. 109-43, Sec. 2(a)(5)(A)(i), added
cl. (i) and struck out former cl. (i) which read as follows: "For
fiscal year 2005, the Secretary is expected to meet all of the
performance goals identified for the fiscal year if the total of
the amounts so appropriated for fiscal years 2003 through 2005,
excluding the amount of fees appropriated for such fiscal years, is
equal to or greater than the sum of -
"(I) $205,720,000 multiplied by the adjustment factor
applicable to fiscal year 2003;
"(II) $205,720,000 multiplied by the adjustment factor
applicable to fiscal year 2004; and
"(III) $205,720,000 multiplied by the adjustment factor
applicable to fiscal year 2005."
Subsec. (g)(1)(B)(ii). Pub. L. 109-43, Sec. 2(a)(5)(A)(ii), added
introductory provisions and struck out former introductory
provisions which read as follows: "For fiscal year 2005, if the
total of the amounts so appropriated for fiscal years 2003 through
2005, excluding the amount of fees appropriated for such fiscal
years, is less than the sum that applies under clause (i) for
fiscal year 2005, the following applies:".
Subsec. (g)(1)(C). Pub. L. 109-43, Sec. 2(a)(5)(B)(i),
substituted "2005 and" for "2003 through" and inserted "more than 1
percent" after "years, is".
Subsec. (g)(1)(C)(ii). Pub. L. 109-43, Sec. 2(a)(5)(B)(ii),
substituted "amount that applies" for "sum that applies".
Subsec. (g)(1)(D)(i). Pub. L. 109-43, Sec. 2(a)(5)(C), inserted
"more than 1 percent" after "year, is".
Subsec. (h)(3)(D), (E). Pub. L. 109-43, Sec. 2(a)(6), added
subpar. (D) and struck out former subpars. (D) and (E) which read
as follows:
"(D) $32,615,000 for fiscal year 2006; and
"(E) $35,000,000 for fiscal year 2007,".
2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
correction to directory language of Pub. L. 107-250, Sec. 102(a),
which enacted this section.
Subsec. (a). Pub. L. 108-214, Sec. 2(d)(2)(A), designated
introductory provisions of subsec. (a) as par. (1), inserted
heading, substituted "this section." for "this section as
follows:", and redesignated former par. (1) as (2).
Subsec. (a)(1)(A). Pub. L. 108-214, Sec. 2(a)(2)(A)(i),
substituted, in introductory provisions, "subsections (d) and (e)"
for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i),
subject to any adjustment under subsection (c)(3) of this section",
and, in cl. (vii), "clause (i), subject to any adjustment under
subsection (e)(2)(C)(ii)" for "clause (i), subject to any
adjustment under subsection (c)(3) of this section and any
adjustment under subsection (e)(2)(C)(ii)".
Subsec. (a)(1)(D)(i), (ii). Pub. L. 108-214, Sec. 2(a)(2)(A)(ii),
substituted "application, report," for "application".
Subsec. (d)(1). Pub. L. 108-214, Sec. 2(d)(2)(B)(i), substituted
"subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.
Subsec. (d)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(B), substituted
"firms, which show" for "firms. which show" in second sentence.
Subsec. (e)(1). Pub. L. 108-214, Sec. 2(a)(2)(C)(i),
(d)(2)(B)(ii), substituted "For fiscal year 2004 and each
subsequent fiscal year, where" for "Where" and "subsection
(a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".
Subsec. (e)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(I),
substituted "firms, which show" for "firms. which show".
Subsec. (e)(2)(C). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(II),
(d)(2)(B)(iii), substituted "For fiscal year 2004 and each
subsequent fiscal year, where" for "Where" in cl. (i), "subsection
(a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and
(ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)"
in cl. (ii).
Subsec. (f). Pub. L. 108-214, Sec. 2(a)(2)(D), struck out "for
filing" after "accepted".
Subsec. (h)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(E), designated
existing provisions as cl. (i), inserted heading, redesignated
former cls. (i) and (ii) as subcls. (I) and (II), respectively, of
cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as
items (aa) and (bb), respectively, of cl. (i)(II), and added cl.
(ii).
Subsec. (j). Pub. L. 108-214, Sec. 2(d)(2)(B)(iv), substituted
"subsection (a)(2)(D)" for "subsection (a)(1)(D)".
EFFECTIVE AND TERMINATION DATES
Section effective Oct. 26, 2002, except for certain premarket
fees, and ceases to be effective Oct. 1, 2007, see sections 106 and
107 of Pub. L. 107-250, set out as notes under section 379i of this
title.
FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS
Pub. L. 107-250, title I, Sec. 102(b), Oct. 26, 2002, 116 Stat.
1600, as amended by Pub. L. 108-214, Sec. 2(d)(2)(C), (3)(B), Apr.
1, 2004, 118 Stat. 577, provided that: "A person submitting a
premarket report to the Secretary of Health and Human Services is
exempt from the fee under section 738(a)(2)(A)(ii) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as
added by subsection (a) of this section) if -
"(1) the premarket report is the first such report submitted to
the Secretary by the person; and
"(2) before October 1, 2002, the person submitted a premarket
application to the Secretary for the same device as the device
for which the person is submitting the premarket report."
-FOOTNOTE-
(!1) See References in Text note below.
(!2) So in original. The period probably should be a comma.
-End-
-CITE-
21 USC subpart 4 - fees relating to animal drugs 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 4 - fees relating to animal drugs
-HEAD-
SUBPART 4 - FEES RELATING TO ANIMAL DRUGS
-STATAMEND-
TERMINATION OF SUBPART
For termination of subpart by section 5 of Pub. L. 108-130, see
Termination Date note set out under section 379j-11 of this title.
-End-
-CITE-
21 USC Sec. 379j-11 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 4 - fees relating to animal drugs
-HEAD-
Sec. 379j-11. Definitions
-STATUTE-
For purposes of this part:
(1) The term "animal drug application" means an application for
approval of any new animal drug submitted under section
360b(b)(1) of this title. Such term does not include either a new
animal drug application submitted under section 360b(b)(2) of
this title or a supplemental animal drug application.
(2) The term "supplemental animal drug application" means -
(A) a request to the Secretary to approve a change in an
animal drug application which has been approved; or
(B) a request to the Secretary to approve a change to an
application approved under section 360b(c)(2) of this title for
which data with respect to safety or effectiveness are
required.
(3) The term "animal drug product" means each specific strength
or potency of a particular active ingredient or ingredients in
final dosage form marketed by a particular manufacturer or
distributor, which is uniquely identified by the labeler code and
product code portions of the national drug code, and for which an
animal drug application or a supplemental animal drug application
has been approved.
(4) The term "animal drug establishment" means a foreign or
domestic place of business which is at one general physical
location consisting of one or more buildings all of which are
within 5 miles of each other, at which one or more animal drug
products are manufactured in final dosage form.
(5) The term "investigational animal drug submission" means -
(A) the filing of a claim for an investigational exemption
under section 360b(j) of this title for a new animal drug
intended to be the subject of an animal drug application or a
supplemental animal drug application, or
(B) the submission of information for the purpose of enabling
the Secretary to evaluate the safety or effectiveness of an
animal drug application or supplemental animal drug application
in the event of their filing.
(6) The term "animal drug sponsor" means either an applicant
named in an animal drug application, except for an approved
application for which all subject products have been removed from
listing under section 360 of this title, or a person who has
submitted an investigational animal drug submission that has not
been terminated or otherwise rendered inactive by the Secretary.
(7) The term "final dosage form" means, with respect to an
animal drug product, a finished dosage form which is approved for
administration to an animal without substantial further
manufacturing. Such term includes animal drug products intended
for mixing in animal feeds.
(8) The term "process for the review of animal drug
applications" means the following activities of the Secretary
with respect to the review of animal drug applications,
supplemental animal drug applications, and investigational animal
drug submissions:
(A) The activities necessary for the review of animal drug
applications, supplemental animal drug applications, and
investigational animal drug submissions.
(B) The issuance of action letters which approve animal drug
applications or supplemental animal drug applications or which
set forth in detail the specific deficiencies in animal drug
applications, supplemental animal drug applications, or
investigational animal drug submissions and, where appropriate,
the actions necessary to place such applications, supplements
or submissions in condition for approval.
(C) The inspection of animal drug establishments and other
facilities undertaken as part of the Secretary's review of
pending animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.
(D) Monitoring of research conducted in connection with the
review of animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.
(E) The development of regulations and policy related to the
review of animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.
(F) Development of standards for products subject to review.
(G) Meetings between the agency and the animal drug sponsor.
(H) Review of advertising and labeling prior to approval of
an animal drug application or supplemental animal drug
application, but not such activities after an animal drug has
been approved.
(9) The term "costs of resources allocated for the process for
the review of animal drug applications" means the expenses
incurred in connection with the process for the review of animal
drug applications for -
(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with respect to
the review of specific animal drug applications, supplemental
animal drug applications, or investigational animal drug
submissions, and costs related to such officers, employees,
committees, and contractors, including costs for travel,
education, and recruitment and other personnel activities,
(B) management of information, and the acquisition,
maintenance, and repair of computer resources,
(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other necessary
materials and supplies, and
(D) collecting fees under section 379j-12 of this title and
accounting for resources allocated for the review of animal
drug applications, supplemental animal drug applications, and
investigational animal drug submissions.
(10) The term "adjustment factor" applicable to a fiscal year
refers to the formula set forth in section 379g(8) of this title
with the base or comparator year being 2003.
(11) The term "affiliate" refers to the definition set forth in
section 379g(9) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 739, as added Pub. L. 108-130, Sec.
3, Nov. 18, 2003, 117 Stat. 1361.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 5 of Pub. L. 108-130, see
Termination Date note below.
-MISC1-
TERMINATION DATE
Pub. L. 108-130, Sec. 5, Nov. 18, 2003, 117 Stat. 1371, provided
that: "The amendments made by section 3 [enacting this subpart]
shall not be in effect after October 1, 2008, and section 4
[enacting provisions set out as a note below] shall not be in
effect after 120 days after such date."
FINDINGS
Pub. L. 108-130, Sec. 2, Nov. 18, 2003, 117 Stat. 1361, provided
that: "Congress finds as follows:
"(1) Prompt approval of safe and effective new animal drugs is
critical to the improvement of animal health and the public
health.
"(2) Animal health and the public health will be served by
making additional funds available for the purpose of augmenting
the resources of the Food and Drug Administration that are
devoted to the process for review of new animal drug
applications.
"(3) The fees authorized by this Act [enacting this subpart and
provisions set out as notes under this section and section 301 of
this title] will be dedicated toward expediting the animal drug
development process and the review of new and supplemental animal
drug applications and investigational animal drug submissions as
set forth in the goals identified, for purposes of part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act [this subpart], in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Energy and Commerce of the House of Representatives and the
Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate as set forth in the Congressional Record."
ACCOUNTABILITY AND REPORTS
Pub. L. 108-130, Sec. 4, Nov. 18, 2003, 117 Stat. 1370, provided
that:
"(a) Public Accountability. -
"(1) Consultation. - In developing recommendations to Congress
for the goals and plans for meeting the goals for the process for
the review of animal drug applications for the fiscal years after
fiscal year 2008, and for the reauthorization of sections 739 and
740 of the Federal Food, Drug, and Cosmetic Act (as added by
section 3) [42 U.S.C. 379j-11, 379j-12], the Secretary of Health
and Human Services (referred to in this section as the
'Secretary') shall consult with the Committee on Energy and
Commerce of the House of Representatives, the Committee on
Health, Education, Labor, and Pensions of the Senate, appropriate
scientific and academic experts, veterinary professionals,
representatives of consumer advocacy groups, and the regulated
industry.
"(2) Recommendations. - The Secretary shall -
"(A) publish in the Federal Register recommendations under
paragraph (1), after negotiations with the regulated industry;
"(B) present the recommendations to the Committees referred
to in that paragraph;
"(C) hold a meeting at which the public may comment on the
recommendations; and
"(D) provide for a period of 30 days for the public to
provide written comments on the recommendations.
"(b) Performance Reports. - Beginning with fiscal year 2004, not
later than 60 days after the end of each fiscal year during which
fees are collected under part 4 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act [this subpart], the
Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
2(3) of this Act [set out as a note above] toward expediting the
animal drug development process and the review of the new and
supplemental animal drug applications and investigational animal
drug submissions during such fiscal year, the future plans of the
Food and Drug Administration for meeting the goals, the review
times for abbreviated new animal drug applications, and the
administrative procedures adopted by the Food and Drug
Administration to ensure that review times for abbreviated new
animal drug applications are not increased from their current level
due to activities under the user fee program.
"(c) Fiscal Report. - Beginning with fiscal year 2004, not later
than 120 days after the end of each fiscal year during which fees
are collected under the part described in subsection (b), the
Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report on
the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of
the fees collected during such fiscal year for which the report is
made."
-End-
-CITE-
21 USC Sec. 379j-12 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part C - Fees
subpart 4 - fees relating to animal drugs
-HEAD-
Sec. 379j-12. Authority to assess and use animal drug fees
-STATUTE-
(a) Types of fees
Beginning in fiscal year 2004, the Secretary shall assess and
collect fees in accordance with this section as follows:
(1) Animal drug application and supplement fee
(A) In general
Each person that submits, on or after September 1, 2003, an
animal drug application or a supplemental animal drug
application shall be subject to a fee as follows:
(i) A fee established in subsection (b) of this section for
an animal drug application; and
(ii) A fee established in subsection (b) of this section
for a supplemental animal drug application for which safety
or effectiveness data are required, in an amount that is
equal to 50 percent of the amount of the fee under clause
(i).
(B) Payment
The fee required by subparagraph (A) shall be due upon
submission of the animal drug application or supplemental
animal drug application.
(C) Exception for previously filed application or supplement
If an animal drug application or a supplemental animal drug
application was submitted by a person that paid the fee for
such application or supplement, was accepted for filing, and
was not approved or was withdrawn (without a waiver or refund),
the submission of an animal drug application or a supplemental
animal drug application for the same product by the same person
(or the person's licensee, assignee, or successor) shall not be
subject to a fee under subparagraph (A).
(D) Refund of fee if application refused for filing
The Secretary shall refund 75 percent of the fee paid under
subparagraph (B) for any animal drug application or
supplemental animal drug application which is refused for
filing.
(E) Refund of fee if application withdrawn
If an animal drug application or a supplemental animal drug
application is withdrawn after the application or supplement
was filed, the Secretary may refund the fee or portion of the
fee paid under subparagraph (B) if no substantial work was
performed on the application or supplement after the
application or supplement was filed. The Secretary shall have
the sole discretion to refund the fee under this paragraph. A
determination by the Secretary concerning a refund under this
paragraph shall not be reviewable.
(2) Animal drug product fee
Each person -
(A) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing under
section 360 of this title, and
(B) who, after September 1, 2003, had pending before the
Secretary an animal drug application or supplemental animal
drug application;
shall pay for each such animal drug product the annual fee
established in subsection (b) of this section. Such fee shall be
payable for the fiscal year in which the animal drug product is
first submitted for listing under section 360 of this title, or
is submitted for relisting under section 360 of this title if the
animal drug product has been withdrawn from listing and relisted.
After such fee is paid for that fiscal year, such fee shall be
payable on or before January 31 of each year. Such fee shall be
paid only once for each animal drug product for a fiscal year in
which the fee is payable.
(3) Animal drug establishment fee
Each person -
(A) who owns or operates, directly or through an affiliate,
an animal drug establishment, and
(B) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing under
section 360 of this title, and
(C) who, after September 1, 2003, had pending before the
Secretary an animal drug application or supplemental animal
drug application,
shall be assessed an annual fee established in subsection (b) of
this section for each animal drug establishment listed in its
approved animal drug application as an establishment that
manufactures the animal drug product named in the application.
The annual establishment fee shall be assessed in each fiscal
year in which the animal drug product named in the application is
assessed a fee under paragraph (2) unless the animal drug
establishment listed in the application does not engage in the
manufacture of the animal drug product during the fiscal year.
The fee shall be paid on or before January 31 of each year. The
establishment shall be assessed only one fee per fiscal year
under this section: Provided, however, that where a single
establishment manufactures both animal drug products and
prescription drug products, as defined in section 379g(3) of this
title, such establishment shall be assessed both the animal drug
establishment fee and the prescription drug establishment fee, as
set forth in section 379h(a)(2) of this title, within a single
fiscal year.
(4) Animal drug sponsor fee
Each person -
(A) who meets the definition of an animal drug sponsor within
a fiscal year; and
(B) who, after September 1, 2003, had pending before the
Secretary an animal drug application, a supplemental animal
drug application, or an investigational animal drug submission,
shall be assessed an annual fee established under subsection (b)
of this section. The fee shall be paid on or before January 31 of
each year. Each animal drug sponsor shall pay only one such fee
each fiscal year.
(b) Fee amounts
Except as provided in subsection (a)(1) of this section and
subsections (c), (d), (f), and (g) of this section, the fees
required under subsection (a) of this section shall be established
to generate fee revenue amounts as follows:
(1) Total fee revenues for application and supplement fees
The total fee revenues to be collected in animal drug
application fees under subsection (a)(1)(A)(i) of this section
and supplemental animal drug application fees under subsection
(a)(1)(A)(ii) of this section shall be $1,250,000 in fiscal year
2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal
years 2006, 2007, and 2008.
(2) Total fee revenues for product fees
The total fee revenues to be collected in product fees under
subsection (a)(2) of this section shall be $1,250,000 in fiscal
year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
fiscal years 2006, 2007, and 2008.
(3) Total fee revenues for establishment fees
The total fee revenues to be collected in establishment fees
under subsection (a)(3) of this section shall be $1,250,000 in
fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000
in fiscal years 2006, 2007, and 2008.
(4) Total fee revenues for sponsor fees
The total fee revenues to be collected in sponsor fees under
subsection (a)(4) of this section shall be $1,250,000 in fiscal
year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
fiscal years 2006, 2007, and 2008.
(c) Adjustments
(1) Inflation adjustment
The revenues established in subsection (b) of this section
shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year to reflect the greater of -
(A) the total percentage change that occurred in the Consumer
Price Index for all urban consumers (all items; United States
city average) for the 12-month period ending June 30 preceding
the fiscal year for which fees are being established; or
(B) the total percentage change for the previous fiscal year
in basic pay under the General Schedule in accordance with
section 5332 of title 5, as adjusted by any locality-based
comparability payment pursuant to section 5304 of such title
for Federal employees stationed in the District of Columbia.
The adjustment made each fiscal year by this subsection will be
added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2004 under this subsection.
(2) Workload adjustment
After the fee revenues are adjusted for inflation in accordance
with paragraph (1), the fee revenues shall be further adjusted
each fiscal year after fiscal year 2004 to reflect changes in
review workload. With respect to such adjustment:
(A) This adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of animal drug applications, supplemental animal drug
applications for which data with respect to safety or
effectiveness are required, manufacturing supplemental animal
drug applications, investigational animal drug study
submissions, and investigational animal drug protocol
submissions submitted to the Secretary. The Secretary shall
publish in the Federal Register the fees resulting from this
adjustment and the supporting methodologies.
(B) Under no circumstances shall this workload adjustment
result in fee revenues for a fiscal year that are less than the
fee revenues for that fiscal year established in subsection (b)
of this section, as adjusted for inflation under paragraph (1).
(3) Final year adjustment
For fiscal year 2008, the Secretary may further increase the
fees to provide for up to 3 months of operating reserves of
carryover user fees for the process for the review of animal drug
applications for the first 3 months of fiscal year 2009. If the
Food and Drug Administration has carryover balances for the
process for the review of animal drug applications in excess of 3
months of such operating reserves, then this adjustment will not
be made. If this adjustment is necessary, then the rationale for
the amount of the increase shall be contained in the annual
notice setting fees for fiscal year 2008.
(4) Annual fee setting
The Secretary shall establish, 60 days before the start of each
fiscal year beginning after September 30, 2003, for that fiscal
year, animal drug application fees, supplemental animal drug
application fees, animal drug sponsor fees, animal drug
establishment fees, and animal drug product fees based on the
revenue amounts established under subsection (b) of this section
and the adjustments provided under this subsection.
(5) Limit
The total amount of fees charged, as adjusted under this
subsection, for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for the process for
the review of animal drug applications.
(d) Fee waiver or reduction
(1) In general
The Secretary shall grant a waiver from or a reduction of 1 or
more fees assessed under subsection (a) of this section where the
Secretary finds that -
(A) the assessment of the fee would present a significant
barrier to innovation because of limited resources available to
such person or other circumstances,
(B) the fees to be paid by such person will exceed the
anticipated present and future costs incurred by the Secretary
in conducting the process for the review of animal drug
applications for such person,
(C) the animal drug application or supplemental animal drug
application is intended solely to provide for use of the animal
drug in -
(i) a Type B medicated feed (as defined in section
558.3(b)(3) of title 21, Code of Federal Regulations (or any
successor regulation)) intended for use in the manufacture of
Type C free-choice medicated feeds, or
(ii) a Type C free-choice medicated feed (as defined in
section 558.3(b)(4) of title 21, Code of Federal Regulations
(or any successor regulation)),
(D) the animal drug application or supplemental animal drug
application is intended solely to provide for a minor use or
minor species indication, or
(E) the sponsor involved is a small business submitting its
first animal drug application to the Secretary for review.
(2) Use of standard costs
In making the finding in paragraph (1)(B), the Secretary may
use standard costs.
(3) Rules for small businesses
(A) Definition
In paragraph (1)(E), the term "small business" means an
entity that has fewer than 500 employees, including employees
of affiliates.
(B) Waiver of application fee
The Secretary shall waive under paragraph (1)(E) the
application fee for the first animal drug application that a
small business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is granted such
a waiver, the small business or its affiliate shall pay
application fees for all subsequent animal drug applications
and supplemental animal drug applications for which safety or
effectiveness data are required in the same manner as an entity
that does not qualify as a small business.
(C) Certification
The Secretary shall require any person who applies for a
waiver under paragraph (1)(E) to certify their qualification
for the waiver. The Secretary shall periodically publish in the
Federal Register a list of persons making such certifications.
(e) Effect of failure to pay fees
An animal drug application or supplemental animal drug
application submitted by a person subject to fees under subsection
(a) of this section shall be considered incomplete and shall not be
accepted for filing by the Secretary until all fees owed by such
person have been paid. An investigational animal drug submission
under section 379j-11(5)(B) of this title that is submitted by a
person subject to fees under subsection (a) of this section shall
be considered incomplete and shall not be accepted for review by
the Secretary until all fees owed by such person have been paid.
The Secretary may discontinue review of any animal drug
application, supplemental animal drug application or
investigational animal drug submission from a person if such person
has not submitted for payment all fees owed under this section by
30 days after the date upon which they are due.
(f) Assessment of fees
(1) Limitation
Fees may not be assessed under subsection (a) of this section
for a fiscal year beginning after fiscal year 2003 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of fees
appropriated for such fiscal year) are equal to or greater than
the amount of appropriations for the salaries and expenses of the
Food and Drug Administration for the fiscal year 2003 (excluding
the amount of fees appropriated for such fiscal year) multiplied
by the adjustment factor applicable to the fiscal year involved.
(2) Authority
If the Secretary does not assess fees under subsection (a) of
this section during any portion of a fiscal year because of
paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
animal drug applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug sponsors,
animal drug establishments and animal drug products at any time
in such fiscal year notwithstanding the provisions of subsection
(a) of this section relating to the date fees are to be paid.
(g) Crediting and availability of fees
(1) In general
Fees authorized under subsection (a) of this section shall be
collected and available for obligation only to the extent and in
the amount provided in advance in appropriations Acts. Such fees
are authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salary and expenses with such fiscal
year limitation. The sums transferred shall be available solely
for the process for the review of animal drug applications.
(2) Collections and appropriation acts
(A) In general
The fees authorized by this section -
(i) shall be retained in each fiscal year in an amount not
to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year,
and
(ii) shall only be collected and available to defray
increases in the costs of the resources allocated for the
process for the review of animal drug applications (including
increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process) over such costs,
excluding costs paid from fees collected under this section,
for fiscal year 2003 multiplied by the adjustment factor.
(B) Compliance
The Secretary shall be considered to have met the
requirements of subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated for the process
for the review of animal drug applications -
(i) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
(ii)(I) are more than 3 percent below the level specified
in subparagraph (A)(ii), and fees assessed for the fiscal
year following the subsequent fiscal year are decreased by
the amount in excess of 3 percent by which such costs fell
below the level specified in subparagraph (A)(ii); and
(II) such costs are not more than 5 percent below the level
specified in subparagraph (A)(ii).
(3) Authorization of appropriations
There are authorized to be appropriated for fees under this
section -
(A) $5,000,000 for fiscal year 2004;
(B) $8,000,000 for fiscal year 2005;
(C) $10,000,000 for fiscal year 2006;
(D) $10,000,000 for fiscal year 2007; and
(E) $10,000,000 for fiscal year 2008;
as adjusted to reflect adjustments in the total fee revenues made
under this section and changes in the total amounts collected by
animal drug application fees, supplemental animal drug
application fees, animal drug sponsor fees, animal drug
establishment fees, and animal drug product fees.
(4) Offset
Any amount of fees collected for a fiscal year under this
section that exceeds the amount of fees specified in
appropriations Acts for such fiscal year shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected
under this section pursuant to appropriation Acts for a
subsequent fiscal year.
(h) Collection of unpaid fees
In any case where the Secretary does not receive payment of a fee
assessed under subsection (a) of this section within 30 days after
it is due, such fee shall be treated as a claim of the United
States Government subject to subchapter II of chapter 37 of title
31.
(i) Written requests for waivers, reductions, and refunds
To qualify for consideration for a waiver or reduction under
subsection (d) of this section, or for a refund of any fee
collected in accordance with subsection (a) of this section, a
person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee
is due.
(j) Construction
This section may not be construed to require that the number of
full-time equivalent positions in the Department of Health and
Human Services, for officers, employees, and advisory committees
not engaged in the process of the review of animal drug
applications, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
(k) Abbreviated new animal drug applications
The Secretary shall -
(1) to the extent practicable, segregate the review of
abbreviated new animal drug applications from the process for the
review of animal drug applications, and
(2) adopt other administrative procedures to ensure that review
times of abbreviated new animal drug applications do not increase
from their current level due to activities under the user fee
program.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 740, as added Pub. L. 108-130, Sec.
3, Nov. 18, 2003, 117 Stat. 1363.)
-STATAMEND-
TERMINATION OF SECTION
For termination of section by section 5 of Pub. L. 108-130, see
Termination Date note below.
-MISC1-
TERMINATION DATE
Section not effective after Oct. 1, 2008, see section 5 of Pub.
L. 108-130, set out as a note under section 379j-11 of this title.
-End-
-CITE-
21 USC Part D - Information and Education 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part D - Information and Education
-HEAD-
PART D - INFORMATION AND EDUCATION
-End-
-CITE-
21 USC Sec. 379k 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part D - Information and Education
-HEAD-
Sec. 379k. Information system
-STATUTE-
The Secretary shall establish and maintain an information system
to track the status and progress of each application or submission
(including a petition, notification, or other similar form of
request) submitted to the Food and Drug Administration requesting
agency action.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 741, as added Pub. L. 105-115, title
IV, Sec. 407(a), Nov. 21, 1997, 111 Stat. 2370.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
REPORT ON STATUS OF SYSTEM
Section 407(b) of Pub. L. 105-115 provided that not later than 1
year after Nov. 21, 1997, Secretary of Health and Human Services
was to submit report to Congress on status of system to be
established under this section, including projected costs of system
and concerns about confidentiality.
-End-
-CITE-
21 USC Sec. 379l 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part D - Information and Education
-HEAD-
Sec. 379l. Education
-STATUTE-
(a) In general
The Secretary shall conduct training and education programs for
the employees of the Food and Drug Administration relating to the
regulatory responsibilities and policies established by this
chapter, including programs for -
(1) scientific training;
(2) training to improve the skill of officers and employees
authorized to conduct inspections under section 374 of this
title;
(3) training to achieve product specialization in such
inspections; and
(4) training in administrative process and procedure and
integrity issues.
(b) Intramural fellowships and other training programs
The Secretary, acting through the Commissioner, may, through
fellowships and other training programs, conduct and support
intramural research training for predoctoral and postdoctoral
scientists and physicians.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 742, as added Pub. L. 105-115, title
IV, Sec. 408(a), Nov. 21, 1997, 111 Stat. 2371.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Part E - Environmental Impact Review 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part E - Environmental Impact Review
-HEAD-
PART E - ENVIRONMENTAL IMPACT REVIEW
-End-
-CITE-
21 USC Sec. 379o 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part E - Environmental Impact Review
-HEAD-
Sec. 379o. Environmental impact
-STATUTE-
Notwithstanding any other provision of law, an environmental
impact statement prepared in accordance with the regulations
published in part 25 of title 21, Code of Federal Regulations (as
in effect on August 31, 1997) in connection with an action carried
out under (or a recommendation or report relating to) this chapter,
shall be considered to meet the requirements for a detailed
statement under section 4332(2)(C) of title 42.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 746, as added Pub. L. 105-115, title
IV, Sec. 411, Nov. 21, 1997, 111 Stat. 2373.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Part F - National Uniformity for Nonprescription
Drugs and Preemption for Labeling
or Packaging of Cosmetics 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part F - National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
-HEAD-
PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
-End-
-CITE-
21 USC Sec. 379r 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part F - National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
-HEAD-
Sec. 379r. National uniformity for nonprescription drugs
-STATUTE-
(a) In general
Except as provided in subsection (b), (c)(1), (d), (e), or (f) of
this section, no State or political subdivision of a State may
establish or continue in effect any requirement -
(1) that relates to the regulation of a drug that is not
subject to the requirements of section 353(b)(1) or 353(f)(1)(A)
of this title; and
(2) that is different from or in addition to, or that is
otherwise not identical with, a requirement under this chapter,
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
seq.).
(b) Exemption
(1) In general
Upon application of a State or political subdivision thereof,
the Secretary may by regulation, after notice and opportunity for
written and oral presentation of views, exempt from subsection
(a) of this section, under such conditions as may be prescribed
in such regulation, a State or political subdivision requirement
that -
(A) protects an important public interest that would
otherwise be unprotected, including the health and safety of
children;
(B) would not cause any drug to be in violation of any
applicable requirement or prohibition under Federal law; and
(C) would not unduly burden interstate commerce.
(2) Timely action
The Secretary shall make a decision on the exemption of a State
or political subdivision requirement under paragraph (1) not
later than 120 days after receiving the application of the State
or political subdivision under paragraph (1).
(c) Scope
(1) In general
This section shall not apply to -
(A) any State or political subdivision requirement that
relates to the practice of pharmacy; or
(B) any State or political subdivision requirement that a
drug be dispensed only upon the prescription of a practitioner
licensed by law to administer such drug.
(2) Safety or effectiveness
For purposes of subsection (a) of this section, a requirement
that relates to the regulation of a drug shall be deemed to
include any requirement relating to public information or any
other form of public communication relating to a warning of any
kind for a drug.
(d) Exceptions
(1) In general
In the case of a drug described in subsection (a)(1) of this
section that is not the subject of an application approved under
section 355 of this title or section 357 of this title (as in
effect on the day before November 21, 1997) or a final regulation
promulgated by the Secretary establishing conditions under which
the drug is generally recognized as safe and effective and not
misbranded, subsection (a) of this section shall apply only with
respect to a requirement of a State or political subdivision of a
State that relates to the same subject as, but is different from
or in addition to, or that is otherwise not identical with -
(A) a regulation in effect with respect to the drug pursuant
to a statute described in subsection (a)(2) of this section; or
(B) any other requirement in effect with respect to the drug
pursuant to an amendment to such a statute made on or after
November 21, 1997.
(2) State initiatives
This section shall not apply to a State requirement adopted by
a State public initiative or referendum enacted prior to
September 1, 1997.
(e) No effect on product liability law
Nothing in this section shall be construed to modify or otherwise
affect any action or the liability of any person under the product
liability law of any State.
(f) State enforcement authority
Nothing in this section shall prevent a State or political
subdivision thereof from enforcing, under any relevant civil or
other enforcement authority, a requirement that is identical to a
requirement of this chapter.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 751, as added Pub. L. 105-115, title
IV, Sec. 412(a), Nov. 21, 1997, 111 Stat. 2373.)
-REFTEXT-
REFERENCES IN TEXT
The Poison Prevention Packaging Act of 1970, referred to in
subsec. (a)(2), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
amended, which is classified principally to chapter 39A (Sec. 1471
et seq.) of Title 15, Commerce and Trade. For complete
classification of this Act to the Code, see Short Title note set
out under section 1471 of Title 15 and Tables.
The Fair Packaging and Labeling Act, referred to in subsec.
(a)(2), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended,
which is classified generally to chapter 39 (Sec. 1451 et seq.) of
Title 15, Commerce and Trade. For complete classification of this
Act to the Code, see Short Title note set out under section 1451 of
Title 15 and Tables.
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 379s 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part F - National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
-HEAD-
Sec. 379s. Preemption for labeling or packaging of cosmetics
-STATUTE-
(a) In general
Except as provided in subsection (b), (d), or (e) of this
section, no State or political subdivision of a State may establish
or continue in effect any requirement for labeling or packaging of
a cosmetic that is different from or in addition to, or that is
otherwise not identical with, a requirement specifically applicable
to a particular cosmetic or class of cosmetics under this chapter,
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
seq.).
(b) Exemption
Upon application of a State or political subdivision thereof, the
Secretary may by regulation, after notice and opportunity for
written and oral presentation of views, exempt from subsection (a)
of this section, under such conditions as may be prescribed in such
regulation, a State or political subdivision requirement for
labeling or packaging that -
(1) protects an important public interest that would otherwise
be unprotected;
(2) would not cause a cosmetic to be in violation of any
applicable requirement or prohibition under Federal law; and
(3) would not unduly burden interstate commerce.
(c) Scope
For purposes of subsection (a) of this section, a reference to a
State requirement that relates to the packaging or labeling of a
cosmetic means any specific requirement relating to the same aspect
of such cosmetic as a requirement specifically applicable to that
particular cosmetic or class of cosmetics under this chapter for
packaging or labeling, including any State requirement relating to
public information or any other form of public communication.
(d) No effect on product liability law
Nothing in this section shall be construed to modify or otherwise
affect any action or the liability of any person under the product
liability law of any State.
(e) State initiative
This section shall not apply to a State requirement adopted by a
State public initiative or referendum enacted prior to September 1,
1997.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 752, as added Pub. L. 105-115, title
IV, Sec. 412(d), Nov. 21, 1997, 111 Stat. 2376.)
-REFTEXT-
REFERENCES IN TEXT
The Poison Prevention Packaging Act of 1970, referred to in
subsec. (a), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
amended, which is classified principally to chapter 39A (Sec. 1471
et seq.) of Title 15, Commerce and Trade. For complete
classification of this Act to the Code, see Short Title note set
out under section 1471 of Title 15 and Tables.
The Fair Packaging and Labeling Act, referred to in subsec. (a),
is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
15, Commerce and Trade. For complete classification of this Act to
the Code, see Short Title note set out under section 1451 of Title
15 and Tables.
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Part G - Safety Reports 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part G - Safety Reports
-HEAD-
PART G - SAFETY REPORTS
-End-
-CITE-
21 USC Sec. 379v 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part G - Safety Reports
-HEAD-
Sec. 379v. Safety report disclaimers
-STATUTE-
With respect to any entity that submits or is required to submit
a safety report or other information in connection with the safety
of a product (including a product that is a food, drug, device,
dietary supplement, or cosmetic) under this chapter (and any
release by the Secretary of that report or information), such
report or information shall not be construed to reflect necessarily
a conclusion by the entity or the Secretary that the report or
information constitutes an admission that the product involved
malfunctioned, caused or contributed to an adverse experience, or
otherwise caused or contributed to a death, serious injury, or
serious illness. Such an entity need not admit, and may deny, that
the report or information submitted by the entity constitutes an
admission that the product involved malfunctioned, caused or
contributed to an adverse experience, or caused or contributed to a
death, serious injury, or serious illness.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 756, as added Pub. L. 105-115, title
IV, Sec. 420, Nov. 21, 1997, 111 Stat. 2379.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Part H - Serious Adverse Event Reports 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part H - Serious Adverse Event Reports
-HEAD-
PART H - SERIOUS ADVERSE EVENT REPORTS
-End-
-CITE-
21 USC Sec. 379aa 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part H - Serious Adverse Event Reports
-HEAD-
Sec. 379aa. Serious adverse event reporting for nonprescription
drugs
-STATUTE-
(a) Definitions
In this section:
(1) Adverse event
The term "adverse event" means any health-related event
associated with the use of a nonprescription drug that is
adverse, including -
(A) an event occurring from an overdose of the drug, whether
accidental or intentional;
(B) an event occurring from abuse of the drug;
(C) an event occurring from withdrawal from the drug; and
(D) any failure of expected pharmacological action of the
drug.
(2) Nonprescription drug
The term "nonprescription drug" means a drug that is -
(A) not subject to section 353(b) of this title; and
(B) not subject to approval in an application submitted under
section 355 of this title.
(3) Serious adverse event
The term "serious adverse event" is an adverse event that -
(A) results in -
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity;
or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical
or surgical intervention to prevent an outcome described under
subparagraph (A).
(4) Serious adverse event report
The term "serious adverse event report" means a report that is
required to be submitted to the Secretary under subsection (b).
(b) Reporting requirement
(1) In general
The manufacturer, packer, or distributor whose name (pursuant
to section 352(b)(1) of this title) appears on the label of a
nonprescription drug marketed in the United States (referred to
in this section as the "responsible person") shall submit to the
Secretary any report received of a serious adverse event
associated with such drug when used in the United States,
accompanied by a copy of the label on or within the retail
package of such drug.
(2) Retailer
A retailer whose name appears on the label described in
paragraph (1) as a distributor may, by agreement, authorize the
manufacturer or packer of the nonprescription drug to submit the
required reports for such drugs to the Secretary so long as the
retailer directs to the manufacturer or packer all adverse events
associated with such drug that are reported to the retailer
through the address or telephone number described in section
352(x) of this title.
(c) Submission of reports
(1) Timing of reports
The responsible person shall submit to the Secretary a serious
adverse event report no later than 15 business days after the
report is received through the address or phone number described
in section 352(x) of this title.
(2) New medical information
The responsible person shall submit to the Secretary any new
medical information, related to a submitted serious adverse event
report that is received by the responsible person within 1 year
of the initial report, no later than 15 business days after the
new information is received by the responsible person.
(3) Consolidation of reports
The Secretary shall develop systems to ensure that duplicate
reports of, and new medical information related to, a serious
adverse event shall be consolidated into a single report.
(4) Exemption
The Secretary, after providing notice and an opportunity for
comment from interested parties, may establish an exemption to
the requirements under paragraphs (1) and (2) if the Secretary
determines that such exemption would have no adverse effect on
public health.
(d) Contents of reports
Each serious adverse event report under this section shall be
submitted to the Secretary using the MedWatch form, which may be
modified by the Secretary for nonprescription drugs, and may be
accompanied by additional information.
(e) Maintenance and inspection of records
(1) Maintenance
The responsible person shall maintain records related to each
report of an adverse event received by the responsible person for
a period of 6 years.
(2) Records inspection
(A) In general
The responsible person shall permit an authorized person to
have access to records required to be maintained under this
section, during an inspection pursuant to section 374 of this
title.
(B) Authorized person
For purposes of this paragraph, the term "authorized person"
means an officer or employee of the Department of Health and
Human Services who has -
(i) appropriate credentials, as determined by the
Secretary; and
(ii) been duly designated by the Secretary to have access
to the records required under this section.
(f) Protected information
A serious adverse event report submitted to the Secretary under
this section, including any new medical information submitted under
subsection (c)(2), or an adverse event report voluntarily submitted
to the Secretary shall be considered to be -
(1) a safety report under section 379v of this title and may be
accompanied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
(2) a record about an individual under section 552a of title 5
(commonly referred to as the "Privacy Act of 1974") and a medical
or similar file the disclosure of which would constitute a
violation of section 552 of such title 5 (commonly referred to as
the "Freedom of Information Act"), and shall not be publicly
disclosed unless all personally identifiable information is
redacted.
(g) Rule of construction
The submission of any adverse event report in compliance with
this section shall not be construed as an admission that the
nonprescription drug involved caused or contributed to the adverse
event.
(h) Preemption
(1) In general
No State or local government shall establish or continue in
effect any law, regulation, order, or other requirement, related
to a mandatory system for adverse event reports for
nonprescription drugs, that is different from, in addition to, or
otherwise not identical to, this section.
(2) Effect of section
(A) In general
Nothing in this section shall affect the authority of the
Secretary to provide adverse event reports and information to
any health, food, or drug officer or employee of any State,
territory, or political subdivision of a State or territory,
under a memorandum of understanding between the Secretary and
such State, territory, or political subdivision.
(B) Personally-identifiable information
Notwithstanding any other provision of law, personally-
identifiable information in adverse event reports provided by
the Secretary to any health, food, or drug officer or employee
of any State, territory, or political subdivision of a State or
territory, shall not -
(i) be made publicly available pursuant to any State or
other law requiring disclosure of information or records; or
(ii) otherwise be disclosed or distributed to any party
without the written consent of the Secretary and the person
submitting such information to the Secretary.
(C) Use of safety reports
Nothing in this section shall permit a State, territory, or
political subdivision of a State or territory, to use any
safety report received from the Secretary in a manner
inconsistent with subsection (g) or section 379v of this title.
(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section
such sums as may be necessary.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 760, as added Pub. L. 109-462, Sec.
2(a), Dec. 22, 2006, 120 Stat. 3469.)
-MISC1-
EFFECTIVE DATE
Section effective 1 year after Dec. 22, 2006, see section 2(e)(1)
of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
note under section 352 of this title.
MODIFICATIONS
Pub. L. 109-462, Sec. 2(b), Dec. 22, 2006, 120 Stat. 3472,
provided that: "The Secretary of Health and Human Services may
modify requirements under the amendments made by this section
[enacting this section and amending sections 331 and 352 of this
title] in accordance with section 553 of title 5, United States
Code, to maintain consistency with international harmonization
efforts over time."
GUIDANCE
Pub. L. 109-462, Sec. 2(e)(3), Dec. 22, 2006, 120 Stat. 3472,
provided that: "Not later than 270 days after the date of enactment
of this Act [Dec. 22, 2006], the Secretary of Health and Human
Services shall issue guidance on the minimum data elements that
should be included in a serious adverse event report described
under the amendments made by this Act [see Short Title of 2006
Amendment note set out under section 301 of this title]."
Pub. L. 109-462, Sec. 3(d)(3), Dec. 22, 2006, 120 Stat. 3475,
enacted provisions substantially identical to those enacted by Pub.
L. 109-462, Sec. 2(b), set out above.
-End-
-CITE-
21 USC Sec. 379aa-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VII - GENERAL AUTHORITY
Part H - Serious Adverse Event Reports
-HEAD-
Sec. 379aa-1. Serious adverse event reporting for dietary
supplements
-STATUTE-
(a) Definitions
In this section:
(1) Adverse event
The term "adverse event" means any health-related event
associated with the use of a dietary supplement that is adverse.
(2) Serious adverse event
The term "serious adverse event" is an adverse event that -
(A) results in -
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity;
or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical
or surgical intervention to prevent an outcome described under
subparagraph (A).
(3) Serious adverse event report
The term "serious adverse event report" means a report that is
required to be submitted to the Secretary under subsection (b).
(b) Reporting requirement
(1) In general
The manufacturer, packer, or distributor of a dietary
supplement whose name (pursuant to section 343(e)(1) of this
title) appears on the label of a dietary supplement marketed in
the United States (referred to in this section as the
"responsible person") shall submit to the Secretary any report
received of a serious adverse event associated with such dietary
supplement when used in the United States, accompanied by a copy
of the label on or within the retail packaging of such dietary
supplement.
(2) Retailer
A retailer whose name appears on the label described in
paragraph (1) as a distributor may, by agreement, authorize the
manufacturer or packer of the dietary supplement to submit the
required reports for such dietary supplements to the Secretary so
long as the retailer directs to the manufacturer or packer all
adverse events associated with such dietary supplement that are
reported to the retailer through the address or telephone number
described in section 343(y) of this title.
(c) Submission of reports
(1) Timing of reports
The responsible person shall submit to the Secretary a serious
adverse event report no later than 15 business days after the
report is received through the address or phone number described
in section 343(y) of this title.
(2) New medical information
The responsible person shall submit to the Secretary any new
medical information, related to a submitted serious adverse event
report that is received by the responsible person within 1 year
of the initial report, no later than 15 business days after the
new information is received by the responsible person.
(3) Consolidation of reports
The Secretary shall develop systems to ensure that duplicate
reports of, and new medical information related to, a serious
adverse event shall be consolidated into a single report.
(4) Exemption
The Secretary, after providing notice and an opportunity for
comment from interested parties, may establish an exemption to
the requirements under paragraphs (1) and (2) if the Secretary
determines that such exemption would have no adverse effect on
public health.
(d) Contents of reports
Each serious adverse event report under this section shall be
submitted to the Secretary using the MedWatch form, which may be
modified by the Secretary for dietary supplements, and may be
accompanied by additional information.
(e) Maintenance and inspection of records
(1) Maintenance
The responsible person shall maintain records related to each
report of an adverse event received by the responsible person for
a period of 6 years.
(2) Records inspection
(A) In general
The responsible person shall permit an authorized person to
have access to records required to be maintained under this
section during an inspection pursuant to section 374 of this
title.
(B) Authorized person
For purposes of this paragraph, the term "authorized person"
means an officer or employee of the Department of Health and
Human Services, who has -
(i) appropriate credentials, as determined by the
Secretary; and
(ii) been duly designated by the Secretary to have access
to the records required under this section.
(f) Protected information
A serious adverse event report submitted to the Secretary under
this section, including any new medical information submitted under
subsection (c)(2), or an adverse event report voluntarily submitted
to the Secretary shall be considered to be -
(1) a safety report under section 379v of this title and may be
accompanied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
(2) a record about an individual under section 552a of title 5
(commonly referred to as the "Privacy Act of 1974") and a medical
or similar file the disclosure of which would constitute a
violation of section 552 of such title 5 (commonly referred to as
the "Freedom of Information Act"), and shall not be publicly
disclosed unless all personally identifiable information is
redacted.
(g) Rule of construction
The submission of any adverse event report in compliance with
this section shall not be construed as an admission that the
dietary supplement involved caused or contributed to the adverse
event.
(h) Preemption
(1) In general
No State or local government shall establish or continue in
effect any law, regulation, order, or other requirement, related
to a mandatory system for adverse event reports for dietary
supplements, that is different from, in addition to, or otherwise
not identical to, this section.
(2) Effect of section
(A) In general
Nothing in this section shall affect the authority of the
Secretary to provide adverse event reports and information to
any health, food, or drug officer or employee of any State,
territory, or political subdivision of a State or territory,
under a memorandum of understanding between the Secretary and
such State, territory, or political subdivision.
(B) Personally-identifiable information
Notwithstanding any other provision of law, personally-
identifiable information in adverse event reports provided by
the Secretary to any health, food, or drug officer or employee
of any State, territory, or political subdivision of a State or
territory, shall not -
(i) be made publicly available pursuant to any State or
other law requiring disclosure of information or records; or
(ii) otherwise be disclosed or distributed to any party
without the written consent of the Secretary and the person
submitting such information to the Secretary.
(C) Use of safety reports
Nothing in this section shall permit a State, territory, or
political subdivision of a State or territory, to use any
safety report received from the Secretary in a manner
inconsistent with subsection (g) or section 379v of this title.
(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section
such sums as may be necessary.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 761, as added Pub. L. 109-462, Sec.
3(a), Dec. 22, 2006, 120 Stat. 3472.)
-MISC1-
EFFECTIVE DATE
Section effective 1 year after Dec. 22, 2006, see section 3(d)(1)
of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
note under section 343 of this title.
-End-
-CITE-
21 USC SUBCHAPTER VIII - IMPORTS AND EXPORTS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
-HEAD-
SUBCHAPTER VIII - IMPORTS AND EXPORTS
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-CITE-
21 USC Sec. 381 01/03/2007
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TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
-HEAD-
Sec. 381. Imports and exports
-STATUTE-
(a) Imports; list of registered foreign establishments; samples
from unregistered foreign establishments; examination and refusal
of admission
The Secretary of the Treasury shall deliver to the Secretary of
Health and Human Services, upon his request, samples of food,
drugs, devices, and cosmetics which are being imported or offered
for import into the United States, giving notice thereof to the
owner or consignee, who may appear before the Secretary of Health
and Human Services and have the right to introduce testimony. The
Secretary of Health and Human Services shall furnish to the
Secretary of the Treasury a list of establishments registered
pursuant to subsection (i) of section 360 of this title and shall
request that if any drugs and devices manufactured, prepared,
propagated, compounded, or processed in an establishment not so
registered are imported or offered for import into the United
States, samples of such drugs and devices be delivered to the
Secretary of Health and Human Services, with notice of such
delivery to the owner or consignee, who may appear before the
Secretary of Health and Human Services and have the right to
introduce testimony. If it appears from the examination of such
samples or otherwise that (1) such article has been manufactured,
processed, or packed under insanitary conditions or, in the case of
a device, the methods used in, or the facilities or controls used
for, the manufacture, packing, storage, or installation of the
device do not conform to the requirements of section 360j(f) of
this title, or (2) such article is forbidden or restricted in sale
in the country in which it was produced or from which it was
exported, or (3) such article is adulterated, misbranded, or in
violation of section 355 of this title, then such article shall be
refused admission, except as provided in subsection (b) of this
section. If such article is subject to a requirement under section
379aa or 379aa-1 of this title and if the Secretary has credible
evidence or information indicating that the responsible person (as
defined in such section 379aa or 379aa-1 of this title) has not
complied with a requirement of such section 379aa or 379aa-1 of
this title with respect to any such article, or has not allowed
access to records described in such section 379aa or 379aa-1 of
this title, then such article shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of the
Treasury shall cause the destruction of any such article refused
admission unless such article is exported, under regulations
prescribed by the Secretary of the Treasury, within ninety days of
the date of notice of such refusal or within such additional time
as may be permitted pursuant to such regulations. Clause (2) of the
third sentence of this paragraph (!1) shall not be construed to
prohibit the admission of narcotic drugs the importation of which
is permitted under the Controlled Substances Import and Export Act
[21 U.S.C. 951 et seq.].
(b) Disposition of refused articles
Pending decision as to the admission of an article being imported
or offered for import, the Secretary of the Treasury may authorize
delivery of such article to the owner or consignee upon the
execution by him of a good and sufficient bond providing for the
payment of such liquidated damages in the event of default as may
be required pursuant to regulations of the Secretary of the
Treasury. If it appears to the Secretary of Health and Human
Services that (1) an article included within the provisions of
clause (3) of subsection (a) of this section can, by relabeling or
other action, be brought into compliance with this chapter or
rendered other than a food, drug, device, or cosmetic, or (2) with
respect to an article included within the provision of the fourth
sentence of subsection (a), the responsible person (as defined in
section 379aa or 379aa-1 of this title) can take action that would
assure that the responsible person is in compliance with section
379aa or 379aa-1 of this title, as the case may be, final
determination as to admission of such article may be deferred and,
upon filing of timely written application by the owner or consignee
and the execution by him of a bond as provided in the preceding
provisions of this subsection, the Secretary may, in accordance
with regulations, authorize the applicant, or, with respect to
clause (2), the responsible person, to perform such relabeling or
other action specified in such authorization (including destruction
or export of rejected articles or portions thereof, as may be
specified in the Secretary's authorization). All such relabeling or
other action pursuant to such authorization shall in accordance
with regulations be under the supervision of an officer or employee
of the Department of Health and Human Services designated by the
Secretary, or an officer or employee of the Department of the
Treasury designated by the Secretary of the Treasury.
(c) Charges concerning refused articles
All expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection (a) of
this section and the supervision of the relabeling or other action
authorized under the provisions of subsection (b) of this section,
the amount of such expenses to be determined in accordance with
regulations, and all expenses in connection with the storage,
cartage, or labor with respect to any article refused admission
under subsection (a) of this section, shall be paid by the owner or
consignee and, in default of such payment, shall constitute a lien
against any future importations made by such owner or consignee.
(d) Reimportation
(1) Except as provided in paragraph (2) and section 384 of this
title, no drug subject to section 353(b) of this title or composed
wholly or partly of insulin which is manufactured in a State and
exported may be imported into the United States unless the drug is
imported by the manufacturer of the drug.
(2) The Secretary may authorize the importation of a drug the
importation of which is prohibited by paragraph (1) if the drug is
required for emergency medical care.
(3)(A) Subject to subparagraph (B), no component of a drug, no
component part or accessory of a device, or other article of device
requiring further processing, which is ready or suitable for use
for health-related purposes, and no article of a food additive,
color additive, or dietary supplement, including a product in bulk
form, shall be excluded from importation into the United States
under subsection (a) of this section if each of the following
conditions is met:
(i) The importer of such article of a drug or device or
importer of such article of a food additive, color additive, or
dietary supplement submits to the Secretary, at the time of
initial importation, a statement in accordance with the
following:
(I) Such statement provides that such article is intended to
be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug,
biological product, device, food, food additive, color
additive, or dietary supplement that will be exported by the
initial owner or consignee from the United States in accordance
with subsection (e) of this section or section 382 of this
title, or with section 262(h) of title 42.
(II) The statement identifies the manufacturer of such
article and each processor, packer, distributor, or other
entity that had possession of the article in the chain of
possession of the article from the manufacturer to such
importer of the article.
(III) The statement is accompanied by such certificates of
analysis as are necessary to identify such article, unless the
article is a device or is an article described in paragraph
(4).
(ii) At the time of initial importation and before the delivery
of such article to the importer or the initial owner or
consignee, such owner or consignee executes a good and sufficient
bond providing for the payment of such liquidated damages in the
event of default as may be required pursuant to regulations of
the Secretary of the Treasury.
(iii) Such article is used and exported by the initial owner or
consignee in accordance with the intent described under clause
(i)(I), except for any portions of the article that are
destroyed.
(iv) The initial owner or consignee maintains records on the
use or destruction of such article or portions thereof, as the
case may be, and submits to the Secretary any such records
requested by the Secretary.
(v) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions thereof,
and the manner in which such owner or consignee complied with the
requirements of this subparagraph.
(B) Notwithstanding subparagraph (A), the Secretary may refuse
admission to an article that otherwise would be imported into the
United States under such subparagraph if the Secretary determines
that there is credible evidence or information indicating that such
article is not intended to be further processed by the initial
owner or consignee, or incorporated by the initial owner or
consignee, into a drug, biological product, device, food, food
additive, color additive, or dietary supplement that will be
exported by the initial owner or consignee from the United States
in accordance with subsection (e) of this section or section 382 of
this title, or with section 262(h) of title 42.
(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles imported
into the United States under authority of subparagraph (A) meet
each of the conditions established in such subparagraph for
importation.
(4) The importation into the United States of blood, blood
components, source plasma, or source leukocytes or of a component,
accessory, or part thereof is not permitted pursuant to paragraph
(3) unless the importation complies with section 262(a) of title 42
or the Secretary permits the importation under appropriate
circumstances and conditions, as determined by the Secretary. The
importation of tissue or a component or part of tissue is not
permitted pursuant to paragraph (3) unless the importation complies
with section 264 of title 42.
(e) Exports
(1) A food, drug, device, or cosmetic intended for export shall
not be deemed to be adulterated or misbranded under this chapter if
it -
(A) accords to the specifications of the foreign purchaser,
(B) is not in conflict with the laws of the country to which it
is intended for export,
(C) is labeled on the outside of the shipping package that it
is intended for export, and
(D) is not sold or offered for sale in domestic commerce.
(2) Paragraph (1) does not apply to any device -
(A) which does not comply with an applicable requirement of
section 360d or 360e of this title,
(B) which under section 360j(g) of this title is exempt from
either such section, or
(C) which is a banned device under section 360f of this title,
unless, in addition to the requirements of paragraph (1), either
(i) the Secretary has determined that the exportation of the device
is not contrary to public health and safety and has the approval of
the country to which it is intended for export or (ii) the device
is eligible for export under section 382 of this title.
(3) A new animal drug that requires approval under section 360b
of this title shall not be exported pursuant to paragraph (1) if
such drug has been banned in the United States.
(4)(A) Any person who exports a drug, animal drug, or device may
request that the Secretary -
(i) certify in writing that the exported drug, animal drug, or
device meets the requirements of paragraph (1) or section 382 of
this title; or
(ii) certify in writing that the drug, animal drug, or device
being exported meets the applicable requirements of this chapter
upon a showing that the drug or device meets the applicable
requirements of this chapter.
The Secretary shall issue such a certification within 20 days of
the receipt of a request for such certification.
(B) If the Secretary issues a written export certification within
the 20 days prescribed by subparagraph (A), a fee for such
certification may be charged but shall not exceed $175 for each
certification. Fees collected for a fiscal year pursuant to this
subparagraph shall be credited to the appropriation account for
salaries and expenses of the Food and Drug Administration and shall
be available in accordance with appropriations Acts until expended
without fiscal year limitation. Such fees shall be collected in
each fiscal year in an amount equal to the amount specified in
appropriations Acts for such fiscal year and shall only be
collected and available for the costs of the Food and Drug
Administration.
(f) Labeling of exported drugs
(1) If a drug (other than insulin, an antibiotic drug, an animal
drug, or a drug exported under section 382 of this title) being
exported in accordance with subsection (e) of this section is being
exported to a country that has different or additional labeling
requirements or conditions for use and such country requires the
drug to be labeled in accordance with those requirements or uses,
such drug may be labeled in accordance with such requirements and
conditions for use in the country to which such drug is being
exported if it also is labeled in accordance with the requirements
of this chapter.
(2) If, pursuant to paragraph (1), the labeling of an exported
drug includes conditions for use that have not been approved under
this chapter, the labeling must state that such conditions for use
have not been approved under this chapter. A drug exported under
section 382 of this title is exempt from this section.
(g) Warning notice of importation in violation of chapter
(1) With respect to a prescription drug being imported or offered
for import into the United States, the Secretary, in the case of an
individual who is not in the business of such importations, may not
send a warning notice to the individual unless the following
conditions are met:
(A) The notice specifies, as applicable to the importation of
the drug, that the Secretary has made a determination that -
(i) importation is in violation of subsection (a) of this
section because the drug is or appears to be adulterated,
misbranded, or in violation of section 355 of this title;
(ii) importation is in violation of subsection (a) of this
section because the drug is or appears to be forbidden or
restricted in sale in the country in which it was produced or
from which it was exported;
(iii) importation is or appears to be in violation of
subsection (d)(1) of this section; or
(iv) importation otherwise is or appears to be in violation
of Federal law.
(B) The notice does not specify any provision described in
subparagraph (A) that is not applicable to the importation of the
drug.
(C) The notice states the reasons underlying such determination
by the Secretary, including a brief application to the principal
facts involved of the provision of law described in subparagraph
(A) that is the basis of the determination by the Secretary.
(2) For purposes of this section, the term "warning notice", with
respect to the importation of a drug, means a communication from
the Secretary (written or otherwise) notifying a person, or clearly
suggesting to the person, that importing the drug for personal use
is, or appears to be, a violation of this chapter.
(h) Protection against adulteration of food
(1) The Secretary shall give high priority to increasing the
number of inspections under this section for the purpose of
enabling the Secretary to inspect food offered for import at ports
of entry into the United States, with the greatest priority given
to inspections to detect the intentional adulteration of food.
(2) The Secretary shall give high priority to making necessary
improvements to the information management systems of the Food and
Drug Administration that contain information related to foods
imported or offered for import into the United States for purposes
of improving the ability of the Secretary to allocate resources,
detect the intentional adulteration of food, and facilitate the
importation of food that is in compliance with this chapter.
(3) The Secretary shall improve linkages with other regulatory
agencies of the Federal Government that share responsibility for
food safety, and shall with respect to such safety improve linkages
with the States and Indian tribes (as defined in section 450b(e) of
title 25).
(i) Testing for rapid detection of adulteration of food
(1) For use in inspections of food under this section, the
Secretary shall provide for research on the development of tests
and sampling methodologies -
(A) whose purpose is to test food in order to rapidly detect
the adulteration of the food, with the greatest priority given to
detect the intentional adulteration of food; and
(B) whose results offer significant improvements over the
available technology in terms of accuracy, timing, or costs.
(2) In providing for research under paragraph (1), the Secretary
shall give priority to conducting research on the development of
tests that are suitable for inspections of food at ports of entry
into the United States.
(3) In providing for research under paragraph (1), the Secretary
shall as appropriate coordinate with the Director of the Centers
for Disease Control and Prevention, the Director of the National
Institutes of Health, the Administrator of the Environmental
Protection Agency, and the Secretary of Agriculture.
(4) The Secretary shall annually submit to the Committee on
Energy and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the Senate,
a report describing the progress made in research under paragraph
(1), including progress regarding paragraph (2).
(j) Temporary holds at ports of entry
(1) If an officer or qualified employee of the Food and Drug
Administration has credible evidence or information indicating that
an article of food presents a threat of serious adverse health
consequences or death to humans or animals, and such officer or
qualified employee is unable to inspect, examine, or investigate
such article upon the article being offered for import at a port of
entry into the United States, the officer or qualified employee
shall request the Secretary of Treasury to hold the food at the
port of entry for a reasonable period of time, not to exceed 24
hours, for the purpose of enabling the Secretary to inspect,
examine, or investigate the article as appropriate.
(2) The Secretary shall request the Secretary of Treasury to
remove an article held pursuant to paragraph (1) to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any
person from the port of entry into the United States for the
article, or from the secure facility to which the article has been
removed, as the case may be. Subsection (b) of this section does
not authorize the delivery of the article pursuant to the execution
of a bond while the article is so held.
(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if the
Secretary or an official designated by the Secretary approves the
request. An official may not be so designated unless the official
is the director of the district under this chapter in which the
article involved is located, or is an official senior to such
director.
(4) With respect to an article of food for which a request under
paragraph (1) is made, the Secretary, promptly after the request is
made, shall notify the State in which the port of entry involved is
located that the request has been made, and as applicable, that
such article is being held under this subsection.
(k) Importation by debarred persons
(1) If an article of food is being imported or offered for import
into the United States, and the importer, owner, or consignee of
the article is a person who has been debarred under section
335a(b)(3) of this title, such article shall be held at the port of
entry for the article, and may not be delivered to such person.
Subsection (b) of this section does not authorize the delivery of
the article pursuant to the execution of a bond while the article
is so held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is so
held, the article shall not be transferred by any person from the
port of entry into the United States for the article, or from the
secure facility to which the article has been removed, as the case
may be.
(2) An article of food held under paragraph (1) may be delivered
to a person who is not a debarred person under section 335a(b)(3)
of this title if such person affirmatively establishes, at the
expense of the person, that the article complies with the
requirements of this chapter, as determined by the Secretary.
(l) Failure to register
(1) (!2) If an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to the
Secretary under section 350d of this title, such article shall be
held at the port of entry for the article, and may not be delivered
to the importer, owner, or consignee of the article, until the
foreign facility is so registered. Subsection (b) of this section
does not authorize the delivery of the article pursuant to the
execution of a bond while the article is so held. The article shall
be removed to a secure facility, as appropriate. During the period
of time that such article is so held, the article shall not be
transferred by any person from the port of entry into the United
States for the article, or from the secure facility to which the
article has been removed, as the case may be.
(m) Prior notice of imported food shipments
(1) In the case of an article of food that is being imported or
offered for import into the United States, the Secretary, after
consultation with the Secretary of the Treasury, shall by
regulation require, for the purpose of enabling such article to be
inspected at ports of entry into the United States, the submission
to the Secretary of a notice providing the identity of each of the
following: The article; the manufacturer and shipper of the
article; if known within the specified period of time that notice
is required to be provided, the grower of the article; the country
from which the article originates; the country from which the
article is shipped; and the anticipated port of entry for the
article. An article of food imported or offered for import without
submission of such notice in accordance with the requirements under
this paragraph shall be refused admission into the United States.
Nothing in this section may be construed as a limitation on the
port of entry for an article of food.
(2)(A) Regulations under paragraph (1) shall require that a
notice under such paragraph be provided by a specified period of
time in advance of the time of the importation of the article of
food involved or the offering of the food for import, which period
shall be no less than the minimum amount of time necessary for the
Secretary to receive, review, and appropriately respond to such
notification, but may not exceed five days. In determining the
specified period of time required under this subparagraph, the
Secretary may consider, but is not limited to consideration of, the
effect on commerce of such period of time, the locations of the
various ports of entry into the United States, the various modes of
transportation, the types of food imported into the United States,
and any other such consideration. Nothing in the preceding sentence
may be construed as a limitation on the obligation of the Secretary
to receive, review, and appropriately respond to any notice under
paragraph (1).
(B)(i) If an article of food is being imported or offered for
import into the United States and a notice under paragraph (1) is
not provided in advance in accordance with the requirements under
paragraph (1), such article shall be held at the port of entry for
the article, and may not be delivered to the importer, owner, or
consignee of the article, until such notice is submitted to the
Secretary, and the Secretary examines the notice and determines
that the notice is in accordance with the requirements under
paragraph (1). Subsection (b) of this section does not authorize
the delivery of the article pursuant to the execution of a bond
while the article is so held. The article shall be removed to a
secure facility, as appropriate. During the period of time that
such article is so held, the article shall not be transferred by
any person from the port of entry into the United States for the
article, or from the secure facility to which the article has been
removed, as the case may be.
(ii) In carrying out clause (i) with respect to an article of
food, the Secretary shall determine whether there is in the
possession of the Secretary any credible evidence or information
indicating that such article presents a threat of serious adverse
health consequences or death to humans or animals.
(3)(A) This subsection may not be construed as limiting the
authority of the Secretary to obtain information under any other
provision of this chapter.
(B) This subsection may not be construed as authorizing the
Secretary to impose any requirements with respect to a food to the
extent that it is within the exclusive jurisdiction of the
Secretary of Agriculture pursuant to the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
(n) Labeling of food refused admission
(1) If a food has been refused admission under subsection (a) of
this section, other than such a food that is required to be
destroyed, the Secretary may require the owner or consignee of the
food to affix to the container of the food a label that clearly and
conspicuously bears the statement: "UNITED STATES: REFUSED ENTRY".
(2) All expenses in connection with affixing a label under
paragraph (1) shall be paid by the owner or consignee of the food
involved, and in default of such payment, shall constitute a lien
against future importations made by such owner or consignee.
(3) A requirement under paragraph (1) remains in effect until the
Secretary determines that the food involved has been brought into
compliance with this chapter.
(o) Registration statement
If an article that is a drug or device is being imported or
offered for import into the United States, and the importer, owner,
or consignee of such article does not, at the time of offering the
article for import, submit to the Secretary a statement that
identifies the registration under section 360(i) of this title of
each establishment that with respect to such article is required
under such section to register with the Secretary, the article may
be refused admission. If the article is refused admission for
failure to submit such a statement, the article shall be held at
the port of entry for the article, and may not be delivered to the
importer, owner, or consignee of the article, until such a
statement is submitted to the Secretary. Subsection (b) of this
section does not authorize the delivery of the article pursuant to
the execution of a bond while the article is so held. The article
shall be removed to a secure facility, as appropriate. During the
period of time that such article is so held, the article shall not
be transferred by any person from the port of entry into the United
States for the article, or from the secure facility to which the
article has been removed, as the case may be.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 801, 52 Stat. 1058; Oct. 18, 1949,
ch. 696, Secs. 1-3, 63 Stat. 882; Pub. L. 87-781, title III, Sec.
306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90-399, Sec. 106, July
13, 1968, 82 Stat. 353; Pub. L. 91-513, title II, Sec. 701(h), Oct.
27, 1970, 84 Stat. 1282; Pub. L. 94-295, Secs. 3(f), 4(b)(3), May
28, 1976, 90 Stat. 578, 580; Pub. L. 100-293, Sec. 3, Apr. 22,
1988, 102 Stat. 96; Pub. L. 102-300, Sec. 6(b)(1), June 16, 1992,
106 Stat. 240; Pub. L. 102-353, Sec. 5, Aug. 26, 1992, 106 Stat.
943; Pub. L. 103-80, Sec. 3(cc), (dd)(1), Aug. 13, 1993, 107 Stat.
778, 779; Pub. L. 104-134, title II, Sec. 2102(a)-(c), Apr. 26,
1996, 110 Stat. 1321-313, 1321-314; Pub. L. 104-180, title VI, Sec.
603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105-115,
title I, Sec. 125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L.
106-387, Sec. 1(a) [title VII, Secs. 745(c)(1), 746(c)], Oct. 28,
2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188, title
III, Secs. 302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a),
321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667,
668, 670, 672, 676; Pub. L. 109-462, Sec. 5(a), Dec. 22, 2006, 120
Stat. 3475.)
-REFTEXT-
REFERENCES IN TEXT
The Controlled Substances Import and Export Act, referred to in
subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84
Stat. 1285, as amended, which is classified principally to
subchapter II (Sec. 951 et seq.) of chapter 13 of this title. For
complete classification of this Act to the Code, see Short Title
note set out under section 951 of this title and Tables.
The Federal Meat Inspection Act, referred to in subsec.
(m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as
added Pub. L. 90-201, Dec. 15, 1967, 81 Stat. 584, and amended,
which are classified generally to subchapters I to IV (Sec. 601 et
seq.) of chapter 12 of this title. For complete classification of
this Act to the Code, see Short Title note set out under section
601 of this title and Tables.
The Poultry Products Inspection Act, referred to in subsec.
(m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as
amended, which is classified generally to chapter 10 (Sec. 451 et
seq.) of this title. For complete classification of this Act to the
Code, see Short Title note set out under section 451 of this title
and Tables.
The Egg Products Inspection Act, referred to in subsec.
(m)(3)(B), is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
amended, which is classified generally to chapter 15 (Sec. 1031 et
seq.) of this title. For complete classification of this Act to the
Code, see Short Title note set out under section 1031 of this title
and Tables.
-MISC1-
AMENDMENTS
2006 - Subsec. (a). Pub. L. 109-462, Sec. 5(a)(1), inserted after
third sentence "If such article is subject to a requirement under
section 379aa or 379aa-1 of this title and if the Secretary has
credible evidence or information indicating that the responsible
person (as defined in such section 379aa or 379aa-1 of this title)
has not complied with a requirement of such section 379aa or 379aa-
1 of this title with respect to any such article, or has not
allowed access to records described in such section 379aa or 379aa-
1 of this title, then such article shall be refused admission,
except as provided in subsection (b) of this section."
Subsec. (b). Pub. L. 109-462, Sec. 5(a)(2), in second sentence,
inserted "(1)" before "an article included", "or (2) with respect
to an article included within the provision of the fourth sentence
of subsection (a), the responsible person (as defined in section
379aa or 379aa-1 of this title) can take action that would assure
that the responsible person is in compliance with section 379aa or
379aa-1 of this title, as the case may be," before "final
determination", and ", or, with respect to clause (2), the
responsible person," before "to perform".
2002 - Subsec. (d)(3). Pub. L. 107-188, Sec. 322(a), amended par.
(3) generally. Prior to amendment, par. (3) read as follows: "No
component of a drug, no component part or accessory of a device, or
other article of device requiring further processing, which is
ready or suitable for use for health-related purposes, and no food
additive, color additive, or dietary supplement, including a
product in bulk form, shall be excluded from importation into the
United States under subsection (a) of this section if -
"(A) the importer of such article of a drug or device or
importer of the food additive, color additive, or dietary
supplement submits a statement to the Secretary, at the time of
initial importation, that such article of a drug or device, food
additive, color additive, or dietary supplement is intended to be
further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee into a drug,
biological product, device, food, food additive, color additive,
or dietary supplement that will be exported by such owner or
consignee from the United States in accordance with subsection
(e) of this section or section 382 of this title or section
262(h) of title 42;
"(B) the initial owner or consignee responsible for such
imported article maintains records that identify the use of such
imported article and upon request of the Secretary submits a
report that provides an accounting of the exportation or the
disposition of the imported article, including portions that have
been destroyed, and the manner in which such person complied with
the requirements of this paragraph; and
"(C) any imported component, part, article, or accessory of a
drug or device and any food additive, color additive, or dietary
supplement not incorporated or further processed as described in
subparagraph (A) is destroyed or exported by the owner or
consignee."
Subsec. (h). Pub. L. 107-188, Sec. 302(a)-(c), added subsec. (h).
Subsec. (i). Pub. L. 107-188, Sec. 302(d), added subsec. (i).
Subsec. (j). Pub. L. 107-188, Sec. 303(c), added subsec. (j).
Subsec. (k). Pub. L. 107-188, Sec. 304(e), added subsec. (k).
Subsec. (l). Pub. L. 107-188, Sec. 305(c), added subsec. (l).
Subsec. (m). Pub. L. 107-188, Sec. 307(a), added subsec. (m).
Subsec. (n). Pub. L. 107-188, Sec. 308(a), added subsec. (n).
Subsec. (o). Pub. L. 107-188, Sec. 321(b)(1), added subsec. (o).
2000 - Subsec. (d)(1). Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(c)(1)], inserted "and section 384 of this title" after
"paragraph (2)".
Subsec. (g). Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(c)],
added subsec. (g).
1997 - Subsec. (d)(1). Pub. L. 105-115 inserted "or composed
wholly or partly of insulin" after "353(b) of this title".
1996 - Subsec. (d)(3). Pub. L. 104-180, Sec. 603(a), substituted
"accessory of a device, or other article of device requiring
further processing, which is ready" for "accessory of a device
which is ready" in introductory provisions, inserted "further
processed by the initial owner or consignee, or" after "is intended
to be" in subpar. (A), and inserted "article," after "part," and
"or further processed" after "incorporated" in subpar. (C).
Pub. L. 104-134, Sec. 2102(a)(1), added par. (3)
Subsec. (d)(4). Pub. L. 104-134, Sec. 2102(a)(1), added par. (4).
Subsec. (e)(1). Pub. L. 104-134, Sec. 2102(b)(1), struck out
concluding provisions which read as follows: "This paragraph does
not authorize the exportation of any new animal drug, or an animal
feed bearing or containing a new animal drug, which is unsafe
within the meaning of section 360b of this title."
Subsec. (e)(2). Pub. L. 104-134, Sec. 2102(b)(2), in concluding
provisions, substituted "either (i) the Secretary" for "the
Secretary" and added cl. (ii).
Subsec. (e)(3), (4). Pub. L. 104-134, Sec. 2102(b)(3), added
pars. (3) and (4).
Subsec. (f). Pub. L. 104-180, Sec. 603(b), inserted "(other than
insulin, an antibiotic drug, an animal drug, or a drug exported
under section 382 of this title)" after "If a drug" in par. (1) and
"A drug exported under section 382 of this title is exempt from
this section." at end of par. (2).
Pub. L. 104-134, Sec. 2102(c), added subsec. (f).
1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture" after "Secretary of"
in two places in first sentence.
Subsec. (b). Pub. L. 103-80, Sec. 3(cc), substituted "Secretary
of Health and Human Services" for "Administrator" after "If it
appears to the", "Secretary" for "Administrator" after "provisions
of this subsection, the", "Secretary's" for "Administrator's" after
"as may be specified in the", "Department of Health and Human
Services" for "Federal Security Agency", and "Secretary" for
"Administrator" after "designated by the".
1992 - Subsecs. (a), (b). Pub. L. 102-300, which directed the
substitution of "Health and Human Services" for "Health, Education,
and Welfare" wherever appearing, was executed in second sentence of
subsec. (a), but could not be executed in first sentence of subsec.
(a) or in subsec. (b) because such words did not appear. See 1993
Amendment note above and Transfer of Functions note below.
Subsec. (d)(1). Pub. L. 102-353 substituted "manufacturer of" for
"person who manufactured".
1988 - Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and
redesignated former subsec. (d) as (e).
1976 - Subsec. (a). Pub. L. 94-295, Secs. 3(f)(2), 4(b)(3),
expanded provisions requiring the Secretary of Health, Education,
and Welfare to request that the Secretary of the Treasury deliver
to the Secretary of Health, Education, and Welfare items imported
or offered for import into the United States that were
manufactured, prepared, propagated, compounded, or processed in non-
registered establishments by extending the provisions to include
devices imported or offered for import, and, in cl. (1), inserted
reference to devices which were manufactured, packed, stored, or
installed using methods, facilities, or controls not conforming to
the requirements of section 360j(f) of this title.
Subsec. (d). Pub. L. 94-295, Sec. 3(f)(1), designated existing
provisions as par. (1) and added par. (2).
1970 - Subsec. (a). Pub. L. 91-513 substituted "Clause (2) of the
third sentence of this paragraph" for "This paragraph" and "the
Controlled Substances Import and Export Act" for "section 173 of
this title" in last sentence.
1968 - Subsec. (d). Pub. L. 90-399 provided that nothing in
subsec. (d) shall authorize the exportation of any new animal drug,
or an animal feed bearing or containing a new animal drug, which is
unsafe within the meaning of section 360b of this title.
1962 - Subsec. (a). Pub. L. 87-781 inserted provisions requiring
the Secretary of Health, Education, and Welfare to furnish the
Secretary of the Treasury a list of establishments registered under
section 360(i) of this title, and to request that samples of any
drugs from any establishments not so registered be delivered to the
Secretary of Health, Education, and Welfare, with notice of
delivery to the consignee who may appear before the Secretary to
testify.
1949 - Subsec. (a). Act Oct. 18, 1949, Sec. 1, inserted before
period at end of second sentence ", except as provided in
subsection (b) of this section. The Secretary of the Treasury shall
cause the destruction of any such article refused admission unless
such article is exported, under regulations prescribed by the
Secretary of the Treasury within ninety days of the notice of such
refusal or within such additional time as may be permitted pursuant
to such regulations".
Subsec. (b). Act Oct. 18, 1949, Sec. 2, provided for express
statutory authority for the long-standing administrative practice
of releasing imported articles that do not comply with the
requirements of the law so that they may be relabeled or given
appropriate treatment to bring them into compliance.
Subsec. (c). Act Oct. 18, 1949, Sec. 3, charged all costs,
including salaries and travel and subsistence expenses of officers
and employees, against importers.
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 5(b), Dec. 22, 2006, 120 Stat. 3476,
provided that: "The amendments made by this section [amending this
section] shall take effect 1 year after the date of enactment of
this Act [Dec. 22, 2006]."
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by section 321(b)(1) of Pub. L. 107-188 effective upon
the expiration of the 180-day period beginning June 12, 2002, see
section 321(c) of Pub. L. 107-188, set out as a note under section
331 of this title.
Amendment by section 322(a) of Pub. L. 107-188 effective upon the
expiration of the 90-day period beginning June 12, 2002, see
section 322(c) of Pub. L. 107-188, set out as a note under section
331 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
as a note under section 353 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment of subsec. (d) by Pub. L. 90-399 effective on first day
of thirteenth calendar month after July 13, 1968, see section
108(a) of Pub. L. 90-399, set out as an Effective Date and
Transitional Provisions note under section 360b of this title.
REGULATIONS
Pub. L. 107-188, title III, Sec. 307(c), June 12, 2002, 116 Stat.
672, provided that:
"(1) In general. - Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary of Health and
Human Services shall promulgate proposed and final regulations for
the requirement of providing notice in accordance with section
801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
381(m)] (as added by subsection (a) of this section). Such
requirement of notification takes effect -
"(A) upon the effective date of such final regulations; or
"(B) upon the expiration of such 18-month period if the final
regulations have not been made effective as of the expiration of
such period, subject to compliance with the final regulations
when the final regulations are made effective.
"(2) Default; minimum period of advance notice. - If under
paragraph (1) the requirement for providing notice in accordance
with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 381(m)] takes effect without final regulations having been
made effective, then for purposes of such requirement, the
specified period of time that the notice is required to be made in
advance of the time of the importation of the article of food
involved or the offering of the food for import shall be not fewer
than eight hours and not more than five days, which shall remain in
effect until the final regulations are made effective."
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for violation of law or any civil seizure or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotic and Dangerous
Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
continued and brought to final determination in accord with laws
and regulations in effect prior to Oct. 27, 1970, see section 702
of Pub. L. 91-513, set out as a note under section 321 of this
title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188
Pub. L. 107-188, title III, Sec. 308(c), June 12, 2002, 116 Stat.
673, provided that: "With respect to articles of food that are
imported or offered for import into the United States, nothing in
this section [amending this section and section 343 of this title]
shall be construed to limit the authority of the Secretary of
Health and Human Services or the Secretary of the Treasury to
require the marking of refused articles of food under any other
provision of law."
-TRANS-
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
STUDY AND REPORT ON TRADE IN PHARMACEUTICALS
Pub. L. 108-173, title XI, Sec. 1123, Dec. 8, 2003, 117 Stat.
2469, provided that: "The President's designees shall conduct a
study and report on issues related to trade and pharmaceuticals."
FINDINGS
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(b)], Oct. 28,
2000, 114 Stat. 1549, 1549A-40, provided that: "The Congress finds
as follows:
"(1) Patients and their families sometimes have reason to
import into the United States drugs that have been approved by
the Food and Drug Administration ('FDA').
"(2) There have been circumstances in which -
"(A) an individual seeking to import such a drug has received
a notice from FDA that importing the drug violates or may
violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.]; and
"(B) the notice failed to inform the individual of the
reasons underlying the decision to send the notice.
"(3) FDA should not send a warning notice regarding the
importation of a drug without providing to the individual
involved a statement of the underlying reasons for the notice."
-FOOTNOTE-
(!1) So in original. Probably should be "subsection".
(!2) So in original. No par. (2) has been enacted.
-End-
-CITE-
21 USC Sec. 382 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
-HEAD-
Sec. 382. Exports of certain unapproved products
-STATUTE-
(a) Drugs or devices intended for human or animal use which require
approval or licensing
A drug or device -
(1) which, in the case of a drug -
(A)(i) requires approval by the Secretary under section 355
of this title before such drug may be introduced or delivered
for introduction into interstate commerce; or
(ii) requires licensing by the Secretary under section 262 of
title 42 or by the Secretary of Agriculture under the Act of
March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum
Toxin Act) before it may be introduced or delivered for
introduction into interstate commerce;
(B) does not have such approval or license; and
(C) is not exempt from such sections or Act; and
(2) which, in the case of a device -
(A) does not comply with an applicable requirement under
section 360d or 360e of this title;
(B) under section 360j(g) of this title is exempt from either
such section; or
(C) is a banned device under section 360f of this title, is
adulterated, misbranded, and in violation of such sections or
Act unless the export of the drug or device is, except as
provided in subsection (f) of this section, authorized under
subsection (b), (c), (d), or (e) of this section or section
381(e)(2) of this title. If a drug or device described in
paragraphs (1) and (2) may be exported under subsection (b) of
this section and if an application for such drug or device
under section 355 or 360e of this title or section 262 of title
42 was disapproved, the Secretary shall notify the appropriate
public health official of the country to which such drug will
be exported of such disapproval.
(b) List of eligible countries for export; criteria for addition to
list; direct export; petition for exemption
(1)(A) A drug or device described in subsection (a) of this
section may be exported to any country, if the drug or device
complies with the laws of that country and has valid marketing
authorization by the appropriate authority -
(i) in Australia, Canada, Israel, Japan, New Zealand,
Switzerland, or South Africa; or
(ii) in the European Union or a country in the European
Economic Area (the countries in the European Union and the
European Free Trade Association) if the drug or device is
marketed in that country or the drug or device is authorized for
general marketing in the European Economic Area.
(B) The Secretary may designate an additional country to be
included in the list of countries described in clauses (i) and (ii)
of subparagraph (A) if all of the following requirements are met in
such country:
(i) Statutory or regulatory requirements which require the
review of drugs and devices for safety and effectiveness by an
entity of the government of such country and which authorize the
approval of only those drugs and devices which have been
determined to be safe and effective by experts employed by or
acting on behalf of such entity and qualified by scientific
training and experience to evaluate the safety and effectiveness
of drugs and devices on the basis of adequate and well-controlled
investigations, including clinical investigations, conducted by
experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs and devices.
(ii) Statutory or regulatory requirements that the methods used
in, and the facilities and controls used for -
(I) the manufacture, processing, and packing of drugs in the
country are adequate to preserve their identity, quality,
purity, and strength; and
(II) the manufacture, preproduction design validation,
packing, storage, and installation of a device are adequate to
assure that the device will be safe and effective.
(iii) Statutory or regulatory requirements for the reporting of
adverse reactions to drugs and devices and procedures to withdraw
approval and remove drugs and devices found not to be safe or
effective.
(iv) Statutory or regulatory requirements that the labeling and
promotion of drugs and devices must be in accordance with the
approval of the drug or device.
(v) The valid marketing authorization system in such country or
countries is equivalent to the systems in the countries described
in clauses (i) and (ii) of subparagraph (A).
The Secretary shall not delegate the authority granted under this
subparagraph.
(C) An appropriate country official, manufacturer, or exporter
may request the Secretary to take action under subparagraph (B) to
designate an additional country or countries to be added to the
list of countries described in clauses (i) and (ii) of subparagraph
(A) by submitting documentation to the Secretary in support of such
designation. Any person other than a country requesting such
designation shall include, along with the request, a letter from
the country indicating the desire of such country to be designated.
(2) A drug described in subsection (a) of this section may be
directly exported to a country which is not listed in clause (i) or
(ii) of paragraph (1)(A) if -
(A) the drug complies with the laws of that country and has
valid marketing authorization by the responsible authority in
that country; and
(B) the Secretary determines that all of the following
requirements are met in that country:
(i) Statutory or regulatory requirements which require the
review of drugs for safety and effectiveness by an entity of
the government of such country and which authorize the approval
of only those drugs which have been determined to be safe and
effective by experts employed by or acting on behalf of such
entity and qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs on the basis of
adequate and well-controlled investigations, including clinical
investigations, conducted by experts qualified by scientific
training and experience to evaluate the safety and
effectiveness of drugs.
(ii) Statutory or regulatory requirements that the methods
used in, and the facilities and controls used for the
manufacture, processing, and packing of drugs in the country
are adequate to preserve their identity, quality, purity, and
strength.
(iii) Statutory or regulatory requirements for the reporting
of adverse reactions to drugs and procedures to withdraw
approval and remove drugs found not to be safe or effective.
(iv) Statutory or regulatory requirements that the labeling
and promotion of drugs must be in accordance with the approval
of the drug.
(3) The exporter of a drug described in subsection (a) of this
section which would not meet the conditions for approval under this
chapter or conditions for approval of a country described in clause
(i) or (ii) of paragraph (1)(A) may petition the Secretary for
authorization to export such drug to a country which is not
described in clause (i) or (ii) of paragraph (1)(A) or which is not
described in paragraph (2). The Secretary shall permit such export
if -
(A) the person exporting the drug -
(i) certifies that the drug would not meet the conditions for
approval under this chapter or the conditions for approval of a
country described in clause (i) or (ii) of paragraph (1)(A);
and
(ii) provides the Secretary with credible scientific
evidence, acceptable to the Secretary, that the drug would be
safe and effective under the conditions of use in the country
to which it is being exported; and
(B) the appropriate health authority in the country to which
the drug is being exported -
(i) requests approval of the export of the drug to such
country;
(ii) certifies that the health authority understands that the
drug is not approved under this chapter or in a country
described in clause (i) or (ii) of paragraph (1)(A); and
(iii) concurs that the scientific evidence provided pursuant
to subparagraph (A) is credible scientific evidence that the
drug would be reasonably safe and effective in such country.
The Secretary shall take action on a request for export of a drug
under this paragraph within 60 days of receiving such request.
(c) Investigational use exemption
A drug or device intended for investigational use in any country
described in clause (i) or (ii) of subsection (b)(1)(A) of this
section may be exported in accordance with the laws of that country
and shall be exempt from regulation under section 355(i) or 360j(g)
of this title.
(d) Anticipation of market authorization
A drug or device intended for formulation, filling, packaging,
labeling, or further processing in anticipation of market
authorization in any country described in clause (i) or (ii) of
subsection (b)(1)(A) of this section may be exported for use in
accordance with the laws of that country.
(e) Diagnosis, prevention, or treatment of tropical disease
(1) A drug or device which is used in the diagnosis, prevention,
or treatment of a tropical disease or another disease not of
significant prevalence in the United States and which does not
otherwise qualify for export under this section shall, upon
approval of an application, be permitted to be exported if the
Secretary finds that the drug or device will not expose patients in
such country to an unreasonable risk of illness or injury and the
probable benefit to health from the use of the drug or device
(under conditions of use prescribed, recommended, or suggested in
the labeling or proposed labeling of the drug or device) outweighs
the risk of injury or illness from its use, taking into account the
probable risks and benefits of currently available drug or device
treatment.
(2) The holder of an approved application for the export of a
drug or device under this subsection shall report to the Secretary -
(A) the receipt of any credible information indicating that the
drug or device is being or may have been exported from a country
for which the Secretary made a finding under paragraph (1)(A) to
a country for which the Secretary cannot make such a finding; and
(B) the receipt of any information indicating adverse reactions
to such drug.
(3)(A) If the Secretary determines that -
(i) a drug or device for which an application is approved under
paragraph (1) does not continue to meet the requirements of such
paragraph; or
(ii) the holder of an approved application under paragraph (1)
has not made the report required by paragraph (2),
the Secretary may, after providing the holder of the application an
opportunity for an informal hearing, withdraw the approved
application.
(B) If the Secretary determines that the holder of an approved
application under paragraph (1) or an importer is exporting a drug
or device from the United States to an importer and such importer
is exporting the drug or device to a country for which the
Secretary cannot make a finding under paragraph (1) and such export
presents an imminent hazard, the Secretary shall immediately
prohibit the export of the drug or device to such importer, provide
the person exporting the drug or device from the United States
prompt notice of the prohibition, and afford such person an
opportunity for an expedited hearing.
(f) Prohibition of export of drug or device
A drug or device may not be exported under this section -
(1) if the drug or device is not manufactured, processed,
packaged, and held in substantial conformity with current good
manufacturing practice requirements or does not meet
international standards as certified by an international
standards organization recognized by the Secretary;
(2) if the drug or device is adulterated under clause (1),
(2)(A), or (3) of section 351(a) or subsection (c) or (d) of
section 351 of this title;
(3) if the requirements of subparagraphs (A) through (D) of
section 381(e)(1) of this title have not been met;
(4)(A) if the drug or device is the subject of a notice by the
Secretary or the Secretary of Agriculture of a determination that
the probability of reimportation of the exported drug or device
would present an imminent hazard to the public health and safety
of the United States and the only means of limiting the hazard is
to prohibit the export of the drug or device; or
(B) if the drug or device presents an imminent hazard to the
public health of the country to which the drug or device would be
exported;
(5) if the labeling of the drug or device is not -
(A) in accordance with the requirements and conditions for
use in -
(i) the country in which the drug or device received valid
marketing authorization under subsection (b) of this section;
and
(ii) the country to which the drug or device would be
exported; and
(B) in the language and units of measurement of the country
to which the drug or device would be exported or in the
language designated by such country; or
(6) if the drug or device is not promoted in accordance with
the labeling requirements set forth in paragraph (5).
In making a finding under paragraph (4)(B), (5), or (6) the
Secretary shall consult with the appropriate public health official
in the affected country.
(g) Notification of Secretary
The exporter of a drug or device exported under subsection (b)(1)
of this section shall provide a simple notification to the
Secretary identifying the drug or device when the exporter first
begins to export such drug or device to any country listed in
clause (i) or (ii) of subsection (b)(1)(A) of this section. When an
exporter of a drug or device first begins to export a drug or
device to a country which is not listed in clause (i) or (ii) of
subsection (b)(1)A) (!1) of this section, the exporter shall
provide a simple notification to the Secretary identifying the drug
or device and the country to which such drug or device is being
exported. Any exporter of a drug or device shall maintain records
of all drugs or devices exported and the countries to which they
were exported.
(h) References to Secretary and term "drug"
For purposes of this section -
(1) a reference to the Secretary shall in the case of a
biological product which is required to be licensed under the Act
of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832-833)
(commonly known as the Virus-Serum Toxin Act) be considered to be
a reference to the Secretary of Agriculture, and
(2) the term "drug" includes drugs for human use as well as
biologicals under section 262 of title 42 or the Act of March 4,
1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin
Act).
(i) Exportation
Insulin and antibiotic drugs may be exported without regard to
the requirements in this section if the insulin and antibiotic
drugs meet the requirements of section 381(e)(1) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 802, as added Pub. L. 99-660, title
I, Sec. 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104-
134, title III, Sec. 2102(d)(1), Apr. 26, 1996, 110 Stat. 1321-
315; Pub. L. 104-180, title VI, Sec. 603(c), Aug. 6, 1996, 110
Stat. 1595; Pub. L. 105-115, title I, Sec. 125(c), Nov. 21, 1997,
111 Stat. 2326.)
-REFTEXT-
REFERENCES IN TEXT
Act of March 4, 1913 (known as the Virus-Serum Toxin Act),
referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the
eighth paragraph under the heading "Bureau of Animal Industry" of
act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is
classified generally to chapter 5 (Sec. 151 et seq.) of this title.
For complete classification of this Act to the Code, see Short
Title note set out under section 151 of this title and Tables.
-MISC1-
AMENDMENTS
1997 - Subsec. (i). Pub. L. 105-115 added subsec. (i).
1996 - Pub. L. 104-134 reenacted section catchline without change
and amended text generally. Prior to amendment, text related to
exports of certain unapproved products, including provisions
relating to drugs intended for human or animal use which required
approval or licensing, conditions for export, active pursuit of
drug approval or licensing, application for export, contents,
approval or disapproval, list of eligible countries for export, and
criteria for list change, report to Secretary by holder of approved
application, events requiring report, and annual report to
Secretary on pursuit of approval of drug, export of drug under
approved application prohibited under certain conditions,
determination by Secretary of noncompliance, failure of active
pursuit of drug approval, imminent hazard of drug to public health,
or exportation of drug to noneligible country, notices, hearings,
and prohibition on exportation of drug under certain circumstances,
drugs used in prevention or treatment of tropical disease, and
reference to Secretary and holder of application.
Subsec. (f)(5). Pub. L. 104-180 substituted "if the labeling of
the drug or device is not" for "if the drug or device is not
labeled".
-FOOTNOTE-
(!1) So in original. Probably should be subsection "(b)(1)(A)".
-End-
-CITE-
21 USC Sec. 383 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
-HEAD-
Sec. 383. Office of International Relations
-STATUTE-
(a) Establishment
There is established in the Department of Health and Human
Services an Office of International Relations.
(b) Agreements with foreign countries
In carrying out the functions of the office under subsection (a)
of this section, the Secretary may enter into agreements with
foreign countries to facilitate commerce in devices between the
United States and such countries consistent with the requirements
of this chapter. In such agreements, the Secretary shall encourage
the mutual recognition of -
(1) good manufacturing practice regulations promulgated under
section 360j(f) of this title, and
(2) other regulations and testing protocols as the Secretary
determines to be appropriate.
(c) Harmonizing regulatory requirements
(1) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of
Commerce, in meetings with representatives of other countries to
discuss methods and approaches to reduce the burden of regulation
and harmonize regulatory requirements if the Secretary determines
that such harmonization continues consumer protections consistent
with the purposes of this chapter.
(2) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of
Commerce, in efforts to move toward the acceptance of mutual
recognition agreements relating to the regulation of drugs,
biological products, devices, foods, food additives, and color
additives, and the regulation of good manufacturing practices,
between the European Union and the United States.
(3) The Secretary shall regularly participate in meetings with
representatives of other foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements.
(4) The Secretary shall, not later than 180 days after November
21, 1997, make public a plan that establishes a framework for
achieving mutual recognition of good manufacturing practices
inspections.
(5) Paragraphs (1) through (4) shall not apply with respect to
products defined in section 321(ff) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec.
15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115,
title IV, Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)
-MISC1-
AMENDMENTS
1997 - Subsec. (c). Pub. L. 105-115 added subsec. (c).
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
REPORT ON ACTIVITIES OF OFFICE OF INTERNATIONAL RELATIONS
Section 15(b) of Pub. L. 101-629 directed Secretary of Health and
Human Services, not later than 2 years after Nov. 28, 1990, to
prepare and submit to the appropriate committees of Congress a
report on the activities of the Office of International Relations
under 21 U.S.C. 383.
-End-
-CITE-
21 USC Sec. 384 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII - IMPORTS AND EXPORTS
-HEAD-
Sec. 384. Importation of prescription drugs
-STATUTE-
(a) Definitions
In this section:
(1) Importer
The term "importer" means a pharmacist or wholesaler.
(2) Pharmacist
The term "pharmacist" means a person licensed by a State to
practice pharmacy, including the dispensing and selling of
prescription drugs.
(3) Prescription drug
The term "prescription drug" means a drug subject to section
353(b) of this title, other than -
(A) a controlled substance (as defined in section 802 of this
title);
(B) a biological product (as defined in section 262 of title
42);
(C) an infused drug (including a peritoneal dialysis
solution);
(D) an intravenously injected drug;
(E) a drug that is inhaled during surgery; or
(F) a drug which is a parenteral drug, the importation of
which pursuant to subsection (b) of this section is determined
by the Secretary to pose a threat to the public health, in
which case section 381(d)(1) of this title shall continue to
apply.
(4) Qualifying laboratory
The term "qualifying laboratory" means a laboratory in the
United States that has been approved by the Secretary for the
purposes of this section.
(5) Wholesaler
(A) In general
The term "wholesaler" means a person licensed as a wholesaler
or distributor of prescription drugs in the United States under
section 353(e)(2)(A) of this title.
(B) Exclusion
The term "wholesaler" does not include a person authorized to
import drugs under section 381(d)(1) of this title.
(b) Regulations
The Secretary, after consultation with the United States Trade
Representative and the Commissioner of Customs, shall promulgate
regulations permitting pharmacists and wholesalers to import
prescription drugs from Canada into the United States.
(c) Limitation
The regulations under subsection (b) of this section shall -
(1) require that safeguards be in place to ensure that each
prescription drug imported under the regulations complies with
section 355 of this title (including with respect to being safe
and effective for the intended use of the prescription drug),
with sections 351 and 352 of this title, and with other
applicable requirements of this chapter;
(2) require that an importer of a prescription drug under the
regulations comply with subsections (d)(1) and (e) of this
section; and
(3) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the public
health or as a means to facilitate the importation of
prescription drugs.
(d) Information and records
(1) In general
The regulations under subsection (b) of this section shall
require an importer of a prescription drug under subsection (b)
of this section to submit to the Secretary the following
information and documentation:
(A) The name and quantity of the active ingredient of the
prescription drug.
(B) A description of the dosage form of the prescription
drug.
(C) The date on which the prescription drug is shipped.
(D) The quantity of the prescription drug that is shipped.
(E) The point of origin and destination of the prescription
drug.
(F) The price paid by the importer for the prescription drug.
(G) Documentation from the foreign seller specifying -
(i) the original source of the prescription drug; and
(ii) the quantity of each lot of the prescription drug
originally received by the seller from that source.
(H) The lot or control number assigned to the prescription
drug by the manufacturer of the prescription drug.
(I) The name, address, telephone number, and professional
license number (if any) of the importer.
(J)(i) In the case of a prescription drug that is shipped
directly from the first foreign recipient of the prescription
drug from the manufacturer:
(I) Documentation demonstrating that the prescription drug
was received by the recipient from the manufacturer and
subsequently shipped by the first foreign recipient to the
importer.
(II) Documentation of the quantity of each lot of the
prescription drug received by the first foreign recipient
demonstrating that the quantity being imported into the
United States is not more than the quantity that was received
by the first foreign recipient.
(III)(aa) In the case of an initial imported shipment,
documentation demonstrating that each batch of the
prescription drug in the shipment was statistically sampled
and tested for authenticity and degradation.
(bb) In the case of any subsequent shipment, documentation
demonstrating that a statistically valid sample of the
shipment was tested for authenticity and degradation.
(ii) In the case of a prescription drug that is not shipped
directly from the first foreign recipient of the prescription
drug from the manufacturer, documentation demonstrating that
each batch in each shipment offered for importation into the
United States was statistically sampled and tested for
authenticity and degradation.
(K) Certification from the importer or manufacturer of the
prescription drug that the prescription drug -
(i) is approved for marketing in the United States and is
not adulterated or misbranded; and
(ii) meets all labeling requirements under this chapter.
(L) Laboratory records, including complete data derived from
all tests necessary to ensure that the prescription drug is in
compliance with established specifications and standards.
(M) Documentation demonstrating that the testing required by
subparagraphs (J) and (L) was conducted at a qualifying
laboratory.
(N) Any other information that the Secretary determines is
necessary to ensure the protection of the public health.
(2) Maintenance by the Secretary
The Secretary shall maintain information and documentation
submitted under paragraph (1) for such period of time as the
Secretary determines to be necessary.
(e) Testing
The regulations under subsection (b) of this section shall
require -
(1) that testing described in subparagraphs (J) and (L) of
subsection (d)(1) of this section be conducted by the importer or
by the manufacturer of the prescription drug at a qualified
laboratory;
(2) if the tests are conducted by the importer -
(A) that information needed to -
(i) authenticate the prescription drug being tested; and
(ii) confirm that the labeling of the prescription drug
complies with labeling requirements under this chapter;
be supplied by the manufacturer of the prescription drug to the
pharmacist or wholesaler; and
(B) that the information supplied under subparagraph (A) be
kept in strict confidence and used only for purposes of testing
or otherwise complying with this chapter; and
(3) may include such additional provisions as the Secretary
determines to be appropriate to provide for the protection of
trade secrets and commercial or financial information that is
privileged or confidential.
(f) Registration of foreign sellers
Any establishment within Canada engaged in the distribution of a
prescription drug that is imported or offered for importation into
the United States shall register with the Secretary the name and
place of business of the establishment and the name of the United
States agent for the establishment.
(g) Suspension of importation
The Secretary shall require that importations of a specific
prescription drug or importations by a specific importer under
subsection (b) of this section be immediately suspended on
discovery of a pattern of importation of that specific prescription
drug or by that specific importer of drugs that are counterfeit or
in violation of any requirement under this section, until an
investigation is completed and the Secretary determines that the
public is adequately protected from counterfeit and violative
prescription drugs being imported under subsection (b) of this
section.
(h) Approved labeling
The manufacturer of a prescription drug shall provide an importer
written authorization for the importer to use, at no cost, the
approved labeling for the prescription drug.
(i) Charitable contributions
Notwithstanding any other provision of this section, section
381(d)(1) of this title continues to apply to a prescription drug
that is donated or otherwise supplied at no charge by the
manufacturer of the drug to a charitable or humanitarian
organization (including the United Nations and affiliates) or to a
government of a foreign country.
(j) Waiver authority for importation by individuals
(1) Declarations
Congress declares that in the enforcement against individuals
of the prohibition of importation of prescription drugs and
devices, the Secretary should -
(A) focus enforcement on cases in which the importation by an
individual poses a significant threat to public health; and
(B) exercise discretion to permit individuals to make such
importations in circumstances in which -
(i) the importation is clearly for personal use; and
(ii) the prescription drug or device imported does not
appear to present an unreasonable risk to the individual.
(2) Waiver authority
(A) In general
The Secretary may grant to individuals, by regulation or on a
case-by-case basis, a waiver of the prohibition of importation
of a prescription drug or device or class of prescription drugs
or devices, under such conditions as the Secretary determines
to be appropriate.
(B) Guidance on case-by-case waivers
The Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in which the
Secretary will consistently grant waivers on a case-by-case
basis under subparagraph (A), so that individuals may know with
the greatest practicable degree of certainty whether a
particular importation for personal use will be permitted.
(3) Drugs imported from Canada
In particular, the Secretary shall by regulation grant
individuals a waiver to permit individuals to import into the
United States a prescription drug that -
(A) is imported from a licensed pharmacy for personal use by
an individual, not for resale, in quantities that do not exceed
a 90-day supply;
(B) is accompanied by a copy of a valid prescription;
(C) is imported from Canada, from a seller registered with
the Secretary;
(D) is a prescription drug approved by the Secretary under
subchapter V of this chapter;
(E) is in the form of a final finished dosage that was
manufactured in an establishment registered under section 360
of this title; and
(F) is imported under such other conditions as the Secretary
determines to be necessary to ensure public safety.
(k) Construction
Nothing in this section limits the authority of the Secretary
relating to the importation of prescription drugs, other than with
respect to section 381(d)(1) of this title as provided in this
section.
(l) Effectiveness of section
(1) Commencement of program
This section shall become effective only if the Secretary
certifies to the Congress that the implementation of this section
will -
(A) pose no additional risk to the public's health and
safety; and
(B) result in a significant reduction in the cost of covered
products to the American consumer.
(2) Termination of program
(A) In general
If, after the date that is 1 year after the effective date of
the regulations under subsection (b) of this section and before
the date that is 18 months after the effective date, the
Secretary submits to Congress a certification that, in the
opinion of the Secretary, based on substantial evidence
obtained after the effective date, the benefits of
implementation of this section do not outweigh any detriment of
implementation of this section, this section shall cease to be
effective as of the date that is 30 days after the date on
which the Secretary submits the certification.
(B) Procedure
The Secretary shall not submit a certification under
subparagraph (A) unless, after a hearing on the record under
sections 556 and 557 of title 5, the Secretary -
(i)(I) determines that it is more likely than not that
implementation of this section would result in an increase in
the risk to the public health and safety;
(II) identifies specifically, in qualitative and
quantitative terms, the nature of the increased risk;
(III) identifies specifically the causes of the increased
risk; and
(IV)(aa) considers whether any measures can be taken to
avoid, reduce, or mitigate the increased risk; and
(bb) if the Secretary determines that any measures
described in item (aa) would require additional statutory
authority, submits to Congress a report describing the
legislation that would be required;
(ii) identifies specifically, in qualitative and
quantitative terms, the benefits that would result from
implementation of this section (including the benefit of
reductions in the cost of covered products to consumers in
the United States, allowing consumers to procure needed
medication that consumers might not otherwise be able to
procure without foregoing other necessities of life); and
(iii)(I) compares in specific terms the detriment
identified under clause (i) with the benefits identified
under clause (ii); and
(II) determines that the benefits do not outweigh the
detriment.
(m) Authorization of appropriations
There are authorized to be appropriated such sums as are
necessary to carry out this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 108-173, title
XI, Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.)
-MISC1-
PRIOR PROVISIONS
A prior section 384, act June 25, 1938, ch. 675, Sec. 804, as
added Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(c)(2)], Oct.
28, 2000, 114 Stat. 1549, 1549A-36, related to importation of
covered products, prior to repeal by Pub. L. 108-173, title XI,
Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions, personnel, assets, and liabilities of
the United States Customs Service of the Department of the
Treasury, including functions of the Secretary of the Treasury
relating thereto, to the Secretary of Homeland Security, and for
treatment of related references, see sections 203(1), 551(d),
552(d), and 557 of Title 6, Domestic Security, and the Department
of Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-MISC2-
STUDY AND REPORT ON IMPORTATION OF DRUGS
Pub. L. 108-173, title XI, Sec. 1122, Dec. 8, 2003, 117 Stat.
2469, directed the Secretary of Health and Human Services to
conduct a study on the importation of drugs into the United States
pursuant to this section and to submit to Congress, not later than
12 months after Dec. 8, 2003, a report providing the findings of
such study.
-End-
-CITE-
21 USC SUBCHAPTER IX - MISCELLANEOUS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
SUBCHAPTER IX - MISCELLANEOUS
-End-
-CITE-
21 USC Sec. 391 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 391. Separability clause
-STATUTE-
If any provision of this chapter is declared unconstitutional, or
the applicability thereof to any person or circumstances is held
invalid, the constitutionality of the remainder of the chapter and
the applicability thereof to other persons and circumstances shall
not be affected thereby.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 901, 52 Stat. 1059.)
-End-
-CITE-
21 USC Sec. 392 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 392. Exemption of meats and meat food products
-STATUTE-
(a) Law determinative of exemption
Meats and meat food products shall be exempt from the provisions
of this chapter to the extent of the application or the extension
thereto of the Meat Inspection Act, approved March 4, 1907, as
amended [21 U.S.C. 601 et seq.].
(b) Laws unaffected
Nothing contained in this chapter shall be construed as in any
way affecting, modifying, repealing, or superseding the provisions
of section 351 of Public Health Service Act [42 U.S.C. 262]
(relating to viruses, serums, toxins, and analogous products
applicable to man); the virus, serum, toxin, and analogous products
provisions, applicable to domestic animals, of the Act of Congress
approved March 4, 1913 (37 Stat. 832-833) [21 U.S.C. 151 et seq.];
the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26,
ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et
seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141
et seq.].
-SOURCE-
(June 25, 1938, ch. 675, Sec. 902(b), (c), 52 Stat. 1059; Pub. L.
90-399, Sec. 107, July 13, 1968, 82 Stat. 353.)
-REFTEXT-
REFERENCES IN TEXT
The Meat Inspection Act, approved March 4, 1907, as amended,
referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I
to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which
are classified generally to subchapters I to IV (Sec. 601 et seq.)
of chapter 12 of this title. For complete classification of this
Act to the Code, see Short Title note set out under section 601 of
this title and Tables.
Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4,
1913, ch. 145, 37 Stat. 828, as amended. The provisions of such act
referred to relating to viruses, etc., applicable to domestic
animals, are contained in the eighth paragraph under the heading
"Bureau of Animal Industry", 37 Stat. 832, as amended, popularly
known as the Virus-Serum-Toxin Act, which is classified generally
to chapter 5 (Sec. 151 et seq.) of this title. For complete
classification of this Act to the Code, see Short Title note set
out under section 151 of this title and Tables.
The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title
26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch.
337, 29 Stat. 253, as amended, which had been classified to chapter
10 (Sec. 1000 et seq.) of Title 26, Internal Revenue, and included
as chapter 17 (Sec. 2350 et seq.) of Title 26, Internal Revenue
Code of 1939. Such chapter 17 was covered by section 4831 et seq.
of Title 26, Internal Revenue Code, prior to the repeal of section
4831 et seq. of Title 26 by Pub. L. 93-490, Sec. 3(a)(1), Oct. 26,
1974, 88 Stat. 1466.
The Filled Milk Act of March 4, 1923, referred to in subsec. (b),
is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is
classified generally to chapter 3 (Sec. 61 et seq.) of this title.
For complete classification of this Act to the Code, see Short
Title note set out under section 61 of this title and Tables.
The Import Milk Act of February 15, 1927, referred to in subsec.
(b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended,
which is classified generally to subchapter IV (Sec. 141 et seq.)
of chapter 4 of this title. For complete classification of this Act
to the Code, see Short Title note set out under section 141 of this
title and Tables.
-COD-
CODIFICATION
Subsecs. (a) and (b) of this section comprise respectively
subsecs. (b) and (c) of section 902 of act June 25, 1938. Subsecs.
(a) and (d) of section 902 of act June 25, 1938, which prescribed
the effective date of this chapter and made appropriations
available, are set out as notes under section 301 of this title and
this section, respectively.
-MISC1-
AMENDMENTS
1968 - Subsec. (b). Pub. L. 90-399 substituted "section 262 of
title 42 (relating to viruses, serums, toxins, and analogous
products applicable to man)" for "the virus serum, and toxin Act of
July 1, 1902" and inserted reference to "the virus, serum, toxin,
and analogous products provisions, applicable to domestic animals,
of the Act of Congress approved March 4, 1913".
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
AVAILABILITY OF APPROPRIATIONS
Section 902(d) of act June 25, 1938, provided that: "In order to
carry out the provisions of this Act which take effect [see section
902(a) of act June 25, 1938, set out as an Effective Date note
under section 301 of this title] prior to the repeal of the Food
and Drugs Act of June 30, 1906, as amended [sections 1 to 15 of
this title], appropriations available for the enforcement of such
Act of June 30, 1906, are also authorized to be made available to
carry out such provisions."
-End-
-CITE-
21 USC Sec. 393 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 393. Food and Drug Administration
-STATUTE-
(a) In general
There is established in the Department of Health and Human
Services the Food and Drug Administration (hereinafter in this
section referred to as the "Administration").
(b) Mission
The Administration shall -
(1) promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on the
marketing of regulated products in a timely manner;
(2) with respect to such products, protect the public health by
ensuring that -
(A) foods are safe, wholesome, sanitary, and properly
labeled;
(B) human and veterinary drugs are safe and effective;
(C) there is reasonable assurance of the safety and
effectiveness of devices intended for human use;
(D) cosmetics are safe and properly labeled; and
(E) public health and safety are protected from electronic
product radiation;
(3) participate through appropriate processes with
representatives of other countries to reduce the burden of
regulation, harmonize regulatory requirements, and achieve
appropriate reciprocal arrangements; and
(4) as determined to be appropriate by the Secretary, carry out
paragraphs (1) through (3) in consultation with experts in
science, medicine, and public health, and in cooperation with
consumers, users, manufacturers, importers, packers,
distributors, and retailers of regulated products.
(c) Interagency collaboration
The Secretary shall implement programs and policies that will
foster collaboration between the Administration, the National
Institutes of Health, and other science-based Federal agencies, to
enhance the scientific and technical expertise available to the
Secretary in the conduct of the duties of the Secretary with
respect to the development, clinical investigation, evaluation, and
postmarket monitoring of emerging medical therapies, including
complementary therapies, and advances in nutrition and food
science.
(d) Commissioner
(1) Appointment
There shall be in the Administration a Commissioner of Food and
Drugs (hereinafter in this section referred to as the
"Commissioner") who shall be appointed by the President by and
with the advice and consent of the Senate.
(2) General powers
The Secretary, through the Commissioner, shall be responsible
for executing this chapter and for -
(A) providing overall direction to the Food and Drug
Administration and establishing and implementing general
policies respecting the management and operation of programs
and activities of the Food and Drug Administration;
(B) coordinating and overseeing the operation of all
administrative entities within the Administration;
(C) research relating to foods, drugs, cosmetics, and devices
in carrying out this chapter;
(D) conducting educational and public information programs
relating to the responsibilities of the Food and Drug
Administration; and
(E) performing such other functions as the Secretary may
prescribe.
(e) Technical and scientific review groups
The Secretary through the Commissioner of Food and Drugs may,
without regard to the provisions of title 5 governing appointments
in the competitive service and without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such title relating
to classification and General Schedule pay rates, establish such
technical and scientific review groups as are needed to carry out
the functions of the Administration, including functions under this
chapter, and appoint and pay the members of such groups, except
that officers and employees of the United States shall not receive
additional compensation for service as members of such groups.
(f) Agency plan for statutory compliance
(1) In general
Not later than 1 year after November 21, 1997, the Secretary,
after consultation with appropriate scientific and academic
experts, health care professionals, representatives of patient
and consumer advocacy groups, and the regulated industry, shall
develop and publish in the Federal Register a plan bringing the
Secretary into compliance with each of the obligations of the
Secretary under this chapter. The Secretary shall review the plan
biannually and shall revise the plan as necessary, in
consultation with such persons.
(2) Objectives of agency plan
The plan required by paragraph (1) shall establish objectives
and mechanisms to achieve such objectives, including objectives
related to -
(A) maximizing the availability and clarity of information
about the process for review of applications and submissions
(including petitions, notifications, and any other similar
forms of request) made under this chapter;
(B) maximizing the availability and clarity of information
for consumers and patients concerning new products;
(C) implementing inspection and postmarket monitoring
provisions of this chapter;
(D) ensuring access to the scientific and technical expertise
needed by the Secretary to meet obligations described in
paragraph (1);
(E) establishing mechanisms, by July 1, 1999, for meeting the
time periods specified in this chapter for the review of all
applications and submissions described in subparagraph (A) and
submitted after November 21, 1997; and
(F) eliminating backlogs in the review of applications and
submissions described in subparagraph (A), by January 1, 2000.
(g) Annual report
The Secretary shall annually prepare and publish in the Federal
Register and solicit public comment on a report that -
(1) provides detailed statistical information on the
performance of the Secretary under the plan described in
subsection (f) of this section;
(2) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of the
Secretary; and
(3) identifies any regulatory policy that has a significant
negative impact on compliance with any objective of the plan or
any statutory obligation and sets forth any proposed revision to
any such regulatory policy.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 903, as added Pub. L. 100-607, title
V, Sec. 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100-
690, title II, Sec. 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L.
105-115, title IV, Secs. 406, 414, Nov. 21, 1997, 111 Stat. 2369,
2377.)
-REFTEXT-
REFERENCES IN TEXT
The provisions of title 5 governing appointments in the
competitive service, referred to in subsec. (e), are classified
generally to section 3301 et seq. of Title 5, Government
Organization and Employees.
-COD-
CODIFICATION
Another section 903 of the Federal Food, Drug, and Cosmetic Act
was renumbered section 904 and is classified to section 394 of this
title.
-MISC1-
AMENDMENTS
1997 - Subsec. (b). Pub. L. 105-115, Sec. 406(a)(2), added
subsec. (b). Former subsec. (b) redesignated (d).
Subsec. (c). Pub. L. 105-115, Sec. 414, added subsec. (c). Former
subsec. (c) redesignated (e).
Subsecs. (d), (e). Pub. L. 105-115, Sec. 406(a)(1), redesignated
subsecs. (b) and (c) as (d) and (e), respectively.
Subsecs. (f), (g). Pub. L. 105-115, Sec. 406(b), added subsecs.
(f) and (g).
1988 - Subsec. (b)(2). Pub. L. 100-690 substituted "shall be
responsible for executing this chapter and" for "shall be
responsible".
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE
Section 503(c) of title V of Pub. L. 100-607 provided that:
"(1) Except as provided in paragraph (2), the amendments made by
this title [enacting this section and amending sections 5315 and
5316 of Title 5, Government Organization and Employees] shall take
effect on the date of enactment of this Act [Nov. 4, 1988].
"(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 393(b)(1)] (as added by subsection (a) of this
section) shall apply to the appointments of Commissioners of Food
and Drugs made after the date of enactment of this Act."
OFFICE OF MINOR USE AND MINOR SPECIES ANIMAL DRUG DEVELOPMENT
Pub. L. 108-282, title I, Sec. 102(b)(7), Aug. 2, 2004, 118 Stat.
905, provided that: "The Secretary of Health and Human Services
shall establish within the Center for Veterinary Medicine (of the
Food and Drug Administration), an Office of Minor Use and Minor
Species Animal Drug Development that reports directly to the
Director of the Center for Veterinary Medicine. This office shall
be responsible for overseeing the development and legal marketing
of new animal drugs for minor uses and minor species. There is
authorized to be appropriated to carry out this subsection
$1,200,000 for fiscal year 2004 and such sums as may be necessary
for each fiscal year thereafter."
REGULATIONS FOR SUNSCREEN PRODUCTS
Section 129 of Pub. L. 105-115 provided that: "Not later than 18
months after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services shall issue regulations for
over-the-counter sunscreen products for the prevention or treatment
of sunburn."
FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD
Section 413 of Pub. L. 105-115 provided that:
"(a) List and Analysis. - The Secretary of Health and Human
Services shall, acting through the Food and Drug Administration -
"(1) compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and
"(2) provide a quantitative and qualitative analysis of the
mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1)
within 2 years after the date of enactment of the Food and Drug
Administration Modernization Act of 1997 [Nov. 21, 1997] and shall
provide the analysis required by paragraph (2) within 2 years after
such date of enactment.
"(b) Study. - The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall conduct a study of
the effect on humans of the use of mercury compounds in nasal
sprays. Such study shall include data from other studies that have
been made of such use.
"(c) Study of Mercury Sales. -
"(1) Study. - The Secretary of Health and Human Services,
acting through the Food and Drug Administration and subject to
appropriations, shall conduct, or shall contract with the
Institute of Medicine of the National Academy of Sciences to
conduct, a study of the effect on humans of the use of elemental,
organic, or inorganic mercury when offered for sale as a drug or
dietary supplement. Such study shall, among other things,
evaluate -
"(A) the scope of mercury use as a drug or dietary
supplement; and
"(B) the adverse effects on health of children and other
sensitive populations resulting from exposure to, or ingestion
or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the
Administrator of the Environmental Protection Agency, the Chair
of the Consumer Product Safety Commission, and the Administrator
of the Agency for Toxic Substances and Disease Registry, and, to
the extent the Secretary believes necessary or appropriate, with
any other Federal or private entity.
"(2) Regulations. - If, in the opinion of the Secretary, the
use of elemental, organic, or inorganic mercury offered for sale
as a drug or dietary supplement poses a threat to human health,
the Secretary shall promulgate regulations restricting the sale
of mercury intended for such use. At a minimum, such regulations
shall be designed to protect the health of children and other
sensitive populations from adverse effects resulting from
exposure to, or ingestion or inhalation of, mercury. Such
regulations, to the extent feasible, should not unnecessarily
interfere with the availability of mercury for use in religious
ceremonies."
MANAGEMENT ACTIVITIES STUDY
Pub. L. 102-571, title II, Sec. 205, Oct. 29, 1992, 106 Stat.
4502, directed Comptroller General to conduct a study of management
of activities of the Food and Drug Administration that are related
to dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances and submit an interim report to
Congress, not later than 6 months after Oct. 29, 1992, with a final
report to be submitted not later than 12 months after Oct. 29,
1992.
CONGRESSIONAL FINDINGS
Section 502 of Pub. L. 100-607 provided that: "Congress finds
that -
"(1) the public health has been effectively protected by the
presence of the Food and Drug Administration during the last
eighty years;
"(2) the presence and importance of the Food and Drug
Administration must be guaranteed; and
"(3) the independence and integrity of the Food and Drug
Administration need to be enhanced in order to ensure the
continuing protection of the public health."
-End-
-CITE-
21 USC Sec. 393a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 393a. Office of Pediatric Therapeutics
-STATUTE-
(a) Establishment
The Secretary of Health and Human Services shall establish an
Office of Pediatric Therapeutics within the Food and Drug
Administration.
(b) Duties
The Office of Pediatric Therapeutics shall be responsible for
coordination and facilitation of all activities of the Food and
Drug Administration that may have any effect on a pediatric
population or the practice of pediatrics or may in any other way
involve pediatric issues.
(c) Staff
The staff of the Office of Pediatric Therapeutics shall
coordinate with employees of the Department of Health and Human
Services who exercise responsibilities relating to pediatric
therapeutics and shall include -
(1) one or more additional individuals with expertise
concerning ethical issues presented by the conduct of clinical
research in the pediatric population; and
(2) one or more additional individuals with expertise in
pediatrics as may be necessary to perform the activities
described in subsection (b) of this section.
-SOURCE-
(Pub. L. 107-109, Sec. 6, Jan. 4, 2002, 115 Stat. 1414.)
-COD-
CODIFICATION
Section was enacted as part of the Best Pharmaceuticals for
Children Act, and not as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC Sec. 394 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 394. Scientific review groups
-STATUTE-
Without regard to the provisions of title 5 governing
appointments in the competitive service and without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of such
title relating to classification and General Schedule pay rates,
the Commissioner of Food and Drugs may -
(1) establish such technical and scientific review groups as
are needed to carry out the functions of the Food and Drug
Administration (including functions prescribed under this
chapter); and
(2) appoint and pay the members of such groups, except that
officers and employees of the United States shall not receive
additional compensation for service as members of such groups.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 904, formerly Sec. 903, as added Pub.
L. 101-635, title III, Sec. 301, Nov. 28, 1990, 104 Stat. 4584;
renumbered Sec. 904, Pub. L. 103-43, title XX, Sec. 2006(1), June
10, 1993, 107 Stat. 209.)
-REFTEXT-
REFERENCES IN TEXT
The provisions of title 5 governing appointments in the
competitive service, referred to in text, are classified generally
to section 3301 et seq. of Title 5, Government Organization and
Employees.
-End-
-CITE-
21 USC Sec. 395 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 395. Loan repayment program
-STATUTE-
(a) In general
(1) Authority for program
Subject to paragraph (2), the Secretary shall carry out a
program of entering into contracts with appropriately qualified
health professionals under which such health professionals agree
to conduct research, as employees of the Food and Drug
Administration, in consideration of the Federal Government
agreeing to repay, for each year of such service, not more than
$20,000 of the principal and interest of the educational loans of
such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health
professional pursuant to paragraph (1) unless such professional -
(A) has a substantial amount of educational loans relative to
income; and
(B) agrees to serve as an employee of the Food and Drug
Administration for purposes of paragraph (1) for a period of
not less than 3 years.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment
Program established in subpart III of part D of title III of the
Public Health Service Act [42 U.S.C. 254l et seq.], the provisions
of such subpart shall, except as inconsistent with subsection (a)
of this section, apply to the program established in such
subsection in the same manner and to the same extent as such
provisions apply to the National Health Service Corps Loan
Repayment Program.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 1994 through 1996.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 905, as added Pub. L. 103-43, title
XX, Sec. 2006(2), June 10, 1993, 107 Stat. 210.)
-REFTEXT-
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec. (b), is act
July 1, 1944, ch. 373, 58 Stat. 682, as amended. Subpart III of
part D of title III of the Act is classified generally to subpart
III [Sec. 254l et seq.] of part D of subchapter II of chapter 6A of
Title 42, The Public Health and Welfare. For complete
classification of this Act to the Code, see Short Title note set
out under section 201 of Title 42 and Tables.
-End-
-CITE-
21 USC Sec. 396 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 396. Practice of medicine
-STATUTE-
Nothing in this chapter shall be construed to limit or interfere
with the authority of a health care practitioner to prescribe or
administer any legally marketed device to a patient for any
condition or disease within a legitimate health care practitioner-
patient relationship. This section shall not limit any existing
authority of the Secretary to establish and enforce restrictions on
the sale or distribution, or in the labeling, of a device that are
part of a determination of substantial equivalence, established as
a condition of approval, or promulgated through regulations.
Further, this section shall not change any existing prohibition on
the promotion of unapproved uses of legally marketed devices.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 906, as added Pub. L. 105-115, title
II, Sec. 214, Nov. 21, 1997, 111 Stat. 2348.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 397 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 397. Contracts for expert review
-STATUTE-
(a) In general
(1) Authority
The Secretary may enter into a contract with any organization
or any individual (who is not an employee of the Department) with
relevant expertise, to review and evaluate, for the purpose of
making recommendations to the Secretary on, part or all of any
application or submission (including a petition, notification,
and any other similar form of request) made under this chapter
for the approval or classification of an article or made under
section 351(a) of the Public Health Service Act (42 U.S.C.
262(a)) with respect to a biological product. Any such contract
shall be subject to the requirements of section 379 of this title
relating to the confidentiality of information.
(2) Increased efficiency and expertise through contracts
The Secretary may use the authority granted in paragraph (1)
whenever the Secretary determines that use of a contract
described in paragraph (1) will improve the timeliness of the
review of an application or submission described in paragraph
(1), unless using such authority would reduce the quality, or
unduly increase the cost, of such review. The Secretary may use
such authority whenever the Secretary determines that use of such
a contract will improve the quality of the review of an
application or submission described in paragraph (1), unless
using such authority would unduly increase the cost of such
review. Such improvement in timeliness or quality may include
providing the Secretary increased scientific or technical
expertise that is necessary to review or evaluate new therapies
and technologies.
(b) Review of expert review
(1) In general
Subject to paragraph (2), the official of the Food and Drug
Administration responsible for any matter for which expert review
is used pursuant to subsection (a) of this section shall review
the recommendations of the organization or individual who
conducted the expert review and shall make a final decision
regarding the matter in a timely manner.
(2) Limitation
A final decision by the Secretary on any such application or
submission shall be made within the applicable prescribed time
period for review of the matter as set forth in this chapter or
in the Public Health Service Act (42 U.S.C. 201 et seq.).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 907, as added Pub. L. 105-115, title
IV, Sec. 415, Nov. 21, 1997, 111 Stat. 2377.)
-REFTEXT-
REFERENCES IN TEXT
The Public Health Service Act, referred to in subsec. (b)(2), is
act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is
classified generally to chapter 6A (Sec. 201 et seq.) of Title 42,
The Public Health and Welfare. For complete classification of this
Act to the Code, see Short Title note set out under section 201 of
Title 42 and Tables.
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 398 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 398. Notices to States regarding imported food
-STATUTE-
(a) In general
If the Secretary has credible evidence or information indicating
that a shipment of imported food or portion thereof presents a
threat of serious adverse health consequences or death to humans or
animals, the Secretary shall provide notice regarding such threat
to the States in which the food is held or will be held, and to the
States in which the manufacturer, packer, or distributor of the
food is located, to the extent that the Secretary has knowledge of
which States are so involved. In providing notice to a State, the
Secretary shall request the State to take such action as the State
considers appropriate, if any, to protect the public health
regarding the food involved.
(b) Rule of construction
Subsection (a) of this section may not be construed as limiting
the authority of the Secretary with respect to food under any other
provision of this chapter.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 908, as added Pub. L. 107-188, title
III, Sec. 310, June 12, 2002, 116 Stat. 673.)
-End-
-CITE-
21 USC Sec. 399 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX - MISCELLANEOUS
-HEAD-
Sec. 399. Grants to States for inspections
-STATUTE-
(a) In general
The Secretary is authorized to make grants to States,
territories, and Indian tribes (as defined in section 450b(e) of
title 25) that undertake examinations, inspections, and
investigations, and related activities under section 372 of this
title. The funds provided under such grants shall only be available
for the costs of conducting such examinations, inspections,
investigations, and related activities.
(b) Notices regarding adulterated imported food
The Secretary may make grants to the States for the purpose of
assisting the States with the costs of taking appropriate action to
protect the public health in response to notification under section
398 of this title, including planning and otherwise preparing to
take such action.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are
authorized to be appropriated $10,000,000 for fiscal year 2002, and
such sums as may be necessary for each of the fiscal years 2003
through 2006.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 909, as added Pub. L. 107-188, title
III, Sec. 311, June 12, 2002, 116 Stat. 673.)
-End-
-CITE-
21 USC CHAPTER 10 - POULTRY AND POULTRY PRODUCTS
INSPECTION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-MISC1-
Sec.
451. Congressional statement of findings.
452. Congressional declaration of policy.
453. Definitions.
454. Federal and State cooperation in development and
administration of State poultry product inspection
programs.
455. Inspection in official establishments.
456. Operation of premises, facilities and equipment.
457. Labeling and container standards.
458. Prohibited acts.
459. Compliance by all establishments.
460. Miscellaneous activities subject to regulation.
461. Offenses and punishment.
462. Reporting of violations; notice; opportunity to
present views.
463. Rules and regulations.
464. Exemptions.
465. Limitations upon entry of poultry products and other
materials into official establishments.
466. Imports.
467. Inspection services.
467a. Administrative detention; duration; pending judicial
proceedings; notification of government authorities;
release; removal of official marks.
467b. Seizure and condemnation.
467c. Federal court jurisdiction of enforcement and
injunction proceedings and other kinds of cases;
limitations; United States as plaintiff; subpenas.
467d. Administration and enforcement; applicability of
penalty provisions; conduct of inquiries; power and
jurisdiction of courts.
467e. Non-Federal jurisdiction of federally regulated
matters; prohibition of additional or different
requirements for establishments with inspection
services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements;
concurrent jurisdiction over distribution for human
food purposes of adulterated or misbranded and
imported articles; other matters.
467f. Federal Food, Drug, and Cosmetic Act applications.
468. Cost of inspection; overtime.
469. Authorization of appropriations.
470. Omitted.
471. Safe Meat and Poultry Inspection Panel.
-End-
-CITE-
21 USC Sec. 451 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 451. Congressional statement of findings
-STATUTE-
Poultry and poultry products are an important source of the
Nation's total supply of food. They are consumed throughout the
Nation and the major portion thereof moves in interstate or foreign
commerce. It is essential in the public interest that the health
and welfare of consumers be protected by assuring that poultry
products distributed to them are wholesome, not adulterated, and
properly marked, labeled, and packaged. Unwholesome, adulterated,
or misbranded poultry products impair the effective regulation of
poultry products in interstate or foreign commerce, are injurious
to the public welfare, destroy markets for wholesome, not
adulterated, and properly labeled and packaged poultry products,
and result in sundry losses to poultry producers and processors of
poultry and poultry products, as well as injury to consumers. It is
hereby found that all articles and poultry which are regulated
under this chapter are either in interstate or foreign commerce or
substantially affect such commerce, and that regulation by the
Secretary of Agriculture and cooperation by the States and other
jurisdictions as contemplated by this chapter are appropriate to
prevent and eliminate burdens upon such commerce, to effectively
regulate such commerce, and to protect the health and welfare of
consumers.
-SOURCE-
(Pub. L. 85-172, Sec. 2, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-
492, Sec. 2, Aug. 18, 1968, 82 Stat. 791.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 inserted provisions stating it to be
necessary that the health and welfare of consumers be protected by
assuring that poultry products distributed to them are wholesome,
not adulterated, and properly marked, labeled, and packaged,
provisions that misbranded poultry products impair the effective
regulation of poultry products and destroy markets for wholesome,
not adulterated, and properly labeled and packaged poultry
products, and result in sundry losses to poultry producers and
processors of poultry and poultry products, as well as injury to
consumers, and provisions that all articles and poultry which are
regulated by this chapter are either in interstate or foreign
commerce or substantially affect such commerce and that regulation
by the Secretary of Agriculture and cooperation by the states and
other jurisdictions as contemplated by this chapter are appropriate
to serve the specified aims, and struck out provisions that all
poultry and poultry products which have or are required to have
inspection under this chapter are either in the current of
interstate or foreign commerce or directly affect such commerce,
provisions that that part entering directly into the current of
interstate or foreign commerce cannot be effectively inspected and
regulated without also inspecting and regulating all poultry and
poultry products in the same establishment, and provisions
authorizing the Secretary to designate major consuming areas.
EFFECTIVE DATE OF 1968 AMENDMENT
Section 20 of Pub. L. 90-492 provided that: "This Act [see Short
Title of 1968 Amendment note below] shall become effective upon
enactment [Aug. 18, 1968] except as provided in paragraphs (a)
through (c):
"(a) The provisions of subparagraphs (a)(2)(A) and (a)(3) of
section 9 of the Poultry Products Inspection Act, as amended by
section 9 of this Act [section 458(a)(2)(A) and (a)(3) of this
title], shall become effective upon the expiration of sixty days
after enactment hereof [Aug. 18, 1968].
"(b) Section 14 of this Act, amending section 15 of the Poultry
Products Inspection Act [section 464 of this title], shall become
effective upon the expiration of sixty days after enactment hereof
[Aug. 18, 1968].
"(c) Paragraph 11(d) of the Poultry Products Inspection Act, as
added by section 11 of this Act [section 460(d) of this title],
shall become effective upon the expiration of sixty days after
enactment hereof [Aug. 18, 1968]."
EFFECTIVE DATE
Section 29, formerly section 22, of Pub. L. 85-172, as renumbered
by Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat. 805, provided
that: "This Act [this chapter] shall take effect upon enactment
[Aug. 28, 1957], except that no person shall be subject to the
provisions of this Act [this chapter] prior to January 1, 1959,
unless such person after January 1, 1958, applies for and receives
inspection for poultry or poultry products in accordance with the
provisions of this Act [this chapter] and pursuant to regulations
promulgated by the Secretary hereunder, in any establishment
processing poultry or poultry products in commerce or in a
designated major consuming area. Any person who voluntarily applies
for and receives such inspection after January 1, 1958, shall be
subject, on and after the date he commences to receive such
inspection, to all of the provisions and penalties provided for in
this Act [this chapter] with respect to all poultry or poultry
products handled in the establishment for which such said
application for inspection is made."
SHORT TITLE OF 1968 AMENDMENT
Section 1 of Pub. L. 90-492 provided: "That this Act [enacting
sections 467a to 467f and 470 of this title, amending this section
and sections 452 to 461, 463 to 465, and 467 of this title, and
enacting provisions set out as notes under this section] may be
cited as the 'Wholesome Poultry Products Act'."
SHORT TITLE
Section 1 of Pub. L. 85-172 provided: "That this Act [enacting
this chapter and provisions set out as notes under this section]
may be cited as the 'Poultry Products Inspection Act'."
SEPARABILITY
Section 19 of Pub. L. 90-492 provided that: "If any provisions of
this Act or of the amendments made hereby [see Short Title of 1968
Amendment note above] or the application thereof to any person or
circumstances is held invalid, the validity of the remainder of the
Act and the remaining amendments and of the application of such
provision to other persons and circumstances shall not be affected
thereby."
Section 28, formerly section 21, of Pub. L. 85-172, as renumbered
by Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat. 805, provided
that: "If any provision of this Act [this chapter] or the
application thereof to any person or circumstances is held invalid,
the validity of the remainder of the Act and of the application of
such provision to other persons and circumstances shall not be
affected thereby."
FOOD ADDITIVES AMENDMENT OF 1958
Pub. L. 85-929, Sec. 7, Sept. 6, 1958, 72 Stat. 1789, provided
that: "Nothing in this Act [amending sections 321, 331, 342, 346,
and 348 of this title and section 210 of Title 42, The Public
Health and Welfare, and enacting provisions set out as notes under
sections 321 and 342 of this title] shall be construed to exempt
any meat or meat food product or any person from any requirement
imposed by or pursuant to the Poultry Products Inspection Act (21
U.S.C. 451 and the following) [this chapter] or the Meat Inspection
Act of March 4, 1907, 34 Stat. 1260, as amended and extended (21
U.S.C. 71 and the following) [see section 601 et seq. of this
title]."
-End-
-CITE-
21 USC Sec. 452 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 452. Congressional declaration of policy
-STATUTE-
It is hereby declared to be the policy of the Congress to provide
for the inspection of poultry and poultry products and otherwise
regulate the processing and distribution of such articles as
hereinafter prescribed to prevent the movement or sale in
interstate or foreign commerce of, or the burdening of such
commerce by, poultry products which are adulterated or misbranded.
It is the intent of Congress that when poultry and poultry products
are condemned because of disease, the reason for condemnation in
such instances shall be supported by scientific fact, information,
or criteria, and such condemnation under this chapter shall be
achieved through uniform inspection standards and uniform
applications thereof.
-SOURCE-
(Pub. L. 85-172, Sec. 3, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-
492, Sec. 3, Aug. 18, 1968, 82 Stat. 792.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 inserted provisions declaring the policy of
Congress to be to otherwise regulate the processing and
distribution of poultry and poultry products as hereinafter
prescribed so as to prevent the movement or sale in interstate
commerce of, or the burdening of such commerce by poultry products
which are adulterated or misbranded, and provisions that declared
the policy of Congress to be that condemnation of diseased poultry
and poultry products shall be achieved through uniform inspection
standards and supported by scientific fact or criteria, and struck
out provisions that declared the policy of Congress to be to
provide for inspection by the inspection service to prevent the
movement in interstate commerce or foreign commerce or in a
designated major consuming area of poultry products which are
unwholesome, adulterated, or otherwise unfit for human food.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 453 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 453. Definitions
-STATUTE-
For purposes of this chapter -
(a) The term "commerce" means commerce between any State, any
territory, or the District of Columbia, and any place outside
thereof; or within any territory not organized with a legislative
body, or the District of Columbia.
(b) Except as otherwise provided in this chapter, the term
"State" means any State of the United States and the Commonwealth
of Puerto Rico.
(c) The term "territory" means Guam, the Virgin Islands of the
United States, American Samoa, and any other territory or
possession of the United States, excluding the Canal Zone.
(d) The term "United States" means the States, the District of
Columbia, and the territories of the United States.
(e) The term "poultry" means any domesticated bird, whether live
or dead.
(f) The term "poultry product" means any poultry carcass, or part
thereof; or any product which is made wholly or in part from any
poultry carcass or part thereof, excepting products which contain
poultry ingredients only in a relatively small proportion or
historically have not been considered by consumers as products of
the poultry food industry, and which are exempted by the Secretary
from definition as a poultry product under such conditions as the
Secretary may prescribe to assure that the poultry ingredients in
such products are not adulterated and that such products are not
represented as poultry products.
(g) The term "adulterated" shall apply to any poultry product
under one or more of the following circumstances:
(1) if it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case
the substance is not an added substance, such article shall not
be considered adulterated under this clause if the quantity of
such substance in or on such article does not ordinarily render
it injurious to health;
(2)(A) if it bears or contains (by reason of administration of
any substance to the live poultry or otherwise) any added
poisonous or added deleterious substance (other than one which is
(i) a pesticide chemical in or on a raw agricultural commodity;
(ii) a food additive; or (iii) a color additive) which may, in
the judgment of the Secretary, make such article unfit for human
food;
(B) if it is, in whole or in part, a raw agricultural commodity
and such commodity bears or contains a pesticide chemical which
is unsafe within the meaning of section 346a of this title;
(C) if it bears or contains any food additive which is unsafe
within the meaning of section 348 of this title;
(D) if it bears or contains any color additive which is unsafe
within the meaning of section 379e of this title: Provided, That
an article which is not otherwise deemed adulterated under clause
(B), (C), or (D) shall nevertheless be deemed adulterated if use
of the pesticide chemical, food additive, or color additive in or
on such article is prohibited by regulations of the Secretary in
official establishments;
(3) if it consists in whole or in part of any filthy, putrid,
or decomposed substance or is for any other reason unsound,
unhealthful, unwholesome, or otherwise unfit for human food;
(4) if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(5) if it is, in whole or in part, the product of any poultry
which has died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(7) if it has been intentionally subjected to radiation, unless
the use of the radiation was in conformity with a regulation or
exemption in effect pursuant to section 348 of this title;
(8) if any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or if any substance has been
substituted, wholly or in part therefor; or if damage or
inferiority has been concealed in any manner; or if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is.
(h) The term "misbranded" shall apply to any poultry product
under one or more of the following circumstances:
(1) if its labeling is false or misleading in any particular;
(2) if it is offered for sale under the name of another food;
(3) if it is an imitation of another food, unless its label
bears, in type of uniform size and prominence, the word
"imitation" and immediately thereafter, the name of the food
imitated;
(4) if its container is so made, formed, or filled as to be
misleading;
(5) unless it bears a label showing (A) the name and the place
of business of the manufacturer, packer, or distributor; and (B)
an accurate statement of the quantity of the product in terms of
weight, measure, or numerical count: Provided, That under clause
(B) of this subparagraph (5), reasonable variations may be
permitted, and exemptions as to small packages or articles not in
packages or other containers may be established by regulations
prescribed by the Secretary;
(6) if any word, statement, or other information required by or
under authority of this chapter to appear on the label or other
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(7) if it purports to be or is represented as a food for which
a definition and standard of identity or composition has been
prescribed by regulations of the Secretary under section 457 of
this title unless (A) it conforms to such definition and
standard, and (B) its label bears the name of the food specified
in the definition and standard and, insofar as may be required by
such regulations, the common names of optional ingredients (other
than spices, flavoring, and coloring) present in such food;
(8) if it purports to be or is represented as a food for which
a standard or standards of fill of container have been prescribed
by regulations of the Secretary under section 457 of this title,
and it falls below the standard of fill of container applicable
thereto, unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below such
standard;
(9) if it is not subject to the provisions of subparagraph (7),
unless its label bears (A) the common or usual name of the food,
if any there be, and (B) in case it is fabricated from two or
more ingredients, the common or usual name of each such
ingredient; except that spices, flavorings, and colorings may,
when authorized by the Secretary, be designated as spices,
flavorings, and colorings without naming each: Provided, That to
the extent that compliance with the requirements of clause (B) of
this subparagraph (9) is impracticable or results in deception or
unfair competition, exemptions shall be established by
regulations promulgated by the Secretary;
(10) if it purports to be or is represented for special dietary
uses unless its label bears such information concerning its
vitamin, mineral, and other dietary properties as the Secretary,
after consultation with the Secretary of Health and Human
Services, determines to be, and by regulations prescribes as,
necessary in order fully to inform purchasers as to its value for
such uses;
(11) if it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative unless it bears
labeling stating that fact: Provided, That, to the extent that
compliance with the requirements of this subparagraph (11) is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary; or
(12) if it fails to bear on its containers, and in the case of
nonconsumer packaged carcasses (if the Secretary so requires)
directly thereon, as the Secretary may by regulations prescribe,
the official inspection legend and official establishment number
of the establishment where the article was processed, and,
unrestricted by any of the foregoing, such other information as
the Secretary may require in such regulations to assure that it
will not have false or misleading labeling and that the public
will be informed of the manner of handling required to maintain
the article in a wholesome condition.
(i) The term "Secretary" means the Secretary of Agriculture or
his delegate.
(j) The term "person" means any individual, partnership,
corporation, association, or other business unit.
(k) The term "inspector" means: (1) an employee or official of
the United States Government authorized by the Secretary to inspect
poultry and poultry products under the authority of this chapter,
or (2) any employee or official of the government of any State or
territory or the District of Columbia authorized by the Secretary
to inspect poultry and poultry products under authority of this
chapter, under an agreement entered into between the Secretary and
the appropriate State or other agency.
(l) The term "official mark" means the official inspection legend
or any other symbol prescribed by regulation of the Secretary to
identify the status of any article or poultry under this chapter.
(m) The term "official inspection legend" means any symbol
prescribed by regulations of the Secretary showing that an article
was inspected for wholesomeness in accordance with this chapter.
(n) The term "official certificate" means any certificate
prescribed by regulations of the Secretary for issuance by an
inspector or other person performing official functions under this
chapter.
(o) The term "official device" means any device prescribed or
authorized by the Secretary for use in applying any official mark.
(p) The term "official establishment" means any establishment as
determined by the Secretary at which inspection of the slaughter of
poultry, or the processing of poultry products, is maintained under
the authority of this chapter.
(q) The term "inspection service" means the official Government
service within the Department of Agriculture designated by the
Secretary as having the responsibility for carrying out the
provisions of this chapter.
(r) The term "container" or "package" includes any box, can, tin,
cloth, plastic, or other receptacle, wrapper, or cover.
(s) The term "label" means a display of written, printed, or
graphic matter upon any article or the immediate container (not
including packaged liners) of any article; and the term "labeling"
means all labels and other written, printed, or graphic matter (1)
upon any article or any of its containers or wrappers, or (2)
accompanying such article.
(t) The term "shipping container" means any container used or
intended for use in packaging the product packed in an immediate
container.
(u) The term "immediate container" includes any consumer package;
or any other container in which poultry products, not consumer
packaged, are packed.
(v) The term "capable of use as human food" shall apply to any
carcass, or part or product of a carcass, of any poultry, unless it
is denatured or otherwise identified as required by regulations
prescribed by the Secretary to deter its use as human food, or it
is naturally inedible by humans.
(w) The term "processed" means slaughtered, canned, salted,
stuffed, rendered, boned, cut up, or otherwise manufactured or
processed.
(x) The term "Federal Food, Drug, and Cosmetic Act" means the Act
so entitled, approved June 25, 1938 (52 Stat. 1040) [21 U.S.C. 301
et seq.], and Acts amendatory thereof or supplementary thereto.
(y) The terms "pesticide chemical", "food additive", "color
additive", and "raw agricultural commodity" shall have the same
meanings for purposes of this chapter as under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(z) The term "poultry products broker" means any person engaged
in the business of buying or selling poultry products on
commission, or otherwise negotiating purchases or sales of such
articles other than for his own account or as an employee of
another person.
(aa) The term "renderer" means any person engaged in the business
of rendering carcasses, or parts or products of the carcasses, of
poultry, except rendering conducted under inspection or exemption
under this chapter.
(bb) The term "animal food manufacturer" means any person engaged
in the business of manufacturing or processing animal food derived
wholly or in part from carcasses, or parts or products of the
carcasses, of poultry.
-SOURCE-
(Pub. L. 85-172, Sec. 4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87-
498, June 25, 1962, 76 Stat. 110; Pub. L. 90-492, Sec. 4, Aug. 18,
1968, 82 Stat. 792; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17,
1979, 93 Stat. 695; Pub. L. 102-571, title I, Sec. 107(13), Oct.
29, 1992, 106 Stat. 4499.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in pars.
(x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
-MISC1-
AMENDMENTS
1992 - Subsec. (g)(2)(D). Pub. L. 102-571 substituted "379e" for
"376".
1968 - Pub. L. 90-492 inserted definitions of "State",
"territory", "United States", "misbranded", "official mark",
"official inspection legend", "official certificate", "official
device", "capable of use as human food", "processed", "Federal
Food, Drug, and Cosmetic Act", "pesticide chemical", "poultry
products broker", "renderer", and "animal food manufacturer",
revised definitions of "commerce", "poultry", "poultry product",
"adulterated", "Secretary", "inspector", "container" or "package",
"label", and "immediate container", reenacted without change
definitions of "person", "official establishment", "inspection
service", and "shipping container", and deleted definition of
"wholesome", "unwholesome", and "official inspection mark".
1962 - Par. (a). Pub. L. 87-498 struck out references to
Territories or possessions, and inserted definition of "State".
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (h)(10)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 454 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 454. Federal and State cooperation in development and
administration of State poultry product inspection programs
-STATUTE-
(a) State laws; planning, technical and financial assistance;
advisory committees
It is the policy of the Congress to protect the consuming public
from poultry products that are adulterated or misbranded and to
assist in efforts by State and other government agencies to
accomplish this objective. In furtherance of this policy -
(1) The Secretary is authorized, whenever he determines that it
would effectuate the purposes of this chapter, to cooperate with
the appropriate State agency in developing and administering a
State poultry product inspection program in any State which has
enacted a mandatory State poultry product inspection law that
imposes ante mortem and post mortem inspection, reinspection and
sanitation requirements that are at least equal to those under
this chapter, with respect to all or certain classes of persons
engaged in the State in slaughtering poultry or processing
poultry products for use as human food solely for distribution
within such State.
(2) The Secretary is further authorized, whenever he determines
that it would effectuate the purposes of this chapter, to
cooperate with appropriate State agencies in developing and
administering State programs under State laws containing
authorities at least equal to those provided in section 460 of
this title; and to cooperate with other agencies of the United
States in carrying out any provisions of this chapter. In
carrying out the provisions of this chapter, the Secretary may
conduct such examinations, investigations, and inspections as he
determines practicable through any officer or employee of any
State or Territory or the District of Columbia commissioned by
the Secretary for such purpose.
(3) Cooperation with State agencies under this section may
include furnishing to the appropriate State agency (i) advisory
assistance in planning and otherwise developing an adequate State
program under the State law; and (ii) technical and laboratory
assistance and training (including necessary curricular and
instructional materials and equipment), and financial and other
aid for administration of such a program. The amount to be
contributed to any State by the Secretary under this section from
Federal funds for any year shall not exceed 50 per centum of the
estimated total cost of the cooperative program; and the Federal
funds shall be allocated among the States desiring to cooperate
on an equitable basis. Such cooperation and payment shall be
contingent at all times upon the administration of the State
program in a manner which the Secretary, in consultation with the
appropriate advisory committee appointed under subparagraph (4),
deems adequate to effectuate the purposes of this section.
(4) The Secretary may appoint advisory committees consisting of
such representatives of appropriate State agencies as the
Secretary and the State agencies may designate to consult with
him concerning State and Federal programs with respect to poultry
product inspection and other matters within the scope of this
chapter, including evaluating State programs for purposes of this
chapter, and obtaining better coordination and more uniformity
among the State programs and between the Federal and State
programs and adequate protection of consumers.
(b) Appropriate State agency; performance of functions by
subordinate governmental unit
The appropriate State agency with which the Secretary may
cooperate under this chapter shall be a single agency in the State
which is primarily responsible for the coordination of the State
programs having objectives similar to those under this chapter.
When the State program includes performance of certain functions by
a municipality or other subordinate governmental unit, such unit
shall be deemed to be a part of the State agency for purposes of
this section.
(c) Intrastate activities; designation of State for regulation;
publication of designation; exempted operations; termination of
designation; review of operations in nondesignated States; annual
report
(1) If the Secretary has reason to believe, by thirty days prior
to the expiration of two years after August 18, 1968, that a State
has failed to develop or is not enforcing, with respect to all
establishments within its jurisdiction (except those that would be
exempted from Federal inspection under subparagraph (2) of this
paragraph (c)) at which poultry are slaughtered, or poultry
products are processed for use as human food, solely for
distribution within such State, and the products of such
establishments, requirements at least equal to those imposed under
sections 451 to 453, 455 to 459, 461 to 467d of this title, he
shall promptly notify the Governor of the State of this fact. If
the Secretary determines, after consultation with the Governor of
the State, or representative selected by him, that such
requirements have not been developed and activated, he shall
promptly after the expiration of such two-year period designate
such State as one in which the provisions of said sections of this
chapter shall apply to operations and transactions wholly within
such State: Provided, That if the Secretary has reason to believe
that the State will activate such requirements within one
additional year, he may delay such designation for said period, and
not designate the State, if he determines at the end of the year
that the State then has such requirements in effective operation.
The Secretary shall publish any such designation in the Federal
Register and, upon the expiration of thirty days after such
publication, the provisions of said sections of this chapter shall
apply to operations and transactions and to persons engaged therein
in the State to the same extent and in the same manner as if such
operations and transactions were conducted in or for commerce.
However, notwithstanding any other provision of this section, if
the Secretary determines that any establishment within a State is
producing adulterated poultry products for distribution within such
State which would clearly endanger the public health he shall
notify the Governor of the State and the appropriate advisory
committee provided for by subparagraph (a)(4) of this section of
such fact for effective action under State or local law. If the
State does not take action to prevent such endangering of the
public health within a reasonable time after such notice, as
determined by the Secretary, in light of the risk to public health,
the Secretary may forthwith designate any such establishment as
subject to the provisions of said sections of this chapter, and
thereupon the establishment and operator thereof shall be subject
to such provisions as though engaged in commerce until such time as
the Secretary determines that such State has developed and will
enforce requirements at least equal to those imposed under said
sections.
(2) The provisions of this chapter requiring inspection of the
slaughter of poultry and the processing of poultry products shall
not apply to operations of types traditionally and usually
conducted at retail stores and restaurants, when conducted at any
retail store or restaurant or similar retail-type establishment for
sale in normal retail quantities or service of such articles to
consumers at such establishments if such establishments are subject
to such inspection provisions only under this paragraph (c). For
the purposes of this subparagraph, operations conducted at a
restaurant central kitchen facility shall be considered as being
conducted at a restaurant if the restaurant central kitchen
prepares poultry products that are ready to eat when they leave
such facility and are served in meals or as entrees only to
customers at restaurants owned or operated by the same person
owning or operating such facility: Provided, That such facility
shall be subject to the provisions of section 460(b) of this title:
Provided further, That the facility may be subject to the
inspection requirements of this chapter for as long as the
Secretary deems necessary, if the Secretary determines that the
sanitary conditions or practices of the facility or the processing
procedures or methods at the facility are such that any of its
poultry products are rendered adulterated.
(3) Whenever the Secretary determines that any State designated
under this paragraph (c) has developed and will enforce State
poultry products inspection requirements at least equal to those
imposed under the aforesaid sections of this chapter, with respect
to the operations and transactions within such State which are
regulated under subparagraph (1) of this paragraph (c), he shall
terminate the designation of such State under this paragraph (c),
but this shall not preclude the subsequent redesignation of the
State at any time upon thirty days' notice to the Governor and
publication in the Federal Register in accordance with this
paragraph, and any State may be designated upon such notice and
publication, at any time after the period specified in this
paragraph whether or not the State has theretofore been designated,
upon the Secretary determining that it is not effectively enforcing
requirements at least equal to those imposed under said sections.
(4) The Secretary shall promptly upon August 18, 1968, and
periodically thereafter, but at least annually, review the
requirements, including the enforcement thereof, of the several
States not designated under this paragraph (c), with respect to the
slaughter, and the processing, storage, handling, and distribution
of poultry products, and inspection of such operations, and
annually report thereon to the Committee on Agriculture of the
House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate in the report required in
section 470 (!1) of this title.
(d) "State" defined
As used in this section, the term "State" means any State
(including the Commonwealth of Puerto Rico) or organized territory.
-SOURCE-
(Pub. L. 85-172, Sec. 5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-
492, Sec. 5, Aug. 18, 1968, 82 Stat. 796; Pub. L. 98-487, Sec. 2,
Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103-437, Sec. 8(1), Nov. 2,
1994, 108 Stat. 4588.)
-REFTEXT-
REFERENCES IN TEXT
Section 470 of this title, referred to in subsec. (c)(4), was
omitted from the Code.
-COD-
CODIFICATION
In par. (c)(1), (4), "August 18, 1968" substituted for "enactment
of the Wholesome Poultry Products Act".
-MISC1-
AMENDMENTS
1994 - Subsec. (c)(4). Pub. L. 103-437 substituted "Agriculture,
Nutrition, and Forestry" for "Agriculture and Forestry".
1984 - Par. (c)(2). Pub. L. 98-487 inserted provisions relating
to operations conducted at a restaurant central kitchen facility.
1968 - Pub. L. 90-492 substituted provisions authorizing the
Secretary to cooperate with the appropriate state agency in the
development and administration of state poultry product inspection
programs in those states having mandatory poultry product
inspection laws and those states having laws at least equal to the
provisions of section 460 of this title, provisions authorizing
planning, technical and financial assistance and the appointment of
advisory committees, provisions designating the appropriate state
agency with which the Secretary may cooperate, provisions
authorizing the Secretary to designate states as subject to the
regulatory provisions of this chapter when the requirements of the
specified section have not been complied with or when the specified
intrastate activities are present, provisions exempting from the
requirements of this chapter operations of the types traditionally
and usually conducted at retail stores and restaurants, provisions
authorizing the Secretary to terminate the aforementioned
designation of states as subject to the regulatory provisions of
this chapter, and provisions authorizing the Secretary to review
the operations in nondesignated states and make an annual report
thereon, for provisions authorizing the Secretary, upon application
by any appropriate state or local official or agency or by any
appropriate local poultry industry group and after public hearing,
to designate major consuming areas as subject to the regulatory
provisions of this chapter where the Secretary finds that poultry
or poultry products are handled or consumed in such volume as to
affect, burden or obstruct the movement of inspected poultry
products in interstate commerce.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 455 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 455. Inspection in official establishments
-STATUTE-
(a) Ante mortem inspection
For the purpose of preventing the entry into or flow or movement
in commerce of, or the burdening of commerce by, any poultry
product which is capable of use as human food and is adulterated,
the Secretary shall, where and to the extent considered by him
necessary, cause to be made by inspectors ante mortem inspection of
poultry in each official establishment processing poultry or
poultry products for commerce or otherwise subject to inspection
under this chapter.
(b) Post mortem inspection; quarantine, segregation, and
reinspection
The Secretary, whenever processing operations are being
conducted, shall cause to be made by inspectors post mortem
inspection of the carcass of each bird processed, and at any time
such quarantine, segregation, and reinspection as he deems
necessary of poultry and poultry products capable of use as human
food in each official establishment processing such poultry or
poultry products for commerce or otherwise subject to inspection
under this chapter.
(c) Condemnation; appeal; reprocessing
All poultry carcasses and parts thereof and other poultry
products found to be adulterated shall be condemned and shall, if
no appeal be taken from such determination of condemnation, be
destroyed for human food purposes under the supervision of an
inspector: Provided, That carcasses, parts, and products, which may
by reprocessing be made not adulterated, need not be so condemned
and destroyed if so reprocessed under the supervision of an
inspector and thereafter found to be not adulterated. If an appeal
be taken from such determination, the carcasses, parts, or products
shall be appropriately marked and segregated pending completion of
an appeal inspection, which appeal shall be at the cost of the
appellant if the Secretary determines that the appeal is frivolous.
If the determination of condemnation is sustained the carcasses,
parts, and products shall be destroyed for human food purposes
under the supervision of an inspector.
-SOURCE-
(Pub. L. 85-172, Sec. 6, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-
492, Sec. 6, Aug. 18, 1968, 82 Stat. 798.)
-MISC1-
AMENDMENTS
1968 - Par. (a). Pub. L. 90-492, Sec. 6(a), substituted "of, or
the burdening of commerce by, any poultry product which is capable
of use as human food and is adulterated," for "or a designated
major consuming area of any poultry product which is unwholesome or
adulterated," "each official establishment" for "any official
establishment", and "otherwise subject to inspection under this
chapter" for "in, or for marketing in a designated city or area".
Par. (b). Pub. L. 90-492, Sec. 6(b), substituted "segregation,
and reinspection" for "segregation, reinspection", and "otherwise
subject to inspection under this chapter" for "in, or for marketing
in a designated city or area", and inserted "capable of use as
human food" after "necessary of poultry and poultry products".
Par. (c). Pub. L. 90-492, Sec. 6(c), inserted "other" before
"poultry products", and substituted "to be adulterated" for "to be
unwholesome or adulterated", "made not adulterated" for "made not
unwholesome and not adulterated", and "to be not adulterated" for
"to be not unwholesome and not adulterated".
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
APPLICABILITY OF CHAPTER REQUIREMENTS TO BIRDS OF THE ORDER RATITAE
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 752], Oct. 28, 2000,
114 Stat. 1549, 1549A-41, provided that: "Effective 180 days after
the date of the enactment of this Act [Oct. 28, 2000] and
continuing for the remainder of fiscal year 2001 and each
subsequent fiscal year, establishments in the United States that
slaughter or process birds of the order Ratitae, such as ostriches,
emus and rheas, and squab, for distribution in commerce as human
food shall be subject to the ante mortem and post mortem
inspection, reinspection, and sanitation requirements of the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.) rather than
the voluntary poultry inspection program of the Department of
Agriculture under section 203 of the Agricultural Marketing Act of
1946 (7 U.S.C. 1622)."
-End-
-CITE-
21 USC Sec. 456 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 456. Operation of premises, facilities and equipment
-STATUTE-
(a) Sanitary practices
Each official establishment slaughtering poultry or processing
poultry products for commerce or otherwise subject to inspection
under this chapter shall have such premises, facilities, and
equipment, and be operated in accordance with such sanitary
practices, as are required by regulations promulgated by the
Secretary for the purpose of preventing the entry into or flow or
movement in commerce or burdensome effect upon commerce, of poultry
products which are adulterated.
(b) Refusal of inspection
The Secretary shall refuse to render inspection to any
establishment whose premises, facilities, or equipment, or the
operation thereof, fail to meet the requirements of this section.
-SOURCE-
(Pub. L. 85-172, Sec. 7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-
492, Sec. 7, Aug. 18, 1968, 82 Stat. 799.)
-MISC1-
AMENDMENTS
1968 - Par. (a). Pub. L. 90-492 substituted "otherwise subject to
inspection under this chapter" for "in or for marketing in a
designated major consuming area", "burdensome effect upon commerce"
for "in a designated major consuming area", and "which are
adulterated" for "which are unwholesome or adulterated".
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 457 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 457. Labeling and container standards
-STATUTE-
(a) Requirements for shipping containers and immediate containers;
nonconsumer packaged carcasses
All poultry products inspected at any official establishment
under the authority of this chapter and found to be not
adulterated, shall at the time they leave the establishment bear,
in distinctly legible form, on their shipping containers and
immediate containers as the Secretary may require, the information
required under paragraph (h) of section 453 of this title. In
addition, the Secretary whenever he determines such action is
practicable and necessary for the protection of the public, may
require nonconsumer packaged carcasses at the time they leave the
establishment to bear directly thereon in distinctly legible form
any information required under such paragraph (h).
(b) Labeling requirements; definitions and standards of identity or
composition or articles and standards of fill of container;
standards consistent with Federal Food, Drug, and Cosmetic Act;
consistency between Federal and State standards
The Secretary, whenever he determines such action is necessary
for the protection of the public, may prescribe: (1) the styles and
sizes of type to be used with respect to material required to be
incorporated in labeling to avoid false or misleading labeling in
marketing and labeling any articles or poultry subject to this
chapter; (2) definitions and standards of identity or composition
or articles subject to this chapter and standards of fill of
container for such articles not inconsistent with any such
standards established under the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.], and there shall be consultation
between the Secretary and the Secretary of Health and Human
Services prior to the issuance of such standards under either Act
relating to articles subject to this chapter to avoid inconsistency
in such standards and possible impairment of the coordinated
effective administration of this chapter and the Federal Food,
Drug, and Cosmetic Act. There shall also be consultation between
the Secretary and an appropriate advisory committee provided for in
section 454 of this title, prior to the issuance of such standards
under this chapter, to avoid, insofar as feasible, inconsistency
between Federal and State standards.
(c) Use of trade names; false or misleading marking or labeling;
misleading form or size of container
No article subject to this chapter shall be sold or offered for
sale by any person in commerce, under any name or other marking or
labeling which is false or misleading, or in any container of a
misleading form or size, but established trade names and other
marking and labeling and containers which are not false or
misleading and which are approved by the Secretary are permitted.
(d) Withholding use of false or misleading mark, label, or
container size or form; modification; hearing; conclusiveness of
determination; appeal
If the Secretary has reason to believe that any marking or
labeling or the size or form of any container in use or proposed
for use with respect to any article subject to this chapter is
false or misleading in any particular, he may direct that such use
be withheld unless the marking, labeling, or container is modified
in such manner as he may prescribe so that it will not be false or
misleading. If the person using or proposing to use the marketing,
labeling, or container does not accept the determination of the
Secretary, such person may request a hearing, but the use of the
marking, labeling, or container shall, if the Secretary so directs,
be withheld pending hearing and final determination by the
Secretary. Any such determination by the Secretary shall be
conclusive unless, within thirty days after receipt of notice of
such final determination, the person adversely affected thereby
appeals to the United States Court of Appeals for the circuit in
which such person has its principal place of business or to the
United States Court of Appeals for the District of Columbia
Circuit. The provisions of section 194 of title 7 shall be
applicable to appeals taken under this section.
-SOURCE-
(Pub. L. 85-172, Sec. 8, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-
492, Sec. 8, Aug. 18, 1968, 82 Stat. 799; Pub. L. 96-88, title V,
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in par.
(b), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
-MISC1-
AMENDMENTS
1968 - Par. (a). Pub. L. 90-492 substituted provisions requiring
shipping containers and immediate containers, as the Secretary may
order, to bear the information required under section 453(h) of
this title, and provisions, whenever the Secretary determines such
action to be practicable and necessary, requiring nonconsumer
packaged carcasses at the time they leave the official
establishment to bear the information required under the
aforementioned section, for provisions requiring shipping
containers to bear the official mark and the approved plant number
of the official establishment in which the contents were processed,
provisions requiring immediate containers to bear the official
inspection mark, the name of the product, a statement of
ingredients, the net weight or other appropriate measure of the
contents, the name and address of the processor, and the approved
plant number of the official establishment in which the contents
were processed, and provisions authorizing the Secretary to make
reasonable variations and grant exemptions from the foregoing
labeling requirements.
Par. (b). Pub. L. 90-492 added par. (b). Provisions of former
par. (b) were redesignated as pars. (c) and (d).
Par. (c). Pub. L. 90-492 redesignated part of provisions of
former par. (b) as (c) and made changes in phraseology.
Par. (d). Pub. L. 90-492 redesignated part of provisions of
former par. (b) as (d) and extended the authority of the Secretary
to withhold from use products which have false or misleading
markings or containers.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (b) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 458 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 458. Prohibited acts
-STATUTE-
(a) No person shall -
(1) slaughter any poultry or process any poultry products which
are capable of use as human food at any establishment processing
any such articles for commerce, except in compliance with the
requirements of this chapter;
(2) sell, transport, offer for sale or transportation, or
receive for transportation, in commerce, (A) any poultry products
which are capable of use as human food and are adulterated or
misbranded at the time of such sale, transportation, offer for
sale or transportation, or receipt for transportation; or (B) any
poultry products required to be inspected under this chapter
unless they have been so inspected and passed;
(3) do, with respect to any poultry products which are capable
of use as human food, any act while they are being transported in
commerce or held for sale after such transportation, which is
intended to cause or has the effect of causing such products to
be adulterated or misbranded;
(4) sell, transport, offer for sale or transportation, or
receive for transportation, in commerce or from an official
establishment, any slaughtered poultry from which the blood,
feathers, feet, head, or viscera have not been removed in
accordance with regulations promulgated by the Secretary, except
as may be authorized by regulations of the Secretary;
(5) use to his own advantage, or reveal other than to the
authorized representatives of the United States Government or any
State or other government in their official capacity, or as
ordered by a court in any judicial proceedings, any information
acquired under the authority of this chapter concerning any
matter which is entitled to protection as a trade secret.
(b) No brand manufacturer, printer, or other person shall cast,
print, lithograph, or otherwise make any device containing any
official mark or simulation thereof, or any label bearing any such
mark or simulation, or any form of official certificate or
simulation thereof, except as authorized by the Secretary.
(c) No person shall -
(1) forge any official device, mark, or certificate;
(2) without authorization from the Secretary use any official
device, mark, or certificate, or simulation thereof, or alter,
detach, deface, or destroy any official device, mark, or
certificate;
(3) contrary to the regulations prescribed by the Secretary,
fail to use, or to detach, deface, or destroy any official
device, mark, or certificate;
(4) knowingly possess, without promptly notifying the Secretary
or his representative, any official device or any counterfeit,
simulated, forged, or improperly altered official certificate or
any device or label or any carcass of any poultry, or part or
product thereof, bearing any counterfeit, simulated, forged, or
improperly altered official mark;
(5) knowingly make any false statement in any shipper's
certificate or other nonofficial or official certificate provided
for in the regulations prescribed by the Secretary; or
(6) knowingly represent that any article has been inspected and
passed, or exempted, under this chapter when, in fact, it has
respectively, not been so inspected and passed, or exempted.
-SOURCE-
(Pub. L. 85-172, Sec. 9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90-
492, Sec. 9, Aug. 18, 1968, 82 Stat. 800.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 made revisions in form and phraseology,
added to the enumerated prohibited acts slaughtering poultry or
processing any poultry products capable of use as human food,
except in compliance with the requirements of this chapter, selling
and transporting adulterated or misbranded poultry products or
uninspected poultry products, adulterating or misbranding poultry
products while they are being transported in commerce or held for
sale after such transportation, treating carcasses not in
accordance with regulations promulgated by the Secretary,
possessing, without notifying the Secretary, any official device or
any counterfeit, simulated, etc., official certificate, or any
device or label bearing any counterfeit, simulated, etc., official
mark, and making false representations and statements, and
clarified application to brand manufacturers and printers of
existing provisions prohibiting the counterfeiting of official
marks, labels, or certificates.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
amendment of pars. (a)(2)(A) and (a)(3) effective upon the
expiration of sixty days after Aug. 18, 1968, see section 20 of
Pub. L. 90-492, set out as a note under section 451 of this title.
-End-
-CITE-
21 USC Sec. 459 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 459. Compliance by all establishments
-STATUTE-
No establishment processing poultry or poultry products for
commerce otherwise subject to this chapter shall process any
poultry or poultry product except in compliance with the
requirements of this chapter.
-SOURCE-
(Pub. L. 85-172, Sec. 10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
492, Sec. 10, Aug. 18, 1968, 82 Stat. 801.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 substituted "otherwise subject to this
chapter" for "in or for marketing in a designated major consuming
area".
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 460 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 460. Miscellaneous activities subject to regulation
-STATUTE-
(a) Prohibition of inspection of articles not intended for use as
human food; denaturation or other identification prior to
distribution in commerce; inedible articles
Inspection shall not be provided under this chapter at any
establishment for the slaughter of poultry or the processing of any
carcasses or parts or products of poultry, which are not intended
for use as human food, but such articles shall, prior to their
offer for sale or transportation in commerce, unless naturally
inedible by humans, be denatured or otherwise identified as
prescribed by regulations of the Secretary to deter their use for
human food. No person shall buy, sell, transport, or offer for sale
or transportation, or receive for transportation, in commerce, or
import, any poultry carcasses or parts or products thereof which
are not intended for use as human food unless they are denatured or
otherwise identified as required by the regulations of the
Secretary or are naturally inedible by humans.
(b) Recordkeeping requirements; persons liable; scope of
disclosure; access to places of business; examination of records,
facilities, and inventories; copies; samples
The following classes of persons shall, for such period of time
as the Secretary may by regulations prescribe, not to exceed two
years unless otherwise directed by the Secretary for good cause
shown, keep such records as are properly necessary for the
effective enforcement of this chapter in order to insure against
adulterated or misbranded poultry products for the American
consumer; and all persons subject to such requirements shall, at
all reasonable times, upon notice by a duly authorized
representative of the Secretary, afford such representative access
to their places of business and opportunity to examine the
facilities, inventory, and records thereof, to copy all such
records, and to take reasonable samples of their inventory upon
payment of the fair market value therefor -
(1) Any person that engages in the business of slaughtering any
poultry or processing, freezing, packaging, or labeling any
carcasses, or parts or products of carcasses, of any poultry, for
commerce, for use as human food or animal food;
(2) Any person that engages in the business of buying or
selling (as poultry products brokers, wholesalers or otherwise),
or transporting, in commerce, or storing in or for commerce, or
importing, any carcasses, or parts or products of carcasses, of
any poultry;
(3) Any person that engages in business, in or for commerce, as
a renderer, or engages in the business of buying, selling, or
transporting, in commerce, or importing, any dead, dying,
disabled, or diseased poultry or parts of the carcasses of any
poultry that died otherwise than by slaughter.
(c) Registration of business, name of person, and trade names
No person shall engage in business, in or for commerce, as a
poultry products broker, renderer, or animal food manufacturer, or
engage in business in commerce as a wholesaler of any carcasses, or
parts or products of the carcasses, of any poultry, whether
intended for human food or other purposes, or engage in business as
a public warehouseman storing any such articles in or for commerce,
or engage in the business of buying, selling, or transporting in
commerce, or importing, any dead, dying, disabled, or diseased
poultry, or parts of the carcasses of any poultry that died
otherwise than by slaughter, unless when required by regulations of
the Secretary, he has registered with the Secretary his name, and
the address of each place of business at which, and all trade names
under which, he conducts such business.
(d) Regulation of transactions, transportation, or importation of
dead, dying, disabled or diseased poultry or carcasses to prevent
use as human food
No person engaged in the business of buying, selling, or
transporting in commerce, or importing, dead, dying, disabled, or
diseased poultry, or any parts of the carcasses of any poultry that
died otherwise than by slaughter, shall buy, sell, transport, offer
for sale or transportation, or receive for transportation, in
commerce, or import, any dead, dying, disabled, or diseased poultry
or parts of the carcasses of any poultry that died otherwise than
by slaughter, unless such transaction, transportation or
importation is made in accordance with such regulations as the
Secretary may prescribe to assure that such poultry, or the
unwholesome parts or products thereof, will be prevented from being
used for human food.
(e) Federal provisions applicable to State or Territorial business
transactions of a local nature and not subject to local authority
The authority conferred on the Secretary by paragraph (b), (c),
or (d) of this section with respect to persons engaged in the
specified kinds of business in or for commerce may be exercised
with respect to persons engaged, in any State or organized
territory, in such kinds of business but not in or for commerce,
whenever the Secretary determines, after consultation with an
appropriate advisory committee provided for in section 454 of this
title, that the State or territory does not have at least equal
authority under its laws or such authority is not exercised in a
manner to effectuate the purposes of this chapter, including the
State or territory providing for the Secretary or his
representative being afforded access to such places of business and
the facilities, inventories, and records thereof, and the taking of
reasonable samples, where he determines necessary in carrying out
his responsibilities under this chapter; and in such case the
provisions of paragraph (b), (c), or (d) of this section,
respectively, shall apply to such persons to the same extent and in
the same manner as if they were engaged in such business in or for
commerce and the transactions involved were in commerce.
-SOURCE-
(Pub. L. 85-172, Sec. 11, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
492, Sec. 11, Aug. 18, 1968, 82 Stat. 801.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 designated existing provisions as par. (b),
added pars. (a), and (c) to (e), and in par. (b), as so designated,
extended the types of persons required to maintain records
necessary for the enforcement of this chapter, required such
persons to give representatives of the Secretary access to their
places of business, and opportunity to examine records, facilities,
and inventories and to copy records and take inventory samples upon
payment.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
par. (d) effective upon the expiration of sixty days after Aug. 18,
1968, see section 20 of Pub. L. 90-492, set out as a note under
section 451 of this title.
-End-
-CITE-
21 USC Sec. 461 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 461. Offenses and punishment
-STATUTE-
(a) Violations; liability of agents, employees, and employers
Any person who violates the provisions of section 458, 459, 460,
463, or 466 of this title shall be fined not more than $1,000 or
imprisoned not more than one year, or both; but if such violation
involves intent to defraud, or any distribution or attempted
distribution of an article that is adulterated (except as defined
in section 453(g)(8) of this title), such person shall be fined not
more than $10,000 or imprisoned not more than three years, or both.
When construing or enforcing the provisions of said sections the
act, omission, or failure of any person acting for or employed by
any individual, partnership, corporation, or association within the
scope of his employment or office shall in every case be deemed the
act, omission, or failure of such individual, partnership,
corporation, or association, as well as of such person.
(b) Liability of carrier
No carrier shall be subject to the penalties of this chapter,
other than the penalties for violation of section 460 of this
title, by reason of his receipt, carriage, holding, or delivery, in
the usual course of business, as a carrier, of poultry or poultry
products, owned by another person unless the carrier has knowledge,
or is in possession of facts which would cause a reasonable person
to believe that such poultry or poultry products were not inspected
or marked in accordance with the provisions of this chapter or were
otherwise not eligible for transportation under this chapter or
unless the carrier refuses to furnish on request of a
representative of the Secretary the name and address of the person
from whom he received such poultry or poultry products, and copies
of all documents, if any there be, pertaining to the delivery of
the poultry or poultry products to such carrier.
(c) Assaulting, resisting, or impeding certain persons; murder;
punishments
Any person who forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while engaged in or on
account of the performance of his official duties under this
chapter shall be fined not more than $5,000 or imprisoned not more
than three years, or both. Whoever, in the commission of any such
acts, uses a deadly or dangerous weapon, shall be fined not more
than $10,000 or imprisoned not more than ten years, or both.
Whoever kills any person while engaged in or on account of the
performance of his official duties under this chapter shall be
punished as provided under sections 1111 and 1114 of title 18.
-SOURCE-
(Pub. L. 85-172, Sec. 12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-
492, Sec. 12, Aug. 18, 1968, 82 Stat. 802.)
-MISC1-
AMENDMENTS
1968 - Par. (a). Pub. L. 90-492, Sec. 12(a), inserted reference
to violations of section 463 of this title, and substituted
provisions that violators of the enumerated sections shall be fined
not more than $1,000 or imprisoned not more than one year, or both,
but that in cases involving intent to defraud, or any distribution
or attempt to distribute adulterated articles, except as defined in
section 453(g) of this title, the violators shall be fined not more
than $10,000 or imprisoned not more than three years, or both, for
provisions that violators shall be guilty of a misdemeanor and
subject to imprisonment for not more than six months or a fine of
not more than $3,000, or both, with increased fines and
imprisonment for any subsequent violations.
Par. (b). Pub. L. 90-492, Sec. 12(b), substituted "of poultry"
for "of slaughtered poultry", "such poultry" for "such slaughtered
poultry", and "otherwise not eligible" for "not otherwise
eligible", and inserted provision that no carrier shall be subject
to punishment unless the carrier refuses to furnish the name and
address of the person from whom he received such poultry or poultry
products, and copies of any documents pertaining to the delivery of
the poultry or poultry products to such carrier.
Par. (c). Pub. L. 90-492, Sec. 12(c), added par. (c).
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 462 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 462. Reporting of violations; notice; opportunity to present
views
-STATUTE-
Before any violation of this chapter is reported by the Secretary
to any United States attorney for institution of a criminal
proceeding, the person against whom such proceeding is contemplated
shall be given reasonable notice of the alleged violation and
opportunity to present his views orally or in writing with regard
to such contemplated proceeding. Nothing in this chapter shall be
construed as requiring the Secretary to report for criminal
prosecution violations of this chapter whenever he believes that
the public interest will be adequately served and compliance with
the chapter obtained by a suitable written notice or warning.
-SOURCE-
(Pub. L. 85-172, Sec. 13, Aug. 28, 1957, 71 Stat. 447.)
-End-
-CITE-
21 USC Sec. 463 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 463. Rules and regulations
-STATUTE-
(a) Storage and handling of poultry products; violation of
regulations
The Secretary may by regulations prescribe conditions under which
poultry products capable of use as human food, shall be stored or
otherwise handled by any person engaged in the business of buying,
selling, freezing, storing, or transporting, in or for commerce, or
importing, such articles, whenever the Secretary deems such action
necessary to assure that such articles will not be adulterated or
misbranded when delivered to the consumer. Violation of any such
regulation is prohibited.
(b) Other necessary rules and regulations
The Secretary shall promulgate such other rules and regulations
as are necessary to carry out the provisions of this chapter.
(c) Oral presentation of views
In applying the provisions of section 553(c) of title 5 to
proposed rule making under this chapter, an opportunity for the
oral presentation of views shall be accorded all interested
persons.
-SOURCE-
(Pub. L. 85-172, Sec. 14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-
492, Sec. 13, Aug. 18, 1968, 82 Stat. 803.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 designated existing provisions as par. (b),
added pars. (a) and (c), and in par. (b), as so designated,
substituted "such other rules" for "such rules".
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 464 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 464. Exemptions
-STATUTE-
(a) Persons exempted
The Secretary shall, by regulation and under such conditions as
to sanitary standards, practices, and procedures as he may
prescribe, exempt from specific provisions of this chapter -
(1) retail dealers with respect to poultry products sold
directly to consumers in individual retail stores, if the only
processing operation performed by such retail dealers is the
cutting up of poultry products on the premises where such sales
to consumers are made;
(2) for such period of time as the Secretary determines that it
would be impracticable to provide inspection and the exemption
will aid in the effective administration of this chapter, any
person engaged in the processing of poultry or poultry products
for commerce and the poultry or poultry products processed by
such person: Provided, however, That no such exemption shall
continue in effect on and after January 1, 1970; and
(3) persons slaughtering, processing, or otherwise handling
poultry or poultry products which have been or are to be
processed as required by recognized religious dietary laws, to
the extent that the Secretary determines necessary to avoid
conflict with such requirements while still effectuating the
purposes of this chapter.
(b) Territorial exemption
The Secretary may, under such sanitary conditions as he may by
regulations prescribe, exempt from the inspection requirements of
this chapter the slaughter of poultry, and the processing of
poultry products, by any person in any Territory not organized with
a legislative body, solely for distribution within such Territory,
when the Secretary determines that it is impracticable to provide
such inspection within the limits of funds appropriated for
administration of this chapter and that such exemption will aid in
the effective administration of this chapter.
(c) Personal slaughtering; custom slaughtering; name and address of
the poultry producer or processor in lieu of other labeling
requirements; small enterprises; slaughterers or processors of
specified number of turkeys; poultry producers raising poultry on
own farms
(1) The Secretary shall, by regulation and under such conditions,
including sanitary standards, practices, and procedures, as he may
prescribe, exempt from specific provisions of this chapter -
(A) the slaughtering by any person of poultry of his own
raising, and the processing by him and transportation in commerce
of the poultry products exclusively for use by him and members of
his household and his nonpaying guests and employees;
(B) the custom slaughter by any person of poultry delivered by
the owner thereof for such slaughter, and the processing by such
slaughterer and transportation in commerce of the poultry
products exclusively for use, in the household of such owner, by
him and members of his household and his nonpaying guests and
employees: Provided, That such custom slaughterer does not engage
in the business of buying or selling any poultry products capable
of use as human food;
(C) the slaughtering and processing of poultry products in any
State or Territory or the District of Columbia by any poultry
producer on his own premises with respect to sound and healthy
poultry raised on his premises and the distribution by any person
solely within such jurisdiction of the poultry products derived
from such operations, if, in lieu of other labeling requirements,
such poultry products are identified with the name and address of
such poultry producer, and if they are not otherwise misbranded,
and are sound, clean, and fit for human food when so distributed;
and
(D) the slaughtering of sound and healthy poultry or the
processing of poultry products of such poultry in any State or
territory or the District of Columbia by any poultry producer or
other person for distribution by him solely within such
jurisdiction directly to household consumers, restaurants,
hotels, and boarding houses, for use in their own dining rooms,
or in the preparation of meals for sales direct to consumers, if,
in lieu of other labeling requirements, such poultry products are
identified with the name and address of the processor, and if
they are not otherwise misbranded and are sound, clean, and fit
for human food when distributed by such processor.
The exemptions provided for in clauses (C) and (D) above shall not
apply if the poultry producer or other person engages in the
current calendar year in the business of buying or selling any
poultry or poultry products other than as specified in such
clauses.
(2) In addition to the specific exemptions provided herein, the
Secretary shall, when he determines that the protection of
consumers from adulterated or misbranded poultry products will not
be impaired by such action, provide by regulation, consistent with
subparagraph (3), for the exemption of the operation and products
of small enterprises (including poultry producers), not exempted
under subparagraph (1), which are engaged in any State or Territory
or the District of Columbia in slaughtering and/or cutting up
poultry for distribution as carcasses or parts thereof solely for
distribution within such jurisdiction, from such provisions of this
chapter as he deems appropriate, while still protecting the public
from adulterated or misbranded products, under such conditions,
including sanitary requirements, as he shall prescribe to
effectuate the purposes of this chapter.
(3) No exemption under subparagraph (1)(C) or (D) or subparagraph
(2) shall apply to any poultry producer or other person who, in the
current calendar year -
(A) slaughters or processes the products of more than 20,000
poultry; or
(B) slaughters or processes the products of poultry at a
facility used for slaughtering or processing of the products of
poultry by any other poultry producer or person.
Notwithstanding clause (B), the Secretary may grant such exemption
to any poultry producer or other person if the Secretary
determines, upon application of such poultry producer or other
person, that granting such exemption will not impair effectuating
the purposes of this chapter.
(4) The provisions of this chapter shall not apply to poultry
producers with respect to poultry of their own raising on their own
farms if (i) such producers slaughter not more than 1,000 poultry
during the calendar year for which this exemption is being
determined; (ii) such poultry producers do not engage in buying or
selling poultry products other than those produced from poultry
raised on their own farms; and (iii) none of such poultry moves in
commerce (as defined in section 453(a) of this title).
(d) Pizzas containing poultry products
(1) Under such terms and conditions as the Secretary shall
prescribe through rules and regulations issued under this section
that may be necessary to ensure food safety and protect public
health such as special handling procedures, the Secretary shall
exempt pizzas containing a poultry product from the inspection
requirements of this chapter if -
(A) the poultry product components of the pizzas have been
prepared, inspected, and passed in a cured or cooked form as
ready-to-eat in compliance with the requirements of this chapter;
and
(B) the pizzas are to be served in public or private nonprofit
institutions.
(2) The Secretary may withdraw or modify any exemption under this
subsection whenever the Secretary determines such action is
necessary to ensure food safety and to protect public health. The
Secretary may reinstate or further modify any exemption withdrawn
or modified under this subsection.
(e) Applicability of adulteration and misbranding provisions to
articles exempted from inspection
The adulteration and misbranding provisions of this chapter,
other than the requirement of the inspection legend, shall apply to
articles which are exempted from inspection under this section,
except as otherwise specified under paragraphs (a) and (d).
(f) Suspension or termination of exemption
The Secretary may by order suspend or terminate any exemption
under this section with respect to any person whenever he finds
that such action will aid in effectuating the purposes of this
chapter.
-SOURCE-
(Pub. L. 85-172, Sec. 15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-
492, Sec. 14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97-206, June
30, 1982, 96 Stat. 136; Pub. L. 102-237, title X, Sec. 1016(b),
Dec. 13, 1991, 105 Stat. 1903.)
-MISC1-
AMENDMENTS
1991 - Subsecs. (d) to (f). Pub. L. 102-237 added subsec. (d),
redesignated former subsec. (d) as (e) and substituted "(d)" for
"(c)", and redesignated former subsec. (e) as (f).
1982 - Par. (c)(3). Pub. L. 97-206, Sec. 1, substituted
provisions that no exemption would be given to persons who during
the current calendar year either slaughter or process the products
of more than 20,000 poultry, or slaughter or process such poultry
at a facility of another poultry producer or person, but that, in
the latter case, the Secretary may grant the exemption upon
application of such poultry producer or person if granting such
exemption would not impair the purposes of this chapter, for
provisions that an exemption would not be granted to those who
slaughter or process the products of more than 5,000 turkeys or an
equivalent number of poultry of all species in the current calendar
year (four birds of other species being deemed equivalent of one
turkey).
Par. (c)(4)(i). Pub. L. 97-206, Sec. 2, substituted "1,000
poultry during the calendar year for which this exemption is being
determined" for "250 turkeys, or not more than an equivalent number
of birds of all species during the calendar year for which this
exemption is being determined (four birds of other species being
deemed the equivalent of one turkey)".
1968 - Par. (a). Pub. L. 90-492, Sec. 14(a), (b), redesignated
subpars. (2) to (4) as (1) to (3), respectively, and in subpar.
(2), as so redesignated, substituted "January 1, 1970" for "July 1,
1960". Former subpar. (1), which exempted poultry producers with
respect to poultry of their own raising on their own farms which
they sold directly to household consumers, hotels, etc., for use in
their own dining rooms or in the preparation of meals for sales
direct to consumers only, provided that such producers did not
engage in buying or selling poultry products other than those
produced from poultry raised on their own farms, was struck out.
Pars. (b) to (e). Pub. L. 90-492, Sec. 14(c), added pars. (b) to
(d) and redesignated former par. (b) as (e).
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective upon the expiration of
sixty days after Aug. 18, 1968, see section 20(b) of Pub. L. 90-
492, set out as a note under section 451 of this title.
REGULATIONS
Section 1016(c) of Pub. L. 102-237 provided that: "No later than
August 1, 1992, the Secretary of Agriculture shall issue final
rules, through prior notice and comment rulemaking procedures, to
implement the exemption authorized by section 23(c) of the Federal
Meat Inspection Act [21 U.S.C. 623(c)] (as added by subsection (a))
and the exemption authorized by section 15(d) of the Poultry
Products Inspection Act [21 U.S.C. 464(d)] (as added by subsection
(b)). Prior to the issuance of the final rules, the Secretary shall
hold at least one public hearing examining the public health and
food safety issues raised by the granting of each of the
exemptions."
STUDIES CONCERNING GRANT OF FUTURE EXEMPTIONS FOR POULTRY AND MEAT
FOOD PRODUCTS
Section 1016(d) of Pub. L. 102-237 directed Secretary of
Agriculture in consultation with National Academy of Sciences to
conduct a study on meat food and poultry products inspection
exemptions under Federal Meat Inspection Act and Poultry Products
Inspection Act and a study on an exemption from requirements of
such Acts for certain wholesale meat outlets selling to hotels and
other similar institutional users not later than 24 months after
Dec. 13, 1991, and on completion of each study to provide the
results to Committee on Agriculture of House of Representatives and
Committee on Agriculture, Nutrition, and Forestry of Senate.
-End-
-CITE-
21 USC Sec. 465 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 465. Limitations upon entry of poultry products and other
materials into official establishments
-STATUTE-
The Secretary may limit the entry of poultry products and other
materials into any official establishment, under such conditions as
he may prescribe to assure that allowing the entry of such articles
into such inspected establishments will be consistent with the
purposes of this chapter.
-SOURCE-
(Pub. L. 85-172, Sec. 16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-
492, Sec. 15, Aug. 18, 1968, 82 Stat. 805.)
-MISC1-
AMENDMENTS
1968 - Pub. L. 90-492 substituted provisions authorizing the
Secretary to limit the entry of poultry products and other
materials into any official establishment for provisions that any
person distributing unwholesome or adulterated exempted poultry or
poultry products intended for human consumption shall be guilty of
a misdemeanor and subject to penalties upon conviction thereof.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 466 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 466. Imports
-STATUTE-
(a) Compliance with standards and regulations; status after
importation
No slaughtered poultry, or parts or products thereof, of any kind
shall be imported into the United States unless they are healthful,
wholesome, fit for human food, not adulterated, and contain no dye,
chemical, preservative, or ingredient which renders them
unhealthful, unwholesome, adulterated, or unfit for human food and
unless they also comply with the rules and regulations made by the
Secretary of Agriculture to assure that imported poultry or poultry
products comply with the standards provided for in this chapter.
All imported, slaughtered poultry, or parts or products thereof,
shall after entry into the United States in compliance with such
rules and regulations be deemed and treated as domestic slaughtered
poultry, or parts or products thereof, within the meaning and
subject to the provisions of this chapter and the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and Acts amendatory
of, supplemental to, or in substitution for such chapter and Act.
(b) Rules and regulations; destruction and exportation of refused
imports
The Secretary of Agriculture is authorized to make rules and
regulations to carry out the purposes of this section and in such
rules and regulations the Secretary of Agriculture may prescribe
the terms and conditions for the destruction of all slaughtered
poultry, or parts or products thereof, offered for entry and
refused admission into the United States unless such slaughtered
poultry, or parts or products thereof, be exported by the consignee
within the time fixed therefor in such rules and regulations.
(c) Storage, cartage and labor charges for imports refused
admission
All charges for storage, cartage, and labor with respect to any
product which is refused admission pursuant to this section shall
be paid by the owner or consignee, and in default of such payment
shall constitute a lien against any other products imported
thereafter by or for such owner or consignee.
(d) Domestic standards and processing facilities applicable;
enforcement
(1) Notwithstanding any other provision of law, all poultry, or
parts or products of poultry, capable of use as human food offered
for importation into the United States shall -
(A) be subject to inspection, sanitary, quality, species
verification, and residue standards that achieve a level of
sanitary protection equivalent to that achieved under United
States standards; and
(B) have been processed in facilities and under conditions that
achieve a level of sanitary protection equivalent to that
achieved under United States standards.
(2)(A) The Secretary may treat as equivalent to a United States
standard a standard of an exporting country described in paragraph
(1) if the exporting country provides the Secretary with scientific
evidence or other information, in accordance with risk assessment
methodologies determined appropriate by the Secretary, to
demonstrate that the standard of the exporting country achieves the
level of sanitary protection achieved under the United States
standard. For the purposes of this subsection, the term "sanitary
protection" means protection to safeguard public health.
(B) The Secretary may -
(i) determine, on a scientific basis, that the standard of the
exporting country does not achieve the level of protection that
the Secretary considers appropriate; and
(ii) provide the basis for the determination in writing to the
exporting country on request.
(3) Any such imported poultry article that does not meet such
standards shall not be permitted entry into the United States.
(4) The Secretary shall enforce this subsection through -
(A) random inspections for such species verification and for
residues; and
(B) random sampling and testing of internal organs and fat of
carcasses for residues at the point of slaughter by the exporting
country, in accordance with methods approved by the Secretary.
-SOURCE-
(Pub. L. 85-172, Sec. 17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99-
198, title XVII, Sec. 1701(a), Dec. 23, 1985, 99 Stat. 1633; Pub.
L. 103-182, title III, Sec. 361(e), Dec. 8, 1993, 107 Stat. 2123;
Pub. L. 103-465, title IV, Sec. 431(k), Dec. 8, 1994, 108 Stat.
4969.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
-MISC1-
AMENDMENTS
1994 - Subsec. (d)(1). Pub. L. 103-465, Sec. 431(k)(1), amended
par. (1) generally. Prior to amendment, par. (1) read as follows:
"Notwithstanding any other provision of law, except as provided in
paragraph (2), all poultry, or parts or products thereof, capable
of use as human food offered for importation into the United States
shall -
"(A) be subject to the same inspection, sanitary, quality,
species verification, and residue standards applied to products
produced in the United States; and
"(B) have been processed in facilities and under conditions
that are the same as those under which similar products are
processed in the United States."
Subsec. (d)(2)(A). Pub. L. 103-465, Sec. 431(k)(2)(A), amended
subpar. (A) generally. Prior to amendment, subpar. (A) read as
follows: "Notwithstanding any other provision of law, all poultry,
or parts or products of poultry, capable of use as human food
offered for importation into the United States from Canada and
Mexico shall -
"(i) comply with paragraph (1); or
"(ii)(I) be subject to inspection, sanitary, quality, species
verification, and residue standards that are equivalent to United
States standards; and
"(II) have been processed in facilities and under conditions
that meet standards that are equivalent to United States
standards."
Subsec. (d)(2)(B), (C). Pub. L. 103-465, Sec. 431(k)(2)(B), (C),
redesignated subpar. (C) as (B) and struck out former subpar. (B)
which read as follows: "The Secretary may treat as equivalent to a
United States standard a standard of Canada or Mexico described in
subparagraph (A)(ii) if the exporting country provides the
Secretary with scientific evidence or other information, in
accordance with risk assessment methodologies agreed to by the
Secretary and the exporting country, to demonstrate that the
standard of the exporting country achieves the level of protection
that the Secretary considers appropriate."
1993 - Subsec. (d). Pub. L. 103-182, in par. (1), inserted
"except as provided in paragraph (2)," before "all poultry" in
introductory provisions, added par. (2), and redesignated former
pars. (2) and (3) as (3) and (4), respectively.
1985 - Par. (d). Pub. L. 99-198 added par. (d).
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-465 effective, except as otherwise
provided, on the date of entry into force of the World Trade
Organization Agreement with respect to the United States [Jan. 1,
1995], see section 451 of Pub. L. 103-465, set out as an Effective
Date note under section 3601 of Title 19, Customs Duties.
EFFECTIVE DATE OF 1985 AMENDMENT
Section 1701(b) of Pub. L. 99-198 proved that: "The amendment
made by this section [amending this section] shall become effective
6 months after the date of enactment of this Act [Dec. 23, 1985]."
-End-
-CITE-
21 USC Sec. 467 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467. Inspection services
-STATUTE-
(a) Refusal or withdrawal; hearing; business unfitness based upon
certain convictions; persons responsibly connected with the
business
The Secretary may (for such period, or indefinitely, as he deems
necessary to effectuate the purposes of this chapter) refuse to
provide, or withdraw, inspection service under this chapter with
respect to any establishment if he determines, after opportunity
for a hearing is accorded to the applicant for, or recipient of,
such service, that such applicant or recipient is unfit to engage
in any business requiring inspection upon this chapter because the
applicant or recipient or anyone responsibly connected with the
applicant or recipient, has been convicted, in any Federal or State
court, within the previous ten years of (1) any felony or more than
one misdemeanor under any law based upon the acquiring, handling,
or distributing of adulterated, mislabeled, or deceptively packaged
food or fraud in connection with transactions in food; or (2) any
felony, involving fraud, bribery, extortion, or any other act or
circumstances indicating a lack of the integrity needed for the
conduct of operations affecting the public health. For the purpose
of this paragraph a person shall be deemed to be responsibly
connected with the business if he was a partner, officer, director,
holder, or owner of 10 per centum or more of its voting stock or
employee in a managerial or executive capacity.
(b) Hearing to determine validity of withdrawal or refusal of
inspection services; continuation of withdrawal or refusal
Upon the withdrawal of inspection service from any official
establishment for failure to destroy condemned poultry products as
required under section 455 of this title, or other failure of an
official establishment to comply with the requirements as to
premises, facilities, or equipment, or the operation thereof, as
provided in section 456 of this title, or the refusal of inspection
service to any applicant therefor because of failure to comply with
any requirements under section 456 of this title, the applicant
for, or recipient of, the service shall, upon request, be afforded
opportunity for a hearing with respect to the merits or validity of
such action; but such withdrawal or refusal shall continue in
effect unless otherwise ordered by the Secretary.
(c) Finality and conclusiveness of determination; judicial review;
record
The determination and order of the Secretary when made after
opportunity for hearing, with respect to withdrawal or refusal of
inspection service under this chapter shall be final and conclusive
unless the affected applicant for, or recipient of, inspection
service files application for judicial review within thirty days
after the effective date of such order in the United States Court
of Appeals as provided in section 457 of this title. Judicial
review of any such order shall be upon the record upon which the
determination and order are based. The provisions of section 194 of
title 7 shall be applicable to appeals taken under this section.
-SOURCE-
(Pub. L. 85-172, Sec. 18, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-
492, Sec. 16, Aug. 18, 1968, 82 Stat. 805.)
-MISC1-
AMENDMENTS
1968 - Par. (a). Pub. L. 90-492 substituted provisions
authorizing the Secretary to refuse or withdraw inspection services
subsequent to a hearing determining that the applicant or recipient
is unfit to engage in any business requiring inspection under this
chapter based upon the specified considerations, for provisions
granting the Secretary exclusive jurisdiction within the scope of
this chapter and exempting poultry and poultry products from the
provisions of the Federal Food, Drug, and Cosmetic Act, as amended,
to the extent of the application or the extension thereof of the
provisions of this chapter.
Par. (b). Pub. L. 90-492 substituted provisions granting a
hearing, upon request by the applicant or recipient, to determine
the merits and validity of the withdrawal or refusal of inspection
services and continuing such withdrawal or refusal in effect,
unless otherwise ordered by the Secretary, for provisions
authorizing the Secretary to cooperate with other branches of
government and with State agencies and to conduct examinations,
investigations, and inspections through any officer or employee of
a State commissioned by the Secretary for such purpose.
Par. (c). Pub. L. 90-492 added par. (c).
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section
20 of Pub. L. 90-492, set out as a note under section 451 of this
title.
-End-
-CITE-
21 USC Sec. 467a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467a. Administrative detention; duration; pending judicial
proceedings; notification of government authorities; release;
removal of official marks
-STATUTE-
Whenever any poultry product, or any product exempted from the
definition of a poultry product, or any dead, dying, disabled, or
diseased poultry is found by any authorized representative of the
Secretary upon any premises where it is held for purposes of, or
during or after distribution in, commerce or otherwise subject to
this chapter, and there is reason to believe that any such article
is adulterated or misbranded and is capable of use as human food,
or that it has not been inspected, in violation of the provisions
of this chapter or of any other Federal law or the laws of any
State or Territory, or the District of Columbia, or that it has
been or is intended to be, distributed in violation of any such
provisions, it may be detained by such representative for a period
not to exceed twenty days, pending action under section 467b of
this title or notification of any Federal, State, or other
governmental authorities having jurisdiction over such article or
poultry, and shall not be moved by any person, from the place at
which it is located when so detained, until released by such
representative. All official marks may be required by such
representative to be removed from such article or poultry before it
is released unless it appears to the satisfaction of the Secretary
that the article or poultry is eligible to retain such marks.
-SOURCE-
(Pub. L. 85-172, Sec. 19, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 805.)
-End-
-CITE-
21 USC Sec. 467b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467b. Seizure and condemnation
-STATUTE-
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury;
sales restrictions; bonds; court costs and fees, storage, and
other expenses against claimants; jury trial; United States as
plaintiff
(1) Any poultry product, or any dead, dying, disabled, or
diseased poultry, that is being transported in commerce or
otherwise subject to this chapter, or is held for sale in the
United States after such transportation, and that (A) is or has
been processed, sold, transported, or otherwise distributed or
offered or received for distribution in violation of this chapter,
or (B) is capable of use as human food and is adulterated or
misbranded, or (C) in any other way is in violation of this
chapter, shall be liable to be proceeded against and seized and
condemned, at any time, on a libel of information in any United
States district court or other proper court as provided in section
467c of this title within the jurisdiction of which the article or
poultry is found.
(2) If the article or poultry is condemned it shall, after entry
of the decree, (A) be distributed in accordance with paragraph (5),
or (B) be disposed of by destruction or sale as the court may
direct and the proceeds, if sold, less the court costs and fees,
and storage and other proper expenses, shall be paid into the
Treasury of the United States, but the article or poultry shall not
be sold contrary to the provisions of this chapter, or the laws of
the jurisdiction in which it is sold: Provided, That upon the
execution and delivery of a good and sufficient bond conditioned
that the article or poultry shall not be sold or otherwise disposed
of contrary to the provisions of this chapter, or the laws of the
jurisdiction in which disposal is made, the court may direct that
such article or poultry be delivered to the owner thereof subject
to such supervision by authorized representatives of the Secretary
as is necessary to insure compliance with the applicable laws.
(3) When a decree of condemnation is entered against the article
or poultry and it is released under bond, or destroyed, court costs
and fees, and storage and other proper expenses shall be awarded
against the person, if any, intervening as claimant of the article
or poultry.
(4) The proceedings in such libel cases shall conform, as nearly
as may be, to the proceedings in admiralty, except that either
party may demand trial by jury of any issue of fact joined in any
case, and all such proceedings shall be at the suit of and in the
name of the United States.
(5)(A) An article that is condemned under paragraph (1) may as
the court may direct, after entry of the decree, be distributed
without charge to nonprofit, private entities or to Federal, State,
or local government entities engaged in the distribution of food
without charge to individuals, if such article -
(i) is capable of use as a human food;
(ii) has been inspected under this chapter and found to be
wholesome and not to be adulterated within the meaning of
paragraphs (1) through (7) of section 453(g) of this title and a
determination is made at the time of the entry of the decree that
such article is wholesome and not so adulterated; and
(iii) is plainly marked "Not for Sale" on such article or its
container.
(B) The United States may not be held legally responsible for any
article that is distributed under subparagraph (A) to a nonprofit,
private entity or to a Federal, State, or local government entity,
if such article -
(i) was found after inspection under this chapter to be
wholesome and not adulterated within the meaning of paragraphs
(1) through (7) of section 453(g) of this title and a
determination was made at the time of the entry of the decree
that such article was wholesome and not so adulterated; and
(ii) was plainly marked "Not for Sale" on such article or its
container.
(C) The person from whom such article was seized and condemned
may not be held legally responsible for such article, if such
article -
(i) was found after inspection under this chapter to be
wholesome and not adulterated within the meaning of paragraphs
(1) through (7) of section 453(g) of this title and a
determination was made at the time of entry of the decree that
such article was wholesome and not so adulterated; and
(ii) was plainly marked "Not for Sale" on such article or its
container.
(b) Condemnation or seizure under other provisions unaffected
The provisions of this section shall in no way derogate from
authority for condemnation or seizure conferred by other provisions
of this chapter, or other laws.
-SOURCE-
(Pub. L. 85-172, Sec. 20, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 806; amended Pub. L. 101-205, Sec. 2, Dec. 7,
1989, 103 Stat. 1830.)
-MISC1-
AMENDMENTS
1989 - Subsec. (a). Pub. L. 101-205 designated first sentence as
par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
respectively, designated second sentence as par. (2) and inserted
"(A) be distributed in accordance with paragraph (5), or (B)" after
"entry of the decree,", designated third and fourth sentences as
pars. (3) and (4), respectively, and added par. (5).
-End-
-CITE-
21 USC Sec. 467c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467c. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations; United States
as plaintiff; subpenas
-STATUTE-
The United States district courts, the District Court of Guam,
the District Court of the Virgin Islands, the highest court of
American Samoa, and the United States courts of the other
territories, are vested with jurisdiction specifically to enforce,
and to prevent and restrain violations of, this chapter, and shall
have jurisdiction in all other kinds of cases arising under this
chapter, except as provided in section 457(d) or 467 of this title.
All proceedings for the enforcement or to restrain violations of
this chapter shall be by and in the name of the United States.
Subpenas for witnesses who are required to attend a court of the
United States, in any district, may run into any other district in
any such proceeding.
-SOURCE-
(Pub. L. 85-172, Sec. 21, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 806.)
-End-
-CITE-
21 USC Sec. 467d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467d. Administration and enforcement; applicability of penalty
provisions; conduct of inquiries; power and jurisdiction of
courts
-STATUTE-
For the efficient administration and enforcement of this chapter,
the provision (including penalties) of sections 46, 48, 49 and 50
of title 15 (except paragraphs (c) through (h) of section 46 and
the last paragraph of section 49 (!1) of title 15), and the
provisions of section 409(l) (!1) of title 47, are made applicable
to the jurisdiction, powers, and duties of the Secretary in
administering and enforcing the provisions of this chapter and to
any person with respect to whom such authority is exercised. The
Secretary, in person or by such agents as he may designate, may
prosecute any inquiry necessary to his duties under this chapter in
any part of the United States, and the powers conferred by said
sections 49 and 50 of title 15 on the district courts of the United
States may be exercised for the purposes of this chapter by any
court designated in section 467c of this title.
-SOURCE-
(Pub. L. 85-172, Sec. 22, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 807.)
-REFTEXT-
REFERENCES IN TEXT
The last paragraph of section 49 of title 15, and the provisions
of section 409(l) of title 47, referred to in text, which related
to immunity of witnesses, were repealed by sections 211 and 242,
respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
929, 930. For provisions relating to immunity of witnesses, see
section 6001 et seq. of Title 18, Crimes and Criminal Procedure.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 467e 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467e. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for
establishments with inspection services and as to marking,
labeling, packaging, and ingredients; recordkeeping and related
requirements; concurrent jurisdiction over distribution for human
food purposes of adulterated or misbranded and imported articles;
other matters
-STATUTE-
Requirements within the scope of this chapter with respect to
premises, facilities and operations of any official establishment
which are in addition to, or different than those made under this
chapter may not be imposed by any State or Territory or the
District of Columbia, except that any such jurisdiction may impose
recordkeeping and other requirements within the scope of paragraph
(b) of section 460 of this title, if consistent therewith, with
respect to any such establishment. Marking, labeling, packaging, or
ingredient requirements (or storage or handling requirements found
by the Secretary to unduly interfere with the free flow of poultry
products in commerce) in addition to, or different than, those made
under this chapter may not be imposed by any State or Territory or
the District of Columbia with respect to articles prepared at any
official establishment in accordance with the requirements under
this chapter, but any State or Territory or the District of
Columbia may, consistent with the requirements under this chapter
exercise concurrent jurisdiction with the Secretary over articles
required to be inspected under this chapter for the purpose of
preventing the distribution for human food purposes of any such
articles which are adulterated or misbranded and are outside of
such an establishment, or, in the case of imported articles which
are not at such an establishment, after their entry into the United
States. This chapter shall not preclude any State or Territory or
the District of Columbia from making requirement or taking other
action, consistent with this chapter, with respect to any other
matters regulated under this chapter.
-SOURCE-
(Pub. L. 85-172, Sec. 23, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 807.)
-End-
-CITE-
21 USC Sec. 467f 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 467f. Federal Food, Drug, and Cosmetic Act applications
-STATUTE-
(a) Exemptions; authorities under food, drug, and cosmetic
provisions unaffected
Poultry and poultry products shall be exempt from the provisions
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
to the extent of the application or extension thereto of the
provisions of this chapter, except that the provisions of this
chapter shall not derogate from any authority conferred by the
Federal Food, Drug, and Cosmetic Act prior to August 18, 1968.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services
The detainer authority conferred by section 467a of this title
shall apply to any authorized representative of the Secretary of
Health and Human Services for purposes of the enforcement of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with
respect to any poultry carcass, or part or product thereof, that is
outside any official establishment, and for such purposes the first
reference to the Secretary in section 467a of this title shall be
deemed to refer to the Secretary of Health and Human Services.
-SOURCE-
(Pub. L. 85-172, Sec. 24, as added Pub. L. 90-492, Sec. 17, Aug.
18, 1968, 82 Stat. 807; amended Pub. L. 96-88, title V, Sec.
509(b), Oct. 17, 1979, 93 Stat. 695.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in text, is
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to chapter 9 (Sec. 301 et seq.) of this title.
For complete classification of this Act to the Code, see section
301 of this title and Tables.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (b) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-End-
-CITE-
21 USC Sec. 468 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 468. Cost of inspection; overtime
-STATUTE-
The cost of inspection rendered under the requirements of this
chapter, shall be borne by the United States, except the cost of
overtime and holiday pay paid pursuant to the (!1) section 2219a of
title 7.
-SOURCE-
(Pub. L. 85-172, Sec. 25, formerly Sec. 19, Aug. 28, 1957, 71 Stat.
448, renumbered Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat.
805; Pub. L. 107-171, title X, Sec. 10703(c)(1), May 13, 2002, 116
Stat. 517.)
-REFTEXT-
REFERENCES IN TEXT
Section 2219a of title 7, referred to in text, was in the
original "section 10703 of the Farm Security and Rural Investment
Act of 2002", meaning section 10703 of Pub. L. 107-171, which
enacted section 2219a of Title 7, Agriculture, amended this
section, section 695 of this title, and section 5549 of Title 5,
Government Organization and Employees, and repealed section 394 of
Title 7.
-MISC1-
AMENDMENTS
2002 - Pub. L. 107-171 substituted "except the cost of overtime
and holiday pay paid pursuant to the section 2219a of title 7." for
"except that the cost of overtime and holiday work performed in
establishments subject to the provisions of this chapter at such
rates as the Secretary may determine shall be borne by such
establishments. Sums received by the Secretary in reimbursement for
sums paid out by him for such premium pay work shall be available
without fiscal year limitation to carry out the purposes of this
section."
-FOOTNOTE-
(!1) So in original. The word "the" probably should not appear.
-End-
-CITE-
21 USC Sec. 469 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 469. Authorization of appropriations
-STATUTE-
There is authorized to be appropriated such sums as are necessary
to carry out the provisions of this chapter.
-SOURCE-
(Pub. L. 85-172, Sec. 26, formerly Sec. 20, Aug. 28, 1957, 71 Stat.
449, renumbered Pub. L. 90-492, Sec. 17, Aug. 18, 1968, 82 Stat.
805.)
-End-
-CITE-
21 USC Sec. 470 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 470. Omitted
-COD-
CODIFICATION
Section, Pub. L. 85-172, Sec. 27, as added Pub. L. 90-492, Sec.
17, Aug. 18, 1968, 82 Stat. 807; amended Pub. L. 103-437, Sec.
8(1), Nov. 2, 1994, 108 Stat. 4588, which required the Secretary of
Agriculture to report annually to the Committee on Agriculture of
the House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate on the slaughter of poultry
and the processing and distribution of poultry parts and products,
terminated, effective May 15, 2000, pursuant to section 3003 of
Pub. L. 104-66, as amended, set out as a note under section 1113 of
Title 31, Money and Finance. See, also, page 46 of House Document
No. 103-7.
-End-
-CITE-
21 USC Sec. 471 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 10 - POULTRY AND POULTRY PRODUCTS INSPECTION
-HEAD-
Sec. 471. Safe Meat and Poultry Inspection Panel
-STATUTE-
(a) Review and evaluation
The advisory panel known as the "Safe Meat and Poultry Inspection
Panel" established by section 679a of this title shall review and
evaluate, as the panel considers necessary, the adequacy,
necessity, safety, cost-effectiveness, and scientific merit of -
(1) inspection procedures of, and work rules and worker
relations involving Federal employees employed in, plants
inspected under this chapter;
(2) informal petitions or proposals for changes in inspection
procedures, processes, and techniques of plants inspected under
this chapter;
(3) formal changes in poultry inspection regulations
promulgated under this chapter, whether in notice, proposed, or
final form; and
(4) such other matters as may be referred to the panel by the
Secretary regarding the quality or effectiveness of a safe and
cost-effective poultry inspection system under this chapter.
(b) Reports
(1) In general
The Safe Meat and Poultry Inspection Panel shall submit to the
Secretary a report on the results of each review and evaluation
carried out under paragraph (1), including such recommendations
as the panel considers appropriate.
(2) Reports on formal changes
In the case of a report concerning a formal change in poultry
inspection regulations, the report shall be made within the time
limits prescribed for formal comments on such changes.
-SOURCE-
(Pub. L. 85-172, Sec. 30, as added Pub. L. 104-127, title IX, Sec.
918(a)(2), Apr. 4, 1996, 110 Stat. 1190.)
-End-
-CITE-
21 USC CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS
-HEAD-
CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS
-End-
-CITE-
21 USC Secs. 501 to 517 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 11 - MANUFACTURE OF NARCOTIC DRUGS
-HEAD-
Secs. 501 to 517. Repealed.
-MISC1-
Secs. 501 to 517. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(10), Oct. 27, 1970, 84 Stat. 1292.
Sections, Pub. L. 86-429, Apr. 22, 1960, 74 Stat. 55, provided
for licensing and control of the manufacture of all narcotic drugs
and was known as the "Narcotic Manufacturing Act of 1960". Sections
1 to 3 and 5 to 22 of said Pub. L. 86-429 were classified
respectively to sections 501, 501 notes, and 502 to 517 of this
title. Section 4 of Pub. L. 86-429 was classified to sections 4702,
4731, and 4731 note of Title 26, Internal Revenue Code. See section
801 et seq. of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as a note under section 951 of this title. For provisions
postponing such effective date if the Attorney General postpones
the effective date of section 826 of this title, see section
1105(c) of Pub. L. 91-513, set out as an Effective Date note under
section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of these sections by section 1101
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a note under
sections 171 to 174 of this title.
-End-
-CITE-
21 USC CHAPTER 12 - MEAT INSPECTION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
-HEAD-
CHAPTER 12 - MEAT INSPECTION
-MISC1-
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND
MISBRANDING
Sec.
601. Definitions.
602. Congressional statement of findings.
603. Inspection of meat and meat food products.
604. Post mortem examination of carcasses and marking or
labeling; destruction of carcasses condemned;
reinspection.
605. Examination of carcasses brought into slaughtering or
packing establishments, and of meat food products
issued from and returned thereto; conditions for
entry.
606. Inspectors of meat food products; marks of inspection;
destruction of condemned products; products for
export.
607. Labeling, marking, and container requirements.
608. Sanitary inspection and regulation of slaughtering and
packing establishments; rejection of adulterated meat
or meat food products.
609. Examination of animals and food products thereof,
slaughtered and prepared during nighttime.
610. Prohibited acts.
611. Devices, marks, labels, and certificates; simulations.
612 to 614. Repealed.
615. Inspection of carcasses, meat of which is intended for
export.
616. Inspectors of carcasses, etc., meat of which is
intended for export; certificates of condition.
617. Clearance prohibited to vessel carrying meat for
export without inspector's certificate.
618. Delivery of inspectors' certificates, and of copies.
619. Marking, labeling, or other identification to show
kinds of animals from which derived; separate
establishments for preparation and slaughtering
activities.
620. Imports.
621. Inspectors to make examinations provided for;
appointment; duties; regulations.
622. Bribery of or gifts to inspectors or other officers
and acceptance of gifts.
623. Exemptions from inspection requirements.
624. Storage and handling regulations; violations;
exemption of establishments subject to non-Federal
jurisdiction.
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
641. Prohibition of subchapter I inspection of articles not
intended for use as human food; denaturation or other
identification prior to distribution in commerce;
inedible articles.
642. Recordkeeping requirements.
643. Registration of business, name of person, and trade
names.
644. Regulation of transactions, transportation, or
importation of 4-D animals to prevent use as human
food.
645. Federal provisions applicable to State or Territorial
business transactions of a local nature and not
subject to local authority.
SUBCHAPTER III - FEDERAL AND STATE COOPERATION
661. Federal and State cooperation.
SUBCHAPTER IV - AUXILIARY PROVISIONS
671. Inspection services; refusal or withdrawal; hearing;
business unfitness based upon certain convictions;
other provisions for withdrawal of services
unaffected; responsible connection with business;
finality of Secretary's actions; judicial review;
record.
672. Administrative detention; duration; pending judicial
proceedings; notification of governmental
authorities; release.
673. Seizure and condemnation.
674. Federal court jurisdiction of enforcement and
injunction proceedings and other kinds of cases;
limitations of section 607(e) of this title.
675. Assaulting, resisting, or impeding certain persons;
murder; protection of such persons.
676. Violations.
677. Other Federal laws applicable for administration and
enforcement of chapter; location of inquiries;
jurisdiction of Federal courts.
678. Non-Federal jurisdiction of federally regulated
matters; prohibition of additional or different
requirements for establishments with inspection
services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements;
concurrent jurisdiction over distribution for human
food purposes of adulterated or misbranded and
imported articles; other matters.
679. Application of Federal Food, Drug, and Cosmetic Act.
679a. Safe Meat and Poultry Inspection Panel.
679b. Pasteurization of meat and poultry.
679c. Expansion of Food Safety Inspection Service
activities.
680. Authorization of appropriations.
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
691. Omitted.
692. Inspection extended to reindeer.
693. Inspection of dairy products for export.
694. Authorization of appropriations.
695. Payment of cost of meat-inspection service; exception.
-End-
-CITE-
21 USC SUBCHAPTER I - INSPECTION REQUIREMENTS;
ADULTERATION AND MISBRANDING 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND
MISBRANDING
-End-
-CITE-
21 USC Sec. 601 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 601. Definitions
-STATUTE-
As used in this chapter, except as otherwise specified, the
following terms shall have the meanings stated below:
(a) The term "Secretary" means the Secretary of Agriculture of
the United States or his delegate.
(b) The term "firm" means any partnership, association, or other
unincorporated business organization.
(c) The term "meat broker" means any person, firm, or corporation
engaged in the business of buying or selling carcasses, parts of
carcasses, meat, or meat food products of cattle, sheep, swine,
goats, horses, mules, or other equines on commission, or otherwise
negotiating purchases or sales of such articles other than for his
own account or as an employee of another person, firm, or
corporation.
(d) The term "renderer" means any person, firm, or corporation
engaged in the business of rendering carcasses or parts or products
of the carcasses, of cattle, sheep, swine, goats, horses, mules, or
other equines, except rendering conducted under inspection or
exemption under this subchapter.
(e) The term "animal food manufacturer" means any person, firm,
or corporation engaged in the business of manufacturing or
processing animal food derived wholly or in part from carcasses, or
parts or products of the carcasses, of cattle, sheep, swine, goats,
horses, mules, or other equines.
(f) The term "State" means any State of the United States and the
Commonwealth of Puerto Rico.
(g) The term "Territory" means Guam, the Virgin Islands of the
United States, American Samoa, and any other territory or
possession of the United States, excluding the Canal Zone.
(h) The term "commerce" means commerce between any State, any
Territory, or the District of Columbia, and any place outside
thereof; or within any Territory not organized with a legislative
body, or the District of Columbia.
(i) The term "United States" means the States, the District of
Columbia, and the Territories of the United States.
(j) The term "meat food product" means any product capable of use
as human food which is made wholly or in part from any meat or
other portion of the carcass of any cattle, sheep, swine, or goats,
excepting products which contain meat or other portions of such
carcasses only in a relatively small proportion or historically
have not been considered by consumers as products of the meat food
industry, and which are exempted from definition as a meat food
product by the Secretary under such conditions as he may prescribe
to assure that the meat or other portions of such carcasses
contained in such product are not adulterated and that such
products are not represented as meat food products. This term as
applied to food products of equines shall have a meaning comparable
to that provided in this paragraph with respect to cattle, sheep,
swine, and goats.
(k) The term "capable of use as human food" shall apply to any
carcass, or part or product of a carcass, of any animal, unless it
is denatured or otherwise identified as required by regulations
prescribed by the Secretary to deter its use as human food, or it
is naturally inedible by humans.
(l) The term "prepared" means slaughtered, canned, salted,
rendered, boned, cut up, or otherwise manufactured or processed.
(m) The term "adulterated" shall apply to any carcass, part
thereof, meat or meat food product under one or more of the
following circumstances:
(1) if it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case
the substance is not an added substance, such article shall not
be considered adulterated under this clause if the quantity of
such substance in or on such article does not ordinarily render
it injurious to health;
(2)(A) if it bears or contains (by reason of administration of
any substance to the live animal or otherwise) any added
poisonous or added deleterious substance (other than one which is
(i) a pesticide chemical in or on a raw agricultural commodity;
(ii) a food additive; or (iii) a color additive) which may, in
the judgment of the Secretary, make such article unfit for human
food;
(B) if it is, in whole or in part, a raw agricultural commodity
and such commodity bears or contains a pesticide chemical which
is unsafe within the meaning of section 346a of this title,
(C) if it bears or contains any food additive which is unsafe
within the meaning of section 348 of this title,
(D) if it bears or contains any color additive which is unsafe
within the meaning of section 379e of this title: Provided, That
an article which is not adulterated under clause (B), (C), or (D)
shall nevertheless be deemed adulterated if use of the pesticide
chemical, food additive, or color additive in or on such article
is prohibited by regulations of the Secretary in establishments
at which inspection is maintained under this subchapter;
(3) if it consists in whole or in part of any filthy, putrid,
or decomposed substance or is for any other reason unsound,
unhealthful, unwholesome, or otherwise unfit for human food;
(4) if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(5) if it is, in whole or in part, the product of an animal
which has died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(7) if it has been intentionally subjected to radiation, unless
the use of the radiation was in conformity with a regulation or
exemption in effect pursuant to section 348 of this title;
(8) if any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or if any substance has been
substituted, wholly or in part therefor; or if damage or
inferiority has been concealed in any manner; or if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is; or
(9) if it is margarine containing animal fat and any of the raw
material used therein consisted in whole or in part of any
filthy, putrid, or decomposed substance.
(n) The term "misbranded" shall apply to any carcass, part
thereof, meat or meat food product under one or more of the
following circumstances:
(1) if its labeling is false or misleading in any particular;
(2) if it is offered for sale under the name of another food;
(3) if it is an imitation of another food, unless its label
bears, in type of uniform size and prominence, the word
"imitation" and immediately thereafter, the name of the food
imitated;
(4) if its container is so made, formed, or filled as to be
misleading;
(5) if in a package or other container unless it bears a label
showing (A) the name and place of business of the manufacturer,
packer, or distributor; and (B) an accurate statement of the
quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (B) of this
subparagraph (5), reasonable variations may be permitted, and
exemptions as to small packages may be established, by
regulations prescribed by the Secretary;
(6) if any word, statement, or other information required by or
under authority of this chapter to appear on the label or other
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(7) if it purports to be or is represented as a food for which
a definition and standard of identity or composition has been
prescribed by regulations of the Secretary under section 607 of
this title unless (A) it conforms to such definition and
standard, and (B) its label bears the name of the food specified
in the definition and standard and, insofar as may be required by
such regulations, the common names of optional ingredients (other
than spices, flavoring, and coloring) present in such food;
(8) if it purports to be or is represented as a food for which
a standard or standards of fill of container have been prescribed
by regulations of the Secretary under section 607 of this title,
and it falls below the standard of fill of container applicable
thereto, unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below such
standard;
(9) if it is not subject to the provisions of subparagraph (7),
unless its label bears (A) the common or usual name of the food,
if any there be, and (B) in case it is fabricated from two or
more ingredients, the common or usual name of each such
ingredient; except that spices, flavorings, and colorings may,
when authorized by the Secretary, be designated as spices,
flavorings, and colorings without naming each: Provided, That to
the extent that compliance with the requirements of clause (B) of
this subparagraph (9) is impracticable, or results in deception
or unfair competition, exemptions shall be established by
regulations promulgated by the Secretary;
(10) if it purports to be or is represented for special dietary
uses, unless its label bears such information concerning its
vitamin, mineral, and other dietary properties as the Secretary,
after consultation with the Secretary of Health and Human
Services, determines to be, and by regulations prescribes as,
necessary in order fully to inform purchasers as to its value for
such uses;
(11) if it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative, unless it bears
labeling stating that fact: Provided, That, to the extent that
compliance with the requirements of this subparagraph (11) is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary; or
(12) if it fails to bear, directly thereon or on its container,
as the Secretary may by regulations prescribe, the inspection
legend and, unrestricted by any of the foregoing, such other
information as the Secretary may require in such regulations to
assure that it will not have false or misleading labeling and
that the public will be informed of the manner of handling
required to maintain the article in a wholesome condition.
(o) The term "label" means a display of written, printed, or
graphic matter upon the immediate container (not including package
liners) of any article.
(p) The term "labeling" means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.
(q) The term "Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.]" means the Act so entitled, approved June 25, 1938 (52
Stat. 1040), and Acts amendatory thereof or supplementary thereto.
(r) The terms "pesticide chemical," "food additive," "color
additive," and "raw agricultural commodity" shall have the same
meanings for purposes of this chapter as under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(s) The term "official mark" means the official inspection legend
or any other symbol prescribed by regulations of the Secretary to
identify the status of any article or animal under this chapter.
(t) The term "official inspection legend" means any symbol
prescribed by regulations of the Secretary showing that an article
was inspected and passed in accordance with this chapter.
(u) The term "official certificate" means any certificate
prescribed by regulations of the Secretary for issuance by an
inspector or other person performing official functions under this
chapter.
(v) The term "official device" means any device prescribed or
authorized by the Secretary for use in applying any official mark.
(w) The term "amenable species" means -
(1) those species subject to the provisions of this chapter on
the day before November 10, 2005; and
(2) any additional species of livestock that the Secretary
considers appropriate.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 1, as added Pub. L. 90-201,
Sec. 2, Dec. 15, 1967, 81 Stat. 584; amended Pub. L. 96-88, title
V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-571, title
I, Sec. 107(14), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 109-97,
title VII, Sec. 798[(a)](2), Nov. 10, 2005, 119 Stat. 2166.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in pars.
(q) and (r), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
-MISC1-
AMENDMENTS
2005 - Par. (w). Pub. L. 109-97 added par. (w).
1992 - Par. (m)(2)(D). Pub. L. 102-571 substituted "379e" for
"376".
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (n)(10)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 2005 AMENDMENT
Pub. L. 109-97, title VII, Sec. 798(b), Nov. 10, 2005, 119 Stat.
2166, provided that: "The amendments made by subsection (a)
[amending this section and sections 603 to 605, 608, 609, 615, and
617 to 621 of this title] shall take effect on the day after the
effective date of section 794 of the Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies
Appropriations Act, 2006 [section 794 of Pub. L. 109-97, 119 Stat.
2164, effective 120 days after Nov. 10, 2005]."
EFFECTIVE DATE
Section 20 of Pub. L. 90-201 provided that: "This Act [see Short
Title note below] shall become effective upon enactment [Dec. 15,
1967] except as provided in paragraphs (a) through (d):
"(a) The provisions of paragraph (b)(1) and (c) of section 10 and
the provisions of section 20 of the Federal Meat Inspection Act, as
amended by sections 7 and 10 of this Act [sections 610 and 620 of
this title], and the provisions of section 18 of this Act repealing
paragraph (b) of section 306 of the Tariff Act of 1930 [section
1306(b) of Title 19, Customs Duties], shall become effective upon
the expiration of sixty days after enactment [Dec. 15, 1967],
hereof.
"(b) The provisions of title I of the Federal Meat Inspection
Act, as amended by this Act [this subchapter], shall become
effective with respect to equines (other than horses) and their
carcasses and parts thereof, meat, and meat food products thereof
upon the expiration of sixty days after enactment [Dec. 15, 1967]
hereof.
"(c) Section 11 of this Act, amending section 23, of the Federal
Meat Inspection Act [section 623 of this title], shall become
effective upon the expiration of sixty days after enactment hereof
[Dec. 15, 1967].
"(d) Section 204 of the Federal Meat Inspection Act, as added by
section 14 of this Act [section 644 of this title], shall become
effective upon the expiration of sixty days after enactment hereof
[Dec. 15, 1967]."
SHORT TITLE OF 1986 AMENDMENT
Pub. L. 99-641, title IV, Sec. 401, Nov. 10, 1986, 100 Stat.
3567, provided that: "This title [amending sections 606, 609, 621,
671, and 676 of this title and enacting provisions set out as notes
under sections 606, 609, 621, 671, and 676 of this title] may be
cited as the 'Processed Products Inspection Improvement Act of
1986'."
SHORT TITLE OF 1978 AMENDMENT
Pub. L. 95-445, Sec. 1, Oct. 10, 1978, 92 Stat. 1069, provided:
"That this Act [amending sections 603, 610, and 620 of this title
and sections 1902 and 1904 of Title 7, Agriculture, repealing
sections 1903 and 1905 of Title 7, and enacting provisions set out
as notes under this section and section 603 of this title] may be
cited as the 'Humane Methods of Slaughter Act of 1978'."
SHORT TITLE
Section 1 of Pub. L. 90-201 provided in part: "That this Act
[enacting this section and sections 602, 624, 641 to 645, 661, 671
to 680, and 691 of this title, amending sections 603 to 623 of this
title, repealing section 96 of this title and section 1306(b) of
Title 19, Customs Duties, and enacting provisions set out as notes
under this section] may be cited as the 'Wholesome Meat Act'."
Section 1 of Pub. L. 90-201 provided in part that the provisions
of act Mar. 4, 1907, as amended, classified to subchapters I to IV
of this chapter, are designated as the "Federal Meat Inspection
Act".
SEPARABILITY
Section 19 of Pub. L. 90-201 provided that: "If any provision of
this Act or of the amendments made hereby [see Short Title note
above] or the application thereof to any person or circumstances is
held invalid, the validity of the remainder of the Act and the
remaining amendments [see Short Title note above] and of the
application of such provision to other persons and circumstances
shall not be affected thereby."
-End-
-CITE-
21 USC Sec. 602 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 602. Congressional statement of findings
-STATUTE-
Meat and meat food products are an important source of the
Nation's total supply of food. They are consumed throughout the
Nation and the major portion thereof moves in interstate or foreign
commerce. It is essential in the public interest that the health
and welfare of consumers be protected by assuring that meat and
meat food products distributed to them are wholesome, not
adulterated, and properly marked, labeled, and packaged.
Unwholesome, adulterated, or misbranded meat or meat food products
impair the effective regulation of meat and meat food products in
interstate or foreign commerce, are injurious to the public
welfare, destroy markets for wholesome, not adulterated, and
properly labeled and packaged meat and meat food products, and
result in sundry losses to livestock producers and processors of
meat and meat food products, as well as injury to consumers. The
unwholesome, adulterated, mislabeled, or deceptively packaged
articles can be sold at lower prices and compete unfairly with the
wholesome, not adulterated, and properly labeled and packaged
articles, to the detriment of consumers and the public generally.
It is hereby found that all articles and animals which are
regulated under this chapter are either in interstate or foreign
commerce or substantially affect such commerce, and that regulation
by the Secretary and cooperation by the States and other
jurisdictions as contemplated by this chapter are appropriate to
prevent and eliminate burdens upon such commerce, to effectively
regulate such commerce, and to protect the health and welfare of
consumers.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 2, as added Pub. L. 90-201,
Sec. 2, Dec. 15, 1967, 81 Stat. 587.)
-End-
-CITE-
21 USC Sec. 603 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 603. Inspection of meat and meat food products
-STATUTE-
(a) Examination of animals before slaughtering; diseased animals
slaughtered separately and carcasses examined
For the purpose of preventing the use in commerce of meat and
meat food products which are adulterated, the Secretary shall cause
to be made, by inspectors appointed for that purpose, an
examination and inspection of all amenable species before they
shall be allowed to enter into any slaughtering, packing, meat-
canning, rendering, or similar establishment, in which they are to
be slaughtered and the meat and meat food products thereof are to
be used in commerce; and all amenable species found on such
inspection to show symptoms of disease shall be set apart and
slaughtered separately from all other cattle, sheep, swine, goats,
horses, mules, or other equines, and when so slaughtered the
carcasses of said cattle, sheep, swine, goats, horses, mules, or
other equines shall be subject to a careful examination and
inspection, all as provided by the rules and regulations to be
prescribed by the Secretary, as provided for in this subchapter.
(b) Humane methods of slaughter
For the purpose of preventing the inhumane slaughtering of
livestock, the Secretary shall cause to be made, by inspectors
appointed for that purpose, an examination and inspection of the
method by which amenable species are slaughtered and handled in
connection with slaughter in the slaughtering establishments
inspected under this chapter. The Secretary may refuse to provide
inspection to a new slaughtering establishment or may cause
inspection to be temporarily suspended at a slaughtering
establishment if the Secretary finds that any cattle, sheep, swine,
goats, horses, mules, or other equines have been slaughtered or
handled in connection with slaughter at such establishment by any
method not in accordance with the Act of August 27, 1958 (72 Stat.
862; 7 U.S.C. 1901-1906) until the establishment furnishes
assurances satisfactory to the Secretary that all slaughtering and
handling in connection with slaughter of livestock shall be in
accordance with such a method.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 3, formerly 1st par., 34
Stat. 1260; renumbered Sec. 3 and amended Pub. L. 90-201, Secs. 1,
3, 12(a), (b), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 95-
445, Sec. 2, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 109-97, title
VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-REFTEXT-
REFERENCES IN TEXT
Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85-
765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
Agriculture. For complete classification of this Act to the Code,
see Tables.
Sections 1903 and 1905 of Title 7, included within reference to
Act of August 27, 1958, were repealed by Pub. L. 95-445, Sec. 5(b),
Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7
of Pub. L. 95-445, set out as an Effective Date of 1978 Amendment
note below.
-COD-
CODIFICATION
Section was formerly classified to section 71 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines" wherever
appearing.
1978 - Pub. L. 95-445 designated existing provisions as subsec.
(a) and added subsec. (b).
1967 - Pub. L. 90-201, Secs. 3, 12(a), (b), struck out
"interstate or foreign" before "commerce" in two places,
substituted "Secretary shall" for "Secretary, at his discretion,
may", and struck out "of Agriculture" after "Secretary", included
horses, mules, and other equines, and horses, mules, or other
equines in the list of animals, and substituted "adulterated" for
"unsound, unhealthful, unwholesome, or otherwise unfit for human
food", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Section 7 of Pub. L. 95-445 provided that: "The provisions of
this Act [see Short Title of 1978 Amendment note set out under
section 601 of this title] shall become effective one year after
the date of enactment [Oct. 10, 1978]. However, such provisions
shall not apply to a person, firm, or corporation for such
additional period of time, not to exceed eighteen months, as may be
determined by the Secretary, if the Secretary, upon application,
finds that compliance with the provisions of this Act on its
effective date would cause undue hardship on such person, firm, or
corporation."
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
RELIGIOUS FREEDOM; RITUAL SLAUGHTER
Section 6 of Pub. L. 95-445 provided that: "Nothing in this Act
[see Short Title of 1978 Amendment note set out under section 601
of this title] shall be construed to prohibit, abridge, or in any
way hinder the religious freedom of any person or group.
Notwithstanding any other provision of this Act, in order to
protect freedom of religion, ritual slaughter and the handling or
other preparation of livestock for ritual slaughter are exempted
from the terms of this Act. For the purposes of this section the
term 'ritual slaughter' means slaughter in accordance with section
2(b) of the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C.
1902(b))."
-End-
-CITE-
21 USC Sec. 604 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 604. Post mortem examination of carcasses and marking or
labeling; destruction of carcasses condemned; reinspection
-STATUTE-
For the purposes hereinbefore set forth the Secretary shall cause
to be made by inspectors appointed for that purpose a post mortem
examination and inspection of the carcasses and parts thereof of
all amenable species to be prepared at any slaughtering, meat-
canning, salting, packing, rendering, or similar establishment in
any State, Territory, or the District of Columbia as articles of
commerce which are capable of use as human food; and the carcasses
and parts thereof of all such animals found to be not adulterated
shall be marked, stamped, tagged, or labeled as "Inspected and
passed"; and said inspectors shall label, mark, stamp, or tag as
"Inspected and condemned" all carcasses and parts thereof of
animals found to be adulterated; and all carcasses and parts
thereof thus inspected and condemned shall be destroyed for food
purposes by the said establishment in the presence of an inspector,
and the Secretary may remove inspectors from any such establishment
which fails to so destroy any such condemned carcass or part
thereof, and said inspectors, after said first inspection, shall,
when they deem it necessary, reinspect said carcasses or parts
thereof to determine whether since the first inspection the same
have become adulterated, and if any carcass or any part thereof
shall, upon examination and inspection subsequent to the first
examination and inspection, be found to be adulterated, it shall be
destroyed for food purposes by the said establishment in the
presence of an inspector, and the Secretary may remove inspectors
from any establishment which fails to so destroy any such condemned
carcass or part thereof.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 4, formerly 2nd par., 34
Stat. 1260; renumbered Sec. 4 and amended Pub. L. 90-201, Secs. 1,
3, 4, 12(a)-(d), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-
97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 72 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines".
1967 - Pub. L. 90-201, Secs. 3, 4, 12(a)-(d), struck out
"interstate or foreign" before "commerce" and "of Agriculture"
after "Secretary" in three places; struck out "for human
consumption" before "at any slaughtering" and "for transportation
or sale" after "District of Columbia" and inserted "which are
capable of use as human food" after "commerce"; included horses,
mules, and other equines in the list of animals; substituted
"adulterated" for "unsound, unhealthful, unwholesome, or otherwise
unfit for human food" after " 'Inspected and condemned,' all
carcasses and parts thereof of animals found to be" and before ",
it shall be destroyed"; substituted "not adulterated" for "sound,
healthful, wholesome, and fit for human food"; and substituted
"adulterated" for "unsound, unhealthful, unwholesome, or in any way
unfit for human food" before "and if any carcass", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 605 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 605. Examination of carcasses brought into slaughtering or
packing establishments, and of meat food products issued from and
returned thereto; conditions for entry
-STATUTE-
The foregoing provisions shall apply to all carcasses or parts of
carcasses of amenable species or the meat or meat products thereof
which may be brought into any slaughtering, meat-canning, salting,
packing, rendering, or similar establishment, and such examination
and inspection shall be had before the said carcasses or parts
thereof shall be allowed to enter into any department wherein the
same are to be treated and prepared for meat food products; and the
foregoing provisions shall also apply to all such products, which,
after having been issued from any slaughtering, meat-canning,
salting, packing, rendering, or similar establishment, shall be
returned to the same or to any similar establishment where such
inspection is maintained. The Secretary may limit the entry of
carcasses, parts of carcasses, meat and meat food products, and
other materials into any establishment at which inspection under
this subchapter is maintained, under such conditions as he may
prescribe to assure that allowing the entry of such articles into
such inspected establishments will be consistent with the purposes
of this chapter.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 5, formerly 3rd par., 34
Stat. 1261; renumbered Sec. 5 and amended Pub. L. 90-201, Secs. 1,
5, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-97,
title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 73 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines".
1967 - Pub. L. 90-201, Secs. 5, 12(a), limited entry of articles
into establishments under such prescribed conditions as would be
consistent with the purpose of this chapter and included horses,
mules, and other equines in the list of animals, respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 606 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 606. Inspectors of meat food products; marks of inspection;
destruction of condemned products; products for export
-STATUTE-
For the purposes hereinbefore set forth the Secretary shall cause
to be made, by inspectors appointed for that purpose, an
examination and inspection of all meat food products prepared for
commerce in any slaughtering, meat-canning, salting, packing,
rendering, or similar establishment, and for the purposes of any
examination and inspection and inspectors shall have access at all
times, by day or night, whether the establishment be operated or
not, to every part of said establishment; and said inspectors shall
mark, stamp, tag, or label as "Inspected and passed" all such
products found to be not adulterated; and said inspectors shall
label, mark, stamp, or tag as "Inspected and condemned" all such
products found adulterated, and all such condemned meat food
products shall be destroyed for food purposes, as hereinbefore
provided, and the Secretary may remove inspectors from any
establishment which fails to so destroy such condemned meat food
products: Provided, That subject to the rules and regulations of
the Secretary the provisions of this section in regard to
preservatives shall not apply to meat food products for export to
any foreign country and which are prepared or packed according to
the specifications or directions of the foreign purchaser, when no
substance is used in the preparation or packing thereof in conflict
with the laws of the foreign country to which said article is to be
exported; but if said article shall be in fact sold or offered for
sale for domestic use or consumption then this proviso shall not
exempt said article from the operation of all the other provisions
of this chapter.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 6, formerly 4th par., 34
Stat. 1261; renumbered Sec. 6 and amended Pub. L. 90-201, Secs. 1,
3, 12(e), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99-641,
title IV, Sec. 403(a), Nov. 10, 1986, 100 Stat. 3567.)
-COD-
CODIFICATION
Section was formerly classified to section 74 of this title.
-MISC1-
AMENDMENTS
1986 - Pub. L. 99-641 temporarily added subsecs. (a) to (c) and
struck out former undesignated provisions which read as follows:
"For the purposes hereinbefore set forth the Secretary shall cause
to be made, by inspectors appointed for that purpose, an
examination and inspection of all meat food products prepared for
commerce in any slaughtering, meat-canning, salting, packing,
rendering, or similar establishment, and for the purposes of any
examination and inspection and inspectors shall have access at all
times, by day or night, whether the establishment be operated or
not, to every part of said establishment; and said inspectors shall
mark, stamp, tag, or label as 'Inspected and passed' all such
products found to be not adulterated; and said inspectors shall
label, mark, stamp, or tag as 'Inspected and condemned' all such
products found adulterated, and all such condemned meat food
products shall be destroyed for food purposes, as hereinbefore
provided, and the Secretary may remove inspectors from any
establishment which fails to so destroy such condemned meat food
products: Provided, That", designated remaining provisions as
subsec. (d), and inserted "Notwithstanding the preceding provisions
of this section,". See Effective and Termination Dates of 1986
Amendment note below.
1967 - Pub. L. 90-201, Secs. 3, 12(e), struck out "interstate or
foreign" before "commerce" and "of Agriculture" after "Secretary"
in three places, and substituted "not adulterated" for "sound,
healthful, and wholesome, and which contains no dyes, chemicals,
preservatives, or ingredients which render such meat or meat food
products unsound, unhealthful, unwholesome, or unfit for human
food" and "adulterated" for "unsound, unhealthful, and unwholesome,
or which contain dyes, chemicals, preservatives, or ingredients
which render such meat or meat food products unsound, unhealthful,
unwholesome, or unfit for human food," respectively.
EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT
Section 403(a) of Pub. L. 99-641 provided in part that the
amendment of this section by Pub. L. 99-641 is effective only
during the 6-year period beginning Nov. 10, 1986.
Section 408 of title IV of Pub. L. 99-641 provided that:
"(a) General Effective Date. - Except as provided in subsection
(b) of this section, this title and the amendments made by this
title [amending sections 606, 609, 621, 671, and 676 of this title
and enacting provisions set out as notes under sections 606, 609,
621, 671, and 676 of this title] shall become effective on the date
of the enactment of this Act [Nov. 10, 1986].
"(b) Temporary Application of Existing Law. - Sections 6, 9, and
21 of the Federal Meat Inspection Act (21 U.S.C. 606, 609, and
621), as in effect immediately before the date of the enactment of
this Act [Nov. 10, 1986], shall apply with respect to
establishments until the Secretary of Agriculture first issues
rules and regulations to implement the amendments made by section
403(a) [amending this section]."
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
SAVINGS PROVISION
Section 404 of Pub. L. 99-641 provided that: "The expiration date
provisions of section 403 [enacting provisions set out as notes
under this section and sections 609, 621, 671, and 676 of this
title] shall not have the effect of releasing or extinguishing any
penalty, forfeiture, or liability incurred under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), as amended by section 403
[amending this section and sections 609, 621, 671, and 676 of this
title], or under the rules or regulations issued under such Act."
INSPECTION SERVICES FOR ESTABLISHMENTS NOT PARTICIPATING IN TOTAL
PLANT QUALITY-CONTROL PROGRAM
Section 403(e) of Pub. L. 99-641 provided that: "The amendments
made by this section [amending this section and sections 609, 621,
671, and 676 of this title] shall not be construed to authorize the
Secretary of Agriculture to refuse to provide inspection under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) at an
establishment solely because such establishment does not
participate in a total plant quality-control program."
DETECTION OF RESIDUE IN LIVESTOCK AND PROGRAM FOR TRACING OF
LIVESTOCK
Section 405 of Pub. L. 99-641 provided that: "It is the sense of
Congress that the Secretary of Agriculture should -
"(1) carry out a program to detect residues in livestock that
are subject to inspection under title I of the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.); and
"(2) evaluate the feasibility of, and develop, a program that
would enable the Secretary to trace any particular livestock that
are subject to inspection under title I of the Federal Meat
Inspection Act, in order to identify the producer of such
livestock."
REPORTS TO CONGRESS
Pub. L. 99-641, title IV, Sec. 406, Nov. 10, 1986, 100 Stat.
3571, which required the Secretary of Agriculture to submit an
annual report to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate describing any action proposed or taken by
the Secretary to implement amendments made by section 403 of Pub.
L. 99-641 (amending this section and sections 609, 621, 671, and
676 of this title), to carry out a program for detecting residues
in livestock, or to develop a program for tracing particular
livestock in order to identify the producer, and describing any
personnel action proposed or taken by the Secretary as a result of
amendments made by section 403 of Pub. L. 99-641 along with any
effort made by the Secretary to minimize any adverse economic
effect of the amendments on employees of the Department of
Agriculture, terminated, effective May 15, 2000, pursuant to
section 3003 of Pub. L. 104-66, as amended, set out as a note under
section 1113 of Title 31, Money and Finance. See, also, page 46 of
House Document No. 103-7.
CONGRESSIONAL REEVALUATION OF INSPECTION PROGRAM
Section 407 of Pub. L. 99-641 provided that: "It is the sense of
Congress that, not later than 6 years after the date of the
enactment of this Act [Nov. 10, 1986], Congress shall -
"(1) evaluate the operation and effects of the amendments made
by section 403 [amending this section and sections 609, 621, 671,
and 676 of this title], for the purpose of determining whether to
extend or modify the operation of such amendments; and
"(2) enact such legislation as may be necessary to efficiently
and effectively carry out the Federal Meat Inspection Act (21
U.S.C. 601 et seq.)."
-End-
-CITE-
21 USC Sec. 607 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 607. Labeling, marking, and container requirements
-STATUTE-
(a) Labeling receptacles or coverings of meat or meat food products
inspected and passed; supervision by inspectors
When any meat or meat food product prepared for commerce which
has been inspected as hereinbefore provided and marked "Inspected
and passed" shall be placed or packed in any can, pot, tin, canvas,
or other receptacle or covering in any establishment where
inspection under the provisions of this chapter is maintained, the
person, firm, or corporation preparing said product shall cause a
label to be attached to said can, pot, tin, canvas, or other
receptacle or covering, under the supervision of an inspector,
which label shall state that the contents thereof have been
"inspected and passed" under the provisions of this chapter; and no
inspection and examination of meat or meat food products deposited
or inclosed in cans, tins, pots, canvas, or other receptacle or
covering in any establishment where inspection under the provisions
of this chapter is maintained shall be deemed to be complete until
such meat or meat food products have been sealed or inclosed in
said can, tin, pot, canvas, or other receptacle or covering under
the supervision of an inspector.
(b) Information on articles or containers; legible form
All carcasses, parts of carcasses, meat and meat food products
inspected at any establishment under the authority of this
subchapter and found to be not adulterated, shall at the time they
leave the establishment bear, in distinctly legible form, directly
thereon or on their containers, as the Secretary may require, the
information required under paragraph (n) of section 601 of this
title.
(c) Labeling: type styles and sizes; definitions and standards of
identity or composition; standards of fill of container;
consistency of Federal and Federal-State standards
The Secretary, whenever he determines such action is necessary
for the protection of the public, may prescribe: (1) the styles and
sizes of type to be used with respect to material required to be
incorporated in labeling to avoid false or misleading labeling in
marketing and labeling any articles or animals subject to this
subchapter or subchapter II of this chapter; (2) definitions and
standards of identity or composition for articles subject to this
subchapter and standards of fill of container for such articles not
inconsistent with any such standards established under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there
shall be consultation between the Secretary and the Secretary of
Health and Human Services prior to the issuance of such standards
under either Act relating to articles subject to this chapter to
avoid inconsistency in such standards and possible impairment of
the coordinated effective administration of these Acts. There shall
also be consultation between the Secretary and an appropriate
advisory committee provided for in section 661 of this title, prior
to the issuance of such standards under this chapter, to avoid,
insofar as feasible, inconsistency between Federal and State
standards.
(d) Sales under false or misleading name, other marking or labeling
or in containers of misleading form or size; trade names, and
other marking, labeling, and containers approved by Secretary
No article subject to this subchapter shall be sold or offered
for sale by any person, firm, or corporation, in commerce, under
any name or other marking or labeling which is false or misleading,
or in any container of a misleading form or size, but established
trade names and other marking and labeling and containers which are
not false or misleading and which are approved by the Secretary are
permitted.
(e) Use withholding directive respecting false or misleading
marking, labeling, or container; modification of false or
misleading matter; hearing; withholding use pending proceedings;
finality of Secretary's action; judicial review; application of
section 194 of title 7
If the Secretary has reason to believe that any marking or
labeling or the size or form of any container in use or proposed
for use with respect to any article subject to this subchapter is
false or misleading in any particular, he may direct that such use
be withheld unless the marking, labeling, or container is modified
in such manner as he may prescribe so that it will not be false or
misleading. If the person, firm, or corporation using or proposing
to use the marking, labeling or container does not accept the
determination of the Secretary, such person, firm, or corporation
may request a hearing, but the use of the marking, labeling, or
container shall, if the Secretary so directs, be withheld pending
hearing and final determination by the Secretary. Any such
determination by the Secretary shall be conclusive unless, within
thirty days after receipt of notice of such final determination,
the person, firm, or corporation adversely affected thereby appeals
to the United States court of appeals for the circuit in which such
person, firm, or corporation has its principal place of business or
to the United States Court of Appeals for the District of Columbia
Circuit. The provisions of section 194 of title 7 shall be
applicable to appeals taken under this section.
(f) Lamb and mutton
The Secretary, consistent with United States international
obligations, shall establish standards for the labeling of sheep
carcasses, parts of sheep carcasses, sheepmeat, and sheepmeat food
products.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 7, formerly 5th par., 34
Stat. 1262; renumbered Sec. 7 and amended Pub. L. 90-201, Secs. 1,
3(a), 6, Dec. 15, 1967, 81 Stat. 584, 588; Pub. L. 96-88, title V,
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 104-127, title
II, Sec. 279, Apr. 4, 1996, 110 Stat. 979.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(c)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
Either Act and these Acts, referred to in subsec. (c)(2), mean
the Federal Meat Inspection Act and the Federal Food, Drug, and
Cosmetic Act. The Federal Meat Inspection Act is act Mar. 4, 1907,
ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201,
81 Stat. 584, and amended, which are classified generally to
subchapters I to IV (Sec. 601 et seq.), respectively, of this
chapter. For complete classification of this Act to the Code, see
Short Title note under section 601 of this title and Tables.
-COD-
CODIFICATION
Section was formerly classified to section 75 of this title.
-MISC1-
AMENDMENTS
1996 - Subsec. (f). Pub. L. 104-127 added subsec. (f).
1967 - Subsec. (a). Pub. L. 90-201, Secs. 3(a), 6(a), (b), struck
out "interstate or foreign" before "commerce" and provisions
prohibiting sales of meat or meat food products in interstate or
foreign commerce under any false or deceptive names and permitting
trade names or names which are usual to such products and are not
false and deceptive and are approved by the Secretary of
Agriculture, now incorporated in subsec. (d), and designated
remaining provisions as subsecs. (a), respectively.
Subsecs. (b) to (e). Pub. L. 90-201, Sec. 6(c), added subsecs.
(b) to (e).
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsec. (c)(2)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 608 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 608. Sanitary inspection and regulation of slaughtering and
packing establishments; rejection of adulterated meat or meat
food products
-STATUTE-
The Secretary shall cause to be made, by experts in sanitation or
by other competent inspectors, such inspection of all slaughtering,
meat canning, salting, packing, rendering, or similar
establishments in which amenable species are slaughtered and the
meat and meat food products thereof are prepared for commerce as
may be necessary to inform himself concerning the sanitary
conditions of the same, and to prescribe the rules and regulations
of sanitation under which such establishments shall be maintained;
and where the sanitary conditions of any such establishment are
such that the meat or meat food products are rendered adulterated,
he shall refuse to allow said meat or meat food products to be
labeled, marked, stamped or tagged as "inspected and passed."
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 8, formerly 6th par., 34
Stat. 1262; renumbered Sec. 8 and amended Pub. L. 90-201, Secs. 1,
3, 12(a), (f), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-
97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 76 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines".
1967 - Pub. L. 90-201, Secs. 3, 12(a), (f), struck out
"interstate or foreign" before "commerce" and "of Agriculture"
after "Secretary", included horses, mules, and other equines in the
list of animals, and substituted "adulterated" for "unclean,
unsound, unhealthful, unwholesome, or otherwise unfit for human
food", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 609 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 609. Examination of animals and food products thereof,
slaughtered and prepared during nighttime
-STATUTE-
The Secretary shall cause an examination and inspection of all
amenable species, and the food products thereof, slaughtered and
prepared in the establishments hereinbefore described for the
purposes of commerce to be made during the nighttime as well as
during the daytime when the slaughtering of said amenable species,
or the preparation of said food products is conducted during the
nighttime.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 9, formerly 7th par., 34
Stat. 1262; renumbered Sec. 9 and amended Pub. L. 90-201, Secs. 1,
3, 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 99-641,
title IV, Sec. 403(d)(1), Nov. 10, 1986, 100 Stat. 3570; Pub. L.
109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat.
2166.)
-COD-
CODIFICATION
Section was formerly classified to section 77 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines" in two
places.
1986 - Pub. L. 99-641 temporarily inserted ", except as provided
in section 606 of this title," after first reference to "other
equines, and". See Effective and Termination Dates of 1986
Amendment note below.
1967 - Pub. L. 90-201, Secs. 3, 12(a), struck out "interstate or
foreign" before "commerce" and "of Agriculture" after "Secretary"
and included horses, mules, and other equines in the list of
animals, respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT
Section 403(d)(1) of Pub. L. 99-641 provided that the amendment
made by that section is effective only during the 6-year period
beginning Nov. 10, 1986.
Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
this section as in effect immediately before Nov. 10, 1986, applies
with respect to establishments until the Secretary of Agriculture
first issues rules and regulations to implement the amendments made
by section 403(a) of Pub. L. 99-641 to section 606 of this title,
see section 408 of Pub. L. 99-641, set out as a note under section
606 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e)
and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
Services for Establishments Not Participating in Total Plant
Quality-Control Program" and "Savings Provision", respectively,
under section 606 of this title.
-End-
-CITE-
21 USC Sec. 610 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 610. Prohibited acts
-STATUTE-
No person, firm, or corporation shall, with respect to any
cattle, sheep, swine, goats, horses, mules, or other equines, or
any carcasses, parts of carcasses, meat or meat food products of
any such animals -
(a) Slaughtering animals or preparation of articles capable of
use as human food
slaughter any such animals or prepare any such articles which
are capable of use as human food at any establishment preparing
any such articles for commerce, except in compliance with the
requirements of this chapter;
(b) Humane methods of slaughter
slaughter or handle in connection with slaughter any such
animals in any manner not in accordance with the Act of August
27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906);
(c) Sales, transportation, and other transactions
sell, transport, offer for sale or transportation, or receive
for transportation, in commerce, (1) any such articles which (A)
are capable of use as human food and (B) are adulterated or
misbranded at the time of such sale, transportation, offer for
sale or transportation, or receipt for transportation; or (2) any
articles required to be inspected under this subchapter unless
they have been so inspected and passed;
(d) Adulteration or misbranding
do, with respect to any such articles which are capable of use
as human food, any act while they are being transported in
commerce or held for sale after such transportation, which is
intended to cause or has the effect of causing such articles to
be adulterated or misbranded.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 10, formerly 8th par., 34
Stat. 1262; renumbered Sec. 10 and amended Pub. L. 90-201, Secs. 1,
7, Dec. 15, 1967, 81 Stat. 584, 589; Pub. L. 95-445, Sec. 3, Oct.
10, 1978, 92 Stat. 1069.)
-REFTEXT-
REFERENCES IN TEXT
Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85-
765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
Agriculture. For complete classification of this Act to the Code,
see Tables.
Sections 1903 and 1905 of Title 7, included within reference to
Act of August 27, 1958, were repealed by Pub. L. 95-445, Sec. 5(b),
Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7
of Pub. L. 95-445, set out as an Effective Date of 1978 Amendment
note under section 603 of this title.
-COD-
CODIFICATION
Section was formerly classified to section 78 of this title.
-MISC1-
AMENDMENTS
1978 - Subsecs. (b) to (d). Pub. L. 95-445 added subsec. (b) and
redesignated former subsecs. (b) and (c) as (c) and (d),
respectively.
1967 - Pub. L. 90-201, Sec. 7, included the list of animals and
prohibited, except in compliance with requirements of this chapter,
slaughtering animals or preparation of articles capable of use as
human food, sales, transportation, and other transactions, and acts
of adulteration or misbranding, incorporating in subsec. (b)(2)
existing prohibition on distributions in interstate or foreign
commerce of noninspected articles.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-445 effective one year after Oct. 10,
1978, and an additional eighteen month period thereafter in
hardship cases, see section 7 of Pub. L. 95-445, set out as an
Effective Date of 1978 Amendment note under section 603 of this
title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
subsecs. (b)(1) and (c) of this section effective upon expiration
of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90-
201, set out as an Effective Date note under section 601 of this
title.
-End-
-CITE-
21 USC Sec. 611 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 611. Devices, marks, labels, and certificates; simulations
-STATUTE-
(a) Devices to be made under authorization of Secretary
No brand manufacturer, printer, or other person, firm, or
corporation shall cast, print, lithograph, or otherwise make any
device containing any official mark or simulation thereof, or any
label bearing any such mark or simulation, or any form of official
certificate or simulation thereof, except as authorized by the
Secretary.
(b) Other misconduct
No person, firm, or corporation shall -
(1) forge any official device, mark, or certificate;
(2) without authorization from the Secretary use any official
device, mark, or certificate, or simulation thereof, or alter,
detach, deface, or destroy any official device, mark, or
certificate;
(3) contrary to the regulations prescribed by the Secretary,
fail to use, or to detach, deface, or destroy any official
device, mark, or certificate;
(4) knowingly possess, without promptly notifying the Secretary
or his representative, any official device or any counterfeit,
simulated, forged, or improperly altered official certificate or
any device or label or any carcass of any animal, or part or
product thereof, bearing any counterfeit, simulated, forged, or
improperly altered official mark;
(5) knowingly make any false statement in any shipper's
certificate or other nonofficial or official certificate provided
for in the regulations prescribed by the Secretary; or
(6) knowingly represent that any article has been inspected and
passed, or exempted, under this chapter when, in fact, it has,
respectively, not been so inspected and passed, or exempted.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 11, formerly 9th par., 34
Stat. 1263; renumbered Sec. 11 and amended Pub. L. 90-201, Secs. 1,
8, Dec. 15, 1967, 81 Stat. 584, 589.)
-COD-
CODIFICATION
Section was formerly classified to section 79 of this title.
-MISC1-
AMENDMENTS
1967 - Pub. L. 90-201, Sec. 8, clarified application to brand
manufacturers and printers of existing prohibition against
counterfeiting official marks, labels or certificates, the
provisions with respect to forgery, unauthorized use or failure to
use official marks, or similar items, and similar offenses, and
existing prohibitions with respect to false statements in official
or nonofficial certificates, and added restriction upon possession
of official devices, or devices, labels, meat, or other articles
bearing counterfeit official marks, counterfeit official
certificates, or similar items, and prohibition against false
representations.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Secs. 612 to 614 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Secs. 612 to 614. Repealed.
-MISC1-
Secs. 612 to 614. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(19), May 13, 2002, 116 Stat. 508.
Section 612, act Mar. 4, 1907, ch. 2907, title I, Sec. 12,
formerly 10th par., 34 Stat. 1263; renumbered Sec. 12 and amended
Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
588, 592, related to inspection of animals for export. Section was
formerly classified to section 80 of this title.
Section 613, act Mar. 4, 1907, ch. 2907, title I, Sec. 13,
formerly 11th par., 34 Stat. 1263; renumbered Sec. 13 and amended
Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
588, 592, related to inspectors of animals for export and
certificates of condition. Section was formerly classified to
section 81 of this title.
Section 614, act Mar. 4, 1907, ch. 2907, title I, Sec. 14,
formerly 12th par., 34 Stat. 1263; renumbered Sec. 14 and amended
Pub. L. 90-201, Secs. 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584,
588, 592, prohibited clearance to vessel carrying animals for
export without inspector's certificate. Section was formerly
classified to section 82 of this title.
-End-
-CITE-
21 USC Sec. 615 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 615. Inspection of carcasses, meat of which is intended for
export
-STATUTE-
The Secretary shall also cause to be made a careful inspection of
the carcasses and parts thereof of all amenable species, the meat
of which, fresh, salted, canned, corned, packed, cured, or
otherwise prepared, is intended and offered for export to any
foreign country, at such times and places and in such manner as he
may deem proper.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 15, formerly 13th par., 34
Stat. 1263; renumbered Sec. 15 and amended Pub. L. 90-201, Secs. 1,
3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109-97,
title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 83 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines".
1967 - Pub. L. 90-201, Secs. 3(b), 12(a), struck out "of
Agriculture" after "Secretary" and included horses, mules, and
other equines in the list of animals, respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 616 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 616. Inspectors of carcasses, etc., meat of which is intended
for export; certificates of condition
-STATUTE-
For the purpose of section 615 of this title the Secretary may
appoint inspectors who shall be authorized to give an official
certificate stating the condition in which said cattle, sheep,
swine, goats, horses, mules, or other equines, and the meat
thereof, are found.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 16, formerly 14th par., 34
Stat. 1263; renumbered Sec. 16 and amended Pub. L. 90-201, Secs. 1,
3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592.)
-COD-
CODIFICATION
Section was formerly classified to section 84 of this title.
-MISC1-
AMENDMENTS
1967 - Pub. L. 90-201, Secs. 3(b), 12(a), struck out "of
Agriculture" after "Secretary", and included horses, mules, or
other equines in the list of animals.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 617 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 617. Clearance prohibited to vessel carrying meat for export
without inspector's certificate
-STATUTE-
No clearance shall be given to any vessel having on board any
fresh, salted, canned, corned, or packed beef, mutton, pork, goat
or equine meat for export to and sale in a foreign country from any
port in the United States, until the owner or shipper thereof shall
obtain from an inspector appointed under the provisions of this
chapter a certificate that the said amenable species were sound and
healthy at the time of inspection, and that their meat is sound and
wholesome, unless the Secretary shall have waived the requirements
of such certificate for the country to which said amenable species
or meats are to be exported.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 17, formerly 15th par., 34
Stat. 1263; renumbered Sec. 17 and amended Pub. L. 90-201, Secs. 1,
3(b), 12(a), (g), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L.
109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat.
2166.)
-COD-
CODIFICATION
Section was formerly classified to section 85 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines" in two
places.
1967 - Pub. L. 90-201, Secs. 3(b), 12(a), (g), struck out "of
Agriculture" after "Secretary", included horses, mules, and other
equines in the list of animals, and substituted "goat or equine
meat" for "or goat meat, being the meat of animals killed after
March 4, 1907, or except as hereinbefore provided", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 618 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 618. Delivery of inspectors' certificates, and of copies
-STATUTE-
The inspectors provided for under this subchapter shall be
authorized to give official certificates of the condition of the
carcasses and products of amenable species; and one copy of every
certificate granted under the provisions of this chapter shall be
filed in the Department of Agriculture, another copy shall be
delivered to the owner or shipper, and when the amenable species,
or their carcasses and products are sent abroad, a third copy shall
be delivered to the chief officer of the vessel on which the
shipment shall be made.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 18, formerly 16th par., 34
Stat. 1263; renumbered Sec. 18 and amended Pub. L. 90-201, Secs. 1,
12(a), (h), Dec. 15, 1967, 81 Stat. 584, 592; Pub. L. 107-171,
title X, Sec. 10418(b)(4), May 13, 2002, 116 Stat. 508; Pub. L. 109-
97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
"Provided for under this subchapter" was in the original
"provided for herein".
Section was formerly classified to section 86 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines" in two
places.
2002 - Pub. L. 107-171 substituted "of the carcasses and products
of cattle, sheep, swine, goats, horses, mules, and other equines"
for "of the cattle, sheep, swine, goats, horses, mules, and other
equines, their carcasses and products as described in this
subchapter".
1967 - Pub. L. 90-201, Sec. 12(a), (h), included horses, mules,
and other equines in the list of animals and struck out "sound and
wholesome" before "conditions", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 619 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 619. Marking, labeling, or other identification to show kinds
of animals from which derived; separate establishments for
preparation and slaughtering activities
-STATUTE-
No person, firm, or corporation shall sell, transport, offer for
sale or transportation, or receive for transportation, in commerce,
any carcasses of species designated by regulations in effect on the
day before November 10, 2005, or parts of such carcasses, or the
meat or meat food products thereof, unless they are plainly and
conspicuously marked or labeled or otherwise identified as required
by regulations prescribed by the Secretary to show the kinds of
animals from which they were derived. When required by the
Secretary, with respect to establishments at which inspection is
maintained under this subchapter, such animals and their carcasses,
parts thereof, meat and meat food products shall be prepared in
establishments separate from those in which other amenable species
are slaughtered or their carcasses, parts thereof, meat or meat
food products are prepared.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 19, formerly 17th par., 34
Stat. 1264; renumbered Sec. 19 and amended Pub. L. 90-201, Secs. 1,
9, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 109-97, title VII,
Sec. 798[(a)](3), Nov. 10, 2005, 119 Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 87 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "species designated by
regulations in effect on the day before November 10, 2005," for
"horses, mules, or other equines" and "other amenable species" for
"cattle, sheep, swine, or goats".
1967 - Pub. L. 90-201, Sec. 9, substituted provisions for
marking, labeling, or other identification of kinds of animals
whence the articles are derived and for separate establishments for
preparation and slaughtering activities for prohibition against
transportation or sale of meat or meat food products without
complying with inspection provisions. See section 610(b) of this
title.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L, 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration, of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 620 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 620. Imports
-STATUTE-
(a) Adulteration or misbranding prohibition; compliance with
inspection, building construction standards, and other
provisions; humane methods of slaughter; treatment as domestic
articles subject to this chapter and food, drug, and cosmetic
provisions; marking and labeling; personal consumption exemption
No carcasses, parts of carcasses, meat or meat food products of
cattle, sheep, swine, goats, horses, mules, or other equines which
are capable of use as human food, shall be imported into the United
States if such articles are adulterated or misbranded and unless
they comply with all the inspection, building, construction
standards, and all other provisions of this chapter and regulations
issued thereunder applicable to such articles in commerce within
the United States. No such carcasses, parts of carcasses, meat or
meat food products shall be imported into the United States unless
the livestock from which they were produced was slaughtered and
handled in connection with slaughter in accordance with the Act of
August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906). All such
imported articles shall, upon entry into the United States, be
deemed and treated as domestic articles subject to the other
provisions of this chapter and the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.]: Provided, That they shall be marked
and labeled as required by such regulations for imported articles:
Provided further, That nothing in this section shall apply to any
individual who purchases meat or meat products outside the United
States for his own consumption except that the total amount of such
meat or meat products shall not exceed fifty pounds.
(b) Terms and conditions for destruction
The Secretary may prescribe the terms and conditions for the
destruction of all such articles which are imported contrary to
this section, unless (1) they are exported by the consignee within
the time fixed therefor by the Secretary, or (2) in the case of
articles which are not in compliance with the chapter solely
because of misbranding, such articles are brought into compliance
with the chapter under supervision of authorized representatives of
the Secretary.
(c) Payment of storage, cartage, and labor charges by owner or
consignee; liens
All charges for storage, cartage, and labor with respect to any
article which is imported contrary to this section shall be paid by
the owner or consignee, and in default of such payment shall
constitute a lien against such article and any other article
thereafter imported under this chapter by or for such owner or
consignee.
(d) Prohibition
The knowing importation of any article contrary to this section
is prohibited.
(e) Omitted
(f) Inspection and other standards; applicability, enforcement,
etc.; certifications
Notwithstanding any other provision of law, all carcasses, parts
of carcasses, meat, and meat food products of cattle, sheep, swine,
goats, horses, mules, or other equines, capable of use as human
food, offered for importation into the United States shall be
subject to the inspection, sanitary, quality, species verification,
and residue standards applied to products produced in the United
States. Any such imported meat articles that do not meet such
standards shall not be permitted entry in to the United States. The
Secretary shall enforce this provision through (1) the imposition
of random inspections for such species verification and for
residues, and (2) random sampling and testing of internal organs
and fat of the carcasses for residues at the point of slaughter by
the exporting country in accordance with methods approved by the
Secretary. Each foreign country from which such meat articles are
offered for importation into the United States shall obtain a
certification issued by the Secretary stating that the country
maintains a program using reliable analytical methods to ensure
compliance with the United States standards for residues in such
meat articles. No such meat article shall be permitted entry into
the United States from a country for which the Secretary has not
issued such certification. The Secretary shall periodically review
such certifications and shall revoke any certification if the
Secretary determines that the country involved is not maintaining a
program that uses reliable analytical methods to ensure compliance
with United States standards for residues in such meat articles.
The consideration of any application for a certification under this
subsection and the review of any such certification, by the
Secretary, shall include the inspection of individual
establishments to ensure that the inspection program of the foreign
country involved is meeting such United States standards.
(g) Administration of animal drugs or antibiotics; terms and
conditions; entry order violations
The Secretary may prescribe terms and conditions under which
amenable species that have been administered an animal drug or
antibiotic banned for use in the United States may be imported for
slaughter and human consumption. No person shall enter amenable
species into the United States in violation of any order issued
under this subsection by the Secretary.
(h) Reciprocal meat inspection requirement
(1) As used in this subsection:
(A) The term "meat articles" means carcasses, meat and meat
food products of cattle, sheep, swine, goats, horses, mules, or
other equines, that are capable of use as human food.
(B) The term "standards" means inspection, building
construction, sanitary, quality, species verification, residue,
and other standards that are applicable to meat articles.
(2) On request of the Committee on Agriculture or the Committee
on Ways and Means of the House of Representatives or the Committee
on Agriculture, Nutrition, and Forestry or the Committee on Finance
of the Senate, or at the initiative of the Secretary, the Secretary
shall, as soon as practicable, determine whether a particular
foreign country applies standards for the importation of meat
articles from the United States that are not related to public
health concerns about end-product quality that can be substantiated
by reliable analytical methods.
(3) If the Secretary determines that a foreign country applies
standards described in paragraph (2) -
(A) the Secretary shall consult with the United States Trade
Representative; and
(B) within 30 days after the determination of the Secretary
under paragraph (2), the Secretary and the United States Trade
Representative shall recommend to the President whether action
should be taken under paragraph (4).
(4) Within 30 days after receiving a recommendation for action
under paragraph (3), the President shall, if and for such time as
the President considers appropriate, prohibit imports into the
United States of any meat articles produced in such foreign country
unless it is determined that the meat articles produced in that
country meet the standards applicable to meat articles in commerce
within the United States.
(5) The action authorized under paragraph (4) may be used instead
of, or in addition to, any other action taken under any other law.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 20, formerly 18th par., 34
Stat. 1264; renumbered Sec. 20 and amended Pub. L. 90-201, Secs. 1,
10, Dec. 15, 1967, 81 Stat. 584, 590; Pub. L. 95-445, Sec. 4, Oct.
10, 1978, 92 Stat. 1069; Pub. L. 97-98, title XI, Sec. 1122, Dec.
22, 1981, 95 Stat. 1273; Pub. L. 99-198, title XVII, Sec. 1702,
Dec. 23, 1985, 99 Stat. 1634; Pub. L. 100-418, title IV, Sec. 4604,
Aug. 23, 1988, 102 Stat. 1408; Pub. L. 103-182, title III, Sec.
361(f), Dec. 8, 1993, 107 Stat. 2124; Pub. L. 103-437, Sec. 8(2),
Nov. 2, 1994, 108 Stat. 4588; Pub. L. 103-465, title IV, Sec.
431(l), Dec. 8, 1994, 108 Stat. 4970; Pub. L. 109-97, title VII,
Sec. 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
-REFTEXT-
REFERENCES IN TEXT
Act of August 27, 1958, referred to in subsec. (a), is Pub. L. 85-
765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 (Sec. 1901 et seq.) of Title 7,
Agriculture. Sections 1903 and 1905 of Title 7, included within
reference to Act of August 27, 1958, were repealed by Pub. L. 95-
445, Sec. 5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set
forth in section 7 of Pub. L. 95-445, set out as an Effective Date
of 1978 Amendment note under section 603 of this title. For
complete classification of this Act to the Code, see Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this act to the Code,
see section 301 of this title and Tables.
-COD-
CODIFICATION
Subsec. (e) of this section, which required the Secretary to
submit to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate a comprehensive and detailed written annual
report on the administration of this section, terminated, effective
May 15, 2000, pursuant to section 3003 of Pub. L. 104-66, as
amended, set out as a note under section 1113 of Title 31, Money
and Finance. See, also, page 46 of House Document No. 103-7.
Section was formerly classified to section 88 of this title.
-MISC1-
AMENDMENTS
2005 - Subsec. (g). Pub. L. 109-97 substituted "amenable species"
for "cattle, sheep, swine, goats, horses, mules, and other equines"
in two places.
1994 - Subsec. (e). Pub. L. 103-437 substituted "Agriculture,
Nutrition, and Forestry" for "Agriculture and Forestry" in
introductory provisions.
Subsec. (e)(1)(A), (B). Pub. L. 103-465, Sec. 431(l)(1), amended
subpars. (A) and (B) generally. Prior to amendment, subpars. (A)
and (B) read as follows:
"(A) Subject to subparagraphs (B) and (C), a certification by the
Secretary that foreign plants in Canada and Mexico that export
carcasses or meat or meat products referred to in subsection (a) of
this section have complied with paragraph (2) or with requirements
that are equivalent to United States requirements with regard to
all inspection and building construction standards, and all other
provisions of this chapter and regulations issued under this
chapter.
"(B) Subject to subparagraph (C), the Secretary may treat as
equivalent to a United States requirement a requirement described
in subparagraph (A) if the exporting country provides the Secretary
with scientific evidence or other information, in accordance with
risk assessment methodologies agreed to by the Secretary and the
exporting country, to demonstrate that the requirement or standard
of the exporting country achieves the level of protection that the
Secretary considers appropriate."
Subsec. (e)(2) to (7). Pub. L. 103-465, Sec. 431(l)(2), (3),
redesignated pars. (3) to (7) as (2) to (6), respectively, and
struck out former par. (2) which read as follows: "A certification
by the Secretary that, except as provided in paragraph (1), foreign
plants that export carcasses or meat or meat products referred to
in subsection (a) of this section have complied with requirements
that are at least equal to all inspection and building construction
standards and all other provisions of this chapter and regulations
issued under this chapter."
1993 - Subsec. (e). Pub. L. 103-182, Sec. 361(f)(1), substituted
"not be limited to the following:" for "not be limited to - " in
introductory provisions.
Subsec. (e)(1) to (7). Pub. L. 103-182, Sec. 361(f)(2)-(7), added
pars. (1) and (2), struck out former par. (1), redesignated pars.
(2) to (6) as (3) to (7), respectively, substituted "The" for "the"
at beginning of each par., substituted period for semicolon at end
of pars. (3) to (5), and substituted period for "; and" at end of
par. (6). Prior to amendment, former par. (1) read as follows: "a
certification by the Secretary that foreign plants exporting
carcasses or meat or meat products referred to in subsection (a) of
this section have complied with requirements at least equal to all
the inspection, building construction standards, and all other
provisions of this chapter and regulations issued thereunder;".
1988 - Subsec. (e)(6). Pub. L. 100-418, Sec. 4604(b), added par.
(6).
Subsec. (h). Pub. L. 100-418, Sec. 4604(a), added subsec. (h).
1985 - Subsec. (f). Pub. L. 99-198, Sec. 1702(a), struck out
provision which had made this subsection effective six months after
Dec. 22, 1981, and inserted provisions requiring that each foreign
country from which meat articles are offered for importation into
the United States obtain a certification issued by the Secretary
stating that the country maintains a program using reliable
analytical methods to ensure compliance with the United States
standards for residues in such meat articles, that no meat article
be permitted entry into the United States from a country for which
the Secretary has not issued such certification, that the Secretary
periodically review such certifications and revoke any
certification if the Secretary determines that the country involved
is not maintaining a program that uses reliable analytical methods
to ensure compliance with United States standards for residues in
such meat articles, and that the consideration of any application
for a certification under this subsection and the review of any
such certification, by the Secretary, include the inspection of
individual establishments to ensure that the inspection program of
the foreign country involved is meeting such United States
standards.
Subsec. (g). Pub. L. 99-198, Sec. 1702(b), added subsec. (g).
1981 - Subsec. (f). Pub. L. 97-98 added subsec. (f).
1978 - Subsec. (a). Pub. L. 95-445 prohibited imports which do
not comply with humane methods of slaughter.
1967 - Pub. L. 90-201, Sec. 10, substituted imported articles
provisions for penalty provisions deeming offenses as misdemeanors
and punishable by fine of $10,000 or imprisonment for two years or
both. See section 676(a) of this title.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-465 effective, except as otherwise
provided, on the date of entry into force of the World Trade
Organization Agreement with respect to the United States [Jan. 1,
1995], see section 451 of Pub. L. 103-465, set out as an Effective
Date note under section 3601 of Title 19, Customs Duties.
EFFECTIVE DATE OF 1981 AMENDMENT
Amendment by Pub. L. 97-98 effective Dec. 22, 1981, see section
1801 of Pub. L. 97-98, set out as an Effective Date note under
section 4301 of Title 7, Agriculture.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-445 effective one year after Oct. 10,
1978, and an additional eighteen-month period thereafter in
hardship cases, see section 7 of Pub. L. 95-445, set out as a note
under section 603 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective upon expiration of sixty
days after Dec. 15, 1967, see section 20(a) of Pub. L. 90-201, set
out as an Effective Date note under section 601 of this title.
-End-
-CITE-
21 USC Sec. 621 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 621. Inspectors to make examinations provided for;
appointment; duties; regulations
-STATUTE-
The Secretary shall appoint from time to time inspectors to make
examination and inspection of all amenable species, inspection of
which is hereby provided for and of all carcasses and parts
thereof, and of all meats and meat food products thereof, and of
the sanitary conditions of all establishments in which such meat
and meat food products hereinbefore described are prepared; and
said inspectors shall refuse to stamp, mark, tag, or label any
carcass or any part thereof, or meat food product therefrom,
prepared in any establishment hereinbefore mentioned, until the
same shall have actually been inspected and found to be not
adulterated; and shall perform such other duties as are provided by
this chapter and by the rules and regulations to be prescribed by
said Secretary; and said Secretary shall, from time to time, make
such rules and regulations as are necessary for the efficient
execution of the provisions of this chapter, and all inspections
and examinations made under this chapter, shall be such and made in
such manner as described in the rules and regulations prescribed by
said Secretary not inconsistent with provisions of this chapter.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 21, formerly 19th par., 34
Stat. 1264; renumbered Sec. 21 and amended Pub. L. 90-201, Secs. 1,
3(b), 12(a), (i), Dec. 15, 1967, 81 Stat. 584, 588, 592, 593; Pub.
L. 99-641, title IV, Sec. 403(d)(2), Nov. 10, 1986, 100 Stat. 3570;
Pub. L. 109-97, title VII, Sec. 798[(a)](1), Nov. 10, 2005, 119
Stat. 2166.)
-COD-
CODIFICATION
Section was formerly classified to section 89 of this title.
-MISC1-
AMENDMENTS
2005 - Pub. L. 109-97 substituted "amenable species" for "cattle,
sheep, swine, goats, horses, mules, and other equines".
1986 - Pub. L. 99-641 temporarily substituted "thereof, and of
meat food products" for "and meat food products", which
substitution was made for the first such reference as the probable
intent of Congress. See Effective and Termination Dates of 1986
Amendment note below.
1967 - Pub. L. 90-201, Secs. 3(b), 12(a), (i), struck out "of
Agriculture" after "Secretary" in four places, included horses,
mules, and other equines in the list of animals, and substituted
"not adulterated" for "sound, healthful, wholesome, and fit for
human food, and to contain no dyes, chemicals, preservatives, or
ingredients which render such meat food product unsound,
unhealthful, unwholesome, or unfit for human food; and to have been
prepared under proper sanitary conditions, hereinbefore provided
for", respectively.
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-97 effective the day after 120 days
after Nov. 10, 2005, see section 798(b) of Pub. L. 109-97, set out
as a note under section 601 of this title.
EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT
Section 403(d)(2) of Pub. L. 99-641 provided that the amendment
made by that section is effective only during the 6-year period
beginning on Nov. 10, 1986.
Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
this section as in effect immediately before Nov. 10, 1986, applies
with respect to establishments until the Secretary of Agriculture
first issues rules and regulations to implement the amendments made
by section 403(a) of Pub. L. 99-641 to section 606 of this title,
see section 408 of Pub. L. 99-641, set out as a note under section
606 of this title.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e)
and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
Services for Establishments Not Participating in Total Plant
Quality-Control Program" and "Savings Provision", respectively,
under section 606 of this title.
-End-
-CITE-
21 USC Sec. 622 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 622. Bribery of or gifts to inspectors or other officers and
acceptance of gifts
-STATUTE-
Any person, firm, or corporation, or any agent or employee of any
person, firm, or corporation, who shall give, pay, or offer,
directly or indirectly, to any inspector, deputy inspector, chief
inspector, or any other officer or employee of the United States
authorized to perform any of the duties prescribed by this chapter
or by the rules and regulations of the Secretary any money or other
thing of value, with intent to influence said inspector, deputy
inspector, chief inspector, or other officer or employee of the
United States in the discharge of any duty provided for in this
chapter, shall be deemed guilty of a felony, and, upon conviction
thereof, shall be punished by a fine not less than $5,000 nor more
than $10,000 and by imprisonment not less than one year nor more
than three years; and any inspector, deputy inspector, chief
inspector, or other officer or employee of the United States
authorized to perform any of the duties prescribed by this chapter
who shall accept any money, gift, or other thing of value from any
person, firm, or corporation, or officers, agents, or employees
thereof, given with intent to influence his official action, or who
shall receive or accept from any person, firm, or corporation
engaged in commerce any gift, money, or other thing of value, given
with any purpose or intent whatsoever, shall be deemed guilty of a
felony and shall, upon conviction thereof, be summarily discharged
from office and shall be punished by a fine not less than $1,000
nor more than $10,000 and by imprisonment not less than one year
nor more than three years.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 22, formerly 20th par., 34
Stat. 1264; renumbered Sec. 22 and amended Pub. L. 90-201, Secs. 1,
3, Dec. 15, 1967, 81 Stat. 584, 588.)
-COD-
CODIFICATION
Section was formerly classified to section 90 of this title.
-MISC1-
AMENDMENTS
1967 - Pub. L. 90-201, Sec. 3, struck out "interstate or foreign"
before "commerce" and "of Agriculture" after "Secretary".
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment
effective upon expiration of sixty days after Dec. 15, 1967, see
section 20(b) of Pub. L. 90-201, set out as an Effective Date note
under section 601 of this title.
-End-
-CITE-
21 USC Sec. 623 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 623. Exemptions from inspection requirements
-STATUTE-
(a) Personal slaughtering and custom slaughtering for personal,
household, guest, and employee uses
The provisions of this subchapter requiring inspection of the
slaughter of animals and the preparation of the carcasses, parts
thereof, meat and meat food products at establishments conducting
such operations for commerce shall not apply to the slaughtering by
any person of animals of his own raising, and the preparation by
him and transportation in commerce of the carcasses, parts thereof,
meat and meat food products of such animals exclusively for use by
him and members of his household and his nonpaying guests and
employees; nor to the custom slaughter by any person, firm, or
corporation of cattle, sheep, swine or goats delivered by the owner
thereof for such slaughter, and the preparation by such slaughterer
and transportation in commerce of the carcasses, parts thereof,
meat and meat food products of such animals, exclusively for use,
in the household of such owner, by him and members of his household
and his nonpaying guests and employees; nor to the custom
preparation by any person, firm, or corporation of carcasses, parts
thereof, meat or meat food products, derived from the slaughter by
any person of cattle, sheep, swine, or goats of his own raising, or
from game animals, delivered by the owner thereof for such custom
preparation, and transportation in commerce of such custom prepared
articles, exclusively for use in the household of such owner, by
him and members of his household and his nonpaying guests and
employees: Provided, That in cases where such person, firm, or
corporation engages in such custom operations at an establishment
at which inspection under this subchapter is maintained, the
Secretary may exempt from such inspection at such establishment any
animals slaughtered or any meat or meat food products otherwise
prepared on such custom basis: Provided further, That custom
operations at any establishment shall be exempt from inspection
requirements as provided by this section only if the establishment
complies with regulations which the Secretary is hereby authorized
to promulgate to assure that any carcasses, parts thereof, meat or
meat food products wherever handled on a custom basis, or any
containers or packages containing such articles, are separated at
all times from carcasses, parts thereof, meat or meat food products
prepared for sale, and that all such articles prepared on a custom
basis, or any containers or packages containing such articles, are
plainly marked "Not for Sale" immediately after being prepared and
kept so identified until delivered to the owner and that the
establishment conducting the custom operation is maintained and
operated in a sanitary manner.
(b) Territorial exemption; refusal, withdrawal, or modification
The Secretary may, under such sanitary conditions as he may by
regulations prescribe, exempt from the inspection requirements of
this subchapter the slaughter of animals, and the preparation of
carcasses, parts thereof, meat and meat food products, by any
person, firm, or corporation in any Territory not organized with a
legislative body solely for distribution within such Territory when
the Secretary determines that it is impracticable to provide such
inspection within the limits of funds appropriated for
administration of this chapter and that such exemption will
otherwise facilitate enforcement of this chapter. The Secretary may
refuse, withdraw, or modify any exemption under this subsection in
his discretion whenever he determines such action is necessary to
effectuate the purposes of this chapter.
(c) Pizzas containing meat food products
(1) Under such terms and conditions as the Secretary shall
prescribe through rules and regulations issued under section 624 of
this title that may be necessary to ensure food safety and protect
public health such as special handling procedures, the Secretary
shall exempt pizzas containing a meat food product from the
inspection requirements of this chapter if -
(A) the meat food product components of the pizzas have been
prepared, inspected, and passed in a cured or cooked form as
ready-to-eat in compliance with the requirements of this chapter;
and
(B) the pizzas are to be served in public or private nonprofit
institutions.
(2) The Secretary may withdraw or modify any exemption under this
subsection whenever the Secretary determines such action is
necessary to ensure food safety and to protect public health. The
Secretary may reinstate or further modify any exemption withdrawn
or modified under this subsection.
(d) Adulteration and misbranding provisions applicable to
inspection-free articles
The adulteration and misbranding provisions of this subchapter,
other than the requirement of the inspection legend, shall apply to
articles which are exempted from inspection or not required to be
inspected under this section.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 23, formerly 21st, 22nd
pars., 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235;
renumbered Sec. 23 and amended Pub. L. 90-201, Secs. 1, 11, Dec.
15, 1967, 81 Stat. 584, 591; Pub. L. 91-342, July 18, 1970, 84
Stat. 438; Pub. L. 102-237, title X, Sec. 1016(a), Dec. 13, 1991,
105 Stat. 1902.)
-COD-
CODIFICATION
Section was formerly classified to sections 91 and 92 of this
title.
-MISC1-
AMENDMENTS
1991 - Subsecs. (c), (d). Pub. L. 102-237 added subsec. (c) and
redesignated former subsec. (c) as (d).
1970 - Subsec. (a). Pub. L. 91-342 changed proviso so as to
permit custom slaughterers to conduct a separate inspected meat
business, continued the exemption for owners to slaughter and
process their own animals for their own use, authorized the
Secretary to exempt custom slaughtering and processing performed by
an inspected establishment, and required that custom slaughtered
articles be clearly marked "not for sale".
1967 - Pub. L. 90-201, Sec. 11, substituted provisions for
personal, custom, and territorial slaughtering exemptions and for
application of adulteration and misbranding provisions to
inspection-free articles for farmer definition and retail butcher
and retail dealer exemption provisions.
1938 - Act June 29, 1948, amended section generally.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90-201 effective upon expiration of sixty
days after Dec. 15, 1967, see section 20(c) of Pub. L. 90-201, set
out as an Effective Date note under section 601 of this title.
REGULATIONS
Secretary to issue final rules no later than Aug. 1, 1992, to
implement exemption authorized by subsec. (c) of this section, see
section 1016(c) of Pub. L. 102-237, set out as a note under section
464 of this title.
-End-
-CITE-
21 USC Sec. 624 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER I - INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING
-HEAD-
Sec. 624. Storage and handling regulations; violations; exemption
of establishments subject to non-Federal jurisdiction
-STATUTE-
The Secretary may by regulations prescribe conditions under which
carcasses, parts of carcasses, meat, and meat food products of
cattle, sheep, swine, goats, horses, mules, or other equines,
capable of use as human food, shall be stored or otherwise handled
by any person, firm, or corporation engaged in the business of
buying, selling, freezing, storing, or transporting, in or for
commerce, or importing, such articles, whenever the Secretary deems
such action necessary to assure that such articles will not be
adulterated or misbranded when delivered to the consumer. Violation
of any such regulation is prohibited. However, such regulations
shall not apply to the storage or handling of such articles at any
retail store or other establishment in any State or organized
Territory that would be subject to this section only because of
purchases in commerce, if the storage and handling of such articles
at such establishment is regulated under the laws of the State or
Territory in which such establishment is located, in a manner which
the Secretary, after consultation with the appropriate advisory
committee provided for in section 661 of this title, determines is
adequate to effectuate the purposes of this section.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title I, Sec. 24, as added Pub. L. 90-201,
Sec. 13, Dec. 15, 1967, 81 Stat. 593.)
-End-
-CITE-
21 USC SUBCHAPTER II - MEAT PROCESSORS AND RELATED
INDUSTRIES 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-End-
-CITE-
21 USC Sec. 641 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
Sec. 641. Prohibition of subchapter I inspection of articles not
intended for use as human food; denaturation or other
identification prior to distribution in commerce; inedible
articles
-STATUTE-
Inspection shall not be provided under subchapter I of this
chapter at any establishment for the slaughter of cattle, sheep,
swine, goats, horses, mules, or other equines, or the preparation
of any carcasses or parts or products of such animals, which are
not intended for use as human food, but such articles shall, prior
to their offer for sale or transportation in commerce, unless
naturally inedible by humans, be denatured or otherwise identified
as prescribed by regulations of the Secretary to deter their use
for human food. No person, firm, or corporation shall buy, sell,
transport, or offer for sale or transportation, or receive for
transportation, in commerce, or import, any carcasses, parts
thereof, meat or meat food products of any such animals, which are
not intended for use as human food unless they are denatured or
otherwise identified as required by the regulations of the
Secretary or are naturally inedible by humans.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title II, Sec. 201, as added Pub. L. 90-
201, Sec. 14, Dec. 15, 1967, 81 Stat. 593.)
-MISC1-
EFFECTIVE DATE
Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90-
201, set out as a note under section 601 of this title.
-End-
-CITE-
21 USC Sec. 642 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
Sec. 642. Recordkeeping requirements
-STATUTE-
(a) Classes of persons bound; scope of disclosure; access to places
of business; examination of records, facilities, and inventories;
copies; samples
The following classes of persons, firms, and corporations shall
keep such records as will fully and correctly disclose all
transactions involved in their businesses; and all persons, firms,
and corporations subject to such requirements shall, at all
reasonable times upon notice by a duly authorized representative of
the Secretary, afford such representative access to their places of
business and opportunity to examine the facilities, inventory, and
records thereof, to copy all such records, and to take reasonable
samples of their inventory upon payment of the fair market value
therefor -
(1) Any persons, firms, or corporations that engage, for
commerce, in the business of slaughtering any cattle, sheep,
swine, goats, horses, mules, or other equines, or preparing,
freezing, packaging, or labeling any carcasses, or parts or
products of carcasses, of any such animals, for use as human food
or animal food;
(2) Any persons, firms, or corporations that engage in the
business of buying or selling (as meat brokers, wholesalers or
otherwise), or transporting in commerce, or storing in or for
commerce, or importing, any carcasses, or parts or products of
carcasses, of any such animals;
(3) Any persons, firms, or corporations that engage in
business, in or for commerce, as renderers, or engage in the
business of buying, selling, or transporting, in commerce, or
importing, any dead, dying, disabled, or diseased cattle, sheep,
swine, goats, horses, mules, or other equines, or parts of the
carcasses of any such animals that died otherwise than by
slaughter.
(b) Period of maintenance
Any record required to be maintained by this section shall be
maintained for such period of time as the Secretary may by
regulations prescribe.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title II, Sec. 202, as added Pub. L. 90-
201, Sec. 14, Dec. 15, 1967, 81 Stat. 593.)
-End-
-CITE-
21 USC Sec. 643 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
Sec. 643. Registration of business, name of person, and trade names
-STATUTE-
No person, firm, or corporation shall engage in business, in or
for commerce, as a meat broker, renderer, or animal food
manufacturer, or engage in business in commerce as a wholesaler of
any carcasses, or parts or products of the carcasses, of any
cattle, sheep, swine, goats, horses, mules, or other equines,
whether intended for human food or other purposes, or engage in
business as a public warehouseman storing any such articles in or
for commerce, or engage in the business of buying, selling, or
transporting in commerce, or importing, any dead, dying, disabled,
or diseased animals of the specified kinds, or parts of the
carcasses of any such animals that died otherwise than by
slaughter, unless, when required by regulations of the Secretary,
he has registered with the Secretary his name, and the address of
each place of business at which, and all trade names under which,
he conducts such business.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title II, Sec. 203, as added Pub. L. 90-
201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)
-End-
-CITE-
21 USC Sec. 644 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
Sec. 644. Regulation of transactions, transportation, or
importation of 4-D animals to prevent use as human food
-STATUTE-
No person, firm, or corporation engaged in the business of
buying, selling, or transporting in commerce, or importing, dead,
dying, disabled, or diseased animals, or any parts of the carcasses
of any animals that died otherwise than by slaughter, shall buy,
sell, transport, offer for sale or transportation, or receive for
transportation, in commerce, or import, any dead, dying, disabled,
or diseased cattle, sheep, swine, goats, horses, mules or other
equines, or parts of the carcasses of any such animals that died
otherwise than by slaughter, unless such transaction,
transportation or importation is made in accordance with such
regulations as the Secretary may prescribe to assure that such
animals, or the unwholesome parts or products thereof, will be
prevented from being used for human food purposes.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title II, Sec. 204, as added Pub. L. 90-
201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)
-End-
-CITE-
21 USC Sec. 645 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER II - MEAT PROCESSORS AND RELATED INDUSTRIES
-HEAD-
Sec. 645. Federal provisions applicable to State or Territorial
business transactions of a local nature and not subject to local
authority
-STATUTE-
The authority conferred on the Secretary by section 642, 643, or
644 of this title with respect to persons, firms, and corporations
engaged in the specified kinds of business in or for commerce may
be exercised with respect to persons, firms, or corporations
engaged, in any State or organized Territory, in such kinds of
business but not in or for commerce, whenever the Secretary
determines, after consultation with an appropriate advisory
committee provided for in section 661 of this title, that the State
or territory does not have at least equal authority under its laws
or such authority is not exercised in a manner to effectuate the
purposes of this chapter including the State providing for the
Secretary or his representative being afforded access to such
places of business and the facilities, inventories, and records
thereof, and the taking of reasonable samples, where he determines
necessary in carrying out his responsibilities under this chapter;
and in such case the provisions of section 642, 643, or 644 of this
title, respectively, shall apply to such persons, firms, and
corporations to the same extent and in the same manner as if they
were engaged in such business in or for commerce and the
transactions involved were in commerce.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title II, Sec. 205, as added Pub. L. 90-
201, Sec. 14, Dec. 15, 1967, 81 Stat. 594.)
-End-
-CITE-
21 USC SUBCHAPTER III - FEDERAL AND STATE COOPERATION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER III - FEDERAL AND STATE COOPERATION
-HEAD-
SUBCHAPTER III - FEDERAL AND STATE COOPERATION
-End-
-CITE-
21 USC Sec. 661 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER III - FEDERAL AND STATE COOPERATION
-HEAD-
Sec. 661. Federal and State cooperation
-STATUTE-
(a) Congressional statement of policy
It is the policy of the Congress to protect the consuming public
from meat and meat food products that are adulterated or misbranded
and to assist in efforts by State and other Government agencies to
accomplish this objective. In furtherance of this policy -
(1) Development and administration of State meat inspection
program equal to subchapter I ante and post mortem inspection,
reinspection, and sanitation requirements
The Secretary is authorized, whenever he determines that it
would effectuate the purposes of this chapter, to cooperate with
the appropriate State agency in developing and administering a
State meat inspection program in any State which has enacted a
State meat inspection law that imposes mandatory ante mortem and
post mortem inspection, reinspection and sanitation requirements
that are at least equal to those under subchapter I of this
chapter, with respect to all or certain classes of persons
engaged in the State in slaughtering cattle, sheep, swine, goats,
or equines, or preparing the carcasses, parts thereof, meat or
meat food products, of any such animals for use as human food
solely for distribution within such State.
(2) Development and administration of State program with
authorities equal to subchapter II authorities; cooperation
with Federal agencies
The Secretary is further authorized, whenever he determines
that it would effectuate the purposes of this chapter, to
cooperate with appropriate State agencies in developing and
administering State programs under State laws containing
authorities at least equal to those provided in subchapter II of
this chapter; and to cooperate with other agencies of the United
States in carrying out any provisions of this chapter.
(3) Scope of cooperation: advisory assistance, technical and
laboratory assistance and training, and financial and other
aid; limitation on amount; equitable allocation of Federal
funds; adequacy of State program to obtain Federal cooperation
and payments
Cooperation with State agencies under this section may include
furnishing to the appropriate State agency (i) advisory
assistance in planning and otherwise developing an adequate State
program under the State law; and (ii) technical and laboratory
assistance and training (including necessary curricular and
instructional materials and equipment), and financial and other
aid for administration of such a program. The amount to be
contributed to any State by the Secretary under this section from
Federal funds for any year shall not exceed 50 per centum of the
estimated total cost of the cooperative program; and the Federal
funds shall be allocated among the States desiring to cooperate
on an equitable basis. Such cooperation and payment shall be
contingent at all times upon the administration of the State
program in a manner which the Secretary, in consultation with the
appropriate advisory committee appointed under paragraph (4),
deems adequate to effectuate the purposes of this section.
(4) Advisory committees
The Secretary may appoint advisory committees consisting of
such representatives of appropriate State agencies as the
Secretary and the State agencies may designate to consult with
him concerning State and Federal programs with respect to meat
inspection and other matters within the scope of this chapter,
including evaluating State programs for purposes of this chapter
and obtaining better coordination and more uniformity among the
State programs and between the Federal and State programs and
adequate protection of consumers.
(b) Single State agency; subordinate governmental unit as part of
State agency
The appropriate State agency with which the Secretary may
cooperate under this chapter shall be a single agency in the State
which is primarily responsible for the coordination of the State
programs having objectives similar to those under this chapter.
When the State program includes performance of certain functions by
a municipality or other subordinate governmental unit, such unit
shall be deemed to be a part of the State agency for purposes of
this section.
(c) State meat inspection requirements
(1) Notice to Governor of nondevelopment or nonenforcement;
designation of State as subject to subchapters I and IV; delay
and revocation of designation; publication in Federal Register;
notice of production of adulterated meat or meat food products;
designation of State
If the Secretary has reason to believe, by thirty days prior to
the expiration of two years after December 15, 1967, that a State
has failed to develop or is not enforcing, with respect to all
establishments within its jurisdiction (except those that would be
exempted from Federal inspection under subparagraph (2)) at which
cattle, sheep, swine, goats, or equines are slaughtered, or their
carcasses, or parts or products thereof, are prepared for use as
human food, solely for distribution within such State, and the
products of such establishments, requirements at least equal to
those imposed under subchapter I and IV of this chapter, he shall
promptly notify the Governor of the State of this fact. If the
Secretary determines, after consultation with the Governor of the
State, or representative selected by him, that such requirements
have not been developed and activated, he shall promptly after the
expiration of such two-year period designate such State as one in
which the provisions of subchapters I and IV of this chapter shall
apply to operations and transactions wholly within such State:
Provided, That if the Secretary has reason to believe that the
State will activate such requirements within one additional year,
he may delay such designation for said period, and not designate
the State, if he determines at the end of the year that the State
then has such requirements in effective operation. The Secretary
shall publish any such designation in the Federal Register and,
upon the expiration of thirty days after such publication, the
provisions of subchapters I and IV shall apply to operations and
transactions and to persons, firms, and corporations engaged
therein in the State to the same extent and in the same manner as
if such operations and transactions were conducted in or for
commerce. Thereafter, upon request of the Governor, the Secretary
shall revoke such designation if the Secretary determines that such
State has developed and will enforce requirements at least equal to
those imposed under subchapter I and subchapter IV of this chapter:
And provided further, That, notwithstanding any other provision of
this section, if the Secretary determines that any establishment
within a State is producing adulterated meat or meat food products
for distribution within such State which would clearly endanger the
public health he shall notify the Governor of the State and the
appropriate Advisory Committee provided by section 661 of this
title of such fact for effective action under State or local law.
If the State does not take action to prevent such endangering of
the public health within a reasonable time after such notice, as
determined by the Secretary, in light of the risk to public health,
the Secretary may forthwith designate any such establishment as
subject to the provisions of subchapters I and IV of this chapter,
and thereupon the establishment and operator thereof shall be
subject to such provisions as though engaged in commerce until such
time as the Secretary determines that such State has developed and
will enforce requirements at least equal to those imposed under
subchapter I and subchapter IV of this chapter.
(2) Exemptions of retail stores, restaurants, and similar retail-
type establishments; operations conducted at a restaurant
central kitchen facility
The provisions of this chapter requiring inspection of the
slaughter of animals and the preparation of carcasses, parts
thereof, meat and meat food products shall not apply to operations
of types traditionally and usually conducted at retail stores and
restaurants, when conducted at any retail store or restaurant or
similar retail-type establishment for sale in normal retail
quantities or service of such articles to consumers at such
establishments if such establishments are subject to such
inspection provisions only under this paragraph (c). For the
purposes of this subparagraph, operations conducted at a restaurant
central kitchen facility shall be considered as being conducted at
a restaurant if the restaurant central kitchen prepares meat or
meat food products that are ready to eat when they leave such
facility and are served in meals or as entrees only to customers at
restaurants owned or operated by the same person, firm, or
corporation owning or operating such facility: Provided, That such
facility shall be subject to the provisions of section 642 of this
title: Provided further, That the facility may be subject to the
inspection requirements under subchapter I of this chapter for as
long as the Secretary deems necessary, if the Secretary determines
that the sanitary conditions or practices of the facility or the
processing procedures or methods at the facility are such that any
of its meat or meat food products are rendered adulterated.
(3) Termination of designation of State upon development and
enforcement of minimum requirements; redesignation; designation
for nonenforcement of minimum requirements: notice and
publication in Federal Register
Whenever the Secretary determines that any State designated under
this paragraph (c) has developed and will enforce State meat
inspection requirements at least equal to those imposed under
subchapters I and IV of this chapter with respect to the operations
and transactions within such State which are regulated under
paragraph (1), he shall terminate the designation of such State
under this paragraph (c), but this shall not preclude the
subsequent redesignation of the State at any time upon thirty days
notice to the Governor and publication in the Federal Register in
accordance with this paragraph, and any State may be designated
upon such notice and publication at any time after the period
specified in this paragraph whether or not the State has
theretofore been designated upon the Secretary determining that it
is not effectively enforcing requirements at least equal to those
imposed under subchapters I and IV of this chapter.
(4) Periodic review; report to Congressional committees
The Secretary shall promptly upon December 15, 1967, and
periodically thereafter, but at least annually, review the
requirements, including the enforcement thereof, of the several
States not designated under this paragraph (c), with respect to the
slaughter, and the preparation, storage, handling and distribution
of carcasses, parts thereof, meat and meat food products, of such
animals, and inspection of such operations and annually report
thereon to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate in the report required under section 691
(!1) of this title.
(d) "State" defined
As used in this section, the term "State" means any State
(including the Commonwealth of Puerto Rico) or organized Territory.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title III Sec. 301, as added Pub. L. 90-
201, Sec. 15, Dec. 15, 1967, 81 Stat. 595; amended Pub. L. 98-487,
Sec. 1, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103-437, Sec. 8(2),
Nov. 2, 1994, 108 Stat. 4588.)
-REFTEXT-
REFERENCES IN TEXT
Section 691 of this title, referred to in subsec. (c)(4), was
omitted from the Code.
-COD-
CODIFICATION
In subsec. (c)(1), (4), "December 15, 1967" substituted for
"enactment of the Wholesome Meat Act".
-MISC1-
AMENDMENTS
1994 - Subsec. (c)(4). Pub. L. 103-437 substituted "Agriculture,
Nutrition, and Forestry" for "Agriculture and Forestry".
1984 - Subsec. (c)(2). Pub. L. 98-487 inserted provisions
relating to operations conducted at a restaurant central kitchen
facility.
EFFECTIVE DATE
Section effective Dec. 15, 1967, see section 20 of Pub. L. 90-
201, set out as a note under section 601 of this title.
TERMINATION OF ADVISORY COMMITTEES
Advisory committees in existence on Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period following Jan.
5, 1973, and advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year period
beginning on the date of their establishment, unless in the case of
a committee established by the President or an officer of the
Federal Government, such committee is renewed by appropriate action
prior to the expiration of such 2-year period, or in the case of a
committee established by Congress, its duration is otherwise
provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC SUBCHAPTER IV - AUXILIARY PROVISIONS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
SUBCHAPTER IV - AUXILIARY PROVISIONS
-End-
-CITE-
21 USC Sec. 671 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 671. Inspection services; refusal or withdrawal; hearing;
business unfitness based upon certain convictions; other
provisions for withdrawal of services unaffected; responsible
connection with business; finality of Secretary's actions;
judicial review; record
-STATUTE-
The Secretary may (for such period, or indefinitely, as he deems
necessary to effectuate the purposes of this chapter) refuse to
provide, or withdraw, inspection service under subchapter I of this
chapter with respect to any establishment if he determines, after
opportunity for a hearing is accorded to the applicant for, or
recipient of, such service, that such applicant or recipient is
unfit to engage in any business requiring inspection under
subchapter I because the applicant or recipient, or anyone
responsibly connected with the applicant or recipient, has been
convicted, in any Federal or State court, of (1) any felony, or (2)
more than one violation of any law, other than a felony, based upon
the acquiring, handling, or distributing of unwholesome,
mislabeled, or deceptively packaged food or upon fraud in
connection with transactions in food. This section shall not affect
in any way other provisions of this chapter for withdrawal of
inspection services under subchapter I from establishments failing
to maintain sanitary conditions or to destroy condemned carcasses,
parts, meat or meat food products.
For the purpose of this section a person shall be deemed to be
responsibly connected with the business if he was a partner,
officer, director, holder, or owner of 10 per centum or more of its
voting stock or employee in a managerial or executive capacity.
The determination and order of the Secretary with respect thereto
under this section shall be final and conclusive unless the
affected applicant for, or recipient of, inspection service files
application for judicial review within thirty days after the
effective date of such order in the appropriate court as provided
in section 674 of this title. Judicial review of any such order
shall be upon the record upon which the determination and order are
based.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 401, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 597; amended Pub. L. 99-641,
title IV, Sec. 403(b), Nov. 10, 1986, 100 Stat. 3568.)
-MISC1-
AMENDMENTS
1986 - Subsec. (a). Pub. L. 99-641, Sec. 403(b)(1), (2)(B), (C),
temporarily designated provisions which related to authority to
refuse or withdraw inspection service as subsec. (a), struck out
"any felony, or (2)" after "of (1)", and inserted "or (2) any
felony" after "transactions in food". See Effective and Termination
Dates of 1986 Amendment note below.
Pub. L. 99-641, Sec. 403(b)(2)(A), which directed that subsec.
(a) be amended by substituting "applicant for" for "applicant,
for", could not be executed because "applicant, for" does not
appear.
Subsecs. (b) to (e). Pub. L. 99-641, Sec. 403(b)(6), temporarily
added subsecs. (b) to (e). See Effective and Termination Dates of
1986 Amendment note below.
Subsec. (f). Pub. L. 99-641, Sec. 403(b)(3), temporarily
designated provisions which related to other provisions for
withdrawal of inspection services as subsec. (f). See Effective and
Termination Dates of 1986 Amendment note below.
Subsec. (g). Pub. L. 99-641, Sec. 403(b)(4), temporarily
designated provisions which related to responsible connection with
business as subsec. (g). See Effective and Termination Dates of
1986 Amendment note below.
Subsec. (h). Pub. L. 99-641, Sec. 403(b)(5), temporarily
designated provisions which related to finality of determination by
Secretary and to judicial review as subsec. (h), substituted
"Except as provided in subsection (e)(2) of this section, the
determination" for "The determination" and "subsection (e) of this
section" for "this section". See Effective and Termination Dates of
1986 Amendment note below.
EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT
Section 403(b) of Pub. L. 99-641 provided that the amendment made
by that section is effective only during the 6-year period
beginning Nov. 10, 1986.
EFFECTIVE DATE
Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90-
201, set out as a note under section 601 of this title.
CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e)
and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
Services for Establishments Not Participating in Total Plant
Quality-Control Program" and "Savings Provision", respectively,
under section 606 of this title.
-End-
-CITE-
21 USC Sec. 672 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 672. Administrative detention; duration; pending judicial
proceedings; notification of governmental authorities; release
-STATUTE-
Whenever any carcass, part of a carcass, meat or meat food
product of cattle, sheep, swine, goats, horses, mules, or other
equines, or any product exempted from the definition of a meat food
product, or any dead, dying, disabled, or diseased cattle, sheep,
swine, goat, or equine is found by any authorized representative of
the Secretary upon any premises where it is held for purposes of,
or during or after distribution in, commerce or otherwise subject
to subchapter I or II of this chapter, and there is reason to
believe that any such article is adulterated or misbranded and is
capable of use as human food, or that it has not been inspected, in
violation of the provisions of subchapter I of this chapter or of
any other Federal law or the laws of any State or Territory, or the
District of Columbia, or that such article or animal has been or is
intended to be, distributed in violation of any such provisions, it
may be detained by such representative for a period not to exceed
twenty days, pending action under section 673 of this title or
notification of any Federal, State, or other governmental
authorities having jurisdiction over such article or animal, and
shall not be moved by any person, firm, or corporation from the
place at which it is located when so detained, until released by
such representative. All official marks may be required by such
representative to be removed from such article or animal before it
is released unless it appears to the satisfaction of the Secretary
that the article or animal is eligible to retain such marks.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 402, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 598.)
-End-
-CITE-
21 USC Sec. 673 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 673. Seizure and condemnation
-STATUTE-
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury;
sales restrictions; bond; court costs and fees, storage, and
other expenses against claimants; proceedings in admiralty; jury
trial; United States as plaintiff
(1) Any carcass, part of a carcass, meat or meat food product of
cattle, sheep, swine, goats, horses, mules or other equines, or any
dead, dying, disabled, or diseased cattle, sheep, swine, goat, or
equine, that is being transported in commerce or otherwise subject
to subchapter I or II of this chapter, or is held for sale in the
United States after such transportation, and that (A) is or has
been prepared, sold, transported, or otherwise distributed or
offered or received for distribution in violation of this chapter,
or (B) is capable of use as human food and is adulterated or
misbranded, or (C) in any other way is in violation of this
chapter, shall be liable to be proceeded against and seized and
condemned, at any time, on a libel of information in any United
States district court or other proper court as provided in section
674 of this title within the jurisdiction of which the article or
animal is found.
(2) If the article or animal is condemned it shall, after entry
of the decree, (A) be distributed in accordance with paragraph (5),
or (B) be disposed of by destruction or sale as the court may
direct and the proceeds, if sold, less the court costs and fees,
and storage and other proper expenses, shall be paid into the
Treasury of the United States, but the article or animal shall not
be sold contrary to the provisions of this chapter, or the laws of
the jurisdiction in which it is sold: Provided, That upon the
execution and delivery of a good and sufficient bond conditioned
that the article or animal shall not be sold or otherwise disposed
of contrary to the provisions of this chapter, or the laws of the
jurisdiction in which disposal is made, the court may direct that
such article or animal be delivered to the owner thereof subject to
such supervision by authorized representatives of the Secretary as
is necessary to insure compliance with the applicable laws.
(3) When a decree of condemnation is entered against the article
or animal and it is released under bond, or destroyed, court costs
and fees, and storage and other proper expenses shall be awarded
against the person, if any, intervening as claimant of the article
or animal.
(4) The proceedings in such libel cases shall conform, as nearly
as may be, to the proceedings in admiralty, except that either
party may demand trial by jury of any issue of fact joined in any
case, and all such proceedings shall be at the suit of and in the
name of the United States.
(5)(A) An article that is condemned under paragraph (1) may as
the court may direct, after entry of the decree, be distributed
without charge to nonprofit, private entities or to Federal, State,
or local government entities engaged in the distribution of food
without charge to individuals, if such article -
(i) has been inspected under this chapter and found to be
wholesome and not to be adulterated within the meaning of
paragraphs (1) through (7) and (9) of section 601(m) of this
title and a determination is made at the time of the entry of the
decree that such article is wholesome and not so adulterated; and
(ii) is plainly marked "Not for Sale" on such article or its
container.
(B) The United States may not be held legally responsible for any
article that is distributed under subparagraph (A) to a nonprofit,
private entity or to a Federal, State, or local government entity,
if such article -
(i) was found after inspection under this chapter to be
wholesome and not adulterated within the meaning of paragraphs
(1) through (7) and (9) of section 601(m) of this title and a
determination was made at the time of the entry of the decree
that such article was wholesome and not so adulterated; and
(ii) was plainly marked "Not for Sale" on such article or its
container.
(C) The person from whom such article was seized and condemned
may not be held legally responsible for such article, if such
article -
(i) was found after inspection under this chapter to be
wholesome and not adulterated within the meaning of paragraphs
(1) through (7) and (9) of section 601(m) of this title and a
determination was made at the time of the entry of the decree
that such article was wholesome and not so adulterated; and
(ii) was plainly marked "Not for Sale" on such article or its
container.
(b) Condemnation or seizure under other provisions unaffected
The provisions of this section shall in no way derogate from
authority for condemnation or seizure conferred by other provisions
of this chapter, or other laws.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 403, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 598; amended Pub. L. 101-
205, Sec. 1, Dec. 7, 1989, 103 Stat. 1829.)
-MISC1-
AMENDMENTS
1989 - Subsec. (a). Pub. L. 101-205 designated first sentence as
par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
respectively, designated second sentence as par. (2) and inserted
"(A) to be distributed in accordance with paragraph (5), or (B)"
after "entry of the decree,", designated third and fourth sentences
as pars. (3) and (4), respectively, and added par. (5).
-End-
-CITE-
21 USC Sec. 674 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 674. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations of section
607(e) of this title
-STATUTE-
The United States district courts, the District Court of Guam,
the District Court of the Virgin Islands, the highest court of
American Samoa, and the United States courts of the other
Territories, are vested with jurisdiction specifically to enforce,
and to prevent and restrain violations of, this chapter, and shall
have jurisdiction in all other kinds of cases arising under this
chapter, except as provided in section 607(e) of this title.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 404, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)
-End-
-CITE-
21 USC Sec. 675 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 675. Assaulting, resisting, or impeding certain persons;
murder; protection of such persons
-STATUTE-
Any person who forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while engaged in or on
account of the performance of his official duties under this
chapter shall be fined not more than $5,000 or imprisoned not more
than three years, or both. Whoever, in the commission of any such
acts, uses a deadly or dangerous weapon, shall be fined not more
than $10,000 or imprisoned not more than ten years, or both.
Whoever kills any person while engaged in or on account of the
performance of his official duties under this chapter shall be
punished as provided under sections 1111 and 1114 of title 18.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 405, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)
-End-
-CITE-
21 USC Sec. 676 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 676. Violations
-STATUTE-
(a) Misdemeanors; felonies: intent to defraud and distribution of
adulterated articles; good faith
Any person, firm, or corporation who violates any provision of
this chapter for which no other criminal penalty is provided by
this chapter shall upon conviction be subject to imprisonment for
not more than one year, or a fine of not more than $1,000, or both
such imprisonment and fine; but if such violation involves intent
to defraud, or any distribution or attempted distribution of an
article that is adulterated (except as defined in section 601(m)(8)
of this title), such person, firm, or corporation shall be subject
to imprisonment for not more than three years or a fine of not more
than $10,000, or both: Provided, That no person, firm, or
corporation, shall be subject to penalties under this section for
receiving for transportation any article or animal in violation of
this chapter if such receipt was made in good faith, unless such
person, firm, or corporation refuses to furnish on request of a
representative of the Secretary the name and address of the person
from whom he received such article or animal, and copies of all
documents, if any there be, pertaining to the delivery of the
article or animal to him.
(b) Minor violations; written notice of warning of criminal and
civil proceedings
Nothing in this chapter shall be construed as requiring the
Secretary to report for prosecution or for the institution of libel
or injunction proceedings, minor violations of this chapter
whenever he believes that the public interest will be adequately
served by a suitable written notice of warning.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 406, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 599; amended Pub. L. 99-641,
title IV, Sec. 403(c), Nov. 10, 1986, 100 Stat. 3570.)
-MISC1-
AMENDMENTS
1986 - Subsec. (b). Pub. L. 99-641, Sec. 403(c)(1), temporarily
inserted provisions which related to factors required to be
considered by Secretary in determining whether public interest is
served by written notice of warning. See Effective and Termination
Dates of 1986 Amendment note below.
Subsec. (c). Pub. L. 99-641, Sec. 403(c)(2), temporarily added
subsec. (c). See Effective and Termination Dates of 1986 Amendment
note below.
EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT
Section 403(c) of Pub. L. 99-641 provided that the amendment made
by that section is effective only during the 6-year period
beginning Nov. 10, 1986.
CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99-641
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e)
and 404 of Pub. L. 99-641, set out as notes entitled "Inspection
Services for Establishments Not Participating in Total Plant
Quality-Control Program" and "Savings Provision", respectively,
under section 606 of this title.
-End-
-CITE-
21 USC Sec. 677 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 677. Other Federal laws applicable for administration and
enforcement of chapter; location of inquiries; jurisdiction of
Federal courts
-STATUTE-
For the efficient administration and enforcement of this chapter,
the provisions (including penalties) of sections 46, 48, 49 and 50
of title 15 (except paragraphs (c) through (h) of section 46 and
the last paragraph of section 49 (!1) of title 15), and the
provisions of section 409(l) (!1) of title 47; are made applicable
to the jurisdiction, powers, and duties of the Secretary in
administering and enforcing the provisions of this chapter and to
any person, firm, or corporation with respect to whom such
authority is exercised. The Secretary, in person or by such agents
as he may designate, may prosecute any inquiry necessary to his
duties under this chapter in any part of the United States, and the
powers conferred by said sections 49 and 50 of title 15 on the
district courts of the United States may be exercised for the
purposes of this chapter by any court designated in section 674 of
this title.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 407, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 599.)
-REFTEXT-
REFERENCES IN TEXT
The last paragraph of section 49 of title 15, and the provisions
of section 409(l) of title 47, referred to in text, which related
to immunity of witnesses, were repealed by sections 211 and 242,
respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
929, 930. For provisions relating to immunity of witnesses, see
section 6001 et seq. of Title 18, Crimes and Criminal Procedure.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 678 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 678. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for
establishments with inspection services and as to marking,
labeling, packaging, and ingredients; recordkeeping and related
requirements; concurrent jurisdiction over distribution for human
food purposes of adulterated or misbranded and imported articles;
other matters
-STATUTE-
Requirements within the scope of this chapter with respect to
premises, facilities and operations of any establishment at which
inspection is provided under subchapter I of this chapter, which
are in addition to, or different than those made under this chapter
may not be imposed by any State or Territory or the District of
Columbia, except that any such jurisdiction may impose
recordkeeping and other requirements within the scope of section
642 of this title, if consistent therewith, with respect to any
such establishment. Marking, labeling, packaging, or ingredient
requirements in addition to, or different than, those made under
this chapter may not be imposed by any State or Territory or the
District of Columbia with respect to articles prepared at any
establishment under inspection in accordance with the requirements
under subchapter I of this chapter, but any State or Territory or
the District of Columbia may, consistent with the requirements
under this chapter, exercise concurrent jurisdiction with the
Secretary over articles required to be inspected under said
subchapter I, for the purpose of preventing the distribution for
human food purposes of any such articles which are adulterated or
misbranded and are outside of such an establishment, or, in the
case of imported articles which are not at such an establishment,
after their entry into the United States. This chapter shall not
preclude any State or Territory or the District of Columbia from
making requirement (!1) or taking other action, consistent with
this chapter, with respect to any other matters regulated under
this chapter.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 408, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 600.)
-FOOTNOTE-
(!1) So in original. Probably should be "requirements".
-End-
-CITE-
21 USC Sec. 679 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 679. Application of Federal Food, Drug, and Cosmetic Act
-STATUTE-
(a) Authorities under food, drug, and cosmetic provisions
unaffected
Notwithstanding any other provisions of law, including section
902(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
392(a)), the provisions of this chapter shall not derogate from any
authority conferred by the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.] prior to December 15, 1967.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services
The detainer authority conferred by section 672 of this title
shall apply to any authorized representative of the Secretary of
Health and Human Services for purposes of the enforcement of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with
respect to any carcass, part thereof, meat, or meat food product of
cattle, sheep, swine, goats, or equines that is outside any
premises at which inspection is being maintained under this
chapter, and for such purposes the first reference to the Secretary
in section 672 of this title shall be deemed to refer to the
Secretary of Health and Human Services.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 409, as added Pub. L. 90-
201, Sec. 16, Dec. 15, 1967, 81 Stat. 600; amended Pub. L. 96-88,
title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(b), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsec. (b)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-End-
-CITE-
21 USC Sec. 679a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 679a. Safe Meat and Poultry Inspection Panel
-STATUTE-
(a) Establishment
There is established in the Department of Agriculture a permanent
advisory panel to be known as the "Safe Meat and Poultry Inspection
Panel" (referred to in this section as the "panel").
(b) Duties
(1) Review and evaluation
The panel shall review and evaluate, as the panel considers
necessary, the adequacy, necessity, safety, cost-effectiveness,
and scientific merit of -
(A) inspection procedures of, and work rules and worker
relations involving Federal employees employed in, plants
inspected under this chapter;
(B) informal petitions or proposals for changes in inspection
procedures, processes, and techniques of plants inspected under
this chapter;
(C) formal changes in meat inspection regulations promulgated
under this chapter, whether in notice, proposed, or final form;
and
(D) such other matters as may be referred to the panel by the
Secretary regarding the quality or effectiveness of a safe and
cost-effective meat inspection system under this chapter.
(2) Reports
(A) In general
The panel shall submit to the Secretary a report on the
results of each review and evaluation carried out under
paragraph (1), including such recommendations as the panel
considers appropriate.
(B) Reports on formal changes
In the case of a report concerning a formal change in meat
inspection regulations, the report shall be made within the
time limits prescribed for formal comments on such changes.
(C) Publication in Federal Register
Each report of the panel to the Secretary shall be published
in the Federal Register.
(c) Secretarial response
Not later than 90 days after the publication of a panel report
under subsection (b)(2)(C) of this section, the Secretary shall
publish in the Federal Register any response required of the
Secretary to the report.
(d) Composition of panel
The panel shall be composed of 7 members, not fewer than 5 of
whom shall be from the food science, meat science, or poultry
science profession, appointed to staggered terms not to exceed 3
years by the Secretary from nominations received from the National
Institutes of Health and the Federation of American Societies of
Food Animal Science and based on the professional qualifications of
the nominees.
(e) Nominations
(1) Initial panel
In constituting the initial panel, the Secretary shall solicit
6 nominees from the National Institutes of Health and 6 nominees
from the Federation of American Societies of Food Animal Science
for membership on the panel.
(2) Vacancies
Any subsequent vacancy on the panel shall be filled by the
Secretary after soliciting 2 nominees from the National
Institutes of Health and 2 nominees from the Federation of
American Societies of Food Animal Science.
(3) Requirements for nominees
(A) In general
Each nominee provided under paragraph (1) or (2) shall have a
background in public health issues and a scientific expertise
in food, meat, or poultry science or in veterinary science.
(B) Submission of information
The Secretary may require nominees to submit such information
as the Secretary considers necessary prior to completing the
selection process.
(4) Additional nominees
If any list of nominees provided under paragraph (1) or (2) is
unsatisfactory to the Secretary, the Secretary may request the
nominating entities to submit an additional list of nominees.
(f) Travel expenses
While away from the home or regular place of business of a member
of the panel in the performance of services for the panel, the
member shall be allowed travel expenses, including per diem in lieu
of subsistence, at the same rate as a person employed
intermittently in the Government service would be allowed under
section 5703 of title 5.
(g) Conflicts of interest
The Secretary shall promulgate regulations regarding conflicts of
interest with respect to the members of the panel.
(h) Exemption
The Federal Advisory Committee Act (5 U.S.C. App.) and title
XVIII of the Food and Agriculture Act of 1977 (7 U.S.C. 2281 et
seq.) shall not apply to the panel.
(i) Funding
From funds available to the Secretary to carry out this chapter
and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
the Secretary shall allocate such sums as may be necessary to carry
out this section.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 410, as added Pub. L. 104-
127, title IX, Sec. 918(a)(1)(B), Apr. 4, 1996, 110 Stat. 1188.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in subsec. (h),
is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is
set out in the Appendix to Title 5, Government Organization and
Employees.
The Food and Agriculture Act of 1977, referred to in subsec. (h),
is Pub. L. 95-113, Sept. 29, 1977, 91 Stat. 913, as amended. Title
XVIII of the Act is classified generally to chapter 55A (Sec. 2281
et seq.) of Title 7, Agriculture. For complete classification of
this Act to the Code, see Short Title of 1977 Amendment note set
out under section 1281 of Title 7 and Tables.
The Poultry Products Inspection Act, referred to in subsec. (i),
is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
is classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 451 of this title and
Tables.
-MISC1-
PRIOR PROVISIONS
A prior section 410 of act Mar. 4, 1907, was renumbered section
411, and is classified to section 680 of this title.
-End-
-CITE-
21 USC Sec. 679b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 679b. Pasteurization of meat and poultry
-STATUTE-
(1) In general
Effective beginning not later than 30 days after May 13, 2002,
the Secretary of Agriculture shall conduct an education program
regarding the availability and safety of processes and treatments
that eliminate or substantially reduce the level of pathogens on
meat, meat food products, poultry, and poultry products.
(2) Authorization of appropriations
There is authorized to be appropriated such sums as are necessary
to carry out this section.
-SOURCE-
(Pub. L. 107-171, title X, Sec. 10808(a), May 13, 2002, 116 Stat.
530.)
-COD-
CODIFICATION
Section was enacted as part of the Farm Security and Rural
Investment Act of 2002, and not as part of the Federal Meat
Inspection Act which is classified to subchapters I to IV of this
chapter.
-End-
-CITE-
21 USC Sec. 679c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 679c. Expansion of Food Safety Inspection Service activities
-STATUTE-
(a) In general
The Secretary of Agriculture may utilize existing authorities to
give high priority to enhancing and expanding the capacity of the
Food Safety Inspection Service to conduct activities to -
(1) enhance the ability of the Service to inspect and ensure
the safety and wholesomeness of meat and poultry products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and poultry
products, and egg products at points of origin and at ports of
entry;
(3) strengthen the ability of the Service to collaborate with
relevant agencies within the Department of Agriculture and with
other entities in the Federal Government, the States, and Indian
tribes (as defined in section 450b(e) of title 25) through the
sharing of information and technology; and
(4) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) Authorization of appropriations
There is authorized to be appropriated to carry out this section,
$15,000,000 for fiscal year 2002, and such sums as may be necessary
for each subsequent fiscal year.
-SOURCE-
(Pub. L. 107-188, title III, Sec. 332, June 12, 2002, 116 Stat.
679.)
-COD-
CODIFICATION
Section was enacted as part of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, and not as part
of the Federal Meat Inspection Act which is classified to
subchapters I to IV of this chapter.
-End-
-CITE-
21 USC Sec. 680 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER IV - AUXILIARY PROVISIONS
-HEAD-
Sec. 680. Authorization of appropriations
-STATUTE-
There are hereby authorized to be appropriated such sums as may
be necessary to carry out the provisions of this chapter.
-SOURCE-
(Mar. 4, 1907, ch. 2907, title IV, Sec. 411, formerly Sec. 410, as
added Pub. L. 90-201, Sec. 16, Dec. 15, 1967, 81 Stat. 600;
renumbered Sec. 411, Pub. L. 104-127, title IX, Sec. 918(a)(1)(A),
Apr. 4, 1996, 110 Stat. 1188.)
-End-
-CITE-
21 USC SUBCHAPTER V - MISCELLANEOUS PROVISIONS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-End-
-CITE-
21 USC Sec. 691 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 691. Omitted
-COD-
CODIFICATION
Section, Pub. L. 90-201, Sec. 17, Dec. 15, 1967, 81 Stat. 600;
Pub. L. 103-437, Sec. 8(3), Nov. 2, 1994, 108 Stat. 4588, which
required the Secretary of Agriculture to report annually to the
Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate on
the slaughter of animals and the processing and distribution of
carcasses and products, terminated, effective May 15, 2000,
pursuant to section 3003 of Pub. L. 104-66, as amended, set out as
a note under section 1113 of Title 31, Money and Finance. See,
also, page 46 of House Document No. 103-7.
-End-
-CITE-
21 USC Sec. 692 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 692. Inspection extended to reindeer
-STATUTE-
The provisions of the meat inspection law may be extended to the
inspection of reindeer.
-SOURCE-
(June 30, 1914, ch. 131, 38 Stat. 420.)
-REFTEXT-
REFERENCES IN TEXT
The meat inspection law, referred to in text, is classified
generally to this chapter. At the time of enactment, such reference
probably meant the Act of Mar. 4, 1907, ch. 2907, 34 Stat. 1260, as
amended. That Act (formerly classified to section 71 et seq. of
this title), was generally revised by Pub. L. 90-201, Dec. 15,
1967, 81 Stat. 584, and is classified to this chapter. For complete
classification of this Act to the Code, see Tables.
-COD-
CODIFICATION
Section was not enacted as part of the Federal Meat Inspection
Act which is classified to subchapters I to IV of this chapter.
Section was formerly classified to section 94 of this title.
-End-
-CITE-
21 USC Sec. 693 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 693. Inspection of dairy products for export
-STATUTE-
The act of March 3, 1891, as amended, for the inspection of live
cattle and products thereof, shall be deemed to include dairy
products intended for exportation to any foreign country, and the
Secretary of Agriculture may apply, under rules and regulations to
be prescribed by him, the provisions of said act for inspection and
certification appropriate for ascertaining the purity and quality
of such products, and may cause the same to be so marked, stamped,
or labeled as to secure their identity and make known in the
markets of foreign countries to which they may be sent from the
United States their purity, quality, and grade; and all the
provisions of said act relating to live cattle and products thereof
for export shall apply to dairy products so inspected and
certified.
-SOURCE-
(May 23, 1908, ch. 192, 35 Stat. 254.)
-REFTEXT-
REFERENCES IN TEXT
Act of March 3, 1891, referred to in text, is act Mar. 3, 1891,
ch. 555, 26 Stat. 1089, which was superseded by act Mar. 4, 1907,
ch. 2907, 34 Stat. 1260, as amended by act June 29, 1938, ch. 810,
52 Stat. 1235 (formerly classified to section 71 et seq. of this
title). Act Mar. 4, 1907, ch. 2907, was generally revised by Pub.
L. 90-201, Dec. 15, 1967, 81 Stat. 584, and is classified to this
chapter.
-COD-
CODIFICATION
Section was not enacted as part of the Federal Meat Inspection
Act which is classified to subchapters I to IV of this chapter.
Section was formerly classified to sections 94a and 132 of this
title.
-End-
-CITE-
21 USC Sec. 694 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 694. Authorization of appropriations
-STATUTE-
Annual appropriations of the sum of $3,000,000 from the general
fund of the Treasury are authorized for the expenses of the
inspection of cattle, sheep, swine, and goats and the meat and meat
food products thereof which enter into interstate or foreign
commerce and for all expenses necessary to carry into effect the
provisions of this Act relating to meat inspection, including rent
and the employment of labor in Washington and elsewhere, for each
year, and in addition there is authorized to be appropriated such
other sums as may be necessary in the enforcement of the meat
inspection laws.
-SOURCE-
(June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756,
Sec. 2, 48 Stat. 1225.)
-REFTEXT-
REFERENCES IN TEXT
This Act, referred to in text, is act June 30, 1906, ch. 3913, 34
Stat. 669, which made appropriations for the Department of
Agriculture for the fiscal year ending June 30, 1907.
-COD-
CODIFICATION
Section 2 of act June 26, 1934, which was classified to section
725a of former Title 31, Money and Finance, repealed the permanent
appropriation under the title "Meat inspection, Bureau of Animal
Industry (fiscal year) (3-114)" effective July 1, 1935, provided
that such portions of any Acts as make permanent appropriations to
be expended under such account are amended so as to authorize, in
lieu thereof, annual appropriations from the general fund of the
Treasury in identical terms and in such amounts as now provided by
the laws providing such permanent appropriations, and authorized,
in addition thereto, the appropriation of "such other sums as may
be necessary in the enforcement of the meat inspection laws." In
the original, the parenthetical "(U.S.C., title 21, secs. 71 to 96,
inclusive)" followed the phrase "meat inspection laws". The "meat
inspection laws" are classified generally to this chapter.
Section was not enacted as part of the Federal Meat Inspection
Act which is classified to subchapters I to IV of this chapter.
Section was formerly classified to section 95 of this title.
-End-
-CITE-
21 USC Sec. 695 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 12 - MEAT INSPECTION
SUBCHAPTER V - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 695. Payment of cost of meat-inspection service; exception
-STATUTE-
The cost of inspection rendered on and after July 1, 1948, under
the requirements of laws relating to Federal inspection of meat and
meat food products shall be borne by the United States except the
cost of overtime and holiday pay paid pursuant to section 2219a of
title 7.
-SOURCE-
(June 5, 1948, ch. 423, 62 Stat. 344; Pub. L. 107-171, title X,
Sec. 10703(c)(2), May 13, 2002, 116 Stat. 517.)
-REFTEXT-
REFERENCES IN TEXT
Section 2219a of title 7, referred to in text, was in the
original "section 10703 of the Farm Security and Rural Investment
Act of 2002", meaning section 10703 of Pub. L. 107-171, which
enacted section 2219a of Title 7, Agriculture, amended this
section, section 468 of this title, and section 5549 of Title 5,
Government Organization and Employees, and repealed section 394 of
Title 7.
-COD-
CODIFICATION
Section was not enacted as part of the Federal Meat Inspection
Act which is classified to subchapters I to IV of this chapter.
-MISC1-
AMENDMENTS
2002 - Pub. L. 107-171 substituted "overtime and holiday pay paid
pursuant to section 2219a of title 7." for "overtime pursuant to
section 394 of title 7."
Section was formerly classified to section 98 of this title.
-End-
-CITE-
21 USC CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
-HEAD-
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
-MISC1-
SUBCHAPTER I - CONTROL AND ENFORCEMENT
PART A - INTRODUCTORY PROVISIONS
Sec.
801. Congressional findings and declarations: controlled
substances.
801a. Congressional findings and declarations: psychotropic
substances.
802. Definitions.
803. Repealed.
PART B - AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES
811. Authority and criteria for classification of
substances.
812. Schedules of controlled substances.
813. Treatment of controlled substance analogues.
814. Removal of exemption of certain drugs.
PART C - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
821. Rules and regulations.
822. Persons required to register.
823. Registration requirements.
824. Denial, revocation, or suspension of registration.
825. Labeling and packaging.
826. Production quotas for controlled substances.
827. Records and reports of registrants.
828. Order forms.
829. Prescriptions.
830. Regulation of listed chemicals and certain machines.
PART D - OFFENSES AND PENALTIES
841. Prohibited acts A.
842. Prohibited acts B.
843. Prohibited acts C.
844. Penalties for simple possession.
844a. Civil penalty for possession of small amounts of
certain controlled substances.
845 to 845b. Transferred.
846. Attempt and conspiracy.
847. Additional penalties.
848. Continuing criminal enterprise.
849. Transportation safety offenses.
850. Information for sentencing.
851. Proceedings to establish prior convictions.
852. Application of treaties and other international
agreements.
853. Criminal forfeitures.
853a. Transferred.
854. Investment of illicit drug profits.
855. Alternative fine.
856. Maintaining drug-involved premises.
857. Repealed.
858. Endangering human life while illegally manufacturing
controlled substance.
859. Distribution to persons under age twenty-one.
860. Distribution or manufacturing in or near schools and
colleges.
860a. Consecutive sentence for manufacturing or
distributing, or possessing with intent to
manufacture or distribute, methamphetamine on
premises where children are present or reside.
861. Employment or use of persons under 18 years of age in
drug operations.
862. Denial of Federal benefits to drug traffickers and
possessors.
862a. Denial of assistance and benefits for certain
drug-related convictions.
862b. Sanctioning for testing positive for controlled
substances.
863. Drug paraphernalia.
864. Anhydrous ammonia.
865. Smuggling methamphetamine or methamphetamine precursor
chemicals into the United States while using
facilitated entry programs.
PART E - ADMINISTRATIVE AND ENFORCEMENT PROVISIONS
871. Attorney General.
871a. Semiannual reports to Congress.
872. Education and research programs of Attorney General.
872a. Public-private education program.
873. Cooperative arrangements.
874. Advisory committees.
875. Administrative hearings.
876. Subpenas.
877. Judicial review.
878. Powers of enforcement personnel.
879. Search warrants.
880. Administrative inspections and warrants.
881. Forfeitures.
881-1, 881a. Transferred.
882. Injunctions.
883. Enforcement proceedings.
884. Immunity and privilege.
885. Burden of proof; liabilities.
886. Payments and advances.
886a. Diversion Control Fee Account.
887. Coordination and consolidation of post-seizure
administration.
888. Repealed.
889. Production control of controlled substances.
890. Review of Federal sales of chemicals usable to
manufacture controlled substances.
PART F - GENERAL PROVISIONS
901. Severability.
902. Savings provisions.
903. Application of State law.
904. Payment of tort claims.
SUBCHAPTER II - IMPORT AND EXPORT
951. Definitions.
952. Importation of controlled substances.
953. Exportation of controlled substances.
954. Transshipment and in-transit shipment of controlled
substances.
955. Possession on board vessels, etc., arriving in or
departing from United States.
955a to 955d. Transferred.
956. Exemption authority.
957. Persons required to register.
958. Registration requirements.
959. Possession, manufacture, or distribution of controlled
substance.
960. Prohibited acts A.
960a. Foreign terrorist organizations, terrorist persons and
groups.
961. Prohibited acts B.
962. Second or subsequent offenses.
963. Attempt and conspiracy.
964. Additional penalties.
965. Applicability of part E of subchapter I.
966. Authority of Secretary of the Treasury.
967. Smuggling of controlled substances; investigations;
oaths; subpenas; witnesses; evidence; production of
records; territorial limits; fees and mileage of
witnesses.
968. Service of subpena; proof of service.
969. Contempt proceedings.
970. Criminal forfeitures.
971. Notification, suspension of shipment, and penalties
with respect to importation and exportation of listed
chemicals.
-End-
-CITE-
21 USC SUBCHAPTER I - CONTROL AND ENFORCEMENT 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
-HEAD-
SUBCHAPTER I - CONTROL AND ENFORCEMENT
-End-
-CITE-
21 USC Part A - Introductory Provisions 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
-HEAD-
PART A - INTRODUCTORY PROVISIONS
-End-
-CITE-
21 USC Sec. 801 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
-HEAD-
Sec. 801. Congressional findings and declarations: controlled
substances
-STATUTE-
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a
useful and legitimate medical purpose and are necessary to maintain
the health and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and
possession and improper use of controlled substances have a
substantial and detrimental effect on the health and general
welfare of the American people.
(3) A major portion of the traffic in controlled substances flows
through interstate and foreign commerce. Incidents of the traffic
which are not an integral part of the interstate or foreign flow,
such as manufacture, local distribution, and possession,
nonetheless have a substantial and direct effect upon interstate
commerce because -
(A) after manufacture, many controlled substances are
transported in interstate commerce,
(B) controlled substances distributed locally usually have been
transported in interstate commerce immediately before their
distribution, and
(C) controlled substances possessed commonly flow through
interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances
contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate
cannot be differentiated from controlled substances manufactured
and distributed interstate. Thus, it is not feasible to
distinguish, in terms of controls, between controlled substances
manufactured and distributed interstate and controlled substances
manufactured and distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in
controlled substances is essential to the effective control of the
interstate incidents of such traffic.
(7) The United States is a party to the Single Convention on
Narcotic Drugs, 1961, and other international conventions designed
to establish effective control over international and domestic
traffic in controlled substances.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 101, Oct. 27, 1970, 84 Stat. 1242.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in par. (1), was in the original
"this title", meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84
Stat. 1242, as amended, and is popularly known as the "Controlled
Substances Act". For complete classification of title II to the
Code, see second paragraph of Short Title note set out below and
Tables.
-MISC1-
EFFECTIVE DATE
Section 704 of title II of Pub. L. 91-513 provided that:
"(a) Except as otherwise provided in this section, this title
[see Short Title note below] shall become effective on the first
day of the seventh calendar month that begins after the day
immediately preceding the date of enactment [Oct. 27, 1970].
"(b) Parts A, B, E, and F of this title [Parts A, B, E, and F of
this subchapter], section 702 [set out as a note under section 321
of this title], this section, and sections 705 through 709
[sections 901 to 904 of this title and note set out below], shall
become effective upon enactment [Oct. 27, 1970].
"(c) Sections 305 (relating to labels and labeling) [section 825
of this title], and 306 (relating to manufacturing quotas) [section
826 of this title] shall become effective on the date specified in
subsection (a) of this section, except that the Attorney General
may by order published in the Federal Register postpone the
effective date of either or both of these sections for such period
as he may determine to be necessary for the efficient
administration of this title [see Short Title note below]."
SHORT TITLE OF 2006 AMENDMENT
Pub. L. 109-177, title VII, Sec. 701, Mar. 9, 2006, 120 Stat.
256, provided that: "This title [see Tables for classification] may
be cited as the 'Combat Methamphetamine Epidemic Act of 2005'."
SHORT TITLE OF 2005 AMENDMENT
Pub. L. 109-57, Sec. 1(a), Aug. 2, 2005, 119 Stat. 592, provided
that: "This Act [amending section 953 of this title] may be cited
as the 'Controlled Substances Export Reform Act of 2005'."
SHORT TITLE OF 2004 AMENDMENT
Pub. L. 108-358, Sec. 1, Oct. 22, 2004, 118 Stat. 1661, provided
that: "This Act [enacting section 290bb-25f of Title 42, The Public
Health and Welfare, amending sections 802 and 811 of this title,
enacting provisions set out as notes under section 802 of this
title and section 290aa-4 of Title 42 and listed in a table
relating to sentencing guidelines set out as a note under section
994 of Title 28, Judiciary and Judicial Procedure, and amending
provisions set out as a note under section 802 of this title] may
be cited as the 'Anabolic Steroid Control Act of 2004'."
SHORT TITLE OF 2003 AMENDMENT
Pub. L. 108-21, title VI, Sec. 608(a), Apr. 30, 2003, 117 Stat.
691, provided that: "This section [amending sections 843 and 856 of
this title and enacting provisions listed in a table relating to
sentencing guidelines set out as a note under section 994 of Title
28, Judiciary and Judicial Procedure] may be cited as the 'Illicit
Drug Anti-Proliferation Act of 2003'."
SHORT TITLE OF 2000 AMENDMENTS
Pub. L. 106-310, div. B, title XXXV, Sec. 3501, Oct. 17, 2000,
114 Stat. 1222, provided that: "This title [amending sections 823
and 824 of this title] may be cited as the 'Drug Addiction
Treatment Act of 2000'."
Pub. L. 106-310, div. B, title XXXVI, Sec. 3601, Oct. 17, 2000,
114 Stat. 1227, provided that: "This title [enacting section 864 of
this title and sections 290aa-5b and 290bb-9 of Title 42, The
Public Health and Welfare, amending sections 802, 830, 853, 856,
and 863 of this title, sections 3663 and 3663A of Title 18, Crimes
and Criminal Procedure, section 524 of Title 28, Judiciary and
Judicial Procedure, and sections 285o-2 and 3751 of Title 42, and
enacting provisions set out as notes under this section and
sections 802, 872, 873, 886, and 1706 of this title, sections 524
and 994 of Title 28, and sections 201, 290aa-4, 290aa-5b and 3751
of Title 42] may be cited as the 'Methamphetamine Anti-
Proliferation Act of 2000'."
Pub. L. 106-172, Sec. 1, Feb. 18, 2000, 114 Stat. 7, provided
that: "This Act [amending sections 802, 827, 841 and 960 of this
title and enacting provisions set out as notes under this section
and section 812 of this title] may be cited as the 'Hillory J.
Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000'."
SHORT TITLE OF 1998 AMENDMENT
Pub. L. 105-277, div. C, title VIII, Sec. 801(a), Oct. 21, 1998,
112 Stat. 2681-693, provided that: "This title [enacting section
1713 of this title and section 2291-5 of Title 22, Foreign
Relations and Intercourse, amending section 956 of this title, and
enacting provisions set out as notes under sections 801 and 956 of
this title and section 2291 of Title 22] may be cited as the
'Western Hemisphere Drug Elimination Act'."
Pub. L. 105-277, div. C, title VIII, subtitle G (Secs. 871, 872),
Sec. 871, Oct. 21, 1998, 112 Stat. 2681-707, and Pub. L. 105-357,
Sec. 1, Nov. 10, 1998, 112 Stat. 3271, provided that such subtitle
and such Act, which amended section 956 of this title and enacted
provisions set out as notes under section 956 of this title "may be
cited as the 'Controlled Substances Trafficking Prohibition Act'."
Pub. L. 105-277, div. E, Sec. 1, Oct. 21, 1998, 112 Stat. 2681-
759, provided that: "This division [amending sections 841 and 960
of this title and section 13705 of Title 42, The Public Health and
Welfare] may be cited as the 'Methamphetamine Trafficking Penalty
Enhancement Act of 1998'."
SHORT TITLE OF 1996 AMENDMENTS
Pub. L. 104-305, Sec. 1, Oct. 13, 1996, 110 Stat. 3807, provided
that: "This Act [amending sections 841, 844, 959, and 960 of this
title and enacting provisions set out as notes under section 872 of
this title and section 994 of Title 28, Judiciary and Judicial
Procedure] may be cited as the 'Drug-Induced Rape Prevention and
Punishment Act of 1996'."
Pub. L. 104-237, Sec. 1(a), Oct. 3, 1996, 110 Stat. 3099,
provided that: "This Act [enacting section 872a of this title,
amending sections 802, 814, 830, 841 to 844, 853, 881, 959, and 960
of this title and section 1607 of Title 19, Customs Duties, and
enacting provisions set out as notes under this section and
sections 802, 872, and 971 of this title, section 994 of Title 28,
Judiciary and Judicial Procedure, and section 290aa-4 of Title 42,
The Public Health and Welfare] may be cited as the 'Comprehensive
Methamphetamine Control Act of 1996'."
SHORT TITLE OF 1994 AMENDMENT
Pub. L. 103-322, title XVIII, Sec. 180201(a), Sept. 13, 1994, 108
Stat. 2046, provided that: "This section [enacting section 849 of
this title, amending section 841 of this title, and enacting
provisions set out as a note under section 994 of Title 28,
Judiciary and Judicial Procedure] may be cited as the 'Drug Free
Truck Stop Act'."
SHORT TITLE OF 1993 AMENDMENT
Pub. L. 103-200, Sec. 1, Dec. 17, 1993, 107 Stat. 2333, provided
that: "This Act [enacting section 814 of this title, amending
sections 802, 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of
this title, and enacting provisions set out as a note under section
802 of this title] may be cited as the 'Domestic Chemical Diversion
Control Act of 1993'."
SHORT TITLE OF 1990 AMENDMENT
Pub. L. 101-647, title XIX, Sec. 1901, Nov. 29, 1990, 104 Stat.
4851, provided that: "This Act [probably means title XIX of Pub. L.
101-647, which amended sections 333, 802, 812, and 844 of this
title and section 290aa-6 of Title 42, The Public Health and
Welfare, repealed section 333a of this title, and enacted
provisions set out as notes under sections 802 and 829 of this
title] may be cited as the 'Anabolic Steroids Control Act of
1990'."
SHORT TITLE OF 1988 AMENDMENT
Pub. L. 100-690, title VI, Sec. 6001, Nov. 18, 1988, 102 Stat.
4312, provided that: "This title [see Tables for classification]
may be cited as the 'Anti-Drug Abuse Amendments Act of 1988'."
Pub. L. 100-690, title VI, Sec. 6051, Nov. 18, 1988, 102 Stat.
4312, provided that: "This subtitle [subtitle A (Secs. 6051-6061)
of title VI of Pub. L. 100-690, enacting section 971 of this title,
amending sections 802, 830, 841 to 843, 872, 876, 881, 960, and 961
of this title, and enacting provisions set out as notes under
sections 802 and 971 of this title] may be cited as the 'Chemical
Diversion and Trafficking Act of 1988'."
Pub. L. 100-690, title VI, Sec. 6071, Nov. 18, 1988, 102 Stat.
4320, provided that: "This subtitle [subtitle B (Secs. 6071-6080)
of title VI of Pub. L. 100-690, enacting sections 881-1, 887, and
1509 of this title, amending section 881 of this title, section
1594 of Title 19, Customs Duties, section 524 of Title 28,
Judiciary and Judicial Procedure, and section 782 of former Title
49, Transportation, and enacting provisions set out as notes under
section 881 of this title] may be cited as the 'Asset Forfeiture
Amendments Act of 1988'."
SHORT TITLE OF 1986 AMENDMENT
Pub. L. 99-570, Sec. 1, Oct. 27, 1986, 100 Stat. 3207, provided
that: "This Act [see Tables for classification] may be cited as the
'Anti-Drug Abuse Act of 1986'."
Pub. L. 99-570, title I, Sec. 1001, Oct. 27, 1986, 100 Stat. 3207-
2, provided that: "This subtitle [subtitle A (Secs. 1001-1009) of
title I of Pub. L. 99-570, amending sections 802, 841, 845, 845a,
848, 881, 960, and 962 of this title, sections 3553 and 3583 of
Title 18, Crimes and Criminal Procedure, rule 35 of the Federal
Rules of Criminal Procedure, Title 18, Appendix, and section 994 of
Title 28, Judiciary and Judicial Procedure, and enacting provisions
set out as notes under section 841 of this title, sections 3553 and
3583 of Title 18, and rule 35 of the Federal Rules of Criminal
Procedure] may be cited as the 'Narcotics Penalties and Enforcement
Act of 1986'."
Pub. L. 99-570, title I, Sec. 1051, Oct. 27, 1986, 100 Stat. 3207-
8, provided that: "This subtitle [subtitle B (Secs. 1051, 1052) of
title I of Pub. L. 99-570, amending section 844 of this title] may
be cited as the 'Drug Possession Penalty Act of 1986'."
Pub. L. 99-570, title I, Sec. 1101, Oct. 27, 1986, 100 Stat. 3207-
10, provided that: "This subtitle [subtitle C (Secs. 1101-1105) of
title I of Pub. L. 99-570, enacting section 845b of this title and
amending sections 841, 845, and 845a of this title] may be cited as
the 'Juvenile Drug Trafficking Act of 1986'."
Pub. L. 99-570, title I, Sec. 1201, Oct. 27, 1986, 100 Stat. 3207-
13, provided that: "This subtitle [subtitle E (Secs. 1201-1204) of
title I of Pub. L. 99-570, enacting section 813 of this title and
amending section 802 of this title] may be cited as the 'Controlled
Substance Analogue Enforcement Act of 1986'."
Pub. L. 99-570, title I, Sec. 1251, Oct. 27, 1986, 100 Stat. 3207-
14, provided that: "This subtitle [subtitle F (Secs. 1251-1253) of
title I of Pub. L. 99-570, amending section 848 of this title] may
be cited as the 'Continuing Drug Enterprises Act of 1986'."
Pub. L. 99-570, title I, Sec. 1301, Oct. 27, 1986, 100 Stat. 3207-
15, provided that: "This subtitle [subtitle G (Secs. 1301, 1302)
of title I of Pub. L. 99-570, amending section 960 of this title]
may be cited as the 'Controlled Substances Import and Export
Penalties Enhancement Act of 1986'."
Pub. L. 99-570, title I, Sec. 1821, Oct. 27, 1986, 100 Stat. 3207-
51, which provided that subtitle O (Secs. 1821-1823) of title I of
Pub. L. 99-570, enacting section 857 of this title and provisions
set out as a note under section 857 of this title, was to be cited
as the "Mail Order Drug Paraphernalia Control Act", was repealed by
Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov. 29, 1990, 104 Stat.
4859.
Pub. L. 99-570, title I, Sec. 1991, Oct. 27, 1986, 100 Stat. 3207-
59, provided that: "This subtitle [subtitle U (Secs. 1991, 1992)
of title I of Pub. L. 99-570, amending section 881 of this title]
may be cited as the 'Federal Drug Law Enforcement Agent Protection
Act of 1986'."
SHORT TITLE OF 1984 AMENDMENT
Pub. L. 98-473, title II, Sec. 501, Oct. 12, 1984, 98 Stat. 2068,
provided that: "This chapter [chapter V (Secs. 501-525) of title II
of Pub. L. 98-473, enacting section 845a of this title, amending
sections 802, 811, 812, 822-824, 827, 841, 843, 845, 873, 881, 952,
953, 957, 958, 960, and 962 of this title, and enacting provisions
set out as a note under this section] may be cited as the
'Controlled Substances Penalties Amendments Act of 1984'."
Pub. L. 98-473, title II, Sec. 506(a), Oct. 12, 1984, 98 Stat.
2070, provided that: "This part [part B of chapter V (Secs. 506-
525) of title II of Pub. L. 98-473, amending sections 802, 811,
812, 822-824, 827, 843, 873, 881, 952, 953, 957, and 958 of this
title] may be cited as the 'Dangerous Drug Diversion Control Act of
1984'."
SHORT TITLE OF 1978 AMENDMENT
Pub. L. 95-633, Sec. 1, Nov. 10, 1978, 92 Stat. 3768, provided:
"That this Act [enacting sections 801a, 830, and 852 of this title,
amending sections 352, 802, 811, 812, 823, 827, 841 to 843, 872,
881, 952, 953, and 965 of this title and section 242a of Title 42,
The Public Health and Welfare, repealing section 830 of this title
(effective Jan. 1, 1981), and enacting provisions set out as notes
under sections 801a, 812, and 830 of this title] may be cited as
the 'Psychotropic Substances Act of 1978'."
SHORT TITLE OF 1974 AMENDMENT
Pub. L. 93-281, Sec. 1, May 14, 1974, 88 Stat. 124, provided:
"That this Act [amending sections 802, 823, 824, and 827 of this
title] may be cited as the 'Narcotic Addict Treatment Act of
1974'."
SHORT TITLE
Pub. L. 91-513, in the provisions preceding section 1 immediately
following the enacting clause, provided: "That this Act [enacting
this chapter and sections 257a, 2688l-1, 2688n-1, and 3509 of Title
42, The Public Health and Welfare, amending sections 162, 198a,
321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114,
1952, and 4251 of Title 18, Crimes and Criminal Procedure, sections
1584, 2078, 2079, and 2080 of Title 19, Customs Duties, sections
4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and
7655 of Title 26, Internal Revenue Code, section 2901 of Title 28,
Judiciary and Judicial Procedure, section 304m of former Title 40,
Public Buildings, Property, and Works, sections 201, 225a, 242,
242a, 246, 257, 258, 259, 260, 261, 261a, 2688k, 2688l, 2688m,
2688n, 2688o, 2688r, and 3411 of Title 42, The Public Health and
Welfare, section 239a of former Title 46, Shipping, and section 787
of Title 49, Appendix, Transportation, repealing sections 171 to
174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 360a, and
501 to 517 of this title, sections 1401 to 1407 and 3616 of Title
18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to
4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237,
7238, and 7491 of Title 26, sections 529a and 529g of former Title
31, Money and Finance, and section 1421m of Title 48, Territories
and Insular Possessions, and enacting provisions set out as notes
under this section and sections 171, 321, 822, 951, and 957 of this
title] may be cited as the 'Comprehensive Drug Abuse Prevention and
Control Act of 1970'."
Section 100 of title II of Pub. L. 91-513 provided that: "This
title [enacting this subchapter, repealing section 360a of this
title, amending sections 321, 331, 333, 334, 360, 372, and 381 of
this title, sections 1114 and 1952 of Title 18, Crimes and Criminal
Procedure, and section 242 of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under this
section and sections 321 and 822 of this title] may be cited as the
'Controlled Substances Act'."
For short title and complete classification of title III of Pub.
L. 91-513, which enacted subchapter II of this chapter, as the
"Controlled Substances Import and Export Act", see section 1000 of
Pub. L. 91-513, set out as a note under section 951 of this title.
SEVERABILITY
Pub. L. 106-310, div. B, title XXXVI, Sec. 3673, Oct. 17, 2000,
114 Stat. 1246, provided that: "Any provision of this title [see
Short Title of 2000 Amendments note above] held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed as to give the maximum effect
permitted by law, unless such provision is held to be utterly
invalid or unenforceable, in which event such provision shall be
severed from this title and shall not affect the applicability of
the remainder of this title, or of such provision, to other persons
not similarly situated or to other, dissimilar circumstances."
CONTINUATION OF ORDERS, RULES, AND REGULATIONS
Section 705 of title II of Pub. L. 91-513 provided that: "Any
orders, rules, and regulations which have been promulgated under
any law affected by this title [see Short Title note above] and
which are in effect on the day preceding enactment of this title
[Oct. 27, 1970] shall continue in effect until modified,
superseded, or repealed."
ANTI-DRUG MESSAGES ON FEDERAL GOVERNMENT INTERNET SITES
Pub. L. 106-391, title III, Sec. 320, Oct. 30, 2000, 114 Stat.
1597, provided that: "Not later than 90 days after the date of the
enactment of this Act [Oct. 30, 2000], the Administrator [of the
National Aeronautics and Space Administration], in consultation
with the Director of the Office of National Drug Control Policy,
shall place anti-drug messages on Internet sites controlled by the
National Aeronautics and Space Administration."
Pub. L. 106-310, div. B, title XXXVI, Sec. 3671, Oct. 17, 2000,
114 Stat. 1245, provided that: "Not later than 90 days after the
date of the enactment of this Act [Oct. 17, 2000], the head of each
department, agency, and establishment of the Federal Government
shall, in consultation with the Director of the Office of National
Drug Control Policy, place antidrug messages on appropriate
Internet websites controlled by such department, agency, or
establishment which messages shall, where appropriate, contain an
electronic hyperlink to the Internet website, if any, of the
Office."
PROTOCOLS FOR INVESTIGATIONS AND PROSECUTIONS RELATING TO DATE-RAPE
DRUGS AND OTHER CONTROLLED SUBSTANCES; ANNUAL REPORT; NATIONAL
AWARENESS CAMPAIGN
Pub. L. 106-172, Secs. 6, 7, Feb. 18, 2000, 114 Stat. 11,
provided that:
"SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS,
FORENSIC FIELD TESTS, AND COORDINATION MECHANISM FOR
INVESTIGATIONS AND PROSECUTIONS RELATING TO GAMMA
HYDROXYBUTYRIC ACID, OTHER CONTROLLED SUBSTANCES, AND DESIGNER
DRUGS.
"(a) In General. - The Attorney General, in consultation with the
Administrator of the Drug Enforcement Administration and the
Director of the Federal Bureau of Investigation, shall -
"(1) develop -
"(A) model protocols for the collection of toxicology
specimens and the taking of victim statements in connection
with investigations into and prosecutions related to possible
violations of the Controlled Substances Act [21 U.S.C. 801 et
seq.] or other Federal or State laws that result in or
contribute to rape, other crimes of violence, or other crimes
involving abuse of gamma hydroxybutyric acid, other controlled
substances, or so-called 'designer drugs'; and
"(B) model training materials for law enforcement personnel
involved in such investigations; and
"(2) make such protocols and training materials available to
Federal, State, and local personnel responsible for such
investigations.
"(b) Grant. -
"(1) In general. - The Attorney General shall make a grant, in
such amount and to such public or private person or entity as the
Attorney General considers appropriate, for the development of
forensic field tests to assist law enforcement officials in
detecting the presence of gamma hydroxybutyric acid and related
substances.
"(2) Authorization of appropriations. - There are authorized to
be appropriated such sums as may be necessary to carry out this
subsection.
"(c) Report. - Not later than 180 days after the date of the
enactment of this Act [Feb. 18, 2000], the Attorney General shall
submit to the Committees on the Judiciary of the Senate and House
of Representatives a report on current mechanisms for coordinating
Federal, State, and local investigations into and prosecutions
related to possible violations of the Controlled Substances Act [21
U.S.C. 801 et seq.] or other Federal or State laws that result in
or contribute to rape, other crimes of violence, or other crimes
involving the abuse of gamma hydroxybutyric acid, other controlled
substances, or so-called 'designer drugs'. The report shall also
include recommendations for the improvement of such mechanisms.
"SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL
AWARENESS CAMPAIGN.
"(a) Annual Report. - The Secretary of Health and Human Services
(in this section referred to as the 'Secretary') shall periodically
submit to Congress reports each of which provides an estimate of
the number of incidents of the abuse of date-rape drugs (as defined
in subsection (c)) that occurred during the most recent 1-year
period for which data are available. The first such report shall be
submitted not later than January 15, 2000, and subsequent reports
shall be submitted annually thereafter.
"(b) National Awareness Campaign. -
"(1) Development of plan; recommendations of advisory
committee. -
"(A) In general. - The Secretary, in consultation with the
Attorney General, shall develop a plan for carrying out a
national campaign to educate individuals described in
subparagraph (B) on the following:
"(i) The dangers of date-rape drugs.
"(ii) The applicability of the Controlled Substances Act
[21 U.S.C. 801 et seq.] to such drugs, including penalties
under such Act.
"(iii) Recognizing the symptoms that indicate an individual
may be a victim of such drugs, including symptoms with
respect to sexual assault.
"(iv) Appropriately responding when an individual has such
symptoms.
"(B) Intended population. - The individuals referred to in
subparagraph (A) are young adults, youths, law enforcement
personnel, educators, school nurses, counselors of rape
victims, and emergency room personnel in hospitals.
"(C) Advisory committee. - Not later than 180 days after the
date of the enactment of this Act [Feb. 18, 2000], the
Secretary shall establish an advisory committee to make
recommendations to the Secretary regarding the plan under
subparagraph (A). The committee shall be composed of
individuals who collectively possess expertise on the effects
of date-rape drugs and on detecting and controlling the drugs.
"(2) Implementation of plan. - Not later than 180 days after
the date on which the advisory committee under paragraph (1) is
established, the Secretary, in consultation with the Attorney
General, shall commence carrying out the national campaign under
such paragraph in accordance with the plan developed under such
paragraph. The campaign may be carried out directly by the
Secretary and through grants and contracts.
"(3) Evaluation by general accounting office [now Government
Accountability Office]. - Not later than 2 years after the date
on which the national campaign under paragraph (1) is commenced,
the Comptroller General of the United States shall submit to
Congress an evaluation of the effects with respect to date-rape
drugs of the national campaign.
"(c) Definition. - For purposes of this section, the term 'date-
rape drugs' means gamma hydroxybutyric acid and its salts,
isomers, and salts of isomers and such other drugs or substances as
the Secretary, after consultation with the Attorney General,
determines to be appropriate."
CONGRESSIONAL FINDINGS REGARDING METHAMPHETAMINE MANUFACTURE AND
ABUSE
Pub. L. 104-237, Sec. 2, Oct. 3, 1996, 110 Stat. 3100, provided
that: "The Congress finds the following:
"(1) Methamphetamine is a very dangerous and harmful drug. It
is highly addictive and is associated with permanent brain damage
in long-term users.
"(2) The abuse of methamphetamine has increased dramatically
since 1990. This increased use has led to devastating effects on
individuals and the community, including -
"(A) a dramatic increase in deaths associated with
methamphetamine ingestion;
"(B) an increase in the number of violent crimes associated
with methamphetamine ingestion; and
"(C) an increase in criminal activity associated with the
illegal importation of methamphetamine and precursor compounds
to support the growing appetite for this drug in the United
States.
"(3) Illegal methamphetamine manufacture and abuse presents an
imminent public health threat that warrants aggressive law
enforcement action, increased research on methamphetamine and
other substance abuse, increased coordinated efforts to prevent
methamphetamine abuse, and increased monitoring of the public
health threat methamphetamine presents to the communities of the
United States."
SUPPORT FOR INTERNATIONAL EFFORTS TO CONTROL METHAMPHETAMINE AND
PRECURSORS
Pub. L. 104-237, title I, Sec. 101, Oct. 3, 1996, 110 Stat. 3100,
provided that: "The Attorney General, in consultation with the
Secretary of State, shall coordinate international drug enforcement
efforts to decrease the movement of methamphetamine and
methamphetamine precursors into the United States."
INTERAGENCY METHAMPHETAMINE TASK FORCE
Pub. L. 104-237, title V, Sec. 501, Oct. 3, 1996, 110 Stat. 3111,
provided that:
"(a) Establishment. - There is established a 'Methamphetamine
Interagency Task Force' (referred to as the 'interagency task
force') which shall consist of the following members:
"(1) The Attorney General, or a designee, who shall serve as
chair.
"(2) 2 representatives selected by the Attorney General.
"(3) The Secretary of Education or a designee.
"(4) The Secretary of Health and Human Services or a designee.
"(5) 2 representatives of State and local law enforcement and
regulatory agencies, to be selected by the Attorney General.
"(6) 2 representatives selected by the Secretary of Health and
Human Services.
"(7) 5 nongovernmental experts in drug abuse prevention and
treatment to be selected by the Attorney General.
"(b) Responsibilities. - The interagency task force shall be
responsible for designing, implementing, and evaluating the
education and prevention and treatment practices and strategies of
the Federal Government with respect to methamphetamine and other
synthetic stimulants.
"(c) Meetings. - The interagency task force shall meet at least
once every 6 months.
"(d) Funding. - The administrative expenses of the interagency
task force shall be paid out of existing Department of Justice
appropriations.
"(e) FACA. - The Federal Advisory Committee Act (5 U.S.C. App. 2)
[5 U.S.C. App.] shall apply to the interagency task force.
"(f) Termination. - The interagency task force shall terminate 4
years after the date of enactment of this Act [Oct. 3, 1996]."
SUSPICIOUS ORDERS TASK FORCE
Pub. L. 104-237, title V, Sec. 504, Oct. 3, 1996, 110 Stat. 3112,
provided that:
"(a) In General. - The Attorney General shall establish a
'Suspicious Orders Task Force' (the 'Task Force') which shall
consist of -
"(1) appropriate personnel from the Drug Enforcement
Administration (the 'DEA') and other Federal, State, and local
law enforcement and regulatory agencies with the experience in
investigating and prosecuting illegal transactions of listed
chemicals and supplies; and
"(2) representatives from the chemical and pharmaceutical
industry.
"(b) Responsibilities. - The Task Force shall be responsible for
developing proposals to define suspicious orders of listed
chemicals, and particularly to develop quantifiable parameters
which can be used by registrants in determining if an order is a
suspicious order which must be reported to DEA. The quantifiable
parameters to be addressed will include frequency of orders,
deviations from prior orders, and size of orders. The Task Force
shall also recommend provisions as to what types of payment
practices or unusual business practices shall constitute prima
facie suspicious orders. In evaluating the proposals, the Task
Force shall consider effectiveness, cost and feasibility for
industry and government, and other relevant factors.
"(c) Meetings. - The Task Force shall meet at least two times per
year and at such other times as may be determined necessary by the
Task Force.
"(d) Report. - The Task Force shall present a report to the
Attorney General on its proposals with regard to suspicious orders
and the electronic reporting of suspicious orders within one year
of the date of enactment of this Act [Oct. 3, 1996]. Copies of the
report shall be forwarded to the Committees of the Senate and House
of Representatives having jurisdiction over the regulation of
listed chemical and controlled substances.
"(e) Funding. - The administrative expenses of the Task Force
shall be paid out of existing Department of Justice funds or
appropriations.
"(f) FACA. - The Federal Advisory Committee Act (5 U.S.C. App. 2)
[5 U.S.C. App.] shall apply to the Task Force.
"(g) Termination. - The Task Force shall terminate upon
presentation of its report to the Attorney General, or two years
after the date of enactment of this Act [Oct. 3, 1996], whichever
is sooner."
JOINT FEDERAL TASK FORCE ON ILLEGAL DRUG LABORATORIES
Pub. L. 100-690, title II, Sec. 2405, Nov. 18, 1988, 102 Stat.
4231, provided that:
"(a) Establishment of Task Force. - There is established the
Joint Federal Task Force on Illegal Drug Laboratories (hereafter in
this section referred to as the 'Task Force').
"(b) Appointment and Membership of Task Force. - The members of
the Task Force shall be appointed by the Administrators of the
Environmental Protection Agency and the Drug Enforcement
Administration (hereafter in this section referred to as the
'Administrators'). The Task Force shall consist of at least 6 and
not more than 20 members. Each Administrator shall appoint one-half
of the members as follows: (1) the Administrator of the
Environmental Protection Agency shall appoint members from among
Emergency Response Technicians and other appropriate employees of
the Agency; and (2) the Administrator of the Drug Enforcement
Administration shall appoint members from among Special Agents
assigned to field divisions and other appropriate employees of the
Administration.
"(c) Duties of Task Force. - The Task Force shall formulate,
establish, and implement a program for the cleanup and disposal of
hazardous waste produced by illegal drug laboratories. In
formulating such program, the Task Force shall consider the
following factors:
"(1) The volume of hazardous waste produced by illegal drug
laboratories.
"(2) The cost of cleaning up and disposing of hazardous waste
produced by illegal drug laboratories.
"(3) The effectiveness of the various methods of cleaning up
and disposing of hazardous waste produced by illegal drug
laboratories.
"(4) The coordination of the efforts of the Environmental
Protection Agency and the Drug Enforcement Administration in
cleaning up and disposing of hazardous waste produced by illegal
drug laboratories.
"(5) The dissemination of information to law enforcement
agencies that have responsibility for enforcement of drug laws.
"(d) Guidelines. - The Task Force shall recommend to the
Administrators guidelines for cleanup of illegal drug laboratories
to protect the public health and environment. Not later than 180
days after the date of the enactment of this subtitle [Nov. 18,
1988], the Administrators shall formulate and publish such
guidelines.
"(e) Demonstration Projects. -
"(1) The Attorney General shall make grants to, and enter into
contracts with, State and local governments for demonstration
projects to clean up and safely dispose of substances associated
with illegal drug laboratories which may present a danger to
public health or the environment.
"(2) The Attorney General may not under this subsection make a
grant or enter into a contract unless the applicant for such
assistance agrees to comply with the guidelines issued pursuant
to subsection (d).
"(3) The Attorney General shall, through grant or contract,
provide for independent evaluations of the activities carried out
pursuant to this subsection and shall recommend appropriate
legislation to the Congress.
"(f) Funding. - Of the amounts made available to carry out the
Controlled Substances Act [21 U.S.C. 801 et seq.] for fiscal year
1989, not less than $5,000,000 shall be made available to carry out
subsections (d) and (e).
"(g) Reports. - After consultation with the Task Force, the
Administrators shall -
"(1) transmit to the President and to each House of Congress
not later than 270 days after the date of the enactment of this
subtitle [Nov. 18, 1988] a report describing the program
established by the Task Force under subsection (c) (including an
analysis of the factors specified in paragraphs (1) through (5)
of that subsection);
"(2) periodically transmit to the President and to each House
of Congress reports describing the implementation of the program
established by the Task Force under subsection (c) (including an
analysis of the factors specified in paragraphs (1) through (5)
of that subsection) and the progress made in the cleanup and
disposal of hazardous waste produced by illegal drug
laboratories; and
"(3) transmit to each House of Congress a report describing the
findings made as a result of the evaluations referred to in
subsection (e)(3)."
GREAT LAKES DRUG INTERDICTION
Pub. L. 100-690, title VII, Sec. 7404, Nov. 18, 1988, 102 Stat.
4484, provided that:
"(a) Interagency Agreement. - The Secretary of Transportation and
the Secretary of the Treasury shall enter into an agreement for the
purpose of increasing the effectiveness of maritime drug
interdiction activities of the Coast Guard and the Customs Service
in the Great Lakes area.
"(b) Negotiations With Canada on Drug Enforcement Cooperation. -
The Secretary of State is encouraged to enter into negotiations
with appropriate officials of the Government of Canada for the
purpose of establishing an agreement between the United States and
Canada which provides for increased cooperation and sharing of
information between United States and Canadian law enforcement
officials with respect to law enforcement efforts conducted on the
Great Lakes between the United States and Canada."
[For transfer of authorities, functions, personnel, and assets of
the Coast Guard, including the authorities and functions of the
Secretary of Transportation relating thereto, to the Department of
Homeland Security, and for treatment of related references, see
sections 468(b), 551(d), 552(d), and 557 of Title 6, Domestic
Security, and the Department of Homeland Security Reorganization
Plan of November 25, 2002, as modified, set out as a note under
section 542 of Title 6.]
[For transfer of functions, personnel, assets, and liabilities of
the United States Customs Service of the Department of the
Treasury, including functions of the Secretary of the Treasury
relating thereto, to the Secretary of Homeland Security, and for
treatment of related references, see sections 203(1), 551(d),
552(d), and 557 of Title 6, Domestic Security, and the Department
of Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.]
GAO STUDY OF CAPABILITIES OF UNITED STATES TO CONTROL DRUG
SMUGGLING INTO UNITED STATES
Pub. L. 100-180, div. A, title XII, Sec. 1241, Dec. 4, 1987, 101
Stat. 1162, directed Comptroller General of the United States to
conduct a comprehensive study regarding smuggling of illegal drugs
into United States and current capabilities of United States to
deter such smuggling, with special consideration given to issues
involving use of military and National Guard units along with
Customs Service in cooperative drug smuggling interdiction efforts,
and to issue, not later than Apr. 30, 1988, and Mar. 31, 1989,
reports to Congress outlining results of this study.
COMPLIANCE WITH BUDGET ACT
Pub. L. 99-570, Sec. 3, Oct. 27, 1986, 100 Stat. 3207-1, provided
that: "Notwithstanding any other provision of this Act [see Tables
for classification], any spending authority and any credit
authority provided under this Act shall be effective for any fiscal
year only to such extent or in such amounts as are provided in
appropriation Acts. For purposes of this Act, the term 'spending
authority' has the meaning provided in section 401(c)(2) of the
Congressional Budget Act of 1974 [2 U.S.C. 651(c)(2)] and the term
'credit authority' has the meaning provided in section 3(10) of the
Congresssional [sic] Budget Act of 1974 [2 U.S.C. 622(10)]."
DRUG INTERDICTION
Pub. L. 99-570, title III, Secs. 3001-3003, 3301, Oct. 27, 1986,
100 Stat. 3207-73, 3207-74, 3207-98, as amended by Pub. L. 104-66,
title I, Sec. 1091(a), Dec. 21, 1995, 109 Stat. 722, provided that:
"SEC. 3001. SHORT TITLE.
"This title [enacting section 379 of Title 10, Armed Forces,
sections 1590, 1628, 1629, and 2081 of Title 19, Customs Duties,
and section 312a of Title 47, Telegraphs, Telephones, and
Radiotelegraphs, amending section 959 of this title, sections 374
and 911 of Title 10, sections 507, 1401, 1433, 1436, 1454, 1459,
1497, 1509, 1584 to 1586, 1594 to 1595a, 1613, 1613b, 1619, and
1622 of Title 19, section 5316 of Title 31, Money and Finance,
section 12109 of Title 46, Shipping, sections 1901 to 1904 of Title
46, Appendix, Shipping, and sections 1401, 1472, 1474, and 1509 of
former Title 49, Transportation, repealing section 1460 of Title
19, enacting provisions set out as notes under section 801 of this
title, sections 371, 374, 525, and 9441 of Title 10, sections 1613b
and 1654 of Title 19, section 403 of Title 23, Highways, section
1901 of Title 46, Appendix, section 11344 of Title 49, and section
1509 of former Title 49, and repealing provisions set out as a note
under section 89 of Title 14, Coast Guard] may be cited as the
'National Drug Interdiction Improvement Act of 1986'.
"SEC. 3002. FINDINGS.
"The Congress hereby finds that -
"(1) a balanced, coordinated, multifaceted strategy for
combating the growing drug abuse and drug trafficking problem in
the United States is essential in order to stop the flow and
abuse of drugs within our borders;
"(2) a balanced, coordinated, multifaceted strategy for
combating the narcotics drug abuse and trafficking in the United
States should include -
"(A) increased investigations of large networks of drug
smuggler organizations;
"(B) source country drug eradication;
"(C) increased emphasis on stopping narcotics traffickers in
countries through which drugs are transshipped;
"(D) increased emphasis on drug education programs in the
schools and workplace;
"(E) increased Federal Government assistance to State and
local agencies, civic groups, school systems, and officials in
their efforts to combat the drug abuse and trafficking problem
at the local level; and
"(F) increased emphasis on the interdiction of drugs and drug
smugglers at the borders of the United States, in the air, at
sea, and on the land;
"(3) funds to support the interdiction of narcotics smugglers
who threaten the transport of drugs through the air, on the sea,
and across the land borders of the United States should be
emphasized in the Federal Government budget process to the same
extent as the other elements of a comprehensive antidrug effort
are emphasized;
"(4) the Department of Defense and the use of its resources
should be an integral part of a comprehensive, natonal [national]
drug interdiction program;
"(5) the Federal Government civilian agencies engaged in drug
interdiction, particularly the United States Customs Service and
the Coast Guard, currently lack the aircraft, ships, radar,
command, control, communications, and intelligence (C3I) system,
and manpower resources necessary to mount a comprehensive attack
on the narcotics traffickers who threaten the United States;
"(6) the civilian drug interdiction agencies of the United
States are currently interdicting only a small percentage of the
illegal, drug smuggler penetrations in the United States every
year;
"(7) the budgets for our civilian drug interdiction agencies,
primarily the United States Customs Service and the Coast Guard,
have not kept pace with those of the traditional investigative
law enforcement agencies of the Department of Justice; and
"(8) since the amendment of the Posse Comitatus Act (18 U.S.C.
1385) in 1981, the Department of Defense has assisted in the
effort to interdict drugs, but they can do more.
"SEC. 3003. PURPOSES.
"It is the purpose of this title -
"(1) to increase the level of funding and resources available
to civilian drug interdiction agencies of the Federal Government;
"(2) to increase the level of support from the Department of
Defense as consistent with the Posse Comitatus Act [18 U.S.C.
1385], for interdiction of the narcotics traffickers before such
traffickers penetrate the borders of the United States; and
"(3) to improve other drug interdiction programs of the Federal
Government.
"SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG
INTERDICTION TASK FORCE
"(a) Authorization of Appropriations. -
"(1) Establishment of a united states-bahamas drug interdiction
task force. - (A) There is authorized to be established a United
States-Bahamas Drug Interdiction Task Force to be operated
jointly by the United States Government and the Government of the
Bahamas.
"(B) The Secretary of State, the Commandant of the Coast Guard,
the Commissioner of Customs, the Attorney General, and the head
of the National Narcotics Border Interdiction System (NNBIS),
shall upon enactment of this Act [Oct. 27, 1986], immediately
commence negotiations with the Government of the Bahamas to enter
into a detailed agreement for the establishment and operation of
a new drug interdiction task force, including plans for (i) the
joint operation and maintenance of any drug interdiction assets
authorized for the task force in this section and section 3141
[see 19 U.S.C. 2075], and (ii) any training and personnel
enhancements authorized in this section and section 3141.
"(2) Amounts authorized. - There are authorized to be
appropriated, in addition to any other amounts authorized to be
appropriated in this title [see section 3001 of Pub. L. 99-570
set out above], $10,000,000 for the following:
"(A) $9,000,000 for 3 drug interdiction pursuit helicopters
for use primarily for operations of the United States-Bahamas
Drug Interdiction Task Force established under this section;
and
"(B) $1,000,000 to enhance communications capabilities for
the operation of a United States-Bahamas Drug Interdiction Task
Force established under this section.
"(3) Coast guard-bahamas drug interdiction docking facility. -
(A) There is authorized to be appropriated for acquisition,
construction, and improvements for the Coast Guard for fiscal
year 1987, $5,000,000, to be used for initial design engineering,
and other activities for construction of a drug interdiction
docking facility in the Bahamas to facilitate Coast Guard and
Bahamian drug interdiction operations in and through the Bahama
Islands. Of the amounts authorized to be appropriated in this
subsection, such sums as may be necessary shall be available for
necessary communication and air support.
"(B) The Commandant of the Coast Guard shall use such amounts
appropriated pursuant to the authorization in this paragraph as
may be necessary to establish a repair, maintenance, and boat
lift facility to provide repair and maintenance services for both
Coast Guard and Bahamian marine drug interdiction equipment,
vessels, and related assets.
"(b) Concurrence by Secretary of State. - Programs authorized by
this section may be carried out only with the concurrence of the
Secretary of State."
INFORMATION ON DRUG ABUSE AT THE WORKPLACE
Pub. L. 99-570, title IV, Sec. 4303, Oct. 27, 1986, 100 Stat.
3207-154, directed Secretary of Labor to collect such information
as is available on the incidence of drug abuse in the workplace and
efforts to assist workers, including counseling, rehabilitation and
employee assistance programs, to conduct such additional research
as is necessary to assess the impact and extent of drug abuse and
remediation efforts, and submit the findings of such collection and
research to Congress no later than two years from Oct. 27, 1986.
INTERAGENCY COORDINATION
Pub. L. 99-570, title IV, Sec. 4304, Oct. 27, 1986, 100 Stat.
3207-154, provided that:
"(a) The Secretary of Education, the Secretary of Health and
Human Services, and the Secretary of Labor shall each designate an
officer or employee of the Departments of Education, Health and
Human Services, and Labor, respectively, to coordinate interagency
drug abuse prevention activities to prevent duplication of effort.
"(b) Within one year after enactment of this Act [Oct. 27, 1986],
a report shall be jointly submitted to the Congress by such
Secretaries concerning the extent to which States and localities
have been able to implement non-duplicative drug abuse prevention
activities."
SUBSTANCE ABUSE COVERAGE STUDY
Pub. L. 99-570, title VI, Sec. 6005, Oct. 27, 1986, 100 Stat.
3207-160, as amended by Pub. L. 100-690, title II, Sec. 2058(c),
Nov. 18, 1988, 102 Stat. 4214, directed Secretary of Health and
Human Services to contract with Institute of Medicine of National
Academy of Sciences to conduct a study of extent to which cost of
drug abuse treatment is covered by private insurance, public
programs, and other sources of payment, and adequacy of such
coverage for the rehabilitation of drug abusers, and not later than
18 months after execution of such contract to transmit to Congress
a report of results of study, including recommendations of means to
meet the needs identified in such study.
HEALTH INSURANCE COVERAGE FOR DRUG AND ALCOHOL TREATMENT
Pub. L. 99-570, title VI, Sec. 6006, Oct. 27, 1986, 100 Stat.
3207-160, provided that:
"(a) Findings. - The Congress finds that -
"(1) drug and alcohol abuse are problems of grave concern and
consequence in American society;
"(2) over 500,000 individuals are known heroin addicts; 5
million individuals use cocaine; and at least 7 million
individuals regularly use prescription drugs, mostly addictive
ones, without medical supervision;
"(3) 10 million adults and 3 million children and adolescents
abuse alcohol, and an additional 30 to 40 million people are
adversely affected because of close family ties to alcoholics;
"(4) the total cost of drug abuse to the Nation in 1983 was
over $60,000,000,000; and
"(5) the vast majority of health benefits plans provide only
limited coverage for treatment of drug and alcohol addiction,
which is a fact that can discourage the abuser from seeking
treatment or, if the abuser does seek treatment, can cause the
abuser to face significant out of pocket expenses for the
treatment.
"(b) Sense of Congress. - It is the sense of Congress that -
"(1) all employers providing health insurance policies should
ensure that the policies provide adequate coverage for treatment
of drug and alcohol addiction in recognition that the health
consequences and costs for individuals and society can be as
formidable as those resulting from other diseases and illnesses
for which insurance coverage is much more adequate; and
"(2) State insurance commissioners should encourage employers
providing health benefits plans to ensure that the policies
provide more adequate coverage for treatment of drug and alcohol
addiction."
COMMISSION ON MARIHUANA AND DRUG ABUSE
Section 601 of Pub. L. 91-513, as amended by Pub. L. 92-13, May
14, 1971, 85 Stat. 37, provided that:
"(a) [Establishment; composition] There is established a
commission to be known as the Commission on Marihuana and Drug
Abuse (hereafter in this section referred to as the 'Commission').
The Commission shall be composed of -
"(1) two Members of the Senate appointed by the President of
the Senate;
"(2) two Members of the House of Representatives appointed by
the Speaker of the House of Representatives; and
"(3) nine members appointed by the President of the United
States.
At no time shall more than one of the members appointed under
paragraph (1), or more than one of the members appointed under
paragraph (2), or more than five of the members appointed under
paragraph (3) be members of the same political party.
"(b) [Chairman; Vice Chairman; compensation of members; meetings]
(1) The President shall designate one of the members of the
Commission as Chairman and one as Vice Chairman. Seven members of
the Commission shall constitute a quorum, but a lesser number may
conduct hearings.
"(2) Members of the Commission who are Members of Congress or
full-time officers or employees of the United States shall serve
without additional compensation but shall be reimbursed for travel,
subsistence, and other necessary expenses incurred in the
performance of the duties vested in the Commission. Members of the
Commission from private life shall receive $100 per diem while
engaged in the actual performance of the duties vested in the
Commission, plus reimbursement for travel, subsistence, and other
necessary expenses incurred in the performance of such duties.
"(3) The Commission shall meet at the call of the Chairman or at
the call of a majority of the members thereof.
"(c) [Personnel; experts; information from departments and
agencies] (1) The Commission shall have the power to appoint and
fix the compensation of such personnel as it deems advisable,
without regard to the provisions of title 5, United States Code,
governing appointments in the competitive service, and the
provisions of chapter 51 and subchapter III of chapter 53 of such
title, relating to classification and General Schedule pay rates.
"(2) The Commission may procure, in accordance with the
provisions of section 3109 of title 5, United States Code, the
temporary or intermittent services of experts or consultants.
Persons so employed shall receive compensation at a rate to be
fixed by the Commission, but not in excess of $75 per diem,
including traveltime. While away from his home or regular place of
business in the performance of services for the Commission, any
such person may be allowed travel expenses, including per diem in
lieu of subsistence, as authorized by section 5703(b) of title 5,
United States Code, for persons in the Government service employed
intermittently.
"(3) The Commission may secure directly from any department or
agency of the United States information necessary to enable it to
carry out its duties under this section. Upon request of the
Chairman of the Commission, such department or agency shall furnish
such information to the Commission.
"(d) [Marihuana study; report to the President and the Congress]
(1) The Commission shall conduct a study of marihuana including,
but not limited to, the following areas:
"(A) the extent of use of marihuana in the United States to
include its various sources of users, number of arrests, number
of convictions, amount of marihuana seized, type of user, nature
of use;
"(B) an evaluation of the efficacy of existing marihuana laws;
"(C) a study of the pharmacology of marihuana and its immediate
and long-term effects, both physiological and psychological;
"(D) the relationship of marihuana use to aggressive behavior
and crime;
"(E) the relationship between marihuana and the use of other
drugs; and
"(F) the international control of marihuana.
"(2) Within one year after the date on which funds first become
available to carry out this section, the Commission shall submit to
the President and the Congress a comprehensive report on its study
and investigation under this subsection which shall include its
recommendations and such proposals for legislation and
administrative action as may be necessary to carry out its
recommendations.
"(e) [Study and investigation of causes of drug abuse; report to
the President and the Congress; termination of Commission] The
Commission shall conduct a comprehensive study and investigation of
the causes of drug abuse and their relative significance. The
Commission shall submit to the President and the Congress such
interim reports as it deems advisable and shall within two years
after the date on which funds first become available to carry out
this section submit to the President and the Congress a final
report which shall contain a detailed statement of its findings and
conclusions and also such recommendations for legislation and
administrative actions as it deems appropriate. The Commission
shall cease to exist sixty days after the final report is submitted
under this subsection.
"(f) [Limitation on expenditures] Total expenditures of the
Commission shall not exceed $4,000,000."
-EXEC-
EXECUTIVE ORDER NO. 11599
Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which
established the Special Action Office for Drug Abuse Prevention,
was superseded. See Prior Provisions notes set out under section
1111 of this title.
EXECUTIVE ORDER NO. 11641
Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which
established the Office for Drug Abuse Law Enforcement, was revoked
by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.
EXECUTIVE ORDER NO. 11676
Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which
established the Office of National Narcotics Intelligence, was
revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out
below.
EX. ORD. NO. 11727. DRUG LAW ENFORCEMENT
Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:
Reorganization Plan No. 2 of 1973 [set out in the Appendix to
Title 5, Government Organization and Employees], which becomes
effective on July 1, 1973, among other things establishes a Drug
Enforcement Administration in the Department of Justice. In my
message to the Congress transmitting that plan, I stated that all
functions of the Office for Drug Abuse Law Enforcement (established
pursuant to Executive Order No. 11641 of January 28, 1972) and the
Office of National Narcotics Intelligence (established pursuant to
Executive Order No. 11676 of July 27, 1972) would, together with
other related functions, be merged in the new Drug Enforcement
Administration.
NOW, THEREFORE, by virtue of the authority vested in me by the
Constitution and laws of the United States, including section 5317
of title 5 of the United States Code, as amended, it is hereby
ordered as follows:
Section 1. The Attorney General, to the extent permitted by law,
is authorized to coordinate all activities of executive branch
departments and agencies which are directly related to the
enforcement of laws respecting narcotics and dangerous drugs. Each
department and agency of the Federal Government shall, upon request
and to the extent permitted by law, assist the Attorney General in
the performance of functions assigned to him pursuant to this
order, and the Attorney General may, in carrying out those
functions, utilize the services of any other agencies, Federal and
State, as may be available and appropriate.
Sec. 2. Executive Order No. 11641 of January 28, 1972, is revoked
and the Attorney General shall provide for the reassignment of the
functions of the Office for Drug Abuse Law Enforcement and for the
abolishment of that Office.
Sec. 3. Executive Order No. 11676 of July 27, 1972, is hereby
revoked and the Attorney General shall provide for the reassignment
of the functions of the Office of National Narcotics Intelligence
and for the abolishment of that Office.
Sec. 4. Section 1 of Executive Order No. 11708 of March 23, 1973,
as amended [set out as a note under section 5317 of Title 5,
Government Organization and Employees], placing certain positions
in level IV of the Executive Schedule is hereby further amended by
deleting -
(1) "(6) Director, Office for Drug Abuse Law Enforcement,
Department of Justice."; and
(2) "(7) Director, Office of National Narcotics Intelligence,
Department of Justice."
Sec. 5. The Attorney General shall provide for the winding up of
the affairs of the two offices and for the reassignment of their
functions.
Sec. 6. This order shall be effective as of July 1, 1973.
Richard Nixon.
-End-
-CITE-
21 USC Sec. 801a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
-HEAD-
Sec. 801a. Congressional findings and declarations: psychotropic
substances
-STATUTE-
The Congress makes the following findings and declarations:
(1) The Congress has long recognized the danger involved in the
manufacture, distribution, and use of certain psychotropic
substances for nonscientific and nonmedical purposes, and has
provided strong and effective legislation to control illicit
trafficking and to regulate legitimate uses of psychotropic
substances in this country. Abuse of psychotropic substances has
become a phenomenon common to many countries, however, and is not
confined to national borders. It is, therefore, essential that
the United States cooperate with other nations in establishing
effective controls over international traffic in such substances.
(2) The United States has joined with other countries in
executing an international treaty, entitled the Convention on
Psychotropic Substances and signed at Vienna, Austria, on
February 21, 1971, which is designed to establish suitable
controls over the manufacture, distribution, transfer, and use of
certain psychotropic substances. The Convention is not self-
executing, and the obligations of the United States thereunder
may only be performed pursuant to appropriate legislation. It is
the intent of the Congress that the amendments made by this Act,
together with existing law, will enable the United States to meet
all of its obligations under the Convention and that no further
legislation will be necessary for that purpose.
(3) In implementing the Convention on Psychotropic Substances,
the Congress intends that, consistent with the obligations of the
United States under the Convention, control of psychotropic
substances in the United States should be accomplished within the
framework of the procedures and criteria for classification of
substances provided in the Comprehensive Drug Abuse Prevention
and Control Act of 1970 [21 U.S.C. 801 et seq.]. This will insure
that (A) the availability of psychotropic substances to
manufacturers, distributors, dispensers, and researchers for
useful and legitimate medical and scientific purposes will not be
unduly restricted; (B) nothing in the Convention will interfere
with bona fide research activities; and (C) nothing in the
Convention will interfere with ethical medical practice in this
country as determined by the Secretary of Health and Human
Services on the basis of a consensus of the views of the American
medical and scientific community.
-SOURCE-
(Pub. L. 95-633, title I, Sec. 101, Nov. 10, 1978, 92 Stat. 3768;
Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)
-REFTEXT-
REFERENCES IN TEXT
This Act, referred to in par. (2), is Pub. L. 95-633, Nov. 10,
1978, 92 Stat. 2768, as amended, known as the Psychotropic
Substances Act of 1978, which enacted sections 801a, 830, and 852
of this title, amended sections 352, 802, 811, 812, 823, 827, 841
to 843, 872, 881, 952, 953, and 965 of this title and section 242a
of Title 42, The Public Health and Welfare, repealed section 830 of
this title effective Jan. 1, 1981, and enacted provisions set out
as notes under sections 801, 801a, 812, and 830 of this title. For
complete classification of this Act to the Code, see Short Title of
1978 Amendment note set out under section 801 of this title and
Tables.
The Comprehensive Drug Abuse Prevention and Control Act of 1970,
referred to in par. (3), is Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1236, as amended, which is classified principally to this chapter
[Sec. 801 et seq.]. For complete classification of this Act to the
Code, see Short Title note set out under section 801 of this title
and Tables.
-COD-
CODIFICATION
Section was enacted as a part of the Psychotropic Substances Act
of 1978, and not as a part of the Controlled Substances Act which
comprises this subchapter.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (3) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-MISC1-
EFFECTIVE DATE
Section 112 of title I of Pub. L. 95-633 provided that: "This
title [enacting this section and section 852 of this title,
amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953
of this title and section 242a of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under sections
801 and 812 of this title] and the amendments made by this title
shall take effect on the date the Convention on Psychotropic
Substances, signed at Vienna, Austria on February 21, 1971, enters
into force in respect to the United States." [The Convention
entered into force in respect to the United States on July 15,
1980.]
-End-
-CITE-
21 USC Sec. 802 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
-HEAD-
Sec. 802. Definitions
-STATUTE-
As used in this subchapter:
(1) The term "addict" means any individual who habitually uses
any narcotic drug so as to endanger the public morals, health,
safety, or welfare, or who is so far addicted to the use of
narcotic drugs as to have lost the power of self-control with
reference to his addiction.
(2) The term "administer" refers to the direct application of a
controlled substance to the body of a patient or research subject
by -
(A) a practitioner (or, in his presence, by his authorized
agent), or
(B) the patient or research subject at the direction and in the
presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or
any other means.
(3) The term "agent" means an authorized person who acts on
behalf of or at the direction of a manufacturer, distributor, or
dispenser; except that such term does not include a common or
contract carrier, public warehouseman, or employee of the carrier
or warehouseman, when acting in the usual and lawful course of the
carrier's or warehouseman's business.
(4) The term "Drug Enforcement Administration" means the Drug
Enforcement Administration in the Department of Justice.
(5) The term "control" means to add a drug or other substance, or
immediate precursor, to a schedule under part B of this subchapter,
whether by transfer from another schedule or otherwise.
(6) The term "controlled substance" means a drug or other
substance, or immediate precursor, included in schedule I, II, III,
IV, or V of part B of this subchapter. The term does not include
distilled spirits, wine, malt beverages, or tobacco, as those terms
are defined or used in subtitle E of the Internal Revenue Code of
1986.
(7) The term "counterfeit substance" means a controlled substance
which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other
identifying mark, imprint, number, or device, or any likeness
thereof, of a manufacturer, distributor, or dispenser other than
the person or persons who in fact manufactured, distributed, or
dispensed such substance and which thereby falsely purports or is
represented to be the product of, or to have been distributed by,
such other manufacturer, distributor, or dispenser.
(8) The terms "deliver" or "delivery" mean the actual,
constructive, or attempted transfer of a controlled substance or a
listed chemical, whether or not there exists an agency
relationship.
(9) The term "depressant or stimulant substance" means -
(A) a drug which contains any quantity of barbituric acid or
any of the salts of barbituric acid; or
(B) a drug which contains any quantity of (i) amphetamine or
any of its optical isomers; (ii) any salt of amphetamine or any
salt of an optical isomer of amphetamine; or (iii) any substance
which the Attorney General, after investigation, has found to be,
and by regulation designated as, habit forming because of its
stimulant effect on the central nervous system; or
(C) lysergic acid diethylamide; or
(D) any drug which contains any quantity of a substance which
the Attorney General, after investigation, has found to have, and
by regulation designated as having, a potential for abuse because
of its depressant or stimulant effect on the central nervous
system or its hallucinogenic effect.
(10) The term "dispense" means to deliver a controlled substance
to an ultimate user or research subject by, or pursuant to the
lawful order of, a practitioner, including the prescribing and
administering of a controlled substance and the packaging, labeling
or compounding necessary to prepare the substance for such
delivery. The term "dispenser" means a practitioner who so delivers
a controlled substance to an ultimate user or research subject.
(11) The term "distribute" means to deliver (other than by
administering or dispensing) a controlled substance or a listed
chemical. The term "distributor" means a person who so delivers a
controlled substance or a listed chemical.
(12) The term "drug" has the meaning given that term by section
321(g)(1) of this title.
(13) The term "felony" means any Federal or State offense
classified by applicable Federal or State law as a felony.
(14) The term "isomer" means the optical isomer, except as used
in schedule I(c) and schedule II(a)(4). As used in schedule I(c),
the term "isomer" means any optical, positional, or geometric
isomer. As used in schedule II(a)(4), the term "isomer" means any
optical or geometric isomer.
(15) The term "manufacture" means the production, preparation,
propagation, compounding, or processing of a drug or other
substance, either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical
synthesis or by a combination of extraction and chemical synthesis,
and includes any packaging or repackaging of such substance or
labeling or relabeling of its container; except that such term does
not include the preparation, compounding, packaging, or labeling of
a drug or other substance in conformity with applicable State or
local law by a practitioner as an incident to his administration or
dispensing of such drug or substance in the course of his
professional practice. The term "manufacturer" means a person who
manufactures a drug or other substance.
(16) The term "marihuana" means all parts of the plant Cannabis
sativa L., whether growing or not; the seeds thereof; the resin
extracted from any part of such plant; and every compound,
manufacture, salt, derivative, mixture, or preparation of such
plant, its seeds or resin. Such term does not include the mature
stalks of such plant, fiber produced from such stalks, oil or cake
made from the seeds of such plant, any other compound, manufacture,
salt, derivative, mixture, or preparation of such mature stalks
(except the resin extracted therefrom), fiber, oil, or cake, or the
sterilized seed of such plant which is incapable of germination.
(17) The term "narcotic drug" means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin, or independently by means of chemical synthesis,
or by a combination of extraction and chemical synthesis:
(A) Opium, opiates, derivatives of opium and opiates, including
their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers, whenever the existence of such isomers,
esters, ethers, and salts is possible within the specific
chemical designation. Such term does not include the isoquinoline
alkaloids of opium.
(B) Poppy straw and concentrate of poppy straw.
(C) Coca leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine, and derivatives of ecgonine or
their salts have been removed.
(D) Cocaine, its salts, optical and geometric isomers, and
salts of isomers.
(E) Ecgonine, its derivatives, their salts, isomers, and salts
of isomers.
(F) Any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subparagraphs
(A) through (E).
(18) The term "opiate" means any drug or other substance having
an addiction-forming or addiction-sustaining liability similar to
morphine or being capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability.
(19) The term "opium poppy" means the plant of the species
Papaver somniferum L., except the seed thereof.
(20) The term "poppy straw" means all parts, except the seeds, of
the opium poppy, after mowing.
(21) The term "practitioner" means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices or does research,
to distribute, dispense, conduct research with respect to,
administer, or use in teaching or chemical analysis, a controlled
substance in the course of professional practice or research.
(22) The term "production" includes the manufacture, planting,
cultivation, growing, or harvesting of a controlled substance.
(23) The term "immediate precursor" means a substance -
(A) which the Attorney General has found to be and by
regulation designated as being the principal compound used, or
produced primarily for use, in the manufacture of a controlled
substance;
(B) which is an immediate chemical intermediary used or likely
to be used in the manufacture of such controlled substance; and
(C) the control of which is necessary to prevent, curtail, or
limit the manufacture of such controlled substance.
(24) The term "Secretary", unless the context otherwise
indicates, means the Secretary of Health and Human Services.
(25) The term "serious bodily injury" means bodily injury which
involves -
(A) a substantial risk of death;
(B) protracted and obvious disfigurement; or
(C) protracted loss or impairment of the function of a bodily
member, organ, or mental faculty.
(26) The term "State" means a State of the United States, the
District of Columbia, and any commonwealth, territory, or
possession of the United States.
(27) The term "ultimate user" means a person who has lawfully
obtained, and who possesses, a controlled substance for his own use
or for the use of a member of his household or for an animal owned
by him or by a member of his household.
(28) The term "United States", when used in a geographic sense,
means all places and waters, continental or insular, subject to the
jurisdiction of the United States.
(29) The term "maintenance treatment" means the dispensing, for a
period in excess of twenty-one days, of a narcotic drug in the
treatment of an individual for dependence upon heroin or other
morphine-like drugs.
(30) The term "detoxification treatment" means the dispensing,
for a period not in excess of one hundred and eighty days, of a
narcotic drug in decreasing doses to an individual in order to
alleviate adverse physiological or psychological effects incident
to withdrawal from the continuous or sustained use of a narcotic
drug and as a method of bringing the individual to a narcotic drug-
free state within such period.
(31) The term "Convention on Psychotropic Substances" means the
Convention on Psychotropic Substances signed at Vienna, Austria, on
February 21, 1971; and the term "Single Convention on Narcotic
Drugs" means the Single Convention on Narcotic Drugs signed at New
York, New York, on March 30, 1961.
(32)(A) Except as provided in subparagraph (C), the term
"controlled substance analogue" means a substance -
(i) the chemical structure of which is substantially similar to
the chemical structure of a controlled substance in schedule I or
II;
(ii) which has a stimulant, depressant, or hallucinogenic
effect on the central nervous system that is substantially
similar to or greater than the stimulant, depressant, or
hallucinogenic effect on the central nervous system of a
controlled substance in schedule I or II; or
(iii) with respect to a particular person, which such person
represents or intends to have a stimulant, depressant, or
hallucinogenic effect on the central nervous system that is
substantially similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the central nervous
system of a controlled substance in schedule I or II.
(B) The designation of gamma butyrolactone or any other chemical
as a listed chemical pursuant to paragraph (34) or (35) does not
preclude a finding pursuant to subparagraph (A) of this paragraph
that the chemical is a controlled substance analogue.
(C) Such term does not include -
(i) a controlled substance;
(ii) any substance for which there is an approved new drug
application;
(iii) with respect to a particular person any substance, if an
exemption is in effect for investigational use, for that person,
under section 355 of this title to the extent conduct with
respect to such substance is pursuant to such exemption; or
(iv) any substance to the extent not intended for human
consumption before such an exemption takes effect with respect to
that substance.
(33) The term "listed chemical" means any list I chemical or any
list II chemical.
(34) The term "list I chemical" means a chemical specified by
regulation of the Attorney General as a chemical that is used in
manufacturing a controlled substance in violation of this
subchapter and is important to the manufacture of the controlled
substances, and such term includes (until otherwise specified by
regulation of the Attorney General, as considered appropriate by
the Attorney General or upon petition to the Attorney General by
any person) the following:
(A) Anthranilic acid, its esters, and its salts.
(B) Benzyl cyanide.
(C) Ephedrine, its salts, optical isomers, and salts of optical
isomers.
(D) Ergonovine and its salts.
(E) Ergotamine and its salts.
(F) N-Acetylanthranilic acid, its esters, and its salts.
(G) Norpseudoephedrine, its salts, optical isomers, and salts
of optical isomers.
(H) Phenylacetic acid, its esters, and its salts.
(I) Phenylpropanolamine, its salts, optical isomers, and salts
of optical isomers.
(J) Piperidine and its salts.
(K) Pseudoephedrine, its salts, optical isomers, and salts of
optical isomers.
(L) 3,4-Methylenedioxyphenyl-2-propanone.
(M) Methylamine.
(N) Ethylamine.
(O) Propionic anhydride.
(P) Isosafrole.
(Q) Safrole.
(R) Piperonal.
(S) N-Methylephedrine.
(T) N-methylpseudoephedrine.
(U) Hydriodic acid.
(V) Benzaldehyde.
(W) Nitroethane.
(X) Gamma butyrolactone.
(Y) Any salt, optical isomer, or salt of an optical isomer of
the chemicals listed in subparagraphs (M) through (U) of this
paragraph.
(35) The term "list II chemical" means a chemical (other than a
list I chemical) specified by regulation of the Attorney General as
a chemical that is used in manufacturing a controlled substance in
violation of this subchapter, and such term includes (until
otherwise specified by regulation of the Attorney General, as
considered appropriate by the Attorney General or upon petition to
the Attorney General by any person) the following chemicals:
(A) Acetic anhydride.
(B) Acetone.
(C) Benzyl chloride.
(D) Ethyl ether.
(E) Repealed. Pub. L. 101-647, title XXIII, Sec. 2301(b), Nov.
29, 1990, 104 Stat. 4858.
(F) Potassium permanganate.
(G) 2-Butanone (or Methyl Ethyl Ketone).
(H) Toluene.
(I) Iodine.
(J) Hydrochloric gas.
(36) The term "regular customer" means, with respect to a
regulated person, a customer with whom the regulated person has an
established business relationship that is reported to the Attorney
General.
(37) The term "regular importer" means, with respect to a listed
chemical, a person that has an established record as an importer of
that listed chemical that is reported to the Attorney General.
(38) The term "regulated person" means a person who manufactures,
distributes, imports, or exports a listed chemical, a tableting
machine, or an encapsulating machine or who acts as a broker or
trader for an international transaction involving a listed
chemical, a tableting machine, or an encapsulating machine.
(39) The term "regulated transaction" means -
(A) a distribution, receipt, sale, importation, or exportation
of, or an international transaction involving shipment of, a
listed chemical, or if the Attorney General establishes a
threshold amount for a specific listed chemical, a threshold
amount, including a cumulative threshold amount for multiple
transactions (as determined by the Attorney General, in
consultation with the chemical industry and taking into
consideration the quantities normally used for lawful purposes),
of a listed chemical, except that such term does not include -
(i) a domestic lawful distribution in the usual course of
business between agents or employees of a single regulated
person;
(ii) a delivery of a listed chemical to or by a common or
contract carrier for carriage in the lawful and usual course of
the business of the common or contract carrier, or to or by a
warehouseman for storage in the lawful and usual course of the
business of the warehouseman, except that if the carriage or
storage is in connection with the distribution, importation, or
exportation of a listed chemical to a third person, this clause
does not relieve a distributor, importer, or exporter from
compliance with section 830 of this title;
(iii) any category of transaction or any category of
transaction for a specific listed chemical or chemicals
specified by regulation of the Attorney General as excluded
from this definition as unnecessary for enforcement of this
subchapter or subchapter II of this chapter;
(iv) any transaction in a listed chemical that is contained
in a drug that may be marketed or distributed lawfully in the
United States under the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 301 et seq.], subject to clause (v), unless -
(I) the Attorney General has determined under section 814
of this title that the drug or group of drugs is being
diverted to obtain the listed chemical for use in the illicit
production of a controlled substance; and
(II) the quantity of the listed chemical contained in the
drug included in the transaction or multiple transactions
equals or exceeds the threshold established for that chemical
by the Attorney General;
(v) any transaction in a scheduled listed chemical product
that is a sale at retail by a regulated seller or a distributor
required to submit reports under section 830(b)(3) of this
title; or
(vi) any transaction in a chemical mixture which the Attorney
General has by regulation designated as exempt from the
application of this subchapter and subchapter II of this
chapter based on a finding that the mixture is formulated in
such a way that it cannot be easily used in the illicit
production of a controlled substance and that the listed
chemical or chemicals contained in the mixture cannot be
readily recovered; and
(B) a distribution, importation, or exportation of a tableting
machine or encapsulating machine.
(40) The term "chemical mixture" means a combination of two or
more chemical substances, at least one of which is not a list I
chemical or a list II chemical, except that such term does not
include any combination of a list I chemical or a list II chemical
with another chemical that is present solely as an impurity.
(41)(A) The term "anabolic steroid" means any drug or hormonal
substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, corticosteroids, and
dehydroepiandrosterone), and includes -
(i) androstanediol -
(I) 3β,17β-dihydroxy-5α-androstane; and
(II) 3α,17β-dihydroxy-5α-androstane;
(ii) androstanedione (5α-androstan-3,17-dione);
(iii) androstenediol -
(I) 1-androstenediol (3β,17β-dihydroxy-5α-
androst-1-ene);
(II) 1-androstenediol (3α,17β-dihydroxy-5α-
androst-1-ene);
(III) 4-androstenediol (3β,17β-dihydroxy-androst-4-
ene); and
(IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-
ene);
(iv) androstenedione -
(I) 1-androstenedione ([5α]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);
(v) bolasterone (7α,17α-dimethyl-17β-
hydroxyandrost-4-en-3-one);
(vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one);
(vii) calusterone (7β,17α-dimethyl-17β-
hydroxyandrost-4-en-3-one);
(viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);
(ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-
17α-methyl-androst-1,4-dien-3-one);
(x) Δ1-dihydrotestosterone (a.k.a. "1-testosterone")
(17β-hydroxy-5α-androst-1-en-3-one);
(xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);
(xii) drostanolone (17β-hydroxy-2α-methyl-5α-
androstan-3-one);
(xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-
ene);
(xiv) fluoxymesterone (9-fluoro-17α-methyl-
11β,17β-dihydroxyandrost-4-en-3-one);
(xv) formebolone (2-formyl-17α-methyl-11α,17β-
dihydroxyandrost-1,4-dien-3-one);
(xvi) furazabol (17α-methyl-17β-
hydroxyandrostano[2,3-c]-furazan);
(xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one;
(xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-
en-3-one);
(xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-
en-3-one);
(xx) mestanolone (17α-methyl-17β-hydroxy-5α-
androstan-3-one);
(xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-
androstan-3-one);
(xxii) methandienone (17α-methyl-17β-hydroxyandrost-
1,4-dien-3-one);
(xxiii) methandriol (17α-methyl-3β,17β-
dihydroxyandrost-5-ene);
(xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-
1-en-3-one);
(xxv) 17α-methyl-3β, 17β-dihydroxy-5α-
androstane;
(xxvi) 17α-methyl-3α,17β-dihydroxy-5α-
androstane;
(xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-
ene.
(xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-
4-hydroxy-17β-hydroxyestr-4-en-3-one);
(xxix) methyldienolone (17α-methyl-17β-hydroxyestra-
4,9(10)-dien-3-one);
(xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-
4,9-11-trien-3-one);
(xxxi) methyltestosterone (17α-methyl-17β-
hydroxyandrost-4-en-3-one);
(xxxii) mibolerone (7α,17α-dimethyl-17β-
hydroxyestr-4-en-3-one);
(xxxiii) 17α-methyl-Δ1-dihydrotestosterone
(17β-hydroxy-17α-methyl-5α-androst-1-en-3-one)
(a.k.a. "17-α-methyl-1-testosterone");
(xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one);
(xxxv) norandrostenediol -
(I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-
4-ene);
(II) 19-nor-4-androstenediol (3α, 17β-
dihydroxyestr-4-ene);
(III) 19-nor-5-androstenediol (3β, 17β-
dihydroxyestr-5-ene); and
(IV) 19-nor-5-androstenediol (3α, 17β-
dihydroxyestr-5-ene);
(xxxvi) norandrostenedione -
(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;
(xxxvii) norbolethone (13β,17α-diethyl-17β-
hydroxygon-4-en-3-one);
(xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-
one);
(xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-
en-3-one);
(xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-
en-3-one);
(xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-
[5α]-androstan-3-one);
(xlii) oxymesterone (17α-methyl-4,17β-
dihydroxyandrost-4-en-3-one);
(xliii) oxymetholone (17α-methyl-2-hydroxymethylene-
17β-hydroxy-[5α]-androstan-3-one);
(xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-
androst-2-eno[3,2-c]-pyrazole);
(xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-
1-en-3-one);
(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-
dien-17-oic acid lactone);
(xlvii) testosterone (17β-hydroxyandrost-4-en-3-one);
(xlviii) tetrahydrogestrinone (13β,17α-diethyl-
17β-hydroxygon-4,9,11-trien-3-one);
(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);
and
(xlx) (!1) any salt, ester, or ether of a drug or substance
described in this paragraph.
The substances excluded under this subparagraph may at any time be
scheduled by the Attorney General in accordance with the authority
and requirements of subsections (a) through (c) of section 811 of
this title.
(B)(i) Except as provided in clause (ii), such term does not
include an anabolic steroid which is expressly intended for
administration through implants to cattle or other nonhuman species
and which has been approved by the Secretary of Health and Human
Services for such administration.
(ii) If any person prescribes, dispenses, or distributes such
steroid for human use, such person shall be considered to have
prescribed, dispensed, or distributed an anabolic steroid within
the meaning of subparagraph (A).
(42) The term "international transaction" means a transaction
involving the shipment of a listed chemical across an international
border (other than a United States border) in which a broker or
trader located in the United States participates.
(43) The terms "broker" and "trader" mean a person that assists
in arranging an international transaction in a listed chemical by -
(A) negotiating contracts;
(B) serving as an agent or intermediary; or
(C) bringing together a buyer and seller, a buyer and
transporter, or a seller and transporter.
(44) The term "felony drug offense" means an offense that is
punishable by imprisonment for more than one year under any law of
the United States or of a State or foreign country that prohibits
or restricts conduct relating to narcotic drugs, marihuana,
anabolic steroids, or depressant or stimulant substances.
(45)(A) The term "scheduled listed chemical product" means,
subject to subparagraph (B), a product that -
(i) contains ephedrine, pseudoephedrine, or
phenylpropanolamine; and
(ii) may be marketed or distributed lawfully in the United
States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.] as a nonprescription drug.
Each reference in clause (i) to ephedrine, pseudoephedrine, or
phenylpropanolamine includes each of the salts, optical isomers,
and salts of optical isomers of such chemical.
(B) Such term does not include a product described in
subparagraph (A) if the product contains a chemical specified in
such subparagraph that the Attorney General has under section
811(a) of this title added to any of the schedules under section
812(c) of this title. In the absence of such scheduling by the
Attorney General, a chemical specified in such subparagraph may not
be considered to be a controlled substance.
(46) The term "regulated seller" means a retail distributor
(including a pharmacy or a mobile retail vendor), except that such
term does not include an employee or agent of such distributor.
(47) The term "mobile retail vendor" means a person or entity
that makes sales at retail from a stand that is intended to be
temporary, or is capable of being moved from one location to
another, whether the stand is located within or on the premises of
a fixed facility (such as a kiosk at a shopping center or an
airport) or whether the stand is located on unimproved real estate
(such as a lot or field leased for retail purposes).
(48) The term "at retail", with respect to the sale or purchase
of a scheduled listed chemical product, means a sale or purchase
for personal use, respectively.
(49)(A) The term "retail distributor" means a grocery store,
general merchandise store, drug store, or other entity or person
whose activities as a distributor relating to ephedrine,
pseudoephedrine, or phenylpropanolamine products are limited almost
exclusively to sales for personal use, both in number of sales and
volume of sales, either directly to walk-in customers or in face-to-
face transactions by direct sales.
(B) For purposes of this paragraph, entities are defined by
reference to the Standard Industrial Classification (SIC) code, as
follows:
(i) A grocery store is an entity within SIC code 5411.
(ii) A general merchandise store is an entity within SIC codes
5300 through 5399 and 5499.
(iii) A drug store is an entity within SIC code 5912.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 102, Oct. 27, 1970, 84 Stat. 1242;
Pub. L. 93-281, Sec. 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
title I, Sec. 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88,
title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132,
Sec. 16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98-473, title II,
Sec. 507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98-509,
title III, Sec. 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99-
514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99-570, title
I, Secs. 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-
13, 3207-56; Pub. L. 99-646, Sec. 83, Nov. 10, 1986, 100 Stat.
3619; Pub. L. 100-690, title VI, Sec. 6054, Nov. 18, 1988, 102
Stat. 4316; Pub. L. 101-647, title XIX, Sec. 1902(b), title XXIII,
Sec. 2301, title XXXV, Sec. 3599I, Nov. 29, 1990, 104 Stat. 4852,
4858, 4932; Pub. L. 103-200, Secs. 2(a), 7-9(a), Dec. 17, 1993, 107
Stat. 2333, 2340; Pub. L. 103-322, title IX, Sec. 90105(d), title
XXXIII, Sec. 330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat.
1988, 2150; Pub. L. 104-237, title II, Secs. 204(a), 209, title IV,
Sec. 401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107;
Pub. L. 104-294, title VI, Secs. 604(b)(4), 607(j), Oct. 11, 1996,
110 Stat. 3506, 3512; Pub. L. 105-115, title I, Sec. 126(c)(3),
Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106-172, Secs. 3(c), 5(a),
Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106-310, div. B, title
XXXVI, Sec. 3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107-
273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002, 116 Stat.
1808; Pub. L. 108-358, Sec. 2(a), Oct. 22, 2004, 118 Stat. 1661;
Pub. L. 109-162, title XI, Sec. 1180, Jan. 5, 2006, 119 Stat. 3126;
Pub. L. 109-177, title VII, Secs. 711(a)(1), (2)(A), 712(a)(1),
Mar. 9, 2006, 120 Stat. 256, 257, 263.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in pars. (6), (14),
and (32)(A), are set out in section 812(c) of this title.
This subchapter, referred to in introductory provisions and in
par. (39)(A)(iii), (vi), was in the original "this title", meaning
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, and is popularly known as the "Controlled Substances Act".
For complete classification of title II to the Code, see second
paragraph of Short Title note set out under section 801 of this
title and Tables.
Subchapter II of this chapter, referred to in par. (39)(A)(iii),
(vi), was in the original "title III", meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B,
consisting of sections 1101 to 1105 of title III, see Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in pars.
(39)(A)(iv) and (45)(A)(ii), is act June 25, 1938, ch. 675, 52
Stat. 1040, as amended, which is classified generally to chapter 9
(Sec. 301 et seq.) of this title. For complete classification of
this Act to the Code, see section 301 of this title and Tables.
-MISC1-
AMENDMENTS
2006 - Par. (39)(A)(iv). Pub. L. 109-177, Sec. 712(a)(1)(A)(i),
amended cl. (iv) generally. Prior to amendment, cl. (iv) related to
transactions involving drugs containing ephedrine, pseudoephedrine,
or phenylpropanolamine.
Par. (39)(A)(v), (vi). Pub. L. 109-177, Sec. 712(a)(1)(A)(ii),
(iii), added cl. (v) and redesignated former cl. (v) as (vi).
Par. (41)(A)(xvii). Pub. L. 109-162, Sec. 1180(1), substituted
"13β-ethyl-17β-hydroxygon-4-en-3-one;" for "13β-
ethyl-17α-hydroxygon-4-en-3-one;".
Par. (41)(A)(xliv). Pub. L. 109-162, Sec. 1180(2), substituted
"(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-
pyrazole);" for "(17α-methyl-17α-hydroxy-[5α]-
androst-2-eno[3,2-c]-pyrazole);".
Par. (45). Pub. L. 109-177, Secs. 711(a)(1)(B), 712(a)(1)(B),
added par. (45) and struck out former par. (45) which defined
"ordinary over-the-counter pseudoephedrine or phenylpropanolamine
product".
Pars. (46) to (48). Pub. L. 109-177, Secs. 711(a)(1)(B), added
pars. (46) to (48). Former par. (46) redesignated (49).
Par. (49). Pub. L. 109-177, Sec. 711(a)(1)(A), (2)(A),
redesignated par. (46) as (49), substituted "ephedrine,
pseudoephedrine, or" for "pseudoephedrine or" in subpar. (A),
redesignated subpar. (C) as (B), and struck out former subpar. (B)
which read as follows: "For purposes of this paragraph, sale for
personal use means the sale of below-threshold quantities in a
single transaction to an individual for legitimate medical use."
2004 - Par. (41). Pub. L. 108-358, Sec. 2(a)(1), realigned
margins, added subpar. (A), and struck out former subpar. (A) which
defined "anabolic steroid".
Par. (44). Pub. L. 108-358, Sec. 2(a)(2), inserted "anabolic
steroids," after "marihuana,".
2002 - Pars. (43), (44). Pub. L. 107-273 repealed Pub. L. 104-
294, Secs. 604(b)(4), 607(j)(2). See 1996 Amendment note below.
2000 - Par. (32)(A). Pub. L. 106-172, Sec. 5(a)(1), substituted
"subparagraph (C)" for "subparagraph (B)" in introductory
provisions.
Par. (32)(B), (C). Pub. L. 106-172, Sec. 5(a)(2), (3), added
subpar. (B) and redesignated former subpar. (B) as (C).
Par. (34)(X), (Y). Pub. L. 106-172, Sec. 3(c), added subpar. (X)
and redesignated former subpar. (X) as (Y).
Par. (39)(A)(iv)(II). Pub. L. 106-310 substituted "9 grams" for
"24 grams" in two places and inserted before semicolon at end "and
sold in package sizes of not more than 3 grams of pseudoephedrine
base or 3 grams of phenylpropanolamine base".
1997 - Par. (9)(A). Pub. L. 105-115 redesignated cl. (i) as
subpar. (A) and struck out cl. (ii) which read as follows: "any
derivative of barbituric acid which has been designated by the
Secretary as habit forming under section 352(d) of this title; or".
1996 - Par. (26). Pub. L. 104-294, Sec. 607(j)(1), amended par.
(26) generally. Prior to amendment, par. (26) read as follows: "The
term 'State' means any State, territory, or possession of the
United States, the District of Columbia, the Commonwealth of Puerto
Rico, the Trust Territory of the Pacific Islands, and the Canal
Zone."
Par. (34)(P), (S), (U). Pub. L. 104-237, Sec. 209(1), substituted
"Isosafrole" for "Insosafrole" in subpar. (P), "N-Methylephedrine"
for "N-Methylepherdrine" in subpar. (S), and "Hydriodic acid" for
"Hydriotic acid" in subpar. (U).
Par. (35)(G). Pub. L. 104-237, Sec. 209(2), amended subpar. (G)
generally, inserting "(or Methyl Ethyl Ketone)" before period at
end.
Par. (35)(I), (J). Pub. L. 104-237, Sec. 204(a), added subpars.
(I) and (J).
Par. (39)(A)(iv)(I)(aa). Pub. L. 104-237, Sec. 401(a)(1), (b)(1),
substituted ", pseudoephedrine or its salts, optical isomers, or
salts of optical isomers, or phenylpropanolamine or its salts,
optical isomers, or salts of optical isomers unless otherwise
provided by regulation of the Attorney General issued pursuant to
section 814(e) of this title, except that any sale of ordinary over-
the-counter pseudoephedrine or phenylpropanolamine products by
retail distributors shall not be a regulated transaction (except as
provided in section 401(d) of the Comprehensive Methamphetamine
Control Act of 1996);" for "as the only active medicinal ingredient
or contains ephedrine or its salts, optical isomers, or salts of
optical isomers and therapeutically insignificant quantities of
another active medicinal ingredient;".
Par. (39)(A)(iv)(II). Pub. L. 104-237, Sec. 401(a)(2), (b)(2),
inserted ", pseudoephedrine, phenylpropanolamine," after
"ephedrine" and inserted before semicolon ", except that the
threshold for any sale of products containing pseudoephedrine or
phenylpropanolamine products by retail distributors or by
distributors required to submit reports by section 830(b)(3) of
this title shall be 24 grams of pseudoephedrine or 24 grams of
phenylpropanolamine in a single transaction".
Pars. (43), (44). Pub. L. 104-294, Secs. 604(b)(4), 607(j)(2),
which provided for amendment to section identical to Pub. L. 104-
237, Sec. 401(b)(3), below, were repealed by Pub. L. 107-273, Sec.
4002(c)(1).
Pub. L. 104-237, Sec. 401(b)(3), redesignated par. (43), relating
to felony drug offense, as (44).
Pars. (45), (46). Pub. L. 104-237, Sec. 401(b)(4), added pars.
(45) and (46).
1994 - Par. (34)(V), (W). Pub. L. 103-322, Sec. 330024(b),
realigned margins and capitalized first letter.
Par. (35). Pub. L. 103-322, Sec. 330024(d)(1), made technical
correction to directory language of Pub. L. 103-200, Sec.
2(a)(4)(B). See 1993 Amendment note below.
Par. (39)(A)(iv)(II). Pub. L. 103-322, Sec. 330024(a),
substituted "; or" for period at end.
Par. (43). Pub. L. 103-322, Sec. 90105(d), added par. (43)
defining "felony drug offense".
1993 - Par. (33). Pub. L. 103-200, Sec. 2(a)(1), substituted "any
list I chemical or any list II chemical" for "any listed precursor
chemical or listed essential chemical".
Par. (34). Pub. L. 103-200, Sec. 2(a)(2), substituted "list I
chemical" for "listed precursor chemical" and "important to the
manufacture" for "critical to the creation" in introductory
provisions.
Par. (34)(A), (F), (H). Pub. L. 103-200, Sec. 2(a)(3), inserted
", its esters," before "and".
Par. (34)(O). Pub. L. 103-200, Sec. 8(1), (2), redesignated
subpar. (P) as (O) and struck out former subpar. (O) which read as
follows: "D-lysergic acid."
Par. (34)(P) to (S). Pub. L. 103-200, Sec. 8(2), redesignated
subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P)
redesignated (O).
Par. (34)(T). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
(V) as (T). Former subpar. (T) redesignated (S).
Par. (34)(U). Pub. L. 103-200, Sec. 8(1), (2), redesignated
subpar. (X) as (U) and struck out former subpar. (U) which read as
follows: "N-ethylephedrine."
Par. (34)(V). Pub. L. 103-200, Sec. 8(2), (4), added subpar. (V)
and redesignated former subpar. (V) as (T).
Par. (34)(W). Pub. L. 103-200, Sec. 8(1), (4), added subpar. (W)
and struck out former subpar. (W) which read as follows: "N-
ethylpseudoephedrine."
Par. (34)(X). Pub. L. 103-200, Sec. 8(2), (3), redesignated
subpar. (Y) as (X) and substituted "through (U)" for "through (X)".
Par. (34)(Y). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
(Y) as (X).
Par. (35). Pub. L. 103-200, Sec. 2(a)(4)(A), (C), substituted
"list II chemical" for "listed essential chemical" and struck out
"as a solvent, reagent, or catalyst" before "in manufacturing".
Pub. L. 103-200, Sec. 2(a)(4)(B), as amended by Pub. L. 103-322,
Sec. 330024(d)(1), inserted "(other than a list I chemical)" before
"specified" the first time appearing.
Par. (37). Pub. L. 103-200, Sec. 9(a), amended par. (37)
generally. Prior to amendment, par. (37) read as follows: "The term
'regular supplier' means, with respect to a regulated person, a
supplier with whom the regulated person has an established business
relationship that is reported to the Attorney General."
Par. (38). Pub. L. 103-200, Sec. 2(a)(5), inserted before period
at end "or who acts as a broker or trader for an international
transaction involving a listed chemical, a tableting machine, or an
encapsulating machine".
Par. (39)(A). Pub. L. 103-200, Secs. 2(a)(6)(A), 7, in
introductory provisions, substituted "importation, or exportation
of, or an international transaction involving shipment of," for
"importation or exportation of" and inserted "a listed chemical, or
if the Attorney General establishes a threshold amount for a
specific listed chemical," before "a threshold amount,".
Par. (39)(A)(iii). Pub. L. 103-200, Sec. 2(a)(6)(B), inserted "or
any category of transaction for a specific listed chemical or
chemicals" after "transaction".
Par. (39)(A)(iv). Pub. L. 103-200, Sec. 2(a)(6)(C), amended cl.
(iv) generally. Prior to amendment, cl. (iv) read as follows: "any
transaction in a listed chemical that is contained in a drug that
may be marketed or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act; or".
Par. (39)(A)(v). Pub. L. 103-200, Sec. 2(a)(6)(D), inserted
before semicolon at end "which the Attorney General has by
regulation designated as exempt from the application of this
subchapter and subchapter II of this chapter based on a finding
that the mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance and
that the listed chemical or chemicals contained in the mixture
cannot be readily recovered".
Par. (40). Pub. L. 103-200, Sec. 2(a)(7), substituted "list I
chemical or a list II chemical" for "listed precursor chemical or a
listed essential chemical" in two places.
Pars. (42), (43). Pub. L. 103-200, Sec. 2(a)(8), added pars. (42)
and (43).
1990 - Par. (32)(A). Pub. L. 101-647, Sec. 3599I, substituted
"the stimulant" for "the stimulent" in cl. (ii) and "a stimulant"
for "a stimulent" in cl. (iii).
Par. (34)(M) to (Y). Pub. L. 101-647, Sec. 2301(a), added
subpars. (M) to (Y).
Par. (35)(E). Pub. L. 101-647, Sec. 2301(b), struck out subpar.
(E) "Hydriodic acid."
Par. (41). Pub. L. 101-647, Sec. 1902(b), added par. (41).
1988 - Par. (8). Pub. L. 100-690, Sec. 6054(1), inserted "or a
listed chemical" after "a controlled substance".
Par. (11). Pub. L. 100-690, Sec. 6054(2), inserted "or a listed
chemical" after "a controlled substance" in two places.
Pars. (33) to (40). Pub. L. 100-690, Sec. 6054(3), added pars.
(33) to (40).
1986 - Par. (6). Pub. L. 99-514 substituted "Internal Revenue
Code of 1986" for "Internal Revenue Code of 1954".
Par. (14). Pub. L. 99-570, Sec. 1870, and Pub. L. 99-646 amended
par. (14) identically, substituting "any optical" for "the optical"
in second and third sentences.
Par. (25). Pub. L. 99-570, Sec. 1003(b)(1), added par. (25).
Former par. (25) redesignated (26).
Pars. (26) to (31). Pub. L. 99-570, Sec. 1003(b)(2), redesignated
pars. (25) to (30) as (26) to (31), respectively.
Par. (32). Pub. L. 99-570, Sec. 1203, added par. (32).
1984 - Pars. (14) to (16). Pub. L. 98-473, Sec. 507(a), added
par. (14) and redesignated former pars. (14) to (16) as (15) to
(17), respectively.
Par. (17). Pub. L. 98-473, Sec. 507, redesignated former par.
(16) as (17), and expanded and revised definition of "narcotic
drug", including within term poppy straw, cocaine, and ecgonine.
Former par. (17) redesignated (18).
Pars. (18) to (28). Pub. L. 98-473, Sec. 507(a), redesignated
former pars. (17) to (27) as (18) to (28), respectively.
Par. (29). Pub. L. 98-509 which directed the substitution of "one
hundred and eighty" for "twenty-one" in par. (28), was executed to
par. (29) in view of the redesignation of par. (28) as par. (29) by
Pub. L. 98-473.
Pub. L. 98-473, Sec. 507(a), redesignated former par. (28) as
(29). Former par. (29) redesignated (30).
Par. (30). Pub. L. 98-473, Sec. 507(a), redesignated former par.
(29) as (30).
1979 - Par. (4). Pub. L. 96-132 substituted provisions defining
"Drug Enforcement Administration" for provisions defining "Bureau
of Narcotics and Dangerous Drugs".
1978 - Par. (29). Pub. L. 95-633 added par. (29).
1974 - Pars. (27), (28). Pub. L. 93-281 added pars. (27) and
(28).
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (24) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-358, Sec. 2(d), Oct. 22, 2004, 118 Stat. 1664,
provided that: "The amendments made by this section [amending this
section, section 811 of this title, and provisions set out as a
note under this section] shall take effect 90 days after the date
of enactment of this Act [Oct. 22, 2004]."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002,
116 Stat. 1808, provided that the amendment made by section
4002(c)(1) is effective Oct. 11, 1996.
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106-310, div. B, title XXXVI, Sec. 3622(b), Oct. 17,
2000, 114 Stat. 1231, provided that: "The amendments made by
subsection (a) [amending this section] shall take effect 1 year
after the date of the enactment of this Act [Oct. 17, 2000]."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1996 AMENDMENTS
Amendment by section 604(b)(4) of Pub. L. 104-294 effective Sept.
13, 1994, see section 604(d) of Pub. L. 104-294, set out as a note
under section 13 of Title 18, Crimes and Criminal Procedure.
Section 401(g) of Pub. L. 104-237 provided that: "Notwithstanding
any other provision of this Act [see section 1(a) of Pub. L. 104-
237, set out as a Short Title of 1996 Amendments note under
section 801 of this title], this section [amending this section and
section 814 of this title and enacting provisions set out as a note
below] shall not apply to the sale of any pseudoephedrine or
phenylpropanolamine product prior to 12 months after the date of
enactment of this Act [Oct. 3, 1996], except that, on application
of a manufacturer of a particular pseudoephedrine or
phenylpropanolamine drug product, the Attorney General may, in her
sole discretion, extend such effective date up to an additional six
months. Notwithstanding any other provision of law, the decision of
the Attorney General on such an application shall not be subject to
judicial review."
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330024(f) of Pub. L. 103-322 provided that: "The
amendments made by this section [amending this section and sections
824, 960, and 971 of this title] shall take effect as of the date
that is 120 days after the date of enactment of the Domestic
Chemical Diversion Control Act of 1993 [Dec. 17, 1993]."
EFFECTIVE DATE OF 1993 AMENDMENT
Section 11 of Pub. L. 103-200 provided that: "This Act [enacting
section 814 of this title, amending this section and sections 821
to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and
enacting provisions set out as a note under section 801 of this
title] and the amendments made by this Act shall take effect on the
date that is 120 days after the date of enactment of this Act [Dec.
17, 1993]."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 1902(d) of Pub. L. 101-647 provided that: "This section
[amending this section and section 812 of this title and enacting
provisions set out as a note under section 829 of this title] and
the amendment made by this section shall take effect 90 days after
the date of enactment of this Act [Nov. 29, 1990]."
EFFECTIVE DATE OF 1988 AMENDMENT
Section 6061 of title VI of Pub. L. 100-690 provided that:
"Except as otherwise provided in this subtitle, this subtitle
[subtitle A (Secs. 6051-6061) of title VI of Pub. L. 100-690,
enacting section 971 of this title, amending this section and
sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this
title, and enacting provisions set out as notes under this section
and section 971 of this title] shall take effect 120 days after the
enactment of this Act [Nov. 18, 1988]."
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
REGULATIONS
Section 301(b) of Pub. L. 98-509 provided that: "The Secretary of
Health and Human Services shall, within ninety days of the date of
the enactment of this Act [Oct. 19, 1984], promulgate regulations
for the administration of section 102(28) of the Controlled
Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and
shall include in the first report submitted under section 505(b)
[503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa-
2(b)] after the expiration of such ninety days the findings of the
Secretary with respect to the effect of the amendment made by
subsection (a)."
PRESERVATION OF STATE AUTHORITY TO REGULATE SCHEDULED LISTED
CHEMICALS
Pub. L. 109-177, title VII, Sec. 711(g), Mar. 9, 2006, 120 Stat.
263, provided that: "This section [amending this section and
sections 830, 841, 842, and 844 of this title and enacting
provisions set out as notes under sections 830 and 844 of this
title] and the amendments made by this section may not be construed
as having any legal effect on section 708 of the Controlled
Substances Act [21 U.S.C. 903] as applied to the regulation of
scheduled listed chemicals (as defined in section 102(45) of such
Act [21 U.S.C. 802(45)])."
REPORT ON DIVERSION OF ORDINARY, OVER-THE-COUNTER PSEUDOEPHEDRINE
AND PHENYLPROPANOLAMINE PRODUCTS
Pub. L. 106-310, div. B, title XXXVI, Sec. 3642, Oct. 17, 2000,
114 Stat. 1237, provided that:
"(a) Study. - The Attorney General shall conduct a study of the
use of ordinary, over-the-counter pseudoephedrine and
phenylpropanolamine products in the clandestine production of
illicit drugs. Sources of data for the study shall include the
following:
"(1) Information from Federal, State, and local clandestine
laboratory seizures and related investigations identifying the
source, type, or brand of drug products being utilized and how
they were obtained for the illicit production of methamphetamine
and amphetamine.
"(2) Information submitted voluntarily from the pharmaceutical
and retail industries involved in the manufacture, distribution,
and sale of drug products containing ephedrine, pseudoephedrine,
and phenylpropanolamine, including information on changes in the
pattern, volume, or both, of sales of ordinary, over-the-counter
pseudoephedrine and phenylpropanolamine products.
"(b) Report. -
"(1) Requirement. - Not later than 1 year after the date of the
enactment of this Act [Oct. 17, 2000], the Attorney General shall
submit to Congress a report on the study conducted under
subsection (a).
"(2) Elements. - The report shall include -
"(A) the findings of the Attorney General as a result of the
study; and
"(B) such recommendations on the need to establish additional
measures to prevent diversion of ordinary, over-the-counter
pseudoephedrine and phenylpropanolamine (such as a threshold on
ordinary, over-the-counter pseudoephedrine and
phenylpropanolamine products) as the Attorney General considers
appropriate.
"(3) Matters considered. - In preparing the report, the
Attorney General shall consider the comments and recommendations
including the comments on the Attorney General's proposed
findings and recommendations, of State and local law enforcement
and regulatory officials and of representatives of the industry
described in subsection (a)(2).
"(c) Regulation of Retail Sales. -
"(1) In general. - Notwithstanding section 401(d) of the
Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104-
237] (21 U.S.C. 802 note) and subject to paragraph (2), the
Attorney General shall establish by regulation a single-
transaction limit of not less than 24 grams of ordinary, over-
the-counter pseudoephedrine or phenylpropanolamine (as the case
may be) for retail distributors, if the Attorney General finds,
in the report under subsection (b), that -
"(A) there is a significant number of instances (as set forth
in paragraph (3)(A) of such section 401(d) for purposes of such
section) where ordinary, over-the-counter pseudoephedrine
products, phenylpropanolamine products, or both such products
that were purchased from retail distributors were widely used
in the clandestine production of illicit drugs; and
"(B) the best practical method of preventing such use is the
establishment of single-transaction limits for retail
distributors of either or both of such products.
"(2) Due process. - The Attorney General shall establish the
single-transaction limit under paragraph (1) only after notice,
comment, and an informal hearing."
REGULATION OF RETAIL SALES OF CERTAIN PRECURSOR CHEMICALS; EFFECT
ON THRESHOLDS; COMBINATION EPHEDRINE PRODUCTS
Pub. L. 104-237, title IV, Sec. 401(d)-(f), Oct. 3, 1996, 110
Stat. 3108, which authorized the Attorney General to establish a
single-transaction limit of 24 grams for pseudoephedrine,
phenylpropanolamine, and combination ephedrine products for retail
distributors, was repealed by Pub. L. 109-177, title VII, Sec.
712(b), Mar. 9, 2006, 120 Stat. 264.
EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41)
Pub. L. 101-647, title XIX, Sec. 1903, Nov. 29, 1990, 104 Stat.
4853, as amended by Pub. L. 108-358, Sec. 2(c), Oct. 22, 2004, 118
Stat. 1663, provided that:
"(a) Drugs for Treatment of Rare Diseases. - If the Attorney
General finds that a drug listed in paragraph (41) of section 102
of the Controlled Substances Act (as added by section 2 [1902] of
this Act) is -
"(1) approved by the Food and Drug Administration as an
accepted treatment for a rare disease or condition, as defined in
section 526 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb); and
"(2) does not have a significant potential for abuse, the
Attorney General may exempt such drug from any production
regulations otherwise issued under the Controlled Substances Act
as may be necessary to ensure adequate supplies of such drug for
medical purposes.
"(b) Date of Issuance of Regulations. - The Attorney General
shall issue regulations implementing this section not later than 45
days after the date of enactment of this Act [Nov. 29, 1990],
except that the regulations required under section 3(a) [former
1903(a)] shall be issued not later than 180 days after the date of
enactment of this Act."
-FOOTNOTE-
(!1) So in original. Probably should be "(l)".
-End-
-CITE-
21 USC Sec. 803 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
-HEAD-
Sec. 803. Repealed.
-MISC1-
Sec. 803. Repealed. Pub. L. 95-137, Sec. 1(b), Oct. 18, 1977, 91
Stat. 1169.
Section, Pub. L. 91-513, title II, Sec. 103, Oct. 27, 1970, 84
Stat. 1245, authorized Bureau of Narcotics and Dangerous Drugs to
add, during fiscal year 1971, 300 agents, together with necessary
supporting personnel, and provided for appropriations of $6,000,000
to carry out such addition.
-End-
-CITE-
21 USC Part B - Authority To Control; Standards and
Schedules 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part B - Authority To Control; Standards and Schedules
-HEAD-
PART B - AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES
-End-
-CITE-
21 USC Sec. 811 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part B - Authority To Control; Standards and Schedules
-HEAD-
Sec. 811. Authority and criteria for classification of substances
-STATUTE-
(a) Rules and regulations of Attorney General; hearing
The Attorney General shall apply the provisions of this
subchapter to the controlled substances listed in the schedules
established by section 812 of this title and to any other drug or
other substance added to such schedules under this subchapter.
Except as provided in subsections (d) and (e) of this section, the
Attorney General may by rule -
(1) add to such a schedule or transfer between such schedules
any drug or other substance if he -
(A) finds that such drug or other substance has a potential
for abuse, and
(B) makes with respect to such drug or other substance the
findings prescribed by subsection (b) of section 812 of this
title for the schedule in which such drug is to be placed; or
(2) remove any drug or other substance from the schedules if he
finds that the drug or other substance does not meet the
requirements for inclusion in any schedule.
Rules of the Attorney General under this subsection shall be made
on the record after opportunity for a hearing pursuant to the
rulemaking procedures prescribed by subchapter II of chapter 5 of
title 5. Proceedings for the issuance, amendment, or repeal of such
rules may be initiated by the Attorney General (1) on his own
motion, (2) at the request of the Secretary, or (3) on the petition
of any interested party.
(b) Evaluation of drugs and other substances
The Attorney General shall, before initiating proceedings under
subsection (a) of this section to control a drug or other substance
or to remove a drug or other substance entirely from the schedules,
and after gathering the necessary data, request from the Secretary
a scientific and medical evaluation, and his recommendations, as to
whether such drug or other substance should be so controlled or
removed as a controlled substance. In making such evaluation and
recommendations, the Secretary shall consider the factors listed in
paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this
section and any scientific or medical considerations involved in
paragraphs (1), (4), and (5) of such subsection. The
recommendations of the Secretary shall include recommendations with
respect to the appropriate schedule, if any, under which such drug
or other substance should be listed. The evaluation and the
recommendations of the Secretary shall be made in writing and
submitted to the Attorney General within a reasonable time. The
recommendations of the Secretary to the Attorney General shall be
binding on the Attorney General as to such scientific and medical
matters, and if the Secretary recommends that a drug or other
substance not be controlled, the Attorney General shall not control
the drug or other substance. If the Attorney General determines
that these facts and all other relevant data constitute substantial
evidence of potential for abuse such as to warrant control or
substantial evidence that the drug or other substance should be
removed entirely from the schedules, he shall initiate proceedings
for control or removal, as the case may be, under subsection (a) of
this section.
(c) Factors determinative of control or removal from schedules
In making any finding under subsection (a) of this section or
under subsection (b) of section 812 of this title, the Attorney
General shall consider the following factors with respect to each
drug or other substance proposed to be controlled or removed from
the schedules:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if
known.
(3) The state of current scientific knowledge regarding the
drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a
substance already controlled under this subchapter.
(d) International treaties, conventions, and protocols requiring
control; procedures respecting changes in drug schedules of
Convention on Psychotropic Substances
(1) If control is required by United States obligations under
international treaties, conventions, or protocols in effect on
October 27, 1970, the Attorney General shall issue an order
controlling such drug under the schedule he deems most appropriate
to carry out such obligations, without regard to the findings
required by subsection (a) of this section or section 812(b) of
this title and without regard to the procedures prescribed by
subsections (a) and (b) of this section.
(2)(A) Whenever the Secretary of State receives notification from
the Secretary-General of the United Nations that information has
been transmitted by or to the World Health Organization, pursuant
to article 2 of the Convention on Psychotropic Substances, which
may justify adding a drug or other substance to one of the
schedules of the Convention, transferring a drug or substance from
one schedule to another, or deleting it from the schedules, the
Secretary of State shall immediately transmit the notice to the
Secretary of Health and Human Services who shall publish it in the
Federal Register and provide opportunity to interested persons to
submit to him comments respecting the scientific and medical
evaluations which he is to prepare respecting such drug or
substance. The Secretary of Health and Human Services shall prepare
for transmission through the Secretary of State to the World Health
Organization such medical and scientific evaluations as may be
appropriate regarding the possible action that could be proposed by
the World Health Organization respecting the drug or substance with
respect to which a notice was transmitted under this subparagraph.
(B) Whenever the Secretary of State receives information that the
Commission on Narcotic Drugs of the United Nations proposes to
decide whether to add a drug or other substance to one of the
schedules of the Convention, transfer a drug or substance from one
schedule to another, or delete it from the schedules, the Secretary
of State shall transmit timely notice to the Secretary of Health
and Human Services of such information who shall publish a summary
of such information in the Federal Register and provide opportunity
to interested persons to submit to him comments respecting the
recommendation which he is to furnish, pursuant to this
subparagraph, respecting such proposal. The Secretary of Health and
Human Services shall evaluate the proposal and furnish a
recommendation to the Secretary of State which shall be binding on
the representative of the United States in discussions and
negotiations relating to the proposal.
(3) When the United States receives notification of a scheduling
decision pursuant to article 2 of the Convention on Psychotropic
Substances that a drug or other substance has been added or
transferred to a schedule specified in the notification or receives
notification (referred to in this subsection as a "schedule
notice") that existing legal controls applicable under this
subchapter to a drug or substance and the controls required by the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] do not
meet the requirements of the schedule of the Convention in which
such drug or substance has been placed, the Secretary of Health and
Human Services after consultation with the Attorney General, shall
first determine whether existing legal controls under this
subchapter applicable to the drug or substance and the controls
required by the Federal Food, Drug, and Cosmetic Act, meet the
requirements of the schedule specified in the notification or
schedule notice and shall take the following action:
(A) If such requirements are met by such existing controls but
the Secretary of Health and Human Services nonetheless believes
that more stringent controls should be applied to the drug or
substance, the Secretary shall recommend to the Attorney General
that he initiate proceedings for scheduling the drug or
substance, pursuant to subsections (a) and (b) of this section,
to apply to such controls.
(B) If such requirements are not met by such existing controls
and the Secretary of Health and Human Services concurs in the
scheduling decision or schedule notice transmitted by the
notification, the Secretary shall recommend to the Attorney
General that he initiate proceedings for scheduling the drug or
substance under the appropriate schedule pursuant to subsections
(a) and (b) of this section.
(C) If such requirements are not met by such existing controls
and the Secretary of Health and Human Services does not concur in
the scheduling decision or schedule notice transmitted by the
notification, the Secretary shall -
(i) if he deems that additional controls are necessary to
protect the public health and safety, recommend to the Attorney
General that he initiate proceedings for scheduling the drug or
substance pursuant to subsections (a) and (b) of this section,
to apply such additional controls;
(ii) request the Secretary of State to transmit a notice of
qualified acceptance, within the period specified in the
Convention, pursuant to paragraph 7 of article 2 of the
Convention, to the Secretary-General of the United Nations;
(iii) request the Secretary of State to transmit a notice of
qualified acceptance as prescribed in clause (ii) and request
the Secretary of State to ask for a review by the Economic and
Social Council of the United Nations, in accordance with
paragraph 8 of article 2 of the Convention, of the scheduling
decision; or
(iv) in the case of a schedule notice, request the Secretary
of State to take appropriate action under the Convention to
initiate proceedings to remove the drug or substance from the
schedules under the Convention or to transfer the drug or
substance to a schedule under the Convention different from the
one specified in the schedule notice.
(4)(A) If the Attorney General determines, after consultation
with the Secretary of Health and Human Services, that proceedings
initiated under recommendations made under paragraph (!1) (B) or
(C)(i) of paragraph (3) will not be completed within the time
period required by paragraph 7 of article 2 of the Convention, the
Attorney General, after consultation with the Secretary and after
providing interested persons opportunity to submit comments
respecting the requirements of the temporary order to be issued
under this sentence, shall issue a temporary order controlling the
drug or substance under schedule IV or V, whichever is most
appropriate to carry out the minimum United States obligations
under paragraph 7 of article 2 of the Convention. As a part of such
order, the Attorney General shall, after consultation with the
Secretary, except such drug or substance from the application of
any provision of part C of this subchapter which he finds is not
required to carry out the United States obligations under paragraph
7 of article 2 of the Convention. In the case of proceedings
initiated under subparagraph (B) of paragraph (3), the Attorney
General, concurrently with the issuance of such order, shall
request the Secretary of State to transmit a notice of qualified
acceptance to the Secretary-General of the United Nations pursuant
to paragraph 7 of article 2 of the Convention. A temporary order
issued under this subparagraph controlling a drug or other
substance subject to proceedings initiated under subsections (a)
and (b) of this section shall expire upon the effective date of the
application to the drug or substance of the controls resulting from
such proceedings.
(B) After a notice of qualified acceptance of a scheduling
decision with respect to a drug or other substance is transmitted
to the Secretary-General of the United Nations in accordance with
clause (ii) or (iii) of paragraph (3)(C) or after a request has
been made under clause (iv) of such paragraph with respect to a
drug or substance described in a schedule notice, the Attorney
General, after consultation with the Secretary of Health and Human
Services and after providing interested persons opportunity to
submit comments respecting the requirements of the order to be
issued under this sentence, shall issue an order controlling the
drug or substance under schedule IV or V, whichever is most
appropriate to carry out the minimum United States obligations
under paragraph 7 of article 2 of the Convention in the case of a
drug or substance for which a notice of qualified acceptance was
transmitted or whichever the Attorney General determines is
appropriate in the case of a drug or substance described in a
schedule notice. As a part of such order, the Attorney General
shall, after consultation with the Secretary, except such drug or
substance from the application of any provision of part C of this
subchapter which he finds is not required to carry out the United
States obligations under paragraph 7 of article 2 of the
Convention. If, as a result of a review under paragraph 8 of
article 2 of the Convention of the scheduling decision with respect
to which a notice of qualified acceptance was transmitted in
accordance with clause (ii) or (iii) of paragraph (3)(C) -
(i) the decision is reversed, and
(ii) the drug or substance subject to such decision is not
required to be controlled under schedule IV or V to carry out the
minimum United States obligations under paragraph 7 of article 2
of the Convention,
the order issued under this subparagraph with respect to such drug
or substance shall expire upon receipt by the United States of the
review decision. If, as a result of action taken pursuant to action
initiated under a request transmitted under clause (iv) of
paragraph (3)(C), the drug or substance with respect to which such
action was taken is not required to be controlled under schedule IV
or V, the order issued under this paragraph with respect to such
drug or substance shall expire upon receipt by the United States of
a notice of the action taken with respect to such drug or substance
under the Convention.
(C) An order issued under subparagraph (A) or (B) may be issued
without regard to the findings required by subsection (a) of this
section or by section 812(b) of this title and without regard to
the procedures prescribed by subsection (a) or (b) of this section.
(5) Nothing in the amendments made by the Psychotropic Substances
Act of 1978 or the regulations or orders promulgated thereunder
shall be construed to preclude requests by the Secretary of Health
and Human Services or the Attorney General through the Secretary of
State, pursuant to article 2 or other applicable provisions of the
Convention, for review of scheduling decisions under such
Convention, based on new or additional information.
(e) Immediate precursors
The Attorney General may, without regard to the findings required
by subsection (a) of this section or section 812(b) of this title
and without regard to the procedures prescribed by subsections (a)
and (b) of this section, place an immediate precursor in the same
schedule in which the controlled substance of which it is an
immediate precursor is placed or in any other schedule with a
higher numerical designation. If the Attorney General designates a
substance as an immediate precursor and places it in a schedule,
other substances shall not be placed in a schedule solely because
they are its precursors.
(f) Abuse potential
If, at the time a new-drug application is submitted to the
Secretary for any drug having a stimulant, depressant, or
hallucinogenic effect on the central nervous system, it appears
that such drug has an abuse potential, such information shall be
forwarded by the Secretary to the Attorney General.
(g) Exclusion of non-narcotic substances sold over the counter
without a prescription; dextromethorphan; exemption of substances
lacking abuse potential
(1) The Attorney General shall by regulation exclude any non-
narcotic drug which contains a controlled substance from the
application of this subchapter and subchapter II of this chapter if
such drug may, under the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 301 et seq.], be lawfully sold over the counter without a
prescription.
(2) Dextromethorphan shall not be deemed to be included in any
schedule by reason of enactment of this subchapter unless
controlled after October 27, 1970 pursuant to the foregoing
provisions of this section.
(3) The Attorney General may, by regulation, exempt any compound,
mixture, or preparation containing a controlled substance from the
application of all or any part of this subchapter if he finds such
compound, mixture, or preparation meets the requirements of one of
the following categories:
(A) A mixture, or preparation containing a nonnarcotic
controlled substance, which mixture or preparation is approved
for prescription use, and which contains one or more other active
ingredients which are not listed in any schedule and which are
included therein in such combinations, quantity, proportion, or
concentration as to vitiate the potential for abuse.
(B) A compound, mixture, or preparation which contains any
controlled substance, which is not for administration to a human
being or animal, and which is packaged in such form or
concentration, or with adulterants or denaturants, so that as
packaged it does not present any significant potential for abuse.
(C) Upon the recommendation of the Secretary of Health and
Human Services, a compound, mixture, or preparation which
contains any anabolic steroid, which is intended for
administration to a human being or an animal, and which, because
of its concentration, preparation, formulation or delivery
system, does not present any significant potential for abuse.
(h) Temporary scheduling to avoid imminent hazards to public safety
(1) If the Attorney General finds that the scheduling of a
substance in schedule I on a temporary basis is necessary to avoid
an imminent hazard to the public safety, he may, by order and
without regard to the requirements of subsection (b) of this
section relating to the Secretary of Health and Human Services,
schedule such substance in schedule I if the substance is not
listed in any other schedule in section 812 of this title or if no
exemption or approval is in effect for the substance under section
505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355].
Such an order may not be issued before the expiration of thirty
days from -
(A) the date of the publication by the Attorney General of a
notice in the Federal Register of the intention to issue such
order and the grounds upon which such order is to be issued, and
(B) the date the Attorney General has transmitted the notice
required by paragraph (4).
(2) The scheduling of a substance under this subsection shall
expire at the end of one year from the date of the issuance of the
order scheduling such substance, except that the Attorney General
may, during the pendency of proceedings under subsection (a)(1) of
this section with respect to the substance, extend the temporary
scheduling for up to six months.
(3) When issuing an order under paragraph (1), the Attorney
General shall be required to consider, with respect to the finding
of an imminent hazard to the public safety, only those factors set
forth in paragraphs (4), (5), and (6) of subsection (c) of this
section, including actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or
distribution.
(4) The Attorney General shall transmit notice of an order
proposed to be issued under paragraph (1) to the Secretary of
Health and Human Services. In issuing an order under paragraph (1),
the Attorney General shall take into consideration any comments
submitted by the Secretary in response to a notice transmitted
pursuant to this paragraph.
(5) An order issued under paragraph (1) with respect to a
substance shall be vacated upon the conclusion of a subsequent
rulemaking proceeding initiated under subsection (a) of this
section with respect to such substance.
(6) An order issued under paragraph (1) is not subject to
judicial review.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 201, Oct. 27, 1970, 84 Stat. 1245;
Pub. L. 95-633, title I, Sec. 102(a), Nov. 10, 1978, 92 Stat. 3769;
Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695;
Pub. L. 98-473, title II, Secs. 508, 509(a), Oct. 12, 1984, 98
Stat. 2071, 2072; Pub. L. 108-358, Sec. 2(b), Oct. 22, 2004, 118
Stat. 1663.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (a), (c)(8), (d)(3),
(4)(A), (B), and (g)(2), (3), was in the original "this title",
meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242,
as amended, and is popularly known as the "Controlled Substances
Act". For complete classification of title II to the Code, see
second paragraph of Short Title note set out under section 801 of
this title and Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(d)(3) and (g)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
Schedules I, IV, and V, referred to in subsecs. (d)(4)(A), (B),
and (h)(1), are set out in section 812(c) of this title.
The Psychotropic Substances Act of 1978, referred to in subsec.
(d)(5), is Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 3768, which
enacted sections 801a, 830, and 852 of this title, amended sections
352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and
965 of this title and section 242a of Title 42, The Public Health
and Welfare, repealed section 830 of this title effective Jan. 1,
1981, and enacted provisions set out as notes under sections 801,
801a, 812, and 830 of this title. For complete classification of
this Act to the Code, see Short Title of 1978 Amendment note set
out under section 801 of this title and Tables.
This subchapter and subchapter II of this chapter, referred to in
subsec. (g)(1), was in the original "titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act", which was
translated as meaning titles II and III of the Comprehensive Drug
Abuse Prevention and Control Act of 1970, Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, 1285, as amended, to reflect the probable
intent of Congress. Title II is classified principally to this
subchapter and part A of title III comprises subchapter II of this
chapter. For complete classification of this Act to the Code, see
Short Title notes set out under section 801 of this title and
Tables.
-MISC1-
AMENDMENTS
2004 - Subsec. (g)(1). Pub. L. 108-358, Sec. 2(b)(1), substituted
"drug which contains a controlled substance from the application of
this subchapter and subchapter II of this chapter if such drug" for
"substance from a schedule if such substance".
Subsec. (g)(3)(C). Pub. L. 108-358, Sec. 2(b)(2), added subpar.
(C).
1984 - Subsec. (g)(3). Pub. L. 98-473, Sec. 509(a), added par.
(3).
Subsec. (h). Pub. L. 98-473, Sec. 508, added subsec. (h).
1978 - Subsec. (d). Pub. L. 95-633 designated existing provisions
as par. (1) and added pars. (2) to (5).
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsec. (d)(2),
(3), (4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96-88
which is classified to section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-358 effective 90 days after Oct. 22,
2004, see section 2(d) of Pub. L. 108-358, set out as a note under
section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
-FOOTNOTE-
(!1) So in original. Probably should be "subparagraph".
-End-
-CITE-
21 USC Sec. 812 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part B - Authority To Control; Standards and Schedules
-HEAD-
Sec. 812. Schedules of controlled substances
-STATUTE-
(a) Establishment
There are established five schedules of controlled substances, to
be known as schedules I, II, III, IV, and V. Such schedules shall
initially consist of the substances listed in this section. The
schedules established by this section shall be updated and
republished on a semiannual basis during the two-year period
beginning one year after October 27, 1970, and shall be updated and
republished on an annual basis thereafter.
(b) Placement on schedules; findings required
Except where control is required by United States obligations
under an international treaty, convention, or protocol, in effect
on October 27, 1970, and except in the case of an immediate
precursor, a drug or other substance may not be placed in any
schedule unless the findings required for such schedule are made
with respect to such drug or other substance. The findings required
for each of the schedules are as follows:
(1) Schedule I. -
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted
medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or
other substance under medical supervision.
(2) Schedule II. -
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States or a currently
accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe
psychological or physical dependence.
(3) Schedule III. -
(A) The drug or other substance has a potential for abuse less
than the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate
or low physical dependence or high psychological dependence.
(4) Schedule IV. -
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the
drugs or other substances in schedule III.
(5) Schedule V. -
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the
drugs or other substances in schedule IV.
(c) Initial schedules of controlled substances
Schedules I, II, III, IV, and V shall, unless and until amended
(!1) pursuant to section 811 of this title, consist of the
following drugs or other substances, by whatever official name,
common or usual name, chemical name, or brand name designated:
SCHEDULE I
(a) Unless specifically excepted or unless listed in another
schedule, any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers,
whenever the existence of such isomers, esters, ethers, and salts
is possible within the specific chemical designation:
(1) Acetylmethadol.
(2) Allylprodine.
(3) Alphacetylmathadol.(!2)
(4) Alphameprodine.
(5) Alphamethadol.
(6) Benzethidine.
(7) Betacetylmethadol.
(8) Betameprodine.
(9) Betamethadol.
(10) Betaprodine.
(11) Clonitazene.
(12) Dextromoramide.
(13) Dextrorphan.
(14) Diampromide.
(15) Diethylthiambutene.
(16) Dimenoxadol.
(17) Dimepheptanol.
(18) Dimethylthiambutene.
(19) Dioxaphetyl butyrate.
(20) Dipipanone.
(21) Ethylmethylthiambutene.
(22) Etonitazene.
(23) Etoxeridine.
(24) Furethidine.
(25) Hydroxypethidine.
(26) Ketobemidone.
(27) Levomoramide.
(28) Levophenacylmorphan.
(29) Morpheridine.
(30) Noracymethadol.
(31) Norlevorphanol.
(32) Normethadone.
(33) Norpipanone.
(34) Phenadoxone.
(35) Phenampromide.
(36) Phenomorphan.
(37) Phenoperidine.
(38) Piritramide.
(39) Propheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
(b) Unless specifically excepted or unless listed in another
schedule, any of the following opium derivatives, their salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific
chemical designation:
(1) Acetorphine.
(2) Acetyldihydrocodeine.
(3) Benzylmorphine.
(4) Codeine methylbromide.
(5) Codeine-N-Oxide.
(6) Cyprenorphine.
(7) Desomorphine.
(8) Dihydromorphine.
(9) Etorphine.
(10) Heroin.
(11) Hydromorphinol.
(12) Methyldesorphine.
(13) Methylhydromorphine.
(14) Morphine methylbromide.
(15) Morphine methylsulfonate.
(16) Morphine-N-Oxide.
(17) Myrophine.
(18) Nicocodeine.
(19) Nicomorphine.
(20) Normorphine.
(21) Pholcodine.
(22) Thebacon.
(c) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation, which
contains any quantity of the following hallucinogenic substances,
or which contains any of their salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers
is possible within the specific chemical designation:
(1) 3,4-methylenedioxy amphetamine.
(2) 5-methoxy-3,4-methylenedioxy amphetamine.
(3) 3,4,5-trimethoxy amphetamine.
(4) Bufotenine.
(5) Diethyltryptamine.
(6) Dimethyltryptamine.
(7) 4-methyl-2,5-diamethoxyamphetamine.
(8) Ibogaine.
(9) Lysergic acid diethylamide.
(10) Marihuana.
(11) Mescaline.
(12) Peyote.
(13) N-ethyl-3-piperidyl benzilate.
(14) N-methyl-3-piperidyl benzilate.
(15) Psilocybin.
(16) Psilocyn.
(17) Tetrahydrocannabinols.
SCHEDULE II
(a) Unless specifically excepted or unless listed in another
schedule, any of the following substances whether produced directly
or indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination
of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate.
(2) Any salt, compound, derivative, or preparation thereof
which is chemically equivalent or identical with any of the
substances referred to in clause (1), except that these
substances shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) coca (!3) leaves, except coca leaves and extracts of coca
leaves from which cocaine, ecgonine, and derivatives of ecgonine
or their salts have been removed; cocaine, its salts, optical and
geometric isomers, and salts of isomers; ecgonine, its
derivatives, their salts, isomers, and salts of isomers; or any
compound, mixture, or preparation which contains any quantity of
any of the substances referred to in this paragraph.
(b) Unless specifically excepted or unless listed in another
schedule, any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters and ethers,
whenever the existence of such isomers, esters, ethers, and salts
is possible within the specific chemical designation:
(1) Alphaprodine.
(2) Anileridine.
(3) Bezitramide.
(4) Dihydrocodeine.
(5) Diphenoxylate.
(6) Fentanyl.
(7) Isomethadone.
(8) Levomethorphan.
(9) Levorphanol.
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-
diphenyl butane.
(13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-
diphenylpropane-carboxylic acid.
(14) Pethidine.
(15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-
phenylpiperidine.
(16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-
carboxylate.
(17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-
carboxylic acid.
(18) Phenazocine.
(19) Piminodine.
(20) Racemethorphan.
(21) Racemorphan.
(c) Unless specifically excepted or unless listed in another
schedule, any injectable liquid which contains any quantity of
methamphetamine, including its salts, isomers, and salts of
isomers.
SCHEDULE III
(a) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
stimulant effect on the central nervous system:
(1) Amphetamine, its salts, optical isomers, and salts of its
optical isomers.
(2) Phenmetrazine and its salts.
(3) Any substance (except an injectable liquid) which contains
any quantity of methamphetamine, including its salts, isomers,
and salts of isomers.
(4) Methylphenidate.
(b) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of the following substances having a
depressant effect on the central nervous system:
(1) Any substance which contains any quantity of a derivative
of barbituric acid, or any salt of a derivative of barbituric
acid.
(2) Chorhexadol.
(3) Glutethimide.
(4) Lysergic acid.
(5) Lysergic acid amide.
(6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane.
(9) Sulfonethylmethane.
(10) Sulfonmethane.
(c) Nalorphine.
(d) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation
containing limited quantities of any of the following narcotic
drugs, or any salts thereof:
(1) Not more than 1.8 grams of codeine per 100 milliliters or
not more than 90 milligrams per dosage unit, with an equal or
greater quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per 100 milliliters or
not more than 90 milligrams per dosage unit, with one or more
active, non-narcotic ingredients in recognized therapeutic
amounts.
(3) Not more than 300 milligrams of dihydrocodeinone per 100
milliliters or not more than 15 milligrams per dosage unit, with
a fourfold or greater quantity of an isoquinoline alkaloid of
opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100
milliliters or not more than 15 milligrams per dosage unit, with
one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(5) Not more than 1.8 grams of dihydrocodeine per 100
milliliters or not more than 90 milligrams per dosage unit, with
one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100
milliliters or not more than 15 milligrams per dosage unit, with
one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(7) Not more than 500 milligrams of opium per 100 milliliters
or per 100 grams, or not more than 25 milligrams per dosage unit,
with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(8) Not more than 50 milligrams of morphine per 100 milliliters
or per 100 grams with one or more active, nonnarcotic ingredients
in recognized therapeutic amounts.
(e) Anabolic steroids.
SCHEDULE IV
(1) Barbital.
(2) Chloral betaine.
(3) Chloral hydrate.
(4) Ethchlorvynol.
(5) Ethinamate.
(6) Methohexital.
(7) Meprobamate.
(8) Methylphenobarbital.
(9) Paraldehyde.
(10) Petrichloral.
(11) Phenobarbital.
SCHEDULE V
Any compound, mixture, or preparation containing any of the
following limited quantities of narcotic drugs, which shall include
one or more nonnarcotic active medicinal ingredients in sufficient
proportion to confer upon the compound, mixture, or preparation
valuable medicinal qualities other than those possessed by the
narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milliliters
or per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100
milliliters or per 100 grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less
than 25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters
or per 100 grams.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 202, Oct. 27, 1970, 84 Stat. 1247;
Pub. L. 95-633, title I, Sec. 103, Nov. 10, 1978, 92 Stat. 3772;
Pub. L. 98-473, title II, Secs. 507(c), 509(b), Oct. 12, 1984, 98
Stat. 2071, 2072; Pub. L. 99-570, title I, Sec. 1867, Oct. 27,
1986, 100 Stat. 3207-55; Pub. L. 99-646, Sec. 84, Nov. 10, 1986,
100 Stat. 3619; Pub. L. 101-647, title XIX, Sec. 1902(a), Nov. 29,
1990, 104 Stat. 4851.)
-MISC1-
AMENDMENTS
1990 - Subsec. (c). Pub. L. 101-647 added item (e) at end of
schedule III.
1986 - Subsec. (c). Pub. L. 99-646 amended schedule II(a)(4)
generally. Prior to amendment, schedule II(a)(4) read as follows:
"Coca leaves (except coca leaves and extracts of coca leaves from
which cocaine, ecgonine, and derivatives of ecgonine or their salts
have been removed); cocaine, its salts, optical and geometric
isomers, and salts of isomers; and ecgonine, its derivatives, their
salts, isomers, and salts of isomers."
Pub. L. 99-570 amended schedule II(a)(4) generally. Prior to
amendment, schedule II(a)(4) read as follows: "Coca leaves and any
salt, compound, derivative, or preparation of coca leaves
(including cocaine and ecgonine and their salts, isomers,
derivatives, and salts of isomers and derivatives), and any salt,
compound, derivative, or preparation thereof which is chemically
equivalent or identical with any of these substances, except that
the substances shall not include decocainized coca leaves or
extraction of coca leaves, which extractions do not contain cocaine
or ecgonine."
1984 - Subsec. (c). Pub. L. 98-473, Sec. 507(c), in schedule
II(a)(4) added applicability to cocaine and ecgonine and their
salts, isomers, etc.
Subsec. (d). Pub. L. 98-473, Sec. 509(b), struck out subsec. (d)
which related to authority of Attorney General to except stimulants
or depressants containing active medicinal ingredients.
1978 - Subsec. (d)(3). Pub. L. 95-633 added cl. (3).
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-647 effective 90 days after Nov. 29,
1990, see section 1902(d) of Pub. L. 101-647, set out as a note
under section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
CONGRESSIONAL FINDING; EMERGENCY SCHEDULING OF GHB IN CONTROLLED
SUBSTANCES ACT
Pub. L. 106-172, Secs. 2, 3(a), Feb. 18, 2000, 114 Stat. 7, 8,
provided that:
"SEC. 2. FINDINGS.
"Congress finds as follows:
"(1) Gamma hydroxybutyric acid (also called G, Liquid X, Liquid
Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop) has
become a significant and growing problem in law enforcement. At
least 20 States have scheduled such drug in their drug laws and
law enforcement officials have been experiencing an increased
presence of the drug in driving under the influence, sexual
assault, and overdose cases especially at night clubs and
parties.
"(2) A behavioral depressant and a hypnotic, gamma
hydroxybutyric acid ('GHB') is being used in conjunction with
alcohol and other drugs with detrimental effects in an increasing
number of cases. It is difficult to isolate the impact of such
drug's ingestion since it is so typically taken with an ever-
changing array of other drugs and especially alcohol which
potentiates its impact.
"(3) GHB takes the same path as alcohol, processes via alcohol
dehydrogenase, and its symptoms at high levels of intake and as
impact builds are comparable to alcohol ingestion/intoxication.
Thus, aggression and violence can be expected in some individuals
who use such drug.
"(4) If taken for human consumption, common industrial
chemicals such as gamma butyrolactone and 1.4-butanediol are
swiftly converted by the body into GHB. Illicit use of these and
other GHB analogues and precursor chemicals is a significant and
growing law enforcement problem.
"(5) A human pharmaceutical formulation of gamma hydroxybutyric
acid is being developed as a treatment for cataplexy, a serious
and debilitating disease. Cataplexy, which causes sudden and
total loss of muscle control, affects about 65 percent of the
estimated 180,000 Americans with narcolepsy, a sleep disorder.
People with cataplexy often are unable to work, drive a car, hold
their children or live a normal life.
"(6) Abuse of illicit GHB is an imminent hazard to public
safety that requires immediate regulatory action under the
Controlled Substances Act (21 U.S.C. 801 et seq.).
"SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND
LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.
"(a) Emergency Scheduling of GHB. -
"(1) In general. - The Congress finds that the abuse of illicit
gamma hydroxybutyric acid is an imminent hazard to the public
safety. Accordingly, the Attorney General, notwithstanding
sections 201(a), 201(b), 201(c), and 202 of the Controlled
Substances Act [21 U.S.C. 811(a)-(c), 812], shall issue, not
later than 60 days after the date of the enactment of this Act
[Feb. 18, 2000], a final order that schedules such drug (together
with its salts, isomers, and salts of isomers) in the same
schedule under section 202(c) of the Controlled Substances Act as
would apply to a scheduling of a substance by the Attorney
General under section 201(h)(1) of such Act (relating to imminent
hazards to the public safety), except as follows:
"(A) For purposes of any requirements that relate to the
physical security of registered manufacturers and registered
distributors, the final order shall treat such drug, when the
drug is manufactured, distributed, or possessed in accordance
with an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 355(i)] (whether the
exemption involved is authorized before, on, or after the date
of the enactment of this Act [Feb. 18, 2000]), as being in the
same schedule as that recommended by the Secretary of Health
and Human Services for the drug when the drug is the subject of
an authorized investigational new drug application (relating to
such section 505(i)). The recommendation referred to in the
preceding sentence is contained in the first paragraph of the
letter transmitted on May 19, 1999, by such Secretary (acting
through the Assistant Secretary for Health) to the Attorney
General (acting through the Deputy Administrator of the Drug
Enforcement Administration), which letter was in response to
the letter transmitted by the Attorney General (acting through
such Deputy Administrator) on September 16, 1997. In publishing
the final order in the Federal Register, the Attorney General
shall publish a copy of the letter that was transmitted by the
Secretary of Health and Human Services.
"(B) In the case of gamma hydroxybutyric acid that is
contained in a drug product for which an application is
approved under section 505 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 355] (whether the application involved
is approved before, on, or after the date of the enactment of
this Act [Feb. 18, 2000]), the final order shall schedule such
drug in the same schedule as that recommended by the Secretary
of Health and Human Services for authorized formulations of the
drug. The recommendation referred to in the preceding sentence
is contained in the last sentence of the fourth paragraph of
the letter referred to in subparagraph (A) with respect to May
19, 1999.
"(2) Failure to issue order. - If the final order is not issued
within the period specified in paragraph (1), gamma
hydroxybutyric acid (together with its salts, isomers, and salts
of isomers) is deemed to be scheduled under section 202(c) of the
Controlled Substances Act [21 U.S.C. 812(c)] in accordance with
the policies described in paragraph (1), as if the Attorney
General had issued a final order in accordance with such
paragraph."
PLACEMENT OF PIPRADROL AND SPA IN SCHEDULE IV TO CARRY OUT
OBLIGATION UNDER CONVENTION ON PSYCHOTROPIC SUBSTANCES
Section 102(c) of Pub. L. 95-633 provided that: "For the purpose
of carrying out the minimum United States obligations under
paragraph 7 of article 2 of the Convention on Psychotropic
Substances, signed at Vienna, Austria, on February 21, 1971, with
respect to pipradrol and SPA (also known as (-)-1-dimethylamino-1,2-
diphenylethane), the Attorney General shall by order, made without
regard to sections 201 and 202 of the Controlled Substances Act
[this section and section 811 of this title], place such drugs in
schedule IV of such Act [see subsec. (c) of this section]."
Provision of section 102(c) of Pub. L. 95-633, set out above,
effective on the date the Convention on Psychotropic Substances
enters into force in the United States [July 15, 1980], see section
112 of Pub. L. 95-633, set out as an Effective Date note under
section 801a of this title.
-FOOTNOTE-
(!1) Revised schedules are published in the Code of Federal
Regulations, Part 1308 of Title 21, Food and Drugs.
(!2) So in original. Probably should be "Alphacetylmethadol."
(!3) So in original. Probably should be capitalized.
-End-
-CITE-
21 USC Sec. 813 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part B - Authority To Control; Standards and Schedules
-HEAD-
Sec. 813. Treatment of controlled substance analogues
-STATUTE-
A controlled substance analogue shall, to the extent intended for
human consumption, be treated, for the purposes of any Federal law
as a controlled substance in schedule I.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 203, as added Pub. L. 99-570, title
I, Sec. 1202, Oct. 27, 1986, 100 Stat. 3207-13; amended Pub. L. 100-
690, title VI, Sec. 6470(c), Nov. 18, 1988, 102 Stat. 4378.)
-REFTEXT-
REFERENCES IN TEXT
Schedule I, referred to in text, is set out in section 812(c) of
this title.
-MISC1-
AMENDMENTS
1988 - Pub. L. 100-690 substituted "any Federal law" for "this
subchapter and subchapter II of this chapter".
-End-
-CITE-
21 USC Sec. 814 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part B - Authority To Control; Standards and Schedules
-HEAD-
Sec. 814. Removal of exemption of certain drugs
-STATUTE-
(a) Removal of exemption
The Attorney General shall by regulation remove from exemption
under section 802(39)(A)(iv) of this title a drug or group of drugs
that the Attorney General finds is being diverted to obtain a
listed chemical for use in the illicit production of a controlled
substance.
(b) Factors to be considered
In removing a drug or group of drugs from exemption under
subsection (a) of this section, the Attorney General shall
consider, with respect to a drug or group of drugs that is proposed
to be removed from exemption -
(1) the scope, duration, and significance of the diversion;
(2) whether the drug or group of drugs is formulated in such a
way that it cannot be easily used in the illicit production of a
controlled substance; and
(3) whether the listed chemical can be readily recovered from
the drug or group of drugs.
(c) Specificity of designation
The Attorney General shall limit the designation of a drug or a
group of drugs removed from exemption under subsection (a) of this
section to the most particularly identifiable type of drug or group
of drugs for which evidence of diversion exists unless there is
evidence, based on the pattern of diversion and other relevant
factors, that the diversion will not be limited to that particular
drug or group of drugs.
(d) Reinstatement of exemption with respect to particular drug
products
(1) Reinstatement
On application by a manufacturer of a particular drug product
that has been removed from exemption under subsection (a) of this
section, the Attorney General shall by regulation reinstate the
exemption with respect to that particular drug product if the
Attorney General determines that the particular drug product is
manufactured and distributed in a manner that prevents diversion.
(2) Factors to be considered
In deciding whether to reinstate the exemption with respect to
a particular drug product under paragraph (1), the Attorney
General shall consider -
(A) the package sizes and manner of packaging of the drug
product;
(B) the manner of distribution and advertising of the drug
product;
(C) evidence of diversion of the drug product;
(D) any actions taken by the manufacturer to prevent
diversion of the drug product; and
(E) such other factors as are relevant to and consistent with
the public health and safety, including the factors described
in subsection (b) of this section as applied to the drug
product.
(3) Status pending application for reinstatement
A transaction involving a particular drug product that is the
subject of a bona fide pending application for reinstatement of
exemption filed with the Attorney General not later than 60 days
after a regulation removing the exemption is issued pursuant to
subsection (a) of this section shall not be considered to be a
regulated transaction if the transaction occurs during the
pendency of the application and, if the Attorney General denies
the application, during the period of 60 days following the date
on which the Attorney General denies the application, unless -
(A) the Attorney General has evidence that, applying the
factors described in subsection (b) of this section to the drug
product, the drug product is being diverted; and
(B) the Attorney General so notifies the applicant.
(4) Amendment and modification
A regulation reinstating an exemption under paragraph (1) may
be modified or revoked with respect to a particular drug product
upon a finding that -
(A) applying the factors described in subsection (b) of this
section to the drug product, the drug product is being
diverted; or
(B) there is a significant change in the data that led to the
issuance of the regulation.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 204, as added Pub. L. 103-200, Sec.
2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104-237,
title IV, Sec. 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109-
177, title VII, Sec. 712(a)(2), Mar. 9, 2006, 120 Stat. 263.)
-MISC1-
AMENDMENTS
2006 - Subsec. (e). Pub. L. 109-177 struck out subsec. (e). Text
read as follows: "Pursuant to subsection (d)(1) of this section,
the Attorney General shall by regulation reinstate the exemption
with respect to a particular ephedrine, pseudoephedrine, or
phenylpropanolamine drug product if the Attorney General determines
that the drug product is manufactured and distributed in a manner
that prevents diversion. In making this determination the Attorney
General shall consider the factors listed in subsection (d)(2) of
this section. Any regulation issued pursuant to this subsection may
be amended or revoked based on the factors listed in subsection
(d)(4) of this section."
1996 - Subsec. (e). Pub. L. 104-237 added subsec. (e).
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by Pub. L. 104-237 not applicable to sale of any
pseudoephedrine or phenylpropanolamine product prior to 12 months
after Oct. 3, 1996, except that, on application of manufacturer of
particular drug product, Attorney General may exercise sole and
judicially unreviewable discretion to extend such effective date up
to additional 6 months, see section 401(g) of Pub. L. 104-237, set
out as a note under section 802 of this title.
EFFECTIVE DATE
Section effective on date that is 120 days after Dec. 17, 1993,
see section 11 of Pub. L. 103-200, set out as an Effective Date of
1993 Amendment note under section 802 of this title.
-End-
-CITE-
21 USC Part C - Registration of Manufacturers,
Distributors, and Dispensers of
Controlled Substances 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
PART C - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
-End-
-CITE-
21 USC Sec. 821 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 821. Rules and regulations
-STATUTE-
The Attorney General is authorized to promulgate rules and
regulations and to charge reasonable fees relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances and to listed chemicals.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 301, Oct. 27, 1970, 84 Stat. 1253;
Pub. L. 103-200, Sec. 3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L.
108-447, div. B, title VI, Sec. 633(b), Dec. 8, 2004, 118 Stat.
2922.)
-MISC1-
AMENDMENTS
2004 - Pub. L. 108-447 substituted "listed chemicals" for "the
registration and control of regulated persons and of regulated
transactions".
1993 - Pub. L. 103-200 inserted before period at end "and to the
registration and control of regulated persons and of regulated
transactions".
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
-End-
-CITE-
21 USC Sec. 822 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 822. Persons required to register
-STATUTE-
(a) Period of registration
(1) Every person who manufactures or distributes any controlled
substance or list I chemical, or who proposes to engage in the
manufacture or distribution of any controlled substance or list I
chemical, shall obtain annually a registration issued by the
Attorney General in accordance with the rules and regulations
promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any
controlled substance, shall obtain from the Attorney General a
registration issued in accordance with the rules and regulations
promulgated by him. The Attorney General shall, by regulation,
determine the period of such registrations. In no event, however,
shall such registrations be issued for less than one year nor for
more than three years.
(b) Authorized activities
Persons registered by the Attorney General under this subchapter
to manufacture, distribute, or dispense controlled substances or
list I chemicals are authorized to possess, manufacture,
distribute, or dispense such substances or chemicals (including any
such activity in the conduct of research) to the extent authorized
by their registration and in conformity with the other provisions
of this subchapter.
(c) Exceptions
The following persons shall not be required to register and may
lawfully possess any controlled substance or list I chemical under
this subchapter:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance or list I
chemical if such agent or employee is acting in the usual course
of his business or employment.
(2) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of the controlled substance or
list I chemical is in the usual course of his business or
employment.
(3) An ultimate user who possesses such substance for a purpose
specified in section 802(25) (!1) of this title.
(d) Waiver
The Attorney General may, by regulation, waive the requirement
for registration of certain manufacturers, distributors, or
dispensers if he finds it consistent with the public health and
safety.
(e) Separate registration
A separate registration shall be required at each principal place
of business or professional practice where the applicant
manufactures, distributes, or dispenses controlled substances or
list I chemicals.
(f) Inspection
The Attorney General is authorized to inspect the establishment
of a registrant or applicant for registration in accordance with
the rules and regulations promulgated by him.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 302, Oct. 27, 1970, 84 Stat. 1253;
Pub. L. 98-473, title II, Sec. 510, Oct. 12, 1984, 98 Stat. 2072;
Pub. L. 103-200, Sec. 3(b), Dec. 17, 1993, 107 Stat. 2336.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (b) and (c), was in the
original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, as amended, and is popularly known as the
"Controlled Substances Act". For complete classification of title
II to the Code, see second paragraph of Short Title note set out
under section 801 of this title and Tables.
Section 802(25) of this title, referred to in subsec. (c)(3), was
redesignated section 802(26) of this title by Pub. L. 98-473, title
II, Sec. 507(a), Oct. 12, 1984, 98 Stat. 2071, and was further
redesignated section 802(27) of this title by Pub. L. 99-570, title
I, Sec. 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.
-MISC1-
AMENDMENTS
1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 3(b)(1), inserted
"or list I chemical" after "controlled substance" in two places.
Subsec. (b). Pub. L. 103-200, Sec. 3(b)(2), inserted "or list I
chemicals" after "controlled substances" and "or chemicals" after
"such substances".
Subsec. (c). Pub. L. 103-200, Sec. 3(b)(3), inserted "or list I
chemical" after "controlled substance" wherever appearing.
Subsec. (e). Pub. L. 103-200, Sec. 3(b)(4), inserted "or list I
chemicals" after "controlled substances".
1984 - Subsec. (a). Pub. L. 98-473 designated existing provisions
as par. (1), struck out provisions relating to dispensing
controlled substances, and added par. (2).
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
PROVISIONAL REGISTRATION
Section 703 of Pub. L. 91-513, as amended by Pub. L. 99-514, Sec.
2, Oct. 22, 1986, 100 Stat. 2095, provided that:
"(a)(1) Any person who -
"(A) is engaged in manufacturing, distributing, or dispensing
any controlled substance on the day before the effective date of
section 302 [this section], and
"(B) is registered on such day under section 510 of the Federal
Food, Drug, and Cosmetic Act [section 360 of this title] or under
section 4722 of the Internal Revenue Code of 1986 [formerly
I.R.C. 1954, section 4722 of Title 26],
shall, with respect to each establishment for which such
registration is in effect under any such section, be deemed to have
a provisional registration under section 303 [section 823 of this
title] for the manufacture, distribution, or dispensing (as the
case may be) of controlled substances.
"(2) During the period his provisional registration is in effect
under this section, the registration number assigned such person
under such section 510 [section 360 of this title] or under such
section 4722 [section 4722 of Title 26] (as the case may be) shall
be his registration number for purposes of section 303 of this
title [section 823 of this title].
"(b) The provisions of section 304 [section 824 of this title],
relating to suspension and revocation of registration, shall apply
to a provisional registration under this section.
"(c) Unless sooner suspended or revoked under subsection (b), a
provisional registration of a person under subsection (a)(1) of
this section shall be in effect until -
"(1) the date on which such person has registered with the
Attorney General under section 303 [section 823 of this title] or
has had his registration denied under such section, or
"(2) such date as may be prescribed by the Attorney General for
registration of manufacturers, distributors, or dispensers, as
the case may be,
whichever occurs first."
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 823 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 823. Registration requirements
-STATUTE-
(a) Manufacturers of controlled substances in schedule I or II
The Attorney General shall register an applicant to manufacture
controlled substances in schedule I or II if he determines that
such registration is consistent with the public interest and with
United States obligations under international treaties,
conventions, or protocols in effect on May 1, 1971. In determining
the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of
particular controlled substances and any controlled substance in
schedule I or II compounded therefrom into other than legitimate
medical, scientific, research, or industrial channels, by
limiting the importation and bulk manufacture of such controlled
substances to a number of establishments which can produce an
adequate and uninterrupted supply of these substances under
adequately competitive conditions for legitimate medical,
scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing
these substances and the development of new substances;
(4) prior conviction record of applicant under Federal and
State laws relating to the manufacture, distribution, or
dispensing of such substances;
(5) past experience in the manufacture of controlled
substances, and the existence in the establishment of effective
control against diversion; and
(6) such other factors as may be relevant to and consistent
with the public health and safety.
(b) Distributors of controlled substances in schedule I or II
The Attorney General shall register an applicant to distribute a
controlled substance in schedule I or II unless he determines that
the issuance of such registration is inconsistent with the public
interest. In determining the public interest, the following factors
shall be considered:
(1) maintenance of effective control against diversion of
particular controlled substances into other than legitimate
medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State
laws relating to the manufacture, distribution, or dispensing of
such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and consistent
with the public health and safety.
(c) Limits of authorized activities
Registration granted under subsections (a) and (b) of this
section shall not entitle a registrant to (1) manufacture or
distribute controlled substances in schedule I or II other than
those specified in the registration, or (2) manufacture any
quantity of those controlled substances in excess of the quota
assigned pursuant to section 826 of this title.
(d) Manufacturers of controlled substances in schedule III, IV, or
V
The Attorney General shall register an applicant to manufacture
controlled substances in schedule III, IV, or V, unless he
determines that the issuance of such registration is inconsistent
with the public interest. In determining the public interest, the
following factors shall be considered:
(1) maintenance of effective controls against diversion of
particular controlled substances and any controlled substance in
schedule III, IV, or V compounded therefrom into other than
legitimate medical, scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing
these substances and the development of new substances;
(4) prior conviction record of applicant under Federal or State
laws relating to the manufacture, distribution, or dispensing of
such substances;
(5) past experience in the manufacture, distribution, and
dispensing of controlled substances, and the existence in the
establishment of effective controls against diversion; and
(6) such other factors as may be relevant to and consistent
with the public health and safety.
(e) Distributors of controlled substances in schedule III, IV, or V
The Attorney General shall register an applicant to distribute
controlled substances in schedule III, IV, or V, unless he
determines that the issuance of such registration is inconsistent
with the public interest. In determining the public interest, the
following factors shall be considered:
(1) maintenance of effective controls against diversion of
particular controlled substances into other than legitimate
medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State
laws relating to the manufacture, distribution, or dispensing of
such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and consistent
with the public health and safety.
(f) Research by practitioners; pharmacies; research applications;
construction of Article 7 of the Convention on Psychotropic
Substances
The Attorney General shall register practitioners (including
pharmacies, as distinguished from pharmacists) to dispense, or
conduct research with, controlled substances in schedule II, III,
IV, or V, if the applicant is authorized to dispense, or conduct
research with respect to, controlled substances under the laws of
the State in which he practices. The Attorney General may deny an
application for such registration if he determines that the
issuance of such registration would be inconsistent with the public
interest. In determining the public interest, the following factors
shall be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Separate registration under this part for practitioners engaging in
research with controlled substances in schedule II, III, IV, or V,
who are already registered under this part in another capacity,
shall not be required. Registration applications by practitioners
wishing to conduct research with controlled substances in schedule
I shall be referred to the Secretary, who shall determine the
qualifications and competency of each practitioner requesting
registration, as well as the merits of the research protocol. The
Secretary, in determining the merits of each research protocol,
shall consult with the Attorney General as to effective procedures
to adequately safeguard against diversion of such controlled
substances from legitimate medical or scientific use. Registration
for the purpose of bona fide research with controlled substances in
schedule I by a practitioner deemed qualified by the Secretary may
be denied by the Attorney General only on a ground specified in
section 824(a) of this title. Article 7 of the Convention on
Psychotropic Substances shall not be construed to prohibit, or
impose additional restrictions upon, research involving drugs or
other substances scheduled under the convention which is conducted
in conformity with this subsection and other applicable provisions
of this subchapter.
(g) Practitioners dispensing narcotic drugs for narcotic treatment;
annual registration; separate registration; qualifications;
waiver
(1) Except as provided in paragraph (2), practitioners who
dispense narcotic drugs to individuals for maintenance treatment or
detoxification treatment shall obtain annually a separate
registration for that purpose. The Attorney General shall register
an applicant to dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment (or both)
(A) if the applicant is a practitioner who is determined by the
Secretary to be qualified (under standards established by the
Secretary) to engage in the treatment with respect to which
registration is sought;
(B) if the Attorney General determines that the applicant will
comply with standards established by the Attorney General
respecting (i) security of stocks of narcotic drugs for such
treatment, and (ii) the maintenance of records (in accordance
with section 827 of this title) on such drugs; and
(C) if the Secretary determines that the applicant will comply
with standards established by the Secretary (after consultation
with the Attorney General) respecting the quantities of narcotic
drugs which may be provided for unsupervised use by individuals
in such treatment.
(2)(A) Subject to subparagraphs (D) and (J), the requirements of
paragraph (1) are waived in the case of the dispensing (including
the prescribing), by a practitioner, of narcotic drugs in schedule
III, IV, or V or combinations of such drugs if the practitioner
meets the conditions specified in subparagraph (B) and the narcotic
drugs or combinations of such drugs meet the conditions specified
in subparagraph (C).
(B) For purposes of subparagraph (A), the conditions specified in
this subparagraph with respect to a practitioner are that, before
the initial dispensing of narcotic drugs in schedule III, IV, or V
or combinations of such drugs to patients for maintenance or
detoxification treatment, the practitioner submit to the Secretary
a notification of the intent of the practitioner to begin
dispensing the drugs or combinations for such purpose, and that the
notification contain the following certifications by the
practitioner:
(i) The practitioner is a qualifying physician (as defined in
subparagraph (G)).
(ii) With respect to patients to whom the practitioner will
provide such drugs or combinations of drugs, the practitioner has
the capacity to refer the patients for appropriate counseling and
other appropriate ancillary services.
(iii) The total number of such patients of the practitioner at
any one time will not exceed the applicable number. For purposes
of this clause, the applicable number is 30, unless, not sooner
than 1 year after the date on which the practitioner submitted
the initial notification, the practitioner submits a second
notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients. A second notification
under this clause shall contain the certifications required by
clauses (i) and (ii) of this subparagraph. The Secretary may by
regulation change such total number.
(C) For purposes of subparagraph (A), the conditions specified in
this subparagraph with respect to narcotic drugs in schedule III,
IV, or V or combinations of such drugs are as follows:
(i) The drugs or combinations of drugs have, under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or section
262 of title 42, been approved for use in maintenance or
detoxification treatment.
(ii) The drugs or combinations of drugs have not been the
subject of an adverse determination. For purposes of this clause,
an adverse determination is a determination published in the
Federal Register and made by the Secretary, after consultation
with the Attorney General, that the use of the drugs or
combinations of drugs for maintenance or detoxification treatment
requires additional standards respecting the qualifications of
practitioners to provide such treatment, or requires standards
respecting the quantities of the drugs that may be provided for
unsupervised use.
(D)(i) A waiver under subparagraph (A) with respect to a
practitioner is not in effect unless (in addition to conditions
under subparagraphs (B) and (C)) the following conditions are met:
(I) The notification under subparagraph (B) is in writing and
states the name of the practitioner.
(II) The notification identifies the registration issued for
the practitioner pursuant to subsection (f) of this section.
(III) If the practitioner is a member of a group practice, the
notification states the names of the other practitioners in the
practice and identifies the registrations issued for the other
practitioners pursuant to subsection (f) of this section.
(ii) Upon receiving a notification under subparagraph (B), the
Attorney General shall assign the practitioner involved an
identification number under this paragraph for inclusion with the
registration issued for the practitioner pursuant to subsection (f)
of this section. The identification number so assigned shall be
appropriate to preserve the confidentiality of patients for whom
the practitioner has dispensed narcotic drugs under a waiver under
subparagraph (A).
(iii) Not later than 45 days after the date on which the
Secretary receives a notification under subparagraph (B), the
Secretary shall make a determination of whether the practitioner
involved meets all requirements for a waiver under subparagraph
(B). If the Secretary fails to make such determination by the end
of the such 45-day period, the Attorney General shall assign the
physician an identification number described in clause (ii) at the
end of such period.
(E)(i) If a practitioner is not registered under paragraph (1)
and, in violation of the conditions specified in subparagraphs (B)
through (D), dispenses narcotic drugs in schedule III, IV, or V or
combinations of such drugs for maintenance treatment or
detoxification treatment, the Attorney General may, for purposes of
section 824(a)(4) of this title, consider the practitioner to have
committed an act that renders the registration of the practitioner
pursuant to subsection (f) of this section to be inconsistent with
the public interest.
(ii)(I) Upon the expiration of 45 days from the date on which the
Secretary receives a notification under subparagraph (B), a
practitioner who in good faith submits a notification under
subparagraph (B) and reasonably believes that the conditions
specified in subparagraphs (B) through (D) have been met shall, in
dispensing narcotic drugs in schedule III, IV, or V or combinations
of such drugs for maintenance treatment or detoxification
treatment, be considered to have a waiver under subparagraph (A)
until notified otherwise by the Secretary, except that such a
practitioner may commence to prescribe or dispense such narcotic
drugs for such purposes prior to the expiration of such 45-day
period if it facilitates the treatment of an individual patient and
both the Secretary and the Attorney General are notified by the
practitioner of the intent to commence prescribing or dispensing
such narcotic drugs.
(II) For purposes of subclause (I), the publication in the
Federal Register of an adverse determination by the Secretary
pursuant to subparagraph (C)(ii) shall (with respect to the
narcotic drug or combination involved) be considered to be a
notification provided by the Secretary to practitioners, effective
upon the expiration of the 30-day period beginning on the date on
which the adverse determination is so published.
(F)(i) With respect to the dispensing of narcotic drugs in
schedule III, IV, or V or combinations of such drugs to patients
for maintenance or detoxification treatment, a practitioner may, in
his or her discretion, dispense such drugs or combinations for such
treatment under a registration under paragraph (1) or a waiver
under subparagraph (A) (subject to meeting the applicable
conditions).
(ii) This paragraph may not be construed as having any legal
effect on the conditions for obtaining a registration under
paragraph (1), including with respect to the number of patients who
may be served under such a registration.
(G) For purposes of this paragraph:
(i) The term "group practice" has the meaning given such term
in section 1395nn(h)(4) of title 42.
(ii) The term "qualifying physician" means a physician who is
licensed under State law and who meets one or more of the
following conditions:
(I) The physician holds a subspecialty board certification in
addiction psychiatry from the American Board of Medical
Specialties.
(II) The physician holds an addiction certification from the
American Society of Addiction Medicine.
(III) The physician holds a subspecialty board certification
in addiction medicine from the American Osteopathic
Association.
(IV) The physician has, with respect to the treatment and
management of opiate-dependent patients, completed not less
than eight hours of training (through classroom situations,
seminars at professional society meetings, electronic
communications, or otherwise) that is provided by the American
Society of Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Medical Association, the
American Osteopathic Association, the American Psychiatric
Association, or any other organization that the Secretary
determines is appropriate for purposes of this subclause.
(V) The physician has participated as an investigator in one
or more clinical trials leading to the approval of a narcotic
drug in schedule III, IV, or V for maintenance or
detoxification treatment, as demonstrated by a statement
submitted to the Secretary by the sponsor of such approved
drug.
(VI) The physician has such other training or experience as
the State medical licensing board (of the State in which the
physician will provide maintenance or detoxification treatment)
considers to demonstrate the ability of the physician to treat
and manage opiate-dependent patients.
(VII) The physician has such other training or experience as
the Secretary considers to demonstrate the ability of the
physician to treat and manage opiate-dependent patients. Any
criteria of the Secretary under this subclause shall be
established by regulation. Any such criteria are effective only
for 3 years after the date on which the criteria are
promulgated, but may be extended for such additional discrete 3-
year periods as the Secretary considers appropriate for
purposes of this subclause. Such an extension of criteria may
only be effectuated through a statement published in the
Federal Register by the Secretary during the 30-day period
preceding the end of the 3-year period involved.
(H)(i) In consultation with the Administrator of the Drug
Enforcement Administration, the Administrator of the Substance
Abuse and Mental Health Services Administration, the Director of
the National Institute on Drug Abuse, and the Commissioner of Food
and Drugs, the Secretary shall issue regulations (through notice
and comment rulemaking) or issue practice guidelines to address the
following:
(I) Approval of additional credentialing bodies and the
responsibilities of additional credentialing bodies.
(II) Additional exemptions from the requirements of this
paragraph and any regulations under this paragraph.
Nothing in such regulations or practice guidelines may authorize
any Federal official or employee to exercise supervision or control
over the practice of medicine or the manner in which medical
services are provided.
(ii) Not later than 120 days after October 17, 2000, the
Secretary shall issue a treatment improvement protocol containing
best practice guidelines for the treatment and maintenance of
opiate-dependent patients. The Secretary shall develop the protocol
in consultation with the Director of the National Institute on Drug
Abuse, the Administrator of the Drug Enforcement Administration,
the Commissioner of Food and Drugs, the Administrator of the
Substance Abuse and Mental Health Services Administration and other
substance abuse disorder professionals. The protocol shall be
guided by science.
(I) During the 3-year period beginning on the date of approval by
the Food and Drug Administration of a drug in schedule III, IV, or
V, a State may not preclude a practitioner from dispensing or
prescribing such drug, or combination of such drugs, to patients
for maintenance or detoxification treatment in accordance with this
paragraph unless, before the expiration of that 3-year period, the
State enacts a law prohibiting a practitioner from dispensing such
drugs or combinations of drug.(!1)
(J)(i) This paragraph takes effect the date referred to in
subparagraph (I), and remains in effect thereafter.
(ii) For purposes relating to clause (iii), the Secretary and the
Attorney General may, during the 3-year period beginning on
December 29, 2006, make determinations in accordance with the
following:
(I) The Secretary may make a determination of whether
treatments provided under waivers under subparagraph (A) have
been effective forms of maintenance treatment and detoxification
treatment in clinical settings; may make a determination of
whether such waivers have significantly increased (relative to
the beginning of such period) the availability of maintenance
treatment and detoxification treatment; and may make a
determination of whether such waivers have adverse consequences
for the public health.
(II) The Attorney General may make a determination of the
extent to which there have been violations of the numerical
limitations established under subparagraph (B) for the number of
individuals to whom a practitioner may provide treatment; may
make a determination of whether waivers under subparagraph (A)
have increased (relative to the beginning of such period) the
extent to which narcotic drugs in schedule III, IV, or V or
combinations of such drugs are being dispensed or possessed in
violation of this chapter; and may make a determination of
whether such waivers have adverse consequences for the public
health.
(iii) If, before the expiration of the period specified in clause
(ii), the Secretary or the Attorney General publishes in the
Federal Register a decision, made on the basis of determinations
under such clause, that subparagraph (B)(iii) should be applied by
limiting the total number of patients a practitioner may treat to
30, then the provisions in such subparagraph (B)(iii) permitting
more than 30 patients shall not apply, effective 60 days after the
date on which the decision is so published. The Secretary shall in
making any such decision consult with the Attorney General, and
shall in publishing the decision in the Federal Register include
any comments received from the Attorney General for inclusion in
the publication. The Attorney General shall in making any such
decision consult with the Secretary, and shall in publishing the
decision in the Federal Register include any comments received from
the Secretary for inclusion in the publication.
(h) Applicants for distribution of list I chemicals
The Attorney General shall register an applicant to distribute a
list I chemical unless the Attorney General determines that
registration of the applicant is inconsistent with the public
interest. Registration under this subsection shall not be required
for the distribution of a drug product that is exempted under
clause (iv) or (v) of section 802(39)(A) of this title. In
determining the public interest for the purposes of this
subsection, the Attorney General shall consider -
(1) maintenance by the applicant of effective controls against
diversion of listed chemicals into other than legitimate
channels;
(2) compliance by the applicant with applicable Federal, State,
and local law;
(3) any prior conviction record of the applicant under Federal
or State laws relating to controlled substances or to chemicals
controlled under Federal or State law;
(4) any past experience of the applicant in the manufacture and
distribution of chemicals; and
(5) such other factors as are relevant to and consistent with
the public health and safety.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 303, Oct. 27, 1970, 84 Stat. 1253;
Pub. L. 93-281, Sec. 3, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
title I, Sec. 109, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98-473,
title II, Sec. 511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103-200,
Sec. 3(c), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106-310, div. B,
title XXXV, Sec. 3502(a), Oct. 17, 2000, 114 Stat. 1222; Pub. L.
107-273, div. B, title II, Sec. 2501, Nov. 2, 2002, 116 Stat. 1803;
Pub. L. 109-56, Sec. 1(a), (b), Aug. 2, 2005, 119 Stat. 591; Pub.
L. 109-177, title VII, Sec. 712(a)(3), Mar. 9, 2006, 120 Stat. 263;
Pub. L. 109-469, title XI, Sec. 1102, Dec. 29, 2006, 120 Stat.
3540.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to
(f) and (g)(2), are set out in section 812(c) of this title.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(g)(2)(C)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
This chapter, referred to in subsec. (g)(2)(J)(ii)(II), was in
the original "this Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84
Stat. 1236, as amended. For complete classification of this Act to
the Code, see Short Title note set out under section 801 of this
title and Tables.
-MISC1-
AMENDMENTS
2006 - Subsec. (g)(2)(B)(iii). Pub. L. 109-469, Sec. 1102(1),
substituted "unless, not sooner than 1 year after the date on which
the practitioner submitted the initial notification, the
practitioner submits a second notification to the Secretary of the
need and intent of the practitioner to treat up to 100 patients. A
second notification under this clause shall contain the
certifications required by clauses (i) and (ii) of this
subparagraph. The" for "except that the".
Subsec. (g)(2)(J)(i). Pub. L. 109-469, Sec. 1102(2)(A),
substituted "thereafter." for "thereafter except as provided in
clause (iii) (relating to a decision by the Secretary or the
Attorney General that this paragraph should not remain in effect)."
Subsec. (g)(2)(J)(ii). Pub. L. 109-469, Sec. 1102(2)(B),
substituted "December 29, 2006" for "October 17, 2000" in
introductory provisions.
Subsec. (g)(2)(J)(iii). Pub. L. 109-469, Sec. 1102(2)(C),
substituted "subparagraph (B)(iii) should be applied by limiting
the total number of patients a practitioner may treat to 30, then
the provisions in such subparagraph (B)(iii) permitting more than
30 patients shall not apply, effective" for "this paragraph should
not remain in effect, this paragraph ceases to be in effect".
Subsec. (h). Pub. L. 109-177 substituted "clause (iv) or (v) of
section 802(39)(A) of this title" for "section 802(39)(A)(iv) of
this title" in introductory provisions.
2005 - Subsec. (g)(2)(B)(iii). Pub. L. 109-56, Sec. 1(b),
substituted "The total" for "In any case in which the practitioner
is not in a group practice, the total".
Subsec. (g)(2)(B)(iv). Pub. L. 109-56, Sec. 1(a), struck out cl.
(iv) which read as follows: "In any case in which the practitioner
is in a group practice, the total number of such patients of the
group practice at any one time will not exceed the applicable
number. For purposes of this clause, the applicable number is 30,
except that the Secretary may by regulation change such total
number, and the Secretary for such purposes may by regulation
establish different categories on the basis of the number of
practitioners in a group practice and establish for the various
categories different numerical limitations on the number of such
patients that the group practice may have."
2002 - Subsec. (g)(2)(I). Pub. L. 107-273, Sec. 2501(1), which
directed the substitution of "on the date of approval by the Food
and Drug Administration of a drug in schedule III, IV, or V, a
State may not preclude a practitioner from dispensing or
prescribing such drug, or combination of such drugs," for "on
October 17, 2000, a State may not preclude a practitioner from
dispensing or prescribing drugs in schedule III, IV, or V, or
combinations of such drugs,", was executed by making the
substitution for the phrase which in the original began with "on
the date of the enactment of the Drug Addiction Treatment Act of
2000," rather than the editorial translation "on October 17, 2000,"
to reflect the probable intent of Congress.
Subsec. (g)(2)(J)(i). Pub. L. 107-273, Sec. 2501(2), which
directed the substitution of "the date referred to in subparagraph
(I)," for "October 17, 2000," was executed by making the
substitution for text which in the original read "the date of the
enactment of the Drug Addiction Treatment Act of 2000," rather than
the editorial translation "October 17, 2000," to reflect the
probable intent of Congress.
2000 - Subsec. (g). Pub. L. 106-310 designated existing
provisions as par. (1), substituted "Except as provided in
paragraph (2), practitioners who dispense" for "Practitioners who
dispense", redesignated former pars. (1) to (3) as subpars. (A) to
(C), respectively, of par. (1) and redesignated former subpars. (A)
and (B) of former par. (2) as cls. (i) and (ii), respectively, of
subpar. (B) of par. (1), and added par. (2).
1993 - Subsec. (h). Pub. L. 103-200 added subsec. (h).
1984 - Subsec. (f). Pub. L. 98-473 amended subsec. (f) generally,
substituting provisions relating to registration authority of
Attorney General respecting dispensation or conduct of research
with controlled research, and separate authority of Secretary
respecting registration, for provisions relating to general
registration requirements respecting dispensation or conduct of
research with controlled or nonnarcotic controlled substances.
1978 - Subsec. (f). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1974 - Subsec. (g). Pub. L. 93-281 added subsec. (g).
EFFECTIVE DATE OF 2005 AMENDMENT
Pub. L. 109-56, Sec. 1(c), Aug. 2, 2005, 119 Stat. 591, provided
that: "This section [amending this section] shall take effect on
the date of enactment of this Act [Aug. 2, 2005]."
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
PROVISIONAL REGISTRATION
For provisional registration of persons engaged in manufacturing,
distributing, or dispensing of controlled substances on the day
before the effective date of section 822 of this title who are
registered on such date under section 360 of this title or section
4722 of Title 26, Internal Revenue Code, see section 703 of Pub. L.
91-513, set out as a note under section 822 of this title.
-FOOTNOTE-
(!1) So in original. Probably should be "combinations of
drugs.".
-End-
-CITE-
21 USC Sec. 824 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 824. Denial, revocation, or suspension of registration
-STATUTE-
(a) Grounds
A registration pursuant to section 823 of this title to
manufacture, distribute, or dispense a controlled substance or a
list I chemical may be suspended or revoked by the Attorney General
upon a finding that the registrant -
(1) has materially falsified any application filed pursuant to
or required by this subchapter or subchapter II of this chapter;
(2) has been convicted of a felony under this subchapter or
subchapter II of this chapter or any other law of the United
States, or of any State, relating to any substance defined in
this subchapter as a controlled substance or a list I chemical;
(3) has had his State license or registration suspended,
revoked, or denied by competent State authority and is no longer
authorized by State law to engage in the manufacturing,
distribution, or dispensing of controlled substances or list I
chemicals or has had the suspension, revocation, or denial of his
registration recommended by competent State authority;
(4) has committed such acts as would render his registration
under section 823 of this title inconsistent with the public
interest as determined under such section; or
(5) has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of
title 42.
A registration pursuant to section 823(g)(1) of this title to
dispense a narcotic drug for maintenance treatment or
detoxification treatment may be suspended or revoked by the
Attorney General upon a finding that the registrant has failed to
comply with any standard referred to in section 823(g)(1) of this
title.
(b) Limits of revocation or suspension
The Attorney General may limit revocation or suspension of a
registration to the particular controlled substance or list I
chemical with respect to which grounds for revocation or suspension
exist.
(c) Service of show cause order; proceedings
Before taking action pursuant to this section, or pursuant to a
denial of registration under section 823 of this title, the
Attorney General shall serve upon the applicant or registrant an
order to show cause why registration should not be denied, revoked,
or suspended. The order to show cause shall contain a statement of
the basis thereof and shall call upon the applicant or registrant
to appear before the Attorney General at a time and place stated in
the order, but in no event less than thirty days after the date of
receipt of the order. Proceedings to deny, revoke, or suspend shall
be conducted pursuant to this section in accordance with subchapter
II of chapter 5 of title 5. Such proceedings shall be independent
of, and not in lieu of, criminal prosecutions or other proceedings
under this subchapter or any other law of the United States.
(d) Suspension of registration in cases of imminent danger
The Attorney General may, in his discretion, suspend any
registration simultaneously with the institution of proceedings
under this section, in cases where he finds that there is an
imminent danger to the public health or safety. A failure to comply
with a standard referred to in section 823(g)(1) of this title may
be treated under this subsection as grounds for immediate
suspension of a registration granted under such section. A
suspension under this subsection shall continue in effect until the
conclusion of such proceedings, including judicial review thereof,
unless sooner withdrawn by the Attorney General or dissolved by a
court of competent jurisdiction.
(e) Suspension and revocation of quotas
The suspension or revocation of a registration under this section
shall operate to suspend or revoke any quota applicable under
section 826 of this title.
(f) Disposition of controlled substances or list I chemicals
In the event the Attorney General suspends or revokes a
registration granted under section 823 of this title, all
controlled substances or list I chemicals owned or possessed by the
registrant pursuant to such registration at the time of suspension
or the effective date of the revocation order, as the case may be,
may, in the discretion of the Attorney General, be placed under
seal. No disposition may be made of any controlled substances or
list I chemicals under seal until the time for taking an appeal has
elapsed or until all appeals have been concluded except that a
court, upon application therefor, may at any time order the sale of
perishable controlled substances or list I chemicals. Any such
order shall require the deposit of the proceeds of the sale with
the court. Upon a revocation order becoming final, all such
controlled substances or list I chemicals (or proceeds of sale
deposited in court) shall be forfeited to the United States; and
the Attorney General shall dispose of such controlled substances or
list I chemicals in accordance with section 881(e) of this title.
All right, title, and interest in such controlled substances or
list I chemicals shall vest in the United States upon a revocation
order becoming final.
(g) Seizure or placement under seal of controlled substances or
list I chemicals
The Attorney General may, in his discretion, seize or place under
seal any controlled substances or list I chemicals owned or
possessed by a registrant whose registration has expired or who has
ceased to practice or do business in the manner contemplated by his
registration. Such controlled substances or list I chemicals shall
be held for the benefit of the registrant, or his successor in
interest. The Attorney General shall notify a registrant, or his
successor in interest, who has any controlled substance or list I
chemical seized or placed under seal of the procedures to be
followed to secure the return of the controlled substance or list I
chemical and the conditions under which it will be returned. The
Attorney General may not dispose of any controlled substance or
list I chemical seized or placed under seal under this subsection
until the expiration of one hundred and eighty days from the date
such substance or chemical was seized or placed under seal.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 304, Oct. 27, 1970, 84 Stat. 1255;
Pub. L. 93-281, Sec. 4, May 14, 1974, 88 Stat. 125; Pub. L. 98-473,
title II, Secs. 304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073;
Pub. L. 100-93, Sec. 8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L.
103-200, Sec. 3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103-322,
title XXXIII, Sec. 330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub.
L. 106-310, div. B, title XXXV, Sec. 3502(b), Oct. 17, 2000, 114
Stat. 1227.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in subsec. (a)(1), (2), was in the
original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, as amended, and is popularly known as the
"Controlled Substances Act". For complete classification of title
II to the Code, see second paragraph of Short Title note set out
under section 801 of this title and Tables.
Subchapter II of this chapter, referred to in subsec. (a)(1),
(2), was in the original "title III", meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B,
consisting of sections 1101 to 1105 of title III, see Tables.
-MISC1-
AMENDMENTS
2000 - Subsec. (a). Pub. L. 106-310, Sec. 3502(b)(1), substituted
"section 823(g)(1) of this title" for "section 823(g) of this
title" in two places in concluding provisions.
Subsec. (d). Pub. L. 106-310, Sec. 3502(b)(2), substituted
"section 823(g)(1) of this title" for "section 823(g) of this
title".
1994 - Subsec. (g). Pub. L. 103-322 inserted "or chemical" after
"such substance" in last sentence.
1993 - Subsec. (a). Pub. L. 103-200, Sec. 3(d)(1), inserted "or a
list I chemical" after "controlled substance" in introductory
provisions and par. (2) and inserted "or list I chemicals" after
"controlled substances" in par. (3).
Subsec. (b). Pub. L. 103-200, Sec. 3(d)(2), inserted "or list I
chemical" after "controlled substance".
Subsec. (f). Pub. L. 103-200, Sec. 3(d)(3), inserted "or list I
chemicals" after "controlled substances" wherever appearing.
Subsec. (g). Pub. L. 103-200, Sec. 3(d)(4), inserted "or list I
chemicals" after "controlled substances" in two places and "or list
I chemical" after "controlled substance" wherever appearing.
1987 - Subsec. (a)(5). Pub. L. 100-93 added par. (5).
1984 - Subsec. (a)(3). Pub. L. 98-473, Sec. 512(1), inserted
provisions relating to suspension, etc., recommended by competent
State authority.
Subsec. (a)(4). Pub. L. 98-473, Sec. 512(2), added par. (4).
Subsec. (f). Pub. L. 98-473, Sec. 304, inserted provisions
relating to vesting of right, title, and interest in the United
States.
Subsec. (g). Pub. L. 98-473, Sec. 513, added subsec. (g).
1974 - Subsec. (a). Pub. L. 93-281, Sec. 4(a), provided for
revocation or suspension of a registration pursuant to section
823(g) of this title for failure of a registrant to comply with
standards referred to in such section 823(g).
Subsec. (d). Pub. L. 93-281, Sec. 4(b), substituted "A suspension
under this subsection" for "Such suspension" in third sentence.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-322 effective 120 days after Dec. 17,
1993, see section 330024(f) of Pub. L. 103-322, set out as a note
under section 802 of this title.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE OF 1987 AMENDMENT
Amendment by Pub. L. 100-93 effective at end of fourteen-day
period beginning Aug. 18, 1987, and inapplicable to administrative
proceedings commenced before end of such period, see section 15(a)
of Pub. L. 100-93, set out as a note under section 1320a-7 of Title
42, The Public Health and Welfare.
PROVISIONAL REGISTRATION
Applicability of this section to provisional registrations, see
section 703 of Pub. L. 91-513, set out as a note under section 822
of this title.
-End-
-CITE-
21 USC Sec. 825 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 825. Labeling and packaging
-STATUTE-
(a) Symbol
It shall be unlawful to distribute a controlled substance in a
commercial container unless such container, when and as required by
regulations of the Attorney General, bears a label (as defined in
section 321(k) of this title) containing an identifying symbol for
such substance in accordance with such regulations. A different
symbol shall be required for each schedule of controlled
substances.
(b) Unlawful distribution without identifying symbol
It shall be unlawful for the manufacturer of any controlled
substance to distribute such substance unless the labeling (as
defined in section 321(m) of this title) of such substance
contains, when and as required by regulations of the Attorney
General, the identifying symbol required under subsection (a) of
this section.
(c) Warning on label
The Secretary shall prescribe regulations under section 353(b) of
this title which shall provide that the label of a drug listed in
schedule II, III, or IV shall, when dispensed to or for a patient,
contain a clear, concise warning that it is a crime to transfer the
drug to any person other than the patient.
(d) Containers to be securely sealed
It shall be unlawful to distribute controlled substances in
schedule I or II, and narcotic drugs in schedule III or IV, unless
the bottle or other container, stopper, covering, or wrapper
thereof is securely sealed as required by regulations of the
Attorney General.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 305, Oct. 27, 1970, 84 Stat. 1256.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, and IV, referred to in subsecs. (c) and
(d), are set out in section 812(c) of this title.
-MISC1-
EFFECTIVE DATE
Section effective on first day of seventh calendar month that
begins after Oct. 26, 1970, but with Attorney General authorized to
postpone such effective date for such period as he might determine
to be necessary for the efficient administration of this
subchapter, see section 704(c) of Pub. L. 91-513, set out as a note
under section 801 of this title.
-End-
-CITE-
21 USC Sec. 826 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 826. Production quotas for controlled substances
-STATUTE-
(a) Establishment of total annual needs
The Attorney General shall determine the total quantity and
establish production quotas for each basic class of controlled
substance in schedules I and II and for ephedrine, pseudoephedrine,
and phenylpropanolamine to be manufactured each calendar year to
provide for the estimated medical, scientific, research, and
industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. Production quotas shall be established in terms of
quantities of each basic class of controlled substance and not in
terms of individual pharmaceutical dosage forms prepared from or
containing such a controlled substance.
(b) Individual production quotas; revised quotas
The Attorney General shall limit or reduce individual production
quotas to the extent necessary to prevent the aggregate of
individual quotas from exceeding the amount determined necessary
each year by the Attorney General under subsection (a) of this
section. The quota of each registered manufacturer for each basic
class of controlled substance in schedule I or II or for ephedrine,
pseudoephedrine, or phenylpropanolamine shall be revised in the
same proportion as the limitation or reduction of the aggregate of
the quotas. However, if any registrant, before the issuance of a
limitation or reduction in quota, has manufactured in excess of his
revised quota, the amount of the excess shall be subtracted from
his quota for the following year.
(c) Manufacturing quotas for registered manufacturers
On or before October 1 of each year, upon application therefor by
a registered manufacturer, the Attorney General shall fix a
manufacturing quota for the basic classes of controlled substances
in schedules I and II and for ephedrine, pseudoephedrine, and
phenylpropanolamine that the manufacturer seeks to produce. The
quota shall be subject to the provisions of subsections (a) and (b)
of this section. In fixing such quotas, the Attorney General shall
determine the manufacturer's estimated disposal, inventory, and
other requirements for the calendar year; and, in making his
determination, the Attorney General shall consider the
manufacturer's current rate of disposal, the trend of the national
disposal rate during the preceding calendar year, the
manufacturer's production cycle and inventory position, the
economic availability of raw materials, yield and stability
problems, emergencies such as strikes and fires, and other factors.
(d) Quotas for registrants who have not manufactured controlled
substance during one or more preceding years
The Attorney General shall, upon application and subject to the
provisions of subsections (a) and (b) of this section, fix a quota
for a basic class of controlled substance in schedule I or II for
any registrant who has not manufactured that basic class of
controlled substance or ephedrine, pseudoephedrine, or
phenylpropanolamine during one or more preceding calendar years. In
fixing such quota, the Attorney General shall take into account the
registrant's reasonably anticipated requirements for the current
year; and, in making his determination of such requirements, he
shall consider such factors specified in subsection (c) of this
section as may be relevant.
(e) Quota increases
At any time during the year any registrant who has applied for or
received a manufacturing quota for a basic class of controlled
substance in schedule I or II or for ephedrine, pseudoephedrine, or
phenylpropanolamine may apply for an increase in that quota to meet
his estimated disposal, inventory, and other requirements during
the remainder of that year. In passing upon the application the
Attorney General shall take into consideration any occurrences
since the filing of the registrant's initial quota application that
may require an increased manufacturing rate by the registrant
during the balance of the year. In passing upon the application the
Attorney General may also take into account the amount, if any, by
which the determination of the Attorney General under subsection
(a) of this section exceeds the aggregate of the quotas of all
registrants under this section.
(f) Incidental production exception
Notwithstanding any other provisions of this subchapter, no
registration or quota may be required for the manufacture of such
quantities of controlled substances in schedules I and II or
ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally
and necessarily result from the manufacturing process used for the
manufacture of a controlled substance or of ephedrine,
pseudoephedrine, or phenylpropanolamine with respect to which its
manufacturer is duly registered under this subchapter. The Attorney
General may, by regulation, prescribe restrictions on the retention
and disposal of such incidentally produced substances or chemicals.
(g) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
Each reference in this section to ephedrine, pseudoephedrine, or
phenylpropanolamine includes each of the salts, optical isomers,
and salts of optical isomers of such chemical.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 306, Oct. 27, 1970, 84 Stat. 1257;
Pub. L. 94-273, Sec. 3(16), Apr. 21, 1976, 90 Stat. 377; Pub. L.
109-177, title VII, Sec. 713, Mar. 9, 2006, 120 Stat. 264.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I and II, referred to in text, are set out in section
812(c) of this title.
-MISC1-
AMENDMENTS
2006 - Subsec. (a). Pub. L. 109-177, Sec. 713(1), inserted "and
for ephedrine, pseudoephedrine, and phenylpropanolamine" after "for
each basic class of controlled substance in schedules I and II".
Subsec. (b). Pub. L. 109-177, Sec. 713(2), inserted "or for
ephedrine, pseudoephedrine, or phenylpropanolamine" after "for each
basic class of controlled substance in schedule I or II".
Subsec. (c). Pub. L. 109-177, Sec. 713(3), inserted "and for
ephedrine, pseudoephedrine, and phenylpropanolamine" after "for the
basic classes of controlled substances in schedules I and II".
Subsec. (d). Pub. L. 109-177, Sec. 713(4), inserted "or
ephedrine, pseudoephedrine, or phenylpropanolamine" after "that
basic class of controlled substance".
Subsec. (e). Pub. L. 109-177, Sec. 713(5), inserted "or for
ephedrine, pseudoephedrine, or phenylpropanolamine" after "for a
basic class of controlled substance in schedule I or II".
Subsec. (f). Pub. L. 109-177, Sec. 713(6), inserted "or
ephedrine, pseudoephedrine, or phenylpropanolamine" after
"controlled substances in schedules I and II", "or of ephedrine,
pseudoephedrine, or phenylpropanolamine" after "the manufacture of
a controlled substance", and "or chemicals" after "such
incidentally produced substances".
Subsec. (g). Pub. L. 109-177, Sec. 713(7), added subsec. (g).
1976 - Subsec. (c). Pub. L. 94-273 substituted "October" for
"July".
EFFECTIVE DATE
Section effective on first day of seventh calendar month that
begins after Oct. 26, 1970, but with Attorney General authorized to
postpone such effective date for such period as he might determine
to be necessary for the efficient administration of this
subchapter, see section 704(c) of Pub. L. 91-513, set out as a note
under section 801 of this title.
COORDINATION WITH UNITED STATES TRADE REPRESENTATIVE
Pub. L. 109-177, title VII, Sec. 718, Mar. 9, 2006, 120 Stat.
267, provided that: "In implementing sections 713 through 717 and
section 721 of this title [amending this section and sections 830,
842, 952, 960, and 971 of this title], the Attorney General shall
consult with the United States Trade Representative to ensure
implementation complies with all applicable international treaties
and obligations of the United States."
-End-
-CITE-
21 USC Sec. 827 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 827. Records and reports of registrants
-STATUTE-
(a) Inventory
Except as provided in subsection (c) of this section -
(1) every registrant under this subchapter shall, on May 1,
1971, or as soon thereafter as such registrant first engages in
the manufacture, distribution, or dispensing of controlled
substances, and every second year thereafter, make a complete and
accurate record of all stocks thereof on hand, except that the
regulations prescribed under this section shall permit each such
biennial inventory (following the initial inventory required by
this paragraph) to be prepared on such registrant's regular
general physical inventory date (if any) which is nearest to and
does not vary by more than six months from the biennial date that
would otherwise apply;
(2) on the effective date of each regulation of the Attorney
General controlling a substance that immediately prior to such
date was not a controlled substance, each registrant under this
subchapter manufacturing, distributing, or dispensing such
substance shall make a complete and accurate record of all stocks
thereof on hand; and
(3) on and after May 1, 1971, every registrant under this
subchapter manufacturing, distributing, or dispensing a
controlled substance or substances shall maintain, on a current
basis, a complete and accurate record of each such substance
manufactured, received, sold, delivered, or otherwise disposed of
by him, except that this paragraph shall not require the
maintenance of a perpetual inventory.
(b) Availability of records
Every inventory or other record required under this section (1)
shall be in accordance with, and contain such relevant information
as may be required by, regulations of the Attorney General, (2)
shall (A) be maintained separately from all other records of the
registrant, or (B) alternatively, in the case of nonnarcotic
controlled substances, be in such form that information required by
the Attorney General is readily retrievable from the ordinary
business records of the registrant, and (3) shall be kept and be
available, for at least two years, for inspection and copying by
officers or employees of the United States authorized by the
Attorney General.
(c) Nonapplicability
The foregoing provisions of this section shall not apply -
(1)(A) to the prescribing of controlled substances in schedule
II, III, IV, or V by practitioners acting in the lawful course of
their professional practice unless such substance is prescribed
in the course of maintenance or detoxification treatment of an
individual; or
(B) to the administering of a controlled substance in schedule
II, III, IV, or V unless the practitioner regularly engages in
the dispensing or administering of controlled substances and
charges his patients, either separately or together with charges
for other professional services, for substances so dispensed or
administered or unless such substance is administered in the
course of maintenance treatment or detoxification treatment of an
individual;
(2)(A) to the use of controlled substances, at establishments
registered under this subchapter which keep records with respect
to such substances, in research conducted in conformity with an
exemption granted under section 355(i) or 360b(j) of this title;
(B) to the use of controlled substances, at establishments
registered under this subchapter which keep records with respect
to such substances, in preclinical research or in teaching; or
(3) to the extent of any exemption granted to any person, with
respect to all or part of such provisions, by the Attorney
General by or pursuant to regulation on the basis of a finding
that the application of such provisions (or part thereof) to such
person is not necessary for carrying out the purposes of this
subchapter.
Nothing in the Convention on Psychotropic Substances shall be
construed as superseding or otherwise affecting the provisions of
paragraph (1)(B), (2), or (3) of this subsection.
(d) Periodic reports to Attorney General
Every manufacturer registered under section 823 of this title
shall, at such time or times and in such form as the Attorney
General may require, make periodic reports to the Attorney General
of every sale, delivery or other disposal by him of any controlled
substance, and each distributor shall make such reports with
respect to narcotic controlled substances, identifying by the
registration number assigned under this subchapter the person or
establishment (unless exempt from registration under section 822(d)
of this title) to whom such sale, delivery, or other disposal was
made.
(e) Reporting and recordkeeping requirements of drug conventions
In addition to the reporting and recordkeeping requirements under
any other provision of this subchapter, each manufacturer
registered under section 823 of this title shall, with respect to
narcotic and nonnarcotic controlled substances manufactured by it,
make such reports to the Attorney General, and maintain such
records, as the Attorney General may require to enable the United
States to meet its obligations under articles 19 and 20 of the
Single Convention on Narcotic Drugs and article 16 of the
Convention on Psychotropic Substances. The Attorney General shall
administer the requirements of this subsection in such a manner as
to avoid the unnecessary imposition of duplicative requirements
under this subchapter on manufacturers subject to the requirements
of this subsection.
(f) Investigational uses of drugs; procedures
Regulations under sections 355(i) and 360(j) of this title,
relating to investigational use of drugs, shall include such
procedures as the Secretary, after consultation with the Attorney
General, determines are necessary to insure the security and
accountability of controlled substances used in research to which
such regulations apply.
(g) Change of address
Every registrant under this subchapter shall be required to
report any change of professional or business address in such
manner as the Attorney General shall by regulation require.
(h) Reporting requirements for GHB
In the case of a drug product containing gamma hydroxybutyric
acid for which an application has been approved under section 355
of this title, the Attorney General may, in addition to any other
requirements that apply under this section with respect to such a
drug product, establish any of the following as reporting
requirements:
(1) That every person who is registered as a manufacturer of
bulk or dosage form, as a packager, repackager, labeler,
relabeler, or distributor shall report acquisition and
distribution transactions quarterly, not later than the 15th day
of the month succeeding the quarter for which the report is
submitted, and annually report end-of-year inventories.
(2) That all annual inventory reports shall be filed no later
than January 15 of the year following that for which the report
is submitted and include data on the stocks of the drug product,
drug substance, bulk drug, and dosage forms on hand as of the
close of business December 31, indicating whether materials
reported are in storage or in process of manufacturing.
(3) That every person who is registered as a manufacturer of
bulk or dosage form shall report all manufacturing transactions
both inventory increases, including purchases, transfers, and
returns, and reductions from inventory, including sales,
transfers, theft, destruction, and seizure, and shall provide
data on material manufactured, manufactured from other material,
use in manufacturing other material, and use in manufacturing
dosage forms.
(4) That all reports under this section must include the
registered person's registration number as well as the
registration numbers, names, and other identifying information of
vendors, suppliers, and customers, sufficient to allow the
Attorney General to track the receipt and distribution of the
drug.
(5) That each dispensing practitioner shall maintain for each
prescription the name of the prescribing practitioner, the
prescribing practitioner's Federal and State registration
numbers, with the expiration dates of these registrations,
verification that the prescribing practitioner possesses the
appropriate registration to prescribe this controlled substance,
the patient's name and address, the name of the patient's
insurance provider and documentation by a medical practitioner
licensed and registered to prescribe the drug of the patient's
medical need for the drug. Such information shall be available
for inspection and copying by the Attorney General.
(6) That section 830(b)(3) of this title (relating to mail
order reporting) applies with respect to gamma hydroxybutyric
acid to the same extent and in the same manner as such section
applies with respect to the chemicals and drug products specified
in subparagraph (A)(i) of such section.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 307, Oct. 27, 1970, 84 Stat. 1258;
Pub. L. 93-281, Sec. 5, May 14, 1974, 88 Stat. 125; Pub. L. 95-633,
title I, Secs. 104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub.
L. 98-473, title II, Secs. 514, 515, Oct. 12, 1984, 98 Stat. 2074;
Pub. L. 106-172, Sec. 4, Feb. 18, 2000, 114 Stat. 9.)
-REFTEXT-
REFERENCES IN TEXT
Schedules II, III, IV, and V, referred to in subsec. (c), are set
out in section 812(c) of this title.
-MISC1-
AMENDMENTS
2000 - Subsec. (h). Pub. L. 106-172 added subsec. (h).
1984 - Subsec. (c)(1)(A). Pub. L. 98-473, Sec. 514(a),
substituted "to the prescribing of controlled substances in
schedule II, III, IV, or V by practitioners acting in the lawful
course of their professional practice unless such substance is
prescribed in the course of maintenance or detoxification treatment
of an individual" for "with respect to any narcotic controlled
substance in schedule II, III, IV, or V, to the prescribing or
administering of such substance by a practitioner in the lawful
course of his professional practice unless such substance was
prescribed or administered in the course of maintenance treatment
or detoxification treatment of an individual".
Subsec. (c)(1)(B). Pub. L. 98-473, Sec. 514(b), substituted "to
the administering of a controlled substance in schedule II, III,
IV, or V unless the practitioner regularly engages in the
dispensing or administering of controlled substances and charges
his patients, either separately or together with charges for other
professional services, for substances so dispensed or administered
or unless such substance is administered in the course of
maintenance treatment or detoxification treatment of an individual"
for "with respect to nonnarcotic controlled substances in schedule
II, III, IV, or V, to any practitioner who dispenses such
substances to his patients, unless the practitioner is regularly
engaged in charging his patients, either separately or together
with charges for other professional services, for substances so
dispensed".
Subsec. (g). Pub. L. 98-473, Sec. 515, added subsec. (g).
1978 - Subsec. (c). Pub. L. 95-633, Sec. 110, inserted provision
following par. (3) relating to the construction of the Convention
on Psychotropic Substances.
Subsecs. (e), (f). Pub. L. 95-633 added subsec. (e) and
redesignated former subsec. (e) as (f).
1974 - Subsec. (c)(1)(A). Pub. L. 93-281 substituted "any
narcotic controlled substance" for "narcotic controlled substances"
and made section applicable to any narcotic controlled substance
prescribed or administered in the course of maintenance treatment
or detoxification treatment of an individual.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
-End-
-CITE-
21 USC Sec. 828 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 828. Order forms
-STATUTE-
(a) Unlawful distribution of controlled substances
It shall be unlawful for any person to distribute a controlled
substance in schedule I or II to another except in pursuance of a
written order of the person to whom such substance is distributed,
made on a form to be issued by the Attorney General in blank in
accordance with subsection (d) of this section and regulations
prescribed by him pursuant to this section.
(b) Nonapplicability of provisions
Nothing in subsection (a) of this section shall apply to -
(1) the exportation of such substances from the United States
in conformity with subchapter II of this chapter;
(2) the delivery of such a substance to or by a common or
contract carrier for carriage in the lawful and usual course of
its business, or to or by a warehouseman for storage in the
lawful and usual course of its business; but where such carriage
or storage is in connection with the distribution by the owner of
the substance to a third person, this paragraph shall not relieve
the distributor from compliance with subsection (a) of this
section.
(c) Preservation and availability
(1) Every person who in pursuance of an order required under
subsection (a) of this section distributes a controlled substance
shall preserve such order for a period of two years, and shall make
such order available for inspection and copying by officers and
employees of the United States duly authorized for that purpose by
the Attorney General, and by officers or employees of States or
their political subdivisions who are charged with the enforcement
of State or local laws regulating the production, or regulating the
distribution or dispensing, of controlled substances and who are
authorized under such laws to inspect such orders.
(2) Every person who gives an order required under subsection (a)
of this section shall, at or before the time of giving such order,
make or cause to be made a duplicate thereof on a form to be issued
by the Attorney General in blank in accordance with subsection (d)
of this section and regulations prescribed by him pursuant to this
section, and shall, if such order is accepted, preserve such
duplicate for a period of two years and make it available for
inspection and copying by the officers and employees mentioned in
paragraph (1) of this subsection.
(d) Issuance
(1) The Attorney General shall issue forms pursuant to
subsections (a) and (c)(2) of this section only to persons validly
registered under section 823 of this title (or exempted from
registration under section 822(d) of this title). Whenever any such
form is issued to a person, the Attorney General shall, before
delivery thereof, insert therein the name of such person, and it
shall be unlawful for any other person (A) to use such form for the
purpose of obtaining controlled substances or (B) to furnish such
form to any person with intent thereby to procure the distribution
of such substances.
(2) The Attorney General may charge reasonable fees for the
issuance of such forms in such amounts as he may prescribe for the
purpose of covering the cost to the United States of issuing such
forms, and other necessary activities in connection therewith.
(e) Unlawful acts
It shall be unlawful for any person to obtain by means of order
forms issued under this section controlled substances for any
purpose other than their use, distribution, dispensing, or
administration in the conduct of a lawful business in such
substances or in the course of his professional practice or
research.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 308, Oct. 27, 1970, 84 Stat. 1259.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I and II, referred to in subsec. (a), are set out in
section 812(c) of this title.
-End-
-CITE-
21 USC Sec. 829 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 829. Prescriptions
-STATUTE-
(a) Schedule II substances
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in
schedule II, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may
be dispensed without the written prescription of a practitioner,
except that in emergency situations, as prescribed by the Secretary
by regulation after consultation with the Attorney General, such
drug may be dispensed upon oral prescription in accordance with
section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall
be retained in conformity with the requirements of section 827 of
this title. No prescription for a controlled substance in schedule
II may be refilled.
(b) Schedule III and IV substances
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in
schedule III or IV, which is a prescription drug as determined
under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.], may be dispensed without a written or oral prescription in
conformity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such
prescriptions may not be filled or refilled more than six months
after the date thereof or be refilled more than five times after
the date of the prescription unless renewed by the practitioner.
(c) Schedule V substances
No controlled substance in schedule V which is a drug may be
distributed or dispensed other than for a medical purpose.
(d) Non-prescription drugs with abuse potential
Whenever it appears to the Attorney General that a drug not
considered to be a prescription drug under the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.] should be so considered
because of its abuse potential, he shall so advise the Secretary
and furnish to him all available data relevant thereto.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 309, Oct. 27, 1970, 84 Stat. 1260.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(a), (b), and (d), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
Schedules II, III, IV, and V, referred to in subsecs. (a) to (c),
are set out in section 812(c) of this title.
-MISC1-
EFFECT OF SCHEDULING ON PRESCRIPTIONS
Pub. L. 101-647, title XIX, Sec. 1902(c), Nov. 29, 1990, 104
Stat. 4852, provided that: "Any prescription for anabolic steroids
subject to refill on or after the date of enactment of the
amendments made by this section [Nov. 29, 1990] may be refilled
without restriction under section 309(a) of the Controlled
Substances Act (21 U.S.C. 829(a))."
-End-
-CITE-
21 USC Sec. 830 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part C - Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
-HEAD-
Sec. 830. Regulation of listed chemicals and certain machines
-STATUTE-
(a) Record of regulated transactions
(1) Each regulated person who engages in a regulated transaction
involving a listed chemical, a tableting machine, or an
encapsulating machine shall keep a record of the transaction for
two years after the date of the transaction.
(2) A record under this subsection shall be retrievable and shall
include the date of the regulated transaction, the identity of each
party to the regulated transaction, a statement of the quantity and
form of the listed chemical, a description of the tableting machine
or encapsulating machine, and a description of the method of
transfer. Such record shall be available for inspection and copying
by the Attorney General.
(3) It is the duty of each regulated person who engages in a
regulated transaction to identify each other party to the
transaction. It is the duty of such other party to present proof of
identity to the regulated person. The Attorney General shall
specify by regulation the types of documents and other evidence
that constitute proof of identity for purposes of this paragraph.
(b) Reports to Attorney General
(1) Each regulated person shall report to the Attorney General,
in such form and manner as the Attorney General shall prescribe by
regulation -
(A) any regulated transaction involving an extraordinary
quantity of a listed chemical, an uncommon method of payment or
delivery, or any other circumstance that the regulated person
believes may indicate that the listed chemical will be used in
violation of this subchapter;
(B) any proposed regulated transaction with a person whose
description or other identifying characteristic the Attorney
General furnishes in advance to the regulated person;
(C) any unusual or excessive loss or disappearance of a listed
chemical under the control of the regulated person; and
(D) any regulated transaction in a tableting machine or an
encapsulating machine.
Each report under subparagraph (A) shall be made at the earliest
practicable opportunity after the regulated person becomes aware of
the circumstance involved. A regulated person may not complete a
transaction with a person whose description or identifying
characteristic is furnished to the regulated person under
subparagraph (B) unless the transaction is approved by the Attorney
General. The Attorney General shall make available to regulated
persons guidance documents describing transactions and
circumstances for which reports are required under subparagraph (A)
and subparagraph (C).
(2) A regulated person that manufactures a listed chemical shall
report annually to the Attorney General, in such form and manner
and containing such specific data as the Attorney General shall
prescribe by regulation, information concerning listed chemicals
manufactured by the person. The requirement of the preceding
sentence shall not apply to the manufacture of a drug product that
is exempted under section 802(39)(A)(iv) of this title.
(3) Mail order reporting. - (A) As used in this paragraph:
(i) The term "drug product" means an active ingredient in
dosage form that has been approved or otherwise may be lawfully
marketed under the Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.] for distribution in the United States.
(ii) The term "valid prescription" means a prescription which
is issued for a legitimate medical purpose by an individual
practitioner licensed by law to administer and prescribe the
drugs concerned and acting in the usual course of the
practitioner's professional practice.
(B) Each regulated person who engages in a transaction with a
nonregulated person or who engages in an export transaction which -
(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine
(including drug products containing these chemicals); and
(ii) uses or attempts to use the Postal Service or any private
or commercial carrier;
shall, on a monthly basis, submit a report of each such transaction
conducted during the previous month to the Attorney General in such
form, containing such data, and at such times as the Attorney
General shall establish by regulation.
(C) The data required for such reports shall include -
(i) the name of the purchaser;
(ii) the quantity and form of the ephedrine, pseudoephedrine,
or phenylpropanolamine purchased; and
(iii) the address to which such ephedrine, pseudoephedrine, or
phenylpropanolamine was sent.
(D) Except as provided in subparagraph (E), the following
distributions to a nonregulated person, and the following export
transactions, shall not be subject to the reporting requirement in
subparagraph (B):
(i) Distributions of sample packages of drug products when such
packages contain not more than two solid dosage units or the
equivalent of two dosage units in liquid form, not to exceed 10
milliliters of liquid per package, and not more than one package
is distributed to an individual or residential address in any 30-
day period.
(ii) Distributions of drug products by retail distributors that
may not include face-to-face transactions to the extent that such
distributions are consistent with the activities authorized for a
retail distributor as specified in section 802(49) of this title,
except that this clause does not apply to sales of scheduled
listed chemical products at retail.
(iii) Distributions of drug products to a resident of a long
term care facility (as that term is defined in regulations
prescribed by the Attorney General) or distributions of drug
products to a long term care facility for dispensing to or for
use by a resident of that facility.
(iv) Distributions of drug products pursuant to a valid
prescription.
(v) Exports which have been reported to the Attorney General
pursuant to section 954 or 971 of this title or which are subject
to a waiver granted under section 971(f)(2) of this title.
(vi) Any quantity, method, or type of distribution or any
quantity, method, or type of distribution of a specific listed
chemical (including specific formulations or drug products) or of
a group of listed chemicals (including specific formulations or
drug products) which the Attorney General has excluded by
regulation from such reporting requirement on the basis that such
reporting is not necessary for the enforcement of this subchapter
or subchapter II of this chapter.
(E) The Attorney General may revoke any or all of the exemptions
listed in subparagraph (D) for an individual regulated person if he
finds that drug products distributed by the regulated person are
being used in violation of this subchapter or subchapter II of this
chapter. The regulated person shall be notified of the revocation,
which will be effective upon receipt by the person of such notice,
as provided in section 971(c)(1) of this title, and shall have the
right to an expedited hearing as provided in section 971(c)(2) of
this title.
(c) Confidentiality of information obtained by Attorney General;
non-disclosure; exceptions
(1) Except as provided in paragraph (2), any information obtained
by the Attorney General under this section which is exempt from
disclosure under section 552(a) of title 5, by reason of section
552(b)(4) of such title, is confidential and may not be disclosed
to any person.
(2) Information referred to in paragraph (1) may be disclosed
only -
(A) to an officer or employee of the United States engaged in
carrying out this subchapter, subchapter II of this chapter, or
the customs laws;
(B) when relevant in any investigation or proceeding for the
enforcement of this subchapter, subchapter II of this chapter, or
the customs laws;
(C) when necessary to comply with an obligation of the United
States under a treaty or other international agreement; or
(D) to a State or local official or employee in conjunction
with the enforcement of controlled substances laws or chemical
control laws.
(3) The Attorney General shall -
(A) take such action as may be necessary to prevent
unauthorized disclosure of information by any person to whom such
information is disclosed under paragraph (2); and
(B) issue guidelines that limit, to the maximum extent
feasible, the disclosure of proprietary business information,
including the names or identities of United States exporters of
listed chemicals, to any person to whom such information is
disclosed under paragraph (2).
(4) Any person who is aggrieved by a disclosure of information in
violation of this section may bring a civil action against the
violator for appropriate relief.
(5) Notwithstanding paragraph (4), a civil action may not be
brought under such paragraph against investigative or law
enforcement personnel of the Drug Enforcement Administration.
(d) Scheduled listed chemicals; restrictions on sales quantity;
requirements regarding nonliquid forms
With respect to ephedrine base, pseudoephedrine base, or
phenylpropanolamine base in a scheduled listed chemical product -
(1) the quantity of such base sold at retail in such a product
by a regulated seller, or a distributor required to submit
reports by subsection (b)(3) may not, for any purchaser, exceed a
daily amount of 3.6 grams, without regard to the number of
transactions; and
(2) such a seller or distributor may not sell such a product in
nonliquid form (including gel caps) at retail unless the product
is packaged in blister packs, each blister containing not more
than 2 dosage units, or where the use of blister packs is
technically infeasible, the product is packaged in unit dose
packets or pouches.
(e) Scheduled listed chemicals; behind-the-counter access; logbook
requirement; training of sales personnel; privacy protections
(1) Requirements regarding retail transactions
(A) In general
Each regulated seller shall ensure that, subject to
subparagraph (F), sales by such seller of a scheduled listed
chemical product at retail are made in accordance with the
following:
(i) In offering the product for sale, the seller places the
product such that customers do not have direct access to the
product before the sale is made (in this paragraph referred
to as "behind-the-counter" placement). For purposes of this
paragraph, a behind-the-counter placement of a product
includes circumstances in which the product is stored in a
locked cabinet that is located in an area of the facility
involved to which customers do have direct access.
(ii) The seller delivers the product directly into the
custody of the purchaser.
(iii) The seller maintains, in accordance with criteria
issued by the Attorney General, a written or electronic list
of such sales that identifies the products by name, the
quantity sold, the names and addresses of purchasers, and the
dates and times of the sales (which list is referred to in
this subsection as the "logbook"), except that such
requirement does not apply to any purchase by an individual
of a single sales package if that package contains not more
than 60 milligrams of pseudoephedrine.
(iv) In the case of a sale to which the requirement of
clause (iii) applies, the seller does not sell such a product
unless -
(I) the prospective purchaser -
(aa) presents an identification card that provides a
photograph and is issued by a State or the Federal
Government, or a document that, with respect to
identification, is considered acceptable for purposes of
sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of
title 8, Code of Federal Regulations (as in effect on or
after March 9, 2006); and
(bb) signs the logbook and enters in the logbook his or
her name, address, and the date and time of the sale; and
(II) the seller -
(aa) determines that the name entered in the logbook
corresponds to the name provided on such identification
and that the date and time entered are correct; and
(bb) enters in the logbook the name of the product and
the quantity sold.
(v) The logbook includes, in accordance with criteria of
the Attorney General, a notice to purchasers that entering
false statements or misrepresentations in the logbook may
subject the purchasers to criminal penalties under section
1001 of title 18, which notice specifies the maximum fine and
term of imprisonment under such section.
(vi) The seller maintains each entry in the logbook for not
fewer than two years after the date on which the entry is
made.
(vii) In the case of individuals who are responsible for
delivering such products into the custody of purchasers or
who deal directly with purchasers by obtaining payments for
the products, the seller has submitted to the Attorney
General a self-certification that all such individuals have,
in accordance with criteria under subparagraph (B)(ii),
undergone training provided by the seller to ensure that the
individuals understand the requirements that apply under this
subsection and subsection (d).
(viii) The seller maintains a copy of such certification
and records demonstrating that individuals referred to in
clause (vii) have undergone the training.
(ix) If the seller is a mobile retail vendor:
(I) The seller complies with clause (i) by placing the
product in a locked cabinet.
(II) The seller does not sell more than 7.5 grams of
ephedrine base, pseudoephedrine base, or
phenylpropanolamine base in such products per customer
during a 30-day period.
(B) Additional provisions regarding certifications and training
(i) In general
A regulated seller may not sell any scheduled listed
chemical product at retail unless the seller has submitted to
the Attorney General the self-certification referred to in
subparagraph (A)(vii). The certification is not effective for
purposes of the preceding sentence unless, in addition to
provisions regarding the training of individuals referred to
in such subparagraph, the certification includes a statement
that the seller understands each of the requirements that
apply under this paragraph and under subsection (d) and
agrees to comply with the requirements.
(ii) Issuance of criteria; self-certification
The Attorney General shall by regulation establish criteria
for certifications under this paragraph. The criteria shall -
(I) provide that the certifications are self-
certifications provided through the program under clause
(iii);
(II) provide that a separate certification is required
for each place of business at which a regulated seller
sells scheduled listed chemical products at retail; and
(III) include criteria for training under subparagraph
(A)(vii).
(iii) Program for regulated sellers
The Attorney General shall establish a program regarding
such certifications and training in accordance with the
following:
(I) The program shall be carried out through an Internet
site of the Department of Justice and such other means as
the Attorney General determines to be appropriate.
(II) The program shall inform regulated sellers that
section 1001 of title 18 applies to such certifications.
(III) The program shall make available to such sellers an
explanation of the criteria under clause (ii).
(IV) The program shall be designed to permit the
submission of the certifications through such Internet
site.
(V) The program shall be designed to automatically
provide the explanation referred to in subclause (III), and
an acknowledgement that the Department has received a
certification, without requiring direct interactions of
regulated sellers with staff of the Department (other than
the provision of technical assistance, as appropriate).
(iv) Availability of certification to State and local
officials
Promptly after receiving a certification under subparagraph
(A)(vii), the Attorney General shall make available a copy of
the certification to the appropriate State and local
officials.
(C) Privacy protections
In order to protect the privacy of individuals who purchase
scheduled listed chemical products, the Attorney General shall
by regulation establish restrictions on disclosure of
information in logbooks under subparagraph (A)(iii). Such
regulations shall -
(i) provide for the disclosure of the information as
appropriate to the Attorney General and to State and local
law enforcement agencies; and
(ii) prohibit accessing, using, or sharing information in
the logbooks for any purpose other than to ensure compliance
with this subchapter or to facilitate a product recall to
protect public health and safety.
(D) False statements or misrepresentations by purchasers
For purposes of section 1001 of title 18, entering
information in the logbook under subparagraph (A)(iii) shall be
considered a matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United
States.
(E) Good faith protection
A regulated seller who in good faith releases information in
a logbook under subparagraph (A)(iii) to Federal, State, or
local law enforcement authorities is immune from civil
liability for such release unless the release constitutes gross
negligence or intentional, wanton, or willful misconduct.
(F) Inapplicability of requirements to certain sales
Subparagraph (A) does not apply to the sale at retail of a
scheduled listed chemical product if a report on the sales
transaction is required to be submitted to the Attorney General
under subsection (b)(3).
(G) Certain measures regarding theft and diversion
A regulated seller may take reasonable measures to guard
against employing individuals who may present a risk with
respect to the theft and diversion of scheduled listed chemical
products, which may include, notwithstanding State law, asking
applicants for employment whether they have been convicted of
any crime involving or related to such products or controlled
substances.
(2) Mail-order reporting; verification of identity of purchaser;
30-day restriction on quantities for individual purchasers
Each regulated person who makes a sale at retail of a scheduled
listed chemical product and is required under subsection (b)(3)
to submit a report of the sales transaction to the Attorney
General is subject to the following:
(A) The person shall, prior to shipping the product, confirm
the identity of the purchaser in accordance with procedures
established by the Attorney General. The Attorney General shall
by regulation establish such procedures.
(B) The person may not sell more than 7.5 grams of ephedrine
base, pseudoephedrine base, or phenylpropanolamine base in such
products per customer during a 30-day period.
(3) Exemptions for certain products
Upon the application of a manufacturer of a scheduled listed
chemical product, the Attorney General may by regulation provide
that the product is exempt from the provisions of subsection (d)
and paragraphs (1) and (2) of this subsection if the Attorney
General determines that the product cannot be used in the illicit
manufacture of methamphetamine.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 310, as added Pub. L. 95-633, title
II, Sec. 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100-
690, title VI, Sec. 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub.
L. 103-200, Secs. 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341;
Pub. L. 104-237, title II, Sec. 208, title IV, Sec. 402, Oct. 3,
1996, 110 Stat. 3104, 3111; Pub. L. 106-310, div. B, title XXXVI,
Sec. 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109-177, title
VII, Secs. 711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar.
9, 2006, 120 Stat. 257, 261, 267.)
-REFTEXT-
REFERENCES IN TEXT
The Food, Drug, and Cosmetic Act, referred to in subsec.
(b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic
Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
is classified generally to chapter 9 (Sec. 301 et seq.) of this
title. For complete classification of this Act to the Code, see
section 301 of this title and Tables.
This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and
(e)(1)(C)(ii), was in the original "this title", meaning title II
of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended, and is
popularly known as the "Controlled Substances Act". For complete
classification of title II to the Code, see second paragraph of
Short Title note set out under section 801 of this title and
Tables.
Subchapter II of this chapter, referred to in subsecs.
(b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original "title
III", meaning title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1285, as amended. Part A of title III comprises subchapter II of
this chapter. For classification of Part B, consisting of sections
1101 to 1105 of title III, see Tables.
-MISC1-
AMENDMENTS
2006 - Subsec. (b)(3)(D)(ii). Pub. L. 109-177, Sec. 711(c)(2),
inserted ", except that this clause does not apply to sales of
scheduled listed chemical products at retail" before period at end.
Pub. L. 109-177, Sec. 711(a)(2)(B), substituted "section 802(49)"
for "section 802(46)".
Subsec. (b)(3)(D)(v). Pub. L. 109-177, Sec. 716(b)(2),
substituted "section 971(f)(2)" for "section 971(e)(2)".
Subsec. (d). Pub. L. 109-177, Sec. 711(b)(1), added subsec. (d).
Subsec. (e)(1). Pub. L. 109-177, Sec. 711(b)(1), added subsec.
heading and par. (1).
Subsec. (e)(2). Pub. L. 109-177, Sec. 711(c)(1), added par. (2).
Subsec. (e)(3). Pub. L. 109-177, Sec. 711(d), added par. (3).
2000 - Subsec. (b)(3). Pub. L. 106-310 added subpars. (A), (D),
and (E), redesignated former subpars. (A) and (B) as (B) and (C),
respectively, and inserted "or who engages in an export
transaction" after "nonregulated person" in introductory provisions
of subpar. (B).
1996 - Subsec. (a)(1). Pub. L. 104-237, Sec. 208, substituted
"for two years after the date of the transaction." for the dash
after "record of the transaction" and struck out subpars. (A) and
(B) which read as follows:
"(A) for 4 years after the date of the transaction, if the listed
chemical is a list I chemical or if the transaction involves a
tableting machine or an encapsulating machine; and
"(B) for 2 years after the date of the transaction, if the listed
chemical is a list II chemical."
Subsec. (b)(3). Pub. L. 104-237, Sec. 402, added par. (3).
1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 2(c)(1), substituted
"list I chemical" for "precursor chemical" in subpar. (A) and "a
list II chemical" for "an essential chemical" in subpar. (B).
Subsec. (b). Pub. L. 103-200, Sec. 10, designated existing
provisions as par. (1), redesignated former pars. (1) to (4) as
subpars. (A) to (D), respectively, in concluding provisions,
substituted "subparagraph (A)" for "paragraph (1)" in two places,
"subparagraph (B)" for "paragraph (2)", and "subparagraph (C)" for
"paragraph (3)", and added par. (2).
Subsec. (c)(2)(D). Pub. L. 103-200, Sec. 2(c)(2), substituted
"chemical control laws" for "precursor chemical laws".
1988 - Pub. L. 100-690 amended section generally, substituting
provisions relating to regulation of listed chemicals and certain
machines for provisions relating to reporting by any person who
distributes, sells, or imports any piperidine.
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109-177, title VII, Sec. 711(b)(2), Mar. 9, 2006, 120
Stat. 261, provided that: "With respect to subsections (d) and
(e)(1) of section 310 of the Controlled Substances Act [21 U.S.C.
830(d), (e)(1)], as added by paragraph (1) of this subsection:
"(A) Such subsection (d) applies on and after the expiration of
the 30-day period beginning on the date of the enactment of this
Act [Mar. 9, 2006].
"(B) Such subsection (e)(1) applies on and after September 30,
2006."
Pub. L. 109-177, title VII, Sec. 711(c)(3), Mar. 9, 2006, 120
Stat. 261, provided that: "The amendments made by paragraphs (1)
and (2) [amending this section] apply on and after the expiration
of the 30-day period beginning on the date of the enactment of this
Act [Mar. 9, 2006]."
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
EFFECTIVE DATE; TIME TO SUBMIT PIPERIDINE REPORT; REQUIRED
INFORMATION
Section 203(a) of title II of Pub. L. 95-633 provided that:
"(1) Except as provided under paragraph (2), the amendments made
by this title [enacting this section and amending sections 841 to
843 of this title] shall take effect on the date of the enactment
of this Act [Nov. 10, 1978].
"(2) Any person required to submit a report under section
310(a)(1) of the Controlled Substances Act [subsec. (a)(1) of this
section] respecting a distribution, sale, or importation of
piperidine during the 90 days after the date of the enactment of
this Act [Nov. 10, 1978] may submit such report any time up to 97
days after such date of enactment.
"(3) Until otherwise provided by the Attorney General by
regulation, the information required to be reported by a person
under section 310(a)(1) of the Controlled Substances Act (as added
by section 202(a)(2) of this title) [subsec. (a)(1) of this
section] with respect to the person's distribution, sale, or
importation of piperidine shall -
"(A) be the information described in subparagraphs (A) and (B)
of such section, and
"(B) except as provided in paragraph (2) of this subsection, be
reported not later than seven days after the date of such
distribution, sale, or importation."
REPEALS
Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
repealed section 203(d) of Pub. L. 95-633, which had provided for
the repeal of this section effective Jan. 1, 1981.
REGULATIONS FOR PIPERIDINE REPORTING
Section 203(b) of Pub. L. 95-633 required the Attorney General to
publish proposed interim regulations for piperidine reporting under
section 830(a) of this title not later than 30 days after
enactment, and final interim regulations not later than 75 days
after enactment, such final interim regulations to be effective on
and after the ninety-first day after enactment.
REPORT TO PRESIDENT AND CONGRESS ON EFFECTIVENESS OF TITLE II OF
PUB. L. 95-633
Section 203(c) of Pub. L. 95-633 required the Attorney General to
analyze and evaluate the impact and effectiveness of the amendments
made by title II of Pub. L. 95-633, and report to the President and
Congress not later than Mar. 1, 1980.
-End-
-CITE-
21 USC Part D - Offenses and Penalties 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
PART D - OFFENSES AND PENALTIES
-End-
-CITE-
21 USC Sec. 841 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 841. Prohibited acts A
-STATUTE-
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful for
any person knowingly or intentionally -
(1) to manufacture, distribute, or dispense, or possess with
intent to manufacture, distribute, or dispense, a controlled
substance; or
(2) to create, distribute, or dispense, or possess with intent
to distribute or dispense, a counterfeit substance.
(b) Penalties
Except as otherwise provided in section 849, 859, 860, or 861 of
this title, any person who violates subsection (a) of this section
shall be sentenced as follows:
(1)(A) In the case of a violation of subsection (a) of this
section involving -
(i) 1 kilogram or more of a mixture or substance containing a
detectable amount of heroin;
(ii) 5 kilograms or more of a mixture or substance containing a
detectable amount of -
(I) coca leaves, except coca leaves and extracts of coca
leaves from which cocaine, ecgonine, and derivatives of
ecgonine or their salts have been removed;
(II) cocaine, its salts, optical and geometric isomers, and
salts of isomers;
(III) ecgonine, its derivatives, their salts, isomers, and
salts of isomers; or
(IV) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subclauses (I)
through (III);
(iii) 50 grams or more of a mixture or substance described in
clause (ii) which contains cocaine base;
(iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or
more of a mixture or substance containing a detectable amount of
phencyclidine (PCP);
(v) 10 grams or more of a mixture or substance containing a
detectable amount of lysergic acid diethylamide (LSD);
(vi) 400 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-
piperidinyl ] propanamide or 100 grams or more of a mixture or
substance containing a detectable amount of any analogue of N-
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(vii) 1000 kilograms or more of a mixture or substance
containing a detectable amount of marihuana, or 1,000 or more
marihuana plants regardless of weight; or
(viii) 50 grams or more of methamphetamine, its salts, isomers,
and salts of its isomers or 500 grams or more of a mixture or
substance containing a detectable amount of methamphetamine, its
salts, isomers, or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may
not be less than 10 years or more than life and if death or serious
bodily injury results from the use of such substance shall be not
less than 20 years or more than life, a fine not to exceed the
greater of that authorized in accordance with the provisions of
title 18 or $4,000,000 if the defendant is an individual or
$10,000,000 if the defendant is other than an individual, or both.
If any person commits such a violation after a prior conviction for
a felony drug offense has become final, such person shall be
sentenced to a term of imprisonment which may not be less than 20
years and not more than life imprisonment and if death or serious
bodily injury results from the use of such substance shall be
sentenced to life imprisonment, a fine not to exceed the greater of
twice that authorized in accordance with the provisions of title 18
or $8,000,000 if the defendant is an individual or $20,000,000 if
the defendant is other than an individual, or both. If any person
commits a violation of this subparagraph or of section 849, 859,
860, or 861 of this title after two or more prior convictions for a
felony drug offense have become final, such person shall be
sentenced to a mandatory term of life imprisonment without release
and fined in accordance with the preceding sentence.
Notwithstanding section 3583 of title 18, any sentence under this
subparagraph shall, in the absence of such a prior conviction,
impose a term of supervised release of at least 5 years in addition
to such term of imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of at least 10
years in addition to such term of imprisonment. Notwithstanding any
other provision of law, the court shall not place on probation or
suspend the sentence of any person sentenced under this
subparagraph. No person sentenced under this subparagraph shall be
eligible for parole during the term of imprisonment imposed
therein.
(B) In the case of a violation of subsection (a) of this section
involving -
(i) 100 grams or more of a mixture or substance containing a
detectable amount of heroin;
(ii) 500 grams or more of a mixture or substance containing a
detectable amount of -
(I) coca leaves, except coca leaves and extracts of coca
leaves from which cocaine, ecgonine, and derivatives of
ecgonine or their salts have been removed;
(II) cocaine, its salts, optical and geometric isomers, and
salts of isomers;
(III) ecgonine, its derivatives, their salts, isomers, and
salts of isomers; or
(IV) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subclauses (I)
through (III);
(iii) 5 grams or more of a mixture or substance described in
clause (ii) which contains cocaine base;
(iv) 10 grams or more of phencyclidine (PCP) or 100 grams or
more of a mixture or substance containing a detectable amount of
phencyclidine (PCP);
(v) 1 gram or more of a mixture or substance containing a
detectable amount of lysergic acid diethylamide (LSD);
(vi) 40 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-
piperidinyl ] propanamide or 10 grams or more of a mixture or
substance containing a detectable amount of any analogue of N-
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(vii) 100 kilograms or more of a mixture or substance
containing a detectable amount of marihuana, or 100 or more
marihuana plants regardless of weight; or
(viii) 5 grams or more of methamphetamine, its salts, isomers,
and salts of its isomers or 50 grams or more of a mixture or
substance containing a detectable amount of methamphetamine, its
salts, isomers, or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may
not be less than 5 years and not more than 40 years and if death or
serious bodily injury results from the use of such substance shall
be not less than 20 years or more than life, a fine not to exceed
the greater of that authorized in accordance with the provisions of
title 18 or $2,000,000 if the defendant is an individual or
$5,000,000 if the defendant is other than an individual, or both.
If any person commits such a violation after a prior conviction for
a felony drug offense has become final, such person shall be
sentenced to a term of imprisonment which may not be less than 10
years and not more than life imprisonment and if death or serious
bodily injury results from the use of such substance shall be
sentenced to life imprisonment, a fine not to exceed the greater of
twice that authorized in accordance with the provisions of title 18
or $4,000,000 if the defendant is an individual or $10,000,000 if
the defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence imposed under this
subparagraph shall, in the absence of such a prior conviction,
include a term of supervised release of at least 4 years in
addition to such term of imprisonment and shall, if there was such
a prior conviction, include a term of supervised release of at
least 8 years in addition to such term of imprisonment.
Notwithstanding any other provision of law, the court shall not
place on probation or suspend the sentence of any person sentenced
under this subparagraph. No person sentenced under this
subparagraph shall be eligible for parole during the term of
imprisonment imposed therein.
(C) In the case of a controlled substance in schedule I or II,
gamma hydroxybutyric acid (including when scheduled as an approved
drug product for purposes of section 3(a)(1)(B) of the Hillory J.
Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000),
or 1 gram of flunitrazepam, except as provided in subparagraphs
(A), (B), and (D), such person shall be sentenced to a term of
imprisonment of not more than 20 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to a term of imprisonment of not less than twenty years
or more than life, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18 or
$1,000,000 if the defendant is an individual or $5,000,000 if the
defendant is other than an individual, or both. If any person
commits such a violation after a prior conviction for a felony drug
offense has become final, such person shall be sentenced to a term
of imprisonment of not more than 30 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to life imprisonment, a fine not to exceed the greater of
twice that authorized in accordance with the provisions of title 18
or $2,000,000 if the defendant is an individual or $10,000,000 if
the defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a
prior conviction, impose a term of supervised release of at least 3
years in addition to such term of imprisonment and shall, if there
was such a prior conviction, impose a term of supervised release of
at least 6 years in addition to such term of imprisonment.
Notwithstanding any other provision of law, the court shall not
place on probation or suspend the sentence of any person sentenced
under the provisions of this subparagraph which provide for a
mandatory term of imprisonment if death or serious bodily injury
results, nor shall a person so sentenced be eligible for parole
during the term of such a sentence.
(D) In the case of less than 50 kilograms of marihuana, except in
the case of 50 or more marihuana plants regardless of weight, 10
kilograms of hashish, or one kilogram of hashish oil or in the case
of any controlled substance in schedule III (other than gamma
hydroxybutyric acid), or 30 milligrams of flunitrazepam, such
person shall, except as provided in paragraphs (4) and (5) of this
subsection, be sentenced to a term of imprisonment of not more than
5 years, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18 or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is other
than an individual, or both. If any person commits such a violation
after a prior conviction for a felony drug offense has become
final, such person shall be sentenced to a term of imprisonment of
not more than 10 years, a fine not to exceed the greater of twice
that authorized in accordance with the provisions of title 18 or
$500,000 if the defendant is an individual or $2,000,000 if the
defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a
prior conviction, impose a term of supervised release of at least 2
years in addition to such term of imprisonment and shall, if there
was such a prior conviction, impose a term of supervised release of
at least 4 years in addition to such term of imprisonment.
(2) In the case of a controlled substance in schedule IV, such
person shall be sentenced to a term of imprisonment of not more
than 3 years, a fine not to exceed the greater of that authorized
in accordance with the provisions of title 18 or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is other
than an individual, or both. If any person commits such a violation
after one or more prior convictions of him for an offense
punishable under this paragraph, or for a felony under any other
provision of this subchapter or subchapter II of this chapter or
other law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or stimulant
substances, have become final, such person shall be sentenced to a
term of imprisonment of not more than 6 years, a fine not to exceed
the greater of twice that authorized in accordance with the
provisions of title 18 or $500,000 if the defendant is an
individual or $2,000,000 if the defendant is other than an
individual, or both. Any sentence imposing a term of imprisonment
under this paragraph shall, in the absence of such a prior
conviction, impose a term of supervised release of at least one
year in addition to such term of imprisonment and shall, if there
was such a prior conviction, impose a term of supervised release of
at least 2 years in addition to such term of imprisonment.
(3) In the case of a controlled substance in schedule V, such
person shall be sentenced to a term of imprisonment of not more
than one year, a fine not to exceed the greater of that authorized
in accordance with the provisions of title 18 or $100,000 if the
defendant is an individual or $250,000 if the defendant is other
than an individual, or both. If any person commits such a violation
after one or more convictions of him for an offense punishable
under this paragraph, or for a crime under any other provision of
this subchapter or subchapter II of this chapter or other law of a
State, the United States, or a foreign country relating to narcotic
drugs, marihuana, or depressant or stimulant substances, have
become final, such person shall be sentenced to a term of
imprisonment of not more than 2 years, a fine not to exceed the
greater of twice that authorized in accordance with the provisions
of title 18 or $200,000 if the defendant is an individual or
$500,000 if the defendant is other than an individual, or both.
(4) Notwithstanding paragraph (1)(D) of this subsection, any
person who violates subsection (a) of this section by distributing
a small amount of marihuana for no remuneration shall be treated as
provided in section 844 of this title and section 3607 of title 18.
(5) Any person who violates subsection (a) of this section by
cultivating or manufacturing a controlled substance on Federal
property shall be imprisoned as provided in this subsection and
shall be fined any amount not to exceed -
(A) the amount authorized in accordance with this section;
(B) the amount authorized in accordance with the provisions of
title 18;
(C) $500,000 if the defendant is an individual; or
(D) $1,000,000 if the defendant is other than an individual;
or both.
(6) Any person who violates subsection (a) of this section, or
attempts to do so, and knowingly or intentionally uses a poison,
chemical, or other hazardous substance on Federal land, and, by
such use -
(A) creates a serious hazard to humans, wildlife, or domestic
animals,
(B) degrades or harms the environment or natural resources, or
(C) pollutes an aquifer, spring, stream, river, or body of
water,
shall be fined in accordance with title 18 or imprisoned not more
than five years, or both.
(7) Penalties for distribution. -
(A) In general. - Whoever, with intent to commit a crime of
violence, as defined in section 16 of title 18 (including rape),
against an individual, violates subsection (a) of this section by
distributing a controlled substance or controlled substance
analogue to that individual without that individual's knowledge,
shall be imprisoned not more than 20 years and fined in
accordance with title 18.
(B) Definition. - For purposes of this paragraph, the term
"without that individual's knowledge" means that the individual
is unaware that a substance with the ability to alter that
individual's ability to appraise conduct or to decline
participation in or communicate unwillingness to participate in
conduct is administered to the individual.
(c) Offenses involving listed chemicals
Any person who knowingly or intentionally -
(1) possesses a listed chemical with intent to manufacture a
controlled substance except as authorized by this subchapter;
(2) possesses or distributes a listed chemical knowing, or
having reasonable cause to believe, that the listed chemical will
be used to manufacture a controlled substance except as
authorized by this subchapter; or
(3) with the intent of causing the evasion of the recordkeeping
or reporting requirements of section 830 of this title, or the
regulations issued under that section, receives or distributes a
reportable amount of any listed chemical in units small enough so
that the making of records or filing of reports under that
section is not required;
shall be fined in accordance with title 18 or imprisoned not more
than 20 years in the case of a violation of paragraph (1) or (2)
involving a list I chemical or not more than 10 years in the case
of a violation of this subsection other than a violation of
paragraph (1) or (2) involving a list I chemical, or both.
(d) Boobytraps on Federal property; penalties; "boobytrap" defined
(1) Any person who assembles, maintains, places, or causes to be
placed a boobytrap on Federal property where a controlled substance
is being manufactured, distributed, or dispensed shall be sentenced
to a term of imprisonment for not more than 10 years or fined under
title 18, or both.
(2) If any person commits such a violation after 1 or more prior
convictions for an offense punishable under this subsection, such
person shall be sentenced to a term of imprisonment of not more
than 20 years or fined under title 18, or both.
(3) For the purposes of this subsection, the term "boobytrap"
means any concealed or camouflaged device designed to cause bodily
injury when triggered by any action of any unsuspecting person
making contact with the device. Such term includes guns,
ammunition, or explosive devices attached to trip wires or other
triggering mechanisms, sharpened stakes, and lines or wires with
hooks attached.
(e) Ten-year injunction as additional penalty
In addition to any other applicable penalty, any person convicted
of a felony violation of this section relating to the receipt,
distribution, manufacture, exportation, or importation of a listed
chemical may be enjoined from engaging in any transaction involving
a listed chemical for not more than ten years.
(f) Wrongful distribution or possession of listed chemicals
(1) Whoever knowingly distributes a listed chemical in violation
of this subchapter (other than in violation of a recordkeeping or
reporting requirement of section 830 of this title) shall, except
to the extent that paragraph (12), (13), or (14) of section 842(a)
of this title applies, be fined under title 18 or imprisoned not
more than 5 years, or both.
(2) Whoever possesses any listed chemical, with knowledge that
the recordkeeping or reporting requirements of section 830 of this
title have not been adhered to, if, after such knowledge is
acquired, such person does not take immediate steps to remedy the
violation shall be fined under title 18 or imprisoned not more than
one year, or both.
(g) Internet sales of date rape drugs
(1) Whoever knowingly uses the Internet to distribute a date rape
drug to any person, knowing or with reasonable cause to believe
that -
(A) the drug would be used in the commission of criminal sexual
conduct; or
(B) the person is not an authorized purchaser;
shall be fined under this subchapter or imprisoned not more than 20
years, or both.
(2) As used in this subsection:
(A) The term "date rape drug" means -
(i) gamma hydroxybutyric acid (GHB) or any controlled
substance analogue of GHB, including gamma butyrolactone (GBL)
or 1,4-butanediol;
(ii) ketamine;
(iii) flunitrazepam; or
(iv) any substance which the Attorney General designates,
pursuant to the rulemaking procedures prescribed by section 553
of title 5, to be used in committing rape or sexual assault.
The Attorney General is authorized to remove any substance from
the list of date rape drugs pursuant to the same rulemaking
authority.
(B) The term "authorized purchaser" means any of the following
persons, provided such person has acquired the controlled
substance in accordance with this chapter:
(i) A person with a valid prescription that is issued for a
legitimate medical purpose in the usual course of professional
practice that is based upon a qualifying medical relationship
by a practitioner registered by the Attorney General. A
"qualifying medical relationship" means a medical relationship
that exists when the practitioner has conducted at least 1
medical evaluation with the authorized purchaser in the
physical presence of the practitioner, without regard to
whether portions of the evaluation are conducted by other heath
(!1) professionals. The preceding sentence shall not be
construed to imply that 1 medical evaluation demonstrates that
a prescription has been issued for a legitimate medical purpose
within the usual course of professional practice.
(ii) Any practitioner or other registrant who is otherwise
authorized by their registration to dispense, procure,
purchase, manufacture, transfer, distribute, import, or export
the substance under this chapter.
(iii) A person or entity providing documentation that
establishes the name, address, and business of the person or
entity and which provides a legitimate purpose for using any
"date rape drug" for which a prescription is not required.
(3) The Attorney General is authorized to promulgate regulations
for record-keeping and reporting by persons handling 1,4-butanediol
in order to implement and enforce the provisions of this section.
Any record or report required by such regulations shall be
considered a record or report required under this chapter.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 401, Oct. 27, 1970, 84 Stat. 1260;
Pub. L. 95-633, title II, Sec. 201, Nov. 10, 1978, 92 Stat. 3774;
Pub. L. 96-359, Sec. 8(c), Sept. 26, 1980, 94 Stat. 1194; Pub. L.
98-473, title II, Secs. 224(a), 502, 503(b)(1), (2), Oct. 12, 1984,
98 Stat. 2030, 2068, 2070; Pub. L. 99-570, title I, Secs. 1002,
1003(a), 1004(a), 1005(a), 1103, title XV, Sec. 15005, Oct. 27,
1986, 100 Stat. 3207-2, 3207-5, 3207-6, 3207-11, 3702-192; Pub. L.
100-690, title VI, Secs. 6055, 6254(h), 6452(a), 6470(g), (h),
6479, Nov. 18, 1988, 102 Stat. 4318, 4367, 4371, 4378, 4381; Pub.
L. 101-647, title X, Sec. 1002(e), title XII, Sec. 1202, title
XXXV, Sec. 3599K, Nov. 29, 1990, 104 Stat. 4828, 4830, 4932; Pub.
L. 103-322, title IX, Sec. 90105(a), (c), title XVIII, Sec.
180201(b)(2)(A), Sept. 13, 1994, 108 Stat. 1987, 1988, 2047; Pub.
L. 104-237, title II, Sec. 206(a), title III, Sec. 302(a), Oct. 3,
1996, 110 Stat. 3103, 3105; Pub. L. 104-305, Sec. 2(a), (b)(1),
Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105-277, div. E, Sec. 2(a),
Oct. 21, 1998, 112 Stat. 2681-759; Pub. L. 106-172, Secs. 3(b)(1),
5(b), 9, Feb. 18, 2000, 114 Stat. 9, 10, 13; Pub. L. 107-273, div.
B, title III, Sec. 3005(a), title IV, Sec. 4002(d)(2)(A), Nov. 2,
2002, 116 Stat. 1805, 1809; Pub. L. 109-177, title VII, Secs.
711(f)(1)(B), 732, Mar. 9, 2006, 120 Stat. 262, 270; Pub. L. 109-
248, title II, Sec. 201, July 27, 2006, 120 Stat. 611.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (a), (b)(1) to (3),
(c)(1), (2), (f)(1), and (g)(1), was in the original "this title",
meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242,
as amended, and is popularly known as the "Controlled Substances
Act". For complete classification of title II to the Code, see
second paragraph of Short Title note set out under section 801 of
this title and Tables.
Schedules I, II, III, IV, and V, referred to in subsec. (b), are
set out in section 812(c) of this title.
Subchapter II of this chapter, referred to in subsec. (b)(1) to
(3), was in the original "title III", meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285, as amended. Part A of title
III comprises subchapter II of this chapter. For classification of
Part B, consisting of sections 1101 to 1105 of title III, see
Tables.
Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid
Date-Rape Prohibition Act of 2000, referred to in subsec.
(b)(1)(C), is section 3(a)(1)(B) of Pub. L. 106-172, which is set
out in a note under section 812 of this title.
This chapter, referred to in subsec. (g)(2)(B), (3), was in the
original "this Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84
Stat. 1236. For complete classification of this Act to the Code,
see Short Title note set out under section 801 of this title and
Tables.
-MISC1-
AMENDMENTS
2006 - Subsec. (b)(5). Pub. L. 109-177, Sec. 732, inserted "or
manufacturing" after "cultivating" in introductory provisions.
Subsec. (f)(1). Pub. L. 109-177, Sec. 711(f)(1)(B), inserted ",
except to the extent that paragraph (12), (13), or (14) of section
842(a) of this title applies," after "shall".
Subsec. (g). Pub. L. 109-248 added subsec. (g).
2002 - Subsec. (b)(1)(A), (B). Pub. L. 107-273, Sec. 3005(a),
substituted "Notwithstanding section 3583 of title 18, any
sentence" for "Any sentence" in concluding provisions.
Subsec. (b)(1)(C), (D). Pub. L. 107-273, Sec. 3005(a),
substituted "Notwithstanding section 3583 of title 18, any
sentence" for "Any sentence".
Subsec. (d)(1). Pub. L. 107-273, Sec. 4002(d)(2)(A)(i),
substituted "or fined under title 18, or both" for "and shall be
fined not more than $10,000".
Subsec. (d)(2). Pub. L. 107-273, Sec. 4002(d)(2)(A)(ii),
substituted "or fined under title 18, or both" for "and shall be
fined not more than $20,000".
2000 - Subsec. (b)(1)(C). Pub. L. 106-172, Sec. 3(b)(1)(A),
inserted "gamma hydroxybutyric acid (including when scheduled as an
approved drug product for purposes of section 3(a)(1)(B) of the
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act
of 2000)," after "schedule I or II," in first sentence.
Subsec. (b)(1)(D). Pub. L. 106-172, Sec. 3(b)(1)(B), substituted
"(other than gamma hydroxybutyric acid), or 30" for ", or 30".
Subsec. (b)(7)(A). Pub. L. 106-172, Sec. 5(b), inserted "or
controlled substance analogue" after "distributing a controlled
substance".
Subsecs. (c) to (g). Pub. L. 106-172, Sec. 9, redesignated
subsecs. (d) to (g) as (c) to (f), respectively.
1998 - Subsec. (b)(1). Pub. L. 105-277 in subpar. (A)(viii)
substituted "50 grams" and "500 grams" for "100 grams" and "1
kilogram", respectively, and in subpar. (B)(viii) substituted "5
grams" and "50 grams" for "10 grams" and "100 grams", respectively.
1996 - Subsec. (b)(1)(C). Pub. L. 104-305, Sec. 2(b)(1)(A),
inserted ", or 1 gram of flunitrazepam," after "schedule I or II".
Subsec. (b)(1)(D). Pub. L. 104-305, Sec. 2(b)(1)(B), inserted "or
30 milligrams of flunitrazepam," after "schedule III,".
Subsec. (b)(7). Pub. L. 104-305, Sec. 2(a), added par. (7).
Subsec. (d). Pub. L. 104-237, Sec. 302(a), in concluding
provisions, substituted "not more than 20 years in the case of a
violation of paragraph (1) or (2) involving a list I chemical or
not more than 10 years in the case of a violation of this
subsection other than a violation of paragraph (1) or (2) involving
a list I chemical," for "not more than 10 years,".
Subsec. (f). Pub. L. 104-237, Sec. 206(a), inserted "manufacture,
exportation," after "distribution," and struck out "regulated"
after "engaging in any".
1994 - Subsec. (b). Pub. L. 103-322, Sec. 180201(b)(2)(A),
inserted "849," before "859," in introductory provisions.
Subsec. (b)(1)(A). Pub. L. 103-322, Secs. 90105(c),
180201(b)(2)(A), in concluding provisions, inserted "849," before
"859," and struck out "For purposes of this subparagraph, the term
'felony drug offense' means an offense that is a felony under any
provision of this subchapter or any other Federal law that
prohibits or restricts conduct relating to narcotic drugs,
marihuana, or depressant or stimulant substances or a felony under
any law of a State or a foreign country that prohibits or restricts
conduct relating to narcotic drugs, marihuana, or depressant or
stimulant substances." before "Any sentence under this
subparagraph".
Subsec. (b)(1)(B). Pub. L. 103-322, Sec. 90105(a), in sentence in
concluding provisions beginning "If any person commits",
substituted "a prior conviction for a felony drug offense has
become final" for "one or more prior convictions for an offense
punishable under this paragraph, or for a felony under any other
provision of this subchapter or subchapter II of this chapter or
other law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or stimulant
substances, have become final".
Subsec. (b)(1)(C). Pub. L. 103-322, Sec. 90105(a), in sentence
beginning "If any person commits", substituted "a prior conviction
for a felony drug offense has become final" for "one or more prior
convictions for an offense punishable under this paragraph, or for
a felony under any other provision of this subchapter or subchapter
II of this chapter or other law of a State, the United States or a
foreign country relating to narcotic drugs, marihuana, or
depressant or stimulant substances, have become final".
Subsec. (b)(1)(D). Pub. L. 103-322, Sec. 90105(a), in sentence
beginning "If any person commits", substituted "a prior conviction
for a felony drug offense has become final" for "one or more prior
convictions of him for an offense punishable under this paragraph,
or for a felony under any other provision of this subchapter or
subchapter II of this chapter or other law of a State, the United
States, or a foreign country relating to narcotic drugs, marihuana,
or depressant or stimulant substances, have become final".
1990 - Subsec. (b). Pub. L. 101-647, Sec. 1002(e)(1), substituted
"section 859, 860, or 861" for "section 845, 845a, or 845b" in
introductory provisions.
Subsec. (b)(1)(A). Pub. L. 101-647, Sec. 1002(e)(1), substituted
"section 859, 860, or 861" for "section 845, 845a, or 845b" in
concluding provisions.
Subsec. (b)(1)(A)(ii)(IV). Pub. L. 101-647, Sec. 3599K,
substituted "any of the substances" for "any of the substance".
Subsec. (b)(1)(A)(viii). Pub. L. 101-647, Sec. 1202, substituted
"or 1 kilogram or more of a mixture or substance containing a
detectable amount of methamphetamine" for "or 100 grams or more of
a mixture or substance containing a detectable amount of
methamphetamine".
Subsec. (b)(1)(B)(ii)(IV). Pub. L. 101-647, Sec. 3599K,
substituted "any of the substances" for "any of the substance".
Subsec. (c). Pub. L. 101-647, Sec. 1002(e)(2), directed amendment
of subsec. (c) by substituting "section 859, 860, or 861 of this
title" for "section 845, 845a, or 845b of this title". Subsec. (c)
was previously repealed by Pub. L. 98-473, Sec. 224(a)(2), as
renumbered by Pub. L. 99-570, Sec. 1005(a), effective Nov. 1, 1987,
and applicable only to offenses committed after the taking effect
of such amendment. See 1984 Amendment note and Effective Date of
1984 Amendment note below.
1988 - Subsec. (b)(1)(A). Pub. L. 100-690, Secs. 6452(a),
6470(g), 6479(1), inserted ", or 1,000 or more marihuana plants
regardless of weight" in cl. (vii), added cl. (viii), substituted
"a prior conviction for a felony drug offense has become final" for
"one or more prior convictions for an offense punishable under this
paragraph, or for a felony under any other provision of this
subchapter or subchapter II of this chapter or other law of a
State, the United States, or a foreign country relating to narcotic
drugs, marihuana, or depressant or stimulant substances, have
become final" in second sentence, and added provisions relating to
sentencing for a person who violates this subpar. or section 485,
485a, or 485b of this title after two or more prior convictions for
a felony drug offense have become final and defining "felony drug
offense".
Subsec. (b)(1)(B). Pub. L. 100-690, Secs. 6470(h), 6479(2),
inserted ", or 100 or more marihuana plants regardless of weight"
in cl. (vii) and added cl. (viii).
Subsec. (b)(1)(D). Pub. L. 100-690, Sec. 6479(3), substituted "50
or more marihuana plants" for "100 or more marihuana plants".
Subsec. (b)(6). Pub. L. 100-690, Sec. 6254(h), added par. (6).
Subsec. (d). Pub. L. 100-690, Sec. 6055(a), amended subsec. (d)
generally. Prior to amendment, subsec. (d) read as follows: "Any
person who knowingly or intentionally -
"(1) possesses any piperidine with intent to manufacture
phencyclidine except as authorized by this subchapter, or
"(2) possesses any piperidine knowing, or having reasonable
cause to believe, that the piperidine will be used to manufacture
phencyclidine except as authorized by this subchapter,
shall be sentenced to a term of imprisonment of not more than 5
years, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18 or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is other
than an individual, or both."
Subsecs. (f), (g). Pub. L. 100-690, Sec. 6055(b), added subsecs.
(f) and (g).
1986 - Pub. L. 99-570, Sec. 1005(a), amended Pub. L. 98-473, Sec.
224(a). See 1984 Amendment note below.
Subsec. (b). Pub. L. 99-570, Sec. 1103(a), substituted ", 845a,
or 845b" for "or 845a" in introductory provisions.
Subsec. (b)(1)(A). Pub. L. 99-570, Sec. 1002(2), amended subpar.
(A) generally. Prior to amendment, subpar. (A) read as follows: "In
the case of a violation of subsection (a) of this section involving
-
"(i) 100 grams or more of a controlled substance in schedule I
or II which is a mixture or substance containing a detectable
amount of a narcotic drug other than a narcotic drug consisting
of -
"(I) coca leaves;
"(II) a compound, manufacture, salt, derivative, or
preparation of coca leaves; or
"(III) a substance chemically identical thereto;
"(ii) a kilogram or more of any other controlled substance in
schedule I or II which is a narcotic drug;
"(iii) 500 grams or more of phencyclidine (PCP); or
"(iv) 5 grams or more of lysergic acid diethylamide (LSD);
such person shall be sentenced to a term of imprisonment of not
more than 20 years, a fine of not more than $250,000, or both. If
any person commits such a violation after one or more prior
convictions of him for an offense punishable under this paragraph,
or for a felony under any other provision of this subchapter or
subchapter II of this chapter or other law of a State, the United
States, or a foreign country relating to narcotic drugs, marihuana,
or depressant or stimulant substances, have become final, such
person shall be sentenced to a term of imprisonment of not more
than 40 years, a fine of not more than $500,000, or both".
Subsec. (b)(1)(B). Pub. L. 99-570, Sec. 1002(2), amended subpar.
(B) generally. Prior to amendment, subpar. (B) read as follows: "In
the case of a controlled substance in schedule I or II except as
provided in subparagraphs (A) and (C),, such person shall be
sentenced to a term of imprisonment of not more than 15 years, a
fine of not more than $125,000, or both. If any person commits such
a violation after one or more prior convictions of him for an
offense punishable under this paragraph, or for a felony under any
other provision of this subchapter or subchapter II of this chapter
or other law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or stimulant
substances, have become final, such person shall be sentenced to a
term of imprisonment of not more than 30 years, a fine of not more
than $250,000, or both. Any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a
prior conviction, impose a special parole term of at least 3 years
in addition to such term of imprisonment and shall, if there was
such a prior conviction, impose a special parole term of at least 6
years in addition to such term of imprisonment."
Subsec. (b)(1)(C). Pub. L. 99-570, Sec. 1002(2), added subpar.
(C). Former subpar. (C) redesignated (D).
Subsec. (b)(1)(D). Pub. L. 99-570, Sec. 1004(a), substituted
"term of supervised release" for "special parole term" in two
places.
Pub. L. 99-570, Secs. 1002(1), 1003(a)(1), redesignated former
subpar. (C) as (D), substituted "a fine not to exceed the greater
of that authorized in accordance with the provisions of title 18 or
$250,000 if the defendant is an individual or $1,000,000 if the
defendant is other than an individual" for "a fine of not more than
$50,000" and "a fine not to exceed the greater of twice that
authorized in accordance with the provisions of title 18 or
$500,000 if the defendant is an individual or $2,000,000 if the
defendant is other than an individual" for "a fine of not more than
$100,000", and inserted "except in the case of 100 or more
marihuana plants regardless of weight,".
Subsec. (b)(2). Pub. L. 99-570, Sec. 1004(a), substituted "term
of supervised release" for "special parole term" in two places.
Pub. L. 99-570, Sec. 1003(a)(2), substituted "a fine not to
exceed the greater of that authorized in accordance with the
provisions of title 18 or $250,000 if the defendant is an
individual or $1,000,000 if the defendant is other than an
individual" for "a fine of not more than $25,000" and "a fine not
to exceed the greater of twice that authorized in accordance with
the provisions of title 18 or $500,000 if the defendant is an
individual or $2,000,000 if the defendant is other than an
individual" for "a fine of not more than $50,000".
Subsec. (b)(3). Pub. L. 99-570, Sec. 1003(a)(3), substituted "a
fine not to exceed the greater of that authorized in accordance
with the provisions of title 18 or $100,000 if the defendant is an
individual or $250,000 if the defendant is other than an
individual" for "a fine of not more than $10,000" and "a fine not
to exceed the greater of twice that authorized in accordance with
the provisions of title 18 or $200,000 if the defendant is an
individual or $500,000 if the defendant is other than an
individual" for "a fine of not more than $20,000".
Subsec. (b)(4). Pub. L. 99-570, Sec. 1003(a)(4), which directed
the substitution of "1(D)" for "1(C)" was executed by substituting
"(1)(D)" for "(1)(C)" as the probable intent of Congress.
Subsec. (b)(5). Pub. L. 99-570, Sec. 1003(a)(5), amended par. (5)
generally. Prior to amendment, par. (5) read as follows:
"Notwithstanding paragraph (1), any person who violates subsection
(a) of this section by cultivating a controlled substance on
Federal property shall be fined not more than -
"(A) $500,000 if such person is an individual; and
"(B) $1,000,000 if such person is not an individual."
Subsec. (c). Pub. L. 99-570, Sec. 1004(a), substituted "term of
supervised release" for "special parole term" wherever appearing,
effective Nov. 1, 1987, the effective date of the repeal of subsec.
(c) by Pub. L. 98-473, Sec. 224(a)(2). See 1984 Amendment note
below.
Pub. L. 99-570, Sec. 1103(b), substituted ", 845a, or 845b" for
"845a" in two places.
Subsec. (d). Pub. L. 99-570, Sec. 1003(a)(6), substituted "a fine
not to exceed the greater of that authorized in accordance with the
provisions of title 18 or $250,000 if the defendant is an
individual or $1,000,000 if the defendant is other than an
individual" for "a fine of not more than $15,000".
Subsec. (e). Pub. L. 99-570, Sec. 15005, added subsec. (e).
1984 - Subsec. (b). Pub. L. 98-473, Sec. 503(b)(1), inserted
reference to section 845a of this title in provisions preceding
par. (1)(A).
Pub. L. 98-473, Sec. 224(a)(1)-(3), (5), which directed amendment
of this subsection effective Nov. 1, 1987 (see section 235(a)(1) of
Pub. L. 98-473 set out as an Effective Date note under section 3551
of Title 18, Crimes and Criminal Procedure) was repealed by Pub. L.
99-570, Sec. 1005(a), and the remaining pars. (4) and (6) of Pub.
L. 98-473, Sec. 224(a), were redesignated as pars. (1) and (2),
respectively.
Subsec. (b)(1)(A). Pub. L. 98-473, Sec. 502(1)(A), added subpar.
(A). Former subpar. (A) redesignated (B).
Subsec. (b)(1)(B). Pub. L. 98-473, Sec. 502(1)(A), (B),
redesignated former subpar. (A) as (B), substituted "except as
provided in subparagraphs (A) and (C)," for "which is a narcotic
drug", "$125,000" for "$25,000", and "$250,000" for "$50,000", and
inserted references to laws of a State and a foreign country.
Former subpar. (B) redesignated (C).
Subsec. (b)(1)(C). Pub. L. 98-473, Sec. 502(1)(A), (C),
redesignated former subpar. (B) as (C), substituted "less than 50
kilograms of marihuana, 10 kilograms of hashish, or one kilogram of
hashish oil" for "a controlled substance in schedule I or II which
is not a narcotic drug", "and (5)" for ", (5), and (6)", "$50,000"
for "$15,000", and "$100,000" for "$30,000", and inserted
references to laws of a State and a foreign country.
Subsec. (b)(2). Pub. L. 98-473, Sec. 502(2), substituted
"$25,000" for "$10,000" and "$50,000" for "$20,000", and inserted
references to laws of a State or of a foreign country.
Subsec. (b)(3). Pub. L. 98-473, Sec. 502(3), substituted
"$10,000" for "$5,000" and "$20,000" for "$10,000", and inserted
references to laws of a State or of a foreign country.
Subsec. (b)(4). Pub. L. 98-473, Sec. 502(4), substituted "(1)(C)"
for "(1)(B)".
Pub. L. 98-473, Sec. 224(a)(1), as renumbered by Pub. L. 99-570,
Sec. 1005(a), substituted "in section 844 of this title and section
3607 of title 18" for "in subsections (a) and (b) of section 844 of
this title".
Subsec. (b)(5). Pub. L. 98-473, Sec. 502(5), (6), added par. (5)
and struck out former par. (5) which related to penalties for
manufacturing, etc., phencyclidine.
Subsec. (b)(6). Pub. L. 98-473, Sec. 502(5), struck out par. (6)
which related to penalties for violations involving a quantity of
marihuana exceeding 1,000 pounds.
Subsec. (c). Pub. L. 98-473, Sec. 224(a)(2), as renumbered by
Pub. L. 99-570, Sec. 1005(a), struck out subsec. (c) which read as
follows: "A special parole term imposed under this section or
section 845, 845a, or 845b of this title may be revoked if its
terms and conditions are violated. In such circumstances the
original term of imprisonment shall be increased by the period of
the special parole term and the resulting new term of imprisonment
shall not be diminished by the time which was spent on special
parole. A person whose special parole term has been revoked may be
required to serve all or part of the remainder of the new term of
imprisonment. A special parole term provided for in this section or
section 845, 845a, or 845b of this title shall be in addition to,
and not in lieu of, any other parole provided for by law."
Pub. L. 98-473, Sec. 503(b)(2), inserted reference to section
845a of this title in two places.
1980 - Subsec. (b)(1)(B). Pub. L. 96-359, Sec. 8(c)(1), inserted
reference to par. (6) of this subsection.
Subsec. (b)(6). Pub. L. 96-359, Sec. 8(c)(2), added par. (6).
1978 - Subsec. (b)(1)(B). Pub. L. 95-633, Sec. 201(1), inserted
", except as provided in paragraphs (4) and (5) of this
subsection," after "such person shall".
Subsec. (b)(5). Pub. L. 95-633, Sec. 201(2), added par. (5).
Subsec. (d). Pub. L. 95-633, Sec. 201(3), added subsec. (d).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by section 6055 of Pub. L. 100-690 effective 120 days
after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set out
as a note under section 802 of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Section 1004(b) of Pub. L. 99-570 provided that: "The amendments
made by this section [amending this section and sections 845, 845a,
960, and 962 of this title] shall take effect on the date of the
taking effect of section 3583 of title 18, United States Code [Nov.
1, 1987]."
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by section 224(a) of Pub. L. 98-473 effective Nov. 1,
1987, and applicable only to offenses committed after the taking
effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
set out as an Effective Date note under section 3551 of Title 18,
Crimes and Criminal Procedure.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
203(a) of Pub. L. 95-633 set out as an Effective Date note under
section 830 of this title.
REPEALS
Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
repealed section 203(d) of Pub. L. 95-633, which had provided for
the repeal of subsec. (d) of this section effective Jan. 1, 1981.
-FOOTNOTE-
(!1) So in original. Probably should be "health".
-End-
-CITE-
21 USC Sec. 842 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 842. Prohibited acts B
-STATUTE-
(a) Unlawful acts
It shall be unlawful for any person -
(1) who is subject to the requirements of part C to distribute
or dispense a controlled substance in violation of section 829 of
this title;
(2) who is a registrant to distribute or dispense a controlled
substance not authorized by his registration to another
registrant or other authorized person or to manufacture a
controlled substance not authorized by his registration;
(3) who is a registrant to distribute a controlled substance in
violation of section 825 of this title;
(4) to remove, alter, or obliterate a symbol or label required
by section 825 of this title;
(5) to refuse or negligently fail to make, keep, or furnish any
record, report, notification, declaration, order or order form,
statement, invoice, or information required under this subchapter
or subchapter II of this chapter;
(6) to refuse any entry into any premises or inspection
authorized by this subchapter or subchapter II of this chapter;
(7) to remove, break, injure, or deface a seal placed upon
controlled substances pursuant to section 824(f) or 881 of this
title or to remove or dispose of substances so placed under seal;
(8) to use, to his own advantage, or to reveal, other than to
duly authorized officers or employees of the United States, or to
the courts when relevant in any judicial proceeding under this
subchapter or subchapter II of this chapter, any information
acquired in the course of an inspection authorized by this
subchapter concerning any method or process which as a trade
secret is entitled to protection, or to use to his own advantage
or reveal (other than as authorized by section 830 of this title)
any information that is confidential under such section;
(9) who is a regulated person to engage in a regulated
transaction without obtaining the identification required by
830(a)(3) of this title.(!1)
(10) negligently to fail to keep a record or make a report
under section 830 of this title;
(11) to distribute a laboratory supply to a person who uses, or
attempts to use, that laboratory supply to manufacture a
controlled substance or a listed chemical, in violation of this
subchapter or subchapter II of this chapter, with reckless
disregard for the illegal uses to which such a laboratory supply
will be put;
(12) who is a regulated seller, or a distributor required to
submit reports under subsection (b)(3) of section 830 of this
title -
(A) to sell at retail a scheduled listed chemical product in
violation of paragraph (1) of subsection (d) of such section,
knowing at the time of the transaction involved (independent of
consulting the logbook under subsection (e)(1)(A)(iii) of such
section) that the transaction is a violation; or
(B) to knowingly or recklessly sell at retail such a product
in violation of paragraph (2) of such subsection (d);
(13) who is a regulated seller to knowingly or recklessly sell
at retail a scheduled listed chemical product in violation of
subsection (e) of such section; or
(14) who is a regulated seller or an employee or agent of such
seller to disclose, in violation of regulations under
subparagraph (C) of section 830(e)(1) of this title, information
in logbooks under subparagraph (A)(iii) of such section, or to
refuse to provide such a logbook to Federal, State, or local law
enforcement authorities.
As used in paragraph (11), the term "laboratory supply" means a
listed chemical or any chemical, substance, or item on a special
surveillance list published by the Attorney General, which contains
chemicals, products, materials, or equipment used in the
manufacture of controlled substances and listed chemicals. For
purposes of paragraph (11), there is a rebuttable presumption of
reckless disregard at trial if the Attorney General notifies a firm
in writing that a laboratory supply sold by the firm, or any other
person or firm, has been used by a customer of the notified firm,
or distributed further by that customer, for the unlawful
production of controlled substances or listed chemicals a firm
distributes and 2 weeks or more after the notification the notified
firm distributes a laboratory supply to the customer.
(b) Manufacture
It shall be unlawful for any person who is a registrant to
manufacture a controlled substance in schedule I or II, or
ephedrine, pseudoephedrine, or phenylpropanolamine or any of the
salts, optical isomers, or salts of optical isomers of such
chemical, which is -
(1) not expressly authorized by his registration and by a quota
assigned to him pursuant to section 826 of this title; or
(2) in excess of a quota assigned to him pursuant to section
826 of this title.
(c) Penalties
(1)(A) Except as provided in subparagraph (B) of this paragraph
and paragraph (2), any person who violates this section shall, with
respect to any such violation, be subject to a civil penalty of not
more than $25,000. The district courts of the United States (or,
where there is no such court in the case of any territory or
possession of the United States, then the court in such territory
or possession having the jurisdiction of a district court of the
United States in cases arising under the Constitution and laws of
the United States) shall have jurisdiction in accordance with
section 1355 of title 28 to enforce this paragraph.
(B) In the case of a violation of paragraph (5) or (10) of
subsection (a) of this section, the civil penalty shall not exceed
$10,000.
(2)(A) If a violation of this section is prosecuted by an
information or indictment which alleges that the violation was
committed knowingly and the trier of fact specifically finds that
the violation was so committed, such person shall, except as
otherwise provided in subparagraph (B) of this paragraph, be
sentenced to imprisonment of not more than one year or a fine under
title 18, or both.
(B) If a violation referred to in subparagraph (A) was committed
after one or more prior convictions of the offender for an offense
punishable under this paragraph (2), or for a crime under any other
provision of this subchapter or subchapter II of this chapter or
other law of the United States relating to narcotic drugs,
marihuana, or depressant or stimulant substances, have become
final, such person shall be sentenced to a term of imprisonment of
not more than 2 years, a fine under title 18, or both.
(C) In addition to the penalties set forth elsewhere in this
subchapter or subchapter II of this chapter, any business that
violates paragraph (11) of subsection (a) of this section shall,
with respect to the first such violation, be subject to a civil
penalty of not more than $250,000, but shall not be subject to
criminal penalties under this section, and shall, for any
succeeding violation, be subject to a civil fine of not more than
$250,000 or double the last previously imposed penalty, whichever
is greater.
(3) Except under the conditions specified in paragraph (2) of
this subsection, a violation of this section does not constitute a
crime, and a judgment for the United States and imposition of a
civil penalty pursuant to paragraph (1) shall not give rise to any
disability or legal disadvantage based on conviction for a criminal
offense.
(4)(A) If a regulated seller, or a distributor required to submit
reports under section 830(b)(3) of this title, violates paragraph
(12) of subsection (a) of this section, or if a regulated seller
violates paragraph (13) of such subsection, the Attorney General
may by order prohibit such seller or distributor (as the case may
be) from selling any scheduled listed chemical product. Any sale of
such a product in violation of such an order is subject to the same
penalties as apply under paragraph (2).
(B) An order under subparagraph (A) may be imposed only through
the same procedures as apply under section 824(c) of this title for
an order to show cause.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 402, Oct. 27, 1970, 84 Stat. 1262;
Pub. L. 95-633, title II, Sec. 202(b)(1), (2), Nov. 10, 1978, 92
Stat. 3776; Pub. L. 100-690, title VI, Sec. 6056, Nov. 18, 1988,
102 Stat. 4318; Pub. L. 104-237, title II, Sec. 205, Oct. 3, 1996,
110 Stat. 3103; Pub. L. 105-277, div. A, Sec. 101(b) [title I, Sec.
117], Oct. 21, 1998, 112 Stat. 2681-50, 2681-68; Pub. L. 107-273,
div. B, title IV, Sec. 4002(b)(16), (d)(2)(B), Nov. 2, 2002, 116
Stat. 1808, 1809; Pub. L. 109-177, title VII, Secs. 711(f)(1)(A),
(2), 714, Mar. 9, 2006, 120 Stat. 262-264.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I and II, referred to in subsec. (b), are set out in
section 812(c) of this title.
-MISC1-
AMENDMENTS
2006 - Subsec. (a)(12) to (14). Pub. L. 109-177, Sec.
711(f)(1)(A), added pars. (12) to (14).
Subsec. (b). Pub. L. 109-177, Sec. 714, inserted ", or ephedrine,
pseudoephedrine, or phenylpropanolamine or any of the salts,
optical isomers, or salts of optical isomers of such chemical,"
after "manufacture a controlled substance in schedule I or II" in
introductory provisions.
Subsec. (c)(4). Pub. L. 109-177, Sec. 711(f)(2), added par. (4).
2002 - Subsec. (c)(2)(A). Pub. L. 107-273, Sec. 4002(d)(2)(B)(i),
substituted "under title 18" for "of not more than $25,000".
Subsec. (c)(2)(B). Pub. L. 107-273, Sec. 4002(d)(2)(B)(ii),
substituted "under title 18" for "of $50,000".
Subsec. (c)(2)(C). Pub. L. 107-273, Sec. 4002(b)(16), realigned
margins.
1998 - Subsec. (a)(5). Pub. L. 105-277, Sec. 101(b) [title I,
Sec. 117(1)], inserted "negligently" before "fail".
Subsec. (a)(10). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
117(2)], inserted "negligently" before "to fail".
Subsec. (c)(1). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
117(3)], designated existing provisions as subpar. (A), inserted
"subparagraph (B) of this paragraph and" before "paragraph (2)",
and added subpar. (B).
1996 - Subsec. (a). Pub. L. 104-237, Sec. 205(a), added par. (11)
and closing provisions.
Subsec. (c)(2)(C). Pub. L. 104-237, Sec. 205(b), added subpar.
(C).
1988 - Subsec. (a)(8). Pub. L. 100-690, Sec. 6056(a), inserted ",
or to use to his own advantage or reveal (other than as authorized
by section 830 of this title) any information that is confidential
under such section" after "protection".
Subsec. (a)(9). Pub. L. 100-690, Sec. 6056(b), amended par. (9)
generally. Prior to amendment, par. (9) read as follows: "to
distribute or sell piperidine in violation of regulations
established under section 830(a)(2) of this title, respecting
presentation of identification."
Subsec. (a)(10). Pub. L. 100-690, Sec. 6056(d), added par. (10).
Subsec. (c)(2)(C). Pub. L. 100-690, Sec. 6056(c), struck out
subpar. (C) which read as follows: "Subparagraphs (A) and (B) shall
not apply to a violation of subsection (a)(5) of this section with
respect to a refusal or failure to make a report required under
section 830(a) of this title (relating to piperidine reporting)."
1978 - Subsec. (a)(9). Pub. L. 95-633, Sec. 202(b)(1), added par.
(9).
Subsec. (c)(2)(C). Pub. L. 95-633, Sec. 202(b)(2), added subpar.
(C).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
203(a) of Pub. L. 95-633 set out as an Effective Date note under
section 830 of this title.
REPEALS
Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
repealed section 203(d) of Pub. L. 95-633, which had provided for
the repeal of subsecs. (a)(9) and (c)(2)(C) of this section
effective Jan. 1, 1981.
-FOOTNOTE-
(!1) So in original. Probably should be "section 830(a)(3) of
this title;".
-End-
-CITE-
21 USC Sec. 843 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 843. Prohibited acts C
-STATUTE-
(a) Unlawful acts
It shall be unlawful for any person knowingly or intentionally -
(1) who is a registrant to distribute a controlled substance
classified in schedule I or II, in the course of his legitimate
business, except pursuant to an order or an order form as
required by section 828 of this title;
(2) to use in the course of the manufacture, distribution, or
dispensing of a controlled substance, or to use for the purpose
of acquiring or obtaining a controlled substance, a registration
number which is fictitious, revoked, suspended, expired, or
issued to another person;
(3) to acquire or obtain possession of a controlled substance
by misrepresentation, fraud, forgery, deception, or subterfuge;
(4)(A) to furnish false or fraudulent material information in,
or omit any material information from, any application, report,
record, or other document required to be made, kept, or filed
under this subchapter or subchapter II of this chapter, or (B) to
present false or fraudulent identification where the person is
receiving or purchasing a listed chemical and the person is
required to present identification under section 830(a) of this
title;
(5) to make, distribute, or possess any punch, die, plate,
stone, or other thing designed to print, imprint, or reproduce
the trademark, trade name, or other identifying mark, imprint, or
device of another or any likeness of any of the foregoing upon
any drug or container or labeling thereof so as to render such
drug a counterfeit substance;
(6) to possess any three-neck round-bottom flask, tableting
machine, encapsulating machine, or gelatin capsule, or any
equipment, chemical, product, or material which may be used to
manufacture a controlled substance or listed chemical, knowing,
intending, or having reasonable cause to believe, that it will be
used to manufacture a controlled substance or listed chemical in
violation of this subchapter or subchapter II of this chapter;
(7) to manufacture, distribute, export, or import any three-
neck round-bottom flask, tableting machine, encapsulating
machine, or gelatin capsule, or any equipment, chemical, product,
or material which may be used to manufacture a controlled
substance or listed chemical, knowing, intending, or having
reasonable cause to believe, that it will be used to manufacture
a controlled substance or listed chemical in violation of this
subchapter or subchapter II of this chapter or, in the case of an
exportation, in violation of this subchapter or subchapter II of
this chapter or of the laws of the country to which it is
exported;
(8) to create a chemical mixture for the purpose of evading a
requirement of section 830 of this title or to receive a chemical
mixture created for that purpose; or
(9) to distribute, import, or export a list I chemical without
the registration required by this subchapter or subchapter II of
this chapter.
(b) Communication facility
It shall be unlawful for any person knowingly or intentionally to
use any communication facility in committing or in causing or
facilitating the commission of any act or acts constituting a
felony under any provision of this subchapter or subchapter II of
this chapter. Each separate use of a communication facility shall
be a separate offense under this subsection. For purposes of this
subsection, the term "communication facility" means any and all
public and private instrumentalities used or useful in the
transmission of writing, signs, signals, pictures, or sounds of all
kinds and includes mail, telephone, wire, radio, and all other
means of communication.
(c) Advertisement
It shall be unlawful for any person to place in any newspaper,
magazine, handbill, or other publications, any written
advertisement knowing that it has the purpose of seeking or
offering illegally to receive, buy, or distribute a Schedule (!1) I
controlled substance. As used in this section the term
"advertisement" includes, in addition to its ordinary meaning, such
advertisements as those for a catalog of Schedule (!1) I controlled
substances and any similar written advertisement that has the
purpose of seeking or offering illegally to receive, buy, or
distribute a Schedule (!1) I controlled substance. The term
"advertisement" does not include material which merely advocates
the use of a similar material, which advocates a position or
practice, and does not attempt to propose or facilitate an actual
transaction in a Schedule (!1) I controlled substance.
(d) Penalties
(1) Except as provided in paragraph (2), any person who violates
this section shall be sentenced to a term of imprisonment of not
more than 4 years, a fine under title 18, or both; except that if
any person commits such a violation after one or more prior
convictions of him for violation of this section, or for a felony
under any other provision of this subchapter or subchapter II of
this chapter or other law of the United States relating to narcotic
drugs, marihuana, or depressant or stimulant substances, have
become final, such person shall be sentenced to a term of
imprisonment of not more than 8 years, a fine under title 18, or
both.
(2) Any person who, with the intent to manufacture or to
facilitate the manufacture of methamphetamine, violates paragraph
(6) or (7) of subsection (a) of this section, shall be sentenced to
a term of imprisonment of not more than 10 years, a fine under
title 18, or both; except that if any person commits such a
violation after one or more prior convictions of that person -
(A) for a violation of paragraph (6) or (7) of subsection (a)
of this section;
(B) for a felony under any other provision of this subchapter
or subchapter II of this chapter; or
(C) under any other law of the United States or any State
relating to controlled substances or listed chemicals,
has become final, such person shall be sentenced to a term of
imprisonment of not more than 20 years, a fine under title 18, or
both.
(e) Additional penalties
In addition to any other applicable penalty, any person convicted
of a felony violation of this section relating to the receipt,
distribution, manufacture, exportation, or importation of a listed
chemical may be enjoined from engaging in any transaction involving
a listed chemical for not more than ten years.
(f) Injunctions
(1) In addition to any penalty provided in this section, the
Attorney General is authorized to commence a civil action for
appropriate declaratory or injunctive relief relating to violations
of this section, section 842 of this title, or 856 (!2) of this
title.
(2) Any action under this subsection may be brought in the
district court of the United States for the district in which the
defendant is located or resides or is doing business.
(3) Any order or judgment issued by the court pursuant to this
subsection shall be tailored to restrain violations of this section
or section 842 of this title.
(4) The court shall proceed as soon as practicable to the hearing
and determination of such an action. An action under this
subsection is governed by the Federal Rules of Civil Procedure
except that, if an indictment has been returned against the
respondent, discovery is governed by the Federal Rules of Criminal
Procedure.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 403, Oct. 27, 1970, 84 Stat. 1263;
Pub. L. 95-633, title II, Sec. 202(b)(3), Nov. 10, 1978, 92 Stat.
3776; Pub. L. 98-473, title II, Sec. 516, Oct. 12, 1984, 98 Stat.
2074; Pub. L. 99-570, title I, Sec. 1866(a), Oct. 27, 1986, 100
Stat. 3207-54; Pub. L. 100-690, title VI, Sec. 6057, Nov. 18, 1988,
102 Stat. 4319; Pub. L. 103-200, Sec. 3(g), Dec. 17, 1993, 107
Stat. 2337; Pub. L. 103-322, title IX, Sec. 90106, Sept. 13, 1994,
108 Stat. 1988; Pub. L. 104-237, title II, Secs. 203(a), 206(b),
Oct. 3, 1996, 110 Stat. 3102, 3103; Pub. L. 107-273, div. B, title
IV, Sec. 4002(d)(2)(C), Nov. 2, 2002, 116 Stat. 1810; Pub. L. 108-
21, title VI, Sec. 608(d), Apr. 30, 2003, 117 Stat. 691.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I and II, referred to in subsecs. (a)(1) and (c), are
set out in section 812(c) of this title.
The Federal Rules of Civil Procedure, referred to in subsec.
(f)(4), are set out in the Appendix to Title 28, Judiciary and
Judicial Procedure.
The Federal Rules of Criminal Procedure, referred to in subsec.
(f)(4), are set out in the Appendix to Title 18, Crimes and
Criminal Procedure.
-MISC1-
AMENDMENTS
2003 - Subsec. (f)(1). Pub. L. 108-21 substituted "this section,
section 842 of this title, or 856 of this title" for "this section
or section 842 of this title".
2002 - Subsec. (d). Pub. L. 107-273 substituted "under title 18,
or both;" for "of not more than $30,000, or both;" in two places
and "under title 18, or both." for "of not more than $60,000, or
both." in two places.
1996 - Subsec. (d). Pub. L. 104-237, Sec. 203(a), inserted par.
(1) designation, substituted "Except as provided in paragraph (2),
any person" for "Any person", and added par. (2).
Subsec. (e). Pub. L. 104-237, Sec. 206(b)(1), inserted
"manufacture, exportation," after "distribution," and struck out
"regulated" after "engaging in any".
Subsec. (f). Pub. L. 104-237, Sec. 206(b)(2), added subsec. (f).
1994 - Subsecs. (c) to (e). Pub. L. 103-322 added subsec. (c) and
redesignated former subsecs. (c) and (d) as (d) and (e),
respectively.
1993 - Subsec. (a)(6), (7). Pub. L. 103-200, Sec. 3(g)(1),
amended pars. (6) and (7) generally. Prior to amendment, pars. (6)
and (7) read as follows:
"(6) to possess any three-neck round-bottom flask, tableting
machine, encapsulating machine, gelatin capsule, or equipment
specially designed or modified to manufacture a controlled
substance, with intent to manufacture a controlled substance except
as authorized by this subchapter;
"(7) to manufacture, distribute, or import any three-neck round-
bottom flask, tableting machine, encapsulating machine, gelatin
capsule, or equipment specially designed or modified to manufacture
a controlled substance, knowing that it will be used to manufacture
a controlled substance except as authorized by this subchapter;
or".
Subsec. (a)(9). Pub. L. 103-200, Sec. 3(g)(2), (3), added par.
(9).
1988 - Subsec. (a)(4)(B). Pub. L. 100-690, Sec. 6057(a)(1),
substituted "a listed chemical" for "piperidine".
Subsec. (a)(6) to (8). Pub. L. 100-690, Sec. 6057(a)(2)-(4),
added pars. (6) to (8).
Subsec. (d). Pub. L. 100-690, Sec. 6057(b), added subsec. (d).
1986 - Subsec. (a)(2). Pub. L. 99-570 substituted a semicolon for
the period at end.
1984 - Subsec. (a)(2). Pub. L. 98-473 added applicability to
dispensing, acquiring, or obtaining a controlled substance, and
applicability to an expired number.
1978 - Subsec. (a)(4). Pub. L. 95-633, Sec. 202(b)(3), designated
existing provisions as subpar. (A) and added subpar. (B).
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, except as
otherwise provided, see section 203(a) of Pub. L. 95-633, set out
as an Effective Date note under section 830 of this title.
REPEALS
Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
repealed section 203(d) of Pub. L. 95-633, which had provided for
the repeal of subsec. (a)(4)(B) of this section effective Jan. 1,
1981.
-FOOTNOTE-
(!1) So in original. Probably should not be capitalized.
(!2) So in original. Probably should be preceded by "section".
-End-
-CITE-
21 USC Sec. 844 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 844. Penalties for simple possession
-STATUTE-
(a) Unlawful acts; penalties
It shall be unlawful for any person knowingly or intentionally to
possess a controlled substance unless such substance was obtained
directly, or pursuant to a valid prescription or order, from a
practitioner, while acting in the course of his professional
practice, or except as otherwise authorized by this subchapter or
subchapter II of this chapter. It shall be unlawful for any person
knowingly or intentionally to possess any list I chemical obtained
pursuant to or under authority of a registration issued to that
person under section 823 of this title or section 958 of this title
if that registration has been revoked or suspended, if that
registration has expired, or if the registrant has ceased to do
business in the manner contemplated by his registration. It shall
be unlawful for any person to knowingly or intentionally purchase
at retail during a 30 day period more than 9 grams of ephedrine
base, pseudoephedrine base, or phenylpropanolamine base in a
scheduled listed chemical product, except that, of such 9 grams,
not more than 7.5 grams may be imported by means of shipping
through any private or commercial carrier or the Postal Service.
Any person who violates this subsection may be sentenced to a term
of imprisonment of not more than 1 year, and shall be fined a
minimum of $1,000, or both, except that if he commits such offense
after a prior conviction under this subchapter or subchapter II of
this chapter, or a prior conviction for any drug, narcotic, or
chemical offense chargeable under the law of any State, has become
final, he shall be sentenced to a term of imprisonment for not less
than 15 days but not more than 2 years, and shall be fined a
minimum of $2,500, except, further, that if he commits such offense
after two or more prior convictions under this subchapter or
subchapter II of this chapter, or two or more prior convictions for
any drug, narcotic, or chemical offense chargeable under the law of
any State, or a combination of two or more such offenses have
become final, he shall be sentenced to a term of imprisonment for
not less than 90 days but not more than 3 years, and shall be fined
a minimum of $5,000. Notwithstanding the preceding sentence, a
person convicted under this subsection for the possession of a
mixture or substance which contains cocaine base shall be
imprisoned not less than 5 years and not more than 20 years, and
fined a minimum of $1,000, if the conviction is a first conviction
under this subsection and the amount of the mixture or substance
exceeds 5 grams, if the conviction is after a prior conviction for
the possession of such a mixture or substance under this subsection
becomes final and the amount of the mixture or substance exceeds 3
grams, or if the conviction is after 2 or more prior convictions
for the possession of such a mixture or substance under this
subsection become final and the amount of the mixture or substance
exceeds 1 gram. Notwithstanding any penalty provided in this
subsection, any person convicted under this subsection for the
possession of flunitrazepam shall be imprisoned for not more than 3
years, shall be fined as otherwise provided in this section, or
both. The imposition or execution of a minimum sentence required to
be imposed under this subsection shall not be suspended or
deferred. Further, upon conviction, a person who violates this
subsection shall be fined the reasonable costs of the investigation
and prosecution of the offense, including the costs of prosecution
of an offense as defined in sections 1918 and 1920 of title 28,
except that this sentence shall not apply and a fine under this
section need not be imposed if the court determines under the
provision of title 18 that the defendant lacks the ability to pay.
(b) Repealed. Pub. L. 98-473, title II, Sec. 219(a), Oct. 12, 1984,
98 Stat. 2027
(c) "Drug, narcotic, or chemical offense" defined
As used in this section, the term "drug, narcotic, or chemical
offense" means any offense which proscribes the possession,
distribution, manufacture, cultivation, sale, transfer, or the
attempt or conspiracy to possess, distribute, manufacture,
cultivate, sell or transfer any substance the possession of which
is prohibited under this subchapter.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 404, Oct. 27, 1970, 84 Stat. 1264;
Pub. L. 98-473, title II, Sec. 219, Oct. 12, 1984, 98 Stat. 2027;
Pub. L. 99-570, title I, Sec. 1052, Oct. 27, 1986, 100 Stat. 3207-
8; Pub. L. 100-690, title VI, Secs. 6371, 6480, Nov. 18, 1988, 102
Stat. 4370, 4382; Pub. L. 101-647, title XII, Sec. 1201, title XIX,
Sec. 1907, Nov. 29, 1990, 104 Stat. 4829, 4854; Pub. L. 104-237,
title II, Sec. 201(a), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 104-
305, Sec. 2(c), Oct. 13, 1996, 110 Stat. 3808; Pub. L. 109-177,
title VII, Sec. 711(e)(1), Mar. 9, 2006, 120 Stat. 262.)
-MISC1-
AMENDMENTS
2006 - Subsec. (a). Pub. L. 109-177 inserted after second
sentence "It shall be unlawful for any person to knowingly or
intentionally purchase at retail during a 30 day period more than 9
grams of ephedrine base, pseudoephedrine base, or
phenylpropanolamine base in a scheduled listed chemical product,
except that, of such 9 grams, not more than 7.5 grams may be
imported by means of shipping through any private or commercial
carrier or the Postal Service."
1996 - Subsec. (a). Pub. L. 104-305 inserted "Notwithstanding any
penalty provided in this subsection, any person convicted under
this subsection for the possession of flunitrazepam shall be
imprisoned for not more than 3 years, shall be fined as otherwise
provided in this section, or both." after "mixture or substance
exceeds 1 gram."
Pub. L. 104-237, Sec. 201(a)(1), inserted after first sentence
"It shall be unlawful for any person knowingly or intentionally to
possess any list I chemical obtained pursuant to or under authority
of a registration issued to that person under section 823 of this
title or section 958 of this title if that registration has been
revoked or suspended, if that registration has expired, or if the
registrant has ceased to do business in the manner contemplated by
his registration." and substituted "drug, narcotic, or chemical"
for "drug or narcotic" in two places.
Subsec. (c). Pub. L. 104-237, Sec. 201(a)(2), substituted "drug,
narcotic, or chemical" for "drug or narcotic".
1990 - Subsec. (a). Pub. L. 101-647, Sec. 1907, inserted subsec.
(a) designation.
Pub. L. 101-647, Sec. 1201, substituted "shall be imprisoned not
less than 5 years and not more than 20 years, and fined a minimum
of $1,000" for "shall be fined under title 18 or imprisoned not
less than 5 years and not more than 20 years, or both".
1988 - Subsec. (a). Pub. L. 100-690, Sec. 6480(1)(A)-(C), struck
out "but not more than $5,000" after "$1,000", "but not more than
$10,000" after "$2,500", and "but not more than $25,000" after
"$5,000" in second sentence.
Pub. L. 100-690, Sec. 6371, inserted provisions relating to
increased penalties in cases of certain serious crack possession
offenses, making offenders subject to fines under title 18 or
imprisonment to terms not less than 5 years nor more than 20 years,
or both.
1986 - Subsec. (a). Pub. L. 99-570 amended subsec. (a) generally.
Prior to amendment, subsec. (a) read as follows: "It shall be
unlawful for any person knowingly or intentionally to possess a
controlled substance unless such substance was obtained directly,
or pursuant to a valid prescription or order, from a practitioner,
while acting in the course of his professional practice, or except
as otherwise authorized by this subchapter or subchapter II of this
chapter. Any person who violates this subsection shall be sentenced
to a term of imprisonment of not more than one year, a fine of not
more than $5,000, or both, except that if he commits such offense
after a prior conviction or convictions under this subsection have
become final, he shall be sentenced to a term of imprisonment of
not more than 2 years, a fine of not more than $10,000 or both."
Subsec. (b). Pub. L. 99-570, in amending subsec. (b) generally,
substituted "Upon the discharge of such person and dismissal of the
proceedings" for "Upon the dismissal of such person and discharge
of the proceedings" in par. (2).
Subsec. (c). Pub. L. 99-570, in amending section generally, added
subsec. (c).
1984 - Pub. L. 98-473 struck out subsec. (a) designation and
struck out subsec. (b) which related to probation before judgment
and expunging of records for first offense.
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109-177, title VII, Sec. 711(e)(2), Mar. 9, 2006, 120
Stat. 262, provided that: "The amendment made by paragraph (1)
[amending this section] applies on and after the expiration of the
30-day period beginning on the date of the enactment of this Act
[Mar. 9, 2006]."
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98-473 effective Nov. 1, 1987, and
applicable only to offenses committed after the taking effect of
such amendment, see section 235(a)(1) of Pub. L. 98-473, set out as
an Effective Date note under section 3551 of Title 18, Crimes and
Criminal Procedure.
-End-
-CITE-
21 USC Sec. 844a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 844a. Civil penalty for possession of small amounts of certain
controlled substances
-STATUTE-
(a) In general
Any individual who knowingly possesses a controlled substance
that is listed in section 841(b)(1)(A) of this title in violation
of section 844 of this title in an amount that, as specified by
regulation of the Attorney General, is a personal use amount shall
be liable to the United States for a civil penalty in an amount not
to exceed $10,000 for each such violation.
(b) Income and net assets
The income and net assets of an individual shall not be relevant
to the determination whether to assess a civil penalty under this
section or to prosecute the individual criminally. However, in
determining the amount of a penalty under this section, the income
and net assets of an individual shall be considered.
(c) Prior conviction
A civil penalty may not be assessed under this section if the
individual previously was convicted of a Federal or State offense
relating to a controlled substance.
(d) Limitation on number of assessments
A civil penalty may not be assessed on an individual under this
section on more than two separate occasions.
(e) Assessment
A civil penalty under this section may be assessed by the
Attorney General only by an order made on the record after
opportunity for a hearing in accordance with section 554 of title
5. The Attorney General shall provide written notice to the
individual who is the subject of the proposed order informing the
individual of the opportunity to receive such a hearing with
respect to the proposed order. The hearing may be held only if the
individual makes a request for the hearing before the expiration of
the 30-day period beginning on the date such notice is issued.
(f) Compromise
The Attorney General may compromise, modify, or remit, with or
without conditions, any civil penalty imposed under this section.
(g) Judicial review
If the Attorney General issues an order pursuant to subsection
(e) of this section after a hearing described in such subsection,
the individual who is the subject of the order may, before the
expiration of the 30-day period beginning on the date the order is
issued, bring a civil action in the appropriate district court of
the United States. In such action, the law and the facts of the
violation and the assessment of the civil penalty shall be
determined de novo, and shall include the right of a trial by jury,
the right to counsel, and the right to confront witnesses. The
facts of the violation shall be proved beyond a reasonable doubt.
(h) Civil action
If an individual does not request a hearing pursuant to
subsection (e) of this section and the Attorney General issues an
order pursuant to such subsection, or if an individual does not
under subsection (g) of this section seek judicial review of such
an order, the Attorney General may commence a civil action in any
appropriate district court of the United States for the purpose of
recovering the amount assessed and an amount representing interest
at a rate computed in accordance with section 1961 of title 28.
Such interest shall accrue from the expiration of the 30-day period
described in subsection (g) of this section. In such an action, the
decision of the Attorney General to issue the order, and the amount
of the penalty assessed by the Attorney General, shall not be
subject to review.
(i) Limitation
The Attorney General may not under this subsection (!1) commence
proceeding against an individual after the expiration of the 5-year
period beginning on the date on which the individual allegedly
violated subsection (a) of this section.
(j) Expungement procedures
The Attorney General shall dismiss the proceedings under this
section against an individual upon application of such individual
at any time after the expiration of 3 years if -
(1) the individual has not previously been assessed a civil
penalty under this section;
(2) the individual has paid the assessment;
(3) the individual has complied with any conditions imposed by
the Attorney General;
(4) the individual has not been convicted of a Federal or State
offense relating to a controlled substance; and
(5) the individual agrees to submit to a drug test, and such
test shows the individual to be drug free.
A nonpublic record of a disposition under this subsection shall be
retained by the Department of Justice solely for the purpose of
determining in any subsequent proceeding whether the person
qualified for a civil penalty or expungement under this section. If
a record is expunged under this subsection, an individual
concerning whom such an expungement has been made shall not be held
thereafter under any provision of law to be guilty of perjury,
false swearing, or making a false statement by reason of his
failure to recite or acknowledge a proceeding under this section or
the results thereof in response to an inquiry made of him for any
purpose.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 405, formerly Pub. L. 100-690,
title VI, Sec. 6486, Nov. 18, 1988, 102 Stat. 4384, renumbered Sec.
405 of Pub. L. 91-513, and amended Pub. L. 101-647, title X, Sec.
1002(g)(1), (2), Nov. 29, 1990, 104 Stat. 4828.)
-MISC1-
PRIOR PROVISIONS
A prior section 405 of Pub. L. 91-513 was renumbered section 418
and is classified to section 859 of this title.
AMENDMENTS
1990 - Subsec. (a). Pub. L. 101-647, Sec. 1002(g)(2)(A), made
technical amendments to references to sections 841(b)(1)(A) and 844
of this title to correct references to corresponding provisions of
original act.
Subsecs. (c), (j)(4). Pub. L. 101-647, Sec. 1002(g)(2)(B), (C),
struck out "as defined in section 802 of this title" after
"controlled substance".
-FOOTNOTE-
(!1) So in original. Probably should be "section".
-End-
-CITE-
21 USC Secs. 845 to 845b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Secs. 845 to 845b. Transferred
-COD-
CODIFICATION
Section 845, Pub. L. 91-513, title II, Sec. 405, Oct. 27, 1970,
84 Stat. 1265, as amended, which related to distribution of
controlled substances to persons under age twenty-one, was
renumbered Sec. 418 of Pub. L. 91-513 by Pub. L. 101-647, title X,
Sec. 1002(a)(1), Nov. 29, 1990, 104 Stat. 4827, and transferred to
section 859 of this title.
Section 845a, Pub. L. 91-513, title II, Sec. 405A, as added Pub.
L. 98-473, title II, Sec. 503(a), Oct. 12, 1984, 98 Stat. 2069, and
amended, which related to distribution or manufacturing of
controlled substances in or near schools and colleges, was
renumbered Sec. 419 of Pub. L. 91-513 by Pub. L. 101-647, title X,
Sec. 1002(b), Nov. 29, 1990, 104 Stat. 4827, and transferred to
section 860 of this title.
Section 845b, Pub. L. 91-513, title II, Sec. 405B, as added Pub.
L. 99-570, title I, Sec. 1102, Oct. 27, 1986, 100 Stat. 3207-10,
and amended, which related to employment or use of persons under 18
years of age in drug operations, was renumbered Sec. 420 of Pub. L.
91-513 by Pub. L. 101-647, title X, Sec. 1002(c), Nov. 29, 1990,
104 Stat. 4827, and transferred to section 861 of this title.
-End-
-CITE-
21 USC Sec. 846 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 846. Attempt and conspiracy
-STATUTE-
Any person who attempts or conspires to commit any offense
defined in this subchapter shall be subject to the same penalties
as those prescribed for the offense, the commission of which was
the object of the attempt or conspiracy.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 406, Oct. 27, 1970, 84 Stat. 1265;
Pub. L. 100-690, title VI, Sec. 6470(a), Nov. 18, 1988, 102 Stat.
4377.)
-MISC1-
AMENDMENTS
1988 - Pub. L. 100-690 substituted "shall be subject to the same
penalties as those prescribed for the offense" for "is punishable
by imprisonment or fine or both which may not exceed the maximum
punishment prescribed for the offense".
-End-
-CITE-
21 USC Sec. 847 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 847. Additional penalties
-STATUTE-
Any penalty imposed for violation of this subchapter shall be in
addition to, and not in lieu of, any civil or administrative
penalty or sanction authorized by law.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 407, Oct. 27, 1970, 84 Stat. 1265.)
-End-
-CITE-
21 USC Sec. 848 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 848. Continuing criminal enterprise
-STATUTE-
(a) Penalties; forfeitures
Any person who engages in a continuing criminal enterprise shall
be sentenced to a term of imprisonment which may not be less than
20 years and which may be up to life imprisonment, to a fine not to
exceed the greater of that authorized in accordance with the
provisions of title 18 or $2,000,000 if the defendant is an
individual or $5,000,000 if the defendant is other than an
individual, and to the forfeiture prescribed in section 853 of this
title; except that if any person engages in such activity after one
or more prior convictions of him under this section have become
final, he shall be sentenced to a term of imprisonment which may
not be less than 30 years and which may be up to life imprisonment,
to a fine not to exceed the greater of twice the amount authorized
in accordance with the provisions of title 18 or $4,000,000 if the
defendant is an individual or $10,000,000 if the defendant is other
than an individual, and to the forfeiture prescribed in section 853
of this title.
(b) Life imprisonment for engaging in continuing criminal
enterprise
Any person who engages in a continuing criminal enterprise shall
be imprisoned for life and fined in accordance with subsection (a)
of this section, if -
(1) such person is the principal administrator, organizer, or
leader of the enterprise or is one of several such principal
administrators, organizers, or leaders; and
(2)(A) the violation referred to in subsection (c)(1) of this
section involved at least 300 times the quantity of a substance
described in subsection 841(b)(1)(B) of this title, or
(B) the enterprise, or any other enterprise in which the
defendant was the principal or one of several principal
administrators, organizers, or leaders, received $10 million
dollars in gross receipts during any twelve-month period of its
existence for the manufacture, importation, or distribution of a
substance described in section 841(b)(1)(B) of this title.
(c) "Continuing criminal enterprise" defined
For purposes of subsection (a) of this section, a person is
engaged in a continuing criminal enterprise if -
(1) he violates any provision of this subchapter or subchapter
II of this chapter the punishment for which is a felony, and
(2) such violation is a part of a continuing series of
violations of this subchapter or subchapter II of this chapter -
(A) which are undertaken by such person in concert with five
or more other persons with respect to whom such person occupies
a position of organizer, a supervisory position, or any other
position of management, and
(B) from which such person obtains substantial income or
resources.
(d) Suspension of sentence and probation prohibited
In the case of any sentence imposed under this section,
imposition or execution of such sentence shall not be suspended,
probation shall not be granted, and the Act of July 15, 1932 (D.C.
Code, secs. 24-203 - 24-207), shall not apply.
(e) Death penalty
(1) In addition to the other penalties set forth in this section -
(A) any person engaging in or working in furtherance of a
continuing criminal enterprise, or any person engaging in an
offense punishable under section 841(b)(1)(A) of this title or
section 960(b)(1) of this title who intentionally kills or
counsels, commands, induces, procures, or causes the intentional
killing of an individual and such killing results, shall be
sentenced to any term of imprisonment, which shall not be less
than 20 years, and which may be up to life imprisonment, or may
be sentenced to death; and
(B) any person, during the commission of, in furtherance of, or
while attempting to avoid apprehension, prosecution or service of
a prison sentence for, a felony violation of this subchapter or
subchapter II of this chapter who intentionally kills or
counsels, commands, induces, procures, or causes the intentional
killing of any Federal, State, or local law enforcement officer
engaged in, or on account of, the performance of such officer's
official duties and such killing results, shall be sentenced to
any term of imprisonment, which shall not be less than 20 years,
and which may be up to life imprisonment, or may be sentenced to
death.
(2) As used in paragraph (1)(B), the term "law enforcement
officer" means a public servant authorized by law or by a
Government agency or Congress to conduct or engage in the
prevention, investigation, prosecution or adjudication of an
offense, and includes those engaged in corrections, probation, or
parole functions.
(g) (!1) to (p) Repealed. Pub. L. 109-177, title II, Sec. 221(2),
Mar. 9, 2006, 120 Stat. 231
(q) Repealed. Pub. L. 109-177, title II, Secs. 221(4), 222(c), Mar.
9, 2006, 120 Stat. 231, 232
(r) Repealed. Pub. L. 109-177, title II, Sec. 221(3), Mar. 9, 2006,
120 Stat. 231
(s) Special provision for methamphetamine
For the purposes of subsection (b), in the case of continuing
criminal enterprise involving methamphetamine or its salts,
isomers, or salts of isomers, paragraph (2)(A) shall be applied by
substituting "200" for "300", and paragraph (2)(B) shall be applied
by substituting "$5,000,000" for "$10 million dollars".
-SOURCE-
(Pub. L. 91-513, title II, Sec. 408, Oct. 27, 1970, 84 Stat. 1265;
Pub. L. 98-473, title II, Secs. 224(b), formerly Sec. 224(c), 305,
Oct. 12, 1984, 98 Stat. 2030, 2050; Pub. L. 99-570, title I, Secs.
1005(b)(2), 1252, 1253, Oct. 27, 1986, 100 Stat. 3207-6, 3207-14;
Pub. L. 100-690, title VI, Sec. 6481, title VII, Sec. 7001, Nov.
18, 1988, 102 Stat. 4382, 4387; Pub. L. 103-322, title XXXIII,
Secs. 330003(e), 330009(d), 330014, Sept. 13, 1994, 108 Stat. 2141,
2143, 2146; Pub. L. 104-132, title I, Sec. 108, title IX, Sec.
903(b), Apr. 24, 1996, 110 Stat. 1226, 1318; Pub. L. 109-177, title
II, Secs. 221, 222(c), title VII, Sec. 733, Mar. 9, 2006, 120 Stat.
231, 232, 270.)
-REFTEXT-
REFERENCES IN TEXT
Act of July 15, 1932 (D.C. Code, secs. 24-203 - 24-207), referred
to in subsec. (d), is act July 15, 1932, ch. 492, 47 Stat. 696, as
amended, which is not classified to the Code.
-MISC1-
AMENDMENTS
2006 - Subsec. (e)(2). Pub. L. 109-177, Sec. 221(1), substituted
"(1)(B)" for "(1)(b)".
Subsecs. (g) to (p). Pub. L. 109-177, Sec. 221(2), struck out
subsecs. (g) to (p) which related to hearing and sentencing
procedures in death penalty cases and sentencing in capital cases
in which the death penalty is not sought or imposed.
Subsec. (q). Pub. L. 109-177, Secs. 221(4), 222(c), struck out
subsec. (q) which related to appeal in capital cases and counsel
for financially unable defendants.
Subsec. (r). Pub. L. 109-177, Sec. 221(3), struck out subsec. (r)
which provided for refusal by State and Federal correctional
employees to participate in executions.
Subsec. (s). Pub. L. 109-177, Sec. 733, added subsec. (s).
1996 - Subsec. (q)(9). Pub. L. 104-132, Sec. 108, amended par.
(9) generally. Prior to amendment, par. (9) read as follows: "Upon
a finding in ex parte proceedings that investigative, expert or
other services are reasonably necessary for the representation of
the defendant, whether in connection with issues relating to guilt
or sentence, the court shall authorize the defendant's attorneys to
obtain such services on behalf of the defendant and shall order the
payment of fees and expenses therefore, under paragraph (10). Upon
a finding that timely procurement of such services could not
practicably await prior authorization, the court may authorize the
provision of and payment for such services nunc pro tunc."
Subsec. (q)(10). Pub. L. 104-132, Sec. 903(b), amended par. (10)
generally. Prior to amendment, par. (10) read as follows:
"Notwithstanding the rates and maximum limits generally applicable
to criminal cases and any other provision of law to the contrary,
the court shall fix the compensation to be paid to attorneys
appointed under this subsection and the fees and expenses to be
paid for investigative, expert, and other reasonably necessary
services authorized under paragraph (9), at such rates or amounts
as the court determines to be reasonably necessary to carry out the
requirements of paragraphs (4) through (9)."
1994 - Subsec. (b)(2)(A). Pub. L. 103-322, Sec. 330003(e),
substituted "subsection (c)(1) of this section" for "subsection
(d)(1) of this section".
Subsec. (n)(11). Pub. L. 103-322, Sec. 330014, made technical
amendment to reference to section 859 of this title to correct
reference to corresponding section of original act.
Subsec. (q)(8). Pub. L. 103-322, Sec. 330009(d), substituted
"applications for writ" for "applications, for writ".
1988 - Subsec. (a). Pub. L. 100-690, Sec. 6481(a), increased
minimum term of imprisonment for first violations to 20 from 10
years and for subsequent violations to 30 from 20 years.
Subsecs. (c), (d). Pub. L. 100-690, Sec. 6481(b), redesignated
subsecs. (d) and (e) as (c) and (d), respectively.
Subsec. (e). Pub. L. 100-690, Sec. 7001(a)(2), added subsec. (e).
Former subsec. (e) redesignated (d).
Pub. L. 100-690, Sec. 7001(a)(1), which directed redesignation of
former subsec. (e) as (f), could not be executed because of prior
redesignation of former subsec. (e) as (d) by Pub. L. 100-690, Sec.
6481(b), which resulted in there not being a subsec. (f).
Subsecs. (g) to (r). Pub. L. 100-690, Sec. 7001(b), added
subsecs. (g) to (r).
1986 - Subsec. (a). Pub. L. 99-570, Sec. 1252, substituted "to a
fine not to exceed the greater of that authorized in accordance
with the provisions of title 18 or $2,000,000 if the defendant is
an individual or $5,000,000 if the defendant is other than an
individual," for "to a fine of not more than $100,000," and "to a
fine not to exceed the greater of twice the amount authorized in
accordance with the provisions of title 18 or $4,000,000 if the
defendant is an individual or $10,000,000 if the defendant is other
than an individual," for "to a fine of not more than $200,000,".
Subsecs. (b) to (e). Pub. L. 99-570, Sec. 1253, added subsec. (b)
and redesignated former subsecs. (b) and (c) as (d) and (e),
respectively, which resulted in there not being a subsec. (c).
1984 - Subsec. (a). Pub. L. 98-473, Sec. 305, struck out par. (1)
designation, substituted references to section 853 of this title
for references to paragraph (2) in two places, and struck out par.
(2) which related to forfeitures to the United States by any person
convicted under par. (1).
Subsec. (d). Pub. L. 98-473, Sec. 305(b), struck out subsec. (d)
relating to jurisdiction of courts of the United States.
Subsec. (e). Pub. L. 98-473, Sec. 224(b), as renumbered by Pub.
L. 99-570, Sec. 1005(b)(2), which directed the amendment of subsec.
(c) of this section by striking out "and section 4202 of title 18
of the United States Code", was executed by striking out that
language in subsec. (e) to reflect the probable intent of Congress
and the intervening amendment by Pub. L. 99-570, Sec. 1253, which
redesignated subsec. (c) as (e). See 1986 Amendment note above.
EFFECTIVE DATE OF 1996 AMENDMENT
Amendment by section 903(b) of Pub. L. 104-132 effective as to
cases commenced or appeals perfected on or after Apr. 24, 1996, see
section 903(c) of Pub. L. 104-132, set out as a note under section
3006A of Title 18, Crimes and Criminal Procedure.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by section 224(b) of Pub. L. 98-473 effective Nov. 1,
1987, and applicable only to offenses committed after the taking
effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
set out as an Effective Date note under section 3551 of Title 18,
Crimes and Criminal Procedure.
GAO STUDY OF COST OF EXECUTIONS
Section 7002 of title VII of Pub. L. 100-690, directed
Comptroller General to conduct a study of cost of executions and
report to Congress, prior to repeal by Pub. L. 104-66, title I,
Sec. 1091(d), Dec. 21, 1995, 109 Stat. 722.
-FOOTNOTE-
(!1) So in original. Section does not contain a subsec. (f), see
1988 Amendment note below.
-End-
-CITE-
21 USC Sec. 849 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 849. Transportation safety offenses
-STATUTE-
(a) Definitions
In this section -
"safety rest area" means a roadside facility with parking
facilities for the rest or other needs of motorists.
"truck stop" means a facility (including any parking lot
appurtenant thereto) that -
(A) has the capacity to provide fuel or service, or both, to
any commercial motor vehicle (as defined in section 31301 of
title 49), operating in commerce (as defined in that section);
and
(B) is located within 2,500 feet of the National System of
Interstate and Defense Highways or the Federal-Aid Primary
System.
(b) First offense
A person who violates section 841(a)(1) of this title or section
856 of this title by distributing or possessing with intent to
distribute a controlled substance in or on, or within 1,000 feet
of, a truck stop or safety rest area is (except as provided in
subsection (b) (!1) of this section) subject to -
(1) twice the maximum punishment authorized by section 841(b)
of this title; and
(2) twice any term of supervised release authorized by section
841(b) of this title for a first offense.
(c) Subsequent offense
A person who violates section 841(a)(1) of this title or section
856 of this title by distributing or possessing with intent to
distribute a controlled substance in or on, or within 1,000 feet
of, a truck stop or a safety rest area after a prior conviction or
convictions under subsection (a) (!2) of this section have become
final is subject to -
(1) 3 times the maximum punishment authorized by section 841(b)
of this title; and
(2) 3 times any term of supervised release authorized by
section 841(b) of this title for a first offense.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 409, as added Pub. L. 103-322,
title XVIII, Sec. 180201(b)(1), Sept. 13, 1994, 108 Stat. 2046.)
-MISC1-
PRIOR PROVISIONS
A prior section 849, Pub. L. 91-513, title II, Sec. 409, Oct. 27,
1970, 84 Stat. 1266; Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100
Stat. 2095, related to dangerous special drug offender sentencing,
prior to repeal by Pub. L. 98-473, title II, Secs. 219(a),
235(a)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, eff. Nov. 1, 1987,
and applicable only to offenses committed after the taking effect
of such repeal.
-FOOTNOTE-
(!1) So in original. Probably should be subsection "(c)".
(!2) So in original. Probably should be subsection "(b)".
-End-
-CITE-
21 USC Sec. 850 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 850. Information for sentencing
-STATUTE-
Except as otherwise provided in this subchapter or section
242a(a) (!1) of title 42, no limitation shall be placed on the
information concerning the background, character, and conduct of a
person convicted of an offense which a court of the United States
may receive and consider for the purpose of imposing an appropriate
sentence under this subchapter or subchapter II of this chapter.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 410, Oct. 27, 1970, 84 Stat. 1269.)
-REFTEXT-
REFERENCES IN TEXT
Section 242a of title 42, referred to in text, was repealed by
Pub. L. 106-310, div. B, title XXXII, Sec. 3201(b)(1), Oct. 17,
2000, 114 Stat. 1190.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 851 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 851. Proceedings to establish prior convictions
-STATUTE-
(a) Information filed by United States Attorney
(1) No person who stands convicted of an offense under this part
shall be sentenced to increased punishment by reason of one or more
prior convictions, unless before trial, or before entry of a plea
of guilty, the United States attorney files an information with the
court (and serves a copy of such information on the person or
counsel for the person) stating in writing the previous convictions
to be relied upon. Upon a showing by the United States attorney
that facts regarding prior convictions could not with due diligence
be obtained prior to trial or before entry of a plea of guilty, the
court may postpone the trial or the taking of the plea of guilty
for a reasonable period for the purpose of obtaining such facts.
Clerical mistakes in the information may be amended at any time
prior to the pronouncement of sentence.
(2) An information may not be filed under this section if the
increased punishment which may be imposed is imprisonment for a
term in excess of three years unless the person either waived or
was afforded prosecution by indictment for the offense for which
such increased punishment may be imposed.
(b) Affirmation or denial of previous conviction
If the United States attorney files an information under this
section, the court shall after conviction but before pronouncement
of sentence inquire of the person with respect to whom the
information was filed whether he affirms or denies that he has been
previously convicted as alleged in the information, and shall
inform him that any challenge to a prior conviction which is not
made before sentence is imposed may not thereafter be raised to
attack the sentence.
(c) Denial; written response; hearing
(1) If the person denies any allegation of the information of
prior conviction, or claims that any conviction alleged is invalid,
he shall file a written response to the information. A copy of the
response shall be served upon the United States attorney. The court
shall hold a hearing to determine any issues raised by the response
which would except the person from increased punishment. The
failure of the United States attorney to include in the information
the complete criminal record of the person or any facts in addition
to the convictions to be relied upon shall not constitute grounds
for invalidating the notice given in the information required by
subsection (a)(1) of this section. The hearing shall be before the
court without a jury and either party may introduce evidence.
Except as otherwise provided in paragraph (2) of this subsection,
the United States attorney shall have the burden of proof beyond a
reasonable doubt on any issue of fact. At the request of either
party, the court shall enter findings of fact and conclusions of
law.
(2) A person claiming that a conviction alleged in the
information was obtained in violation of the Constitution of the
United States shall set forth his claim, and the factual basis
therefor, with particularity in his response to the information.
The person shall have the burden of proof by a preponderance of the
evidence on any issue of fact raised by the response. Any challenge
to a prior conviction, not raised by response to the information
before an increased sentence is imposed in reliance thereon, shall
be waived unless good cause be shown for failure to make a timely
challenge.
(d) Imposition of sentence
(1) If the person files no response to the information, or if the
court determines, after hearing, that the person is subject to
increased punishment by reason of prior convictions, the court
shall proceed to impose sentence upon him as provided by this part.
(2) If the court determines that the person has not been
convicted as alleged in the information, that a conviction alleged
in the information is invalid, or that the person is otherwise not
subject to an increased sentence as a matter of law, the court
shall, at the request of the United States attorney, postpone
sentence to allow an appeal from that determination. If no such
request is made, the court shall impose sentence as provided by
this part. The person may appeal from an order postponing sentence
as if sentence had been pronounced and a final judgment of
conviction entered.
(e) Statute of limitations
No person who stands convicted of an offense under this part may
challenge the validity of any prior conviction alleged under this
section which occurred more than five years before the date of the
information alleging such prior conviction.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 411, Oct. 27, 1970, 84 Stat. 1269.)
-End-
-CITE-
21 USC Sec. 852 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 852. Application of treaties and other international
agreements
-STATUTE-
Nothing in the Single Convention on Narcotic Drugs, the
Convention on Psychotropic Substances, or other treaties or
international agreements shall be construed to limit the provision
of treatment, education, or rehabilitation as alternatives to
conviction or criminal penalty for offenses involving any drug or
other substance subject to control under any such treaty or
agreement.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 412, as added Pub. L. 95-633, title
I, Sec. 107(a), Nov. 10, 1978, 92 Stat. 3773.)
-MISC1-
EFFECTIVE DATE
Section effective on date the Convention on Psychotropic
Substances enters into force in the United States [July 15, 1980],
see section 112 of Pub. L. 95-633, set out as a note under section
801a of this title.
-End-
-CITE-
21 USC Sec. 853 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 853. Criminal forfeitures
-STATUTE-
(a) Property subject to criminal forfeiture
Any person convicted of a violation of this subchapter or
subchapter II of this chapter punishable by imprisonment for more
than one year shall forfeit to the United States, irrespective of
any provision of State law -
(1) any property constituting, or derived from, any proceeds
the person obtained, directly or indirectly, as the result of
such violation;
(2) any of the person's property used, or intended to be used,
in any manner or part, to commit, or to facilitate the commission
of, such violation; and
(3) in the case of a person convicted of engaging in a
continuing criminal enterprise in violation of section 848 of
this title, the person shall forfeit, in addition to any property
described in paragraph (1) or (2), any of his interest in, claims
against, and property or contractual rights affording a source of
control over, the continuing criminal enterprise.
The court, in imposing sentence on such person, shall order, in
addition to any other sentence imposed pursuant to this subchapter
or subchapter II of this chapter, that the person forfeit to the
United States all property described in this subsection. In lieu of
a fine otherwise authorized by this part, a defendant who derives
profits or other proceeds from an offense may be fined not more
than twice the gross profits or other proceeds.
(b) Meaning of term "property"
Property subject to criminal forfeiture under this section
includes -
(1) real property, including things growing on, affixed to, and
found in land; and
(2) tangible and intangible personal property, including
rights, privileges, interests, claims, and securities.
(c) Third party transfers
All right, title, and interest in property described in
subsection (a) of this section vests in the United States upon the
commission of the act giving rise to forfeiture under this section.
Any such property that is subsequently transferred to a person
other than the defendant may be the subject of a special verdict of
forfeiture and thereafter shall be ordered forfeited to the United
States, unless the transferee establishes in a hearing pursuant to
subsection (n) of this section that he is a bona fide purchaser for
value of such property who at the time of purchase was reasonably
without cause to believe that the property was subject to
forfeiture under this section.
(d) Rebuttable presumption
There is a rebuttable presumption at trial that any property of a
person convicted of a felony under this subchapter or subchapter II
of this chapter is subject to forfeiture under this section if the
United States establishes by a preponderance of the evidence that -
(1) such property was acquired by such person during the period
of the violation of this subchapter or subchapter II of this
chapter or within a reasonable time after such period; and
(2) there was no likely source for such property other than the
violation of this subchapter or subchapter II of this chapter.
(e) Protective orders
(1) Upon application of the United States, the court may enter a
restraining order or injunction, require the execution of a
satisfactory performance bond, or take any other action to preserve
the availability of property described in subsection (a) of this
section for forfeiture under this section -
(A) upon the filing of an indictment or information charging a
violation of this subchapter or subchapter II of this chapter for
which criminal forfeiture may be ordered under this section and
alleging that the property with respect to which the order is
sought would, in the event of conviction, be subject to
forfeiture under this section; or
(B) prior to the filing of such an indictment or information,
if, after notice to persons appearing to have an interest in the
property and opportunity for a hearing, the court determines that
-
(i) there is a substantial probability that the United States
will prevail on the issue of forfeiture and that failure to
enter the order will result in the property being destroyed,
removed from the jurisdiction of the court, or otherwise made
unavailable for forfeiture; and
(ii) the need to preserve the availability of the property
through the entry of the requested order outweighs the hardship
on any party against whom the order is to be entered:
Provided, however, That an order entered pursuant to subparagraph
(B) shall be effective for not more than ninety days, unless
extended by the court for good cause shown or unless an indictment
or information described in subparagraph (A) has been filed.
(2) A temporary restraining order under this subsection may be
entered upon application of the United States without notice or
opportunity for a hearing when an information or indictment has not
yet been filed with respect to the property, if the United States
demonstrates that there is probable cause to believe that the
property with respect to which the order is sought would, in the
event of conviction, be subject to forfeiture under this section
and that provision of notice will jeopardize the availability of
the property for forfeiture. Such a temporary order shall expire
not more than ten days after the date on which it is entered,
unless extended for good cause shown or unless the party against
whom it is entered consents to an extension for a longer period. A
hearing requested concerning an order entered under this paragraph
shall be held at the earliest possible time and prior to the
expiration of the temporary order.
(3) The court may receive and consider, at a hearing held
pursuant to this subsection, evidence and information that would be
inadmissible under the Federal Rules of Evidence.
(4) Order to repatriate and deposit. -
(A) In general. - Pursuant to its authority to enter a pretrial
restraining order under this section, the court may order a
defendant to repatriate any property that may be seized and
forfeited, and to deposit that property pending trial in the
registry of the court, or with the United States Marshals Service
or the Secretary of the Treasury, in an interest-bearing account,
if appropriate.
(B) Failure to comply. - Failure to comply with an order under
this subsection, or an order to repatriate property under
subsection (p) of this section, shall be punishable as a civil or
criminal contempt of court, and may also result in an enhancement
of the sentence of the defendant under the obstruction of justice
provision of the Federal Sentencing Guidelines.
(f) Warrant of seizure
The Government may request the issuance of a warrant authorizing
the seizure of property subject to forfeiture under this section in
the same manner as provided for a search warrant. If the court
determines that there is probable cause to believe that the
property to be seized would, in the event of conviction, be subject
to forfeiture and that an order under subsection (e) of this
section may not be sufficient to assure the availability of the
property for forfeiture, the court shall issue a warrant
authorizing the seizure of such property.
(g) Execution
Upon entry of an order of forfeiture under this section, the
court shall authorize the Attorney General to seize all property
ordered forfeited upon such terms and conditions as the court shall
deem proper. Following entry of an order declaring the property
forfeited, the court may, upon application of the United States,
enter such appropriate restraining orders or injunctions, require
the execution of satisfactory performance bonds, appoint receivers,
conservators, appraisers, accountants, or trustees, or take any
other action to protect the interest of the United States in the
property ordered forfeited. Any income accruing to or derived from
property ordered forfeited under this section may be used to offset
ordinary and necessary expenses to the property which are required
by law, or which are necessary to protect the interests of the
United States or third parties.
(h) Disposition of property
Following the seizure of property ordered forfeited under this
section, the Attorney General shall direct the disposition of the
property by sale or any other commercially feasible means, making
due provision for the rights of any innocent persons. Any property
right or interest not exercisable by, or transferable for value to,
the United States shall expire and shall not revert to the
defendant, nor shall the defendant or any person acting in concert
with him or on his behalf be eligible to purchase forfeited
property at any sale held by the United States. Upon application of
a person, other than the defendant or a person acting in concert
with him or on his behalf, the court may restrain or stay the sale
or disposition of the property pending the conclusion of any appeal
of the criminal case giving rise to the forfeiture, if the
applicant demonstrates that proceeding with the sale or disposition
of the property will result in irreparable injury, harm, or loss to
him.
(i) Authority of the Attorney General
With respect to property ordered forfeited under this section,
the Attorney General is authorized to -
(1) grant petitions for mitigation or remission of forfeiture,
restore forfeited property to victims of a violation of this
subchapter, or take any other action to protect the rights of
innocent persons which is in the interest of justice and which is
not inconsistent with the provisions of this section;
(2) compromise claims arising under this section;
(3) award compensation to persons providing information
resulting in a forfeiture under this section;
(4) direct the disposition by the United States, in accordance
with the provisions of section 881(e) of this title, of all
property ordered forfeited under this section by public sale or
any other commercially feasible means, making due provision for
the rights of innocent persons; and
(5) take appropriate measures necessary to safeguard and
maintain property ordered forfeited under this section pending
its disposition.
(j) Applicability of civil forfeiture provisions
Except to the extent that they are inconsistent with the
provisions of this section, the provisions of section 881(d) of
this title shall apply to a criminal forfeiture under this section.
(k) Bar on intervention
Except as provided in subsection (n) of this section, no party
claiming an interest in property subject to forfeiture under this
section may -
(1) intervene in a trial or appeal of a criminal case involving
the forfeiture of such property under this section; or
(2) commence an action at law or equity against the United
States concerning the validity of his alleged interest in the
property subsequent to the filing of an indictment or information
alleging that the property is subject to forfeiture under this
section.
(l) Jurisdiction to enter orders
The district courts of the United States shall have jurisdiction
to enter orders as provided in this section without regard to the
location of any property which may be subject to forfeiture under
this section or which has been ordered forfeited under this
section.
(m) Depositions
In order to facilitate the identification and location of
property declared forfeited and to facilitate the disposition of
petitions for remission or mitigation of forfeiture, after the
entry of an order declaring property forfeited to the United
States, the court may, upon application of the United States, order
that the testimony of any witness relating to the property
forfeited be taken by deposition and that any designated book,
paper, document, record, recording, or other material not
privileged be produced at the same time and place, in the same
manner as provided for the taking of depositions under Rule 15 of
the Federal Rules of Criminal Procedure.
(n) Third party interests
(1) Following the entry of an order of forfeiture under this
section, the United States shall publish notice of the order and of
its intent to dispose of the property in such manner as the
Attorney General may direct. The Government may also, to the extent
practicable, provide direct written notice to any person known to
have alleged an interest in the property that is the subject of the
order of forfeiture as a substitute for published notice as to
those persons so notified.
(2) Any person, other than the defendant, asserting a legal
interest in property which has been ordered forfeited to the United
States pursuant to this section may, within thirty days of the
final publication of notice or his receipt of notice under
paragraph (1), whichever is earlier, petition the court for a
hearing to adjudicate the validity of his alleged interest in the
property. The hearing shall be held before the court alone, without
a jury.
(3) The petition shall be signed by the petitioner under penalty
of perjury and shall set forth the nature and extent of the
petitioner's right, title, or interest in the property, the time
and circumstances of the petitioner's acquisition of the right,
title, or interest in the property, any additional facts supporting
the petitioner's claim, and the relief sought.
(4) The hearing on the petition shall, to the extent practicable
and consistent with the interests of justice, be held within thirty
days of the filing of the petition. The court may consolidate the
hearing on the petition with a hearing on any other petition filed
by a person other than the defendant under this subsection.
(5) At the hearing, the petitioner may testify and present
evidence and witnesses on his own behalf, and cross-examine
witnesses who appear at the hearing. The United States may present
evidence and witnesses in rebuttal and in defense of its claim to
the property and cross-examine witnesses who appear at the hearing.
In addition to testimony and evidence presented at the hearing, the
court shall consider the relevant portions of the record of the
criminal case which resulted in the order of forfeiture.
(6) If, after the hearing, the court determines that the
petitioner has established by a preponderance of the evidence that -
(A) the petitioner has a legal right, title, or interest in the
property, and such right, title, or interest renders the order of
forfeiture invalid in whole or in part because the right, title,
or interest was vested in the petitioner rather than the
defendant or was superior to any right, title, or interest of the
defendant at the time of the commission of the acts which gave
rise to the forfeiture of the property under this section; or
(B) the petitioner is a bona fide purchaser for value of the
right, title, or interest in the property and was at the time of
purchase reasonably without cause to believe that the property
was subject to forfeiture under this section;
the court shall amend the order of forfeiture in accordance with
its determination.
(7) Following the court's disposition of all petitions filed
under this subsection, or if no such petitions are filed following
the expiration of the period provided in paragraph (2) for the
filing of such petitions, the United States shall have clear title
to property that is the subject of the order of forfeiture and may
warrant good title to any subsequent purchaser or transferee.
(o) Construction
The provisions of this section shall be liberally construed to
effectuate its remedial purposes.
(p) Forfeiture of substitute property
(1) In general
Paragraph (2) of this subsection shall apply, if any property
described in subsection (a) of this section, as a result of any
act or omission of the defendant -
(A) cannot be located upon the exercise of due diligence;
(B) has been transferred or sold to, or deposited with, a
third party;
(C) has been placed beyond the jurisdiction of the court;
(D) has been substantially diminished in value; or
(E) has been commingled with other property which cannot be
divided without difficulty.
(2) Substitute property
In any case described in any of subparagraphs (A) through (E)
of paragraph (1), the court shall order the forfeiture of any
other property of the defendant, up to the value of any property
described in subparagraphs (A) through (E) of paragraph (1), as
applicable.
(3) Return of property to jurisdiction
In the case of property described in paragraph (1)(C), the
court may, in addition to any other action authorized by this
subsection, order the defendant to return the property to the
jurisdiction of the court so that the property may be seized and
forfeited.
(q) Restitution for cleanup of clandestine laboratory sites
The court, when sentencing a defendant convicted of an offense
under this subchapter or subchapter II of this chapter involving
the manufacture, the possession, or the possession with intent to
distribute, of amphetamine or methamphetamine, shall -
(1) order restitution as provided in sections 3612 and 3664 of
title 18;
(2) order the defendant to reimburse the United States, the
State or local government concerned, or both the United States
and the State or local government concerned for the costs
incurred by the United States or the State or local government
concerned, as the case may be, for the cleanup associated with
the manufacture of amphetamine or methamphetamine by the
defendant, or on premises or in property that the defendant owns,
resides, or does business in; and
(3) order restitution to any person injured as a result of the
offense as provided in section 3663A of title 18.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 413, as added and amended Pub. L.
98-473, title II, Secs. 303, 2301(d)-(f), Oct. 12, 1984, 98 Stat.
2044, 2192, 2193; Pub. L. 99-570, title I, Secs. 1153(b), 1864,
Oct. 27, 1986, 100 Stat. 3207-13, 3207-54; Pub. L. 104-237, title
II, Sec. 207, Oct. 3, 1996, 110 Stat. 3104; Pub. L. 106-310, div.
B, title XXXVI, Sec. 3613(a), Oct. 17, 2000, 114 Stat. 1229; Pub.
L. 107-56, title III, Sec. 319(d), Oct. 26, 2001, 115 Stat. 314;
Pub. L. 109-177, title VII, Sec. 743(a), Mar. 9, 2006, 120 Stat.
272.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Rules of Evidence, referred to in subsec. (e)(3), are
set out in the Appendix to Title 28, Judiciary and Judicial
Procedure.
The Federal Rules of Criminal Procedure, referred to in subsec.
(m), are set out in the Appendix to Title 18, Crimes and Criminal
Procedure.
-MISC1-
AMENDMENTS
2006 - Subsec. (q). Pub. L. 109-177, Sec. 743(a)(1), inserted ",
the possession, or the possession with intent to distribute," after
"manufacture" in introductory provisions.
Subsec. (q)(2). Pub. L. 109-177, Sec. 743(a)(2), inserted ", or
on premises or in property that the defendant owns, resides, or
does business in" after "by the defendant".
2001 - Subsec. (e)(4). Pub. L. 107-56, Sec. 319(d)(2), added par.
(4).
Subsec. (p). Pub. L. 107-56, Sec. 319(d)(1), inserted heading and
amended text of subsec. (p) generally. Prior to amendment, text
read as follows: "If any of the property described in subsection
(a) of this section, as a result of any act or omission of the
defendant -
"(1) cannot be located upon the exercise of due diligence;
"(2) has been transferred or sold to, or deposited with, a
third party;
"(3) has been placed beyond the jurisdiction of the court;
"(4) has been substantially diminished in value; or
"(5) has been commingled with other property which cannot be
divided without difficulty;
the court shall order the forfeiture of any other property of the
defendant up to the value of any property described in paragraphs
(1) through (5)."
2000 - Subsec. (q). Pub. L. 106-310, Sec. 3613(a)(1), (2), in
introductory provisions, inserted "amphetamine or" before
"methamphetamine" and substituted "shall" for "may".
Subsec. (q)(2). Pub. L. 106-310, Sec. 3613(a)(2), (3), inserted
", the State or local government concerned, or both the United
States and the State or local government concerned" after "to
reimburse the United States", "or the State or local government
concerned, as the case may be," after "costs incurred by the United
States", and "amphetamine or" before "methamphetamine".
Subsec. (q)(3). Pub. L. 106-310, Sec. 3613(a)(4), substituted
"section 3663A of title 18" for "section 3663 of title 18".
1996 - Subsec. (q). Pub. L. 104-237 added subsec. (q).
1986 - Subsec. (c). Pub. L. 99-570, Sec. 1864(1), substituted
"subsection (n)" for "subsection (o)".
Subsec. (f). Pub. L. 99-570, Sec. 1864(2), substituted
"subsection (e)" for "subsection (f)".
Subsec. (i)(1). Pub. L. 99-570, Sec. 1864(3), substituted "this
subchapter" for "this chapter".
Subsec. (k). Pub. L. 99-570, Sec. 1864(1), (4), which directed
the substitution of "subsection (n)" for "subsection (o)" in "the
second subsection (h)", and directed the redesignation of "the
second subsection (h)" as subsection (k), were executed to this
subsection because the "second subsection (h)" had been editorially
redesignated subsec. (k) to reflect the probable intent of
Congress. See 1984 Amendment note below.
Subsec. (p). Pub. L. 99-570, Sec. 1153(b), which directed that
"section 413 of title II of the Comprehensive Drug Abuse Prevention
and Control Act of 1975" be amended "by redesignating subsection
'(p)' as subsection '(q)' " and adding subsec. (p) was executed to
this section, which is section 413 of the Comprehensive Drug Abuse
Prevention and Control Act of 1970, as the probable intent of
Congress, by adding a subsec. (p) in view of the prior
redesignation of subsec. (p) as (o) by Pub. L. 98-473, Sec.
2301(e)(2). See 1984 Amendment note below.
1984 - Subsec. (a). Pub. L. 98-473, Sec. 2301(d), inserted "In
lieu of a fine otherwise authorized by this part, a defendant who
derives profits or other proceeds from an offense may be fined not
more than twice the gross profits or other proceeds."
Subsec. (d). Pub. L. 98-473, Sec. 2301(e), struck out subsec. (d)
which related to forfeiture of property other than that described
in subsec. (a) and the conditions therefor, and redesignated former
subsec. (e) as (d).
Subsecs. (e) to (p). Pub. L. 98-473, Sec. 2301(e)(2), which
directed that this section be amended by redesignating subsecs.
(e), (f), (g), (h), (i), (l), (m), (n), (o), and (p) as subsecs.
(d), (e), (f), (g), (h), (i), (j), (h), (l), (m), (n), and (o),
respectively, was executed by redesignating subsecs. (e) to (p) as
(d) to (o), respectively, to give effect to the probable intent of
Congress.
Subsec. (n)(1). Pub. L. 98-473, Sec. 2301(f), struck out "for at
least seven successive court days" after "to dispose of the
property".
SAVINGS CLAUSE
Pub. L. 109-177, title VII, Sec. 743(b), Mar. 9, 2006, 120 Stat.
273, provided that: "Nothing in this section [amending this
section] shall be interpreted or construed to amend, alter, or
otherwise affect the obligations, liabilities and other
responsibilities of any person under any Federal or State
environmental laws."
-End-
-CITE-
21 USC Sec. 853a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 853a. Transferred
-COD-
CODIFICATION
Section, Pub. L. 100-690, title V, Sec. 5301, Nov. 18, 1988, 102
Stat. 4310, which related to denial of Federal benefits to drug
traffickers and possessors, was renumbered section 421 of the
Controlled Substances Act by Pub. L. 101-647, title X, Sec.
1002(d)(1), Nov. 29, 1990, 104 Stat. 4827, and is classified to
section 862 of this title.
-End-
-CITE-
21 USC Sec. 854 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 854. Investment of illicit drug profits
-STATUTE-
(a) Prohibition
It shall be unlawful for any person who has received any income
derived, directly or indirectly, from a violation of this
subchapter or subchapter II of this chapter punishable by
imprisonment for more than one year in which such person has
participated as a principal within the meaning of section 2 of
title 18, to use or invest, directly or indirectly, any part of
such income, or the proceeds of such income, in acquisition of any
interest in, or the establishment or operation of, any enterprise
which is engaged in, or the activities of which affect interstate
or foreign commerce. A purchase of securities on the open market
for purposes of investment, and without the intention of
controlling or participating in the control of the issuer, or of
assisting another to do so, shall not be unlawful under this
section if the securities of the issuer held by the purchaser, the
members of his immediate family, and his or their accomplices in
any violation of this subchapter or subchapter II of this chapter
after such purchase do not amount in the aggregate to 1 per centum
of the outstanding securities of any one class, and do not confer,
either in law or in fact, the power to elect one or more directors
of the issuer.
(b) Penalty
Whoever violates this section shall be fined not more than
$50,000 or imprisoned not more than ten years, or both.
(c) "Enterprise" defined
As used in this section, the term "enterprise" includes any
individual, partnership, corporation, association, or other legal
entity, and any union or group of individuals associated in fact
although not a legal entity.
(d) Construction
The provisions of this section shall be liberally construed to
effectuate its remedial purposes.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 414, as added Pub. L. 98-473, title
II, Sec. 303, Oct. 12, 1984, 98 Stat. 2049.)
-End-
-CITE-
21 USC Sec. 855 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 855. Alternative fine
-STATUTE-
In lieu of a fine otherwise authorized by this part, a defendant
who derives profits or other proceeds from an offense may be fined
not more than twice the gross profits or other proceeds.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 415, as added Pub. L. 98-473, title
II, Sec. 2302, Oct. 12, 1984, 98 Stat. 2193.)
-End-
-CITE-
21 USC Sec. 856 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 856. Maintaining drug-involved premises
-STATUTE-
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful to -
(1) knowingly open, lease, rent, use, or maintain any place,
whether permanently or temporarily, for the purpose of
manufacturing, distributing, or using any controlled substance;
(2) manage or control any place, whether permanently or
temporarily, either as an owner, lessee, agent, employee,
occupant, or mortgagee, and knowingly and intentionally rent,
lease, profit from, or make available for use, with or without
compensation, the place for the purpose of unlawfully
manufacturing, storing, distributing, or using a controlled
substance.
(b) Criminal penalties
Any person who violates subsection (a) of this section shall be
sentenced to a term of imprisonment of not more than 20 years or a
fine of not more than $500,000, or both, or a fine of $2,000,000
for a person other than an individual.
(c) Violation as offense against property
A violation of subsection (a) of this section shall be considered
an offense against property for purposes of section
3663A(c)(1)(A)(ii) of title 18.
(d) Civil penalites
(1) Any person who violates subsection (a) of this section shall
be subject to a civil penalty of not more than the greater of -
(A) $250,000; or
(B) 2 times the gross receipts, either known or estimated, that
were derived from each violation that is attributable to the
person.
(2) If a civil penalty is calculated under paragraph (1)(B), and
there is more than 1 defendant, the court may apportion the penalty
between multiple violators, but each violator shall be jointly and
severally liable for the civil penalty under this subsection.
(e) Declaratory and injunctive remedies
Any person who violates subsection (a) of this section shall be
subject to declaratory and injunctive remedies as set forth in
section 843(f) of this title.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 416, as added Pub. L. 99-570, title
I, Sec. 1841(a), Oct. 27, 1986, 100 Stat. 3207-52; amended Pub. L.
106-310, div. B, title XXXVI, Sec. 3613(e), Oct. 17, 2000, 114
Stat. 1230; Pub. L. 108-21, title VI, Sec. 608(b)(1), (2), (c),
Apr. 30, 2003, 117 Stat. 691.)
-MISC1-
AMENDMENTS
2003 - Pub. L. 108-21, Sec. 608(b)(2), substituted "Maintaining
drug-involved premises" for "Establishment of manufacturing
operations" in section catchline.
Subsec. (a)(1). Pub. L. 108-21, Sec. 608(b)(1)(A), substituted
"open, lease, rent, use, or maintain any place, whether permanently
or temporarily," for "open or maintain any place".
Subsec. (a)(2). Pub. L. 108-21, Sec. 608(b)(1)(B), added par. (2)
and struck out former par. (2) which read as follows: "manage or
control any building, room, or enclosure, either as an owner,
lessee, agent, employee, or mortgagee, and knowingly and
intentionally rent, lease, or make available for use, with or
without compensation, the building, room, or enclosure for the
purpose of unlawfully manufacturing, storing, distributing, or
using a controlled substance."
Subsecs. (d), (e). Pub. L. 108-21, Sec. 608(c), added subsecs.
(d) and (e).
2000 - Subsec. (c). Pub. L. 106-310 added subsec. (c).
-End-
-CITE-
21 USC Sec. 857 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 857. Repealed.
-MISC1-
Sec. 857. Repealed. Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov.
29, 1990, 104 Stat. 4859.
Section, Pub. L. 99-570, title I, Sec. 1822, Oct. 27, 1986, 100
Stat. 3207-51; Pub. L. 100-690, title VI, Sec. 6485, Nov. 18, 1988,
102 Stat. 4384; Pub. L. 101-647, title XXIV, Sec. 2401(b), Nov. 29,
1990, 104 Stat. 4859, related to interstate and foreign sale and
transportation of drug paraphernalia.
Subsec. (a), which related to unlawful acts, was repealed.
Subsecs. (b) to (f) were redesignated as subsecs. (b) to (f) of
section 422 of the Controlled Substances Act by section 2401(b) of
Pub. L. 101-647 and transferred to section 863(b) to (f) of this
title.
EFFECTIVE DATE
Section 1823 of Pub. L. 99-570 which provided that subtitle O
(Secs. 1821-1823) of title I of Pub. L. 99-570, enacting this
section and provisions set out as a note under section 801 of this
title, was to become effective 90 days after Oct. 27, 1986, was
repealed by Pub. L. 101-647, title XXIV, Sec. 2401(d), Nov. 29,
1990, 104 Stat. 4859.
-End-
-CITE-
21 USC Sec. 858 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 858. Endangering human life while illegally manufacturing
controlled substance
-STATUTE-
Whoever, while manufacturing a controlled substance in violation
of this subchapter, or attempting to do so, or transporting or
causing to be transported materials, including chemicals, to do so,
creates a substantial risk of harm to human life shall be fined in
accordance with title 18 or imprisoned not more than 10 years, or
both.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 417, as added Pub. L. 100-690,
title VI, Sec. 6301(a), Nov. 18, 1988, 102 Stat. 4370.)
-End-
-CITE-
21 USC Sec. 859 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 859. Distribution to persons under age twenty-one
-STATUTE-
(a) First offense
Except as provided in section 860 of this title, any person at
least eighteen years of age who violates section 841(a)(1) of this
title by distributing a controlled substance to a person under
twenty-one years of age is (except as provided in subsection (b) of
this section) subject to (1) twice the maximum punishment
authorized by section 841(b) of this title, and (2) at least twice
any term of supervised release authorized by section 841(b) of this
title, for a first offense involving the same controlled substance
and schedule. Except to the extent a greater minimum sentence is
otherwise provided by section 841(b) of this title, a term of
imprisonment under this subsection shall be not less than one year.
The mandatory minimum sentencing provisions of this subsection
shall not apply to offenses involving 5 grams or less of marihuana.
(b) Second offense
Except as provided in section 860 of this title, any person at
least eighteen years of age who violates section 841(a)(1) of this
title by distributing a controlled substance to a person under
twenty-one years of age after a prior conviction under subsection
(a) of this section (or under section 333(b) of this title as in
effect prior to May 1, 1971) has become final, is subject to (1)
three times the maximum punishment authorized by section 841(b) of
this title, and (2) at least three times any term of supervised
release authorized by section 841(b) of this title, for a second or
subsequent offense involving the same controlled substance and
schedule. Except to the extent a greater minimum sentence is
otherwise provided by section 841(b) of this title, a term of
imprisonment under this subsection shall be not less than one year.
Penalties for third and subsequent convictions shall be governed by
section 841(b)(1)(A) of this title.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 418, formerly Sec. 405, Oct. 27,
1970, 84 Stat. 1265; Pub. L. 98-473, title II, Secs. 224(b),
503(b)(3), Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99-570,
title I, Secs. 1004(a), 1005(b)(1), 1105(a), (b), Oct. 27, 1986,
100 Stat. 3207-6, 3207-11; Pub. L. 100-690, title VI, Secs.
6452(b), 6455, 6456, Nov. 18, 1988, 102 Stat. 4371, 4372;
renumbered Sec. 418 and amended Pub. L. 101-647, title X, Secs.
1002(a), 1003(a), title XXXV, Sec. 3599L, Nov. 29, 1990, 104 Stat.
4827, 4828, 4932.)
-COD-
CODIFICATION
Section was classified to section 845 of this title prior to
renumbering by Pub. L. 101-647.
-MISC1-
AMENDMENTS
1990 - Subsec. (a). Pub. L. 101-647, Sec. 1003(a)(1), substituted
"subject to (1) twice the maximum punishment authorized by section
841(b) of this title" for "punishable by (1) a term of
imprisonment, or a fine, or both, up to twice that authorized by
section 841(b) of this title".
Pub. L. 101-647, Sec. 1002(a)(2)(A), substituted "section 860"
for "section 845a".
Subsec. (b). Pub. L. 101-647, Sec. 3599L, substituted "has become
final" for "have become final".
Pub. L. 101-647, Sec. 1003(a)(2), substituted "subject to (1)
three times the maximum punishment authorized by section 841(b) of
this title" for "punishable by (1) a term of imprisonment, or a
fine, or both, up to three times that authorized by section 841(b)
of this title".
Pub. L. 101-647, Sec. 1002(a)(2)(B), substituted "section 860"
for "section 845a".
1988 - Subsec. (a). Pub. L. 100-690, Sec. 6455, inserted at end
"The mandatory minimum sentencing provisions of this subsection
shall not apply to offenses involving 5 grams or less of
marihuana."
Subsec. (b). Pub. L. 100-690, Sec. 6452(b), struck out "or
subsequent" after "Second" in heading, and in text struck out "or
convictions" after "a prior conviction", and inserted at end
"Penalties for third and subsequent convictions shall be governed
by section 841(b)(1)(A) of this title."
Pub. L. 100-690, Sec. 6456, struck out "The mandatory minimum
sentencing provisions of this paragraph shall not apply to offenses
involving 5 grams or less of marihuana."
1986 - Subsec. (a). Pub. L. 99-570, Sec. 1105(a), inserted
"Except to the extent a greater minimum sentence is otherwise
provided by section 841(b) of this title, a term of imprisonment
under this subsection shall be not less than one year."
Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
release" for "special parole term".
Subsec. (b). Pub. L. 99-570, Sec. 1105(b), inserted "Except to
the extent a greater minimum sentence is otherwise provided by
section 841(b) of this title, a term of imprisonment under this
subsection shall be not less than one year. The mandatory minimum
sentencing provisions of this paragraph shall not apply to offenses
involving 5 grams or less of marihuana."
Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
release" for "special parole term".
1984 - Subsecs. (a), (b). Pub. L. 98-473, Sec. 503(b)(3),
substituted "Except as provided in section 845a of this title, any"
for "Any".
Pub. L. 98-473, Sec. 224(b), which directed amendment of this
section effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98-
473 set out as an Effective Date note under section 3551 of Title
18, Crimes and Criminal Procedure) was repealed by Pub. L. 99-570,
Sec. 1005(b)(1).
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 1004(a) of Pub. L. 99-570 effective on date
of taking effect of section 3583 of Title 18, Crimes and Criminal
Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
out as a note under section 841 of this title.
-End-
-CITE-
21 USC Sec. 860 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 860. Distribution or manufacturing in or near schools and
colleges
-STATUTE-
(a) Penalty
Any person who violates section 841(a)(1) of this title or
section 856 of this title by distributing, possessing with intent
to distribute, or manufacturing a controlled substance in or on, or
within one thousand feet of, the real property comprising a public
or private elementary, vocational, or secondary school or a public
or private college, junior college, or university, or a playground,
or housing facility owned by a public housing authority, or within
100 feet of a public or private youth center, public swimming pool,
or video arcade facility, is (except as provided in subsection (b)
of this section) subject to (1) twice the maximum punishment
authorized by section 841(b) of this title; and (2) at least twice
any term of supervised release authorized by section 841(b) of this
title for a first offense. A fine up to twice that authorized by
section 841(b) of this title may be imposed in addition to any term
of imprisonment authorized by this subsection. Except to the extent
a greater minimum sentence is otherwise provided by section 841(b)
of this title, a person shall be sentenced under this subsection to
a term of imprisonment of not less than one year. The mandatory
minimum sentencing provisions of this paragraph shall not apply to
offenses involving 5 grams or less of marihuana.
(b) Second offenders
Any person who violates section 841(a)(1) of this title or
section 856 of this title by distributing, possessing with intent
to distribute, or manufacturing a controlled substance in or on, or
within one thousand feet of, the real property comprising a public
or private elementary, vocational, or secondary school or a public
or private college, junior college, or university, or a playground,
or housing facility owned by a public housing authority, or within
100 feet of a public or private youth center, public swimming pool,
or video arcade facility, after a prior conviction under subsection
(a) of this section has become final is punishable (1) by the
greater of (A) a term of imprisonment of not less than three years
and not more than life imprisonment or (B) three times the maximum
punishment authorized by section 841(b) of this title for a first
offense, and (2) at least three times any term of supervised
release authorized by section 841(b) of this title for a first
offense. A fine up to three times that authorized by section 841(b)
of this title may be imposed in addition to any term of
imprisonment authorized by this subsection. Except to the extent a
greater minimum sentence is otherwise provided by section 841(b) of
this title, a person shall be sentenced under this subsection to a
term of imprisonment of not less than three years. Penalties for
third and subsequent convictions shall be governed by section
841(b)(1)(A) of this title.
(c) Employing children to distribute drugs near schools or
playgrounds
Notwithstanding any other law, any person at least 21 years of
age who knowingly and intentionally -
(1) employs, hires, uses, persuades, induces, entices, or
coerces a person under 18 years of age to violate this section;
or
(2) employs, hires, uses, persuades, induces, entices, or
coerces a person under 18 years of age to assist in avoiding
detection or apprehension for any offense under this section by
any Federal, State, or local law enforcement official,
is punishable by a term of imprisonment, a fine, or both, up to
triple those authorized by section 841 of this title.
(d) Suspension of sentence; probation; parole
In the case of any mandatory minimum sentence imposed under this
section, imposition or execution of such sentence shall not be
suspended and probation shall not be granted. An individual
convicted under this section shall not be eligible for parole until
the individual has served the mandatory minimum term of
imprisonment as provided by this section.
(e) Definitions
For the purposes of this section -
(1) The term "playground" means any outdoor facility (including
any parking lot appurtenant thereto) intended for recreation,
open to the public, and with any portion thereof containing three
or more separate apparatus intended for the recreation of
children including, but not limited to, sliding boards,
swingsets, and teeterboards.
(2) The term "youth center" means any recreational facility
and/or gymnasium (including any parking lot appurtenant thereto),
intended primarily for use by persons under 18 years of age,
which regularly provides athletic, civic, or cultural activities.
(3) The term "video arcade facility" means any facility,
legally accessible to persons under 18 years of age, intended
primarily for the use of pinball and video machines for amusement
containing a minimum of ten pinball and/or video machines.
(4) The term "swimming pool" includes any parking lot
appurtenant thereto.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 419, formerly Sec. 405A, as added
Pub. L. 98-473, title II, Sec. 503(a), Oct. 12, 1984, 98 Stat.
2069; amended Pub. L. 99-570, title I, Secs. 1004(a), 1104,
1105(c), 1841(b), 1866(b), (c), Oct. 27, 1986, 100 Stat. 3207-6,
3207-11, 3207-52, 3207-55; Pub. L. 99-646, Sec. 28, Nov. 10, 1986,
100 Stat. 3598; Pub. L. 100-690, title VI, Secs. 6452(b)(1), 6457,
6458, Nov. 18, 1988, 102 Stat. 4371, 4373; renumbered Sec. 419 and
amended Pub. L. 101-647, title X, Secs. 1002(b), 1003(b), title
XII, Sec. 1214, title XV, Sec. 1502, title XXXV, Sec. 3599L, Nov.
29, 1990, 104 Stat. 4827, 4829, 4833, 4836, 4932; Pub. L. 103-322,
title XIV, Sec. 140006, title XXXII, Sec. 320107, title XXXIII,
Sec. 330009(a), Sept. 13, 1994, 108 Stat. 2032, 2111, 2143.)
-COD-
CODIFICATION
Section was classified to section 845a of this title prior to
renumbering by Pub. L. 101-647.
-MISC1-
AMENDMENTS
1994 - Subsec. (a). Pub. L. 103-322, Sec. 320107, substituted
"playground, or housing facility owned by a public housing
authority, or within" for "playground, or within".
Subsec. (b). Pub. L. 103-322, Secs. 320107, 330009(a),
substituted "playground, or housing facility owned by a public
housing authority, or within" for "playground, or within" and
inserted a period at end of penultimate sentence.
Subsecs. (c) to (e). Pub. L. 103-322, Sec. 140006, added subsec.
(c) and redesignated former subsecs. (c) and (d) as (d) and (e),
respectively.
1990 - Subsec. (a). Pub. L. 101-647, Sec. 1502(1), inserted "or a
playground," after "university," and struck out "playground," after
"within 100 feet of a".
Pub. L. 101-647, Sec. 1214(1)(C), substituted "a person shall be
sentenced under this subsection to a term of imprisonment of not
less than one year" for "a term of imprisonment under this
subsection shall be not less than one year".
Pub. L. 101-647, Sec. 1214(1)(B), inserted "A fine up to twice
that authorized by section 841(b) of this title may be imposed in
addition to any term of imprisonment authorized by this
subsection."
Pub. L. 101-647, Sec. 1214(1)(A), which directed the amendment of
par. (1) by striking out ", or a fine, or both," could not be
executed because those words did not appear. See note below.
Pub. L. 101-647, Sec. 1003(b)(1), which directed the substitution
of "subject to (1) twice the maximum punishment authorized by
section 841(b) of this title" for "punishable (1) by a term of
imprisonment, or a fine, or both, up to twice that authorized by
section 841(b) of this title", was executed by making the
substitution for "punishable (1) by a term of imprisonment, or
fine, or both, up to twice that authorized by section 841(b) of
this title" to reflect the probable intent of Congress.
Subsec. (b). Pub. L. 101-647, Sec. 3599L, substituted "has become
final" for "have become final".
Pub. L. 101-647, Sec. 1502(2), inserted "or a playground," after
"university," and struck out "playground," after "within 100 feet
of a".
Pub. L. 101-647, Sec. 1214(2)(B), inserted after first sentence
"A fine up to three times that authorized by section 841(b) of this
title may be imposed in addition to any term of imprisonment
authorized by this subsection. Except to the extent a greater
minimum sentence is otherwise provided by section 841(b) of this
title, a person shall be sentenced under this subsection to a term
of imprisonment of not less than three years".
Subsec. (b)(1)(B). Pub. L. 101-647, Sec. 1214(2)(A), which
directed the amendment of subpar. (B) by striking ", or a fine up
to three times that" through "or both", could not be executed
because the language did not appear after execution of the
intervening amendment by Pub. L. 101-647, Sec. 1003(b)(2). See
below.
Pub. L. 101-647, Sec. 1003(b)(2), substituted "three times the
maximum punishment authorized by section 841(b) of this title for a
first offense" for "a term of imprisonment of up to three times
that authorized by section 841(b) of this title for a first
offense, or a fine up to three times that authorized by section
841(b) of this title for a first offense, or both".
Subsec. (c). Pub. L. 101-647, Sec. 1214(3), inserted "mandatory
minimum" after "In the case of any", struck out "subsection (b) of"
after "imposed under", and substituted "An individual convicted
under this section shall not be eligible for parole until the
individual has served the mandatory minimum term of imprisonment as
provided by this section" for "An individual convicted under
subsection (b) of this section shall not be eligible for parole
under chapter 311 of title 18 until the individual has served the
minimum sentence required by such subsection".
1988 - Subsec. (a). Pub. L. 100-690, Secs. 6457, 6458(a),
inserted ", possessing with intent to distribute," after
"distributing" and ", or within 100 feet of a playground, public or
private youth center, public swimming pool, or video arcade
facility," after "university".
Subsec. (b). Pub. L. 100-690, Secs. 6452(b)(1), 6457, 6458(a),
inserted ", possessing with intent to distribute," after
"distributing", and ", or within 100 feet of a playground, public
or private youth center, public swimming pool, or video arcade
facility," after "university", substituted "a prior conviction" for
"a prior conviction or convictions", and inserted at end "Penalties
for third and subsequent convictions shall be governed by section
841(b)(1)(A) of this title."
Subsec. (d). Pub. L. 100-690, Sec. 6458(b), added subsec. (d).
1986 - Subsec. (a). Pub. L. 99-570, Secs. 1104(a), (b), 1105(c),
1841(b)(1), inserted "or section 856 of this title" and "or
manufacturing", substituted "a public or private elementary,
vocational, or secondary school or a public or private college,
junior college, or university" for "a public or private elementary
or secondary school", struck out "involving the same controlled
substance and schedule" after "for a first offense", and inserted
"Except to the extent a greater minimum sentence is otherwise
provided by section 841(b) of this title, a term of imprisonment
under this subsection shall be not less than one year. The
mandatory minimum sentencing provisions of this paragraph shall not
apply to offenses involving 5 grams or less of marihuana."
Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
release" for "special parole term".
Subsec. (b). Pub. L. 99-646 which directed that "parole" be
inserted after "(2) at least three times any special" could not be
executed in view of prior amendment by Pub. L. 99-570, Sec. 1104(c)
below.
Pub. L. 99-570, Sec. 1166(b), which directed that "term of
supervised release" be substituted for "special term" could not be
executed in view of prior amendment by Pub. L. 99-570, Sec. 1104(c)
below.
Pub. L. 99-570, Secs. 1104(a), 1841(b)(2), inserted reference to
section 856 of this title, inserted "or manufacturing" after
"distributing" and substituted "a public or private elementary,
vocational, or secondary school or a public or private college,
junior college, or university" for "a public or private elementary
or secondary school".
Pub. L. 99-570, Sec. 1104(c), amended cls. (1) and (2) generally.
Prior to amendment, cls. (1) and (2) read as follows: "(1) by a
term of imprisonment of not less than three years and not more than
life imprisonment and (2) at least three times any special term
authorized by section 841(b) of this title for a second or
subsequent offense involving the same controlled substance and
schedule."
Subsec. (c). Pub. L. 99-570, Sec. 1866(c), substituted reference
to chapter 311 of title 18 for reference to section 4202 of that
title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 1004(a) of Pub. L. 99-570 effective on date
of taking effect of section 3583 of Title 18, Crimes and Criminal
Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
out as a note under section 841 of this title.
-End-
-CITE-
21 USC Sec. 860a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 860a. Consecutive sentence for manufacturing or distributing,
or possessing with intent to manufacture or distribute,
methamphetamine on premises where children are present or reside
-STATUTE-
Whoever violates section 841(a)(1) of this title by manufacturing
or distributing, or possessing with intent to manufacture or
distribute, methamphetamine or its salts, isomers or salts of
isomers on premises in which an individual who is under the age of
18 years is present or resides, shall, in addition to any other
sentence imposed, be imprisoned for a period of any term of years
but not more than 20 years, subject to a fine, or both.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 419a, as added Pub. L. 109-177,
title VII, Sec. 734(a), Mar. 9, 2006, 120 Stat. 270.)
-End-
-CITE-
21 USC Sec. 861 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 861. Employment or use of persons under 18 years of age in
drug operations
-STATUTE-
(a) Unlawful acts
It shall be unlawful for any person at least eighteen years of
age to knowingly and intentionally -
(1) employ, hire, use, persuade, induce, entice, or coerce, a
person under eighteen years of age to violate any provision of
this subchapter or subchapter II of this chapter;
(2) employ, hire, use, persuade, induce, entice, or coerce, a
person under eighteen years of age to assist in avoiding
detection or apprehension for any offense of this subchapter or
subchapter II of this chapter by any Federal, State, or local law
enforcement official; or
(3) receive a controlled substance from a person under 18 years
of age, other than an immediate family member, in violation of
this subchapter or subchapter II of this chapter.
(b) Penalty for first offense
Any person who violates subsection (a) of this section is subject
to twice the maximum punishment otherwise authorized and at least
twice any term of supervised release otherwise authorized for a
first offense. Except to the extent a greater minimum sentence is
otherwise provided, a term of imprisonment under this subsection
shall not be less than one year.
(c) Penalty for subsequent offenses
Any person who violates subsection (a) of this section after a
prior conviction under subsection (a) of this section has become
final, is subject to three times the maximum punishment otherwise
authorized and at least three times any term of supervised release
otherwise authorized for a first offense. Except to the extent a
greater minimum sentence is otherwise provided, a term of
imprisonment under this subsection shall not be less than one year.
Penalties for third and subsequent convictions shall be governed by
section 841(b)(1)(A) of this title.
(d) Penalty for providing or distributing controlled substance to
underage person
Any person who violates subsection (a)(1) or (2) of this section
(!1)
(1) by knowingly providing or distributing a controlled
substance or a controlled substance analogue to any person under
eighteen years of age; or
(2) if the person employed, hired, or used is fourteen years of
age or younger,
shall be subject to a term of imprisonment for not more than five
years or a fine of not more than $50,000, or both, in addition to
any other punishment authorized by this section.
(e) Suspension of sentence; probation; parole
In any case of any sentence imposed under this section,
imposition or execution of such sentence shall not be suspended and
probation shall not be granted. An individual convicted under this
section of an offense for which a mandatory minimum term of
imprisonment is applicable shall not be eligible for parole under
section 4202 of title 18 (!2) until the individual has served the
mandatory term of imprisonment as enhanced by this section.
(f) Distribution of controlled substance to pregnant individual
Except as authorized by this subchapter, it shall be unlawful for
any person to knowingly or intentionally provide or distribute any
controlled substance to a pregnant individual in violation of any
provision of this subchapter. Any person who violates this
subsection shall be subject to the provisions of subsections (b),
(c), and (e) of this section.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 420, formerly Sec. 405B, as added
Pub. L. 99-570, title I, Sec. 1102, Oct. 27, 1986, 100 Stat. 3207-
10; amended Pub. L. 100-690, title VI, Secs. 6452(b)(1), 6459,
6470(d), Nov. 18, 1988, 102 Stat. 4371, 4373, 4378; renumbered Sec.
420 and amended Pub. L. 101-647, title X, Secs. 1002(c), 1003(c),
title XXXV, Sec. 3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4932.)
-REFTEXT-
REFERENCES IN TEXT
Section 4202 of title 18, referred to in subsec. (e), which, as
originally enacted in Title 18, Crimes and Criminal Procedure,
related to eligibility of prisoners for parole, was repealed and a
new section 4202 enacted as part of the repeal and enactment of a
new chapter 311 (Sec. 4201 et seq.) of Title 18, by Pub. L. 94-233,
Sec. 2, Mar. 15, 1976, 90 Stat. 219. For provisions relating to the
eligibility of prisoners for parole, see section 4205 of Title 18.
Pub. L. 98-473, title II, Secs. 218(a)(5), 235(a)(1), (b)(1), Oct.
12, 1984, 98 Stat. 2027, 2031, 2032, as amended, provided that,
effective on the first day of the first calendar month beginning 36
months after Oct. 12, 1984 (Nov. 1, 1987), chapter 311 of Title 18
is repealed, subject to remaining effective for five years after
Nov. 1, 1987, in certain circumstances. See Effective Date note set
out under section 3551 of Title 18.
-COD-
CODIFICATION
Section was classified to section 845b of this title prior to
renumbering by Pub. L. 101-647.
-MISC1-
AMENDMENTS
1990 - Subsec. (b). Pub. L. 101-647, Sec. 1003(c)(1), which
directed the substitution of "is subject to twice the maximum
punishment otherwise authorized" for "is punishable by a term of
imprisonment up to twice that authorized, or up to twice the fine
authorized, or both," was executed by making the substitution for
"is punishable by a term of imprisonment up to twice that otherwise
authorized, or up to twice the fine otherwise authorized, or both,"
to reflect the probable intent of Congress.
Subsec. (c). Pub. L. 101-647, Sec. 3599L, substituted "has become
final" for "have become final".
Pub. L. 101-647, Sec. 1003(c)(2), which directed the substitution
of "is subject to three times the maximum punishment otherwise
authorized" for "is punishable by a term of imprisonment up to
three times that authorized, or up to three times the fine
authorized, or both," was executed by making the substitution for
"is punishable by a term of imprisonment up to three times that
otherwise authorized, or up to three times the fine otherwise
authorized, or both," to reflect the probable intent of Congress.
1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6459, added par.
(3).
Subsec. (c). Pub. L. 100-690, Sec. 6452(b)(1), struck out "or
convictions" after "a prior conviction" and inserted at end
"Penalties for third and subsequent convictions shall be governed
by section 841(b)(1)(A) of this title."
Subsec. (e). Pub. L. 100-690, Sec. 6470(d), struck out "required
by section 841(b) of this title" after "mandatory term of
imprisonment".
-FOOTNOTE-
(!1) So in original. Probably should be followed by a dash.
(!2) See References in Text note below.
-End-
-CITE-
21 USC Sec. 862 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 862. Denial of Federal benefits to drug traffickers and
possessors
-STATUTE-
(a) Drug traffickers
(1) Any individual who is convicted of any Federal or State
offense consisting of the distribution of controlled substances
shall -
(A) at the discretion of the court, upon the first conviction
for such an offense be ineligible for any or all Federal benefits
for up to 5 years after such conviction;
(B) at the discretion of the court, upon a second conviction
for such an offense be ineligible for any or all Federal benefits
for up to 10 years after such conviction; and
(C) upon a third or subsequent conviction for such an offense
be permanently ineligible for all Federal benefits.
(2) The benefits which are denied under this subsection shall not
include benefits relating to long-term drug treatment programs for
addiction for any person who, if there is a reasonable body of
evidence to substantiate such declaration, declares himself to be
an addict and submits himself to a long-term treatment program for
addiction, or is deemed to be rehabilitated pursuant to rules
established by the Secretary of Health and Human Services.
(b) Drug possessors
(1) Any individual who is convicted of any Federal or State
offense involving the possession of a controlled substance (as such
term is defined for purposes of this subchapter) shall -
(A) upon the first conviction for such an offense and at the
discretion of the court -
(i) be ineligible for any or all Federal benefits for up to
one year;
(ii) be required to successfully complete an approved drug
treatment program which includes periodic testing to insure
that the individual remains drug free;
(iii) be required to perform appropriate community service;
or
(iv) any combination of clause (i), (ii), or (iii); and
(B) upon a second or subsequent conviction for such an offense
be ineligible for all Federal benefits for up to 5 years after
such conviction as determined by the court. The court shall
continue to have the discretion in subparagraph (A) above. In
imposing penalties and conditions under subparagraph (A), the
court may require that the completion of the conditions imposed
by clause (ii) or (iii) be a requirement for the reinstatement of
benefits under clause (i).
(2) The penalties and conditions which may be imposed under this
subsection shall be waived in the case of a person who, if there is
a reasonable body of evidence to substantiate such declaration,
declares himself to be an addict and submits himself to a long-term
treatment program for addiction, or is deemed to be rehabilitated
pursuant to rules established by the Secretary of Health and Human
Services.
(c) Suspension of period of ineligibility
The period of ineligibility referred to in subsections (a) and
(b) of this section shall be suspended if the individual -
(A) completes a supervised drug rehabilitation program after
becoming ineligible under this section;
(B) has otherwise been rehabilitated; or
(C) has made a good faith effort to gain admission to a
supervised drug rehabilitation program, but is unable to do so
because of inaccessibility or unavailability of such a program,
or the inability of the individual to pay for such a program.
(d) Definitions
As used in this section -
(1) the term "Federal benefit" -
(A) means the issuance of any grant, contract, loan,
professional license, or commercial license provided by an
agency of the United States or by appropriated funds of the
United States; and
(B) does not include any retirement, welfare, Social
Security, health, disability, veterans benefit, public housing,
or other similar benefit, or any other benefit for which
payments or services are required for eligibility; and
(2) the term "veterans benefit" means all benefits provided to
veterans, their families, or survivors by virtue of the service
of a veteran in the Armed Forces of the United States.
(e) Inapplicability of this section to Government witnesses
The penalties provided by this section shall not apply to any
individual who cooperates or testifies with the Government in the
prosecution of a Federal or State offense or who is in a Government
witness protection program.
(f) Indian provision
Nothing in this section shall be construed to affect the
obligation of the United States to any Indian or Indian tribe
arising out of any treaty, statute, Executive order, or the trust
responsibility of the United States owing to such Indian or Indian
tribe. Nothing in this subsection shall exempt any individual
Indian from the sanctions provided for in this section, provided
that no individual Indian shall be denied any benefit under Federal
Indian programs comparable to those described in subsection
(d)(1)(B) or (d)(2) of this section.
(g) Presidential report
(1) On or before May 1, 1989, the President shall transmit to the
Congress a report -
(A) delineating the role of State courts in implementing this
section;
(B) describing the manner in which Federal agencies will
implement and enforce the requirements of this section;
(C) detailing the means by which Federal and State agencies,
courts, and law enforcement agencies will exchange and share the
data and information necessary to implement and enforce the
withholding of Federal benefits; and
(D) recommending any modifications to improve the
administration of this section or otherwise achieve the goal of
discouraging the trafficking and possession of controlled
substances.
(2) No later than September 1, 1989, the Congress shall consider
the report of the President and enact such changes as it deems
appropriate to further the goals of this section.
(h) Effective date
The denial of Federal benefits set forth in this section shall
take effect for convictions occurring after September 1, 1989.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 421, formerly Pub. L. 100-690,
title V, Sec. 5301, Nov. 18, 1988, 102 Stat. 4310; renumbered Sec.
421 of Pub. L. 91-513 and amended Pub. L. 101-647, title X, Sec.
1002(d), Nov. 29, 1990, 104 Stat. 4827.)
-COD-
CODIFICATION
Section was classified to section 853a of this title prior to
renumbering by Pub. L. 101-647.
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-647, Sec. 1002(d)(1), renumbered section 853a
of this title as this section.
Subsec. (a)(1). Pub. L. 101-647, Sec. 1002(d)(2), struck out "(as
such terms are defined for purposes of the Controlled Substances
Act)" after "controlled substances" in introductory provisions.
-End-
-CITE-
21 USC Sec. 862a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 862a. Denial of assistance and benefits for certain drug-
related convictions
-STATUTE-
(a) In general
An individual convicted (under Federal or State law) of any
offense which is classified as a felony by the law of the
jurisdiction involved and which has as an element the possession,
use, or distribution of a controlled substance (as defined in
section 802(6) of this title) shall not be eligible for -
(1) assistance under any State program funded under part A of
title IV of the Social Security Act [42 U.S.C. 601 et seq.], or
(2) benefits under the food stamp program (as defined in
section 3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]) or
any State program carried out under the Food Stamp Act of 1977 [7
U.S.C. 2011 et seq.].
(b) Effects on assistance and benefits for others
(1) Program of temporary assistance for needy families
The amount of assistance otherwise required to be provided
under a State program funded under part A of title IV of the
Social Security Act [42 U.S.C. 601 et seq.] to the family members
of an individual to whom subsection (a) of this section applies
shall be reduced by the amount which would have otherwise been
made available to the individual under such part.
(2) Benefits under the Food Stamp Act of 1977
The amount of benefits otherwise required to be provided to a
household under the food stamp program (as defined in section
3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]), or any
State program carried out under the Food Stamp Act of 1977 [7
U.S.C. 2011 et seq.], shall be determined by considering the
individual to whom subsection (a) of this section applies not to
be a member of such household, except that the income and
resources of the individual shall be considered to be income and
resources of the household.
(c) Enforcement
A State that has not exercised its authority under subsection
(d)(1)(A) of this section shall require each individual applying
for assistance or benefits referred to in subsection (a) of this
section, during the application process, to state, in writing,
whether the individual, or any member of the household of the
individual, has been convicted of a crime described in subsection
(a) of this section.
(d) Limitations
(1) State elections
(A) Opt out
A State may, by specific reference in a law enacted after
August 22, 1996, exempt any or all individuals domiciled in the
State from the application of subsection (a) of this section.
(B) Limit period of prohibition
A State may, by law enacted after August 22, 1996, limit the
period for which subsection (a) of this section shall apply to
any or all individuals domiciled in the State.
(2) Inapplicability to convictions occurring on or before August
22, 1996
Subsection (a) of this section shall not apply to a conviction
if the conviction is for conduct occurring on or before August
22, 1996.
(e) "State" defined
For purposes of this section, the term "State" has the meaning
given it -
(1) in section 419(5) of the Social Security Act [42 U.S.C.
619(5)], when referring to assistance provided under a State
program funded under part A of title IV of the Social Security
Act [42 U.S.C. 601 et seq.], and
(2) in section 3(m) of the Food Stamp Act of 1977 [7 U.S.C.
2012(m)], when referring to the food stamp program (as defined in
section 3(h) of the Food Stamp Act of 1977 [7 U.S.C. 2012(h)]) or
any State program carried out under the Food Stamp Act of 1977 [7
U.S.C. 2011 et seq.].
(f) Rule of interpretation
Nothing in this section shall be construed to deny the following
Federal benefits:
(1) Emergency medical services under title XIX of the Social
Security Act [42 U.S.C. 1396 et seq.].
(2) Short-term, noncash, in-kind emergency disaster relief.
(3)(A) Public health assistance for immunizations.
(B) Public health assistance for testing and treatment of
communicable diseases if the Secretary of Health and Human
Services determines that it is necessary to prevent the spread of
such disease.
(4) Prenatal care.
(5) Job training programs.
(6) Drug treatment programs.
-SOURCE-
(Pub. L. 104-193, title I, Sec. 115, Aug. 22, 1996, 110 Stat. 2180;
Pub. L. 105-33, title V, Sec. 5516(a), Aug. 5, 1997, 111 Stat.
620.)
-REFTEXT-
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (a)(1), (b)(1),
(e)(1), and (f)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as
amended. Part A of title IV of the Act is classified generally to
part A (Sec. 601 et seq.) of subchapter IV of chapter 7 of Title
42, The Public Health and Welfare. Title XIX of the Act is
classified generally to subchapter XIX (Sec. 1396 et seq.) of
chapter 7 of Title 42. For complete classification of this Act to
the Code, see section 1305 of Title 42 and Tables.
The Food Stamp Act of 1977, referred to in subsecs. (a)(2),
(b)(2), and (e)(2), is Pub. L. 88-525, Aug. 31, 1964, 78 Stat. 703,
as amended, which is classified generally to chapter 51 (Sec. 2011
et seq.) of Title 7, Agriculture. For complete classification of
this Act to the Code, see Short Title note set out under section
2011 of Title 7 and Tables.
-COD-
CODIFICATION
Section was enacted as part of the Personal Responsibility and
Work Opportunity Reconciliation Act of 1996, and not as part of the
Controlled Substances Act which comprises this subchapter.
-MISC1-
AMENDMENTS
1997 - Subsec. (d)(2). Pub. L. 105-33 substituted "a conviction
if the conviction is for conduct" for "convictions".
EFFECTIVE DATE OF 1997 AMENDMENT
Section 5518(d) of title V of Pub. L. 105-33 provided that: "The
amendments made by this chapter to a provision of the Personal
Responsibility and Work Opportunity Reconciliation Act of 1996
[Pub. L. 104-193] that have not become part of another statute
[chapter 1 (Secs. 5501-5518) of subtitle F of title V of Pub. L.
105-33, amending this section, sections 601 to 603, 604 to 608, 609
to 611, and 612 to 617 of Title 42, The Public Health and Welfare,
and provisions set out as notes under section 612c of Title 7,
Agriculture, and sections 601 and 613 of Title 42] shall take
effect as if the amendments had been included in the provision at
the time the provision became law."
EFFECTIVE DATE
Section effective July 1, 1997, with transition rules relating to
State options to accelerate such date, rules relating to claims,
actions, and proceedings commenced before such date, rules relating
to closing out of accounts for terminated or substantially modified
programs and continuance in office of Assistant Secretary for
Family Support, and provisions relating to termination of
entitlement under AFDC program, see section 116 of Pub. L. 104-193,
as amended, set out as an Effective Date note under section 601 of
Title 42, The Public Health and Welfare.
-End-
-CITE-
21 USC Sec. 862b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 862b. Sanctioning for testing positive for controlled
substances
-STATUTE-
Notwithstanding any other provision of law, States shall not be
prohibited by the Federal Government from testing welfare
recipients for use of controlled substances nor from sanctioning
welfare recipients who test positive for use of controlled
substances.
-SOURCE-
(Pub. L. 104-193, title IX, Sec. 902, Aug. 22, 1996, 110 Stat.
2347.)
-COD-
CODIFICATION
Section was enacted as part of the Personal Responsibility and
Work Opportunity Reconciliation Act of 1996, and not as part of the
Controlled Substances Act which comprises this subchapter.
-End-
-CITE-
21 USC Sec. 863 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 863. Drug paraphernalia
-STATUTE-
(a) In general
It is unlawful for any person -
(1) to sell or offer for sale drug paraphernalia;
(2) to use the mails or any other facility of interstate
commerce to transport drug paraphernalia; or
(3) to import or export drug paraphernalia.
(b) Penalties
Anyone convicted of an offense under subsection (a) of this
section shall be imprisoned for not more than three years and fined
under title 18.
(c) Seizure and forfeiture
Any drug paraphernalia involved in any violation of subsection
(a) of this section shall be subject to seizure and forfeiture upon
the conviction of a person for such violation. Any such
paraphernalia shall be delivered to the Administrator of General
Services, General Services Administration, who may order such
paraphernalia destroyed or may authorize its use for law
enforcement or educational purposes by Federal, State, or local
authorities.
(d) "Drug paraphernalia" defined
The term "drug paraphernalia" means any equipment, product, or
material of any kind which is primarily intended or designed for
use in manufacturing, compounding, converting, concealing,
producing, processing, preparing, injecting, ingesting, inhaling,
or otherwise introducing into the human body a controlled
substance, possession of which is unlawful under this subchapter.
It includes items primarily intended or designed for use in
ingesting, inhaling, or otherwise introducing marijuana,(!1)
cocaine, hashish, hashish oil, PCP, methamphetamine, or
amphetamines into the human body, such as -
(1) metal, wooden, acrylic, glass, stone, plastic, or ceramic
pipes with or without screens, permanent screens, hashish heads,
or punctured metal bowls;
(2) water pipes;
(3) carburetion tubes and devices;
(4) smoking and carburetion masks;
(5) roach clips: meaning objects used to hold burning material,
such as a marihuana cigarette, that has become too small or too
short to be held in the hand;
(6) miniature spoons with level capacities of one-tenth cubic
centimeter or less;
(7) chamber pipes;
(8) carburetor pipes;
(9) electric pipes;
(10) air-driven pipes;
(11) chillums;
(12) bongs;
(13) ice pipes or chillers;
(14) wired cigarette papers; or
(15) cocaine freebase kits.
(e) Matters considered in determination of what constitutes drug
paraphernalia
In determining whether an item constitutes drug paraphernalia, in
addition to all other logically relevant factors, the following may
be considered:
(1) instructions, oral or written, provided with the item
concerning its use;
(2) descriptive materials accompanying the item which explain
or depict its use;
(3) national and local advertising concerning its use;
(4) the manner in which the item is displayed for sale;
(5) whether the owner, or anyone in control of the item, is a
legitimate supplier of like or related items to the community,
such as a licensed distributor or dealer of tobacco products;
(6) direct or circumstantial evidence of the ratio of sales of
the item(s) to the total sales of the business enterprise;
(7) the existence and scope of legitimate uses of the item in
the community; and
(8) expert testimony concerning its use.
(f) Exemptions
This section shall not apply to -
(1) any person authorized by local, State, or Federal law to
manufacture, possess, or distribute such items; or
(2) any item that, in the normal lawful course of business, is
imported, exported, transported, or sold through the mail or by
any other means, and traditionally intended for use with tobacco
products, including any pipe, paper, or accessory.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 422, as added and amended Pub. L.
101-647, title XXIV, Sec. 2401(a)-(c), Nov. 29, 1990, 104 Stat.
4858, 4859; Pub. L. 106-310, div. B, title XXXVI, Sec. 3614, Oct.
17, 2000, 114 Stat. 1230.)
-COD-
CODIFICATION
The text of section 857(b) to (f) of this title, which was
transferred to subsecs. (b) to (f) of this section by Pub. L. 101-
647, Sec. 2401(b), was based on Pub. L. 99-570, title I, Sec.
1822(b)-(f), Oct. 27, 1986, 100 Stat. 3207-51; Pub. L. 100-690,
title VI, Sec. 6485, Nov. 18, 1988, 102 Stat. 4384.
-MISC1-
AMENDMENTS
2000 - Subsec. (d). Pub. L. 106-310 inserted "methamphetamine,"
after "PCP," in introductory provisions.
1990 - Subsec. (b). Pub. L. 101-647, Sec. 2401(c)(1), substituted
"fined under title 18" for "fined not more than $100,000".
Pub. L. 101-647, Sec. 2401(b), redesignated subsec. (b) of
section 857 of this title as subsec. (b) of this section. See
Codification note above.
Subsecs. (c) to (e). Pub. L. 101-647, Sec. 2401(b), redesignated
subsecs. (c) to (e) of section 857 of this title as subsecs. (c) to
(e) of this section. See Codification note above.
Subsec. (f). Pub. L. 101-647, Sec. 2401(c)(2), made technical
amendment to reference to "This section" to correct reference to
corresponding provision of original act.
Pub. L. 101-647, Sec. 2401(b), redesignated subsec. (f) of
section 857 of this title as subsec. (f) of this section. See
Codification note above.
-FOOTNOTE-
(!1) So in original. Probably should be "marihuana,".
-End-
-CITE-
21 USC Sec. 864 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 864. Anhydrous ammonia
-STATUTE-
(a) It is unlawful for any person -
(1) to steal anhydrous ammonia, or
(2) to transport stolen anhydrous ammonia across State lines,
knowing, intending, or having reasonable cause to believe that such
anhydrous ammonia will be used to manufacture a controlled
substance in violation of this part.
(b) Any person who violates subsection (a) of this section shall
be imprisoned or fined, or both, in accordance with section 843(d)
of this title as if such violation were a violation of a provision
of section 843 of this title.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 423, as added Pub. L. 106-310, div.
B, title XXXVI, Sec. 3653(a), Oct. 17, 2000, 114 Stat. 1240.)
-End-
-CITE-
21 USC Sec. 865 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
-HEAD-
Sec. 865. Smuggling methamphetamine or methamphetamine precursor
chemicals into the United States while using facilitated entry
programs
-STATUTE-
(a) Enhanced prison sentence
The sentence of imprisonment imposed on a person convicted of an
offense under the Controlled Substances Act (21 U.S.C. 801 et seq.)
or the Controlled Substances Import and Export Act (21 U.S.C. 951
et seq.), involving methamphetamine or any listed chemical that is
defined in section 102(33) of the Controlled Substances Act (21
U.S.C. 802(33),(!1) shall, if the offense is committed under the
circumstance described in subsection (b), be increased by a
consecutive term of imprisonment of not more than 15 years.
(b) Circumstances
For purposes of subsection (a), the circumstance described in
this subsection is that the offense described in subsection (a) was
committed by a person who -
(1) was enrolled in, or who was acting on behalf of any person
or entity enrolled in, any dedicated commuter lane, alternative
or accelerated inspection system, or other facilitated entry
program administered or approved by the Federal Government for
use in entering the United States; and
(2) committed the offense while entering the United States,
using such lane, system, or program.
(c) Permanent ineligibility
Any person whose term of imprisonment is increased under
subsection (a) shall be permanently and irrevocably barred from
being eligible for or using any lane, system, or program described
in subsection (b)(1).
-SOURCE-
(Pub. L. 109-177, title VII, Sec. 731, Mar. 9, 2006, 120 Stat.
270.)
-REFTEXT-
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (a), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, which is classified principally to this subchapter. For
complete classification of this Act to the Code, see Short Title
note set out under section 801 of this title and Tables.
The Controlled Substances Import and Export Act, referred to in
subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84
Stat. 1285, as amended, which is classified principally to
subchapter II (Sec. 951 et seq.) of this chapter. For complete
classification of this Act to the Code, see Short Title note set
out under section 951 of this title and Tables.
-COD-
CODIFICATION
Section was enacted as part of the USA PATRIOT Improvement and
Reauthorization Act of 2005 and also as part of the Combat
Methamphetamine Epidemic Act of 2005, and not as part of the
Controlled Substances Act which comprises this subchapter.
-FOOTNOTE-
(!1) So in original. A second closing parenthesis probably should
precede the comma.
-End-
-CITE-
21 USC Part E - Administrative and Enforcement Provisions 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
PART E - ADMINISTRATIVE AND ENFORCEMENT PROVISIONS
-End-
-CITE-
21 USC Sec. 871 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 871. Attorney General
-STATUTE-
(a) Delegation of functions
The Attorney General may delegate any of his functions under this
subchapter to any officer or employee of the Department of Justice.
(b) Rules and regulations
The Attorney General may promulgate and enforce any rules,
regulations, and procedures which he may deem necessary and
appropriate for the efficient execution of his functions under this
subchapter.
(c) Acceptance of devises, bequests, gifts, and donations
The Attorney General may accept in the name of the Department of
Justice any form of devise, bequest, gift, or donation where the
donor intends to donate property for the purpose of preventing or
controlling the abuse of controlled substances. He may take all
appropriate steps to secure possession of such property and may
sell, assign, transfer, or convey any such property other than
moneys.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 501, Oct. 27, 1970, 84 Stat. 1270.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in subsecs. (a) and (b), was in the
original "this title", meaning title II of Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, as amended, and is popularly known as the
"Controlled Substances Act". For complete classification of title
II to the Code, see second paragraph of Short Title note set out
under section 801 of this title and Tables.
-End-
-CITE-
21 USC Sec. 871a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 871a. Semiannual reports to Congress
-STATUTE-
(a) In general
The Attorney General shall, on a semiannual basis, submit to the
congressional committees and organizations specified in subsection
(b) reports that -
(1) describe the allocation of the resources of the Drug
Enforcement Administration and the Federal Bureau of
Investigation for the investigation and prosecution of alleged
violations of the Controlled Substances Act [21 U.S.C. 801 et
seq.] involving methamphetamine; and
(2) the measures being taken to give priority in the allocation
of such resources to such violations involving -
(A) persons alleged to have imported into the United States
substantial quantities of methamphetamine or scheduled listed
chemicals (as defined pursuant to the amendment made by section
711(a)(1)); (!1)
(B) persons alleged to have manufactured methamphetamine; and
(C) circumstances in which the violations have endangered
children.
(b) Congressional committees
The congressional committees and organizations referred to in
subsection (a) are -
(1) in the House of Representatives, the Committee on the
Judiciary, the Committee on Energy and Commerce, and the
Committee on Government Reform; and
(2) in the Senate, the Committee on the Judiciary, the
Committee on Commerce, Science, and Transportation, and the
Caucus on International Narcotics Control.
-SOURCE-
(Pub. L. 109-177, title VII, Sec. 736, Mar. 9, 2006, 120 Stat.
271.)
-REFTEXT-
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (a)(1), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, which is classified principally to this subchapter. For
complete classification of this Act to the Code, see Short Title
note set out under section 801 of this title and Tables.
Section 711(a)(1), referred to in subsec. (a)(2)(A), is section
711(a)(1) of Pub. L. 109-177, which amended section 802 of this
title.
-COD-
CODIFICATION
Section was enacted as part of the USA PATRIOT Improvement and
Reauthorization Act of 2005 and also as part of the Combat
Methamphetamine Epidemic Act of 2005, and not as part of the
Controlled Substances Act which comprises this subchapter.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 872 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 872. Education and research programs of Attorney General
-STATUTE-
(a) Authorization
The Attorney General is authorized to carry out educational and
research programs directly related to enforcement of the laws under
his jurisdiction concerning drugs or other substances which are or
may be subject to control under this subchapter. Such programs may
include -
(1) educational and training programs on drug abuse and
controlled substances law enforcement for local, State, and
Federal personnel;
(2) studies or special projects designed to compare the
deterrent effects of various enforcement strategies on drug use
and abuse;
(3) studies or special projects designed to assess and detect
accurately the presence in the human body of drugs or other
substances which are or may be subject to control under this
subchapter, including the development of rapid field
identification methods which would enable agents to detect
microquantities of such drugs or other substances;
(4) studies or special projects designed to evaluate the nature
and sources of the supply of illegal drugs throughout the
country;
(5) studies or special projects to develop more effective
methods to prevent diversion of controlled substances into
illegal channels; and
(6) studies or special projects to develop information
necessary to carry out his functions under section 811 of this
title.
(b) Contracts
The Attorney General may enter into contracts for such
educational and research activities without performance bonds and
without regard to section 5 of title 41.
(c) Identification of research populations; authorization to
withhold
The Attorney General may authorize persons engaged in research to
withhold the names and other identifying characteristics of persons
who are the subjects of such research. Persons who obtain this
authorization may not be compelled in any Federal, State, or local
civil, criminal, administrative, legislative, or other proceeding
to identify the subjects of research for which such authorization
was obtained.
(d) Affect of treaties and other international agreements on
confidentiality
Nothing in the Single Convention on Narcotic Drugs, the
Convention on Psychotropic Substances, or other treaties or
international agreements shall be construed to limit, modify, or
prevent the protection of the confidentiality of patient records or
of the names and other identifying characteristics of research
subjects as provided by any Federal, State, or local law or
regulation.
(e) Use of controlled substances in research
The Attorney General, on his own motion or at the request of the
Secretary, may authorize the possession, distribution, and
dispensing of controlled substances by persons engaged in research.
Persons who obtain this authorization shall be exempt from State or
Federal prosecution for possession, distribution, and dispensing of
controlled substances to the extent authorized by the Attorney
General.
(f) Program to curtail diversion of precursor and essential
chemicals
The Attorney General shall maintain an active program, both
domestic and international, to curtail the diversion of precursor
chemicals and essential chemicals used in the illicit manufacture
of controlled substances.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 502, Oct. 27, 1970, 84 Stat. 1271;
Pub. L. 95-633, title I, Sec. 108(a), Nov. 10, 1978, 92 Stat. 3773;
Pub. L. 100-690, title VI, Sec. 6060, Nov. 18, 1988, 102 Stat.
4320.)
-MISC1-
AMENDMENTS
1988 - Subsec. (f). Pub. L. 100-690 added subsec. (f).
1978 - Subsecs. (d), (e). Pub. L. 95-633 added subsec. (d) and
redesignated former subsec. (d) as (e).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
TRAINING FOR DRUG ENFORCEMENT ADMINISTRATION AND STATE AND LOCAL
LAW ENFORCEMENT PERSONNEL RELATING TO CLANDESTINE LABORATORIES
Pub. L. 106-310, div. B, title XXXVI, Sec. 3623, Oct. 17, 2000,
114 Stat. 1231, provided that:
"(a) In General. -
"(1) Requirement. - The Administrator of the Drug Enforcement
Administration shall carry out the programs described in
subsection (b) with respect to the law enforcement personnel of
States and localities determined by the Administrator to have
significant levels of methamphetamine-related or amphetamine-
related crime or projected by the Administrator to have the
potential for such levels of crime in the future.
"(2) Duration. - The duration of any program under that
subsection may not exceed 3 years.
"(b) Covered Programs. - The programs described in this
subsection are as follows:
"(1) Advanced mobile clandestine laboratory training teams. - A
program of advanced mobile clandestine laboratory training teams,
which shall provide information and training to State and local
law enforcement personnel in techniques utilized in conducting
undercover investigations and conspiracy cases, and other
information designed to assist in the investigation of the
illegal manufacturing and trafficking of amphetamine and
methamphetamine.
"(2) Basic clandestine laboratory certification training. - A
program of basic clandestine laboratory certification training,
which shall provide information and training -
"(A) to Drug Enforcement Administration personnel and State
and local law enforcement personnel for purposes of enabling
such personnel to meet any certification requirements under law
with respect to the handling of wastes created by illegal
amphetamine and methamphetamine laboratories; and
"(B) to State and local law enforcement personnel for
purposes of enabling such personnel to provide the information
and training covered by subparagraph (A) to other State and
local law enforcement personnel.
"(3) Clandestine laboratory recertification and awareness
training. - A program of clandestine laboratory recertification
and awareness training, which shall provide information and
training to State and local law enforcement personnel for
purposes of enabling such personnel to provide recertification
and awareness training relating to clandestine laboratories to
additional State and local law enforcement personnel.
"(c) Authorization of Appropriations. - There are authorized to
be appropriated for each of fiscal years 2000, 2001, and 2002
amounts as follows:
"(1) $1,500,000 to carry out the program described in
subsection (b)(1).
"(2) $3,000,000 to carry out the program described in
subsection (b)(2).
"(3) $1,000,000 to carry out the program described in
subsection (b)(3)."
EDUCATIONAL PROGRAM FOR POLICE DEPARTMENTS
Pub. L. 104-305, Sec. 4, Oct. 13, 1996, 110 Stat. 3809, provided
that: "The Attorney General may -
"(1) create educational materials regarding the use of
controlled substances (as that term is defined in section 102 of
the Controlled Substances Act [21 U.S.C. 802]) in the furtherance
of rapes and sexual assaults; and
"(2) disseminate those materials to police departments
throughout the United States."
STUDY AND REPORT ON MEASURES TO PREVENT SALES OF AGENTS USED IN
METHAMPHETAMINE PRODUCTION
Pub. L. 104-237, title II, Sec. 202, Oct. 3, 1996, 110 Stat.
3101, provided that:
"(a) Study. - The Attorney General of the United States shall
conduct a study on possible measures to effectively prevent the
diversion of red phosphorous, iodine, hydrochloric gas, and other
agents for use in the production of methamphetamine. Nothing in
this section shall preclude the Attorney General from taking any
action the Attorney General already is authorized to take with
regard to the regulation of listed chemicals under current law.
"(b) Report. - Not later than January 1, 1998, the Attorney
General shall submit a report to the Congress of its findings
pursuant to the study conducted under subsection (a) on the need
for and advisability of preventive measures.
"(c) Considerations. - In developing recommendations under
subsection (b), the Attorney General shall consider -
"(1) the use of red phosphorous, iodine, hydrochloric gas, and
other agents in the illegal manufacture of methamphetamine;
"(2) the use of red phosphorous, iodine, hydrochloric gas, and
other agents for legitimate, legal purposes, and the impact any
regulations may have on these legitimate purposes; and
"(3) comments and recommendations from law enforcement,
manufacturers of such chemicals, and the consumers of such
chemicals for legitimate, legal purposes."
-End-
-CITE-
21 USC Sec. 872a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 872a. Public-private education program
-STATUTE-
(a) Advisory panel
The Attorney General shall establish an advisory panel consisting
of an appropriate number of representatives from Federal, State,
and local law enforcement and regulatory agencies with experience
in investigating and prosecuting illegal transactions of precursor
chemicals. The Attorney General shall convene the panel as often as
necessary to develop and coordinate educational programs for
wholesale and retail distributors of precursor chemicals and
supplies.
(b) Continuation of current efforts
The Attorney General shall continue to -
(1) maintain an active program of seminars and training to
educate wholesale and retail distributors of precursor chemicals
and supplies regarding the identification of suspicious
transactions and their responsibility to report such
transactions; and
(2) provide assistance to State and local law enforcement and
regulatory agencies to facilitate the establishment and
maintenance of educational programs for distributors of precursor
chemicals and supplies.
-SOURCE-
(Pub. L. 104-237, title V, Sec. 503, Oct. 3, 1996, 110 Stat. 3112.)
-COD-
CODIFICATION
Section was enacted as part of the Comprehensive Methamphetamine
Control Act of 1996, and not as part of the Controlled Substances
Act which comprises this subchapter.
-End-
-CITE-
21 USC Sec. 873 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 873. Cooperative arrangements
-STATUTE-
(a) Cooperation of Attorney General with local, State, and Federal
agencies
The Attorney General shall cooperate with local, State, and
Federal agencies concerning traffic in controlled substances and in
suppressing the abuse of controlled substances. To this end, he is
authorized to -
(1) arrange for the exchange of information between
governmental officials concerning the use and abuse of controlled
substances;
(2) cooperate in the institution and prosecution of cases in
the courts of the United States and before the licensing boards
and courts of the several States;
(3) conduct training programs on controlled substance law
enforcement for local, State, and Federal personnel;
(4) maintain in the Department of Justice a unit which will
accept, catalog, file, and otherwise utilize all information and
statistics, including records of controlled substance abusers and
other controlled substance law offenders, which may be received
from Federal, State, and local agencies, and make such
information available for Federal, State, and local law
enforcement purposes;
(5) conduct programs of eradication aimed at destroying wild or
illicit growth of plant species from which controlled substances
may be extracted;
(6) assist State and local governments in suppressing the
diversion of controlled substances from legitimate medical,
scientific, and commercial channels by -
(A) making periodic assessments of the capabilities of State
and local governments to adequately control the diversion of
controlled substances;
(B) providing advice and counsel to State and local
governments on the methods by which such governments may
strengthen their controls against diversion; and
(C) establishing cooperative investigative efforts to control
diversion; and
(7) notwithstanding any other provision of law, enter into
contractual agreements with State and local law enforcement
agencies to provide for cooperative enforcement and regulatory
activities under this chapter.(!1)
(b) Requests by Attorney General for assistance from Federal
agencies or instrumentalities
When requested by the Attorney General, it shall be the duty of
any agency or instrumentality of the Federal Government to furnish
assistance, including technical advice, to him for carrying out his
functions under this subchapter; except that no such agency or
instrumentality shall be required to furnish the name of, or other
identifying information about, a patient or research subject whose
identity it has undertaken to keep confidential.
(c) Descriptive and analytic reports by Attorney General to State
agencies of distribution patterns of schedule II substances
having highest rates of abuse
The Attorney General shall annually (1) select the controlled
substance (or controlled substances) contained in schedule II
which, in the Attorney General's discretion, is determined to have
the highest rate of abuse, and (2) prepare and make available to
regulatory, licensing, and law enforcement agencies of States
descriptive and analytic reports on the actual distribution
patterns in such States of each such controlled substance.
(d) Grants by Attorney General
(1) The Attorney General may make grants, in accordance with
paragraph (2), to State and local governments to assist in meeting
the costs of -
(A) collecting and analyzing data on the diversion of
controlled substances,
(B) conducting investigations and prosecutions of such
diversions,
(C) improving regulatory controls and other authorities to
control such diversions,
(D) programs to prevent such diversions,
(E) preventing and detecting forged prescriptions, and
(F) training law enforcement and regulatory personnel to
improve the control of such diversions.
(2) No grant may be made under paragraph (1) unless an
application therefor is submitted to the Attorney General in such
form and manner as the Attorney General may prescribe. No grant may
exceed 80 per centum of the costs for which the grant is made, and
no grant may be made unless the recipient of the grant provides
assurances satisfactory to the Attorney General that it will
obligate funds to meet the remaining 20 per centum of such costs.
The Attorney General shall review the activities carried out with
grants under paragraph (1) and shall report annually to Congress on
such activities.
(3) To carry out this subsection there is authorized to be
appropriated $6,000,000 for fiscal year 1985 and $6,000,000 for
fiscal year 1986.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 503, Oct. 27, 1970, 84 Stat. 1271;
Pub. L. 96-359, Sec. 8(a) Sept. 26, 1980, 94 Stat. 1194; Pub. L. 98-
473, title II, Sec. 517, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 99-
570, title I, Sec. 1868, Oct. 27, 1986, 100 Stat. 3207-55; Pub. L.
99-646, Sec. 85, Nov. 10, 1986, 100 Stat. 3620.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in subsec. (a)(7), was in the original
as added by Pub. L. 99-646 "this Act", meaning Pub. L. 91-513, Oct.
27, 1970, 84 Stat. 1236, as amended. In the subsec. (a)(7) added by
Pub. L. 99-570, the reference was "this title", meaning title II of
Pub. L. 91-513 which is popularly known as the "Controlled
Substances Act" and is classified principally to this subchapter.
For complete classification of this Act and title II to the Code,
see Short Title note set out under section 801 of this title and
Tables.
Schedule II, referred to in subsec. (c), is set out in section
812(c) of this title.
-MISC1-
AMENDMENTS
1986 - Subsec. (a)(7). Pub. L. 99-570 and Pub. L. 99-646 made
substantially identical amendment, adding par. (7).
1984 - Subsec. (a)(6). Pub. L. 98-473, Sec. 517(a), added par.
(6).
Subsec. (d). Pub. L. 98-473, Sec. 517(b), added subsec. (d).
1980 - Subsec. (c). Pub. L. 96-359 added subsec. (c).
ANNUAL REPORT ON COUNTERDRUG INTELLIGENCE MATTERS
Pub. L. 107-306, title VIII, Sec. 826, Nov. 27, 2002, 116 Stat.
2429, provided that:
"(a) Annual Report. - The Counterdrug Intelligence Coordinating
Group shall submit to the appropriate committees of Congress each
year a report on current counterdrug intelligence matters. The
report shall include the recommendations of the Counterdrug
Intelligence Coordinating Group on the appropriate number of
permanent staff, and of detailed personnel, for the staff of the
Counterdrug Intelligence Executive Secretariat.
"(b) Submittal Date. - The date of the submittal each year of the
report required by subsection (a) shall be the date provided in
section 507 of the National Security Act of 1947 [50 U.S.C. 415b],
as added by section 811 of this Act.
"(c) Appropriate Committees of Congress Defined. - In this
section, the term 'appropriate committees of Congress' means -
"(1) the Committees on Appropriations of the Senate and House
of Representatives; and
"(2) the congressional intelligence committees (as defined in
section 3 of the National Security Act of 1947 (50 U.S.C.
401a))."
COMBATING AMPHETAMINE AND METHAMPHETAMINE MANUFACTURING AND
TRAFFICKING
Pub. L. 106-310, div. B, title XXXVI, Sec. 3625, Oct. 17, 2000,
114 Stat. 1233, provided that:
"(a) Activities. - In order to combat the illegal manufacturing
and trafficking in amphetamine and methamphetamine, the
Administrator of the Drug Enforcement Administration may -
"(1) assist State and local law enforcement in small and mid-
sized communities in all phases of investigations related to
such manufacturing and trafficking, including assistance with
foreign-language interpretation;
"(2) staff additional regional enforcement and mobile
enforcement teams related to such manufacturing and trafficking;
"(3) establish additional resident offices and posts of duty to
assist State and local law enforcement in rural areas in
combating such manufacturing and trafficking;
"(4) provide the Special Operations Division of the
Administration with additional agents and staff to collect,
evaluate, interpret, and disseminate critical intelligence
targeting the command and control operations of major amphetamine
and methamphetamine manufacturing and trafficking organizations;
"(5) enhance the investigative and related functions of the
Chemical Control Program of the Administration to implement more
fully the provisions of the Comprehensive Methamphetamine Control
Act of 1996 (Public Law 104-237) [see Short Title of 1996
Amendments note set out under section 801 of this title];
"(6) design an effective means of requiring an accurate
accounting of the import and export of list I chemicals, and
coordinate investigations relating to the diversion of such
chemicals;
"(7) develop a computer infrastructure sufficient to receive,
process, analyze, and redistribute time-sensitive enforcement
information from suspicious order reporting to field offices of
the Administration and other law enforcement and regulatory
agencies, including the continuing development of the Suspicious
Order Reporting and Tracking System (SORTS) and the Chemical
Transaction Database (CTRANS) of the Administration;
"(8) establish an education, training, and communication
process in order to alert the industry to current trends and
emerging patterns in the illegal manufacturing of amphetamine and
methamphetamine; and
"(9) carry out such other activities as the Administrator
considers appropriate.
"(b) Additional Positions and Personnel. -
"(1) In general. - In carrying out activities under subsection
(a), the Administrator may establish in the Administration not
more than 50 full-time positions, including not more than 31
special-agent positions, and may appoint personnel to such
positions.
"(2) Particular positions. - In carrying out activities under
paragraphs (5) through (8) of subsection (a), the Administrator
may establish in the Administration not more than 15 full-time
positions, including not more than 10 diversion investigator
positions, and may appoint personnel to such positions. Any
positions established under this paragraph are in addition to any
positions established under paragraph (1).
"(c) Authorization of Appropriations. - There are authorized to
be appropriated for the Drug Enforcement Administration for each
fiscal year after fiscal year 1999, $9,500,000 for purposes of
carrying out the activities authorized by subsection (a) and
employing personnel in positions established under subsection (b),
of which $3,000,000 shall be available for activities under
paragraphs (5) through (8) of subsection (a) and for employing
personnel in positions established under subsection (b)(2)."
NATIONAL DRUG INTELLIGENCE CENTER
Pub. L. 108-487, title I, Sec. 104(e), Dec. 23, 2004, 118 Stat.
3942, provided that:
"(1) In general. - Of the amount authorized to be appropriated in
subsection (a) [118 Stat. 3941], $42,322,000 shall be available for
the National Drug Intelligence Center. Within such amount, funds
provided for research, development, testing, and evaluation
purposes shall remain available until September 30, 2006, and funds
provided for procurement purposes shall remain available until
September 30, 2007.
"(2) Transfer of funds. - The Director of National Intelligence
shall transfer to the Attorney General funds available for the
National Drug Intelligence Center under paragraph (1). The Attorney
General shall utilize funds so transferred for the activities of
the National Drug Intelligence Center.
"(3) Limitation. - Amounts available for the National Drug
Intelligence Center may not be used in contravention of the
provisions of section 103(d)(1) of the National Security Act of
1947 (50 U.S.C. 403-3(d)(1)).
"(4) Authority. - Notwithstanding any other provision of law, the
Attorney General shall retain full authority over the operations of
the National Drug Intelligence Center."
Similar provisions were contained in the following prior
authorization acts:
Pub. L. 108-177, title I, Sec. 104(e), Dec. 13, 2003, 117 Stat.
2602.
Pub. L. 107-306, title I, Sec. 104(e), Nov. 27, 2002, 116 Stat.
2387.
Pub. L. 107-108, title I, Sec. 104(e), Dec. 28, 2001, 115 Stat.
1396.
Pub. L. 106-567, title I, Sec. 104(e), Dec. 27, 2000, 114 Stat.
2834.
Pub. L. 106-120, title I, Sec. 104(e), Dec. 3, 1999, 113 Stat.
1609.
Pub. L. 105-272, title I, Sec. 104(e), Oct. 20, 1998, 112 Stat.
2398.
Pub. L. 105-107, title I, Sec. 104(e), Nov. 20, 1997, 111 Stat.
2250.
Pub. L. 104-293, title I, Sec. 104(d), Oct. 11, 1996, 110 Stat.
3464.
Pub. L. 103-139, title VIII, Sec. 8056, Nov. 11, 1993, 107 Stat.
1452, provided that: "During the current fiscal year and
thereafter, there is established, under the direction and control
of the Attorney General, the National Drug Intelligence Center,
whose mission it shall be to coordinate and consolidate drug
intelligence from all national security and law enforcement
agencies, and produce information regarding the structure,
membership, finances, communications, and activities of drug
trafficking organizations: Provided, That funding for the operation
of the National Drug Intelligence Center, including personnel costs
associated therewith, shall be provided from the funds appropriated
to the Department of Defense."
Similar provisions were contained in the following prior
appropriation act:
Pub. L. 102-396, title IX, Sec. 9078, Oct. 6, 1992, 106 Stat.
1919.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 874 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 874. Advisory committees
-STATUTE-
The Attorney General may from time to time appoint committees to
advise him with respect to preventing and controlling the abuse of
controlled substances. Members of the committees may be entitled to
receive compensation at the rate of $100 for each day (including
traveltime) during which they are engaged in the actual performance
of duties. While traveling on official business in the performance
of duties for the committees, members of the committees shall be
allowed expenses of travel, including per diem instead of
subsistence, in accordance with subchapter I of chapter 57 of title
5.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 504, Oct. 27, 1970, 84 Stat. 1272.)
-MISC1-
TERMINATION OF ADVISORY COMMITTEES
Advisory committees in existence on Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period following Jan.
5, 1973, and advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year period
beginning on the date of their establishment, unless in the case of
a committee established by the President or an officer of the
Federal Government, such committee is renewed by appropriate action
prior to the expiration of such 2-year period, or in the case of a
committee established by Congress, its duration is otherwise
provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
-End-
-CITE-
21 USC Sec. 875 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 875. Administrative hearings
-STATUTE-
(a) Power of Attorney General
In carrying out his functions under this subchapter, the Attorney
General may hold hearings, sign and issue subpenas, administer
oaths, examine witnesses, and receive evidence at any place in the
United States.
(b) Procedures applicable
Except as otherwise provided in this subchapter, notice shall be
given and hearings shall be conducted under appropriate procedures
of subchapter II of chapter 5 of title 5.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 505, Oct. 27, 1970, 84 Stat. 1272.)
-End-
-CITE-
21 USC Sec. 876 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 876. Subpenas
-STATUTE-
(a) Authorization of use by Attorney General
In any investigation relating to his functions under this
subchapter with respect to controlled substances, listed chemicals,
tableting machines, or encapsulating machines, the Attorney General
may subpena witnesses, compel the attendance and testimony of
witnesses, and require the production of any records (including
books, papers, documents, and other tangible things which
constitute or contain evidence) which the Attorney General finds
relevant or material to the investigation. The attendance of
witnesses and the production of records may be required from any
place in any State or in any territory or other place subject to
the jurisdiction of the United States at any designated place of
hearing; except that a witness shall not be required to appear at
any hearing more than 500 miles distant from the place where he was
served with a subpena. Witnesses summoned under this section shall
be paid the same fees and mileage that are paid witnesses in the
courts of the United States.
(b) Service
A subpena issued under this section may be served by any person
designated in the subpena to serve it. Service upon a natural
person may be made by personal delivery of the subpena to him.
Service may be made upon a domestic or foreign corporation or upon
a partnership or other unincorporated association which is subject
to suit under a common name, by delivering the subpena to an
officer, to a managing or general agent, or to any other agent
authorized by appointment or by law to receive service of process.
The affidavit of the person serving the subpena entered on a true
copy thereof by the person serving it shall be proof of service.
(c) Enforcement
In the case of contumacy by or refusal to obey a subpena issued
to any person, the Attorney General may invoke the aid of any court
of the United States within the jurisdiction of which the
investigation is carried on or of which the subpenaed person is an
inhabitant, or in which he carries on business or may be found, to
compel compliance with the subpena. The court may issue an order
requiring the subpenaed person to appear before the Attorney
General to produce records, if so ordered, or to give testimony
touching the matter under investigation. Any failure to obey the
order of the court may be punished by the court as a contempt
thereof. All process in any such case may be served in any judicial
district in which such person may be found.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 506, Oct. 27, 1970, 84 Stat. 1272;
Pub. L. 100-690, title VI, Sec. 6058, Nov. 18, 1988, 102 Stat.
4319.)
-MISC1-
AMENDMENTS
1988 - Subsec. (a). Pub. L. 100-690 inserted "listed chemicals,
tableting machines, or encapsulating machines," after "with respect
to controlled substances,".
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
-End-
-CITE-
21 USC Sec. 877 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 877. Judicial review
-STATUTE-
All final determinations, findings, and conclusions of the
Attorney General under this subchapter shall be final and
conclusive decisions of the matters involved, except that any
person aggrieved by a final decision of the Attorney General may
obtain review of the decision in the United States Court of Appeals
for the District of Columbia or for the circuit in which his
principal place of business is located upon petition filed with the
court and delivered to the Attorney General within thirty days
after notice of the decision. Findings of fact by the Attorney
General, if supported by substantial evidence, shall be conclusive.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 507, Oct. 27, 1970, 84 Stat. 1273.)
-End-
-CITE-
21 USC Sec. 878 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 878. Powers of enforcement personnel
-STATUTE-
(a) Any officer or employee of the Drug Enforcement
Administration or any State or local law enforcement officer
designated by the Attorney General may -
(1) carry firearms;
(2) execute and serve search warrants, arrest warrants,
administrative inspection warrants, subpenas, and summonses
issued under the authority of the United States;
(3) make arrests without warrant (A) for any offense against
the United States committed in his presence, or (B) for any
felony, cognizable under the laws of the United States, if he has
probable cause to believe that the person to be arrested has
committed or is committing a felony;
(4) make seizures of property pursuant to the provisions of
this subchapter; and
(5) perform such other law enforcement duties as the Attorney
General may designate.
(b) State and local law enforcement officers performing functions
under this section shall not be deemed Federal employees and shall
not be subject to provisions of law relating to Federal employees,
except that such officers shall be subject to section 3374(c) of
title 5.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 508, Oct. 27, 1970, 84 Stat. 1273;
Pub. L. 96-132, Sec. 16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L.
99-570, title I, Sec. 1869, Oct. 27, 1986, 100 Stat. 3207-55; Pub.
L. 99-646, Sec. 86, Nov. 10, 1986, 100 Stat. 3620.)
-MISC1-
AMENDMENTS
1986 - Pub. L. 99-570 and Pub. L. 99-646 amended section
substantially identically designating existing provisions as
subsec. (a) and adding subsec. (b), with the exception of the
amendment of subsec. (a) for which Pub. L. 99-570 directed the
insertion of "or (with respect to offenses under this subchapter or
subchapter II of this chapter) any State or local law enforcement
officer" and Pub. L. 99-646 directed the insertion of "or any State
or local law enforcement officer", the latter of which was executed
to reflect the probable intent of Congress.
1979 - Pub. L. 96-132 substituted "Drug Enforcement
Administration" for "Bureau of Narcotics and Dangerous Drugs".
-End-
-CITE-
21 USC Sec. 879 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 879. Search warrants
-STATUTE-
A search warrant relating to offenses involving controlled
substances may be served at any time of the day or night if the
judge or United States magistrate judge issuing the warrant is
satisfied that there is probable cause to believe that grounds
exist for the warrant and for its service at such time.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 509, Oct. 27, 1970, 84 Stat. 1274;
Pub. L. 93-481, Sec. 3, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 101-
650, title III, Sec. 321, Dec. 1, 1990, 104 Stat. 5117.)
-MISC1-
AMENDMENTS
1974 - Pub. L. 93-481 struck out designation "(a)" before "A
search warrant", and struck out subsec. (b) which permitted
officers authorized to execute search warrants to break open and
enter premises under certain circumstances and which required that
such officers identify themselves and give reasons and authority
for their entry after such entry.
-CHANGE-
CHANGE OF NAME
"United States magistrate judge" substituted in text for "United
States magistrate" pursuant to section 321 of Pub. L. 101-650, set
out as a note under section 631 of Title 28, Judiciary and Judicial
Procedure.
-End-
-CITE-
21 USC Sec. 880 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 880. Administrative inspections and warrants
-STATUTE-
(a) "Controlled premises" defined
As used in this section, the term "controlled premises" means -
(1) places where original or other records or documents
required under this subchapter are kept or required to be kept,
and
(2) places, including factories, warehouses, and other
establishments, and conveyances, where persons registered under
section 823 of this title (or exempt from registration under
section 822(d) of this title or by regulation of the Attorney
General) or regulated persons may lawfully hold, manufacture,
distribute, dispense, administer, or otherwise dispose of
controlled substances or listed chemicals or where records
relating to those activities are maintained.
(b) Grant of authority; scope of inspections
(1) For the purpose of inspecting, copying, and verifying the
correctness of records, reports, or other documents required to be
kept or made under this subchapter and otherwise facilitating the
carrying out of his functions under this subchapter, the Attorney
General is authorized, in accordance with this section, to enter
controlled premises and to conduct administrative inspections
thereof, and of the things specified in this section, relevant to
those functions.
(2) Such entries and inspections shall be carried out through
officers or employees (hereinafter referred to as "inspectors")
designated by the Attorney General. Any such inspector, upon
stating his purpose and presenting to the owner, operator, or agent
in charge of such premises (A) appropriate credentials and (B) a
written notice of his inspection authority (which notice in the
case of an inspection requiring, or in fact supported by, an
administrative inspection warrant shall consist of such warrant),
shall have the right to enter such premises and conduct such
inspection at reasonable times.
(3) Except as may otherwise be indicated in an applicable
inspection warrant, the inspector shall have the right -
(A) to inspect and copy records, reports, and other documents
required to be kept or made under this subchapter;
(B) to inspect, within reasonable limits and in a reasonable
manner, controlled premises and all pertinent equipment, finished
and unfinished drugs, listed chemicals, and other substances or
materials, containers, and labeling found therein, and, except as
provided in paragraph (4) of this subsection, all other things
therein (including records, files, papers, processes, controls,
and facilities) appropriate for verification of the records,
reports, and documents referred to in clause (A) or otherwise
bearing on the provisions of this subchapter; and
(C) to inventory any stock of any controlled substance or
listed chemical therein and obtain samples of any such substance
or chemical.
(4) Except when the owner, operator, or agent in charge of the
controlled premises so consents in writing, no inspection
authorized by this section shall extend to -
(A) financial data;
(B) sales data other than shipment data; or
(C) pricing data.
(c) Situations not requiring warrants
A warrant under this section shall not be required for the
inspection of books and records pursuant to an administrative
subpena issued in accordance with section 876 of this title, nor
for entries and administrative inspections (including seizures of
property) -
(1) with the consent of the owner, operator, or agent in charge
of the controlled premises;
(2) in situations presenting imminent danger to health or
safety;
(3) in situations involving inspection of conveyances where
there is reasonable cause to believe that the mobility of the
conveyance makes it impracticable to obtain a warrant;
(4) in any other exceptional or emergency circumstance where
time or opportunity to apply for a warrant is lacking; or
(5) in any other situations where a warrant is not
constitutionally required.
(d) Administrative inspection warrants; issuance; execution;
probable cause
Issuance and execution of administrative inspection warrants
shall be as follows:
(1) Any judge of the United States or of a State court of
record, or any United States magistrate judge, may, within his
territorial jurisdiction, and upon proper oath or affirmation
showing probable cause, issue warrants for the purpose of
conducting administrative inspections authorized by this
subchapter or regulations thereunder, and seizures of property
appropriate to such inspections. For the purposes of this
section, the term "probable cause" means a valid public interest
in the effective enforcement of this subchapter or regulations
thereunder sufficient to justify administrative inspections of
the area, premises, building, or conveyance, or contents thereof,
in the circumstances specified in the application for the
warrant.
(2) A warrant shall issue only upon an affidavit of an officer
or employee having knowledge of the facts alleged, sworn to
before the judge or magistrate judge and establishing the grounds
for issuing the warrant. If the judge or magistrate judge is
satisfied that grounds for the application exist or that there is
probable cause to believe they exist, he shall issue a warrant
identifying the area, premises, building, or conveyance to be
inspected, the purpose of such inspection, and, where
appropriate, the type of property to be inspected, if any. The
warrant shall identify the items or types of property to be
seized, if any. The warrant shall be directed to a person
authorized under subsection (b)(2) of this section to execute it.
The warrant shall state the grounds for its issuance and the name
of the person or persons whose affidavit has been taken in
support thereof. It shall command the person to whom it is
directed to inspect the area, premises, building, or conveyance
identified for the purpose specified, and, where appropriate,
shall direct the seizure of the property specified. The warrant
shall direct that it be served during normal business hours. It
shall designate the judge or magistrate judge to whom it shall be
returned.
(3) A warrant issued pursuant to this section must be executed
and returned within ten days of its date unless, upon a showing
by the United States of a need therefor, the judge or magistrate
judge allows additional time in the warrant. If property is
seized pursuant to a warrant, the person executing the warrant
shall give to the person from whom or from whose premises the
property was taken a copy of the warrant and a receipt for the
property taken or shall leave the copy and receipt at the place
from which the property was taken. The return of the warrant
shall be made promptly and shall be accompanied by a written
inventory of any property taken. The inventory shall be made in
the presence of the person executing the warrant and of the
person from whose possession or premises the property was taken,
if they are present, or in the presence of at least one credible
person other than the person making such inventory, and shall be
verified by the person executing the warrant. The judge or
magistrate judge, upon request, shall deliver a copy of the
inventory to the person from whom or from whose premises the
property was taken and the applicant for the warrant.
(4) The judge or magistrate judge who has issued a warrant
under this section shall attach to the warrant a copy of the
return and all papers filed in connection therewith and shall
file them with the clerk of the district court of the United
States for the judicial district in which the inspection was
made.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 510, Oct. 27, 1970, 84 Stat. 1274;
Pub. L. 101-647, title XXXV, Sec. 3599M, Nov. 29, 1990, 104 Stat.
4932; Pub. L. 101-650, title III, Sec. 321, Dec. 1, 1990, 104 Stat.
5117; Pub. L. 103-200, Sec. 6, Dec. 17, 1993, 107 Stat. 2339.)
-MISC1-
AMENDMENTS
1993 - Subsec. (a)(2). Pub. L. 103-200, Sec. 6(1), amended par.
(2) generally. Prior to amendment, par. (2) read as follows:
"places, including factories, warehouses, or other establishments,
and conveyances, where persons registered under section 823 of this
title (or exempted from registration under section 822(d) of this
title) may lawfully hold, manufacture, or distribute, dispense,
administer, or otherwise dispose of controlled substances."
Subsec. (b)(3)(B). Pub. L. 103-200, Sec. 6(2)(A), inserted ",
listed chemicals," after "unfinished drugs".
Subsec. (b)(3)(C). Pub. L. 103-200, Sec. 6(2)(B), inserted "or
listed chemical" after "controlled substance" and "or chemical"
after "such substance".
1990 - Subsec. (b)(3)(B). Pub. L. 101-647 substituted "paragraph
(4)" for "paragraph (5)".
-CHANGE-
CHANGE OF NAME
"United States magistrate judge" and "magistrate judge"
substituted for "United States magistrate" and "magistrate",
respectively, wherever appearing in subsec. (d) pursuant to section
321 of Pub. L. 101-650, set out as a note under section 631 of
Title 28, Judiciary and Judicial Procedure.
-MISC2-
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
-End-
-CITE-
21 USC Sec. 881 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 881. Forfeitures
-STATUTE-
(a) Subject property
The following shall be subject to forfeiture to the United States
and no property right shall exist in them:
(1) All controlled substances which have been manufactured,
distributed, dispensed, or acquired in violation of this
subchapter.
(2) All raw materials, products, and equipment of any kind
which are used, or intended for use, in manufacturing,
compounding, processing, delivering, importing, or exporting any
controlled substance or listed chemical in violation of this
subchapter.
(3) All property which is used, or intended for use, as a
container for property described in paragraph (1), (2), or (9).
(4) All conveyances, including aircraft, vehicles, or vessels,
which are used, or are intended for use, to transport, or in any
manner to facilitate the transportation, sale, receipt,
possession, or concealment of property described in paragraph
(1), (2), or (9).
(5) All books, records, and research, including formulas,
microfilm, tapes, and data which are used, or intended for use,
in violation of this subchapter.
(6) All moneys, negotiable instruments, securities, or other
things of value furnished or intended to be furnished by any
person in exchange for a controlled substance or listed chemical
in violation of this subchapter, all proceeds traceable to such
an exchange, and all moneys, negotiable instruments, and
securities used or intended to be used to facilitate any
violation of this subchapter.
(7) All real property, including any right, title, and interest
(including any leasehold interest) in the whole of any lot or
tract of land and any appurtenances or improvements, which is
used, or intended to be used, in any manner or part, to commit,
or to facilitate the commission of, a violation of this
subchapter punishable by more than one year's imprisonment.
(8) All controlled substances which have been possessed in
violation of this subchapter.
(9) All listed chemicals, all drug manufacturing equipment, all
tableting machines, all encapsulating machines, and all gelatin
capsules, which have been imported, exported, manufactured,
possessed, distributed, dispensed, acquired, or intended to be
distributed, dispensed, acquired, imported, or exported, in
violation of this subchapter or subchapter II of this chapter.
(10) Any drug paraphernalia (as defined in section 863 of this
title).
(11) Any firearm (as defined in section 921 of title 18) used
or intended to be used to facilitate the transportation, sale,
receipt, possession, or concealment of property described in
paragraph (1) or (2) and any proceeds traceable to such property.
(b) Seizure procedures
Any property subject to forfeiture to the United States under
this section may be seized by the Attorney General in the manner
set forth in section 981(b) of title 18.
(c) Custody of Attorney General
Property taken or detained under this section shall not be
repleviable, but shall be deemed to be in the custody of the
Attorney General, subject only to the orders and decrees of the
court or the official having jurisdiction thereof. Whenever
property is seized under any of the provisions of this subchapter,
the Attorney General may -
(1) place the property under seal;
(2) remove the property to a place designated by him; or
(3) require that the General Services Administration take
custody of the property and remove it, if practicable, to an
appropriate location for disposition in accordance with law.
(d) Other laws and proceedings applicable
The provisions of law relating to the seizure, summary and
judicial forfeiture, and condemnation of property for violation of
the customs laws; the disposition of such property or the proceeds
from the sale thereof; the remission or mitigation of such
forfeitures; and the compromise of claims shall apply to seizures
and forfeitures incurred, or alleged to have been incurred, under
any of the provisions of this subchapter, insofar as applicable and
not inconsistent with the provisions hereof; except that such
duties as are imposed upon the customs officer or any other person
with respect to the seizure and forfeiture of property under the
customs laws shall be performed with respect to seizures and
forfeitures of property under this subchapter by such officers,
agents, or other persons as may be authorized or designated for
that purpose by the Attorney General, except to the extent that
such duties arise from seizures and forfeitures effected by any
customs officer.
(e) Disposition of forfeited property
(1) Whenever property is civilly or criminally forfeited under
this subchapter the Attorney General may -
(A) retain the property for official use or, in the manner
provided with respect to transfers under section 1616a of title
19, transfer the property to any Federal agency or to any State
or local law enforcement agency which participated directly in
the seizure or forfeiture of the property;
(B) except as provided in paragraph (4), sell, by public sale
or any other commercially feasible means, any forfeited property
which is not required to be destroyed by law and which is not
harmful to the public;
(C) require that the General Services Administration take
custody of the property and dispose of it in accordance with law;
(D) forward it to the Bureau of Narcotics and Dangerous Drugs
for disposition (including delivery for medical or scientific use
to any Federal or State agency under regulations of the Attorney
General); or
(E) transfer the forfeited personal property or the proceeds of
the sale of any forfeited personal or real property to any
foreign country which participated directly or indirectly in the
seizure or forfeiture of the property, if such a transfer -
(i) has been agreed to by the Secretary of State;
(ii) is authorized in an international agreement between the
United States and the foreign country; and
(iii) is made to a country which, if applicable, has been
certified under section 2291j(b) of title 22.
(2)(A) The proceeds from any sale under subparagraph (B) of
paragraph (1) and any moneys forfeited under this subchapter shall
be used to pay -
(i) all property expenses of the proceedings for forfeiture and
sale including expenses of seizure, maintenance of custody,
advertising, and court costs; and
(ii) awards of up to $100,000 to any individual who provides
original information which leads to the arrest and conviction of
a person who kills or kidnaps a Federal drug law enforcement
agent.
Any award paid for information concerning the killing or kidnapping
of a Federal drug law enforcement agent, as provided in clause
(ii), shall be paid at the discretion of the Attorney General.
(B) The Attorney General shall forward to the Treasurer of the
United States for deposit in accordance with section 524(c) of
title 28, any amounts of such moneys and proceeds remaining after
payment of the expenses provided in subparagraph (A), except that,
with respect to forfeitures conducted by the Postal Service, the
Postal Service shall deposit in the Postal Service Fund, under
section 2003(b)(7) of title 39, such moneys and proceeds.
(3) The Attorney General shall assure that any property
transferred to a State or local law enforcement agency under
paragraph (1)(A) -
(A) has a value that bears a reasonable relationship to the
degree of direct participation of the State or local agency in
the law enforcement effort resulting in the forfeiture, taking
into account the total value of all property forfeited and the
total law enforcement effort with respect to the violation of law
on which the forfeiture is based; and
(B) will serve to encourage further cooperation between the
recipient State or local agency and Federal law enforcement
agencies.
(4)(A) With respect to real property described in subparagraph
(B), if the chief executive officer of the State involved submits
to the Attorney General a request for purposes of such
subparagraph, the authority established in such subparagraph is in
lieu of the authority established in paragraph (1)(B).
(B) In the case of property described in paragraph (1)(B) that is
civilly or criminally forfeited under this subchapter, if the
property is real property that is appropriate for use as a public
area reserved for recreational or historic purposes or for the
preservation of natural conditions, the Attorney General, upon the
request of the chief executive officer of the State in which the
property is located, may transfer title to the property to the
State, either without charge or for a nominal charge, through a
legal instrument providing that -
(i) such use will be the principal use of the property; and
(ii) title to the property reverts to the United States in the
event that the property is used otherwise.
(f) Forfeiture and destruction of schedule I and II substances
(1) All controlled substances in schedule I or II that are
possessed, transferred, sold, or offered for sale in violation of
the provisions of this subchapter; all dangerous, toxic, or
hazardous raw materials or products subject to forfeiture under
subsection (a)(2) of this section; and any equipment or container
subject to forfeiture under subsection (a)(2) or (3) of this
section which cannot be separated safely from such raw materials or
products shall be deemed contraband and seized and summarily
forfeited to the United States. Similarly, all substances in
schedule I or II, which are seized or come into the possession of
the United States, the owners of which are unknown, shall be deemed
contraband and summarily forfeited to the United States.
(2) The Attorney General may direct the destruction of all
controlled substances in schedule I or II seized for violation of
this subchapter; all dangerous, toxic, or hazardous raw materials
or products subject to forfeiture under subsection (a)(2) of this
section; and any equipment or container subject to forfeiture under
subsection (a)(2) or (3) of this section which cannot be separated
safely from such raw materials or products under such circumstances
as the Attorney General may deem necessary.
(g) Plants
(1) All species of plants from which controlled substances in
schedules I and II may be derived which have been planted or
cultivated in violation of this subchapter, or of which the owners
or cultivators are unknown, or which are wild growths, may be
seized and summarily forfeited to the United States.
(2) The failure, upon demand by the Attorney General or his duly
authorized agent, of the person in occupancy or in control of land
or premises upon which such species of plants are growing or being
stored, to produce an appropriate registration, or proof that he is
the holder thereof, shall constitute authority for the seizure and
forfeiture.
(3) The Attorney General, or his duly authorized agent, shall
have authority to enter upon any lands, or into any dwelling
pursuant to a search warrant, to cut, harvest, carry off, or
destroy such plants.
(h) Vesting of title in United States
All right, title, and interest in property described in
subsection (a) of this section shall vest in the United States upon
commission of the act giving rise to forfeiture under this section.
(i) Stay of civil forfeiture proceedings
The provisions of section 981(g) of title 18 regarding the stay
of a civil forfeiture proceeding shall apply to forfeitures under
this section.
(j) Venue
In addition to the venue provided for in section 1395 of title 28
or any other provision of law, in the case of property of a
defendant charged with a violation that is the basis for forfeiture
of the property under this section, a proceeding for forfeiture
under this section may be brought in the judicial district in which
the defendant owning such property is found or in the judicial
district in which the criminal prosecution is brought.
(l) (!1) Agreement between Attorney General and Postal Service for
performance of functions
The functions of the Attorney General under this section shall be
carried out by the Postal Service pursuant to such agreement as may
be entered into between the Attorney General and the Postal
Service.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 511, Oct. 27, 1970, 84 Stat. 1276;
Pub. L. 95-633, title III, Sec. 301(a), Nov. 10, 1978, 92 Stat.
3777; Pub. L. 96-132, Sec. 14, Nov. 30, 1979, 93 Stat. 1048; Pub.
L. 98-473, title II, Secs. 306, 309, 518, Oct. 12, 1984, 98 Stat.
2050, 2051, 2075; Pub. L. 99-570, title I, Secs. 1006(c), 1865,
1992, Oct. 27, 1986, 100 Stat. 3207-7, 3207-54, 3207-59; Pub. L. 99-
646, Sec. 74, Nov. 10, 1986, 100 Stat. 3618; Pub. L. 100-690,
title V, Sec. 5105, title VI, Secs. 6059, 6074, 6075, 6077(a), (b),
6253, Nov. 18, 1988, 102 Stat. 4301, 4319, 4323-4325, 4363; Pub. L.
101-189, div. A, title XII, Sec. 1215(a), Nov. 29, 1989, 103 Stat.
1569; Pub. L. 101-647, title XX, Secs. 2003, 2004, 2007, 2008, Nov.
29, 1990, 104 Stat. 4855, 4856; Pub. L. 102-239, Sec. 2, Dec. 17,
1991, 105 Stat. 1912; Pub. L. 103-447, title I, Sec. 102(d), Nov.
2, 1994, 108 Stat. 4693; Pub. L. 104-237, title II, Sec. 201(b),
Oct. 3, 1996, 110 Stat. 3101; Pub. L. 106-185, Secs. 2(c)(2), 5(b),
8(b), Apr. 25, 2000, 114 Stat. 210, 214, 216; Pub. L. 107-273, div.
B, title IV, Sec. 4002(e)(3), Nov. 2, 2002, 116 Stat. 1810.)
-REFTEXT-
REFERENCES IN TEXT
Subchapter II of this chapter, referred to in subsec. (a)(9), was
in the original "title III", meaning title III of Pub. L. 91-513,
Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B,
consisting of sections 1101 to 1105 of title III, see Tables.
The customs laws, referred to in subsec. (d), are classified
generally to Title 19, Customs Duties.
Schedules I and II, referred to in subsecs. (f) and (g), are set
out in section 812(c) of this title.
-MISC1-
AMENDMENTS
2002 - Subsec. (a)(10). Pub. L. 107-273 substituted "section 863
of this title" for "section 1822 of the Mail Order Drug
Paraphernalia Control Act".
2000 - Subsec. (a)(4). Pub. L. 106-185, Sec. 2(c)(2), struck out
before period at end ", except that -
"(A) no conveyance used by any person as a common carrier in
the transaction of business as a common carrier shall be
forfeited under the provisions of this section unless it shall
appear that the owner or other person in charge of such
conveyance was a consenting party or privy to a violation of this
subchapter or subchapter II of this chapter;
"(B) no conveyance shall be forfeited under the provisions of
this section by reason of any act or omission established by the
owner thereof to have been committed or omitted by any person
other than such owner while such conveyance was unlawfully in the
possession of a person other than the owner in violation of the
criminal laws of the United States, or of any State; and
"(C) no conveyance shall be forfeited under this paragraph to
the extent of an interest of an owner, by reason of any act or
omission established by that owner to have been committed or
omitted without the knowledge, consent, or willful blindness of
the owner".
Subsec. (a)(6). Pub. L. 106-185, Sec. 2(c)(2), struck out before
period at end ", except that no property shall be forfeited under
this paragraph, to the extent of the interest of an owner, by
reason of any act or omission established by that owner to have
been committed or omitted without the knowledge or consent of that
owner".
Subsec. (a)(7). Pub. L. 106-185, Sec. 2(c)(2), struck out before
period at end ", except that no property shall be forfeited under
this paragraph, to the extent of an interest of an owner, by reason
of any act or omission established by that owner to have been
committed or omitted without the knowledge or consent of that
owner".
Subsec. (b). Pub. L. 106-185, Sec. 5(b), inserted heading and
amended text of subsec. (b) generally. Prior to amendment, subsec.
(b) authorized the Attorney General to seize property under this
subchapter upon process issued pursuant to the Supplemental Rules
for Certain Admirality and Maritime claims and to seize it without
process in certain described circumstances.
Subsec. (i). Pub. L. 106-185, Sec. 8(b), inserted heading and
amended text of subsec. (i) generally. Prior to amendment, text
read as follows: "The filing of an indictment or information
alleging a violation of this subchapter or subchapter II of this
chapter, or a violation of State or local law that could have been
charged under this subchapter or subchapter II of this chapter,
which is also related to a civil forfeiture proceeding under this
section shall, upon motion of the United States and for good cause
shown, stay the civil forfeiture proceeding."
1996 - Subsec. (a)(2), (6). Pub. L. 104-237, Sec. 201(b)(1),
inserted "or listed chemical" after "controlled substance".
Subsec. (a)(9). Pub. L. 104-237, Sec. 201(b)(2), substituted
"possessed, distributed, dispensed, acquired, or intended to be
distributed, dispensed, acquired," for "possessed, distributed, or
intended to be distributed," and struck out "a felony provision of"
after "in violation of".
1994 - Subsec. (e)(1)(E)(iii). Pub. L. 103-447 substituted
"section 2291j(b) of title 22" for "section 2291(h) of title 22".
1991 - Subsec. (e)(1)(B). Pub. L. 102-239, Sec. 2(1), substituted
"except as provided in paragraph (4), sell" for "sell".
Subsec. (e)(4). Pub. L. 102-239, Sec. 2(2), added par. (4).
1990 - Subsec. (a)(10). Pub. L. 101-647, Sec. 2007, added par.
(10).
Subsec. (a)(11). Pub. L. 101-647, Sec. 2008, added par. (11).
Subsec. (e)(1)(B). Pub. L. 101-647, Sec. 2003, inserted ", by
public sale or any other commercially feasible means," after
"sell".
Subsec. (f). Pub. L. 101-647, Sec. 2004, inserted "; all
dangerous, toxic, or hazardous raw materials or products subject to
forfeiture under subsection (a)(2) of this section; and any
equipment or container subject to forfeiture under subsection
(a)(2) or (3) of this section which cannot be separated safely from
such raw materials or products" after "this subchapter" in pars.
(1) and (2).
1989 - Subsec. (e)(3)(B). Pub. L. 101-189 amended subpar. (B)
generally. Prior to amendment, subpar. (B) read as follows: "is not
so transferred to circumvent any requirement of State law that
prohibits forfeiture or limits use or disposition of property
forfeited to State or local agencies."
1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6059(b), inserted
reference to par. (9).
Subsec. (a)(4). Pub. L. 100-690, Secs. 6059(b), 6075, inserted in
introductory provisions reference to par. (9) and added subpar.
(C).
Subsec. (a)(7). Pub. L. 100-690, Sec. 5105, inserted "(including
any leasehold interest)" after "interest".
Subsec. (a)(9). Pub. L. 100-690, Sec. 6059(a), added par. (9).
Subsec. (e)(1)(A). Pub. L. 100-690, Sec. 6077(b), amended subpar.
(A) generally. Prior to amendment, subpar. (A) read as follows:
"retain the property for official use or transfer the custody or
ownership of any forfeited property to any Federal, State, or local
agency pursuant to section 1616a of title 19;".
Subsec. (e)(1)(E). Pub. L. 100-690, Sec. 6074, added subpar. (E).
Subsec. (e)(2)(B). Pub. L. 100-690, Sec. 6253(b), provided for
deposit of moneys and proceeds in Postal Service Fund in cases of
forfeitures conducted by Postal Service.
Subsec. (e)(3). Pub. L. 100-690, Sec. 6077(a), added par. (3).
Subsec. (l). Pub. L. 100-690, Sec. 6253(a), added subsec. (l).
1986 - Subsec. (b). Pub. L. 99-570, Sec. 1865(1)-(3), and Pub. L.
99-646, Sec. 74(1)-(3), in making identical amendments in
introductory provision and par. (4), struck out "or criminal" after
"subject to civil" and inserted paragraph permitting the Government
to request issuance of a warrant authorizing seizure of property
subject to forfeiture under this section in the same manner as
provided for a search warrant under the Federal Rules of Criminal
Procedure.
Subsec. (e). Pub. L. 99-570, Sec. 1992, designated existing
provisions as par. (1) and former pars. (1) to (4) as subpars. (A)
to (D), respectively, and added par. (2) in lieu of former
concluding provisions which read as follows: "The Attorney General
shall ensure the equitable transfer pursuant to paragraph (1) of
any forfeited property to the appropriate State or local law
enforcement agency so as to reflect generally the contribution of
any such agency participating directly in any of the acts which led
to the seizure or forfeiture of such property. A decision by the
Attorney General pursuant to paragraph (1) shall not be subject to
review. The proceeds from any sale under paragraph (2) and any
moneys forfeited under this subchapter shall be used to pay all
proper expenses of the proceedings for forfeiture and sale
including expenses of seizure, maintenance of custody, advertising,
and court costs. The Attorney General shall forward to the
Treasurer of the United States for deposit in accordance with
section 524(c) of title 28 any amounts of such moneys and proceeds
remaining after payment of such expenses."
Subsec. (f). Pub. L. 99-570, Sec. 1006(c), which directed the
amendment of section 511 of the "Comprehensive Drug Abuse
Prevention Act of 1978" was executed to this section which is
section 511 of the Comprehensive Drug Abuse Prevention Act of 1970,
as the probable intent of Congress, by designating existing
provisions as par. (1), inserting "or II" in two places, and adding
par. (2).
Subsec. (i). Pub. L. 99-570, Sec. 1865(b) and Pub. L. 99-646,
Sec. 74(b), made identical amendments, inserting ", or a violation
of State or local law that could have been charged under this
subchapter or subchapter II of this chapter,".
1984 - Subsec. (a)(7). Pub. L. 98-473, Sec. 306(a), added par.
(7).
Subsec. (a)(8). Pub. L. 98-473, Sec. 518, added par. (8).
Subsec. (b). Pub. L. 98-473, Sec. 306(b)(1), inserted "civil or
criminal" after "property subject to".
Subsec. (b)(4). Pub. L. 98-473, Sec. 306(b)(2), substituted "is
subject to civil or criminal forfeiture under" for "has been used
or is intended to be used in violation of".
Subsec. (c). Pub. L. 98-473, Sec. 306(c)(1), in provisions
preceding par. (1), inserted "any of" after "seized under".
Subsec. (c)(3). Pub. L. 98-473, Sec. 306(c)(2), inserted ", if
practicable," after "remove it".
Subsec. (d). Pub. L. 98-473, Sec. 306(d), inserted "any of" after
"incurred, under".
Subsec. (e). Pub. L. 98-473, Secs. 306(e), 309, inserted "civilly
or criminally" after "Whenever property is" and in provisions
preceding par. (1), inserted provisions relating to transfer of
custody or ownership of forfeited property in par. (1), substituted
"and dispose of it" for "and remove it for disposition" in par.
(3), and, in provisions following par. (4), inserted sentence
requiring the Attorney General to ensure equitable transfer of any
forfeited property, and substituted "accordance with section 524(c)
of title 28" for "the general fund of the United States Treasury".
Subsecs. (h) to (j). Pub. L. 98-473, Sec. 306(f), added subsecs.
(h) to (j).
1979 - Subsec. (d). Pub. L. 96-132 substituted "The provisions"
for "All provisions" and struck out "and the award of compensation
to informers in respect of such forfeitures" after "compromise of
claims".
1978 - Subsec. (a)(6). Pub. L. 95-633, Sec. 301(1), added par.
(6).
Subsec. (e). Pub. L. 95-633, Sec. 301(a)(2), (3), struck out of
cl. (2) provisions relating to use of proceeds of sale and inserted
last sentence relating to the forwarding by the Attorney General of
money and proceeds remaining after payment of expenses.
EFFECTIVE DATE OF 2000 AMENDMENT
Amendment by Pub. L. 106-185 applicable to any forfeiture
proceeding commenced on or after the date that is 120 days after
Apr. 25, 2000, see section 21 of Pub. L. 106-185, set out as a note
under section 1324 of Title 8, Aliens and Nationality.
EFFECTIVE DATE OF 1989 AMENDMENT
Section 1215(b) of Pub. L. 101-189 provided that: "The amendment
made by subsection (a) [amending this section] shall take effect as
of October 1, 1989."
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by section 6059 of Pub. L. 100-690 effective 120 days
after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set out
as a note under section 802 of this title.
Section 6077(c) of Pub. L. 100-690, as amended by Pub. L. 101-
162, title II, Sec. 208, Nov. 21, 1989, 103 Stat. 1005, provided
that: "Section 551(e)(3)(B) of the Controlled Substances Act
[probably means section 511(e)(3)(B) of the Controlled Substances
Act, 21 U.S.C. 881(e)(3)(B)], as enacted by subsection (a), shall
apply with respect to fiscal years beginning after September 30,
1991."
-TRANS-
TRANSFER OF FUNCTIONS
Bureau of Narcotics and Dangerous Drugs, including office of
Director thereof, in Department of Justice abolished by Reorg. Plan
No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, set
out in the Appendix to Title 5, Government Organization and
Employees. Reorg. Plan No. 2 of 1973 also created in Department of
Justice a single, comprehensive agency for enforcement of drug laws
to be known as Drug Enforcement Administration, empowered Attorney
General to authorize performance by officers, employees, and
agencies of Department of functions transferred to him, and
directed Attorney General to coordinate all drug law enforcement
functions to assure maximum cooperation between Drug Enforcement
Administration, Federal Bureau of Investigation, and other units of
Department of Justice involved in drug law enforcement.
-MISC2-
CONSTRUCTIVE SEIZURE PROCEDURES
Pub. L. 101-225, title II, Sec. 210, Dec. 12, 1989, 103 Stat.
1913, provided that: "Not later than 6 months after the date of
enactment of this Act [Dec. 12, 1989], the Secretary of
Transportation and the Secretary of the Treasury, in order to avoid
the devastating economic effects on innocent owners of seizures of
their vessels, shall develop a procedure for constructive seizure
of vessels of the United States engaged in commercial service as
defined in section 2101 of title 46, United States Code, that are
suspected of being used for committing violations of law involving
personal use quantities of controlled substances."
REGULATIONS FOR EXPEDITED ADMINISTRATIVE FORFEITURE PROCEDURES
Section 6079 of Pub. L. 100-690 provided that:
"(a) In General. - Not later than 90 days after the date of
enactment of this Act [Nov. 18, 1988], the Attorney General and the
Secretary of the Treasury shall consult, and after providing a 30-
day public comment period, shall prescribe regulations for
expedited administrative procedures for seizures under section
511(a)(4), (6), and (7) of the Controlled Substances Act (21 U.S.C.
881(a)(4), (6), and (7)); section 596 of the Tariff Act of 1930 (19
U.S.C. 1595a(a)); and section 2 of the Act of August 9, 1939 (53
Stat. 1291; 49 U.S.C. App. 782 [now 49 U.S.C. 80303]) for
violations involving the possession of personal use quantities of a
controlled substance.
"(b) Specifications. - The regulations prescribed pursuant to
subsection (a) shall -
"(1) minimize the adverse impact caused by prolonged detention,
and
"(2) provide for a final administrative determination of the
case within 21 days of seizure, or provide a procedure by which
the defendant can obtain release of the property pending a final
determination of the case. Such regulations shall provide that
the appropriate agency official rendering a final determination
shall immediately return the property if the following conditions
are established:
"(A) the owner or interested party did not know of or consent
to the violation;
"(B) the owner establishes a valid, good faith interest in
the seized property as owner or otherwise; and
"(C)(1) the owner establishes that the owner at no time had
any knowledge or reason to believe that the property in which
the owner claims an interest was being or would be used in a
violation of the law; and
"(2) if the owner at any time had, or should have had,
knowledge or reason to believe that the property in which the
owner claims an interest was being or would be used in a
violation of the law, that the owner did what reasonably could
be expected to prevent the violation.
An owner shall not have the seized property returned under this
subsection if the owner had not acted in a normal and customary
manner to ascertain how the property would be used.
"(c) Notice. - At the time of seizure or upon issuance of a
summons to appear under subsection (d), the officer making the
seizure shall furnish to any person in possession of the conveyance
a written notice specifying the procedures under this section. At
the earliest practicable opportunity after determining ownership of
the seized conveyance, the head of the department or agency that
seizes the conveyance shall furnish a written notice to the owner
and other interested parties (including lienholders) of the legal
and factual basis of the seizure.
"(d) Summons in Lieu of Seizure of Commercial Fishing Industry
Vessels. - Not later than 90 days after the enactment of this Act
[Nov. 18, 1988], the Attorney General, the Secretary of the
Treasury, and the Secretary of Transportation shall prescribe joint
regulations, after a public comment period of at least 30 days,
providing for issuance of a summons to appear in lieu of seizure of
a commercial fishing industry vessel as defined in section
2101(11a), (11b), and (11c) of title 46, United States Code, for
violations involving the possession of personal use quantities of a
controlled substance. These regulations shall apply when the
violation is committed on a commercial fishing industry vessel that
is proceeding to or from a fishing area or intermediate port of
call, or is actively engaged in fishing operations. The authority
provided under this section shall not affect existing authority to
arrest an individual for drug-related offenses or to release that
individual into the custody of the vessel's master. Upon answering
a summons to appear, the procedures set forth in subsections (a),
(b), and (c) of this section shall apply. The jurisdiction of the
district court for any forfeiture incurred shall not be affected by
the use of a summons under this section.
"(e) Personal Use Quantities of a Controlled Substance. - For the
purposes of this section, personal use quantities of a controlled
substance shall not include sweepings or other evidence of non-
personal use amounts."
-FOOTNOTE-
(!1) So in original. No subsec. (k) has been enacted.
-End-
-CITE-
21 USC Secs. 881-1, 881a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Secs. 881-1, 881a. Transferred
-COD-
CODIFICATION
Section 881-1, Pub. L. 91-513, title II, Sec. 511A, as added Pub.
L. 100-690, title VI, Sec. 6080(a), Nov. 18, 1988, 102 Stat. 4326,
which related to expedited procedures for seized conveyances, was
renumbered Sec. 518 of Pub. L. 91-513 by Pub. L. 101-647, title X,
Sec. 1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, transferred to
section 888 of this title and subsequently repealed.
Section 881a, Pub. L. 99-198, title XVII, Sec. 1764, Dec. 23,
1985, 99 Stat. 1652, which related to production control of
controlled substances, was renumbered section 519 of the Controlled
Substances Act by Pub. L. 101-647, title X, Sec. 1002(h)(2), Nov.
29, 1990, 104 Stat. 4828, and is classified to section 889 of this
title.
-End-
-CITE-
21 USC Sec. 882 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 882. Injunctions
-STATUTE-
(a) Jurisdiction
The district courts of the United States and all courts
exercising general jurisdiction in the territories and possessions
of the United States shall have jurisdiction in proceedings in
accordance with the Federal Rules of Civil Procedure to enjoin
violations of this subchapter.
(b) Jury trial
In case of an alleged violation of an injunction or restraining
order issued under this section, trial shall, upon demand of the
accused, be by a jury in accordance with the Federal Rules of Civil
Procedure.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 512, Oct. 27, 1970, 84 Stat. 1278.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Rules of Civil Procedure, referred to in subsecs. (a)
and (b), are set out in the Appendix to Title 28, Judiciary and
Judicial Procedure.
-End-
-CITE-
21 USC Sec. 883 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 883. Enforcement proceedings
-STATUTE-
Before any violation of this subchapter is reported by the
Administrator of the Drug Enforcement Administration to any United
States attorney for institution of a criminal proceeding, the
Administrator may require that the person against whom such
proceeding is contemplated is given appropriate notice and an
opportunity to present his views, either orally or in writing, with
regard to such contemplated proceeding.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 513, Oct. 27, 1970, 84 Stat. 1278;
Pub. L. 96-132, Sec. 16(c), Nov. 30, 1979, 93 Stat. 1049.)
-MISC1-
AMENDMENTS
1979 - Pub. L. 96-132 substituted "Administrator of the Drug
Enforcement Administration" for "Director of the Bureau of
Narcotics and Dangerous Drugs" and "Administrator may" for
"Director may".
-End-
-CITE-
21 USC Sec. 884 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 884. Immunity and privilege
-STATUTE-
(a) Refusal to testify
Whenever a witness refuses, on the basis of his privilege against
self-incrimination, to testify or provide other information in a
proceeding before a court or grand jury of the United States,
involving a violation of this subchapter, and the person presiding
over the proceeding communicates to the witness an order issued
under this section, the witness may not refuse to comply with the
order on the basis of his privilege against self-incrimination. But
no testimony or other information compelled under the order issued
under subsection (b) of this section or any information obtained by
the exploitation of such testimony or other information, may be
used against the witness in any criminal case, including any
criminal case brought in a court of a State, except a prosecution
for perjury, giving a false statement, or otherwise failing to
comply with the order.
(b) Order of United States district court
In the case of any individual who has been or may be called to
testify or provide other information at any proceeding before a
court or grand jury of the United States, the United States
district court for the judicial district in which the proceeding is
or may be held shall issue, upon the request of the United States
attorney for such district, an order requiring such individual to
give any testimony or provide any other information which he
refuses to give or provide on the basis of his privilege against
self-incrimination.
(c) Request by United States attorney
A United States attorney may, with the approval of the Attorney
General or the Deputy Attorney General, the Associate Attorney
General, or any Assistant Attorney General designated by the
Attorney General, request an order under subsection (b) of this
section when in his judgment -
(1) the testimony or other information from such individual may
be necessary to the public interest; and
(2) such individual has refused or is likely to refuse to
testify or provide other information on the basis of his
privilege against self-incrimination.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 514, Oct. 27, 1970, 84 Stat. 1278;
Pub. L. 100-690, title VII, Sec. 7020(f), Nov. 18, 1988, 102 Stat.
4396.)
-MISC1-
AMENDMENTS
1988 - Subsec. (c). Pub. L. 100-690 inserted reference to
Associate Attorney General.
-End-
-CITE-
21 USC Sec. 885 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 885. Burden of proof; liabilities
-STATUTE-
(a) Exemptions and exceptions; presumption in simple possession
offenses
(1) It shall not be necessary for the United States to negative
any exemption or exception set forth in this subchapter in any
complaint, information, indictment, or other pleading or in any
trial, hearing, or other proceeding under this subchapter, and the
burden of going forward with the evidence with respect to any such
exemption or exception shall be upon the person claiming its
benefit.
(2) In the case of a person charged under section 844(a) of this
title with the possession of a controlled substance, any label
identifying such substance for purposes of section 353(b)(2) of
this title shall be admissible in evidence and shall be prima facie
evidence that such substance was obtained pursuant to a valid
prescription from a practitioner while acting in the course of his
professional practice.
(b) Registration and order forms
In the absence of proof that a person is the duly authorized
holder of an appropriate registration or order form issued under
this subchapter, he shall be presumed not to be the holder of such
registration or form, and the burden of going forward with the
evidence with respect to such registration or form shall be upon
him.
(c) Use of vehicles, vessels, and aircraft
The burden of going forward with the evidence to establish that a
vehicle, vessel, or aircraft used in connection with controlled
substances in schedule I was used in accordance with the provisions
of this subchapter shall be on the persons engaged in such use.
(d) Immunity of Federal, State, local and other officials
Except as provided in sections 2234 and 2235 of title 18, no
civil or criminal liability shall be imposed by virtue of this
subchapter upon any duly authorized Federal officer lawfully
engaged in the enforcement of this subchapter, or upon any duly
authorized officer of any State, territory, political subdivision
thereof, the District of Columbia, or any possession of the United
States, who shall be lawfully engaged in the enforcement of any law
or municipal ordinance relating to controlled substances.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 515, Oct. 27, 1970, 84 Stat. 1279.)
-REFTEXT-
REFERENCES IN TEXT
Schedule I, referred to in subsec. (c), is set out in section
812(c) of this title.
-End-
-CITE-
21 USC Sec. 886 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 886. Payments and advances
-STATUTE-
(a) Payment to informers
The Attorney General is authorized to pay any person, from funds
appropriated for the Drug Enforcement Administration, for
information concerning a violation of this subchapter, such sum or
sums of money as he may deem appropriate, without reference to any
moieties or rewards to which such person may otherwise be entitled
by law.
(b) Reimbursement for purchase of controlled substances
Moneys expended from appropriations of the Drug Enforcement
Administration for purchase of controlled substances and
subsequently recovered shall be reimbursed to the current
appropriation for the Administration.(!1)
(c) Advance of funds for enforcement purposes
The Attorney General is authorized to direct the advance of funds
by the Treasury Department in connection with the enforcement of
this subchapter.
(d) Drug Pollution Fund
(1) There is established in the Treasury a trust fund to be known
as the "Drug Pollution Fund" (hereinafter referred to in this
subsection as the "Fund"), consisting of amounts appropriated or
credited to such Fund under section 841(b)(6) of this title.
(2) There are hereby appropriated to the Fund amounts equivalent
to the fines imposed under section 841(b)(6) of this title.
(3) Amounts in the Fund shall be available, as provided in
appropriations Acts, for the purpose of making payments in
accordance with paragraph (4) for the clean up of certain pollution
resulting from the actions referred to in section 841(b)(6) of this
title.
(4)(A) The Secretary of the Treasury, after consultation with the
Attorney General, shall make payments under paragraph (3), in such
amounts as the Secretary determines appropriate, to the heads of
executive agencies or departments that meet the requirements of
subparagraph (B).
(B) In order to receive a payment under paragraph (3), the head
of an executive agency or department shall submit an application in
such form and containing such information as the Secretary of the
Treasury shall by regulation require. Such application shall
contain a description of the fine imposed under section 841(b)(6)
of this title, the circumstances surrounding the imposition of such
fine, and the type and severity of pollution that resulted from the
actions to which such fine applies.
(5) For purposes of subchapter B of chapter 98 of title 26, the
Fund established under this paragraph shall be treated in the same
manner as a trust fund established under subchapter A of such
chapter.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 516, Oct. 27, 1970, 84 Stat. 1279;
Pub. L. 96-132, Sec. 16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L.
100-690, title VI, Sec. 6254(i), Nov. 18, 1988, 102 Stat. 4367.)
-COD-
CODIFICATION
In subsec. (b), "Administration" substituted for "Bureau" as the
probable intent of Congress in view of amendment by Pub. L. 96-132,
which substituted references to the Drug Enforcement Administration
for references to the Bureau of Narcotics and Dangerous Drugs
wherever appearing in text.
-MISC1-
AMENDMENTS
1988 - Subsec. (d). Pub. L. 100-690 added subsec. (d).
1979 - Subsecs. (a), (b). Pub. L. 96-132 substituted "Drug
Enforcement Administration" for "Bureau of Narcotics and Dangerous
Drugs".
REIMBURSEMENT BY DRUG ENFORCEMENT ADMINISTRATION OF EXPENSES
INCURRED TO REMEDIATE METHAMPHETAMINE LABORATORIES
Pub. L. 106-310, div. B, title XXXVI, Sec. 3672, Oct. 17, 2000,
114 Stat. 1246, provided that:
"(a) Reimbursement Authorized. - The Attorney General, acting
through the Administrator of the Drug Enforcement Administration,
may reimburse States, units of local government, Indian tribal
governments, other public entities, and multi-jurisdictional or
regional consortia thereof for expenses incurred to clean up and
safely dispose of substances associated with clandestine
methamphetamine laboratories which may present a danger to public
health or the environment.
"(b) Additional DEA Personnel. - From amounts appropriated or
otherwise made available to carry out this section, the Attorney
General may hire not more than five additional Drug Enforcement
Administration personnel to administer this section.
"(c) Authorization of Appropriations. - There is authorized to be
appropriated to the Attorney General to carry out this section
$20,000,000 for fiscal year 2001."
-FOOTNOTE-
(!1) See Codification note below.
-End-
-CITE-
21 USC Sec. 886a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 886a. Diversion Control Fee Account
-STATUTE-
(1) In general
There is established in the general fund of the Treasury a
separate account which shall be known as the Diversion Control Fee
Account. For fiscal year 1993 and thereafter:
(A) There shall be deposited as offsetting receipts into that
account all fees collected by the Drug Enforcement
Administration, in excess of $15,000,000, for the operation of
its diversion control program.
(B) Such amounts as are deposited into the Diversion Control
Fee Account shall remain available until expended and shall be
refunded out of that account by the Secretary of the Treasury, at
least on a quarterly basis, to reimburse the Drug Enforcement
Administration for expenses incurred in the operation of the
diversion control program. Such reimbursements shall be made
without distinguishing between expenses related to controlled
substance activities and expenses related to chemical activities.
(C) Fees charged by the Drug Enforcement Administration under
its diversion control program shall be set at a level that
ensures the recovery of the full costs of operating the various
aspects of that program.
(D) The amount required to be refunded from the Diversion
Control Fee Account for fiscal year 1994 and thereafter shall be
refunded in accordance with estimates made in the budget request
of the Attorney General for those fiscal years. Any proposed
changes in the amounts designated in said budget requests shall
only be made after notification to the Committees on
Appropriations of the House of Representatives and the Senate
fifteen days in advance.
(2) Definitions
In this section:
(A) Diversion control program
The term "diversion control program" means the controlled
substance and chemical diversion control activities of the Drug
Enforcement Administration.
(B) Controlled substance and chemical diversion control
activities
The term "controlled substance and chemical diversion control
activities" means those activities related to the registration
and control of the manufacture, distribution, dispensing,
importation, and exportation of controlled substances and listed
chemicals.
-SOURCE-
(Pub. L. 102-395, title I, Sec. 111(b), Oct. 6, 1992, 106 Stat.
1843; Pub. L. 105-362, title X, Sec. 1001(b), Nov. 10, 1998, 112
Stat. 3291; Pub. L. 108-447, div. B, title VI, Sec. 633(a), Dec. 8,
2004, 118 Stat. 2921.)
-COD-
CODIFICATION
Section was enacted as part of the Departments of Commerce,
Justice, and State, the Judiciary, and Related Agencies
Appropriations Act, 1993, and not as part of the Controlled
Substances Act which comprises this subchapter.
-MISC1-
AMENDMENTS
2004 - Pub. L. 108-447, Sec. 633(a)(2) to (4), designated
existing provisions as par. (1) and inserted heading, substituted
"program. Such reimbursements shall be made without distinguishing
between expenses related to controlled substance activities and
expenses related to chemical activities" for "program" in par.
(1)(B), and added par. (2).
Pub. L. 108-447, Sec. 633(a)(1), which directed redesignation of
pars. (1) to (5) as subpars. (A) to (E) and adjustment of margins,
was executed by redesignating pars. (1) to (4) as (A) to (D),
respectively, to reflect the probable intent of Congress, because
Pub. L. 105-362 struck out par. (5). See 1998 Amendment note below.
1998 - Par. (5). Pub. L. 105-362 struck out par. (5) which read
as follows: "The Attorney General shall prepare and submit annually
to the Congress, statements of financial condition of the account,
including the beginning balance, receipts, refunds to
appropriations, transfers to the general fund, and the ending
balance."
-End-
-CITE-
21 USC Sec. 887 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 887. Coordination and consolidation of post-seizure
administration
-STATUTE-
The Attorney General and the Secretary of the Treasury shall take
such action as may be necessary to develop and maintain a joint
plan to coordinate and consolidate post-seizure administration of
property seized under this subchapter, subchapter II of this
chapter, or provisions of the customs laws relating to controlled
substances.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 517, as added Pub. L. 100-690,
title VI, Sec. 6078(a), Nov. 18, 1988, 102 Stat. 4325.)
-REFTEXT-
REFERENCES IN TEXT
The customs laws, referred to in text, are classified generally
to Title 19, Customs Duties.
-End-
-CITE-
21 USC Sec. 888 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 888. Repealed.
-MISC1-
Sec. 888. Repealed. Pub. L. 106-185, Sec. 2(c)(3), Apr. 25, 2000,
114 Stat. 210.
Section, Pub. L. 91-513, title II, Sec. 518, formerly Sec. 511A,
as added Pub. L. 100-690, title VI, Sec. 6080(a), Nov. 18, 1988,
102 Stat. 4326; renumbered Sec. 518, Pub. L. 101-647, title X, Sec.
1002(h)(1), Nov. 29, 1990, 104 Stat. 4828, related to expedited
procedures for seized conveyances.
Section was classified to section 881-1 of this title prior to
renumbering by Pub. L. 101-647.
EFFECTIVE DATE OF REPEAL
Repeal applicable to any forfeiture proceeding commenced on or
after the date that is 120 days after Apr. 25, 2000, see section 21
of Pub. L. 106-185, set out as an Effective Date of 2000 Amendment
note under section 1324 of Title 8, Aliens and Nationality.
-End-
-CITE-
21 USC Sec. 889 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 889. Production control of controlled substances
-STATUTE-
(a) Definitions
As used in this section:
(1) The term "controlled substance" has the same meaning given
such term in section 802(6) of this title.
(2) The term "Secretary" means the Secretary of Agriculture.
(3) The term "State" means each of the fifty States, the
District of Columbia, the Commonwealth of Puerto Rico, Guam, the
Virgin Islands of the United States, American Samoa, the
Commonwealth of the Northern Mariana Islands, or the Trust
Territory of the Pacific Islands.
(b) Persons ineligible for Federal agricultural program benefits
Notwithstanding any other provision of law, following December
23, 1985, any person who is convicted under Federal or State law of
planting, cultivation, growing, producing, harvesting, or storing a
controlled substance in any crop year shall be ineligible for -
(1) as to any commodity produced during that crop year, and the
four succeeding crop years, by such person -
(A) any price support or payment made available under the
Agricultural Act of 1949 (7 U.S.C. 1421 et seq.), the Commodity
Credit Corporation Charter Act (15 U.S.C. 714 et seq.), or any
other Act;
(B) a farm storage facility loan made under section 4(h) of
the Commodity Credit Corporation Charter Act (15 U.S.C.
714b(h));
(C) crop insurance under the Federal Crop Insurance Act (7
U.S.C. 1501 et seq.);
(D) a disaster payment made under the Agricultural Act of
1949 (7 U.S.C. 1421 et seq.); or
(E) a loan made, insured or guaranteed under the Consolidated
Farm and Rural Development Act (7 U.S.C. 1921 et seq.) or any
other provision of law administered by the Farmers Home
Administration; or
(2) a payment made under section 4 or 5 of the Commodity Credit
Corporation Charter Act (15 U.S.C. 714b or 714c) for the storage
of an agricultural commodity that is -
(A) produced during that crop year, or any of the four
succeeding crop years, by such person; and
(B) acquired by the Commodity Credit Corporation.
(c) Regulations
Not later than 180 days after December 23, 1985, the Secretary
shall issue such regulations as the Secretary determines are
necessary to carry out this section, including regulations that -
(1) define the term "person";
(2) govern the determination of persons who shall be ineligible
for program benefits under this section; and
(3) protect the interests of tenants and sharecroppers.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 519, formerly Pub. L. 99-198, title
XVII, Sec. 1764, Dec. 23, 1985, 99 Stat. 1652; renumbered Sec. 519
of Pub. L. 91-513, Pub. L. 101-647, title X, Sec. 1002(h)(2), Nov.
29, 1990, 104 Stat. 4828.)
-REFTEXT-
REFERENCES IN TEXT
The Agricultural Act of 1949, referred to in subsec. (b)(1)(A),
(D), is act Oct. 31, 1949, ch. 792, 63 Stat. 1051, as amended,
which is classified principally to chapter 35A (Sec. 1421 et seq.)
of Title 7, Agriculture. For complete classification of this Act to
the Code, see Short Title note set out under section 1421 of Title
7 and Tables.
The Commodity Credit Corporation Charter Act, referred to in
subsec. (b)(1)(A), is act June 29, 1948, ch. 704, 62 Stat. 1070, as
amended, and is classified generally to subchapter II (Sec. 714 et
seq.) of chapter 15 of Title 15, Commerce and Trade. For complete
classification of this Act to the Code, see Short Title note set
out under section 714 of Title 15 and Tables.
The Federal Crop Insurance Act, referred to in subsec. (b)(1)(C),
is title V of act Feb. 16, 1938, ch. 30, 52 Stat. 72, as amended,
which is classified generally to chapter 36 (Sec. 1501 et seq.) of
Title 7, Agriculture. For complete classification of this Act to
the Code, see section 1501 of Title 7 and Tables.
The Consolidated Farm and Rural Development Act, referred to in
subsec. (b)(1)(E), is title III of Pub. L. 87-128, Aug. 8, 1961, 75
Stat. 307, as amended, which is classified principally to chapter
50 (Sec. 1921 et seq.) of Title 7. For complete classification of
this Act to the Code, see Short Title note set out under section
1921 of Title 7 and Tables.
-COD-
CODIFICATION
Section was classified to section 881a of this title prior to
renumbering by Pub. L. 101-647.
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-647 renumbered section 881a of this title as
this section.
-TRANS-
TERMINATION OF TRUST TERRITORY OF THE PACIFIC ISLANDS
For termination of Trust Territory of the Pacific Islands, see
note set out preceding section 1681 of Title 48, Territories and
Insular Possessions.
-End-
-CITE-
21 USC Sec. 890 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part E - Administrative and Enforcement Provisions
-HEAD-
Sec. 890. Review of Federal sales of chemicals usable to
manufacture controlled substances
-STATUTE-
A Federal department or agency may not sell from the stocks of
the department or agency any chemical which, as determined by the
Administrator of the Drug Enforcement Administration, could be used
in the manufacture of a controlled substance unless the
Administrator certifies in writing to the head of the department or
agency that there is no reasonable cause to believe that the sale
of the chemical would result in the illegal manufacture of a
controlled substance.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 520, as added Pub. L. 104-201, div.
A, title X, Sec. 1034(a), Sept. 23, 1996, 110 Stat. 2640.)
-End-
-CITE-
21 USC Part F - General Provisions 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part F - General Provisions
-HEAD-
PART F - GENERAL PROVISIONS
-COD-
CODIFICATION
The letter designation for this Part F was, in the original, Part
G. The original Part F of title II of Pub. L. 91-513, consisting of
section 601 thereof, is set out as a note under section 801 of this
title. The original Part G of title II of Pub. L. 91-513 consisted
of sections 701 to 709. Sections 701 to 705 amended and repealed
sections in this title and in Title 18, Crimes and Criminal
Procedure, and Title 42, The Public Health and Welfare, and enacted
provisions set out as notes under sections 321, 801, and 822 of
this title. See Tables for classifications of said sections 701 to
705. Sections 706 to 709 of Pub. L. 91-513 are set out as sections
901 to 904 of this title and, for purposes of codification,
comprise this Part F.
-End-
-CITE-
21 USC Sec. 901 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part F - General Provisions
-HEAD-
Sec. 901. Severability
-STATUTE-
If a provision of this chapter is held invalid, all valid
provisions that are severable shall remain in effect. If a
provision of this chapter is held invalid in one or more of its
applications, the provision shall remain in effect in all its valid
applications that are severable.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 706, Oct. 27, 1970, 84 Stat. 1284.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1236, as
amended. For complete classification of this Act to the Code, see
Short Title note set out under section 801 of this title and
Tables.
-End-
-CITE-
21 USC Sec. 902 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part F - General Provisions
-HEAD-
Sec. 902. Savings provisions
-STATUTE-
Nothing in this chapter, except this part and, to the extent of
any inconsistency, sections 827(e) and 829 of this title, shall be
construed as in any way affecting, modifying, repealing, or
superseding the provisions of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. Sec. 301 et seq.].
-SOURCE-
(Pub. L. 91-513, title II, Sec. 707, Oct. 27, 1970, 84 Stat. 1284.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in text, is
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to chapter 9 (Sec. 301 et seq.) of this title.
For complete classification of this Act to the Code, see section
301 of this title and Tables.
-End-
-CITE-
21 USC Sec. 903 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part F - General Provisions
-HEAD-
Sec. 903. Application of State law
-STATUTE-
No provision of this subchapter shall be construed as indicating
an intent on the part of the Congress to occupy the field in which
that provision operates, including criminal penalties, to the
exclusion of any State law on the same subject matter which would
otherwise be within the authority of the State, unless there is a
positive conflict between that provision of this subchapter and
that State law so that the two cannot consistently stand together.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 708, Oct. 27, 1970, 84 Stat. 1284.)
-REFTEXT-
REFERENCES IN TEXT
This subchapter, referred to in text, was in the original "this
title", meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1242, as amended, and is popularly known as the "Controlled
Substances Act". For complete classification of title II to the
Code, see second paragraph of Short Title note set out under
section 801 of this title and Tables.
-End-
-CITE-
21 USC Sec. 904 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part F - General Provisions
-HEAD-
Sec. 904. Payment of tort claims
-STATUTE-
Notwithstanding section 2680(k) of title 28, the Attorney
General, in carrying out the functions of the Department of Justice
under this subchapter, is authorized to pay tort claims in the
manner authorized by section 2672 of title 28, when such claims
arise in a foreign country in connection with the operations of the
Drug Enforcement Administration abroad.
-SOURCE-
(Pub. L. 91-513, title II, Sec. 709, Oct. 27, 1970, 84 Stat. 1284;
Pub. L. 93-481, Sec. 1, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 95-
137, Sec. 1(a), Oct. 18, 1977, 91 Stat. 1169; Pub. L. 96-132,
Secs. 13, 15, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 97-414, Sec.
9(g)(1), Jan. 4, 1983, 96 Stat. 2064.)
-MISC1-
AMENDMENTS
1983 - Pub. L. 97-414 struck out subsecs. (a) and (b) which had
provided, respectively, that (a) there were authorized to be
appropriated $105,000,000 for the fiscal year ending June 30, 1975,
$175,000,000 for the fiscal year ending June 30, 1976, $200,000,000
for the fiscal year ending September 30, 1977, $188,000,000 for the
fiscal year ending September 30, 1978, $215,000,000 for the fiscal
year ending September 30, 1979, and $198,336,000 for the fiscal
year ending September 30, 1980, for the expenses of the Department
of Justice in carrying out its functions under this subchapter, and
that (b) no funds appropriated under any other provision of this
chapter could be used for the expenses of the Department of Justice
for which funds were authorized to be appropriated by former
subsection (a) of this section, and removed the subsection
designator (c) before "Notwithstanding".
1979 - Subsec. (a). Pub. L. 96-132, Sec. 15, inserted provisions
authorizing appropriations of $198,336,000 for the fiscal year
ending Sept. 30, 1980.
Subsec. (c). Pub. L. 96-132, Sec. 13, added subsec. (c).
1977 - Subsec. (a). Pub. L. 95-137 substituted "September 30,
1977, $188,000,000 for the fiscal year ending September 30, 1978,
and $215,000,000 for the fiscal year ending September 30, 1979,"
for "June 30, 1977," and struck out "(other than its expenses
incurred in connection with carrying out section 803(a) of this
title)".
1974 - Pub. L. 93-481 designated existing provisions as subsec.
(a), substituted authorization of appropriations for fiscal years
ending June 30, 1975, June 30, 1976, and June 30, 1977, for
authorization of appropriations for fiscal years ending June 30,
1972, June 30, 1973, and June 30, 1974, and added subsec. (b).
-End-
-CITE-
21 USC SUBCHAPTER II - IMPORT AND EXPORT 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
SUBCHAPTER II - IMPORT AND EXPORT
-COD-
CODIFICATION
This subchapter is comprised of Part A of title III of Pub. L. 91-
513, Oct. 27, 1970, 84 Stat. 1285. Part B of title III contains
amendatory, repealing, and transitional provisions generally
classified elsewhere.
-End-
-CITE-
21 USC Sec. 951 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 951. Definitions
-STATUTE-
(a) For purposes of this subchapter -
(1) The term "import" means, with respect to any article, any
bringing in or introduction of such article into any area
(whether or not such bringing in or introduction constitutes an
importation within the meaning of the tariff laws of the United
States).
(2) The term "customs territory of the United States" has the
meaning assigned to such term by general note 2 of the Harmonized
Tariff Schedule of the United States.
(b) Each term defined in section 802 of this title shall have the
same meaning for purposes of this subchapter as such term has for
purposes of subchapter I of this chapter.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1001, Oct. 27, 1970, 84 Stat.
1285; Pub. L. 100-418, title I, Sec. 1214(m), Aug. 23, 1988, 102
Stat. 1158.)
-REFTEXT-
REFERENCES IN TEXT
The Harmonized Tariff Schedule of the United States, referred to
in subsec. (a)(2), is not set out in the Code. See Publication of
Harmonized Tariff Schedule note set out under section 1202 of Title
19, Customs Duties.
This subchapter, referred to in subsecs. (a) and (b), was in the
original "this title", meaning title III of Pub. L. 91-513, Oct.
27, 1970, 84 Stat. 1285, as amended. Part A of title III comprises
this subchapter. For classification of Part B, consisting of
sections 1101 to 1105 of title III, see Tables.
-MISC1-
AMENDMENTS
1988 - Subsec. (a)(2). Pub. L. 100-418 substituted "general note
2 of the Harmonized Tariff Schedule of the United States" for
"general headnote 2 to the Tariff Schedules of the United States".
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-418 effective Jan. 1, 1989, and
applicable with respect to articles entered on or after such date,
see section 1217(b)(1) of Pub. L. 100-418, set out as an Effective
Date note under section 3001 of Title 19, Customs Duties.
EFFECTIVE DATE
Section 1105(a)-(c) of title III of Pub. L. 91-513, as amended by
Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095, provided
that:
"(a) Except as otherwise provided in this section, this title
[see Short Title note below] shall become effective on the first
day of the seventh calendar month that begins after the day
immediately preceding the date of enactment [Oct. 27, 1970].
"(b) Sections 1000, 1001, 1006, 1015, 1016, 1103, 1104 [see Short
Title note below and sections 171 note, 951, 956, 957 note, 965,
and 966 of this title], and this section shall become effective
upon enactment [Oct. 27, 1970].
"(c)(1) If the Attorney General, pursuant to the authority of
section 704(c) of title II [set out as a note under section 801 of
this title], postpones the effective date of section 306 (relating
to manufacturing quotas) [section 826 of this title] for any period
beyond the date specified in section 704(a) [set out as a note
under section 801 of this title], and such postponement applies to
narcotic drugs, the repeal of the Narcotics Manufacturing Act of
1960 [sections 501 to 517 of this title] by paragraph (10) of
section 1101(a) of this title is hereby postponed for the same
period, except that the postponement made by this paragraph shall
not apply to the repeal of sections 4, 5, 13, 15, and 16 of that
Act [which were classified to sections 182, 503, 511, and 513 of
this title and sections 4702, 4731, and 4731 note of Title 26,
Internal Revenue Code].
"(2) Effective for any period of postponement, by paragraph (1)
of this subsection, of the repeal of provisions of the Narcotics
Manufacturing Act of 1960 [sections 501 to 517 of this title], that
Act shall be applied subject to the following modifications:
"(A) The term 'narcotic drug' shall mean a narcotic drug as
defined in section 102(16) of title II [section 802(16) of this
title], and all references, in the Narcotics Manufacturing Act of
1960 [sections 501 to 517 of this title], to a narcotic drug as
defined by section 4731 of the Internal Revenue Code of 1986
[formerly I.R.C. 1954, section 4731 of Title 26] are amended to
refer to a narcotic drug as defined by such section 102(16)
[section 802(16) of this title].
"(B) On and after the date prescribed by the Attorney General
pursuant to clause (2) of section 703(c) of title II, [set out as a
note under section 822 of this title], the requirements of a
manufacturer's license with respect to a basic class of narcotic
drug under the Narcotics Manufacturing Act of 1960 [sections 501 to
517 of this title], and of a registration under section 4722 of the
Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722
of Title 26] as a prerequisite to issuance of such a license, shall
be superseded by a requirement of actual registration (as
distinguished from provisional registration) as a manufacturer of
that class of drug under section 303(a) of title II [section 823(a)
of this title].
"(C) On and after the effective date of the repeal of such
section 4722 [section 4722 of title 26] by section 1101(b)(3) of
this title, but prior to the date specified in subparagraph (B) of
this paragraph, the requirement of registration under such section
4722 [section 4722 of title 26] as a prerequisite of a
manufacturer's license under the Narcotics Manufacturing Act of
1960 [sections 501 to 517 of this title] shall be superseded by a
requirement of either (i) actual registration as a manufacturer
under section 303 of title II [section 823 of this title] or (ii)
provisional registration (by virtue of a preexisting registration
under such section 4722) under section 703 of title II [set out as
a note under section 822 of this title]."
SHORT TITLE
Section 1000 of title III of Pub. L. 91-513 provided that: "This
title [enacting this subchapter, amending sections 162 and 967 of
this title, section 4251 of Title 18, Crimes and Criminal
Procedure, section 1584 of Title 19, Customs Duties, sections 4901,
4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of
Title 26, Internal Revenue Code, section 2901 of Title 28,
Judiciary and Judicial Procedure, sections 529d, 529e, and 529f of
former Title 31, Money and Finance, section 304m of former Title
40, Public Buildings, Property, and Works, section 3411 of Title
42, The Public Health and Welfare, section 239a of former Title 46,
Shipping, and section 787 of former Title 49, Transportation,
repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193,
197, 198, 199, and 501 to 517 of this title, sections 1401 to 1407,
and 3616 of Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to
4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to
4776, 7237, 7238, and 7491 of Title 26, sections 529a and 529g of
former Title 31, section 1421m of Title 48, Territories and Insular
Possessions, and enacting provisions set out as notes under this
section and sections 171 and 957 of this title] may be cited as the
'Controlled Substances Import and Export Act'."
RULES AND REGULATIONS
Section 1105(d) of Pub. L. 91-513 provided: "Any orders, rules
and regulations which have been promulgated under any law affected
by this title [see Short Title note above] and which are in effect
on the day preceding enactment of this title [Oct. 27, 1970] shall
continue in effect until modified, superseded, or repealed."
-End-
-CITE-
21 USC Sec. 952 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 952. Importation of controlled substances
-STATUTE-
(a) Controlled substances in schedule I or II and narcotic drugs in
schedule III, IV, or V; exceptions
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place outside
thereof, any controlled substance in schedule I or II of subchapter
I of this chapter, or any narcotic drug in schedule III, IV, or V
of subchapter I of this chapter, or ephedrine, pseudoephedrine, or
phenylpropanolamine, except that -
(1) such amounts of crude opium, poppy straw, concentrate of
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine,
and phenylpropanolamine, as the Attorney General finds to be
necessary to provide for medical, scientific, or other legitimate
purposes, and
(2) such amounts of any controlled substance in schedule I or
II or any narcotic drug in schedule III, IV, or V that the
Attorney General finds to be necessary to provide for the
medical, scientific, or other legitimate needs of the United
States -
(A) during an emergency in which domestic supplies of such
substance or drug are found by the Attorney General to be
inadequate,
(B) in any case in which the Attorney General finds that
competition among domestic manufacturers of the controlled
substance is inadequate and will not be rendered adequate by
the registration of additional manufacturers under section 823
of this title, or
(C) in any case in which the Attorney General finds that such
controlled substance is in limited quantities exclusively for
scientific, analytical, or research uses,
may be so imported under such regulations as the Attorney General
shall prescribe. No crude opium may be so imported for the purpose
of manufacturing heroin or smoking opium.
(b) Nonnarcotic controlled substances in schedule III, IV, or V
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place
outside thereof, any nonnarcotic controlled substance in
schedule III, IV, or V, unless such nonnarcotic controlled
substance -
(1) is imported for medical, scientific, or other legitimate
uses, and
(2) is imported pursuant to such notification, or declaration,
or in the case of any nonnarcotic controlled substance in
schedule III, such import permit, notification, or declaration,
as the Attorney General may by regulation prescribe, except that
if a nonnarcotic controlled substance in schedule IV or V is also
listed in schedule I or II of the Convention on Psychotropic
Substances it shall be imported pursuant to such import permit
requirements, prescribed by regulation of the Attorney General,
as are required by the Convention.
(c) Coca leaves
In addition to the amount of coca leaves authorized to be
imported into the United States under subsection (a) of this
section, the Attorney General may permit the importation of
additional amounts of coca leaves. All cocaine and ecgonine (and
all salts, derivatives, and preparations from which cocaine or
ecgonine may be synthesized or made) contained in such additional
amounts of coca leaves imported under this subsection shall be
destroyed under the supervision of an authorized representative of
the Attorney General.
(d) Application for increased importation of ephedrine,
pseudoephedrine, or phenylpropanolamine
(1) With respect to a registrant under section 958 of this title
who is authorized under subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine, at any time during the
year the registrant may apply for an increase in the amount of such
chemical that the registrant is authorized to import, and the
Attorney General may approve the application if the Attorney
General determines that the approval is necessary to provide for
medical, scientific, or other legitimate purposes regarding the
chemical.
(2) With respect to the application under paragraph (1):
(A) Not later than 60 days after receiving the application, the
Attorney General shall approve or deny the application.
(B) In approving the application, the Attorney General shall
specify the period of time for which the approval is in effect,
or shall provide that the approval is effective until the
registrant involved is notified in writing by the Attorney
General that the approval is terminated.
(C) If the Attorney General does not approve or deny the
application before the expiration of the 60-day period under
subparagraph (A), the application is deemed to be approved, and
such approval remains in effect until the Attorney General
notifies the registrant in writing that the approval is
terminated.
(e) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine
Each reference in this section to ephedrine, pseudoephedrine, or
phenylpropanolamine includes each of the salts, optical isomers,
and salts of optical isomers of such chemical.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1002, Oct. 27, 1970, 84 Stat.
1285; Pub. L. 95-633, title I, Sec. 105, Nov. 10, 1978, 92 Stat.
3772; Pub. L. 98-473, title II, Secs. 519-521, Oct. 12, 1984, 98
Stat. 2075; Pub. L. 109-177, title VII, Sec. 715, Mar. 9, 2006, 120
Stat. 264.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsecs. (a) and
(b), are set out in section 812(c) of this title.
-MISC1-
AMENDMENTS
2006 - Subsec. (a). Pub. L. 109-177, Sec. 715(1)(A), inserted "or
ephedrine, pseudoephedrine, or phenylpropanolamine," after
"schedule III, IV, or V of subchapter I of this chapter," in
introductory provisions.
Subsec. (a)(1). Pub. L. 109-177, Sec. 715(1)(B), inserted ", and
of ephedrine, pseudoephedrine, and phenylpropanolamine," after
"coca leaves".
Subsecs. (d), (e). Pub. L. 109-177, Sec. 715(2), added subsecs.
(d) and (e).
1984 - Subsec. (a)(1). Pub. L. 98-473, Sec. 519, amended par. (1)
generally, inserting references to poppy straw and concentrate of
poppy straw.
Subsec. (a)(2)(C). Pub. L. 98-473, Sec. 520, added subpar. (C).
Subsec. (b)(2). Pub. L. 98-473, Sec. 521, substituted "is
imported pursuant to such notification, or declaration, or in the
case of any nonnarcotic controlled substance in schedule III, such
import permit, notification, or declaration, as the Attorney
General may by regulation prescribe, except that if a nonnarcotic
controlled substance in schedule IV or V is also listed in schedule
I or II of the Convention on Psychotropic Substances it shall be
imported pursuant to such import permit requirements, prescribed by
regulation of the Attorney General, as are required by the
Convention" for "is imported pursuant to such notification or
declaration requirements as the Attorney General may by regulation
prescribe, except that if a nonnarcotic controlled substance in
schedule III, IV, or V is also listed in schedule I or II of the
Convention on Psychotropic Substances it shall be imported pursuant
to such import permit requirements, prescribed by regulation of the
Attorney General, as are required by the Convention".
1978 - Subsec. (b)(2). Pub. L. 95-633 inserted provision relating
to exception for nonnarcotic controlled substances listed in
schedule I or II of the Convention on Psychotropic Substances.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
-End-
-CITE-
21 USC Sec. 953 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 953. Exportation of controlled substances
-STATUTE-
(a) Narcotic drugs in schedule I, II, III, or IV
It shall be unlawful to export from the United States any
narcotic drug in schedule I, II, III, or IV unless -
(1) it is exported to a country which is a party to -
(A) the International Opium Convention of 1912 for the
Suppression of the Abuses of Opium, Morphine, Cocaine, and
Derivative Drugs, or to the International Opium Convention
signed at Geneva on February 19, 1925; or
(B) the Convention for Limiting the Manufacture and
Regulating the Distribution of Narcotic Drugs concluded at
Geneva, July 13, 1931, as amended by the protocol signed at
Lake Success on December 11, 1946, and the protocol bringing
under international control drugs outside the scope of the
convention of July 13, 1931, for limiting the manufacture and
regulating the distribution of narcotic drugs (as amended by
the protocol signed at Lake Success on December 11, 1946),
signed at Paris, November 19, 1948; or
(C) the Single Convention on Narcotic Drugs, 1961, signed at
New York, March 30, 1961;
(2) such country has instituted and maintains, in conformity
with the conventions to which it is a party, a system for the
control of imports of narcotic drugs which the Attorney General
deems adequate;
(3) the narcotic drug is consigned to a holder of such permits
or licenses as may be required under the laws of the country of
import, and a permit or license to import such drug has been
issued by the country of import;
(4) substantial evidence is furnished to the Attorney General
by the exporter that (A) the narcotic drug is to be applied
exclusively to medical or scientific uses within the country of
import, and (B) there is an actual need for the narcotic drug for
medical or scientific uses within such country; and
(5) a permit to export the narcotic drug in each instance has
been issued by the Attorney General.
(b) Exception for exportation for special scientific purposes
Notwithstanding subsection (a) of this section, the Attorney
General may authorize any narcotic drug (including crude opium and
coca leaves) in schedule I, II, III, or IV to be exported from the
United States to a country which is a party to any of the
international instruments mentioned in subsection (a) of this
section if the particular drug is to be applied to a special
scientific purpose in the country of destination and the
authorities of such country will permit the importation of the
particular drug for such purpose.
(c) Nonnarcotic controlled substances in schedule I or II
It shall be unlawful to export from the United States any
nonnarcotic controlled substance in schedule I or II unless -
(1) it is exported to a country which has instituted and
maintains a system which the Attorney General deems adequate for
the control of imports of such substances;
(2) the controlled substance is consigned to a holder of such
permits or licenses as may be required under the laws of the
country of import;
(3) substantial evidence is furnished to the Attorney General
that (A) the controlled substance is to be applied exclusively to
medical, scientific, or other legitimate uses within the country
to which exported, (B) it will not be exported from such country,
and (C) there is an actual need for the controlled substance for
medical, scientific, or other legitimate uses within the country;
and
(4) a permit to export the controlled substance in each
instance has been issued by the Attorney General.
(d) Exception for exportation for special scientific purposes
Notwithstanding subsection (c) of this section, the Attorney
General may authorize any nonnarcotic controlled substance in
schedule I or II to be exported from the United States if the
particular substance is to be applied to a special scientific
purpose in the country of destination and the authorities of such
country will permit the importation of the particular drug for such
purpose.
(e) Nonnarcotic controlled substances in schedule III or IV;
controlled substances in schedule V
It shall be unlawful to export from the United States to any
other country any nonnarcotic controlled substance in schedule III
or IV or any controlled substances in schedule V unless -
(1) there is furnished (before export) to the Attorney General
documentary proof that importation is not contrary to the laws or
regulations of the country of destination for consumption for
medical, scientific, or other legitimate purposes;
(2) it is exported pursuant to such notification or
declaration, or in the case of any nonnarcotic controlled
substance in schedule III, such export permit, notification, or
declaration as the Attorney General may by regulation prescribe;
and
(3) in the case of a nonnarcotic controlled substance in
schedule IV or V which is also listed in schedule I or II of the
Convention on Psychotropic Substances, it is exported pursuant to
such export permit requirements, prescribed by regulation of the
Attorney General, as are required by the Convention.
(f) Exception for exportation for subsequent export
Notwithstanding subsections (a)(4) and (c)(3) of this section,
the Attorney General may authorize any controlled substance that is
in schedule I or II, or is a narcotic drug in schedule III or IV,
to be exported from the United States to a country for subsequent
export from that country to another country, if each of the
following conditions is met:
(1) Both the country to which the controlled substance is
exported from the United States (referred to in this subsection
as the "first country") and the country to which the controlled
substance is exported from the first country (referred to in this
subsection as the "second country") are parties to the Single
Convention on Narcotic Drugs, 1961, and the Convention on
Psychotropic Substances, 1971.
(2) The first country and the second country have each
instituted and maintain, in conformity with such Conventions, a
system of controls of imports of controlled substances which the
Attorney General deems adequate.
(3) With respect to the first country, the controlled substance
is consigned to a holder of such permits or licenses as may be
required under the laws of such country, and a permit or license
to import the controlled substance has been issued by the
country.
(4) With respect to the second country, substantial evidence is
furnished to the Attorney General by the person who will export
the controlled substance from the United States that -
(A) the controlled substance is to be consigned to a holder
of such permits or licenses as may be required under the laws
of such country, and a permit or license to import the
controlled substance is to be issued by the country; and
(B) the controlled substance is to be applied exclusively to
medical, scientific, or other legitimate uses within the
country.
(5) The controlled substance will not be exported from the
second country.
(6) Within 30 days after the controlled substance is exported
from the first country to the second country, the person who
exported the controlled substance from the United States delivers
to the Attorney General documentation certifying that such export
from the first country has occurred.
(7) A permit to export the controlled substance from the United
States has been issued by the Attorney General.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1003, Oct. 27, 1970, 84 Stat.
1286; Pub. L. 95-633, title I, Sec. 106, Nov. 10, 1978, 92 Stat.
3772; Pub. L. 98-473, title II, Sec. 522, Oct. 12, 1984, 98 Stat.
2076; Pub. L. 109-57, Sec. 1(b), Aug. 2, 2005, 119 Stat. 592.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV and V, referred to in text, are set out
in section 812(c) of this title.
-MISC1-
AMENDMENTS
2005 - Subsec. (f). Pub. L. 109-57 added subsec. (f).
1984 - Subsec. (e). Pub. L. 98-473 in cl. (1) inserted provisions
for consumption for medical, etc., purposes, added cls. (2) and
(3), and struck out former cls. (2) to (4), respectively, relating
to a special controlled substance invoice, two additional copies of
the invoice, and exportation of a nonnarcotic controlled substance
in schedule III, IV, or V, also listed in schedule I or II of the
Convention.
1978 - Subsec. (e)(4). Pub. L. 95-633 added par. (4).
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
-End-
-CITE-
21 USC Sec. 954 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 954. Transshipment and in-transit shipment of controlled
substances
-STATUTE-
Notwithstanding sections 952, 953, and 957 of this title -
(1) A controlled substance in schedule I may -
(A) be imported into the United States for transshipment to
another country, or
(B) be transferred or transshipped from one vessel, vehicle,
or aircraft to another vessel, vehicle, or aircraft within the
United States for immediate exportation,
if and only if it is so imported, transferred, or transshipped
(i) for scientific, medical, or other legitimate purposes in the
country of destination, and (ii) with the prior written approval
of the Attorney General (which shall be granted or denied within
21 days of the request).
(2) A controlled substance in schedule II, III, or IV may be so
imported, transferred, or transshipped if and only if advance
notice is given to the Attorney General in accordance with
regulations of the Attorney General.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1004, Oct. 27, 1970, 84 Stat.
1287.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, and IV, referred to in text, are set out in
section 812(c) of this title.
-End-
-CITE-
21 USC Sec. 955 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 955. Possession on board vessels, etc., arriving in or
departing from United States
-STATUTE-
It shall be unlawful for any person to bring or possess on board
any vessel or aircraft, or on board any vehicle of a carrier,
arriving in or departing from the United States or the customs
territory of the United States, a controlled substance in schedule
I or II or a narcotic drug in schedule III or IV, unless such
substance or drug is a part of the cargo entered in the manifest or
part of the official supplies of the vessel, aircraft, or vehicle.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1005, Oct. 27, 1970, 84 Stat.
1287.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, and IV, referred to in text, are set out in
section 812(c) of this title.
-End-
-CITE-
21 USC Secs. 955a to 955d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Secs. 955a to 955d. Transferred
-COD-
CODIFICATION
Sections, Pub. L. 96-350, Secs. 1-4, Sept. 15, 1980, 94 Stat.
1159, 1160, relating to maritime drug law enforcement, were
transferred to sections 1901 to 1904 of the former Appendix to
Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to
Title 46 were repealed and restated in chapter 705 of Title 46,
Shipping, by Pub. L. 109-304, Secs. 10(2), 19, Oct. 6, 2006, 120
Stat. 1683, 1710. For disposition of sections of the former
Appendix to Title 46, see Disposition Table preceding section 101
of Title 46.
-End-
-CITE-
21 USC Sec. 956 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 956. Exemption authority
-STATUTE-
(a) Individual possessing controlled substance
(1) Subject to paragraph (2), the Attorney General may by
regulation exempt from sections 952(a) and (b), 953, 954, and 955
of this title any individual who has a controlled substance (except
a substance in schedule I) in his possession for his personal
medical use, or for administration to an animal accompanying him,
if he lawfully obtained such substance and he makes such
declaration (or gives such other notification) as the Attorney
General may by regulation require.
(2) Notwithstanding any exemption under paragraph (1), a United
States resident who enters the United States through an
international land border with a controlled substance (except a
substance in schedule I) for which the individual does not possess
a valid prescription issued by a practitioner (as defined in
section 802 of this title) in accordance with applicable Federal
and State law (or documentation that verifies the issuance of such
a prescription to that individual) may not import the controlled
substance into the United States in an amount that exceeds 50
dosage units of the controlled substance.
(b) Compound, mixture, or preparation
The Attorney General may by regulation except any compound,
mixture, or preparation containing any depressant or stimulant
substance listed in paragraph (a) or (b) of schedule III or in
schedule IV or V from the application of all or any part of this
subchapter if (1) the compound, mixture, or preparation contains
one or more active medicinal ingredients not having a depressant or
stimulant effect on the central nervous system, and (2) such
ingredients are included therein in such combinations, quantity,
proportion, or concentration as to vitiate the potential for abuse
of the substances which do have a depressant or stimulant effect on
the central nervous system.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1006, Oct. 27, 1970, 84 Stat.
1288; Pub. L. 105-277, div. C, title VIII, Sec. 872(a), Oct. 21,
1998, 112 Stat. 2681-707; Pub. L. 105-357, Sec. 2(a), Nov. 10,
1998, 112 Stat. 3271.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, III, IV, and V, referred to in text, are set out in
section 812(c) of this title.
-MISC1-
AMENDMENTS
1998 - Subsec. (a). Pub. L. 105-277 and Pub. L. 105-357 amended
subsec. (a) identically, designating existing provisions as par.
(1), substituting "Subject to paragraph (2), the Attorney General"
for "The Attorney General", and adding par. (2).
FEDERAL MINIMUM REQUIREMENT
Pub. L. 105-357, Sec. 2(b), Nov. 10, 1998, 112 Stat. 3271,
provided that: "Section 1006(a)(2) of the Controlled Substances
Import and Export Act [21 U.S.C. 956(a)(2)], as added by this
section, is a minimum Federal requirement and shall not be
construed to limit a State from imposing any additional
requirement."
Pub. L. 105-277, div. C, title VIII, Sec. 872(b), Oct. 21, 1998,
112 Stat. 2681-707, enacted a provision substantially identical to
that enacted by Pub. L. 105-357, Sec. 2(b), set out above.
JURISDICTION OF SECRETARY OF HEALTH AND HUMAN SERVICES
Pub. L. 105-277, div. C, title VIII, Sec. 872(c), Oct. 21, 1998,
112 Stat. 2681-707, and Pub. L. 105-357, Sec. 2(c), Nov. 10, 1998,
112 Stat. 3271, provided that: "The amendment made by subsection
(a) [amending this section] shall not be construed to affect the
jurisdiction of the Secretary of Health and Human Services under
the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.)."
-End-
-CITE-
21 USC Sec. 957 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 957. Persons required to register
-STATUTE-
(a) Coverage
No person may -
(1) import into the customs territory of the United States from
any place outside thereof (but within the United States), or
import into the United States from any place outside thereof, any
controlled substance or list I chemical, or
(2) export from the United States any controlled substance or
list I chemical,
unless there is in effect with respect to such person a
registration issued by the Attorney General under section 958 of
this title, or unless such person is exempt from registration under
subsection (b) of this section.
(b) Exemptions
(1) The following persons shall not be required to register under
the provisions of this section and may lawfully possess a
controlled substance or list I chemical:
(A) An agent or an employee of any importer or exporter
registered under section 958 of this title if such agent or
employee is acting in the usual course of his business or
employment.
(B) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of any controlled substance or
list I chemical is in the usual course of his business or
employment.
(C) An ultimate user who possesses such substance for a purpose
specified in section 802(25) (!1) of this title and in conformity
with an exemption granted under section 956(a) of this title.
(2) The Attorney General may, by regulation, waive the
requirement for registration of certain importers and exporters if
he finds it consistent with the public health and safety; and may
authorize any such importer or exporter to possess controlled
substances or list I chemicals for purposes of importation and
exportation.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1007, Oct. 27, 1970, 84 Stat.
1288; Pub. L. 98-473, title II, Sec. 523, Oct. 12, 1984, 98 Stat.
2076; Pub. L. 103-200, Sec. 3(e), Dec. 17, 1993, 107 Stat. 2337.)
-REFTEXT-
REFERENCES IN TEXT
Section 802(25) of this title, referred to in subsec. (b)(1)(C),
was redesignated section 802(26) of this title by Pub. L. 98-473,
title II, Sec. 507(a), Oct. 12, 1984, 98 Stat. 2071, and was
further redesignated section 802(27) of this title by Pub. L. 99-
570, title I, Sec. 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.
-MISC1-
AMENDMENTS
1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 3(e)(1)(A), inserted
"or list I chemical" after "controlled substance".
Subsec. (a)(2). Pub. L. 103-200, Sec. 3(e)(1)(B), substituted "or
list I chemical," for "in schedule I, II, III, IV, or V,".
Subsec. (b)(1). Pub. L. 103-200, Sec. 3(e)(2)(A), inserted "or
list I chemical" after "controlled substance" in introductory
provisions and subpar. (B).
Subsec. (b)(2). Pub. L. 103-200, Sec. 3(e)(2)(B), inserted "or
list I chemicals" after "controlled substances".
1984 - Subsec. (a)(2). Pub. L. 98-473 inserted reference to
schedule V.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
PROVISIONAL REGISTRATION
Section 1104 of Pub. L. 91-513, as amended by Pub. L. 99-514,
Sec. 2, Oct. 22, 1986, 100 Stat. 2095, provided that:
"(a)(1) Any person -
"(A) who is engaged in importing or exporting any controlled
substance on the day before the effective date of section 1007
[May 1, 1971],
"(B) who notifies the Attorney General that he is so engaged,
and
"(C) who is registered on such day under section 510 of the
Federal Food, Drug, and Cosmetic Act [section 360 of this title]
or under section 4722 of the Internal Revenue Code of 1986
[formerly I.R.C. 1954, section 4722 of title 26],
shall, with respect to each establishment for which such
registration is in effect under any such section, be deemed to have
a provisional registration under section 1008 [section 958 of this
title] for the import or export (as the case may be) of controlled
substances.
"(2) During the period his provisional registration is in effect
under this section, the registration number assigned such person
under such section 510 or under such section 4722 (as the case may
be) shall be his registration number for purposes of part A of this
title [this subchapter].
"(b) The provisions of section 304 [section 824 of this title],
relating to suspension and revocation of registration, shall apply
to a provisional registration under this section.
"(c) Unless sooner suspended or revoked under subsection (b), a
provisional registration of a person under subsection (a)(1) of
this section shall be in effect until -
"(1) the date on which such person has registered with the
Attorney General under section 1008 [section 958 of this title]
or has had his registration denied under such section, or
"(2) such date as may be prescribed by the Attorney General for
registration of importers or exporters, as the case may be,
whichever occurs first."
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 958 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 958. Registration requirements
-STATUTE-
(a) Applicants to import or export controlled substances in
schedule I or II
The Attorney General shall register an applicant to import or
export a controlled substance in schedule I or II if he determines
that such registration is consistent with the public interest and
with United States obligations under international treaties,
conventions, or protocols in effect on May 1, 1971. In determining
the public interest, the factors enumerated in paragraph (1)
through (6) of section 823(a) of this title shall be considered.
(b) Activity limited to specified substances
Registration granted under this section shall not entitle a
registrant to import or export controlled substances other than
specified in the registration.
(c) Applicants to import controlled substances in schedule III, IV,
or V or to export controlled substances in schedule III or IV;
applicants to import or export list I chemicals
(1) The Attorney General shall register an applicant to import a
controlled substance in schedule III, IV, or V or to export a
controlled substance in schedule III or IV, unless he determines
that the issuance of such registration is inconsistent with the
public interest. In determining the public interest, the factors
enumerated in paragraphs (1) through (6) of section 823(d) of this
title shall be considered.
(2)(A) The Attorney General shall register an applicant to import
or export a list I chemical unless the Attorney General determines
that registration of the applicant is inconsistent with the public
interest. Registration under this subsection shall not be required
for the import or export of a drug product that is exempted under
section 802(39)(A)(iv) of this title.
(B) In determining the public interest for the purposes of
subparagraph (A), the Attorney General shall consider the factors
specified in section 823(h) of this title.
(d) Denial of application
(1) The Attorney General may deny an application for registration
under subsection (a) of this section if he is unable to determine
that such registration is consistent with the public interest (as
defined in subsection (a) of this section) and with the United
States obligations under international treaties, conventions, or
protocols in effect on May 1, 1971.
(2) The Attorney General may deny an application for registration
under subsection (c) of this section, or revoke or suspend a
registration under subsection (a) or (c) of this section, if he
determines that such registration is inconsistent with the public
interest (as defined in subsection (a) or (c) of this section) or
with the United States obligations under international treaties,
conventions, or protocols in effect on May 1, 1971.
(3) The Attorney General may limit the revocation or suspension
of a registration to the particular controlled substance, or
substances, or list I chemical or chemicals, with respect to which
grounds for revocation or suspension exist.
(4) Before taking action pursuant to this subsection, the
Attorney General shall serve upon the applicant or registrant an
order to show cause as to why the registration should not be
denied, revoked, or suspended. The order to show cause shall
contain a statement of the basis thereof and shall call upon the
applicant or registrant to appear before the Attorney General, or
his designee, at a time and place stated in the order, but in no
event less than thirty days after the date of receipt of the order.
Proceedings to deny, revoke, or suspend shall be conducted pursuant
to this subsection in accordance with subchapter II of chapter 5 of
title 5. Such proceedings shall be independent of, and not in lieu
of, criminal prosecutions or other proceedings under this
subchapter or any other law of the United States.
(5) The Attorney General may, in his discretion, suspend any
registration simultaneously with the institution of proceedings
under this subsection, in cases where he finds that there is an
imminent danger to the public health and safety. Such suspension
shall continue in effect until the conclusion of such proceedings,
including judicial review thereof, unless sooner withdrawn by the
Attorney General or dissolved by a court of competent jurisdiction.
(6) In the event that the Attorney General suspends or revokes a
registration granted under this section, all controlled substances
or list I chemicals owned or possessed by the registrant pursuant
to such registration at the time of suspension or the effective
date of the revocation order, as the case may be, may, in the
discretion of the Attorney General, be seized or placed under seal.
No disposition may be made of any controlled substances or list I
chemicals under seal until the time for taking an appeal has
elapsed or until all appeals have been concluded, except that a
court, upon application therefor, may at any time order the sale of
perishable controlled substances or list I chemicals. Any such
order shall require the deposit of the proceeds of the sale with
the court. Upon a revocation order becoming final, all such
controlled substances or list I chemicals (or proceeds of the sale
thereof which have been deposited with the court) shall be
forfeited to the United States; and the Attorney General shall
dispose of such controlled substances or list I chemicals in
accordance with section 881(e) of this title.
(e) Registration period
No registration shall be issued under this subchapter for a
period in excess of one year. Unless the regulations of the
Attorney General otherwise provide, sections 822(f), 825, 827, and
830 of this title shall apply to persons registered under this
section to the same extent such sections apply to persons
registered under section 823 of this title.
(f) Rules and regulations
The Attorney General is authorized to promulgate rules and
regulations and to charge reasonable fees relating to the
registration and control of importers and exporters of controlled
substances or listed chemicals.
(g) Scope of authorized activity
Persons registered by the Attorney General under this section to
import or export controlled substances or list I chemicals may
import or export (and for the purpose of so importing or exporting,
may possess) such substances to the extent authorized by their
registration and in conformity with the other provisions of this
subchapter and subchapter I of this chapter.
(h) Separate registrations for each principal place of business
A separate registration shall be required at each principal place
of business where the applicant imports or exports controlled
substances or list I chemicals.
(i) Emergency situations
Except in emergency situations as described in section
952(a)(2)(A) of this title, prior to issuing a registration under
this section to a bulk manufacturer of a controlled substance in
schedule I or II, and prior to issuing a regulation under section
952(a) of this title authorizing the importation of such a
substance, the Attorney General shall give manufacturers holding
registrations for the bulk manufacture of the substance an
opportunity for a hearing.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1008, Oct. 27, 1970, 84 Stat.
1289; Pub. L. 98-473, title II, Secs. 524, 525, Oct. 12, 1984, 98
Stat. 2076; Pub. L. 99-570, title I, Sec. 1866(d), Oct. 27, 1986,
100 Stat. 3207-55; Pub. L. 103-200, Sec. 3(f), Dec. 17, 1993, 107
Stat. 2337; Pub. L. 108-447, div. B, title VI, Sec. 633(c), Dec. 8,
2004, 118 Stat. 2922.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsecs. (a),
(c), and (i), are set out in section 812(c) of this title.
This subchapter, referred to in subsecs. (d)(4) and (g), was in
the original "this title", meaning title III of Pub. L. 91-513,
Oct. 27, 1970, 84 Stat. 1285, as amended. Part A of title III
comprises this subchapter. For classification of Part B, consisting
of sections 1101 to 1105 of title III, see Tables.
-COD-
CODIFICATION
In subsecs. (a) and (d), "May 1, 1971" substituted for "the
effective date of this section" and "the effective date of this
part", respectively.
-MISC1-
AMENDMENTS
2004 - Subsec. (f). Pub. L. 108-447, which directed amendment of
subsec. (f) of section 1088 of the Controlled Substances Import and
Export Act by inserting "and control" after "the registration" and
substituting "listed chemicals" for "list I chemicals under this
section", was executed to subsec. (f) of this section, which is
section 1008 of the Controlled Substances Import and Export Act, to
reflect the probable intent of Congress.
1993 - Subsec. (c). Pub. L. 103-200, Sec. 3(f)(1), designated
existing provisions as par. (1) and added par. (2).
Subsec. (d)(3). Pub. L. 103-200, Sec. 3(f)(2)(A), inserted "or
list I chemical or chemicals," after "substances,".
Subsec. (d)(6). Pub. L. 103-200, Sec. 3(f)(2)(B), inserted "or
list I chemicals" after "controlled substances" wherever appearing.
Subsec. (e). Pub. L. 103-200, Sec. 3(f)(3), inserted reference to
section 830 of this title.
Subsecs. (f) to (h). Pub. L. 103-200, Sec. 3(f)(4), inserted "or
list I chemicals" after "controlled substances".
1986 - Subsec. (e). Pub. L. 99-570 substituted "sections" for
first reference to "section".
1984 - Subsec. (b). Pub. L. 98-473, Sec. 524, substituted
"Registration granted under this section shall not entitle a
registrant to import or export controlled substances other than
specified in the registration" for "Registration granted under
subsection (a) of this section shall not entitle a registrant to
import or export controlled substances in schedule I or II other
than those specified in the registration".
Subsecs. (d) to (i). Pub. L. 98-473, Sec. 525, added subsec. (d),
redesignated former subsec. (d) as (e) and struck out reference to
section 824 of this title, and redesignated former subsecs. (e) to
(h) as (f) to (i), respectively.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
-End-
-CITE-
21 USC Sec. 959 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 959. Possession, manufacture, or distribution of controlled
substance
-STATUTE-
(a) Manufacture or distribution for purpose of unlawful importation
It shall be unlawful for any person to manufacture or distribute
a controlled substance in schedule I or II or flunitrazepam or
listed chemical -
(1) intending that such substance or chemical will be
unlawfully imported into the United States or into waters within
a distance of 12 miles of the coast of the United States; or
(2) knowing that such substance or chemical will be unlawfully
imported into the United States or into waters within a distance
of 12 miles of the coast of the United States.
(b) Possession, manufacture, or distribution by person on board
aircraft
It shall be unlawful for any United States citizen on board any
aircraft, or any person on board an aircraft owned by a United
States citizen or registered in the United States, to -
(1) manufacture or distribute a controlled substance or listed
chemical; or
(2) possess a controlled substance or listed chemical with
intent to distribute.
(c) Acts committed outside territorial jurisdiction of United
States; venue
This section is intended to reach acts of manufacture or
distribution committed outside the territorial jurisdiction of the
United States. Any person who violates this section shall be tried
in the United States district court at the point of entry where
such person enters the United States, or in the United States
District Court for the District of Columbia.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1009, Oct. 27, 1970, 84 Stat.
1289; Pub. L. 99-570, title III, Sec. 3161(a), Oct. 27, 1986, 100
Stat. 3207-94; Pub. L. 104-237, title I, Sec. 102(a), (b), Oct. 3,
1996, 110 Stat. 3100; Pub. L. 104-305, Sec. 2(b)(2)(A), Oct. 13,
1996, 110 Stat. 3807.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I and II, referred to in subsec. (a), are set out in
section 812(c) of this title.
-MISC1-
AMENDMENTS
1996 - Subsec. (a). Pub. L. 104-305 inserted "or flunitrazepam"
after "schedule I or II" in introductory provisions.
Pub. L. 104-237, Sec. 102(a), inserted "or listed chemical" after
"schedule I or II" in introductory provisions and "or chemical"
after "substance" in pars. (1) and (2).
Subsec. (b). Pub. L. 104-237, Sec. 102(b), inserted "or listed
chemical" after "controlled substance" in pars. (1) and (2).
1986 - Pub. L. 99-570 designated first sentence as subsec. (a)
and inserted "or into waters within a distance of 12 miles of the
coast of the United States" in pars. (1) and (2), added subsec.
(b), and designated last two sentences as subsec. (c).
-End-
-CITE-
21 USC Sec. 960 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 960. Prohibited acts A
-STATUTE-
(a) Unlawful acts
Any person who -
(1) contrary to section 952, 953, or 957 of this title,
knowingly or intentionally imports or exports a controlled
substance,
(2) contrary to section 955 of this title, knowingly or
intentionally brings or possesses on board a vessel, aircraft, or
vehicle a controlled substance, or
(3) contrary to section 959 of this title, manufactures,
possesses with intent to distribute, or distributes a controlled
substance,
shall be punished as provided in subsection (b) of this section.
(b) Penalties
(1) In the case of a violation of subsection (a) of this section
involving -
(A) 1 kilogram or more of a mixture or substance containing a
detectable amount of heroin;
(B) 5 kilograms or more of a mixture or substance containing a
detectable amount of -
(i) coca leaves, except coca leaves and extracts of coca
leaves from which cocaine, ecgonine, and derivatives of
ecgonine or their salts have been removed;
(ii) cocaine, its salts, optical and geometric isomers, and
salts or isomers;
(iii) ecgonine, its derivatives, their salts, isomers, and
salts of isomers; or
(iv) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in clauses (i)
through (iii);
(C) 50 grams or more of a mixture or substance described in
subparagraph (B) which contains cocaine base;
(D) 100 grams or more of phencyclidine (PCP) or 1 kilogram or
more of a mixture or substance containing a detectable amount of
phencyclidine (PCP);
(E) 10 grams or more of a mixture or substance containing a
detectable amount of lysergic acid diethylamide (LSD);
(F) 400 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-
piperidinyl] propanamide or 100 grams or more of a mixture or
substance containing a detectable amount of any analogue of N-
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(G) 1000 kilograms or more of a mixture or substance containing
a detectable amount of marihuana; or
(H) 50 grams or more of methamphetamine, its salts, isomers,
and salts of its isomers or 500 grams or more of a mixture or
substance containing a detectable amount of methamphetamine, its
salts, isomers, or salts of its isomers.(!1)
the person committing such violation shall be sentenced to a term
of imprisonment of not less than 10 years and not more than life
and if death or serious bodily injury results from the use of such
substance shall be sentenced to a term of imprisonment of not less
than 20 years and not more than life, a fine not to exceed the
greater of that authorized in accordance with the provisions of
title 18 or $4,000,000 if the defendant is an individual or
$10,000,000 if the defendant is other than an individual, or both.
If any person commits such a violation after a prior conviction for
a felony drug offense has become final, such person shall be
sentenced to a term of imprisonment of not less than 20 years and
not more than life imprisonment and if death or serious bodily
injury results from the use of such substance shall be sentenced to
life imprisonment, a fine not to exceed the greater of twice that
authorized in accordance with the provisions of title 18 or
$8,000,000 if the defendant is an individual or $20,000,000 if the
defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence under this paragraph shall,
in the absence of such a prior conviction, impose a term of
supervised release of at least 5 years in addition to such term of
imprisonment and shall, if there was such a prior conviction,
impose a term of supervised release of at least 10 years in
addition to such term of imprisonment. Notwithstanding any other
provision of law, the court shall not place on probation or suspend
the sentence of any person sentenced under this paragraph. No
person sentenced under this paragraph shall be eligible for parole
during the term of imprisonment imposed therein.
(2) In the case of a violation of subsection (a) of this section
involving -
(A) 100 grams or more of a mixture or substance containing a
detectable amount of heroin;
(B) 500 grams or more of a mixture or substance containing a
detectable amount of -
(i) coca leaves, except coca leaves and extracts of coca
leaves from which cocaine, ecgonine, and derivatives of
ecgonine or their salts have been removed;
(ii) cocaine, its salts, optical and geometric isomers, and
salts or isomers;
(iii) ecgonine, its derivatives, their salts, isomers, and
salts of isomers; or
(iv) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in clauses (i)
through (iii);
(C) 5 grams or more of a mixture or substance described in
subparagraph (B) which contains cocaine base;
(D) 10 grams or more of phencyclidine (PCP) or 100 grams or
more of a mixture or substance containing a detectable amount of
phencyclidine (PCP);
(E) 1 gram or more of a mixture or substance containing a
detectable amount of lysergic acid diethylamide (LSD);
(F) 40 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-
piperidinyl] propanamide or 10 grams or more of a mixture or
substance containing a detectable amount of any analogue of N-
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;
(G) 100 kilograms or more of a mixture or substance containing
a detectable amount of marihuana; or
(H) 5 grams or more of methamphetamine, its salts, isomers, and
salts of its isomers or 50 grams or more of a mixture or
substance containing a detectable amount of methamphetamine, its
salts, isomers, or salts of its isomers.(!2)
the person committing such violat ion shall be sentenced to a term
of imprisonment of not less than 5 years and not more than 40 years
and if death or serious bodily injury results from the use of such
substance shall be sentenced to a term of imprisonment of not less
than twenty years and not more than life, a fine not to exceed the
greater of that authorized in accordance with the provisions of
title 18 or $2,000,000 if the defendant is an individual or
$5,000,000 if the defendant is other than an individual, or both.
If any person commits such a violation after a prior conviction for
a felony drug offense has become final, such person shall be
sentenced to a term of imprisonment of not less than 10 years and
not more than life imprisonment and if death or serious bodily
injury results from the use of such substance shall be sentenced to
life imprisonment, a fine not to exceed the greater of twice that
authorized in accordance with the provisions of title 18 or
$4,000,000 if the defendant is an individual or $10,000,000 if the
defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence imposed under this paragraph
shall, in the absence of such a prior conviction, include a term of
supervised release of at least 4 years in addition to such term of
imprisonment and shall, if there was such a prior conviction,
include a term of supervised release of at least 8 years in
addition to such term of imprisonment. Notwithstanding any other
provision of law, the court shall not place on probation or suspend
the sentence of any person sentenced under this paragraph. No
person sentenced under this paragraph shall be eligible for parole
during the term of imprisonment imposed therein.
(3) In the case of a violation under subsection (a) of this
section involving a controlled substance in schedule I or II, gamma
hydroxybutyric acid (including when scheduled as an approved drug
product for purposes of section 3(a)(1)(B) of the Hillory J. Farias
and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or
flunitrazepam, the person committing such violation shall, except
as provided in paragraphs (1), (2), and (4), be sentenced to a term
of imprisonment of not more than 20 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to a term of imprisonment of not less than twenty years
and not more than life, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18 or
$1,000,000 if the defendant is an individual or $5,000,000 if the
defendant is other than an individual, or both. If any person
commits such a violation after a prior conviction for a felony drug
offense has become final, such person shall be sentenced to a term
of imprisonment of not more than 30 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to life imprisonment, a fine not to exceed the greater of
twice that authorized in accordance with the provisions of title 18
or $2,000,000 if the defendant is an individual or $10,000,000 if
the defendant is other than an individual, or both. Notwithstanding
section 3583 of title 18, any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a
prior conviction, impose a term of supervised release of at least 3
years in addition to such term of imprisonment and shall, if there
was such a prior conviction, impose a term of supervised release of
at least 6 years in addition to such term of imprisonment.
Notwithstanding the prior sentence, and notwithstanding any other
provision of law, the court shall not place on probation or suspend
the sentence of any person sentenced under the provisions of this
paragraph which provide for a mandatory term of imprisonment if
death or serious bodily injury results, nor shall a person so
sentenced be eligible for parole during the term of such a
sentence.
(4) In the case of a violation under subsection (a) of this
section with respect to less than 50 kilograms of marihuana, except
in the case of 100 or more marihuana plants regardless of weight,
less than 10 kilograms of hashish, less than one kilogram of
hashish oil, or any quantity of a controlled substance in schedule
III, IV, or V,(!3) (except a violation involving flunitrazepam and
except a violation involving gamma hydroxybutyric acid) the person
committing such violation shall be imprisoned not more than five
years, or be fined not to exceed the greater of that authorized in
accordance with the provisions of title 18 or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is other
than an individual, or both. If a sentence under this paragraph
provides for imprisonment, the sentence shall, notwithstanding
section 3583 of title 18, in addition to such term of imprisonment,
include (A) a term of supervised release of not less than two years
if such controlled substance is in schedule I, II, III, or (B) a
term of supervised release of not less than one year if such
controlled substance is in schedule IV.
(c) Repealed. Pub. L. 98-473, title II, Sec. 225, formerly Sec.
225(a), Oct. 12, 1984, 98 Stat. 2030, as amended by Pub. L. 99-
570, title I, Sec. 1005(c), Oct. 27, 1986, 100 Stat. 3207-6
(d) Penalty for importation or exportation
A person who knowingly or intentionally -
(1) imports or exports a listed chemical with intent to
manufacture a controlled substance in violation of this
subchapter or subchapter I of this chapter;
(2) exports a listed chemical in violation of the laws of the
country to which the chemical is exported or serves as a broker
or trader for an international transaction involving a listed
chemical, if the transaction is in violation of the laws of the
country to which the chemical is exported;
(3) imports or exports a listed chemical knowing, or having
reasonable cause to believe, that the chemical will be used to
manufacture a controlled substance in violation of this
subchapter or subchapter I of this chapter;
(4) exports a listed chemical, or serves as a broker or trader
for an international transaction involving a listed chemical,
knowing, or having reasonable cause to believe, that the chemical
will be used to manufacture a controlled substance in violation
of the laws of the country to which the chemical is exported;
(5) imports or exports a listed chemical, with the intent to
evade the reporting or recordkeeping requirements of section 971
of this title applicable to such importation or exportation by
falsely representing to the Attorney General that the importation
or exportation qualifies for a waiver of the 15-day notification
requirement granted pursuant to paragraph (2) or (3) of section
971(f) of this title by misrepresenting the actual country of
final destination of the listed chemical or the actual listed
chemical being imported or exported;
(6) imports a listed chemical in violation of section 952 of
this title, imports or exports such a chemical in violation of
section 957 or 971 of this title, or transfers such a chemical in
violation of section 971(d) of this title; or
(7) manufactures, possesses with intent to distribute, or
distributes a listed chemical in violation of section 959 of this
title.(!4)
shall be fined in accordance with title 18, imprisoned not more
than 20 years in the case of a violation of paragraph (1) or (3)
involving a list I chemical or not more than 10 years in the case
of a violation of this subsection other than a violation of
paragraph (1) or (3) involving a list I chemical, or both.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1010, Oct. 27, 1970, 84 Stat.
1290; Pub. L. 98-473, title II, Secs. 225, formerly Sec. 225(a),
504, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99-570, title I,
Secs. 1004(a), 1005(c), 1302, 1866(e), Oct. 27, 1986, 100 Stat.
3207-6, 3207-15, 3207-55; Pub. L. 100-690, title VI, Secs. 6053(c),
6475, Nov. 18, 1988, 102 Stat. 4315, 4380; Pub. L. 101-647, title
XII, Sec. 1204, title XXXV, Sec. 3599J, Nov. 29, 1990, 104 Stat.
4830, 4932; Pub. L. 103-200, Secs. 4(b), 5(b), Dec. 17, 1993, 107
Stat. 2338, 2339; Pub. L. 103-322, title IX, Sec. 90105(a), title
XXXIII, Sec. 330024(d)(2), Sept. 13, 1994, 108 Stat. 1987, 2151;
Pub. L. 104-237, title I, Sec. 102(c), title III, Sec. 302(b), Oct.
3, 1996, 110 Stat. 3100, 3105; Pub. L. 104-305, Sec. 2(b)(2)(B),
(C), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105-277, div. E, Sec.
2(b), Oct. 21, 1998, 112 Stat. 2681-759; Pub. L. 106-172, Sec.
3(b)(2), Feb. 18, 2000, 114 Stat. 9; Pub. L. 107-273, div. B, title
III, Sec. 3005(b), Nov. 2, 2002, 116 Stat. 1806; Pub. L. 109-177,
title VII, Secs. 716(b)(1)(A), 717, Mar. 9, 2006, 120 Stat. 267.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsec. (b), are
set out in section 812(c) of this title.
Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid
Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(3),
is section 3(a)(1)(B) of Pub. L. 106-172, which is set out in a
note under section 812 of this title.
-MISC1-
AMENDMENTS
2006 - Subsec. (d)(5). Pub. L. 109-177, Sec. 716(b)(1)(A),
substituted "paragraph (2) or (3) of section 971(f) of this title"
for "section 971(e)(2) or (3) of this title".
Subsec. (d)(6). Pub. L. 109-177, Sec. 717, amended par. (6)
generally. Prior to amendment, par. (6) read as follows: "imports
or exports a listed chemical in violation of section 957 or 971 of
this title; or".
2002 - Subsec. (b)(1), (2). Pub. L. 107-273, Sec. 3005(b)(1),
substituted "Notwithstanding section 3583 of title 18, any
sentence" for "Any sentence" in concluding provisions.
Subsec. (b)(3). Pub. L. 107-273, Sec. 3005(b)(1), substituted
"Notwithstanding section 3583 of title 18, any sentence" for "Any
sentence".
Subsec. (b)(4). Pub. L. 107-273, Sec. 3005(b)(2), inserted
"notwithstanding section 3583 of title 18," before "in addition to
such term of imprisonment".
2000 - Subsec. (b)(3). Pub. L. 106-172, Sec. 3(b)(2)(A), inserted
"gamma hydroxybutyric acid (including when scheduled as an approved
drug product for purposes of section 3(a)(1)(B) of the Hillory J.
Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000),"
after "schedule I or II," in first sentence.
Subsec. (b)(4). Pub. L. 106-172, Sec. 3(b)(2)(B), substituted
"flunitrazepam and except a violation involving gamma
hydroxybutyric acid)" for "flunitrazepam)".
1998 - Subsec. (b)(1)(H). Pub. L. 105-277, Sec. 2(b)(1),
substituted "50 grams" and "500 grams" for "100 grams" and "1
kilogram", respectively.
Subsec. (b)(2)(H). Pub. L. 105-277, Sec. 2(b)(2), substituted "5
grams" and "50 grams" for "10 grams" and "100 grams", respectively.
1996 - Subsec. (b)(3). Pub. L. 104-305, Sec. 2(b)(2)(B), inserted
"or flunitrazepam," after "schedule I or II,".
Subsec. (b)(4). Pub. L. 104-305, Sec. 2(b)(2)(C), inserted
"(except a violation involving flunitrazepam)" after "schedule III,
IV, or V,".
Subsec. (d). Pub. L. 104-237, Sec. 302(b), in closing provisions,
substituted "not more than 20 years in the case of a violation of
paragraph (1) or (3) involving a list I chemical or not more than
10 years in the case of a violation of this subsection other than a
violation of paragraph (1) or (3) involving a list I chemical," for
"not more than 10 years,".
Subsec. (d)(7). Pub. L. 104-237, Sec. 102(c), added par. (7).
1994 - Subsec. (b)(1), (2). Pub. L. 103-322, Sec. 90105(a), in
sentence in concluding provisions beginning "If any person
commits", substituted "a prior conviction for a felony drug offense
has become final" for "one or more prior convictions for an offense
punishable under this subsection, or for a felony under any other
provision of this subchapter or subchapter I of this chapter or
other law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or stimulant
substances, have become final".
Subsec. (b)(3). Pub. L. 103-322, Sec. 90105(a), in sentence
beginning "If any person commits", substituted "a prior conviction
for a felony drug offense has become final" for "one or more prior
convictions for an offense punishable under this subsection, or for
a felony under any other provision of this subchapter or subchapter
I of this chapter or other law of a State, the United States or a
foreign country relating to narcotic drugs, marihuana, or
depressant or stimulant substances, have become final".
Subsec. (d)(5), (6). Pub. L. 103-322, Sec. 330024(d)(2), amended
directory language of Pub. L. 103-200, Sec. 5(b)(3). See 1993
Amendment note below.
1993 - Subsec. (d). Pub. L. 103-200, Sec. 5(b), as amended by
Pub. L. 103-322, Sec. 330024(d)(2), added pars. (5) and (6).
Pub. L. 103-200, Sec. 4(b), amended subsec. (d) generally. Prior
to amendment, subsec. (d) read as follows: "Any person who
knowingly or intentionally -
"(1) imports or exports a listed chemical with intent to
manufacture a controlled substance in violation of this
subchapter or, in the case of an exportation, in violation of the
law of the country to which the chemical is exported; or
"(2) imports or exports a listed chemical knowing, or having
reasonable cause to believe, that the listed chemical will be
used to manufacture a controlled substance in violation of this
subchapter or, in the case of an exportation, in violation of the
law of the country to which the chemical is exported;
shall be fined in accordance with title 18, or imprisoned not more
than 10 years, or both."
1990 - Subsec. (b)(1)(H). Pub. L. 101-647, Sec. 1204(a), added
subpar. (H).
Subsec. (b)(2). Pub. L. 101-647, Sec. 3599J, substituted
"supervised" for "suspervised" in two places in concluding
provisions.
Subsec. (b)(2)(H). Pub. L. 101-647, Sec. 1204(b), added subpar.
(H).
1988 - Subsec. (a)(3). Pub. L. 100-690, Sec. 6475, substituted
"manufactures, possesses with intent to distribute, or distributes
a controlled substance" for "manufactures or distributes a
controlled substance".
Subsec. (d). Pub. L. 100-690, Sec. 6053(c), added subsec. (d).
1986 - Pub. L. 99-570, Sec. 1005(c), amended Pub. L. 98-473, Sec.
225. See 1984 Amendment note below.
Subsec. (b)(1), (2). Pub. L. 99-570, Sec. 1302(a)(2), added pars.
(1) and (2) and struck out former pars. (1) and (2) which read as
follows:
"(1) In the case of a violation under subsection (a) of this
section involving -
"(A) 100 grams or more of a mixture or substance containing a
detectable amount of a narcotic drug in schedule I or II other
than a narcotic drug consisting of -
"(i) coca leaves;
"(ii) a compound, manufacture, salt, derivative, or
preparation of coca leaves; or
"(iii) a substance chemically identical thereto;
"(B) a kilogram or more of any other narcotic drug in schedule
I or II;
"(C) 500 grams or more of phencyclidine (PCP);
"(D) 5 grams or more of lysergic acid diethylamide (LSD);
the person committing such violation shall be imprisoned for not
more than twenty years, or fined not more than $250,000, or both.
"(2) In the case of a violation under subsection (a) of this
section with respect to a controlled substance in schedule I or II,
the person committing such violation shall, except as provided in
paragraphs (1) and (3), be imprisoned not more than fifteen years,
or fined not more than $125,000, or both. If a sentence under this
paragraph provides for imprisonment, the sentence shall include a
special parole term of not less than three years in addition to
such term of imprisonment."
Subsec. (b)(3). Pub. L. 99-570, Sec. 1302(a)(2), added par. (3).
Former par. (3) redesignated (4).
Subsec. (b)(4). Pub. L. 99-570, Sec. 1302(a)(1), (3), (b)(2),
(3), redesignated former par. (3) as (4), inserted "except in the
case of 100 or more marihuana plants regardless of weight," and
substituted "fined not to exceed the greater of that authorized in
accordance with the provisions of title 18 or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is other
than an individual" for "fined not more than $50,000".
Pub. L. 99-570, Secs. 1302(b)(1), 1866(e), made identical
amendment striking out ", except as provided in paragraph (4)"
after "such violation shall".
Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
release" for "special parole term" in two places.
Subsec. (c). Pub. L. 99-570, Sec. 1004(a), substituted "term of
supervised release" for "special parole term" wherever appearing,
effective Nov. 1, 1987, the effective date of the repeal of subsec.
(c) by Pub. L. 98-473, Sec. 225. See 1984 Amendment note below.
1984 - Subsec. (b). Pub. L. 98-473, Sec. 225(a), which directed
amendment of this subsection effective Nov. 1, 1987 (see section
235(a)(1) of Pub. L. 98-473 set out as an Effective Date note under
section 3551 of Title 18, Crimes and Criminal Procedure) was
omitted in the general amendment of section 225 of Pub. L. 98-473
by Pub. L. 99-570, Sec. 1005(c).
Subsec. (b)(1). Pub. L. 98-473, Sec. 504(1), added par. (1).
Former par. (1) redesignated (2).
Subsec. (b)(2). Pub. L. 98-473, Sec. 504(1), (2), redesignated
former par. (1) as (2), inserted provisions excepting pars. (1) and
(3), and substituted reference to controlled substance for
reference to narcotic drug, and "$125,000" for "$25,000". Former
par. (2) redesignated (3).
Subsec. (b)(3). Pub. L. 98-473, Sec. 504(1), (3), redesignated
former par. (2) as (3) and substituted "less than 50 kilograms of
marihuana, less than 10 kilograms of hashish, less than one
kilogram of hashish oil, or any quantity of a controlled substance
in schedule III, IV, or V, the person committing such violation
shall, except as provided in paragraph (4)" for "a controlled
substance other than a narcotic drug in schedule I or II, the
person committing such violation shall", and "$50,000" for
"$15,000".
Subsec. (c). Pub. L. 98-473, Sec. 225, as amended by Pub. L. 99-
570, Sec. 1005(c), struck out subsec. (c) which related to special
parole terms imposed under this section or section 962 of this
title. Notwithstanding directory language that the amendment be
made to "Section 1515 of the Controlled Substances Import and
Export Act (21 U.S.C. 960)", the amendment was executed to this
section as the probable intent of Congress.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by section 330024(d)(2) of Pub. L. 103-322 effective
120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103-
322, set out as a note under section 802 of this title.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by section 6053(c) of Pub. L. 100-690 effective 120
days after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set
out as a note under section 802 of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 1004(a) of Pub. L. 99-570 effective on date
of taking effect of section 3583 of Title 18, Crimes and Criminal
Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
out as a note under section 841 of this title.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by section 225 of Pub. L. 98-473 effective Nov. 1,
1987, and applicable only to offenses committed after the taking
effect of such amendment, see section 235(a)(1) of Pub. L. 98-473,
set out as an Effective Date note under section 3551 of Title 18,
Crimes and Criminal Procedure.
-FOOTNOTE-
(!1) So in original. The period probably should be a semicolon.
(!2) So in original. The period probably should be a semicolon.
(!3) So in original.
(!4) So in original. The period probably should be a comma.
-End-
-CITE-
21 USC Sec. 960a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 960a. Foreign terrorist organizations, terrorist persons and
groups
-STATUTE-
(a) Prohibited acts
Whoever engages in conduct that would be punishable under section
841(a) (!1) of this title if committed within the jurisdiction of
the United States, or attempts or conspires to do so, knowing or
intending to provide, directly or indirectly, anything of pecuniary
value to any person or organization that has engaged or engages in
terrorist activity (as defined in section 1182(a)(3)(B) of title 8)
or terrorism (as defined in section 2656f(d)(2) of title 22), shall
be sentenced to a term of imprisonment of not less than twice the
minimum punishment under section 841(b)(1),(!1) and not more than
life, a fine in accordance with the provisions of title 18, or
both. Notwithstanding section 3583 of title 18, any sentence
imposed under this subsection shall include a term of supervised
release of at least 5 years in addition to such term of
imprisonment.
(b) Jurisdiction
There is jurisdiction over an offense under this section if -
(1) the prohibited drug activity or the terrorist offense is in
violation of the criminal laws of the United States;
(2) the offense, the prohibited drug activity, or the terrorist
offense occurs in or affects interstate or foreign commerce;
(3) an offender provides anything of pecuniary value for a
terrorist offense that causes or is designed to cause death or
serious bodily injury to a national of the United States while
that national is outside the United States, or substantial damage
to the property of a legal entity organized under the laws of the
United States (including any of its States, districts,
commonwealths, territories, or possessions) while that property
is outside of the United States;
(4) the offense or the prohibited drug activity occurs in whole
or in part outside of the United States (including on the high
seas), and a perpetrator of the offense or the prohibited drug
activity is a national of the United States or a legal entity
organized under the laws of the United States (including any of
its States, districts, commonwealths, territories, or
possessions); or
(5) after the conduct required for the offense occurs an
offender is brought into or found in the United States, even if
the conduct required for the offense occurs outside the United
States.
(c) Proof requirements
To violate subsection (a), a person must have knowledge that the
person or organization has engaged or engages in terrorist activity
(as defined in section 1182(a)(3)(B) of title 8) or terrorism (as
defined in section 2656f(d)(2) of title 22).
(d) Definition
As used in this section, the term "anything of pecuniary value"
has the meaning given the term in section 1958(b)(1) of title 18.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1010A, as added Pub. L. 109-177,
title I, Sec. 122, Mar. 9, 2006, 120 Stat. 225.)
-REFTEXT-
REFERENCES IN TEXT
Section 841, referred to in the original in subsec. (a), probably
should have been a reference to section 401 of Pub. L. 91-513,
which is classified to section 841 of this title. Pub. L. 91-513
does not contain a section 841.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 961 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 961. Prohibited acts B
-STATUTE-
Any person who violates section 954 of this title or fails to
notify the Attorney General of an importation or exportation under
section 971 of this title shall be subject to the following
penalties:
(1) Except as provided in paragraph (2), any such person shall,
with respect to any such violation, be subject to a civil penalty
of not more than $25,000. Sections 842(c)(1) and (c)(3) of this
title shall apply to any civil penalty assessed under this
paragraph.
(2) If such a violation is prosecuted by an information or
indictment which alleges that the violation was committed
knowingly or intentionally and the trier of fact specifically
finds that the violation was so committed, such person shall be
sentenced to imprisonment for not more than one year or a fine of
not more than $25,000 or both.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1011, Oct. 27, 1970, 84 Stat.
1290; Pub. L. 100-690, title VI, Sec. 6053(d), Nov. 18, 1988, 102
Stat. 4316.)
-MISC1-
AMENDMENTS
1988 - Pub. L. 100-690 inserted "or fails to notify the Attorney
General of an importation or exportation under section 971 of this
title".
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
-End-
-CITE-
21 USC Sec. 962 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 962. Second or subsequent offenses
-STATUTE-
(a) Term of imprisonment and fine
Any person convicted of any offense under this subchapter is, if
the offense is a second or subsequent offense, punishable by a term
of imprisonment twice that otherwise authorized, by twice the fine
otherwise authorized, or by both. If the conviction is for an
offense punishable under section 960(b) of this title, and if it is
the offender's second or subsequent offense, the court shall
impose, in addition to any term of imprisonment and fine, twice the
term of supervised release otherwise authorized.
(b) Determination of status
For purposes of this section, a person shall be considered
convicted of a second or subsequent offense if, prior to the
commission of such offense, one or more prior convictions of such
person for a felony drug offense have become final.
(c) Procedures applicable
Section 851 of this title shall apply with respect to any
proceeding to sentence a person under this section.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1012, Oct. 27, 1970, 84 Stat.
1290; Pub. L. 98-473, title II, Secs. 225(b), 505, Oct. 12, 1984,
98 Stat. 2030, 2070; Pub. L. 99-570, title I, Secs. 1004(a),
1005(c), Oct. 27, 1986, 100 Stat. 3207-6; Pub. L. 103-322, title
IX, Sec. 90105(b), Sept. 13, 1994, 108 Stat. 1988.)
-MISC1-
AMENDMENTS
1994 - Subsec. (b). Pub. L. 103-322 substituted "one or more
prior convictions of such person for a felony drug offense have
become final" for "one or more prior convictions of him for a
felony under any provision of this subchapter or subchapter I of
this chapter or other law of a State, the United States, or a
foreign country relating to narcotic drugs, marihuana, or
depressant or stimulant drugs, have become final".
1986 - Subsec. (a). Pub. L. 99-570, Sec. 1005(c), amended Pub. L.
98-473, Sec. 225. See 1984 Amendment note below.
Pub. L. 99-570, Sec. 1004(a), substituted "term of supervised
release" for "special parole term".
1984 - Subsec. (a). Pub. L. 98-473, Sec. 225(b), which directed
amendment of this section effective Nov. 1, 1987 (see section
235(a)(1) of Pub. L. 98-473 set out as an Effective Date note under
section 3551 of Title 18, Crimes and Criminal Procedure) was
omitted in the general amendment of section 225 of Pub. L. 98-473
by Pub. L. 99-570, Sec. 1005(c).
Subsec. (b). Pub. L. 98-473, Sec. 505, inserted references to
laws of a State or of a foreign country.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 1004(a) of Pub. L. 99-570 effective on date
of taking effect of section 3583 of Title 18, Crimes and Criminal
Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set
out as a note under section 841 of this title.
-End-
-CITE-
21 USC Sec. 963 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 963. Attempt and conspiracy
-STATUTE-
Any person who attempts or conspires to commit any offense
defined in this subchapter shall be subject to the same penalties
as those prescribed for the offense, the commission of which was
the object of the attempt or conspiracy.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1013, Oct. 27, 1970, 84 Stat.
1291; Pub. L. 100-690, title VI, Sec. 6470(a), Nov. 18, 1988, 102
Stat. 4377.)
-MISC1-
AMENDMENTS
1988 - Pub. L. 100-690 substituted "shall be subject to the same
penalties as those prescribed for the offense" for "is punishable
by imprisonment or fine or both which may not exceed the maximum
punishment prescribed for the offense".
-End-
-CITE-
21 USC Sec. 964 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 964. Additional penalties
-STATUTE-
Any penalty imposed for violation of this subchapter shall be in
addition to, and not in lieu of, any civil or administrative
penalty or sanction authorized by law.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1014, Oct. 27, 1970, 84 Stat.
1291.)
-End-
-CITE-
21 USC Sec. 965 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 965. Applicability of part E of subchapter I
-STATUTE-
Part E of subchapter I of this chapter shall apply with respect
to functions of the Attorney General (and of officers and employees
of the Bureau of Narcotics and Dangerous Drugs) under this
subchapter, to administrative and judicial proceedings under this
subchapter, and to violations of this subchapter, to the same
extent that such part applies to functions of the Attorney General
(and such officers and employees) under subchapter I of this
chapter, to such proceedings under subchapter I of this chapter,
and to violations of subchapter I of this chapter. For purposes of
the application of this section to section 880 or 881 of this
title, any reference in such section 880 or 881 of this title to
"this subchapter" shall be deemed to be a reference to this
subchapter, any reference to section 823 of this title shall be
deemed to be a reference to section 958 of this title, and any
reference to section 822(d) of this title shall be deemed to be a
reference to section 957(b)(2) of this title.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1015, Oct. 27, 1970, 84 Stat.
1291; Pub. L. 95-633, title III, Sec. 301(b), Nov. 10, 1978, 92
Stat. 3778.)
-MISC1-
AMENDMENTS
1978 - Pub. L. 95-633 inserted "or 881" after "880" wherever
appearing.
-TRANS-
TRANSFER OF FUNCTIONS
For abolition of Bureau of Narcotics and Dangerous Drugs,
including Office of Director thereof, and creation of a single
comprehensive agency for enforcement of drug laws by Reorg. Plan
No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, see
note set out under section 881 of this title.
-End-
-CITE-
21 USC Sec. 966 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 966. Authority of Secretary of the Treasury
-STATUTE-
Nothing in this chapter shall derogate from the authority of the
Secretary of the Treasury under the customs and related laws.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1016, Oct. 27, 1970, 84 Stat.
1291.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1236, as
amended. For complete classification of this Act to the Code, see
Short Title note set out under section 801 of this title and
Tables.
The customs laws, referred to in text, are classified generally
to Title 19, Customs Duties.
-End-
-CITE-
21 USC Sec. 967 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 967. Smuggling of controlled substances; investigations;
oaths; subpenas; witnesses; evidence; production of records;
territorial limits; fees and mileage of witnesses
-STATUTE-
For the purpose of any investigation which, in the opinion of the
Secretary of the Treasury, is necessary and proper to the
enforcement of section 545 of title 18 (relating to smuggling goods
into the United States) with respect to any controlled substance
(as defined in section 802 of this title), the Secretary of the
Treasury may administer oaths and affirmations, subpena witnesses,
compel their attendance, take evidence, and require the production
of records (including books, papers, documents and tangible things
which constitute or contain evidence) relevant or material to the
investigation. The attendance of witnesses and the production of
records may be required from any place within the customs territory
of the United States, except that a witness shall not be required
to appear at any hearing distant more than 100 miles from the place
where he was served with subpena. Witnesses summoned by the
Secretary shall be paid the same fees and mileage that are paid
witnesses in the courts of the United States. Oaths and
affirmations may be made at any place subject to the jurisdiction
of the United States.
-SOURCE-
(Aug. 11, 1955, ch. 800, Sec. 1, 69 Stat. 684; Pub. L. 91-513,
title III, Sec. 1102(t), Oct. 27, 1970, 84 Stat. 1294.)
-COD-
CODIFICATION
Section was not enacted as part of the Comprehensive Drug Abuse
Prevention and Control Act of 1970 which comprises this chapter.
Section was formerly classified to section 1034 of Title 31 prior
to the general revision and enactment of Title 31, Money and
Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
Section was also formerly classified to section 198a of this
title.
-MISC1-
AMENDMENTS
1970 - Pub. L. 91-513 substituted "section 545 of title 18
(relating to smuggling goods into the United States) with respect
to any controlled substance (as defined in section 802 of this
title)" for "the laws of the United States relating to narcotic
drugs and marihuana" and substituted the customs territory of the
United States for any State or any territory or other place subject
to the jurisdiction of the United States is the defined area from
within which the attendance of witnesses and the production of
records may be required, and struck out provisions making the
discretion of the Secretary of the Treasury the determinative
factor as to what is relevant or material to the investigation.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub.
L. 91-513, set out as an Effective Date note under section 951 of
this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of amendment of this section by section 1102
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a note under
sections 171 to 174 of this title.
-End-
-CITE-
21 USC Sec. 968 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 968. Service of subpena; proof of service
-STATUTE-
A subpena of the Secretary of the Treasury may be served by any
person designated in the subpena to serve it. Service upon a
natural person may be made by personal delivery of the subpena to
him. Service may be made upon a domestic or foreign corporation or
upon a partnership or other unincorporated association which is
subject to suit under a common name, by delivering the subpena to
an officer, a managing or general agent, or to any other agent
authorized by appointment or by law to receive service of process.
The affidavit of the person serving the subpena entered on a true
copy thereof by the person serving it shall be proof of service.
-SOURCE-
(Aug. 11, 1955, ch. 800, Sec. 2, 69 Stat. 685.)
-COD-
CODIFICATION
Section was not enacted as part of the Comprehensive Drug Abuse
Prevention and Control Act of 1970 which comprises this chapter.
Section was formerly classified to section 1035 of Title 31 prior
to the general revision and enactment of Title 31, Money and
Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
Section was also formerly classified to section 198b of this
title.
-End-
-CITE-
21 USC Sec. 969 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 969. Contempt proceedings
-STATUTE-
In case of contumacy by, or refusal to obey a subpena issued to,
any person, the Secretary of the Treasury may invoke the aid of any
court of the United States within the jurisdiction of which the
investigation is carried on or of which the subpenaed person is an
inhabitant, carries on business or may be found, to compel
compliance with the subpena of the Secretary of the Treasury. The
court may issue an order requiring the subpenaed person to appear
before the Secretary of the Treasury there to produce records, if
so ordered, or to give testimony touching the matter under
investigation. Any failure to obey the order of the court may be
punished by the court as a contempt thereof. All process in any
such case may be served in the judicial district whereof the
subpenaed person is an inhabitant or wherever he may be found.
-SOURCE-
(Aug. 11, 1955, ch. 800, Sec. 3, 69 Stat. 685.)
-COD-
CODIFICATION
Section was not enacted as part of the Comprehensive Drug Abuse
Prevention and Control Act of 1970 which comprises this chapter.
Section was formerly classified to section 1036 of Title 31 prior
to the general revision and enactment of Title 31, Money and
Finance, by Pub. L. 97-258, Sec. 1, Sept. 13, 1982, 96 Stat. 877.
Section was also formerly classified to section 198c of this
title.
-End-
-CITE-
21 USC Sec. 970 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 970. Criminal forfeitures
-STATUTE-
Section 853 of this title, relating to criminal forfeitures,
shall apply in every respect to a violation of this subchapter
punishable by imprisonment for more than one year.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1017, as added Pub. L. 98-473,
title II, Sec. 307, Oct. 12, 1984, 98 Stat. 2051.)
-End-
-CITE-
21 USC Sec. 971 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
-HEAD-
Sec. 971. Notification, suspension of shipment, and penalties with
respect to importation and exportation of listed chemicals
-STATUTE-
(a) Notification prior to transaction
Each regulated person who imports or exports a listed chemical
shall notify the Attorney General of the importation or exportation
not later than 15 days before the transaction is to take place.
(b) Regular customers or importers
(1) The Attorney General shall provide by regulation for
circumstances in which the requirement of subsection (a) of this
section does not apply to a transaction between a regulated person
and a regular customer or to a transaction that is an importation
by a regular importer. At the time of any importation or
exportation constituting a transaction referred to in the preceding
sentence, the regulated person shall notify the Attorney General of
the transaction.
(2) The regulations under this subsection shall provide that the
initial notification under subsection (a) of this section with
respect to a customer of a regulated person or to an importer
shall, upon the expiration of the 15-day period, qualify the
customer as a regular customer or the importer as a regular
importer, unless the Attorney General otherwise notifies the
regulated person in writing.
(c) Suspension of importation or exportation; disqualification of
regular customers or importers; hearing
(1) The Attorney General may order the suspension of any
importation or exportation of a listed chemical (other than a
regulated transaction to which the requirement of subsection (a) of
this section does not apply by reason of subsection (b) of this
section) or may disqualify any regular customer or regular importer
on the ground that the chemical may be diverted to the clandestine
manufacture of a controlled substance (without regard to the form
of the chemical that may be diverted, including the diversion of a
finished drug product to be manufactured from bulk chemicals to be
transferred). From and after the time when the Attorney General
provides written notice of the order (including a statement of the
legal and factual basis for the order) to the regulated person, the
regulated person may not carry out the transaction.
(2) Upon written request to the Attorney General, a regulated
person to whom an order applies under paragraph (1) is entitled to
an agency hearing on the record in accordance with subchapter II of
chapter 5 of title 5. The hearing shall be held on an expedited
basis and not later than 45 days after the request is made, except
that the hearing may be held at a later time, if so requested by
the regulated person.
(d) Information required in notice; updated notice for change in
circumstances
(1)(A) Information provided in a notice under subsection (a) or
(b) shall include the name of the person to whom the importer or
exporter involved intends to transfer the listed chemical involved,
and the quantity of such chemical to be transferred.
(B) In the case of a notice under subsection (b) submitted by a
regular importer, if the transferee identified in the notice is not
a regular customer, such importer may not transfer the listed
chemical until after the expiration of the 15-day period beginning
on the date on which the notice is submitted to the Attorney
General.
(C) After a notice under subsection (a) or (b) is submitted to
the Attorney General, if circumstances change and the importer or
exporter will not be transferring the listed chemical to the
transferee identified in the notice, or will be transferring a
greater quantity of the chemical than specified in the notice, the
importer or exporter shall update the notice to identify the most
recent prospective transferee or the most recent quantity or both
(as the case may be) and may not transfer the listed chemical until
after the expiration of the 15-day period beginning on the date on
which the update is submitted to the Attorney General, except that
such 15-day restriction does not apply if the prospective
transferee identified in the update is a regular customer. The
preceding sentence applies with respect to changing circumstances
regarding a transferee or quantity identified in an update to the
same extent and in the same manner as such sentence applies with
respect to changing circumstances regarding a transferee or
quantity identified in the original notice under subsection (a) or
(b).
(D) In the case of a transfer of a listed chemical that is
subject to a 15-day restriction under subparagraph (B) or (C), the
transferee involved shall, upon the expiration of the 15-day
period, be considered to qualify as a regular customer, unless the
Attorney General otherwise notifies the importer or exporter
involved in writing.
(2) With respect to a transfer of a listed chemical with which a
notice or update referred to in paragraph (1) is concerned:
(A) The Attorney General, in accordance with the same
procedures as apply under subsection (c)(2) -
(i) may order the suspension of the transfer of the listed
chemical by the importer or exporter involved, except for a
transfer to a regular customer, on the ground that the chemical
may be diverted to the clandestine manufacture of a controlled
substance (without regard to the form of the chemical that may
be diverted, including the diversion of a finished drug product
to be manufactured from bulk chemicals to be transferred),
subject to the Attorney General ordering such suspension before
the expiration of the 15-day period referred to in paragraph
(1) with respect to the importation or exportation (in any case
in which such a period applies); and
(ii) may, for purposes of clause (i) and paragraph (1),
disqualify a regular customer on such ground.
(B) From and after the time when the Attorney General provides
written notice of the order under subparagraph (A) (including a
statement of the legal and factual basis for the order) to the
importer or exporter, the importer or exporter may not carry out
the transfer.
(3) For purposes of this subsection:
(A) The terms "importer" and "exporter" mean a regulated person
who imports or exports a listed chemical, respectively.
(B) The term "transfer", with respect to a listed chemical,
includes the sale of the chemical.
(C) The term "transferee" means a person to whom an importer or
exporter transfers a listed chemical.
(e) Broker or trader for international transaction in listed
chemical
A person located in the United States who is a broker or trader
for an international transaction in a listed chemical that is a
regulated transaction solely because of that person's involvement
as a broker or trader shall, with respect to that transaction, be
subject to all of the notification, reporting, recordkeeping, and
other requirements placed upon exporters of listed chemicals by
this subchapter and subchapter I of this chapter.
(f) Application of notification requirement to exports of listed
chemical; waiver
(1) The Attorney General may by regulation require that the 15-
day notification requirement of subsection (a) of this section
apply to all exports of a listed chemical to a specified country,
regardless of the status of certain customers in such country as
regular customers, if the Attorney General finds that such
notification is necessary to support effective chemical diversion
control programs or is required by treaty or other international
agreement to which the United States is a party.
(2) The Attorney General may by regulation waive the 15-day
notification requirement for exports of a listed chemical to a
specified country if the Attorney General determines that such
notification is not required for effective chemical diversion
control. If the notification requirement is waived, exporters of
the listed chemical shall be required to submit to the Attorney
General reports of individual exportations or periodic reports of
such exportation of the listed chemical, at such time or times and
containing such information as the Attorney General shall establish
by regulation.
(3) The Attorney General may by regulation waive the 15-day
notification requirement for the importation of a listed chemical
if the Attorney General determines that such notification is not
necessary for effective chemical diversion control. If the
notification requirement is waived, importers of the listed
chemical shall be required to submit to the Attorney General
reports of individual importations or periodic reports of the
importation of the listed chemical, at such time or times and
containing such information as the Attorney General shall establish
by regulation.
(g) Return declaration
Within 30 days after a transaction covered by this section is
completed, the importer or exporter shall send the Attorney General
a return declaration containing particulars of the transaction,
including the date, quantity, chemical, container, name of
transferees, and such other information as the Attorney General may
specify in regulations. For importers, a single return declaration
may include the particulars of both the importation and
distribution. If the importer has not distributed all chemicals
imported by the end of the initial 30-day period, the importer
shall file supplemental return declarations no later than 30 days
from the date of any further distribution, until the distribution
or other disposition of all chemicals imported pursuant to the
import notification or any update are accounted for.
(h) Importation and distribution of ephedrine, pseudoephedrine, or
phenylpropanolamine
(1) With respect to a regulated person importing ephedrine,
pseudoephedrine, or phenylpropanolamine (referred to in this
section as an "importer"), a notice of importation under subsection
(a) or (b) shall include all information known to the importer on
the chain of distribution of such chemical from the manufacturer to
the importer.
(2) For the purpose of preventing or responding to the diversion
of ephedrine, pseudoephedrine, or phenylpropanolamine for use in
the illicit production of methamphetamine, the Attorney General
may, in the case of any person who is a manufacturer or distributor
of such chemical in the chain of distribution referred to in
paragraph (1) (which person is referred to in this subsection as a
"foreign-chain distributor"), request that such distributor provide
to the Attorney General information known to the distributor on the
distribution of the chemical, including sales.
(3) If the Attorney General determines that a foreign-chain
distributor is refusing to cooperate with the Attorney General in
obtaining the information referred to in paragraph (2), the
Attorney General may, in accordance with procedures that apply
under subsection (c), issue an order prohibiting the importation of
ephedrine, pseudoephedrine, or phenylpropanolamine in any case in
which such distributor is part of the chain of distribution for
such chemical. Not later than 60 days prior to issuing the order,
the Attorney General shall publish in the Federal Register a notice
of intent to issue the order. During such 60-day period, imports of
the chemical with respect to such distributor may not be restricted
under this paragraph.
-SOURCE-
(Pub. L. 91-513, title III, Sec. 1018, as added Pub. L. 100-690,
title VI, Sec. 6053(a), Nov. 18, 1988, 102 Stat. 4314; amended Pub.
L. 103-200, Secs. 4(a), 5(a), 9(b), Dec. 17, 1993, 107 Stat. 2338-
2340; Pub. L. 103-322, title XXXIII, Sec. 330024(c), Sept. 13,
1994, 108 Stat. 2150; Pub. L. 109-177, title VII, Secs. 716(a),
(b)(1)(B), 721, Mar. 9, 2006, 120 Stat. 265, 267.)
-MISC1-
AMENDMENTS
2006 - Subsec. (b)(1). Pub. L. 109-177, Sec. 716(a)(1),
substituted "or to a transaction that is an importation by a
regular importer" for "or to an importation by a regular importer".
Subsec. (c)(1). Pub. L. 109-177, Sec. 716(b)(1)(B), inserted
"(without regard to the form of the chemical that may be diverted,
including the diversion of a finished drug product to be
manufactured from bulk chemicals to be transferred)" after
"manufacture of a controlled substance".
Subsecs. (d) to (f). Pub. L. 109-177, Sec. 716(a)(2), (3), added
subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and
(f), respectively.
Subsec. (g). Pub. L. 109-177, Sec. 716(a)(4), added subsec. (g).
Subsec. (h). Pub. L. 109-177, Sec. 721, added subsec. (h).
1994 - Subsecs. (b)(1), (2), (c)(1). Pub. L. 103-322, Sec.
330024(c)(2), made technical amendment to directory language of
Pub. L. 103-200, Sec. 9(b). See 1993 Amendment notes below.
Subsec. (e). Pub. L. 103-322, Sec. 330024(c)(1), made technical
amendment to directory language of Pub. L. 103-200, Sec. 5(a). See
1993 Amendment note below.
1993 - Subsec. (b)(1). Pub. L. 103-200, Sec. 9(b)(1)(A), as
amended by Pub. L. 103-322, Sec. 330024(c)(2), substituted "to an
importation by a regular importer" for "regular supplier of the
regulated person".
Subsec. (b)(2). Pub. L. 103-200, Sec. 9(b)(1)(B), as amended by
Pub. L. 103-322, Sec. 330024(c)(2), substituted "a customer of a
regulated person or to an importer" for "a customer or supplier of
a regulated person" and "the importer as a regular importer" for
"regular supplier".
Subsec. (c)(1). Pub. L. 103-200, Sec. 9(b)(2), as amended by Pub.
L. 103-322, Sec. 330024(c)(2), substituted "regular importer" for
"regular supplier".
Subsec. (d). Pub. L. 103-200, Sec. 4(a), added subsec. (d).
Subsec. (e). Pub. L. 103-200, Sec. 5(a), as amended by Pub. L.
103-322, Sec. 330024(c)(1), added subsec. (e).
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-322 effective 120 days after Dec. 17,
1993, see section 330024(f) of Pub. L. 103-322, set out as a note
under section 802 of this title.
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103-200 effective on date that is 120 days
after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as
a note under section 802 of this title.
EFFECTIVE DATE
Section 6053(b) of Pub. L. 100-690 provided that:
"(1) Not later than 45 days after the date of the enactment of
this Act [Nov. 18, 1988], the Attorney General shall forward to the
Director of the Office of Management and Budget proposed
regulations required by the amendment made by subsection (a)
[enacting this section].
"(2) Not later than 55 days after the date of the enactment of
this Act, the Director of the Office of Management and Budget shall
-
"(A) review such proposed regulations of the Attorney General;
and
"(B) forward any comments and recommendations for modifications
to the Attorney General.
"(3) Not later than 60 days after the date of the enactment of
this Act, the Attorney General shall publish the proposed final
regulations required by the amendment made by subsection (a).
"(4) Not later than 120 days after the date of the enactment of
this Act, the Attorney General shall promulgate final regulations
required by the amendment made by subsection (a).
"(5) Subsection (a) of section 1018 of the Controlled Substances
Import and Export Act [subsection (a) of this section], as added by
subsection (a) of this section, shall take effect 90 days after the
promulgation of the final regulations under paragraph (4).
"(6) Each regulated person shall provide to the Attorney General
the identity of any regular customer or regular supplier of the
regulated person not later than 30 days after the promulgation of
the final regulations under paragraph (4). Not later than 60 days
after the end of such 30-day period, each regular customer and
regular supplier so identified shall be a regular customer or
regular supplier for purposes of any applicable exception from the
requirement of subsection (a) of such section 1018, unless the the
[sic] Attorney General otherwise notifies the regulated person in
writing."
Section effective 120 days after Nov. 18, 1988 [except subsec.
(a), see above], see section 6061 of Pub. L. 100-690, set out as an
Effective Date of 1988 Amendment note under section 802 of this
title.
EXCEPTION FOR IODINE TO IMPORTATION AND EXPORTATION REQUIREMENTS
FOR LISTED CHEMICALS
Pub. L. 104-237, title II, Sec. 204(b), Oct. 3, 1996, 110 Stat.
3102, provided that:
"(1) Iodine shall not be subject to the requirements for listed
chemicals provided in section 1018 of the Controlled Substances
Import and Export Act (21 U.S.C. 971).
"(2) Effect of Exception. - The exception made by paragraph (1)
shall not limit the authority of the Attorney General to impose the
requirements for listed chemicals provided in section 1018 of the
Controlled Substances Import and Export Act (21 U.S.C. 971)."
-End-
-CITE-
21 USC CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL
PROGRAMS AND ACTIVITIES 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
ACTIVITIES
-HEAD-
CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
ACTIVITIES
-End-
-CITE-
21 USC Secs. 1001 to 1007 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 14 - ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND
ACTIVITIES
-HEAD-
Secs. 1001 to 1007. Repealed.
-MISC1-
Secs. 1001 to 1007. Repealed. Pub. L. 97-35, title V, Sec.
587(a)(3), Aug. 13, 1981, 95 Stat. 480.
Section 1001, Pub. L. 91-527, Sec. 2, Dec. 3, 1970, 84 Stat.
1385; Pub. L. 93-422, Sec. 2(b), Sept. 21, 1974, 88 Stat. 1154;
Pub. L. 95-336, Sec. 2, Aug. 4, 1978, 92 Stat. 451, set forth
Congressional declaration of purpose for Alcohol and Drug Abuse
Education Act.
Section 1002, Pub. L. 91-527, Sec. 3, Dec. 3, 1970, 84 Stat.
1386; Pub. L. 93-422, Sec. 2(c), Sept. 21, 1974, 88 Stat. 1155;
Pub. L. 95-336, Secs. 3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S.
Res. 30, Mar. 7, 1979; Pub. L. 96-88, title III, Sec. 301(a)(1),
(2)(Q), (b)(1), title V, Sec. 507, Oct. 17, 1979, 93 Stat. 677,
678, 692, set forth grant and contract authority, etc., for
projects and programs.
Section 1003, Pub. L. 91-527, Sec. 4, Dec. 3, 1970, 84 Stat.
1387; Pub. L. 93-422, Sec. 2(d), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96-88, title III, Sec. 301(a)(1), title V, Sec. 507, Oct.
17, 1979, 93 Stat. 677, 692, related to recordkeeping requirements,
and access to and inspection of records.
Section 1004, Pub. L. 91-527, Sec. 5, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93-422, Sec. 2(e), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96-88, title V, Sec. 508(i), Oct. 17, 1979, 93 Stat. 693,
related to technical assistance to local agencies, etc.
Section 1005, Pub. L. 91-527, Sec. 6, Dec. 3, 1970, 84 Stat.
1388, related to nature of payments.
Section 1006, Pub. L. 91-527, Sec. 7, Dec. 3, 1970, 84 Stat.
1388, related to utilization of services and facilities of Federal
agencies and public and private agencies and institutions.
Section 1007, Pub. L. 91-527, Sec. 8, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93-422, Sec. 2(f), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 95-336, Sec. 5, Aug. 4, 1978, 92 Stat. 453; Pub. L. 96-88,
title III, Sec. 301(a)(1), (2)(Q), title V, Sec. 507, Oct. 17,
1979, 93 Stat. 677, 678, 692, defined "Secretary" and "State".
EFFECTIVE DATE OF REPEAL
Repeal effective Oct. 1, 1982, see section 587(a) of Pub. L. 97-
35, set out as section 3863(a) of Title 20, Education.
-End-
-CITE-
21 USC CHAPTER 15 - EGG PRODUCTS INSPECTION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
CHAPTER 15 - EGG PRODUCTS INSPECTION
-MISC1-
Sec.
1031. Congressional statement of findings.
1032. Congressional declaration of policy.
1033. Definitions.
1034. Inspection of egg products.
1035. Sanitary operating practices in official plants.
1036. Pasteurization and labeling of egg products at
official plants.
1037. Prohibited acts.
1038. Cooperation with appropriate State and other
governmental agencies; utilization of employees;
reimbursement.
1039. Eggs and egg products not intended for use as human
food; inspection; denaturing or otherwise
identifying.
1040. Recordkeeping requirements; persons required to
maintain records; scope of disclosure; access to
records.
1041. Enforcement provisions.
1042. Reporting of violation to United States attorney for
institution of criminal proceedings; procedure;
presentation of views.
1043. Rules and regulations; administration and enforcement.
1044. Exemption of certain activities.
1045. Limitation on entry of eggs and egg products and other
materials into official plants.
1046. Imports.
1047. Refusal or withdrawal of inspection services; hearing;
grounds; person deemed to have responsible connection
with business; finality of order of Secretary;
judicial review; other provisions for refusal of
services unaffected.
1048. Administrative detention of violative articles;
duration; release; removal of official marks.
1049. Seizure and condemnation proceedings.
1050. Jurisdiction of district courts; United States as
plaintiff in enforcement and restraining proceedings;
subpenas for witnesses.
1051. Other Federal laws applicable for administration and
enforcement of chapter; prosecution of inquiries;
exercise of jurisdiction.
1052. State or local regulation.
1053. Inspection and administration costs.
1054. Annual report to Congressional committees.
1055. Authorization of appropriations.
1056. Separability.
-End-
-CITE-
21 USC Sec. 1031 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1031. Congressional statement of findings
-STATUTE-
Eggs and egg products are an important source of the Nation's
total supply of food, and are used in food in various forms. They
are consumed throughout the Nation and the major portion thereof
moves in interstate or foreign commerce. It is essential, in the
public interest, that the health and welfare of consumers be
protected by the adoption of measures prescribed herein for
assuring that eggs and egg products distributed to them and used in
products consumed by them are wholesome, otherwise not adulterated,
and properly labeled and packaged. Lack of effective regulation for
the handling or disposition of unwholesome, otherwise adulterated,
or improperly labeled or packaged egg products and certain
qualities of eggs is injurious to the public welfare and destroys
markets for wholesome, not adulterated, and properly labeled and
packaged eggs and egg products and results in sundry losses to
producers and processors, as well as injury to consumers.
Unwholesome, otherwise adulterated, or improperly labeled or
packaged products can be sold at lower prices and compete unfairly
with the wholesome, not adulterated, and properly labeled and
packaged products, to the detriment of consumers and the public
generally. It is hereby found that all egg products and the
qualities of eggs which are regulated under this chapter are either
in interstate or foreign commerce, or substantially affect such
commerce, and that regulation by the Secretary of Agriculture and
the Secretary of Health and Human Services, and cooperation by the
States and other jurisdictions, as contemplated by this chapter,
are appropriate to prevent and eliminate burdens upon such
commerce, to effectively regulate such commerce, and to protect the
health and welfare of consumers.
-SOURCE-
(Pub. L. 91-597, Sec. 2, Dec. 29, 1970, 84 Stat. 1620; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
amended, which enacted this chapter, amended sections 633 and 636
of Title 15, Commerce and Trade, and enacted provisions set out as
notes under this section. For complete classification of this Act
to the Code, see Short Title note set out below and Tables.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in text pursuant to
section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-MISC1-
EFFECTIVE DATE
Section 29 of Pub. L. 91-597 provided that: "The provisions of
this Act [enacting this chapter, amending sections 633 and 636 of
Title 15, Commerce and Trade, and enacting provisions set out as
notes under this section] with respect to egg products shall take
effect six months after enactment [Dec. 29, 1970]. Otherwise, this
Act shall take effect eighteen months after enactment."
SHORT TITLE
Section 1 of Pub. L. 91-597 provided: "That this Act [enacting
this chapter, amending sections 633 and 636 of Title 15, Commerce
and Trade, and enacting provisions set as notes under this section]
may be cited as the 'Egg Products Inspection Act'."
MAINTENANCE OF EGGS AT PROPER TEMPERATURE
Pub. L. 102-237, title X, Sec. 1012(a), Dec. 13, 1991, 105 Stat.
1899, provided that:
"(1) Findings. - Congress finds that -
"(A) food borne illness is a serious health problem;
"(B) its incidence can be reduced through proper handling of
food; and
"(C) eggs are perishable and therefore are particularly
susceptible to supporting microbial growth if proper temperature
controls are not maintained.
"(2) Purposes. - It is the purpose of this section [amending
sections 1034, 1037, 1041, 1042, 1046, and 1052 of this title and
enacting provisions set out as a note under section 1034 of this
title] to prescribe the temperature at which eggs are maintained in
order to reduce the potential for harmful microbial growth to
protect the health and welfare of consumers."
-End-
-CITE-
21 USC Sec. 1032 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1032. Congressional declaration of policy
-STATUTE-
It is hereby declared to be the policy of the Congress to provide
for the inspection of certain egg products, restrictions upon the
disposition of certain qualities of eggs, and uniformity of
standards for eggs, and otherwise regulate the processing and
distribution of eggs and egg products as hereinafter prescribed to
prevent the movement or sale for human food, of eggs and egg
products which are adulterated or misbranded or otherwise in
violation of this chapter.
-SOURCE-
(Pub. L. 91-597, Sec. 3, Dec. 29, 1970, 84 Stat. 1621.)
-End-
-CITE-
21 USC Sec. 1033 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1033. Definitions
-STATUTE-
For purposes of this chapter -
(a) The term "adulterated" applies to any egg or egg product
under one or more of the following circumstances -
(1) if it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case
the substance is not an added substance, such article shall not
be considered adulterated under this clause if the quantity of
such substance in or on such article does not ordinarily render
it injurious to health;
(2)(A) if it bears or contains any added poisonous or added
deleterious substance (other than one which is (i) a pesticide
chemical in or on a raw agricultural commodity; (ii) a food
additive; or (iii) a color additive) which may, in the judgment
of the Secretary, make such article unfit for human food;
(B) if it is, in whole or in part, a raw agricultural commodity
and such commodity bears or contains a pesticide chemical which
is unsafe within the meaning of section 346a of this title;
(C) if it bears or contains any food additive which is unsafe
within the meaning of section 348 of this title;
(D) if it bears or contains any color additive which is unsafe
within the meaning of section 379e of this title: Provided, That
an article which is not otherwise deemed adulterated under clause
(B), (C), or (D) shall nevertheless be deemed adulterated if use
of the pesticide chemical, food additive, or color additive, in
or on such article, is prohibited by regulations of the Secretary
in official plants;
(3) if it consists in whole or in part of any filthy, putrid,
or decomposed substance, or if it is otherwise unfit for human
food;
(4) if it has been prepared, packaged, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(5) if it is an egg which has been subjected to incubation or
the product of any egg which has been subjected to incubation;
(6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(7) if it has been intentionally subjected to radiation, unless
the use of the radiation was in conformity with a regulation or
exemption in effect pursuant to section 348 of this title; or
(8) if any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or if any substance has been
substituted, wholly or in part therefor; or if damage or
inferiority has been concealed in any manner; or if any substance
has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is.
(b) The term "capable of use as human food" shall apply to any
egg or egg product, unless it is denatured, or otherwise
identified, as required by regulations prescribed by the Secretary
to deter its use as human food.
(c) The term "commerce" means interstate, foreign, or intrastate
commerce.
(d) The term "container" or "package" includes any box, can, tin,
plastic, or other receptacle, wrapper, or cover.
(1) The term "immediate container" means any consumer package; or
any other container in which egg products, not consumer packaged,
are packed.
(2) The term "shipping container" means any container used in
packaging a product packed in an immediate container.
(e) The term "egg handler" means any person who engages in any
business in commerce which involves buying or selling any eggs (as
a poultry producer or otherwise), or processing any egg products,
or otherwise using any eggs in the preparation of human food.
(f) The term "egg product" means any dried, frozen, or liquid
eggs, with or without added ingredients, excepting products which
contain eggs only in a relatively small proportion or historically
have not been, in the judgment of the Secretary, considered by
consumers as products of the egg food industry, and which may be
exempted by the Secretary under such conditions as he may prescribe
to assure that the egg ingredients are not adulterated and such
products are not represented as egg products.
(g) The term "egg" means the shell egg of the domesticated
chicken, turkey, duck, goose, or guinea.
(1) The term "check" means an egg that has a broken shell or
crack in the shell but has its shell membranes intact and contents
not leaking.
(2) The term "clean and sound shell egg" means any egg whose
shell is free of adhering dirt or foreign material and is not
cracked or broken.
(3) The term "dirty egg" means an egg that has a shell that is
unbroken and has adhering dirt or foreign material.
(4) The term "incubator reject" means an egg that has been
subjected to incubation and has been removed from incubation during
the hatching operations as infertile or otherwise unhatchable.
(5) The term "inedible" means eggs of the following descriptions:
black rots, yellow rots, white rots, mixed rots (addled eggs), sour
eggs, eggs with green whites, eggs with stuck yolks, moldy eggs,
musty eggs, eggs showing blood rings, and eggs containing embryo
chicks (at or beyond the blood ring stage).
(6) The term "leaker" means an egg that has a crack or break in
the shell and shell membranes to the extent that the egg contents
are exposed or are exuding or free to exude through the shell.
(7) The term "loss" means an egg that is unfit for human food
because it is smashed or broken so that its contents are leaking;
or overheated, frozen, or contaminated; or an incubator reject; or
because it contains a bloody white, large meat spots, a large
quantity of blood, or other foreign material.
(8) The term "restricted egg" means any check, dirty egg,
incubator reject, inedible, leaker, or loss.
(h) The term "Fair Packaging and Labeling Act" [15 U.S.C. 1451 et
seq.] means the Act so entitled, approved November 3, 1966 (80
Stat. 1296), and Acts amendatory thereof or supplementary thereto.
(i) The term "Federal Food, Drug, and Cosmetic Act" [21 U.S.C.
301 et seq.] means the Act so entitled, approved June 25, 1938 (52
Stat. 1040), and Acts amendatory thereof or supplementary thereto.
(j) The term "inspection" means the application of such
inspection methods and techniques as are deemed necessary by the
responsible Secretary to carry out the provisions of this chapter.
(k) The term "inspector" means:
(1) any employee or official of the United States Government
authorized to inspect eggs or egg products under the authority of
this chapter; or
(2) any employee or official of the government of any State or
local jurisdiction authorized by the Secretary to inspect eggs or
egg products under the authority of this chapter, under an
agreement entered into between the Secretary and the appropriate
State or other agency.
(l) The term "misbranded" shall apply to egg products which are
not labeled and packaged in accordance with the requirements
prescribed by regulations of the Secretary under section 1036 of
this title.
(m) The term "official certificate" means any certificate
prescribed by regulations of the Secretary for issuance by an
inspector or other person performing official functions under this
chapter.
(n) The term "official device" means any device prescribed or
authorized by the Secretary for use in applying any official mark.
(o) The term "official inspection legend" means any symbol
prescribed by regulations of the Secretary showing that egg
products were inspected in accordance with this chapter.
(p) The term "official mark" means the official inspection legend
or any other symbol prescribed by regulations of the Secretary to
identify the status of any article under this chapter.
(q) The term "official plant" means any plant, as determined by
the Secretary, at which inspection of the processing of egg
products is maintained by the Department of Agriculture under the
authority of this chapter.
(r) The term "official standards" means the standards of quality,
grades, and weight classes for eggs, in effect upon the effective
date of this chapter, or as thereafter amended, under the
Agricultural Marketing Act of 1946 (60 Stat. 1087, as amended; 7
U.S.C. 1621 et seq.).
(s) The term "pasteurize" means the subjecting of each particle
of egg products to heat or other treatments to destroy harmful
viable micro-organisms by such processes as may be prescribed by
regulations of the Secretary.
(t) The term "person" means any individual, partnership,
corporation, association, or other business unit.
(u) The terms "pesticide chemical," "food additive," "color
additive," and "raw agricultural commodity" shall have the same
meaning for purposes of this chapter as under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(v) The term "plant" means any place of business where egg
products are processed.
(w) The term "processing" means manufacturing egg products,
including breaking eggs or filtering, mixing, blending,
pasteurizing, stabilizing, cooling, freezing, drying, or packaging
egg products.
(x) The term "Secretary" means the Secretary of Agriculture or
his delegate.
(y) The term "State" means any State of the United States, the
Commonwealth of Puerto Rico, the Virgin Islands of the United
States, and the District of Columbia.
(z) The term "United States" means the States.
-SOURCE-
(Pub. L. 91-597, Sec. 4, Dec. 29, 1970, 84 Stat. 1621; Pub. L. 102-
571, title I, Sec. 107(15), Oct. 29, 1992, 106 Stat. 4499.)
-REFTEXT-
REFERENCES IN TEXT
The Fair Packaging and Labeling Act, referred to in subsec. (h),
is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
15, Commerce and Trade. For complete classification of this Act to
the Code, see Short Title note set out under section 1451 of Title
15 and Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(i) and (u), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
The effective date of this chapter, referred to in subsec. (r),
means the effective date of Pub. L. 91-597. For such effective
date, see Effective Date note set out under section 1031 of this
title.
The Agricultural Marketing Act of 1946, referred to in subsec.
(r), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, as
amended, which is classified generally to chapter 38 (Sec. 1621 et
seq.) of Title 7, Agriculture. For complete classification of this
Act to the Code, see Short Title note set out under section 1621 of
Title 7 and Tables.
-MISC1-
AMENDMENTS
1992 - Subsec. (a)(2)(D). Pub. L. 102-571 substituted "379e" for
"376".
-End-
-CITE-
21 USC Sec. 1034 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1034. Inspection of egg products
-STATUTE-
(a) Processing operations and establishments subject to coverage;
rules and regulations
For the purpose of preventing the entry into or flow or movement
in commerce of, or the burdening of commerce by, any egg product
which is capable of use as human food and is misbranded or
adulterated, the Secretary shall, whenever processing operations
are being conducted, cause continuous inspection to be made, in
accordance with the regulations promulgated under this chapter, of
the processing of egg products, in each plant processing egg
products for commerce, unless exempted under section 1044 of this
title. Without restricting the application of the preceding
sentence to other kinds of establishments within its provisions,
any food manufacturing establishment, institution, or restaurant
which uses any eggs that do not meet the requirements of section
1044(a)(1) of this title in the preparation of any articles for
human food shall be deemed to be a plant processing egg products,
with respect to such operations.
(b) Authority of Secretary to retain, segregate, and reinspect eggs
and egg products
The Secretary, at any time, shall cause such retention,
segregation, and reinspection as he deems necessary of eggs and egg
products capable of use as human food in each official plant.
(c) Condemnation of adulterated products; destruction or
reprocessing; procedure upon appeal from determination of
adulteration
Eggs and egg products found to be adulterated at official plants
shall be condemned and, if no appeal be taken from such
determination of condemnation, such articles shall be destroyed for
human food purposes under the supervision of an inspector:
Provided, That articles which may by reprocessing be made not
adulterated need not be condemned and destroyed if so reprocessed
under the supervision of an inspector and thereafter found to be
not adulterated. If an appeal be taken from such determination, the
eggs or egg products shall be appropriately marked and segregated
pending completion of an appeal inspection, which appeal shall be
at the cost of the appellant if the Secretary determines that the
appeal is frivolous. If the determination of condemnation is
sustained, the eggs or egg products shall be destroyed for human
food purposes under the supervision of an inspector.
(d) Inspection of business premises, facilities, inventory,
operations, and records of egg handlers; inspection of records
and inventory of others required to keep records; authority of
Secretary of Health and Human Services to inspect food
manufacturing establishments, institutions, and restaurants;
access to places of business
The Secretary shall cause such other inspections to be made of
the business premises, facilities, inventory, operations, and
records of egg handlers, and the records and inventory of other
persons required to keep records under section 1040 of this title,
as he deems appropriate (and in the case of shell egg packers,
packing eggs for the ultimate consumer, at least once each calendar
quarter) to assure that only eggs fit for human food are used for
such purpose, and otherwise to assure compliance by egg handlers
and other persons with the requirements of section 1037 of this
title, except that the Secretary of Health and Human Services shall
cause such inspections to be made as he deems appropriate to assure
compliance with such requirements at food manufacturing
establishments, institutions, and restaurants, other than plants
processing egg products. Representatives of said Secretaries shall
be afforded access to all such places of business for purposes of
making the inspections provided for in this chapter.
(e) Refrigeration and labeling requirements
(1) Subject to paragraphs (2), (3), and (4), the Secretary shall
make such inspections as the Secretary considers appropriate of a
facility of an egg handler (including a transport vehicle) to
determine if shell eggs destined for the ultimate consumer -
(A) are being held under refrigeration at an ambient
temperature of no greater than 45 degrees Fahrenheit after
packing; and
(B) contain labeling that indicates that refrigeration is
required.
(2) In the case of a shell egg packer packing eggs for the
ultimate consumer, the Secretary shall make an inspection in
accordance with paragraph (1) at least once each calendar quarter.
(3) The Secretary of Health and Human Services shall cause such
inspections to be made as the Secretary considers appropriate to
ensure compliance with the requirements of paragraph (1) at food
manufacturing establishments, institutions, and restaurants, other
than plants packing eggs.
(4) The Secretary shall not make an inspection as provided in
paragraph (1) on any egg handler with a flock of not more than
3,000 layers.
(5) A representative of the Secretary and the Secretary of Health
and Human Services shall be afforded access to a place of business
referred to in this subsection, including a transport vehicle, for
purposes of making an inspection required under this subsection.
-SOURCE-
(Pub. L. 91-597, Sec. 5, Dec. 29, 1970, 84 Stat. 1624; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
237, title X, Sec. 1012(b), Dec. 13, 1991, 105 Stat. 1899.)
-MISC1-
AMENDMENTS
1991 - Subsec. (e). Pub. L. 102-237 added subsec. (e).
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsec. (d)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1991 AMENDMENT
Section 1012(h) of Pub. L. 102-237 provided that: "This section
and the amendments made by this section [amending this section and
sections 1037, 1041, 1042, 1046, and 1052 of this title and
enacting provisions set out as a note under section 1031 of this
title] shall become effective 12 months after the Secretary of
Agriculture promulgates final regulations implementing this section
and the amendments." [Final regulations were promulgated Aug. 20,
1998, effective Aug. 27, 1999. See 63 F.R. 45663.]
-End-
-CITE-
21 USC Sec. 1035 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1035. Sanitary operating practices in official plants
-STATUTE-
(a) Premises, facilities, and equipment
Each official plant shall be operated in accordance with such
sanitary practices and shall have such premises, facilities, and
equipment as are required by regulations promulgated by the
Secretary to effectuate the purposes of this chapter, including
requirements for segregation and disposition of restricted eggs.
(b) Refusal by Secretary to inspect nonconforming plants
The Secretary shall refuse to render inspection to any plant
whose premises, facilities, or equipment, or the operation thereof,
fail to meet the requirements of this section.
-SOURCE-
(Pub. L. 91-597, Sec. 6, Dec. 29, 1970, 84 Stat. 1625.)
-End-
-CITE-
21 USC Sec. 1036 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1036. Pasteurization and labeling of egg products at official
plants
-STATUTE-
(a) Contents of label
Egg products inspected at any official plant under the authority
of this chapter and found to be not adulterated shall be
pasteurized before they leave the official plant, except as
otherwise permitted by regulations of the Secretary, and shall at
the time they leave the official plant, bear in distinctly legible
form on their shipping containers or immediate containers, or both,
when required by regulations of the Secretary, the official
inspection legend and official plant number, of the plant where the
products were processed, and such other information as the
Secretary may require by regulations to describe the products
adequately and to assure that they will not have false or
misleading labeling.
(b) False or misleading or use of nonapproved labeling or
containers; determination by Secretary; procedures applicable;
appeal
No labeling or container shall be used for egg products at
official plants if it is false or misleading or has not been
approved as required by the regulations of the Secretary. If the
Secretary has reason to believe that any labeling or the size or
form of any container in use or proposed for use with respect to
egg products at any official plant is false or misleading in any
particular, he may direct that such use be withheld unless the
labeling or container is modified in such manner as he may
prescribe so that it will not be false or misleading. If the person
using or proposing to use the labeling or container does not accept
the determination of the Secretary, such person may request a
hearing, but the use of the labeling or container shall, if the
Secretary so directs, be withheld pending hearing and final
determination by the Secretary. Any such determination by the
Secretary shall be conclusive unless, within thirty days after
receipt of notice of such final determination, the person adversely
affected thereby appeals to the United States court of appeals for
the circuit in which such person has its principal place of
business or to the United States Court of Appeals for the District
of Columbia Circuit. The provisions of section 194 of title 7,(!1)
shall be applicable to appeals taken under this section.
-SOURCE-
(Pub. L. 91-597, Sec. 7, Dec. 29, 1970, 84 Stat. 1625.)
-FOOTNOTE-
(!1) So in original. The comma probably should not appear.
-End-
-CITE-
21 USC Sec. 1037 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1037. Prohibited acts
-STATUTE-
(a)(1) No person shall buy, sell, or transport, or offer to buy
or sell, or offer or receive for transportation, in any business in
commerce any restricted eggs, capable of use as human food, except
as authorized by regulations of the Secretary under such conditions
as he may prescribe to assure that only eggs fit for human food are
used for such purpose.
(2) No egg handler shall possess with intent to use, or use, any
restricted eggs in the preparation of human food for commerce
except that such eggs may be so possessed and used when authorized
by regulations of the Secretary under such conditions as he may
prescribe to assure that only eggs fit for human food are used for
such purpose.
(b)(1) No person shall process any egg products for commerce at
any plant except in compliance with the requirements of this
chapter.
(2) No person shall buy, sell, or transport, or offer to buy or
sell, or offer or receive for transportation, in commerce any egg
products required to be inspected under this chapter unless they
have been so inspected and are labeled and packaged in accordance
with the requirements of section 1036 of this title.
(3) No operator of any official plant shall fail to comply with
any requirements of section 1035(a) of this title or the
regulations thereunder.
(4) No operator of any official plant shall allow any egg
products to be moved from such plant if they are adulterated or
misbranded and capable of use as human food.
(c) No egg handler shall possess any eggs after the eggs have
been packed into a container that is destined for the ultimate
consumer unless the eggs are stored and transported under
refrigeration at an ambient temperature of no greater than 45
degrees Fahrenheit, as prescribed by rules and regulations
promulgated by the Secretary.
(d) No person shall violate any provision of section 1039, 1040
or 1046 of this title.
(e) No person shall -
(1) manufacture, cast, print, lithograph, or otherwise make any
device containing any official mark or simulation thereof, or any
label bearing any such mark or simulation, or any form of
official certificate or simulation thereof, except as authorized
by the Secretary;
(2) forge or alter any official device, mark, or certificate;
(3) without authorization from the Secretary, use any official
device, mark, or certificate, or simulation thereof, or detach,
deface, or destroy any official device or mark; or use any
labeling or container ordered to be withheld from use under
section 1036 of this title after final judicial affirmance of
such order or expiration of the time for appeal if no appeal is
taken under said section;
(4) contrary to the regulations prescribed by the Secretary,
fail to use, or to detach, deface, or destroy any official
device, mark, or certificate;
(5) knowingly possess, without promptly notifying the Secretary
or his representative, any official device or any counterfeit,
simulated, forged, or improperly altered official certificate or
any device or label, or any eggs or egg products bearing any
counterfeit, simulated, forged, or improperly altered official
mark;
(6) knowingly make any false statement in any shipper's
certificate or other nonofficial or official certificate provided
for in the regulations prescribed by the Secretary;
(7) knowingly represent that any article has been inspected or
exempted, under this chapter, when, in fact, it has,
respectively, not been so inspected or exempted; and
(8) refuse access, at any reasonable time, to any
representative of the Secretary of Agriculture or the Secretary
of Health and Human Services, to any plant or other place of
business subject to inspection under any provisions of this
chapter.
(f) No person, while an official or employee of the United States
Government or any State or local governmental agency, or
thereafter, shall use to his own advantage, or reveal other than to
the authorized representatives of the United States Government or
any State or other government in their official capacity, or as
ordered by a court in a judicial proceeding, any information
acquired under the authority of this chapter concerning any matter
which is entitled to protection as a trade secret.
-SOURCE-
(Pub. L. 91-597, Sec. 8, Dec. 29, 1970, 84 Stat. 1626; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
237, title X, Sec. 1012(c), Dec. 13, 1991, 105 Stat. 1899.)
-MISC1-
AMENDMENTS
1991 - Subsecs. (c) to (f). Pub. L. 102-237 added subsec. (c) and
redesignated former subsecs. (c) to (e) as (d) to (f),
respectively.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsec. (e)(8)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102-237 effective 12 months after
promulgation of final implementing regulations, see section 1012(h)
of Pub. L. 102-237, set out as a note under section 1034 of this
title.
-End-
-CITE-
21 USC Sec. 1038 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1038. Cooperation with appropriate State and other
governmental agencies; utilization of employees; reimbursement
-STATUTE-
The Secretary shall, whenever he determines that it would
effectuate the purposes of this chapter, cooperate with appropriate
State and other governmental agencies, in carrying out any
provisions of this chapter. In carrying out the provisions of this
chapter, the Secretary may conduct such examinations,
investigations, and inspections as he determines practicable
through any officer or employee of any such agency commissioned by
him for such purpose. The Secretary shall reimburse the States and
other agencies for the costs incurred by them in such cooperative
programs.
-SOURCE-
(Pub. L. 91-597, Sec. 9, Dec. 29, 1970, 84 Stat. 1627.)
-End-
-CITE-
21 USC Sec. 1039 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1039. Eggs and egg products not intended for use as human
food; inspection; denaturing or otherwise identifying
-STATUTE-
Inspection shall not be provided under this chapter at any plant
for the processing of any egg products which are not intended for
use as human food, but such articles, prior to their offer for sale
or transportation in commerce, shall be denatured or otherwise
identified as prescribed by regulations of the Secretary to deter
their use for human food. No person shall buy, sell, or transport
or offer to buy or sell, or offer or receive for transportation, in
commerce, any restricted eggs or egg products which are not
intended for use as human food unless they are denatured or
otherwise identified as required by the regulations of the
Secretary.
-SOURCE-
(Pub. L. 91-597, Sec. 10, Dec. 29, 1970, 84 Stat. 1627.)
-End-
-CITE-
21 USC Sec. 1040 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1040. Recordkeeping requirements; persons required to maintain
records; scope of disclosure; access to records
-STATUTE-
For the purpose of enforcing the provisions of this chapter and
the regulations promulgated thereunder, all persons engaged in the
business of transporting, shipping, or receiving any eggs or egg
products in commerce or holding such articles so received, and all
egg handlers, shall maintain such records showing, for such time
and in such form and manner, as the Secretary of Agriculture or the
Secretary of Health and Human Services may prescribe, to the extent
that they are concerned therewith, the receipt, delivery, sale,
movement, and disposition of all eggs and egg products handled by
them, and shall, upon the request of a duly authorized
representative of either of said Secretaries, permit him at
reasonable times to have access to and to copy all such records.
-SOURCE-
(Pub. L. 91-597, Sec. 11, Dec. 29, 1970, 84 Stat. 1627; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-End-
-CITE-
21 USC Sec. 1041 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1041. Enforcement provisions
-STATUTE-
(a) Violations of section 1037; term of imprisonment and fine
Any person who commits any offense prohibited by section 1037 of
this title shall upon conviction be subject to imprisonment for not
more than one year, or a fine of not more than $5,000, or both such
imprisonment and fine, but if such violation involves intent to
defraud, or any distribution or attempted distribution of any
article that is known to be adulterated (except as defined in
section 1033(a)(8) of this title), such person shall be subject to
imprisonment for not more than three years or a fine of not more
than $10,000, or both.
(b) Persons preventing enforcement of chapter; term of imprisonment
and fine
Any person who forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while engaged in or on
account of the performance of his official duties under this
chapter shall be fined not more than $5,000 or imprisoned not more
than three years or both. Whoever, in the commission of any such
act, uses a deadly or dangerous weapon, shall be fined not more
than $10,000 or imprisoned not more than ten years, or both.
Whoever kills any person while engaged in or on account of the
performance of his official duties under this chapter shall be
punished as provided under sections 1111 and 1112 of title 18.
(c) Civil penalty
(1)(A) Except as otherwise provided in this subsection, any
person who violates any provision of this chapter or any regulation
issued under this chapter, other than a violation for which a
criminal penalty has been imposed under this chapter, may be
assessed a civil penalty by the Secretary of not more than $5,000
for each such violation. Each violation to which this subparagraph
applies shall be considered a separate offense.
(B) No penalty shall be assessed against any person under this
subsection unless the person is given notice and opportunity for a
hearing on the record before the Secretary in accordance with
sections 554 and 556 of title 5.
(C) The amount of the civil penalty imposed under this subsection
-
(i) shall be assessed by the Secretary, by written order,
taking into account the gravity of the violation, degree of
culpability, and history of prior offenses; and
(ii) may be reviewed only as provided in paragraph (2).
(2)(A) The determination and order of the Secretary under this
subsection shall be final and conclusive unless the person against
whom such a violation is found under paragraph (1) files an
application for judicial review within 30 days after service of the
order in the United States court of appeals for the circuit in
which the person has its principal place of business or in the
United States Court of Appeals for the District of Columbia
Circuit.
(B) Judicial review of any such order shall be based on the
record on which the determination and order are based.
(C) If the court determines that additional evidence needs to be
taken, the court shall order the hearing to be reopened for this
purpose in such manner and on such terms and conditions as the
court considers proper. The Secretary may modify the findings of
the Secretary as to the facts, or make new findings, on the basis
of the additional evidence so taken.
(3) If any person fails to pay an assessment of a civil penalty
after the penalty has become a final and unappealable order, or
after the appropriate court of appeals has entered a final judgment
in favor of the Secretary, the Secretary shall refer the matter to
the Attorney General. The Attorney General shall institute a civil
action to recover the amount assessed in an appropriate district
court of the United States. In the collection action, the validity
and appropriateness of the Secretary's order imposing the civil
penalty shall not be subject to review.
(4) All penalties collected under this subsection shall be paid
into the Treasury of the United States.
(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty assessed under this
subsection.
(6) Paragraph (1) shall not apply to an official plant.
(d) Scope of liability for violations of section 1037
When construing or enforcing the provisions of section 1037 of
this title, the act, omission, or failure of any person acting for
or employed by any individual, partnership, corporation, or
association within the scope of his employment or office shall in
every case be deemed the act, omission, or failure of such
individual, partnership, corporation, or association, as well as of
such person.
(e) Penalties applicable to carriers or warehousemen
No carrier or warehouseman shall be subject to the penalties of
this chapter, other than the penalties for violation of section
1040 of this title or subsection (c) of this section, by reason of
his receipt, carriage, holding, or delivery, in the usual course of
business, as a carrier or warehouseman of eggs or egg products
owned by another person unless the carrier or warehouseman has
knowledge, or is in possession of facts which would cause a
reasonable person to believe that such eggs or egg products were
not eligible for transportation under, or were otherwise in
violation of, this chapter, or unless the carrier or warehouseman
refuses to furnish on request of a representative of the Secretary
the name and address of the person from whom he received such eggs
or egg products and copies of all documents, if there be any,
pertaining to the delivery of the eggs or egg products to, or by,
such carrier or warehouseman.
-SOURCE-
(Pub. L. 91-597, Sec. 12, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 102-
237, title X, Sec. 1012(d), Dec. 13, 1991, 105 Stat. 1899.)
-MISC1-
AMENDMENTS
1991 - Subsec. (a). Pub. L. 102-237, Sec. 1012(d)(1), (2),
substituted "$5,000" for "$1,000" in first sentence, and
redesignated last sentence, relating to scope of liability for
violations of section 1037 of this title, as subsec. (d).
Subsec. (b). Pub. L. 102-237, Sec. 1012(d)(4), redesignated
subsec. (c) as (b). Former subsec. (b) redesignated (e).
Subsec. (c). Pub. L. 102-237, Sec. 1012(d)(5), added subsec. (c).
Former subsec. (c) redesignated (b).
Subsec. (d). Pub. L. 102-237, Sec. 1012(d)(2), designated last
sentence of subsec. (a), relating to scope of liability for
violations of section 1037 of this title, as subsec. (d).
Subsec. (e). Pub. L. 102-237, Sec. 1012(d)(3), redesignated
subsec. (b) as (e).
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102-237 effective 12 months after
promulgation of final implementing regulations, see section 1012(h)
of Pub. L. 102-237, set out as a note under section 1034 of this
title.
-End-
-CITE-
21 USC Sec. 1042 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1042. Reporting of violation to United States attorney for
institution of criminal proceedings; procedure; presentation of
views
-STATUTE-
Before any violation of this chapter is reported by the Secretary
of Agriculture or Secretary of Health and Human Services to any
United States attorney for institution of a criminal proceeding,
the person against whom such proceeding is contemplated shall be
given reasonable notice of the alleged violation and opportunity to
present his views orally or in writing with regard to such
contemplated proceeding. Nothing in this chapter shall be construed
as requiring the Secretary of Agriculture or Secretary of Health
and Human Services to report for criminal prosecution violations of
this chapter whenever he believes that the public interest will be
adequately served and compliance with this chapter obtained by a
suitable written notice of warning or an action to assess civil
penalties.
-SOURCE-
(Pub. L. 91-597, Sec. 13, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
237, title X, Sec. 1012(e), Dec. 13, 1991, 105 Stat. 1900.)
-MISC1-
AMENDMENTS
1991 - Pub. L. 102-237 inserted "or an action to assess civil
penalties" before period at end.
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102-237 effective 12 months after
promulgation of final implementing regulations, see section 1012(h)
of Pub. L. 102-237, set out as a note under section 1034 of this
title.
-End-
-CITE-
21 USC Sec. 1043 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1043. Rules and regulations; administration and enforcement
-STATUTE-
The Secretary shall promulgate such rules and regulations as he
deems necessary to carry out the purposes or provisions of this
chapter, and shall be responsible for the administration and
enforcement of this chapter except as otherwise provided in section
1034(d) of this title.
-SOURCE-
(Pub. L. 91-597, Sec. 14, Dec. 29, 1970, 84 Stat. 1629.)
-End-
-CITE-
21 USC Sec. 1044 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1044. Exemption of certain activities
-STATUTE-
(a) Regulation for exemptions
The Secretary may, by regulation and under such conditions and
procedures as he may prescribe, exempt from specific provisions of
this chapter -
(1) the sale, transportation, possession, or use of eggs which
contain no more restricted eggs than are allowed by the tolerance
in the official standards of United States consumer grades for
shell eggs;
(2) the processing of egg products at any plant where the
facilities and operating procedures meet such sanitary standards
as may be prescribed by the Secretary, and where the eggs
received or used in the manufacture of egg products contain no
more restricted eggs than are allowed by the official standards
of United States consumer grades for shell eggs, and the egg
products processed at such plant;
(3) the sale of eggs by any poultry producer from his own
flocks directly to a household consumer exclusively for use by
such consumer and members of his household and his nonpaying
guests and employees, and the transportation, possession, and use
of such eggs in accordance with this paragraph;
(4) the processing of egg products by any poultry producer from
eggs of his own flocks' production for sale of such products
directly to a household consumer exclusively for use by such
consumer and members of his household and his nonpaying guests
and employees, and the egg products so processed when handled in
accordance with this paragraph;
(5) the sale of eggs by shell egg packers on his own premises
directly to household consumers for use by such consumer and
members of his household and his nonpaying guests and employees,
and the transportation, possession, and use of such eggs in
accordance with this paragraph;
(6) for such period of time (not to exceed two years) during
the initiation of operations under this chapter as the Secretary
determines that it is impracticable to provide inspection, the
processing of egg products at any class of plants and the egg
products processed at such plants; and
(7) the sale of eggs by any egg producer with an annual egg
production from a flock of three thousand or less hens.
(b) Plants located in noncontiguous areas of United States
The Secretary shall, by regulation and under such procedures as
he may prescribe, exempt any plant located within noncontiguous
areas of the United States from specific provisions of this
chapter, where, despite good faith efforts by the owner of such
plant, such owner has not been able to bring his plant into full
compliance with this chapter: Provided, That in order to provide at
least minimum standards for the protection of the public health,
whenever processing operations are being conducted at any such
plant, continuous inspection shall be maintained to assure that it
is operated in a sanitary manner. No exemption under this
subsection shall be granted for a period extending beyond December
31, 1971.
(c) Suspension or termination of exemptions
The Secretary may immediately suspend or terminate any exemption
under subsection (a)(2) or (6) of this section at any time with
respect to any person, if the conditions of exemption prescribed by
this section or the regulations of the Secretary are not being met.
The Secretary may modify or revoke any regulation granting
exemption under this chapter whenever he deems such action
appropriate to effectuate the purposes of this chapter.
-SOURCE-
(Pub. L. 91-597, Sec. 15, Dec. 29, 1970, 84 Stat. 1629; Pub. L. 92-
67, Aug. 6, 1971, 85 Stat. 173.)
-MISC1-
AMENDMENTS
1971 - Subsecs. (b), (c). Pub. L. 92-67 added subsec. (b) and
redesignated former subsec. (b) as (c).
-End-
-CITE-
21 USC Sec. 1045 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1045. Limitation on entry of eggs and egg products and other
materials into official plants
-STATUTE-
The Secretary may limit the entry of eggs and egg products and
other materials into official plants under such conditions as he
may prescribe to assure that allowing the entry of such articles
into such plants will be consistent with the purposes of this
chapter.
-SOURCE-
(Pub. L. 91-597, Sec. 16, Dec. 29, 1970, 84 Stat. 1630.)
-End-
-CITE-
21 USC Sec. 1046 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1046. Imports
-STATUTE-
(a) Authorization for importation of restricted eggs; prerequisites
for importation of egg products; treatment as domestic articles
subject to this chapter; marking and labeling exemption for
personal consumption
(1) No restricted eggs capable of use as human food shall be
imported into the United States except as authorized by regulations
of the Secretary.
(2) No egg products capable of use as human food shall be
imported into the United States unless they were processed under an
approved continuous inspection system of the government of the
foreign country of origin or subdivision thereof and are labeled
and packaged in accordance with, and otherwise comply with the
standards of this chapter and regulations issued thereunder
applicable to such articles within the United States.
(3) No eggs packed into a container that is destined for the
ultimate consumer shall be imported into the United States unless
the eggs are accompanied by a certification that the eggs have at
all times after packaging been stored and transported under
refrigeration at an ambient temperature of no greater than 45
degrees Fahrenheit, as required by sections 1034(e) and 1037(c) of
this title.
(4) All such imported articles shall upon entry into the United
States be deemed and treated as domestic articles subject to the
other provisions of this chapter: Provided, That they shall be
labeled as required by such regulations for imported articles:
Provided further, That nothing in this section shall apply to eggs
or egg products purchased outside the United States by any
individual for consumption by him and members of his household and
his nonpaying guests and employees.
(b) Terms and conditions for destruction
The Secretary may prescribe the terms and conditions for the
destruction of all such articles which are imported contrary to
this section, unless (1) they are exported by the consignee within
the time fixed therefor by the Secretary or (2) in the case of
articles which are not in compliance solely because of misbranding,
such articles are brought into compliance with this chapter under
supervision of authorized representatives of the Secretary.
(c) Payment of storage, cartage, and labor charges by owner or
consignee; liens
All charges for storage, cartage, and labor with respect to any
article which is imported contrary to this section shall be paid by
the owner or consignee, and in default of such payment shall
constitute a lien against such article and any other article
thereafter imported under this chapter by or for such owner or
consignee.
(d) Prohibition
The importation of any article contrary to this section is
prohibited.
-SOURCE-
(Pub. L. 91-597, Sec. 17, Dec. 29, 1970, 84 Stat. 1630; Pub. L. 102-
237, title X, Sec. 1012(f), Dec. 13, 1991, 105 Stat. 1901.)
-MISC1-
AMENDMENTS
1991 - Subsec. (a). Pub. L. 102-237 designated first sentence as
par. (1) and second sentence as par. (2), added par. (3), and
designated third sentence as par. (4).
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102-237 effective 12 months after
promulgation of final implementing regulations, see section 1012(h)
of Pub. L. 102-237, set out as a note under section 1034 of this
title.
-End-
-CITE-
21 USC Sec. 1047 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1047. Refusal or withdrawal of inspection services; hearing;
grounds; person deemed to have responsible connection with
business; finality of order of Secretary; judicial review; other
provisions for refusal of services unaffected
-STATUTE-
The Secretary (for such period, or indefinitely, as he deems
necessary to effectuate the purposes of this chapter) may refuse to
provide or may withdraw inspection service under this chapter with
respect to any plant if he determines, after opportunity for a
hearing is accorded to the applicant for, or recipient of, such
service, that such applicant or recipient is unfit to engage in any
business requiring inspection under this chapter because the
applicant or recipient or anyone responsibly connected with the
applicant or recipient has been convicted in any Federal or State
court, within the previous ten years, of (1) any felony or more
than one misdemeanor under any law based upon the acquiring,
handling, or distributing of adulterated, mislabeled, or
deceptively packaged food or fraud in connection with transactions
in food, or (2) any felony, involving fraud, bribery, extortion, or
any other act or circumstances indicating a lack of the integrity
needed for the conduct of operations affecting the public health.
For the purpose of this section, a person shall be deemed to be
responsibly connected with the business if he is a partner,
officer, director, holder, or owner of 10 per centum or more of its
voting stock, or employee in a managerial or executive capacity.
The determination and order of the Secretary with respect thereto
under this section shall be final and conclusive unless the
affected applicant for, or recipient of, inspection service files
application for judicial review within thirty days after the
effective date of such order in the United States court of appeals
for the circuit in which such applicant or recipient has its
principal place of business or in the United States Court of
Appeals for the District of Columbia Circuit. Judicial review of
any such order shall be upon the record upon which the
determination and order are based. The provisions of section 194 of
title 7 shall be applicable to appeals taken under this section.
This section shall not affect in any way other provisions of this
chapter for refusal of inspection services.
-SOURCE-
(Pub. L. 91-597, Sec. 18, Dec. 29, 1970, 84 Stat. 1630.)
-End-
-CITE-
21 USC Sec. 1048 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1048. Administrative detention of violative articles;
duration; release; removal of official marks
-STATUTE-
Whenever any eggs or egg products subject to this chapter, are
found by any authorized representative of the Secretary upon any
premises and there is reason to believe that they are or have been
processed, bought, sold, possessed, used, transported, or offered
or received for sale or transportation in violation of this chapter
or that they are in any other way in violation of this chapter, or
whenever any restricted eggs capable of use as human food are found
by such a representative in the possession of any person not
authorized to acquire such eggs under the regulations of the
Secretary, such articles may be detained by such representative for
a reasonable period but not to exceed twenty days, pending action
under section 1049 of this title or notification of any Federal,
State, or other governmental authorities having jurisdiction over
such articles and shall not be moved by any person from the place
at which they are located when so detained until released by such
representative. All official marks may be required by such
representative to be removed from such articles before they are
released unless it appears to the satisfaction of the Secretary
that the articles are eligible to retain such marks.
-SOURCE-
(Pub. L. 91-597, Sec. 19, Dec. 29, 1970, 84 Stat. 1631.)
-End-
-CITE-
21 USC Sec. 1049 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1049. Seizure and condemnation proceedings
-STATUTE-
(a) Jurisdiction; disposal of condemned articles; court costs and
fees; conformity to supplemental rules for admiralty and maritime
claims; jury trial; United States as plaintiff
Any eggs or egg products that are or have been processed, bought,
sold, possessed, used, transported, or offered or received for sale
or transportation, in violation of this chapter, or in any other
way are in violation of this chapter; and any restricted eggs,
capable of use as human food, in the possession of any person not
authorized to acquire such eggs under the regulations of the
Secretary shall be liable to be proceeded against and seized and
condemned, at any time, on a complaint in any United States
district court or other proper court as provided in section 1050 of
this title within the jurisdiction of which the articles are found.
If the articles are condemned they shall, after entry of the
decree, be disposed of by destruction or sale as the court may
direct and the proceeds, if sold, less the court costs and fees,
and storage and other proper expenses, shall be paid into the
Treasury of the United States, but the articles shall not be sold
contrary to the provision of this chapter, the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.] or the Fair Packaging and
Labeling Act [15 U.S.C. 1451 et seq.], or the laws of the
jurisdiction in which they are sold: Provided, That upon the
execution and delivery of a good and sufficient bond conditioned
that the articles shall not be sold or otherwise disposed of
contrary to the provisions of this chapter, the Federal Food, Drug,
and Cosmetic Act, the Fair Packaging and Labeling Act, or the laws
of the jurisdiction in which disposal is made, the court may direct
that they be delivered to the owner thereof subject to such
supervision by authorized representatives of the Secretary as is
necessary to insure compliance with the applicable laws. When a
decree of condemnation is entered against the articles and they are
released under bond, or destroyed, court costs and fees, and
storage and other proper expenses shall be awarded against the
person, if any, intervening as claimant thereof. The proceedings in
such cases shall conform, as nearly as may be, to the supplemental
rules for certain admiralty and maritime claims, except that either
party may demand trial by jury of any issue of fact joined in any
case, and all such proceedings shall be at the suit of and in the
name of the United States.
(b) Condemnation or seizure under other provisions unaffected
The provisions of this section shall in no way derogate from
authority for condemnation or seizure conferred by other provisions
of this chapter, or other laws.
-SOURCE-
(Pub. L. 91-597, Sec. 20, Dec. 29, 1970, 84 Stat. 1631.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
The Fair Packaging and Labeling Act, referred to in subsec. (a),
is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
15, Commerce and Trade. For complete classification of this Act to
the Code, see Short Title note set out under section 1451 of Title
15 and Tables.
-End-
-CITE-
21 USC Sec. 1050 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1050. Jurisdiction of district courts; United States as
plaintiff in enforcement and restraining proceedings; subpenas
for witnesses
-STATUTE-
The United States district courts and the District Court of the
Virgin Islands are vested with jurisdiction specifically to
enforce, and to prevent and restrain violations of, this chapter,
and shall have jurisdiction in all other cases, arising under this
chapter, except as provided in section 1047 of this title. All
proceedings for the enforcement or to restrain violations of this
chapter shall be by and in the name of the United States. Subpenas
for witnesses who are required to attend a court of the United
States, in any district, may run into any other district in any
such proceeding.
-SOURCE-
(Pub. L. 91-597, Sec. 21, Dec. 29, 1970, 84 Stat. 1632.)
-End-
-CITE-
21 USC Sec. 1051 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1051. Other Federal laws applicable for administration and
enforcement of chapter; prosecution of inquiries; exercise of
jurisdiction
-STATUTE-
For the efficient administration and enforcement of this chapter,
the provisions (including penalties) of sections 46, 48, 49, and 50
of title 15 (except paragraphs (c) through (h) of section 46 and
the last paragraph of section 49 (!1) of title 15), and the
provisions of section 409(l) (!1) of title 47, are made applicable
to the jurisdiction, powers, and duties of the Secretary in
administering and enforcing the provisions of this chapter and to
any person with respect to whom such authority is exercised. The
Secretary, in person or by such agents as he may designate, may
prosecute any inquiry necessary to his duties under this chapter in
any part of the United States, and the powers conferred by said
sections 49 and 50 of title 15, on the district courts of the
United States may be exercised for the purposes of this chapter by
any court designated in section 1050 of this title.
-SOURCE-
(Pub. L. 91-597, Sec. 22, Dec. 29, 1970, 84 Stat. 1632.)
-REFTEXT-
REFERENCES IN TEXT
The last paragraph of section 49 of title 15, and the provisions
of section 409(l) of title 47, referred to in text, which related
to immunity of witnesses, were repealed by sections 211 and 242,
respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
929, 930. For provisions relating to immunity of witnesses, see
section 6001 et seq. of Title 18, Crimes and Criminal Procedure.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 1052 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1052. State or local regulation
-STATUTE-
(a) Prohibition against additional or different requirements than
Federal requirements relating to premises, facilities, and
operations at official plants; authority to impose recordkeeping
and related requirements consistent with Federal requirements
Requirements within the scope of this chapter with respect to
premises, facilities, and operations of any official plant which
are in addition to or different than those made under this chapter
may not be imposed by any State or local jurisdiction except that
any such jurisdiction may impose recordkeeping and other
requirements within the scope of section 1040 of this title, if
consistent therewith, with respect to any such plant.
(b) Prohibition against additional or different standards than
Federal standards of quality, etc., or requiring labeling to show
area of production or origin; authority to require name, address,
and license number of processor or packer on containers;
prohibition against additional or different requirements than
Federal requirements relating to labeling, packaging or
ingredients; authority to prevent distribution of violative
articles; validity of nonconflicting laws
For eggs which have moved or are moving in interstate or foreign
commerce, (1) no State or local jurisdiction may require the use of
standards of quality, condition, weight, quantity, or grade which
are in addition to or different from the official Federal
standards, (2) with respect to egg handlers specified in paragraphs
(1) and (2) of section 1034(e) of this title, no State or local
jurisdiction may impose temperature requirements pertaining to eggs
packaged for the ultimate consumer which are in addition to, or
different from, Federal requirements, and (3) no State or local
jurisdiction other than those in noncontiguous areas of the United
States may require labeling to show the State or other geographical
area of production or origin: Provided, however, That this shall
not preclude a State from requiring that the name, address, and
license number of the person processing or packaging eggs, be shown
on each container. Labeling, packaging, or ingredient requirements,
in addition to or different than those made under this chapter, the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and
the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.], may
not be imposed by any State or local jurisdiction, with respect to
egg products processed at any official plant in accordance with the
requirements under this chapter and such Acts. However, any State
or local jurisdiction may exercise jurisdiction with respect to
eggs and egg products for the purpose of preventing the
distribution for human food purposes of any such articles which are
outside of such a plant and are in violation of any of said Federal
Acts or any State or local law consistent therewith. Otherwise the
provisions of this chapter shall not invalidate any law or other
provisions of any State or other jurisdiction in the absence of a
conflict with this chapter.
(c) Applicability of other Federal laws and authority of other
Federal officials relating to eggs, egg products, or other food
products unaffected; authority of Secretary of Agriculture to
regulate official plants processing egg products
The provisions of this chapter shall not affect the applicability
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
or the Fair Packaging and Labeling Act [15 U.S.C. 1451 et seq.] or
other Federal laws to eggs, egg products, or other food products or
diminish any authority conferred on the Secretary of Health and
Human Services or other Federal officials by such other laws,
except that the Secretary of Agriculture shall have exclusive
jurisdiction to regulate official plants processing egg products
and operations thereof as to all matters within the scope of this
chapter.
(d) Detainer authority
The detainer authority conferred on representatives of the
Secretary of Agriculture by section 1048 of this title shall also
apply to any authorized representative of the Secretary of Health
and Human Services for the purposes of section 1034(d) of this
title, with respect to any eggs or egg products that are outside
any plant processing egg products.
-SOURCE-
(Pub. L. 91-597, Sec. 23, Dec. 29, 1970, 84 Stat. 1632; Pub. L. 96-
88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-
237, title X, Sec. 1012(g), Dec. 13, 1991, 105 Stat. 1901.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(b) and (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
The Fair Packaging and Labeling Act, referred to in subsecs. (b)
and (c), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as
amended, which is classified generally to chapter 39 (Sec. 1451 et
seq.) of Title 15, Commerce and Trade. For complete classification
of this Act to the Code, see Short Title note set out under section
1451 of Title 15 and Tables.
-MISC1-
AMENDMENTS
1991 - Subsec. (b). Pub. L. 102-237 substituted "(2) with respect
to egg handlers specified in paragraphs (1) and (2) of section
1034(e) of this title, no State or local jurisdiction may impose
temperature requirements pertaining to eggs packaged for the
ultimate consumer which are in addition to, or different from,
Federal requirements, and (3)" for "and (2)".
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in subsecs. (c) and
(d) pursuant to section 509(b) of Pub. L. 96-88, which is
classified to section 3508(b) of Title 20, Education.
-MISC2-
EFFECTIVE DATE OF 1991 AMENDMENT
Amendment by Pub. L. 102-237 effective 12 months after
promulgation of final implementing regulations, see section 1012(h)
of Pub. L. 102-237, set out as a note under section 1034 of this
title.
-End-
-CITE-
21 USC Sec. 1053 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1053. Inspection and administration costs
-STATUTE-
(a) Overtime and holiday work costs; availability of funds
The cost of inspection rendered under the requirements of this
chapter, and other costs of administration of this chapter, shall
be borne by the United States, except that the cost of overtime and
holiday work performed in official plants subject to the provisions
of this chapter at such rates as the Secretary may determine shall
be borne by such official plants. Sums received by the Secretary
from official plants under this section shall be available without
fiscal year limitation to carry out the purposes of this chapter.
(b) "Holiday" defined
The term "holiday" for the purposes of assessment or
reimbursement of the cost of inspection performed under this
chapter, the Wholesome Poultry Products Act [21 U.S.C. 467a et
seq.] and the Wholesome Meat Act [21 U.S.C. 601 et seq.] shall mean
the legal public holidays specified by the Congress in section
6103(a) of title 5.
-SOURCE-
(Pub. L. 91-597, Sec. 24, Dec. 29, 1970, 84 Stat. 1633.)
-REFTEXT-
REFERENCES IN TEXT
The Wholesome Poultry Products Act, referred to in subsec. (b),
is Pub. L. 90-492, Aug. 18, 1968, 82 Stat. 791, as amended, which
enacted sections 467a to 467f and 470 of this title, amended
sections 451 to 461, 463 to 465, and 467 of this title, and enacted
provisions set out as notes under section 451 of this title. For
complete classification of this Act to the Code, see Short Title of
1968 Amendment note set out under section 451 of this title and
Tables.
The Wholesome Meat Act, referred to in subsec. (b), is Pub. L. 90-
201, Dec. 15, 1967, 81 Stat. 584, as amended, which enacted
sections 601, 602, 624, 641 to 645, 661, 671 to 680, and 691 of
this title, amended sections 603 to 623 of this title, repealed
section 96 of this title and section 1306(b) of Title 19, Customs
Duties, and enacted provisions set out as notes under section 601
of this title. For complete classification of this Act to the Code,
see Short Title note set out under section 601 of this title and
Tables.
-End-
-CITE-
21 USC Sec. 1054 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1054. Annual report to Congressional committees
-STATUTE-
(a) (!1) Not later than March 1 of each year following December
29, 1970, the Secretary shall submit to the Committee on
Agriculture of the House of Representatives and the Committee on
Agriculture, Nutrition, and Forestry of the Senate a comprehensive
and detailed written report with respect to -
(1) the processing, storage, handling, and distribution of eggs
and egg products subject to the provisions of this chapter; the
inspection of establishments operated in connection therewith;
the effectiveness of the operation of the inspection, including
the effectiveness of the operations of State egg inspection
programs; and recommendations for legislation to improve such
program; and
(2) the administration of section 1046 of this title (relating
to imports) during the immediately preceding calendar year,
including but not limited to -
(A) a certification by the Secretary that foreign plants
exporting eggs or egg products to the United States have
complied with requirements of this chapter and regulations
issued thereunder;
(B) the names and locations of plants authorized or permitted
to export eggs or egg products to the United States;
(C) the number of inspectors employed by the Department of
Agriculture in the calendar year concerned who were assigned to
inspect plants referred to in paragraph (B) hereof and the
frequency with which each such plant was inspected by such
inspectors;
(D) the number of inspectors that were licensed by each
country from which any imports were received and that were
assigned, during the calendar year concerned, to inspect such
imports and the facilities in which such imports were handled;
and the frequency and effectiveness of such inspections;
(E) the total volume of eggs and egg products which was
imported into the United States during the calendar year
concerned from each country, including a separate itemization
of the volume of each major category of such imports from each
country during such year, and a detailed report of rejections
of plants and products because of failure to meet appropriate
standards prescribed by this chapter; and
(F) recommendations for legislation to improve such program.
-SOURCE-
(Pub. L. 91-597, Sec. 26, Dec. 29, 1970, 84 Stat. 1634; Pub. L. 103-
437, Sec. 8(4), Nov. 2, 1994, 108 Stat. 4588.)
-MISC1-
AMENDMENTS
1994 - Pub. L. 103-437 substituted "Agriculture, Nutrition, and
Forestry" for "Agriculture and Forestry" in introductory
provisions.
-FOOTNOTE-
(!1) So in original. No subsec. (b) has been enacted.
-End-
-CITE-
21 USC Sec. 1055 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1055. Authorization of appropriations
-STATUTE-
Such sums as are necessary to carry out the provisions of this
chapter are hereby authorized to be appropriated.
-SOURCE-
(Pub. L. 91-597, Sec. 27, Dec. 29, 1970, 84 Stat. 1635.)
-End-
-CITE-
21 USC Sec. 1056 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 15 - EGG PRODUCTS INSPECTION
-HEAD-
Sec. 1056. Separability
-STATUTE-
If any provision of this chapter or the application thereof to
any person or circumstances is held invalid, the validity of the
remainder of the chapter and of the application of such provision
to other persons and circumstances shall not be affected thereby.
-SOURCE-
(Pub. L. 91-597, Sec. 28, Dec. 29, 1970, 84 Stat. 1635.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
amended, which enacted this chapter, amended sections 633 and 636
of Title 15, Commerce and Trade, and enacted provisions set out as
notes under section 1031 of this title. For complete classification
of this Act to the Code, see Short Title note set out under section
1031 of this title and Tables.
-End-
-CITE-
21 USC CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND
REHABILITATION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
-HEAD-
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
-MISC1-
SUBCHAPTER I - GENERAL PROVISIONS
Sec.
1101. Congressional findings.
1102. Congressional declaration of national policy.
1103, 1104. Repealed.
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
1111 to 1114. Repealed.
1115. Notice relating to the control of dangerous drugs.
1116 to 1155. Repealed or Omitted.
SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY
1161 to 1165. Repealed.
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
1171. Drug abuse prevention function appropriations.
1172 to 1176. Repealed, Transferred, or Omitted.
1177. Special project grants and contracts.
1178. Records and audit.
1179. National Drug Abuse Training Center.
1180. Transferred.
1181. Contract authority.
SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE
1191 to 1194. Transferred or Repealed.
-End-
-CITE-
21 USC SUBCHAPTER I - GENERAL PROVISIONS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER I - GENERAL PROVISIONS
-HEAD-
SUBCHAPTER I - GENERAL PROVISIONS
-End-
-CITE-
21 USC Sec. 1101 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER I - GENERAL PROVISIONS
-HEAD-
Sec. 1101. Congressional findings
-STATUTE-
The Congress makes the following findings:
(1) Drug abuse is rapidly increasing in the United States and
now afflicts urban, suburban, and rural areas of the Nation.
(2) Drug abuse seriously impairs individual, as well as
societal, health and well-being.
(3) Drug abuse, especially heroin addiction, substantially
contributes to crime.
(4) The adverse impact of drug abuse inflicts increasing pain
and hardship on individuals, families, and communities and
undermines our institutions.
(5) Too little is known about drug abuse, especially the
causes, and ways to treat and prevent drug abuse.
(6) The success of Federal drug abuse programs and activities
requires a recognition that education, treatment, rehabilitation,
research, training, and law enforcement efforts are interrelated.
(7) The effectiveness of efforts by State and local governments
and by the Federal Government to control and treat drug abuse in
the United States has been hampered by a lack of coordination
among the States, between States and localities, among the
Federal Government, States and localities, and throughout the
Federal establishment.
(8) Control of drug abuse requires the development of a
comprehensive, coordinated long-term Federal strategy that
encompasses both effective law enforcement against illegal drug
traffic and effective health programs to rehabilitate victims of
drug abuse.
(9) The increasing rate of drug abuse constitutes a serious and
continuing threat to national health and welfare, requiring an
immediate and effective response on the part of the Federal
Government.
(10) Although the Congress observed a significant apparent
reduction in the rate of increase of drug abuse during the three-
year period subsequent to March 21, 1972, and in certain areas
of the country apparent temporary reductions in its incidence,
the increase and spread of heroin consumption since 1974, and the
continuing abuse of other dangerous drugs, clearly indicate the
need for effective, ongoing, and highly visible Federal
leadership in the formation and execution of a comprehensive,
coordinated drug abuse policy.
(11) Shifts in the usage of various drugs and in the Nation's
demographic composition require a Federal strategy to adjust the
focus of drug abuse programs to meet new needs and priorities on
a cost-effective basis.
(12) The growing extent of drug abuse indicates an urgent need
for prevention and intervention programs designed to reach the
general population and members of high risk populations such as
youth, women, and the elderly.
(13) Effective control of drug abuse requires high-level
coordination of Federal international and domestic activities
relating to both supply of, and demand for, commonly abused
drugs.
(14) Local governments with high concentrations of drug abuse
should be actively involved in the planning and coordination of
efforts to combat drug abuse.
-SOURCE-
(Pub. L. 92-255, title I, Sec. 101, Mar. 21, 1972, 86 Stat. 66;
Pub. L. 94-237, Sec. 1, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96-
181, Sec. 2, Jan. 2, 1980, 93 Stat. 1309.)
-MISC1-
AMENDMENTS
1980 - Pars. (11) to (14). Pub. L. 96-181 added pars. (11) to
(14).
1976 - Par. (10). Pub. L. 94-237 added par. (10).
SHORT TITLE OF 1980 AMENDMENT
Section 1(a) of Pub. L. 96-181 provided that: "This Act [enacting
sections 1111 to 1117 and 1181 of this title, amending this
section, sections 1102, 1162, 1164, 1176, 1177, 1180, and 1191 to
1193 of this title, and sections 218, 300l-2, 300m-3, and 3733 of
Title 42, The Public Health and Welfare, omitting sections 1118 to
1120 and 1131 to 1133 of this title, enacting provisions set out as
notes under this section and section 1193 of this title, and
amending provisions set out as a note below] may be cited as the
'Drug Abuse Prevention, Treatment, and Rehabilitation Amendments of
1979'."
SHORT TITLE OF 1978 AMENDMENT
Pub. L. 95-461, Sec. 1, Oct. 14, 1978, 92 Stat. 1268, provided
that: "This Act [enacting section 1194 of this title, amending
sections 1172, 1176, 1177, 1192, and 1193 of this title, enacting a
provision set out as a note under section 1172 of this title and
amending a provision set out as a note under section 242 of Title
42, The Public Health and Welfare] may be cited as the 'Drug Abuse
Prevention and Treatment Amendments of 1978'. "
SHORT TITLE
Section 1 of Pub. L. 92-255, as amended by Pub. L. 96-181, Sec.
15(a), Jan. 2, 1980, 93 Stat. 1316, provided that: "This Act
[enacting this chapter, and amending sections 5313, 5315, and 5316
of Title 5, Government Organization and Employees, and sections
218, 246, 257, 2684, 2688a, 2688k, 2688n-1, and 2688t of Title 42,
The Public Health and Welfare] may be cited as the 'Drug Abuse
Prevention, Treatment, and Rehabilitation Act'."
REFERENCES TO DRUG ABUSE OFFICE AND TREATMENT ACT OF 1972
Section 15(b) of Pub. L. 96-181 provided in part that: "Whenever
reference is made in any other Federal law, regulation, ruling, or
order to the Drug Abuse Office and Treatment Act of 1972, the
reference shall be considered to be made to the Drug Abuse
Prevention, Treatment, and Rehabilitation Act."
-End-
-CITE-
21 USC Sec. 1102 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER I - GENERAL PROVISIONS
-HEAD-
Sec. 1102. Congressional declaration of national policy
-STATUTE-
The Congress declares that it is the policy of the United States
and the purpose of this chapter to focus the comprehensive
resources of the Federal Government and bring them to bear on drug
abuse with the objective of significantly reducing the incidence,
as well as the social and personal costs, of drug abuse in the
United States, and to develop and assure the implementation of a
comprehensive, coordinated long-term Federal strategy to combat
drug abuse. To reach these goals, the Congress further declares
that it is the policy of the United States and the purpose of this
chapter to meet the problems of drug abuse through -
(1) comprehensive Federal, State, and local planning for, and
effective use of, Federal assistance to States and to community-
based programs to meet the urgent needs of special populations,
in coordination with all other governmental and nongovernmental
sources of assistance;
(2) the development and support of community-based prevention
programs;
(3) the development and encouragement of effective occupational
prevention and treatment programs within the Government and in
cooperation with the private sector; and
(4) increased Federal commitment to research into the
behavioral and biomedical etiology of, the treatment of, and the
mental and physical health and social and economic consequences
of, drug abuse.
-SOURCE-
(Pub. L. 92-255, title I, Sec. 102, Mar. 21, 1972, 86 Stat. 66;
Pub. L. 94-237, Sec. 2, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96-
181, Sec. 3, Jan. 2, 1980, 93 Stat. 1309.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning Pub. L. 92-255, Mar. 21, 1972, 86 Stat. 65, as
amended, known as the Drug Abuse Prevention, Treatment, and
Rehabilitation Act, which comprises this chapter. For complete
classification of this Act to the Code, see Short Title note set
out under section 1101 of this title and Tables.
-MISC1-
AMENDMENTS
1980 - Pub. L. 96-181 inserted additional declarations of policy
prescribing methods and programs by which the goals are to be
reached.
1976 - Pub. L. 94-237 substituted "objective of significantly
reducing the incidence, as well as the social and personal costs,
of drug abuse in the United States, and to develop and assure the
implementation of" for "immediate objective of significantly
reducing the incidence of drug abuse in the United States within
the shortest possible period of time, and to develop".
-End-
-CITE-
21 USC Sec. 1103 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER I - GENERAL PROVISIONS
-HEAD-
Sec. 1103. Repealed.
-MISC1-
Sec. 1103. Repealed. Pub. L. 100-690, title I, Sec. 1007(c)(1),
Nov. 18, 1988, 102 Stat. 4187.
Section, Pub. L. 92-255, title I, Sec. 103, Mar. 21, 1972, 86
Stat. 67; Pub. L. 94-237, Secs. 3, 4(a), Mar. 19, 1976, 90 Stat.
241, defined "drug abuse prevention function", "drug traffic
prevention function", and "drug abuse function".
EFFECTIVE DATE OF REPEAL
Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
690.
-End-
-CITE-
21 USC Sec. 1104 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER I - GENERAL PROVISIONS
-HEAD-
Sec. 1104. Repealed.
-MISC1-
Sec. 1104. Repealed. Pub. L. 94-237, Sec. 4(c)(1), Mar. 19, 1976,
90 Stat. 244.
Section, Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
Stat. 67, provided, effective June 30, 1975, that the Special
Action Office for Drug Abuse Prevention, each of the positions in
the Office of Director, Deputy Director, and Assistant Director,
and the National Advisory Council for Drug Abuse Prevention were
abolished and former subchapter II of this chapter was repealed.
-End-
-CITE-
21 USC SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-End-
-CITE-
21 USC Secs. 1111 to 1114 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1111 to 1114. Repealed.
-MISC1-
Secs. 1111 to 1114. Repealed. Pub. L. 100-690, title I, Sec.
1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.
Section 1111, Pub. L. 92-255, title II, Sec. 201, as added Pub.
L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98-
473, title II, Sec. 1306, Oct. 12, 1984, 98 Stat. 2170, related to
concentration of Federal effort in drug abuse prevention.
A prior section 1111, Pub. L. 92-255, title II, Sec. 201, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
provided for the establishment of the Office of Drug Abuse Policy,
was omitted in the general revision of this subchapter by Pub. L.
96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309. Previously, the Office
of Drug Abuse Policy was abolished and the functions of the Office
and its Director were transferred to the President by sections 3
and 5 of Reorg. Plan No. 1 of 1977, effective Mar. 27, 1978, as
provided by Ex. Ord. No. 12045, Mar. 27, 1978, 43 F.R. 13347, set
out as notes preceding section 101 of Title 3, The President.
Another prior section 1111, Pub. L. 92-255, title II, Sec. 201,
Mar. 21, 1972, 86 Stat. 67, which provided for the establishment of
the Special Action Office for Drug Abuse Prevention, was repealed
by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67,
eff. June 30, 1975.
Section 1112, Pub. L. 92-255, title II, Sec. 202, as added Pub.
L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
designation of a representative to direct activities required by
this subchapter.
A prior section 1112, Pub. L. 92-255, title II, Sec. 202, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242;
amended Pub. L. 95-83, title III, Sec. 311(d), Aug. 1, 1977, 91
Stat. 398, which provided for the appointment of the Director of
the Office of Drug Abuse Policy, was omitted in the general
revision of this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2,
1980, 93 Stat. 1309.
Another prior section 1112, Pub. L. 92-255, title II, Sec. 202,
Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a
Director of the Special Action Office for Drug Abuse Prevention,
was repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972,
86 Stat. 67, eff. June 30, 1975.
Section 1113, Pub. L. 92-255, title II, Sec. 203, as added Pub.
L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
employment of officers and employees.
A prior section 1113, Pub. L. 92-255, title II, Sec. 203, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
provided for the appointment and functions of Deputy Director of
the Office of Drug Abuse Policy, was omitted in the general
revision of this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2,
1980, 93 Stat. 1309.
Another prior section 1113, Pub. L. 92-255, title II, Sec. 203,
Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a
Deputy Director of the Special Office for Drug Abuse Prevention,
was repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972,
86 Stat. 67, eff. June 30, 1975.
Section 1114, Pub. L. 92-255, title II, Sec. 204, as added Pub.
L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310, related to
acceptance of uncompensated services.
A prior section 1114, Pub. L. 92-255, title II, Sec. 204, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
provided for the delegation of functions by the Director of the
Office of Drug Abuse Policy, was omitted in the general revision of
this subchapter by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
1309.
Another prior section 1114, Pub. L. 92-255, title II, Sec. 204,
Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of
six Assistant Directors, was repealed by Pub. L. 92-255, title I,
Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
Provisions similar to this section were contained in section 1117
of this title prior to the general revision of this subchapter by
Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
EFFECTIVE DATE OF REPEAL
Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
690.
-EXEC-
EXECUTIVE ORDER NO. 12368
Ex. Ord. No. 12368, June 24, 1982, 47 F.R. 27843, as amended by
Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, related to
assignment of drug abuse policy functions.
-End-
-CITE-
21 USC Sec. 1115 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Sec. 1115. Notice relating to the control of dangerous drugs
-STATUTE-
Whenever the Attorney General determines that there is evidence
that -
(1) a drug or other substance, which is not a controlled
substance (as defined in section 802(6) of this title), has a
potential for abuse, or
(2) a controlled substance should be transferred or removed
from a schedule under section 812 of this title,
he shall, prior to initiating any proceeding under section 811(a)
of this title, give the President timely notice of such
determination. Information forwarded to the Attorney General
pursuant to section 811(f) of this title shall also be forwarded by
the Secretary of Health and Human Services to the President.
-SOURCE-
(Pub. L. 92-255, title II, Sec. 201, formerly Sec. 205, as added
Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311; amended Pub.
L. 97-35, title IX, Sec. 973(a), Aug. 13, 1981, 95 Stat. 598;
renumbered Sec. 201, Pub. L. 100-690, title I, Sec. 1007(c)(1),
Nov. 18, 1988, 102 Stat. 4187.)
-MISC1-
PRIOR PROVISIONS
A prior section 201 of Pub. L. 92-255, title II, as added Pub. L.
96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98-
473, title II, Sec. 1306, Oct. 12, 1984, 98 Stat. 2170, related to
concentration of Federal effort in drug abuse prevention, prior to
repeal by Pub. L. 100-690, title I, Sec. 1007(c)(1), Nov. 18, 1988,
102 Stat. 4187.
A prior section 1115, Pub. L. 92-255, title II, Sec. 205, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
provided for employment, functions, and travel expenses of
employees, was omitted in the general revision of this subchapter
by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
Another prior section 1115, Pub. L. 92-255, title II, Sec. 205,
Mar. 21, 1972, 86 Stat. 68, provided for the delegation of
functions by the Director, prior to repeal by Pub. L. 92-255, title
I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
Provisions similar to this section were contained in section 1118
of this title prior to the general revision of this subchapter by
Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
AMENDMENTS
1981 - Pub. L. 97-35 substituted "Health and Human Services" for
"Health, Education, and Welfare".
-End-
-CITE-
21 USC Sec. 1116 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Sec. 1116. Repealed.
-MISC1-
Sec. 1116. Repealed. Pub. L. 100-690, title I, Sec. 1007(c)(1),
Nov. 18, 1988, 102 Stat. 4187.
Section, Pub. L. 92-255, title II, Sec. 206, as added Pub. L. 96-
181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311, provided that this
subchapter not be construed as limiting the statutory authority of
the Secretary of Defense or the Administrator of Veterans' Affairs.
EFFECTIVE DATE OF REPEAL
Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100-
690.
A prior section 1116, Pub. L. 92-255, title II, Sec. 206, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 242, which
provided for the employment and compensation of experts and
consultants, was omitted in the general revision of this subchapter
by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
Another prior section 1116, Pub. L. 92-255, title II, Sec. 206,
Mar. 21, 1972, 86 Stat. 68, which provided for the employment and
prescription of functions for officers and employees by the
Director, was repealed by Pub. L. 92-255, title I, Sec. 104, Mar.
21, 1972, 86 Stat. 67, eff. June 30, 1975.
Provisions similar to this section were contained in section 1119
of this title prior to the general revision of this subchapter by
Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
-End-
-CITE-
21 USC Sec. 1117 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Sec. 1117. Repealed.
-MISC1-
Sec. 1117. Repealed. Pub. L. 98-24, Sec. 4(b), Apr. 26, 1983, 97
Stat. 183.
Section, Pub. L. 92-255, title II, Sec. 207, as added Pub. L. 96-
181, Sec. 4, Jan. 2, 1980, 93 Stat. 1311, required the President
to make annual reports to the Congress on the drug abuse prevention
activities under this subchapter. See section 290aa-4 of Title 42,
The Public Health and Welfare.
A prior section 1117, Pub. L. 92-255, title II, Sec. 207, as
added Pub. L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which
provided for acceptance of uncompensated services, was omitted in
the general revision of this subchapter by Pub. L. 96-181, Sec. 4,
Jan. 2, 1980, 93 Stat. 1309.
Another prior section 1117, Pub. L. 92-255, title II, Sec. 207,
Mar. 21, 1972, 86 Stat. 68, which provided for the procurement of
experts and consultants by the Director, was repealed by Pub. L. 92-
255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
1975.
-End-
-CITE-
21 USC Secs. 1118 to 1120 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1118 to 1120. Omitted
-COD-
CODIFICATION
Section 1118, Pub. L. 92-255, title II, Sec. 208, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
giving of notice to Director prior to initiation of a section
811(a) proceeding, was omitted in the general revision of title II
of Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
1309. See section 1115 of this title.
A prior section 1118, Pub. L. 92-255, title II, Sec. 208, Mar.
21, 1972, 86 Stat. 68, which provided for acceptance of
uncompensated services by Director, was repealed by Pub. L. 92-255,
title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
Section 1119, Pub. L. 92-255, title II, Sec. 210, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
effect of this subchapter on statutory requirements and
authorities, was omitted in the general revision of title II of
Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat.
1309. See section 1116 of this title.
A prior section 1119, Pub. L. 92-255, title II, Sec. 209, Mar.
21, 1972, 86 Stat. 68, which provided for notice by Attorney
General to Director with respect to control of dangerous drugs, was
repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
Stat. 67, eff. June 30, 1975.
A prior section 210 of Pub. L. 92-255, title II, Mar. 21, 1972,
86 Stat. 69, which provided for authority of Director to make
grants and enter into contract, was repealed by Pub. L. 92-255,
title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
Section 1120, Pub. L. 92-255, title II, Sec. 211, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
authorization of appropriations with regard to this subchapter, was
omitted in the general revision of title II of Pub. L. 92-255 by
Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309.
A prior section 1120, Pub. L. 92-255, title II, Sec. 210, Mar.
21, 1972, 86 Stat. 69, which provided for authority of Director to
make grants and enter into contracts, was repealed by Pub. L. 92-
255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
1975.
A prior section 211 of Pub. L. 92-255, title II, Mar. 21, 1972,
86 Stat. 69, which provided for appointment of an acting Director
until position was initially filled, was repealed by Pub. L. 92-
255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30,
1975.
-End-
-CITE-
21 USC Secs. 1121 to 1123 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1121 to 1123. Repealed.
-MISC1-
Secs. 1121 to 1123. Repealed. Pub. L. 92-255, title I, Sec. 104,
Mar. 21, 1972, 86 Stat. 67.
Section 1121, Pub. L. 92-255, title II, Sec. 211, Mar. 21, 1972,
86 Stat. 69, provided for appointment of an acting Director until
position was initially filled.
Section 1122, Pub. L. 92-255, title II, Sec. 213, Mar. 21, 1972,
86 Stat. 69, prohibited Director or any other Federal officer from
waiving or disregarding any limitation or requirement prescribed by
law with respect to any Federal program or activity.
Section 1123, Pub. L. 92-255, title II, Sec. 214, Mar. 21, 1972,
86 Stat. 70, provided for authorization of appropriations, and
fiscal year availability of such appropriations.
EFFECTIVE DATE OF REPEAL
Section 1104 of this title, prior to repeal by section 4(c)(1) of
Pub. L. 94-237, provided for repeal of sections effective June 30,
1975.
-End-
-CITE-
21 USC Secs. 1131 to 1133 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1131 to 1133. Omitted
-COD-
CODIFICATION
Section 1131, Pub. L. 92-255, title II, Sec. 221, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which related to
functions of Director concerning planning and policies, was omitted
in the general revision of title II of Pub. L. 92-255 by Pub. L. 96-
181, Sec. 4, Jan. 2, 1980, 93 Stat. 1309. See section 1111 of this
title.
A prior section 1131, Pub. L. 92-255, title II, Sec. 221, Mar.
21, 1972, 86 Stat. 70, which provided for establishment of overall
planning and policy and the criteria to achieve objectives and
priorities for all Federal drug abuse prevention functions, was
repealed by Pub. L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86
Stat. 67, eff. June 30, 1975.
Section 1132, Pub. L. 92-255, title II, Sec. 222, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 243, which authorized
President to designate Director to represent United States in
negotiations concerning drug abuse functions, was omitted in the
general revision of title II of Pub. L. 92-255 by Pub. L. 96-181,
Sec. 4, Jan. 2, 1980, 93 Stat. 1309. See section 1112 of this
title.
A prior section 1132, Pub. L. 92-255, title II, Sec. 222, Mar.
21, 1972, 86 Stat. 71, which provided for review and modification
of implementation plans and budget requests, was repealed by Pub.
L. 92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June
30, 1975.
Section 1133, Pub. L. 92-255, title II, Sec. 223, as added Pub.
L. 94-237, Sec. 4(b), Mar. 19, 1976, 90 Stat. 244, which related to
an annual report to President and Congress on activities of Office
of Drug Abuse Policy, was omitted in the general revision of title
II of Pub. L. 92-255 by Pub. L. 96-181, Sec. 4, Jan. 2, 1980, 93
Stat. 1309. See section 1117 of this title.
A prior section 1133, Pub. L. 92-255, title II, Sec. 223, Mar.
21, 1972, 86 Stat. 71, which provided for establishment and the
objectives of a Special Fund, was repealed by Pub. L. 92-255, title
I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
-End-
-CITE-
21 USC Secs. 1134 to 1143 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1134 to 1143. Repealed.
-MISC1-
Secs. 1134 to 1143. Repealed. Pub. L. 92-255, title I, Sec. 104,
Mar. 21, 1972, 86 Stat. 67.
Section 1134, Pub. L. 92-255, title II, Sec. 224, Mar. 21, 1972,
86 Stat. 71, provided for establishment of research and development
programs by Director.
Section 1135, Pub. L. 92-255, title II, Sec. 225, Mar. 21, 1972,
86 Stat. 72, provided for establishment of a single non-Federal
share requirement.
Section 1136, Pub. L. 92-255, title II, Sec. 226, Mar. 21, 1972,
86 Stat. 72, provided for Director to make drug prevention function
recommendations to President and to consult with responsible
agencies with respect to drug prevention functions.
Section 1137, Pub. L. 92-255, title II, Sec. 227, Mar. 21, 1972,
86 Stat. 72, provided for resolution of agency conflicts with
regard to drug prevention functions.
Section 1138, Pub. L. 92-255, title II, Sec. 228, Mar. 21, 1972,
86 Stat. 72, provided for communications and liaison with respect
to drug prevention functions by one of Assistant Directors.
Section 1139, Pub. L. 92-255, title II, Sec. 229, Mar. 21, 1972,
86 Stat. 72, provided, with respect to drug prevention functions,
coordination of State and local governments, availability of
information and other services and activities.
Section 1140, Pub. L. 92-255, title II, Sec. 230, Mar. 21, 1972,
86 Stat. 73, provided for a management oversight review by a
Federal officer.
Section 1141, Pub. L. 92-255, title II, Sec. 231, Mar. 21, 1972,
86 Stat. 73, provided for convening of a council of officials of
Federal agencies responsible for drug prevention functions by
Director.
Section 1142, Pub. L. 92-255, title II, Sec. 232, Mar. 21, 1972,
86 Stat. 73, provided for designation of the Director to represent
Government in international negotiations related to drug prevention
functions.
Section 1143, Pub. L. 92-255, title II, Sec. 233, Mar. 21, 1972,
86 Stat. 73, provided for an annual written report to the President
by the Director.
EFFECTIVE DATE OF REPEAL
Section 1104 of this title, prior to repeal by section 4(c)(1) of
Pub. L. 94-237, provided for repeal of sections effective June 30,
1975.
-End-
-CITE-
21 USC Secs. 1151 to 1155 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER II - DRUG ABUSE POLICY COORDINATION
-HEAD-
Secs. 1151 to 1155. Repealed.
-MISC1-
Secs. 1151 to 1155. Repealed. Pub. L. 92-255, title I, Sec. 104,
Mar. 21, 1972, 86 Stat. 67.
Section 1151, Pub. L. 92-255, title II, Sec. 251, Mar. 21, 1972,
86 Stat. 74, provided for establishment of a National Advisory
Council for Drug Abuse Prevention.
Section 1152, Pub. L. 92-255, title II, Sec. 252, Mar. 21, 1972,
86 Stat. 74, provided for membership of National Advisory Council
for Drug Abuse Prevention.
Section 1153, Pub. L. 92-255, title II, Sec. 253, Mar. 21, 1972,
86 Stat. 74, provided for designation of chairman of National
Advisory Council for Drug Abuse Prevention.
Section 1154, Pub. L. 92-255, title II, Sec. 254, Mar. 21, 1972,
86 Stat. 74, provided for compensation and expenses for members of
National Advisory Council for Drug Abuse Prevention.
Section 1155, Pub. L. 92-255, title II, Sec. 255, Mar. 21, 1972,
86 Stat. 74, set forth functions of National Advisory Council for
Drug Abuse Prevention.
EFFECTIVE DATE OF REPEAL
Section 1104 of this title, prior to repeal by section 4(c)(1) of
Pub. L. 94-237, provided for repeal of sections effective June 30,
1975.
-End-
-CITE-
21 USC SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY
-HEAD-
SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY
-End-
-CITE-
21 USC Secs. 1161 to 1165 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER III - NATIONAL DRUG ABUSE STRATEGY
-HEAD-
Secs. 1161 to 1165. Repealed.
-MISC1-
Secs. 1161 to 1165. Repealed. Pub. L. 98-509, title III, Sec.
301(d), Oct. 19, 1984, 98 Stat. 2364.
Section 1161, Pub. L. 92-255, title III, Sec. 301, Mar. 21, 1972,
86 Stat. 74, related to development, and initial promulgation no
later than nine months after Mar. 21, 1972, by the President, of a
national drug abuse strategy.
Section 1162, Pub. L. 92-255, title III, Sec. 302, Mar. 21, 1972,
86 Stat. 75; Pub. L. 94-237, Sec. 4(c)(2), (3), (5)(A), Mar. 19,
1976, 90 Stat. 244; Pub. L. 96-181, Sec. 5(a), (b), Jan. 2, 1980,
93 Stat. 1311; Pub. L. 97-35, title IX, Sec. 973(b), Aug. 13, 1981,
95 Stat. 598, related to establishment and membership of a Strategy
Council, interim provision of services by the Director, and review
and commentary on the national drug abuse strategy by those Federal
officials participating in its preparation.
Section 1163, Pub. L. 92-255, title III, Sec. 303, Mar. 21, 1972,
86 Stat. 75, related to contents of the national drug abuse
strategy.
Section 1164, Pub. L. 92-255, title III, Sec. 304, Mar. 21, 1972,
86 Stat. 75; Pub. L. 94-237, Sec. 4(c)(4), Mar. 19, 1976, 90 Stat.
244; Pub. L. 96-181, Sec. 5(c), Jan. 2, 1980, 93 Stat. 1311,
related to preparation of the national drug abuse strategy.
Section 1165, Pub. L. 92-255, title III, Sec. 305, Mar. 21, 1972,
86 Stat. 75; Pub. L. 94-237, Sec. 5, Mar. 19, 1976, 90 Stat. 244;
Pub. L. 98-24, Sec. 4(a), Apr. 26, 1983, 97 Stat. 183, related to
submission by the President to the Congress, on or before Aug. 1,
1984, and every two years thereafter, of a written report
describing the national drug abuse strategy, and prescribed the
contents of the report.
-End-
-CITE-
21 USC SUBCHAPTER IV - OTHER FEDERAL PROGRAMS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-End-
-CITE-
21 USC Sec. 1171 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1171. Drug abuse prevention function appropriations
-STATUTE-
Any request for appropriations by a department or agency of the
Government submitted after March 21, 1972, shall specify (1) on a
line item basis, that part of the appropriations which the
department or agency is requesting to carry out its drug abuse
prevention functions, and (2) the authorization of the
appropriations requested to carry out each of its drug abuse
prevention functions.
-SOURCE-
(Pub. L. 92-255, title IV, Sec. 404, Mar. 21, 1972, 86 Stat. 77.)
-End-
-CITE-
21 USC Sec. 1172 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1172. Repealed.
-MISC1-
Sec. 1172. Repealed. Pub. L. 98-24, Sec. 2(c)(2), Apr. 26, 1983, 97
Stat. 182.
Section, Pub. L. 92-255, title IV, Sec. 405, Mar. 21, 1972, 86
Stat. 77; Pub. L. 95-461, Sec. 3(b), Oct. 14, 1978, 92 Stat. 1268;
Pub. L. 97-35, title IX, Sec. 973(c)(1), Aug. 13, 1981, 95 Stat.
598, required that the Secretary of Health and Human Services make
periodic reports to the Congress and to the President on drug abuse
in the United States. See section 290aa-4 of Title 42, The Public
Health and Welfare.
-End-
-CITE-
21 USC Sec. 1173 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1173. Transferred and Omitted
-COD-
CODIFICATION
Section, Pub. L. 92-255, title IV, Sec. 406, Mar. 21, 1972, 86
Stat. 78; Pub. L. 97-35, title IX, Sec. 968(a), Aug. 13, 1981, 95
Stat. 595, established additional drug abuse prevention functions
of the Secretary of Health and Human Services.
Subsec. (a) was redesignated as section 503(e) of the Public
Health Service Act by Pub. L. 98-24, Sec. 2(b)(5), Apr. 26, 1983,
97 Stat. 177, and was classified to former section 290aa-2(e) of
Title 42, The Public Health and Welfare, prior to repeal by Pub. L.
102-321, title I, Sec. 101(b), July 10, 1992, 106 Stat. 331.
Subsec. (b), which directed that the Secretary carry out his
functions under subsec. (a) of this section through the National
Institute on Drug Abuse, was omitted.
-End-
-CITE-
21 USC Secs. 1174, 1175 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Secs. 1174, 1175. Transferred
-COD-
CODIFICATION
Section 1174, Pub. L. 92-255, title IV, Sec. 407, Mar. 21, 1972,
86 Stat. 78; Pub. L. 94-237, Sec. 6(a), Mar. 19, 1976, 90 Stat.
244; Pub. L. 94-581, title I, Sec. 111(c)(2), Oct. 21, 1976, 90
Stat. 2852, which prohibited discrimination against drug abusers by
general hospitals, was redesignated section 526 of the Public
Health Service Act by Pub. L. 98-24, Sec. 2(b)(16)(B), Apr. 26,
1983, 97 Stat. 182, and is classified to section 290ee-2 of Title
42, The Public Health and Welfare.
Section 1175, Pub. L. 92-255, title IV, Sec. 408, Mar. 21, 1972,
86 Stat. 79; Pub. L. 93-282, title III, Sec. 303(a), (b), May 14,
1974, 88 Stat. 137, 138; Pub. L. 94-237, Sec. 4(c)(5)(A), (B), Mar.
19, 1976, 90 Stat. 244; Pub. L. 94-581, title I, Sec. 111(c)(3),
Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97-35, title IX, Sec. 973(d),
Aug. 13, 1981, 95 Stat. 598, which related to confidentiality of
patients' records, was redesignated section 527 of the Public
Health Service Act by Pub. L. 98-24, Sec. 2(b)(16)(B), Apr. 26,
1983, 97 Stat. 182, and is classified to section 290ee-3 of Title
42.
-End-
-CITE-
21 USC Sec. 1176 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1176. Repealed.
-MISC1-
Sec. 1176. Repealed. Pub. L. 97-35, title IX, Sec. 969(a), Aug. 13,
1981, 95 Stat. 595.
Section, Pub. L. 92-255, title IV, Sec. 409, Mar. 21, 1972, 86
Stat. 80; Pub. L. 94-237, Secs. 7, 8(a), 9(a)(1), (b)(1), Mar. 19,
1976, 90 Stat. 245-247; Pub. L. 94-371, Sec. 10(a)(1), (b)(1), July
26, 1976, 90 Stat. 1040; Pub. L. 95-83, title III, Sec. 311(a)(3),
Aug. 1, 1977, 91 Stat. 397; Pub. L. 95-461, Secs. 2(a), 4, Oct. 14,
1978, 92 Stat. 1268, 1269; Pub. L. 96-79, title I, Sec. 115(j)(2),
Oct. 4, 1979, 93 Stat. 610; Pub. L. 96-181, Sec. 6, Jan. 2, 1980,
93 Stat. 1311, provided for creation and funding through the fiscal
year ending Sept. 30, 1981, of a program of formula grants to
States to operate State plans for the establishment, conduct, and
coordination of projects for the development of more effective drug
abuse prevention functions in the States and for the evaluation of
such programs.
-End-
-CITE-
21 USC Sec. 1177 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1177. Special project grants and contracts
-STATUTE-
(a) Scope of programs; priority
The Secretary (!1) acting through the National Institute on Drug
Abuse, may make grants to and enter into contracts with individuals
and public and private nonprofit entities -
(1) to provide training seminars, educational programs, and
technical assistance for the development, demonstration, and
evaluation of drug abuse prevention, treatment, and
rehabilitation programs; and
(2) to conduct demonstration and evaluation projects, with a
high priority on prevention and early intervention projects and
on identifying new and more effective drug abuse prevention,
treatment, and rehabilitation programs.
In the implementation of his authority under this section, the
Secretary shall accord a high priority to applications for grants
or contracts for primary prevention programs. For purposes of the
preceding sentence, primary prevention programs include programs
designed to discourage persons from beginning drug abuse. To the
extent that appropriations authorized under this section are used
to fund treatment services, the Secretary shall not limit such
funding to treatment for opiate abuse, but shall also provide
support for treatment for non-opiate drug abuse including polydrug
abuse. Furthermore, nothing shall prevent the use of funds provided
under this section for programs and projects aimed at the
prevention, treatment, and rehabilitation of alcohol abuse and
alcoholism as well as drug abuse.
(b) Authorization of appropriations
There are authorized to be appropriated $25,000,000 for the
fiscal year ending June 30, 1972; $65,000,000 for the fiscal year
ending June 30, 1973; $100,000,000 for the fiscal year ending June
30, 1974; $160,000,000 for each of the fiscal years ending June 30,
1975 and June 30, 1976; $40,000,000 for the period July 1, 1976,
through September 30, 1976; and $160,000,000 for each of the fiscal
years ending September 30, 1977, and September 30, 1978, to carry
out this section. For the fiscal year ending September 30, 1979,
there is authorized to be appropriated (1) $153,000,000 for grants
and contracts under paragraphs (3) and (6) of subsection (a) of
this section for drug abuse treatment programs, and (2) $24,000,000
for grants and contracts under such subsection for other programs
and activities. For grants and contracts under paragraphs (3) and
(6) of subsection (a) of this section for drug abuse treatment
programs there is authorized to be appropriated $149,000,000 for
the fiscal year ending September 30, 1980, and $155,000,000 for the
fiscal year ending September 30, 1981; and for grants and contracts
under such subsection for other programs and activities there is
authorized to be appropriated $20,000,000 for the fiscal year
ending September 30, 1980, and $30,000,000 for the fiscal year
ending September 30, 1981. Of the funds appropriated under the
preceding sentence for the fiscal year ending September 30, 1980,
at least 7 percent of the funds shall be obligated for grants and
contracts for primary prevention and intervention programs designed
to discourage individuals, particularly those in high risk
populations, from abusing drugs; and of the funds appropriated
under the preceding sentence for the next fiscal year, at least 10
percent of the funds shall be obligated for such grants and
contracts. For carrying out the purposes of this section, there are
authorized to be appropriated $15,000,000 for the fiscal year
ending September 30, 1982. Of the funds appropriated under the
preceding sentence, at least 25 per centum of the funds shall be
obligated for grants and contracts for primary prevention and
intervention programs designed to discourage individuals,
particularly individuals in high risk populations, from abusing
drugs.
(c) Coordination of applications for programs in a State;
precedence restriction; project evaluation; application approval;
criteria; proposed performance standards or research protocol
(1) In carrying out this section, the Secretary shall require
coordination of all applications for programs in a State and shall
not give precedence to public agencies over private agencies,
institutions, and organizations, or to State agencies over local
agencies.
(2) Each applicant within a State, upon filing its application
with the Secretary for a grant or contract under this section,
shall submit a copy of its application for review by the State
agency (if any) responsible for the administration of drug abuse
prevention activities. Such State agency shall be given not more
than thirty days from the date of receipt of the application to
submit to the Secretary, in writing, an evaluation of the project
set forth in the application. Such evaluation shall include
comments on the relationship of the project to other projects
pending and approved and to any State comprehensive plan for
treatment and prevention of drug abuse. The State shall furnish the
applicant a copy of any such evaluation. A State if it so desires
may, in writing, waive its rights under this paragraph.
(3) Approval of any application for a grant or contract under
this section by the Secretary, including the earmarking of
financial assistance for a program or project, may be granted only
if the application substantially meets a set of criteria that -
(A) provide that the activities and services for which
assistance under this section is sought will be substantially
administered by or under the supervision of the applicant;
(B) provide for such methods of administration as are necessary
for the proper and efficient operation of such programs or
projects; and
(C) provide for such fiscal control and fund accounting
procedures as may be necessary to assure proper disbursement of
and accounting for Federal funds paid to the applicant.
(4) Each applicant within a State, upon filing its application
with the Secretary for a grant or contract to provide treatment or
rehabilitation services shall provide a proposed performance
standard or standards, to measure, or research protocol to
determine, the effectiveness of such treatment or rehabilitation
program or project.
(d) Programs and projects aimed at underserved groups;
encouragement and special consideration given to applications
The Secretary shall encourage the submission of and give special
consideration to applications under this section to programs and
projects aimed at underserved populations such as racial and ethnic
minorities, Native Americans (including Native Hawaiians and Native
American Pacific Islanders), youth, the elderly, women, handicapped
individuals, and families of drug abusers.
(e) Payments; advances; reimbursement; installments
Payment under grants or contracts under this section may be made
in advance or by way of reimbursement and in such installments as
the Secretary may determine.
(f) Prevention and treatment services
Projects and programs for which grants and contracts are made or
entered into under this section shall, in the case of prevention
and treatment services, seek to (1) be responsive to special
requirements of handicapped individuals in receiving such services;
(2) whenever possible, be community based, insure care of good
quality in general community care facilities and under health
insurance plans, and be integrated with, and provide for the active
participation of, a wide range of public and nongovernmental
agencies, organizations, institutions, and individuals; (3) where a
substantial number of the individuals in the population served by
the project or program are of limited English-speaking ability (A)
utilize the services of outreach workers fluent in the language
spoken by a predominant number of such individuals and develop a
plan and make arrangements responsive to the needs of such
population for providing services to the extent practicable in the
language and cultural context most appropriate to such individuals,
and (B) identify an individual who is fluent both in that language
and English and whose responsibilities shall include providing
guidance to the individuals of limited English-speaking ability and
to appropriate staff members with respect to cultural sensitivities
and bridging linguistic and cultural differences; and (4) where
appropriate, utilize existing community resources (including
community mental health centers).
(g) Authorization by chief executive officer of State required;
maximum amount and duration of grants
(1) No grant may be made under this section to a State or to any
entity within the government of a State unless the grant
application has been duly authorized by the chief executive officer
of such State.
(2) No grant or contract may be made under this section for a
period in excess of five years.
(3)(A) The amount of any grant or contract under this section may
not exceed 100 per centum of the cost of carrying out the grant or
contract in the first fiscal year for which the grant or contract
is made under this section, 80 per centum of such cost in the
second fiscal year for which the grant or contract is made under
this section, 70 per centum of such cost in the third fiscal year
for which the grant or contract is made under this section, and 60
per centum of such cost in each of the fourth and fifth fiscal
years for which the grant or contract is made under this section.
(B) For purposes of this paragraph, no grant or contract shall be
considered to have been made under this section for a fiscal year
ending before September 30, 1981.
-SOURCE-
(Pub. L. 92-255, title IV, Sec. 410, Mar. 21, 1972, 86 Stat. 82;
Pub. L. 94-237, Secs. 10, 11, Mar. 19, 1976, 90 Stat. 247; Pub. L.
94-371, Sec. 10(c)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95-
461, Secs. 2(b), 6(a), Oct. 14, 1978, 92 Stat. 1268, 1270; Pub. L.
96-181, Sec. 7, Jan. 2, 1980, 93 Stat. 1312; Pub. L. 97-35, title
IX, Sec. 970(b)-(f), Aug. 13, 1981, 95 Stat. 596, 597; Pub. L. 98-
24, Sec. 5(a)(3), Apr. 26, 1983, 97 Stat. 183.)
-MISC1-
AMENDMENTS
1983 - Subsec. (d). Pub. L. 98-24 substituted "Native Americans
(including Native Hawaiians and Native American Pacific Islanders)"
for "native Americans".
1981 - Subsec. (a). Pub. L. 97-35, Sec. 970(b), substituted "The
Secretary acting through the National Institute on Drug Abuse, may
make grants to and enter into contracts with individuals, and
public and private nonprofit entities" for "The Secretary shall" in
introductory provision preceding par. (1), reduced the enumeration
of authorized activities of the Secretary from six paragraphs to
two paragraphs thereby eliminating provisions relating to the
recruitment, training, and employment of participants in treatment
programs, the establishment, conduct, and evaluation of drug abuse
prevention, treatment, and rehabilitation programs, the development
of methods to deal with drug abuse in particular areas, the
improvement of drug maintenance techniques or programs, and the
establishment, conduct, and evaluation of drug abuse prevention and
treatment programs, and inserted provision that nothing shall
prevent the use of funds provided under this section for programs
and projects aimed at the prevention, treatment, and rehabilitation
of alcohol abuse and alcoholism as well as drug abuse.
Subsec. (b). Pub. L. 97-35, Sec. 970(c), inserted provisions
relating to fiscal year ending Sept. 30, 1982.
Subsec. (c)(2). Pub. L. 97-35, Sec. 970(d)(1), substituted
"responsible for the administration of drug abuse prevention
activities" for "designated or established under section 1176 of
this title" and "any State" for "the State" and struck out
reference to drug abuse under section 1176 of this title.
Subsec. (c)(3)(D). Pub. L. 97-35, Sec. 970(d)(2), struck out
subpar. (D) which had provided that approval of a grant or contract
could be granted only if the application provided for reasonable
assurances that Federal funds made available under this section
would be used to supplement and increase the level of State, local,
and other non-Federal funds that would in the absence of such
Federal funds be made available for the programs described in this
section and would not supplant State or local funds.
Subsec. (d). Pub. L. 97-35, Sec. 970(e), inserted applicability
to racial and ethnic minorities, handicapped, native Americans, and
families of drug abusers.
Subsec. (g). Pub. L. 97-35, Sec. 970(f), added subsec. (g).
1980 - Subsec. (a)(1). Pub. L. 96-181, Sec. 7(a)(1), substituted
"development, demonstration and evaluation of drug abuse" for
"development of drug abuse".
Subsec. (a)(5). Pub. L. 96-181, Sec. 7(a)(2), substituted "drug
maintenance and detoxification techniques" for "drug maintenance
techniques".
Subsec. (a)(6). Pub. L. 96-181, Sec. 7(a)(3), in provisions
relating to evaluation of drug abuse prevention and treatment
programs, inserted provision that such evaluation be with
particular emphasis on replicating effective prevention and
treatment programs.
Subsec. (b). Pub. L. 96-181, Sec. 7(b), inserted authorization of
appropriations for grants and contracts under pars. (3) and (6) of
subsec. (a) and for other programs and activities for fiscal years
ending Sept. 30, 1980, and Sept. 30, 1981, and required certain
percentage of appropriated funds to be obligated for grants and
contracts for primary prevention and intervention programs designed
to discourage individuals from abusing drugs.
Subsec. (d). Pub. L. 96-181, Sec. 7(c), inserted provisions for
special consideration to applications for programs and projects for
prevention and treatment of drug abuse and drug dependence by
elderly.
Subsec. (f). Pub. L. 96-181, Sec. 7(d), added subsec. (f).
1978 - Subsec. (a). Pub. L. 95-461, Sec. 6(a), inserted provision
requiring Secretary to act through National Institute on Drug Abuse
in making special project grants.
Subsec. (b). Pub. L. 95-461, Sec. 2(b), inserted provisions
authorizing appropriations for fiscal year ending Sept. 30, 1979.
1976 - Subsec. (a). Pub. L. 94-237, Sec. 10(a), inserted
provisions which authorized Secretary to give a high priority to
applications for grants and contracts for primary prevention
programs, and set forth programs included within primary prevention
programs and scope of Secretary's funding authority.
Subsec. (b). Pub. L. 94-237, Sec. 11, substituted "$160,000,000
for each of the fiscal years ending June 30, 1975 and June 30,
1976; $40,000,000 for the period July 1, 1976, through September
30, 1976; and $160,000,000 for each of the fiscal years ending
September 30, 1977, and September 30, 1978," for "and $160,000,000
for the fiscal year ending June 30, 1975,".
Subsec. (c)(4). Pub. L. 94-237, Sec. 10(b), added par. (4).
Subsecs. (d), (e). Pub. L. 94-371 added subsec. (d) and
redesignated former subsec. (d) as (e).
EFFECTIVE DATE OF 1976 AMENDMENT
Section 10(c)(2) of Pub. L. 94-371 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply with
respect to applications submitted for grants or contracts under
section 410 of the Drug Abuse Office and Treatment Act of 1972
[this section] after June 30, 1976."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 1178 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1178. Records and audit
-STATUTE-
(a) Assistance records; contents
Each recipient of assistance under section 1177 of this title
pursuant to grants or contracts entered into under other than
competitive bidding procedures shall keep such records as the
Secretary shall prescribe, including records which fully disclose
the amount and disposition by such recipient of the proceeds of
such grant or contract, the total cost of the project or
undertaking in connection with which such grant or contract is
given or used, and the amount of that portion of the cost of the
project or undertaking supplied by other sources, and such other
records as will facilitate an effective audit.
(b) Access to pertinent information for audit and examination
The Secretary and Comptroller General of the United States, or
any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any books, documents,
papers, and records of such recipients that are pertinent to such
grants or contracts.
-SOURCE-
(Pub. L. 92-255, title IV, Sec. 411, Mar. 21, 1972, 86 Stat. 83;
Pub. L. 97-35, title IX, Sec. 971, Aug. 13, 1981, 95 Stat. 597.)
-MISC1-
AMENDMENTS
1981 - Subsec. (a). Pub. L. 97-35 struck out reference to section
1176 of this title.
-End-
-CITE-
21 USC Sec. 1179 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1179. National Drug Abuse Training Center
-STATUTE-
(a) Establishment; functions; general policies; transfer of
supervision
The Director shall establish a National Drug Abuse Training
Center (hereinafter in this section referred to as the "Center") to
develop, conduct, and support a full range of training programs
relating to drug abuse prevention functions. The Director shall
consult with the National Advisory Council for Drug Abuse
Prevention regarding the general policies of the Center. The
Director may supervise the operation of the Center initially, but
shall transfer the supervision of the operation of the Center to
the National Institute on Drug Abuse not later than December 31,
1974.
(b) Activities and material
The Center shall conduct or arrange for training programs,
seminars, meetings, conferences, and other related activities,
including the furnishing of training and educational materials for
use by others.
(c) Persons eligible for services and facilities
The services and facilities of the Center shall, in accordance
with regulations prescribed by the Director, be available to (1)
Federal, State, and local governmental officials, and their
respective staffs, (2) medical and paramedical personnel, and
educators, and (3) other persons, including drug dependent persons,
requiring training or education in drug abuse prevention.
(d) Authorization of appropriations; fiscal year availability
(1) For the purpose of carrying out this section, there are
authorized to be appropriated $1,000,000 for the fiscal year ending
June 30, 1972, $3,000,000 for the fiscal year ending June 30, 1973,
$5,000,000 for the fiscal year ending June 30, 1974, and $6,000,000
for the fiscal year ending June 30, 1975.
(2) Sums appropriated under this subsection shall remain
available for obligation or expenditure in the fiscal year for
which appropriated and in the fiscal year next following.
-SOURCE-
(Pub. L. 92-255, title IV, Sec. 412, Mar. 21, 1972, 86 Stat. 84.)
-MISC1-
NATIONAL ADVISORY COUNCIL FOR DRUG ABUSE PREVENTION
Section 1151 of this title, which established the National
Advisory Council for Drug Abuse Prevention, was repealed by Pub. L.
92-255, title I, Sec. 104, Mar. 21, 1972, 86 Stat. 67, eff. June
30, 1975.
-End-
-CITE-
21 USC Sec. 1180 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1180. Transferred
-COD-
CODIFICATION
Section, Pub. L. 92-255, title IV, Sec. 413, Mar. 21, 1972, 86
Stat. 84; Pub. L. 96-181, Sec. 8(a), (b)(1), Jan. 2, 1980, 93 Stat.
1313, 1314; Pub. L. 97-35, title IX, Sec. 973(e), Aug. 13, 1981, 95
Stat. 598, which related to drug abuse among government and other
employees, was redesignated section 525 of the Public Health
Service Act by Pub. L. 98-24, Sec. 2(b)(16)(A), Apr. 26, 1983, 97
Stat. 182, and is classified to section 290ee-1 of Title 42, The
Public Health and Welfare.
-End-
-CITE-
21 USC Sec. 1181 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER IV - OTHER FEDERAL PROGRAMS
-HEAD-
Sec. 1181. Contract authority
-STATUTE-
The authority of the Secretary to enter into contracts under this
subchapter and subchapter V of this chapter shall be effective for
any fiscal year only to such extent or in such amounts as are
provided in advance by appropriation Acts.
-SOURCE-
(Pub. L. 92-255, title IV, Sec. 414, as added Pub. L. 96-181, Sec.
9(a), Jan. 2, 1980, 93 Stat. 1314.)
-REFTEXT-
REFERENCES IN TEXT
Subchapter V of this chapter, referred to in text, consisted of
sections 501 to 504 of title V of Pub. L. 92-255, Mar. 21, 1972, 86
Stat. 85, which were classified to sections 1191 to 1194 of this
title, respectively. Sections 501 to 503 were made part of the
Public Health Service Act by Pub. L. 98-24, Sec. 2(b)(4), (11),
(15), Apr. 26, 1983, 97 Stat. 177, 180, 181, and were transferred
to former sections 290aa-2, 290ee, and 290cc, respectively, of
Title 42, The Public Health and Welfare. Section 290aa-2 of Title
42 was repealed by Pub. L. 102-321, Sec. 101(b). Section 290cc of
Title 42 was repealed by Pub. L. 102-321, Sec. 123(c). Section
290ee of Title 42 was omitted in the general revision of part D of
subchapter III-A of chapter 6A of Title 42 by Pub. L. 102-321.
Section 1194 of this title was repealed by Pub. L. 98-24, Sec.
2(c)(2).
-End-
-CITE-
21 USC SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE
-HEAD-
SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE
-End-
-CITE-
21 USC Secs. 1191 to 1193 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE
-HEAD-
Secs. 1191 to 1193. Transferred
-COD-
CODIFICATION
Section 1191, Pub. L. 92-255, title V, Sec. 501, Mar. 21, 1972,
86 Stat. 85; Pub. L. 93-282, title II, Sec. 204, May 14, 1974, 88
Stat. 136; Pub. L. 94-237, Sec. 12(a), Mar. 19, 1976, 90 Stat. 247;
Pub. L. 96-181, Sec. 10, Jan. 2, 1980, 93 Stat. 1314; Pub. L. 97-
35, title IX, Sec. 973(f), Aug. 13, 1981, 95 Stat. 598, which
established the National Institute on Drug Abuse, was redesignated
section 503(a)-(d) of the Public Health Service Act by Pub. L. 98-
24, Sec. 2(b)(4), Apr. 26, 1983, 97 Stat. 177, transferred to
section 290aa-2(a)-(d) of Title 42, The Public Health and Welfare,
and subsequently repealed.
Section 1192, Pub. L. 92-255, title V, Sec. 502, as added Pub. L.
94-237, Sec. 12(b)(1), Mar. 19, 1976, 90 Stat. 247; amended Pub. L.
95-461, Sec. 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96-181, Sec.
11, Jan. 2, 1980, 93 Stat. 1315, which related to the coordination,
information, assistance, and assignment activities and services,
was redesignated section 524 of the Public Health Service Act by
Pub. L. 98-24, Sec. 2(b)(15), Apr. 26, 1983, 97 Stat. 181,
transferred to section 290ee of Title 42, and subsequently omitted.
Section 1193, Pub. L. 92-255, title V, Sec. 503, as added Pub. L.
94-237, Sec. 13(a), Mar. 19, 1976, 90 Stat. 248; amended Pub. L. 95-
461, Sec. 2(c), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 96-181, Sec.
12, Jan. 2, 1980, 93 Stat. 1315; Pub. L. 97-35, title IX, Sec.
972(a), (b), Aug. 13, 1981, 95 Stat. 597, which related to research
and development functions, was redesignated section 515 of the
Public Health Service Act by Pub. L. 98-24, Sec. 2(b)(11), Apr. 26,
1983, 97 Stat. 180, transferred to section 290cc of Title 42, and
subsequently repealed.
-MISC1-
PRIOR PROVISIONS
A prior section 502 of Pub. L. 92-255, Mar. 21, 1972, 86 Stat.
85, amended section 217 of the Public Health Service Act by adding
subsec. (e) [section 218(e) of Title 42, The Public Health and
Welfare], and amended section 266 of the Community Mental Health
Centers Act [former section 2688t of Title 42].
-End-
-CITE-
21 USC Sec. 1194 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 16 - DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
SUBCHAPTER V - NATIONAL INSTITUTE ON DRUG ABUSE
-HEAD-
Sec. 1194. Repealed.
-MISC1-
Sec. 1194. Repealed. Pub. L. 98-24, Sec. 2(c)(2), Apr. 26, 1983, 97
Stat. 182.
Section, Pub. L. 92-255, title V, Sec. 504, as added Pub. L. 95-
461, Sec. 6(b)(1), Oct. 14, 1978, 92 Stat. 1270, related to review
by the Secretary of programs and activities. See section 290aa-5 of
Title 42, The Public Health and Welfare.
-End-
-CITE-
21 USC CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY
-HEAD-
CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY
-End-
-CITE-
21 USC Secs. 1201 to 1204 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 17 - NATIONAL DRUG ENFORCEMENT POLICY
-HEAD-
Secs. 1201 to 1204. Repealed.
-MISC1-
Secs. 1201 to 1204. Repealed. Pub. L. 100-690, title I, Sec.
1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.
Section 1201, Pub. L. 98-473, title II, Sec. 1302, Oct. 12, 1984,
98 Stat. 2168, set forth Congressional findings and declaration of
purpose relating to illegal flow of narcotics into United States.
Section 1202, Pub. L. 98-473, title II, Sec. 1303, Oct. 12, 1984,
98 Stat. 2168, established National Drug Enforcement Policy Board.
Section 1203, Pub. L. 98-473, title II, Sec. 1304, Oct. 12, 1984,
98 Stat. 2169, delineated responsibilities and functions of
National Drug Enforcement Policy Board.
Section 1204, Pub. L. 98-473, title II, Sec. 1305, Oct. 12, 1984,
98 Stat. 2170, related to reports to Congress.
EFFECTIVE DATE OF REPEAL
Section 1007(a)(3) of Pub. L. 100-690 provided that the repeal of
this chapter is effective on 30th day after first Director of
National Drug Control Policy is confirmed by the Senate.
SHORT TITLE
Pub. L. 98-473, title II, Sec. 1301, Oct. 12, 1984, 98 Stat.
2168, which provided that chapter XIII (Secs. 1301 to 1307) of
title II of Pub. L. 98-473 was to be cited as the National
Narcotics Act of 1984, was repealed by Pub. L. 100-690, title I,
Sec. 1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.
-EXEC-
EXECUTIVE ORDER NO. 12590
Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, as amended by
Ex. Ord. No. 13284, Sec. 11, Jan. 23, 2003, 68 F.R. 4076, provided
for the establishment of a National Drug Policy Board, designated
its membership and functions, and authorized coordinating groups.
-End-
-CITE-
21 USC CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON
ALCOHOL AND DRUG ABUSE PREVENTION 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
PREVENTION
-HEAD-
CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
PREVENTION
-End-
-CITE-
21 USC Secs. 1301 to 1308 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 18 - PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE
PREVENTION
-HEAD-
Secs. 1301 to 1308. Omitted
-COD-
CODIFICATION
Section 1301, Pub. L. 99-570, title VIII, Sec. 8002, Oct. 27,
1986, 100 Stat. 3207-161 related to the establishment of the
President's Media Commission on Alcohol and Drug Abuse Prevention.
Section 1302, Pub. L. 99-570, title VIII, Sec. 8003, Oct. 27,
1986, 100 Stat. 3207-161, related to duties of the Commission.
Section 1303, Pub. L. 99-570, title VIII, Sec. 8004, Oct. 27,
1986, 100 Stat. 3207-162, required appointment of members of the
Commission within 30 days after Oct. 27, 1986.
Section 1304, Pub. L. 99-570, title VIII, Sec. 8005, Oct. 27,
1986, 100 Stat. 3207-162, related to meetings.
Section 1305, Pub. L. 99-570, title VIII, Sec. 8006, Oct. 27,
1986, 100 Stat. 3207-163, related to employment of Director and
staff and the procurement of the services of experts and
consultants.
Section 1306, Pub. L. 99-570, title VIII, Sec. 8007, Oct. 27,
1986, 100 Stat. 3207-163, related to the powers of the Commission.
Section 1307, Pub. L. 99-570, title VIII, Sec. 8008, Oct. 27,
1986, 100 Stat. 3207-163, related to an annual report to Congress.
Section 1308, Pub. L. 99-570, title VIII, Sec. 8009, Oct. 27,
1986, 100 Stat. 3207-163, related to termination of Commission
three years after the date on which members of the Commission were
first appointed unless the President extended the authority of the
Commission by Executive order.
-MISC1-
SHORT TITLE
Pub. L. 99-570, title VIII, Sec. 8001, Oct. 27, 1986, 100 Stat.
3207-161, provided that title VIII of Pub. L. 99-570, which enacted
this chapter, was to be cited as the "President's Media Commission
on Alcohol and Drug Abuse Prevention Act".
-End-
-CITE-
21 USC CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS
-HEAD-
CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS
-MISC1-
Sec.
1401. Pesticide monitoring and enforcement information.
1402. Foreign pesticide information.
1403. Pesticide analytical methods.
-End-
-CITE-
21 USC Sec. 1401 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS
-HEAD-
Sec. 1401. Pesticide monitoring and enforcement information
-STATUTE-
(a) Data management systems
(1) Not later than 480 days after August 23, 1988, the Secretary
of Health and Human Services shall place in effect computerized
data management systems for the Food and Drug Administration under
which the Administration will -
(A) record, summarize, and evaluate the results of its program
for monitoring food products for pesticide residues,
(B) identify gaps in its pesticide monitoring program in the
monitoring of (i) pesticides, (ii) food products, and (iii) food
from specific countries and from domestic sources,
(C) detect trends in the presence of pesticide residues in food
products and identify public health problems emerging from the
occurrence of pesticide residues in food products,
(D) focus its testing resources for monitoring pesticide
residues in food on detecting those residues which pose a public
health concern,
(E) prepare summaries of the information listed in subsection
(b) of this section, and
(F) provide information to assist the Environmental Protection
Agency in carrying out its responsibilities under the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et
seq.] and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
et seq.].
(2) As soon as practicable, the Secretary of Health and Human
Services shall develop a means to enable the computerized data
management systems placed into effect under paragraph (1) to make
the summary described in subsection (c) of this section.
(3)(A) Paragraph (1) does not limit the authority of the Food and
Drug Administration to -
(i) use the computerized data management systems placed in
effect under paragraph (1), or
(ii) develop additional data management systems,
to facilitate the regulation of any substance or product covered
under the requirements of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 301 et seq.].
(B) In placing into effect the computerized data management
systems under paragraph (1) and in carrying out paragraph (2), the
Secretary shall comply with applicable regulations governing
computer system design and procurement.
(b) Information
The Food and Drug Administration shall use the computerized data
management systems placed into effect under subsection (a)(1) of
this section to prepare a summary of -
(1) information on -
(A) the types of imported and domestically produced food
products analyzed for compliance with the requirements of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]
regarding the presence of pesticide residues,
(B) the number of samples of each such food product analyzed
for such compliance by country of origin,
(C) the pesticide residues which may be detected using the
testing methods employed,
(D) the pesticide residues in such food detected and the
levels detected,
(E) the compliance status of each sample of such food tested
and the violation rate for each country-product combination,
and
(F) the action taken with respect to each sample of such food
found to be in violation of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] and its ultimate
disposition, and
(2) information on -
(A) the country of origin of each imported food product
referred to in paragraph (1)(A), and
(B) the United States district of entry for each such
imported food product.
(c) Volume data
The Food and Drug Administration shall use the computerized data
management systems placed into effect under subsection (a)(1) of
this section to summarize the volume of each type of food product
subject to the requirements of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.] which is imported into the United
States and which has an entry value which exceeds an amount
established by the Secretary of Health and Human Services. The
summary shall be made by country of origin and district of entry.
Information with respect to volumes of food products to be included
in the summary shall, to the extent feasible, be obtained from data
bases of other Federal agencies.
(d) Compilation
Not later than 90 days after the expiration of 1 year after the
data management systems are placed into effect under subsection (a)
of this section and annually thereafter, the Secretary of Health
and Human Services shall compile a summary of the information
described in subsection (b) of this section with respect to the
previous year. When the Food and Drug Administration is able to
make summaries under subsection (c) of this section, the Secretary
shall include in the compilation under the preceding sentence a
compilation of the information described in subsection (c) of this
section. Compilations under this subsection shall be made available
to Federal and State agencies and other interested persons.
-SOURCE-
(Pub. L. 100-418, title IV, Sec. 4702, Aug. 23, 1988, 102 Stat.
1412.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in subsec. (a)(1)(F), is act June 25, 1947, ch. 125, as amended
generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
classified generally to subchapter II (Sec. 136 et seq.) of chapter
6 of Title 7, Agriculture. For complete classification of this Act
to the Code, see Short Title note set out under section 136 of
Title 7 and Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(a) to (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
-MISC1-
SHORT TITLE
Section 4701 of Pub. L. 100-418 provided that: "This subtitle
[subtitle G (Secs. 4701-4704) of title IV of Pub. L. 100-418,
enacting this chapter] may be cited as the 'Pesticide Monitoring
Improvements Act of 1988'."
IMPORTED MEAT, POULTRY PRODUCTS, EGGS, AND EGG PRODUCTS
Section 4506 of Pub. L. 100-418 provided that:
"(a) Report. - Not later than 90 days after the date of the
enactment of this Act [Aug. 23, 1988], the Secretary of Agriculture
shall submit a report to Congress -
"(1) specifying the planned distribution, in fiscal years 1988
and 1989, of the resources of the Department of Agriculture
available for sampling imported covered products to ensure
compliance with the requirements of the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21
U.S.C. 1031 et seq.) that govern the level of residues of
pesticides, drugs, and other products permitted in or on such
products;
"(2) describing current methods used by the Secretary to
enforce the requirements of such Acts with respect to the level
of residues of pesticides, drugs, and other products permitted in
or on such products;
"(3) responding to the audit report of the Inspector General of
the Department of Agriculture, Number 38002 - 2 - hy, dated
January 14, 1987;
"(4) providing a summary with respect to the importation of
covered products during fiscal years 1987 and 1988 that specifies
-
"(A) the number of samples of each such product taken during
each such fiscal year in carrying out the requirements
described in paragraph (1); and
"(B) for each violation of such requirements during each such
fiscal year -
"(i) the covered products with respect to which such
violation occurred;
"(ii) the residue in or on such product in violation of
such requirements;
"(iii) the country exporting such product;
"(iv) the actions taken in response to such violation and
the reasons for such actions; and
"(v) the level of testing conducted by the countries
exporting such products;
"(5) describing any research conducted by the Secretary to
develop improved methods to detect residues subject to such
requirements in or on covered products; and
"(6) providing any recommendations the Secretary considers
appropriate for legislation to add or modify penalties for
violations of laws, regulations, and other enforcement
requirements governing the level of residues that are permitted
in or on imported covered products.
"(b) Revision. - Not later than November 15, 1989, the Secretary
of Agriculture shall revise, as necessary, the report prepared
under subsection (a) and submit the revision to Congress.
"(c) Definition. - As used in this section, the term 'covered
products' means meat, poultry products, eggs, and egg products."
-End-
-CITE-
21 USC Sec. 1402 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS
-HEAD-
Sec. 1402. Foreign pesticide information
-STATUTE-
(a) Cooperative agreements
The Secretary of Health and Human Services shall enter into
cooperative agreements with the governments of the countries which
are the major sources of food imports into the United States
subject to pesticide residue monitoring by the Food and Drug
Administration for the purpose of improving the ability of the Food
and Drug Administration to assure compliance with the pesticide
tolerance requirements of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 301 et seq.] with regard to imported food.
(b) Information activities
(1) The cooperative agreements entered into under subsection (a)
of this section with governments of foreign countries shall specify
the action to be taken by the parties to the agreements to
accomplish the purpose described in subsection (a) of this section,
including the means by which the governments of the foreign
countries will provide to the Secretary of Health and Human
Services current information identifying each of the pesticides
used in the production, transportation, and storage of food
products imported from production regions of such countries into
the United States.
(2) In the case of a foreign country with which the Secretary is
unable to enter into an agreement under subsection (a) of this
section or for which the information provided under paragraph (1)
is insufficient to assure an effective pesticide monitoring
program, the Secretary shall, to the extent practicable, obtain the
information described in paragraph (1) with respect to such country
from other Federal or international agencies or private sources.
(3) The Secretary of Health and Human Services shall assure that
appropriate offices of the Food and Drug Administration which are
engaged in the monitoring of imported food for pesticide residues
receive the information obtained under paragraph (1) or (2).
(4) The Secretary of Health and Human Services shall make
available any information obtained under paragraph (1) or (2) to
State agencies engaged in the monitoring of imported food for
pesticide residues other than information obtained from private
sources the disclosure of which to such agencies is restricted.
(c) Coordination with other agencies
The Secretary of Health and Human Services shall -
(1) notify in writing the Department of Agriculture, the
Environmental Protection Agency, and the Department of State at
the initiation of negotiations with a foreign country to develop
a cooperative agreement under subsection (a) of this section; and
(2) coordinate the activities of the Department of Health and
Human Services with the activities of those departments and
agencies, as appropriate, during the course of such negotiations.
(d) Report
Not later than one year after August 23, 1988, the Secretary of
Health and Human Services shall report to the Committee on
Agriculture, Nutrition, and Forestry and the Committee on Labor and
Human Resources of the Senate and the House of Representatives on
the activities undertaken by the Secretary to implement this
section. The report shall be made available to appropriate Federal
and State agencies and to interested persons.
-SOURCE-
(Pub. L. 100-418, title IV, Sec. 4703, Aug. 23, 1988, 102 Stat.
1413.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
-CHANGE-
CHANGE OF NAME
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
-End-
-CITE-
21 USC Sec. 1403 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 19 - PESTICIDE MONITORING IMPROVEMENTS
-HEAD-
Sec. 1403. Pesticide analytical methods
-STATUTE-
The Secretary of Health and Human Services shall, in consultation
with the Administrator of the Environmental Protection Agency -
(1) develop a detailed long-range plan and timetable for
research that is necessary for the development of and validation
of -
(A) new and improved analytical methods capable of detecting
at one time the presence of multiple pesticide residues in
food, and
(B) rapid pesticide analytical methods, and
(2) conduct a review to determine whether the use of rapid
pesticide analytical methods by the Secretary would enable the
Secretary to improve the cost-effectiveness of monitoring and
enforcement activities under the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.], including increasing the number of
pesticide residues which can be detected and the number of tests
for pesticide residues which can be conducted in a cost-effective
manner.
The Secretary shall report the plan developed under paragraph (1),
the resources necessary to carry out the research described in such
paragraph, recommendations for the implementation of such research,
and the result of the review conducted under paragraph (2) not
later than the expiration of 240 days after August 23, 1988, to the
Committee on Agriculture, Nutrition, and Forestry and the Committee
on Labor and Human Resources of the Senate and the House of
Representatives.
-SOURCE-
(Pub. L. 100-418, title IV, Sec. 4704, Aug. 23, 1988, 102 Stat.
1414.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in text, is
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to chapter 9 (Sec. 301 et seq.) of this title.
For complete classification of this Act to the Code, see section
301 of this title and Tables.
-CHANGE-
CHANGE OF NAME
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
-End-
-CITE-
21 USC CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
-HEAD-
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
-MISC1-
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
Sec.
1501, 1502. Repealed.
1502a. Transferred.
1503 to 1505. Repealed.
1505a. Annual report on development and deployment of
narcotics detection technologies.
1506 to 1509. Repealed.
SUBCHAPTER II - DRUG-FREE COMMUNITIES
1521. Findings.
1522. Purposes.
1523. Definitions.
1524. Authorization of appropriations.
PART A - DRUG-FREE COMMUNITIES SUPPORT PROGRAM
1531. Establishment of drug-free communities support
program.
1532. Program authorization.
1533. Information collection and dissemination with respect
to grant recipients.
1534. Technical assistance and training.
1535. Supplemental grants for coalition mentoring
activities.
PART B - ADVISORY COMMISSION
1541. Establishment of Advisory Commission.
1542. Duties.
1543. Membership.
1544. Compensation.
1545. Terms of office.
1546. Meetings.
1547. Staff.
1548. Termination.
-End-
-CITE-
21 USC SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL
POLICY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-End-
-CITE-
21 USC Secs. 1501, 1502 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Secs. 1501, 1502. Repealed.
-MISC1-
Secs. 1501, 1502. Repealed. Pub. L. 100-690, title I, Sec. 1009,
Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
2(b), June 27, 1997, 111 Stat. 234.
Section 1501, Pub. L. 100-690, title I, Sec. 1002, Nov. 18, 1988,
102 Stat. 4181, established Office of National Drug Control Policy
in Executive Office of President. See section 1702 of this title.
Section 1502, Pub. L. 100-690, title I, Sec. 1003, Nov. 18, 1988,
102 Stat. 4182; Pub. L. 103-322, title IX, Secs. 90201, 90202,
90207, Sept. 13, 1994, 108 Stat. 1990, 1991, 1995, related to
appointment and duties of Director, Deputy Directors, and Associate
Director of Office of National Drug Control Policy. See section
1703 of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
690, as amended, which was formerly classified to section 1506 of
this title.
SHORT TITLE OF 1997 AMENDMENT
Pub. L. 105-20, Sec. 1, June 27, 1997, 111 Stat. 224, provided
that: "This Act [enacting subchapter II of this chapter and
amending former sections 1504, 1506 to 1508 of this title, section
2291 of Title 22, Foreign Relations and Intercourse, and provisions
set out as notes under this section] may be cited as the 'Drug-Free
Communities Act of 1997'."
SHORT TITLE
Section 1 of Pub. L. 100-690 provided that: "This Act [see Tables
for classification] may be cited as the 'Anti-Drug Abuse Act of
1988'."
Section 1001 of Pub. L. 100-690 provided that: "This subtitle
[subtitle A (Secs. 1001-1048) of title I of Pub. L. 100-690,
enacting this chapter, amending section 1115 of this title,
sections 5312, 5314, and 5315 of Title 5, Government Organization
and Employees, section 1105 of Title 31, Money and Finance, and
section 402 of Title 50, War and National Defense, repealing
sections 1103, 1111 to 1114, 1116, and 1201 to 1204 of this title,
enacting provisions set out as notes under sections 1201 and 1501
of this title, and repealing provisions set out as notes under
section 1201 of this title may be cited as the 'National Narcotics
Leadership Act of 1988'."
REFERENCES TO SUBTITLE A OF PUB. L. 100-690
Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111 Stat. 234, provided
that: "Each reference in Federal law to subtitle A of the Anti-Drug
Abuse Act of 1988 [see section 1001 of Pub. L. 100-690, set out
above], with the exception of section 1001 of such subtitle, in any
provision of law that is in effect on the day before the date of
enactment of this Act [June 27, 1997] shall be deemed to be a
reference to chapter 1 of the National Narcotics Leadership Act of
1988 [chapter 1 of subtitle A (Secs. 1002-1012) of title I of Pub.
L. 100-690, see Tables for classification] (as so designated by
this section)."
-End-
-CITE-
21 USC Sec. 1502a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1502a. Transferred
-COD-
CODIFICATION
Section, Pub. L. 100-690, title I, Sec. 1003A, as added Pub. L.
101-510, div. A, title X, Sec. 1011, Nov. 5, 1990, 104 Stat. 1633,
and amended, which related to the Counter-Drug Technology
Assessment Center, was renumbered section 1008 of Pub. L. 100-690
by Pub. L. 103-322, title IX, Sec. 90204(c)(2), (3), Sept. 13,
1994, 108 Stat. 1994, and transferred to former section 1505 of
this title.
-End-
-CITE-
21 USC Secs. 1503 to 1505 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Secs. 1503 to 1505. Repealed.
-MISC1-
Secs. 1503 to 1505. Repealed. Pub. L. 100-690, title I, Sec. 1009,
Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
2(b), June 27, 1997, 111 Stat. 234.
Section 1503, Pub. L. 100-690, title I, Sec. 1004, Nov. 18, 1988,
102 Stat. 4184, related to coordination between Office of National
Drug Control Policy and executive branch departments and agencies.
See section 1704 of this title.
Section 1504, Pub. L. 100-690, title I, Sec. 1005, Nov. 18, 1988,
102 Stat. 4185; Pub. L. 103-322, title IX, Sec. 90203, Sept. 13,
1994, 108 Stat. 1991; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
Stat. 234, related to annual development and submission of National
Drug Control Strategy by President to Congress. See section 1705 of
this title.
Section 1505, Pub. L. 100-690, title I, Sec. 1008, formerly Sec.
1003A, as added Pub. L. 101-510, div. A, title X, Sec. 1011, Nov.
5, 1990, 104 Stat. 1633; renumbered Sec. 1008 and amended Pub. L.
103-322, title IX, Sec. 90204(a), (b), (c)(2), (3), Sept. 13, 1994,
108 Stat. 1993, 1994, established Counter-Drug Technology
Assessment Center within Office of National Drug Control Policy.
See section 1707 of this title.
A prior section 1505, Pub. L. 100-690, title I, Sec. 1008, Nov.
18, 1988, 102 Stat. 4188, provided for an executive reorganization
study and report to Congress and the President no later than Jan.
15, 1990, prior to repeal by Pub. L. 103-322, Sec. 90204(c)(1).
EFFECTIVE DATE OF REPEAL
Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
690, as amended, which was formerly classified to section 1506 of
this title.
-End-
-CITE-
21 USC Sec. 1505a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1505a. Annual report on development and deployment of
narcotics detection technologies
-STATUTE-
(a) Report requirement
Not later than December 1st of each year, the Director of the
Office of National Drug Control Policy shall submit to Congress and
the President a report on the development and deployment of
narcotics detection technologies by Federal agencies. Each such
report shall be prepared in consultation with the Secretary of
Defense, the Secretary of State, the Secretary of Homeland
Security, and the Secretary of the Treasury.
(b) Matters to be included
Each report under subsection (a) of this section shall include -
(1) a description of each project implemented by a Federal
agency relating to the development or deployment of narcotics
detection technology;
(2) the agency responsible for each project described in
paragraph (1);
(3) the amount of funds obligated or expended to carry out each
project described in paragraph (1) during the fiscal year in
which the report is submitted or during any fiscal year preceding
the fiscal year in which the report is submitted;
(4) the amount of funds estimated to be obligated or expended
for each project described in paragraph (1) during any fiscal
year after the fiscal year in which the report is submitted to
Congress; and
(5) a detailed timeline for implementation of each project
described in paragraph (1).
-SOURCE-
(Pub. L. 105-85, div. A, title X, Sec. 1034, Nov. 18, 1997, 111
Stat. 1884; Pub. L. 107-296, title XVII, Sec. 1704(e)(10), Nov. 25,
2002, 116 Stat. 2315.)
-COD-
CODIFICATION
Section was enacted as part of the National Defense Authorization
Act for Fiscal Year 1998, and not as part of the National Narcotics
Leadership Act of 1988 which comprises this chapter.
-MISC1-
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-296 substituted "of Homeland
Security" for "of Transportation".
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107-296 effective on the date of transfer of
the Coast Guard to the Department of Homeland Security, see section
1704(g) of Pub. L. 107-296, set out as a note under section 101 of
Title 10, Armed Forces.
-End-
-CITE-
21 USC Secs. 1506 to 1508 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Secs. 1506 to 1508. Repealed.
-MISC1-
Secs. 1506 to 1508. Repealed. Pub. L. 100-690, title I, Sec. 1009,
Nov. 18, 1988, 102 Stat. 4188, as amended by Pub. L. 105-20, Sec.
2(b), June 27, 1997, 111 Stat. 234.
Section 1506, Pub. L. 100-690, title I, Sec. 1009, Nov. 18, 1988,
102 Stat. 4188; Pub. L. 103-322, title IX, Sec. 90208(a), Sept. 13,
1994, 108 Stat. 1995; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
Stat. 234, repealed this subchapter, and the amendments made by
this subchapter, except for section 1007, effective Sept. 30, 1997.
Section 1507, Pub. L. 100-690, title I, Sec. 1010, Nov. 18, 1988,
102 Stat. 4188; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111 Stat.
234, defined terms for purposes of this subchapter. See section
1701 of this title.
Section 1508, Pub. L. 100-690, title I, Sec. 1011, Nov. 18, 1988,
102 Stat. 4189; Pub. L. 103-322, title IX, Sec. 90206, Sept. 13,
1994, 108 Stat. 1995; Pub. L. 105-20, Sec. 2(b), June 27, 1997, 111
Stat. 234, authorized appropriations to carry out this subchapter.
See section 1711 of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective Sept. 30, 1997, see section 1009 of Pub. L. 100-
690, as amended, which was formerly classified to section 1506 of
this title.
-End-
-CITE-
21 USC Sec. 1509 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER I - OFFICE OF NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1509. Repealed.
-MISC1-
Sec. 1509. Repealed. Pub. L. 109-469, title XI, Sec. 1101(b), Dec.
29, 2006, 120 Stat. 3539.
Section, Pub. L. 100-690, title VI, Sec. 6073, Nov. 18, 1988, 102
Stat. 4323; Pub. L. 101-647, title XX, Sec. 2001(b), Nov. 29, 1990,
104 Stat. 4854; Pub. L. 102-393, title VI, Sec. 638(c), Oct. 6,
1992, 106 Stat. 1788; Pub. L. 103-322, title IX, Sec. 90205(a),
(d), Sept. 13, 1994, 108 Stat. 1994, 1995; Pub. L. 105-277, div. C,
title VII, Sec. 712, Oct. 21, 1998, 112 Stat. 2681-692, related to
establishment of Special Forfeiture Fund.
-End-
-CITE-
21 USC SUBCHAPTER II - DRUG-FREE COMMUNITIES 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-HEAD-
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-End-
-CITE-
21 USC Sec. 1521 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-HEAD-
Sec. 1521. Findings
-STATUTE-
Congress finds the following:
(1) Substance abuse among youth has more than doubled in the 5-
year period preceding 1996, with substantial increases in the
use of marijuana, inhalants, cocaine, methamphetamine, LSD, and
heroin.
(2) The most dramatic increases in substance abuse has occurred
among 13- and 14-year-olds.
(3) Casual or periodic substance abuse by youth today will
contribute to hard core or chronic substance abuse by the next
generation of adults.
(4) Substance abuse is at the core of other problems, such as
rising violent teenage and violent gang crime, increasing health
care costs, HIV infections, teenage pregnancy, high school
dropouts, and lower economic productivity.
(5) Increases in substance abuse among youth are due in large
part to an erosion of understanding by youth of the high risks
associated with substance abuse, and to the softening of peer
norms against use.
(6)(A) Substance abuse is a preventable behavior and a
treatable disease; and
(B)(i) during the 13-year period beginning with 1979, monthly
use of illegal drugs among youth 12 to 17 years of age declined
by over 70 percent; and
(ii) data suggests that if parents would simply talk to their
children regularly about the dangers of substance abuse, use
among youth could be expected to decline by as much as 30
percent.
(7) Community anti-drug coalitions throughout the United States
are successfully developing and implementing comprehensive, long-
term strategies to reduce substance abuse among youth on a
sustained basis.
(8) Intergovernmental cooperation and coordination through
national, State, and local or tribal leadership and partnerships
are critical to facilitate the reduction of substance abuse among
youth in communities throughout the United States.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1021, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 224.)
-MISC1-
FIVE-YEAR EXTENSION OF DRUG-FREE COMMUNITIES SUPPORT PROGRAM
Pub. L. 107-82, Sec. 1(a), Dec. 14, 2001, 115 Stat. 814, provided
that: "Congress makes the following findings:
"(1) In the next 15 years, the youth population in the United
States will grow by 21 percent, adding 6,500,000 youth to the
population of the United States. Even if drug use rates remain
constant, there will be a huge surge in drug-related problems,
such as academic failure, drug-related violence, and HIV
incidence, simply due to this population increase.
"(2) According to the 1994-1996 National Household Survey, 60
percent of students age 12 to 17 who frequently cut classes and
who reported delinquent behavior in the past 6 months used
marijuana 52 days or more in the previous year.
"(3) The 2000 Washington Kids Count survey conducted by the
University of Washington reported that students whose peers have
little or no involvement with drinking and drugs have higher math
and reading scores than students whose peers had low level
drinking or drug use.
"(4) Substance abuse prevention works. In 1999, only 10 percent
of teens saw marijuana users as popular, compared to 17 percent
in 1998 and 19 percent in 1997. The rate of past-month use of any
drug among 12- to 17-year-olds declined 26 percent between 1997
and 1999. Marijuana use for sixth through eighth graders is at
the lowest point in 5 years, as is use of cocaine, inhalants, and
hallucinogens.
"(5) Community Anti-Drug Coalitions throughout the United
States are successfully developing and implementing
comprehensive, long-term strategies to reduce substance abuse
among youth on a sustained basis. For example:
"(A) The Boston Coalition brought college and university
presidents together to create the Cooperative Agreement on
Underage Drinking. This agreement represents the first
coordinated effort of Boston's many institutions of higher
education to address issues such as binge drinking, underage
drinking, and changing the norms surrounding alcohol abuse that
exist on college and university campuses.
"(B) In 2000, the Coalition for a Drug-Free Greater
Cincinnati surveyed more than 47,000 local students in grades 7
through 12. The results provided evidence that the Coalition's
initiatives are working. For the first time in a decade, teen
drug use in Greater Cincinnati appears to be leveling off. The
data collected from the survey has served as a tool to
strengthen relationships between schools and communities, as
well as facilitate the growth of anti-drug coalitions in
communities where such coalitions had not existed.
"(C) The Miami Coalition used a three-part strategy to
decrease the percentage of high school seniors who reported
using marijuana at least once during the most recent 30-day
period. The development of a media strategy, the creation of a
network of prevention agencies, and discussions with high
school students about the dangers of marijuana all contributed
to a decrease in the percentage of seniors who reported using
marijuana from over 22 percent in 1995 to 9 percent in 1997.
The Miami Coalition was able to achieve these results while
national rates of marijuana use were increasing.
"(D) The Nashville Prevention Partnership worked with
elementary and middle school children in an attempt to
influence them toward positive life goals and discourage them
from using substances. The Partnership targeted an area in East
Nashville and created after school programs, mentoring
opportunities, attendance initiatives, and safe passages to and
from school. Attendance and test scores increased as a result
of the program.
"(E) At a youth-led town meeting sponsored by the Bering
Strait Community Partnership in Nome, Alaska, youth identified
a need for a safe, substance-free space. With help from a
variety of community partners, the Partnership staff and youth
members created the Java Hut, a substance-free coffeehouse
designed for youth. The Java Hut is helping to change norms in
the community by providing a fun, youth-friendly atmosphere and
activities that are not centered around alcohol or marijuana.
"(F) Portland's Regional Drug Initiative (RDI) has promoted
the establishment of drug-free workplaces among the city's
large and small employers. Over 3,000 employers have attended
an RDI training session, and of those, 92 percent have
instituted drug-free workplace policies. As a result, there has
been a 5.5 percent decrease in positive workplace drug tests.
"(G) San Antonio Fighting Back worked to increase the age at
which youth first used illegal substances. Research suggests
that the later the age of first use, the lower the risk that a
young person will become a regular substance abuser. As a
result, the age of first illegal drug use increased from 9.4
years in 1992 to 13.5 years in 1997.
"(H) In 1990, multiple data sources confirmed a trend of
increased alcohol use by teenagers in the Troy community. Using
its 'multiple strategies over multiple sectors' approach, the
Troy Coalition worked with parents, physicians, students,
coaches, and others to address this problem from several
angles. As a result, the rate of twelfth grade students who had
consumed alcohol in the past month decreased from 62.1 percent
to 53.3 percent between 1991 and 1998, and the rate of eighth
grade students decreased from 26.3 percent to 17.4 percent. The
Troy Coalition believes that this decline represents not only a
change in behavior on the part of students, but also a change
in the norms of the community.
"(6) Despite these successes, drug use continues to be a
serious problem facing communities across the United States. For
example:
"(A) According to the Pulse Check: Trends in Drug Abuse Mid-
Year 2000 report -
"(i) crack and powder cocaine remains the most serious drug
problem;
"(ii) marijuana remains the most widely available illicit
drug, and its potency is on the rise;
"(iii) treatment sources report an increase in admissions
with marijuana as the primary drug of abuse - and adolescents
outnumber other age groups entering treatment for marijuana;
"(iv) 80 percent of Pulse Check sources reported increased
availability of club drugs, with ecstasy (MDMA) and ketamine
the most widely cited club drugs and seven sources reporting
that powder cocaine is being used as a club drug by young
adults;
"(v) ecstasy abuse and trafficking is expanding, no longer
confined to the 'rave' scene;
"(vi) the sale and use of club drugs has grown from
nightclubs and raves to high schools, the streets,
neighborhoods, open venues, and younger ages;
"(vii) ecstasy users often are unknowingly purchasing
adulterated tablets or some other substance sold as MDMA; and
"(viii) along with reports of increased heroin snorting as
a route of administration for initiates, there is also an
increase in injecting initiates and the negative health
consequences associated with injection (for example,
increases in HIV/AIDS and Hepatitis C) suggesting that there
is a generational forgetting of the dangers of injection of
the drug.
"(B) The 2000 Parent's Resource Institute for Drug Education
study reported that 23.6 percent of children in the sixth
through twelfth grades used illicit drugs in the past year. The
same study found that monthly usage among this group was 15.3
percent.
"(C) According to the 2000 Monitoring the Future study, the
use of ecstasy among eighth graders increased from 1.7 percent
in 1999 to 3.1 percent in 2000, among tenth graders from 4.4
percent to 5.4 percent, and from 5.6 percent to 8.2 percent
among twelfth graders.
"(D) A 1999 Mellman Group study found that -
"(i) 56 percent of the population in the United States
believed that drug use was increasing in 1999;
"(ii) 92 percent of the population viewed illegal drug use
as a serious problem in the United States; and
"(iii) 73 percent of the population viewed illegal drug use
as a serious problem in their communities.
"(7) According to the 2001 report of the National Center on
Addiction and Substance Abuse at Columbia University entitled
'Shoveling Up: The Impact of Substance Abuse on State Budgets',
using the most conservative assumption, in 1998 States spent
$77,900,000,000 to shovel up the wreckage of substance abuse,
only $3,000,000,000 to prevent and treat the problem and
$433,000,000 for alcohol and tobacco regulation and compliance.
This $77,900,000,000 burden was distributed as follows:
"(A) $30,700,000,000 in the justice system (77 percent of
justice spending).
"(B) $16,500,000,000 in education costs (10 percent of
education spending).
"(C) $15,200,000,000 in health costs (25 percent of health
spending).
"(D) $7,700,000,000 in child and family assistance (32
percent of child and family assistance spending).
"(E) $5,900,000,000 in mental health and developmental
disabilities (31 percent of mental health spending).
"(F) $1,500,000,000 in public safety (26 percent of public
safety spending) and $400,000,000 for the state workforce.
"(8) Intergovernmental cooperation and coordination through
national, State, and local or tribal leadership and partnerships
are critical to facilitate the reduction of substance abuse among
youth in communities across the United States.
"(9) Substance abuse is perceived as a much greater problem
nationally than at the community level. According to a 2001 study
sponsored by The Pew Charitable Trusts, between 1994 and 2000 -
"(A) there was a 43 percent increase in the percentage of
Americans who felt progress was being made in the war on drugs
at the community level;
"(B) only 9 percent of Americans say drug abuse is a 'crisis'
in their neighborhood, compared to 27 percent who say this
about the nation; and
"(C) the percentage of those who felt we lost ground in the
war on drugs on a community level fell by more than a quarter,
from 51 percent in 1994 to 37 percent in 2000."
AUTHORIZATION FOR NATIONAL COMMUNITY ANTIDRUG COALITION INSTITUTE
Pub. L. 107-82, Sec. 4, Dec. 14, 2001, 115 Stat. 821, as amended
by Pub. L. 109-469, title VIII, Sec. 805, Dec. 29, 2006, 120 Stat.
3535, provided that:
"(a) In General. - The Director of the Office of National Drug
Control Policy shall, using amounts authorized to be appropriated
by subsection (d), make a directed grant to Community Anti-Drug
Coalitions of America to provide for the continuation of the
National Community Anti-drug Coalition Institute.
"(b) Use of Grant Amount. - The organization receiving the grant
under subsection (a) shall establish a National Community Antidrug
Coalition Institute to -
"(1) provide education, training, and technical assistance for
coalition leaders and community teams, with emphasis on the
development of coalitions serving economically disadvantaged
areas;
"(2) develop and disseminate evaluation tools, mechanisms, and
measures to better assess and document coalition performance
measures and outcomes; and
"(3) bridge the gap between research and practice by
translating knowledge from research into practical information.
"(c) Authorization of Appropriations. - There is authorized to be
appropriated for purposes of activities under this section,
including the grant under subsection (a), amounts as follows:
"(1) For each of fiscal years 2002 and 2003, $2,000,000.
"(2) For each of fiscal years 2004 and 2005, $1,000,000.
"(3) For each of fiscal years 2006 and 2007, $750,000.
"(4) For each of the fiscal years 2008 through 2012,
$2,000,000."
PROHIBITION AGAINST DUPLICATION OF EFFORT
Pub. L. 107-82, Sec. 5, Dec. 14, 2001, 115 Stat. 821, provided
that: "The Director of the Office of National Drug Control Policy
shall ensure that the same or similar activities are not carried
out, through the use of funds for administrative costs provided
under subchapter II [probably means chapter 2] of the National
Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.) or funds
provided under section 4 of this Act [set out as a note above], by
more than one recipient of such funds."
-End-
-CITE-
21 USC Sec. 1522 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-HEAD-
Sec. 1522. Purposes
-STATUTE-
The purposes of this subchapter are -
(1) to reduce substance abuse among youth in communities
throughout the United States, and over time, to reduce substance
abuse among adults;
(2) to strengthen collaboration among communities, the Federal
Government, and State, local, and tribal governments;
(3) to enhance intergovernmental cooperation and coordination
on the issue of substance abuse among youth;
(4) to serve as a catalyst for increased citizen participation
and greater collaboration among all sectors and organizations of
a community that first demonstrates a long-term commitment to
reducing substance abuse among youth;
(5) to rechannel resources from the fiscal year 1998 Federal
drug control budget to provide technical assistance, guidance,
and financial support to communities that demonstrate a long-term
commitment in reducing substance abuse among youth;
(6) to disseminate to communities timely information regarding
the state-of-the-art practices and initiatives that have proven
to be effective in reducing substance abuse among youth;
(7) to enhance, not supplant, local community initiatives for
reducing substance abuse among youth; and
(8) to encourage the creation of and support for community anti-
drug coalitions throughout the United States.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1022, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 225.)
-End-
-CITE-
21 USC Sec. 1523 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-HEAD-
Sec. 1523. Definitions
-STATUTE-
In this subchapter:
(1) Administrator
The term "Administrator" means the Administrator appointed by
the Director under section 1531(c) of this title.
(2) Advisory Commission
The term "Advisory Commission" means the Advisory Commission
established under section 1541 of this title.
(3) Community
The term "community" shall have the meaning provided that term
by the Administrator, in consultation with the Advisory
Commission.
(4) Director
The term "Director" means the Director of the Office of
National Drug Control Policy.
(5) Eligible coalition
The term "eligible coalition" means a coalition that meets the
applicable criteria under section 1532(a) of this title.
(6) Grant recipient
The term "grant recipient" means the recipient of a grant award
under section 1532 of this title.
(7) Nonprofit organization
The term "nonprofit organization" means an organization
described under section 501(c)(3) of title 26 that is exempt from
taxation under section 501(a) of title 26.
(8) Program
The term "Program" means the program established under section
1531(a) of this title.
(9) Substance abuse
The term "substance abuse" means -
(A) the illegal use or abuse of drugs, including substances
listed in schedules I through V of section 812 of this title;
(B) the abuse of inhalants; or
(C) the use of alcohol, tobacco, or other related product as
such use is prohibited by State or local law.
(10) Youth
The term "youth" shall have the meaning provided that term by
the Administrator, in consultation with the Advisory Commission.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1023, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 225.)
-REFTEXT-
REFERENCES IN TEXT
Section 812 of this title, referred to in par. (9)(A), was in the
original "section 112 of the Controlled Substances Act (21 U.S.C.
812)", and was translated as reading "section 202", meaning section
202 of Pub. L. 91-513, to reflect the probable intent of Congress,
because Pub. L. 91-513 does not contain a section 112.
-End-
-CITE-
21 USC Sec. 1524 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
-HEAD-
Sec. 1524. Authorization of appropriations
-STATUTE-
(a) In general
There are authorized to be appropriated to the Office of National
Drug Control Policy to carry out this subchapter -
(1) $10,000,000 for fiscal year 1998;
(2) $20,000,000 for fiscal year 1999;
(3) $30,000,000 for fiscal year 2000;
(4) $40,000,000 for fiscal year 2001;
(5) $50,600,000 for fiscal year 2002;
(6) $60,000,000 for fiscal year 2003;
(7) $70,000,000 for fiscal year 2004;
(8) $80,000,000 for fiscal year 2005;
(9) $90,000,000 for fiscal year 2006;
(10) $99,000,000 for fiscal year 2007;
(11) $109,000,000 for fiscal year 2008;
(12) $114,000,000 for fiscal year 2009;
(13) $119,000,000 for fiscal year 2010;
(14) $124,000,000 for fiscal year 2011; and
(15) $129,000,000 for fiscal year 2012.
(b) Administrative costs
(1) Limitation
Not more than 3 percent of the funds appropriated for this
subchapter may be used by the Office of National Drug Control
Policy to pay for administrative costs associated with their
responsibilities under the subchapter.
(2) Designated agency
The agency delegated to carry out this program under section
1531(d) of this title may use up to 5 percent of the funds
allocated for grants under this subchapter for administrative
costs associated with carrying out the program.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1024, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 226; amended Pub. L. 107-82, Sec.
1(b), (c), Dec. 14, 2001, 115 Stat. 817; Pub. L. 109-469, title
VIII, Sec. 801, Dec. 29, 2006, 120 Stat. 3535.)
-COD-
CODIFICATION
Pub. L. 109-469, Sec. 801, which directed amendment of section
1024 of the "Drug-Free Communities Act of 1997", was executed to
this section, which is section 1024 of the National Narcotics
Leadership Act of 1988, to reflect the probable intent of Congress.
See 2006 Amendment notes below.
-MISC1-
AMENDMENTS
2006 - Subsec. (a)(11) to (15). Pub. L. 109-469, Sec. 801(a),
added pars. (11) to (15). See Codification note above.
Subsec. (b). Pub. L. 109-469, Sec. 801(b), amended subsec. (b)
generally. See Codification note above. Prior to amendment, text
read as follows: "Not more than the following percentages of the
amounts authorized under subsection (a) of this section may be used
to pay administrative costs:
"(1) 10 percent for fiscal year 1998.
"(2) 6 percent for fiscal year 1999.
"(3) 4 percent for fiscal year 2000.
"(4) 3 percent for fiscal year 2001.
"(5) 6 percent for each of fiscal years 2002 through 2007."
2001 - Subsec. (a)(5) to (10). Pub. L. 107-82, Sec. 1(b), added
pars. (5) to (10) and struck out former par. (5) which read as
follows: "$43,500,000 for fiscal year 2002."
Subsec. (b)(5). Pub. L. 107-82, Sec. 1(c), added par. (5) and
struck out former par. (5) which read as follows: "3 percent for
fiscal year 2002."
-End-
-CITE-
21 USC Part A - Drug-Free Communities Support Program 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
PART A - DRUG-FREE COMMUNITIES SUPPORT PROGRAM
-End-
-CITE-
21 USC Sec. 1531 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
Sec. 1531. Establishment of drug-free communities support program
-STATUTE-
(a) Establishment
The Director shall establish a program to support communities in
the development and implementation of comprehensive, long-term
plans and programs to prevent and treat substance abuse among
youth.
(b) Program
In carrying out the Program, the Director shall -
(1) make and track grants to grant recipients;
(2) provide for technical assistance and training, data
collection, and dissemination of information on state-of-the-art
practices that the Director determines to be effective in
reducing substance abuse; and
(3) provide for the general administration of the Program.
(c) Administration
Not later than 30 days after receiving recommendations from the
Advisory Commission under section 1542(a)(1) of this title, the
Director shall appoint an Administrator to carry out the Program.
(d) Contracting
The Director may employ any necessary staff and may enter into
contracts or agreements with national drug control agencies,
including interagency agreements to delegate authority for the
execution of grants and for such other activities necessary to
carry out this subchapter.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1031, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 226.)
-End-
-CITE-
21 USC Sec. 1532 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
Sec. 1532. Program authorization
-STATUTE-
(a) Grant eligibility
To be eligible to receive an initial grant or a renewal grant
under this part, a coalition shall meet each of the following
criteria:
(1) Application
The coalition shall submit an application to the Administrator
in accordance with section 1533(a)(2) of this title.
(2) Major sector involvement
(A) In general
The coalition shall consist of 1 or more representatives of
each of the following categories:
(i) Youth.
(ii) Parents.
(iii) Businesses.
(iv) The media.
(v) Schools.
(vi) Organizations serving youth.
(vii) Law enforcement.
(viii) Religious or fraternal organizations.
(ix) Civic and volunteer groups.
(x) Health care professionals.
(xi) State, local, or tribal governmental agencies with
expertise in the field of substance abuse (including, if
applicable, the State authority with primary authority for
substance abuse).
(xii) Other organizations involved in reducing substance
abuse.
(B) Elected officials
If feasible, in addition to representatives from the
categories listed in subparagraph (A), the coalition shall have
an elected official (or a representative of an elected
official) from -
(i) the Federal Government; and
(ii) the government of the appropriate State and political
subdivision thereof or the governing body or an Indian tribe
(as that term is defined in section 450b(e) of title 25).
(C) Representation
An individual who is a member of the coalition may serve on
the coalition as a representative of not more than 1 category
listed under subparagraph (A).
(3) Commitment
The coalition shall demonstrate, to the satisfaction of the
Administrator -
(A) that the representatives of the coalition have worked
together on substance abuse reduction initiatives, which, at a
minimum, includes initiatives that target drugs referenced in
section 1523(9)(A) of this title, for a period of not less than
6 months, acting through entities such as task forces,
subcommittees, or community boards; and
(B) substantial participation from volunteer leaders in the
community involved (especially in cooperation with individuals
involved with youth such as parents, teachers, coaches, youth
workers, and members of the clergy).
(4) Mission and strategies
The coalition shall, with respect to the community involved -
(A) have as its principal mission the reduction of substance
abuse, which, at a minimum, includes the use and abuse of drugs
referenced in section 1523(9)(A) of this title, in a
comprehensive and long-term manner, with a primary focus on
youth in the community;
(B) describe and document the nature and extent of the
substance abuse problem, which, at a minimum, includes the use
and abuse of drugs referenced in section 1523(9)(A) of this
title, in the community;
(C)(i) provide a description of substance abuse prevention
and treatment programs and activities, which, at a minimum,
includes programs and activities relating to the use and abuse
of drugs referenced in section 1523(9)(A) of this title, in
existence at the time of the grant application; and
(ii) identify substance abuse programs and service gaps,
which, at a minimum, includes programs and gaps relating to the
use and abuse of drugs referenced in section 1523(9)(A) of this
title, in the community;
(D) develop a strategic plan to reduce substance abuse among
youth, which, at a minimum, includes the use and abuse of drugs
referenced in section 1523(9)(A) of this title, in a
comprehensive and long-term fashion; and
(E) work to develop a consensus regarding the priorities of
the community to combat substance abuse among youth, which, at
a minimum, includes the use and abuse of drugs referenced in
section 1523(9)(A) of this title.
(5) Sustainability
The coalition shall demonstrate that the coalition is an
ongoing concern by demonstrating that the coalition -
(A) is -
(i)(I) a nonprofit organization; or
(II) an entity that the Administrator determines to be
appropriate; or
(ii) part of, or is associated with, an established legal
entity;
(B) receives financial support (including, in the discretion
of the Administrator, in-kind contributions) from non-Federal
sources; and
(C) has a strategy to solicit substantial financial support
from non-Federal sources to ensure that the coalition and the
programs operated by the coalition are self-sustaining.
(6) Accountability
The coalition shall -
(A) establish a system to measure and report outcomes -
(i) consistent with common indicators and evaluation
protocols established by the Administrator; and
(ii) approved by the Administrator;
(B) conduct -
(i) for an initial grant under this part, an initial
benchmark survey of drug use among youth (or use local
surveys or performance measures available or accessible in
the community at the time of the grant application); and
(ii) biennial surveys (or incorporate local surveys in
existence at the time of the evaluation) to measure the
progress and effectiveness of the coalition; and
(C) provide assurances that the entity conducting an
evaluation under this paragraph, or from which the coalition
receives information, has experience -
(i) in gathering data related to substance abuse among
youth; or
(ii) in evaluating the effectiveness of community anti-drug
coalitions.
(7) Additional criteria
The Director shall not impose any eligibility criteria on new
applicants or renewal grantees not provided in this subchapter.
(b) Grant amounts
(1) In general
(A) Grants
(i) In general
Subject to clause (iv), for a fiscal year, the
Administrator may grant to an eligible coalition under this
paragraph, an amount not to exceed the amount of non-Federal
funds raised by the coalition, including in-kind
contributions, for that fiscal year.
(ii) Suspension of grants
If such grant recipient fails to continue to meet the
criteria specified in subsection (a) of this section, the
Administrator may suspend the grant, after providing written
notice to the grant recipient and an opportunity to appeal.
(iii) Renewal grants
Subject to clause (iv), the Administrator may award a
renewal grant to a grant recipient under this subparagraph
for each fiscal year following the fiscal year for which an
initial grant is awarded, in an amount not to exceed the
amount of non-Federal funds raised by the coalition,
including in-kind contributions, for that fiscal year, during
the 4-year period following the period of the initial grant.
(iv) Limitation
The amount of a grant award under this subparagraph may not
exceed $125,000 for a fiscal year.
(B) Coalition awards
(i) In general
Except as provided in clause (ii), the Administrator may,
with respect to a community, make a grant to 1 eligible
coalition that represents that community.
(ii) Exception
The Administrator may make a grant to more than 1 eligible
coalition that represents a community if -
(I) the eligible coalitions demonstrate that the
coalitions are collaborating with one another; and
(II) each of the coalitions has independently met the
requirements set forth in subsection (a) of this section.
(2) Rural coalition grants
(A) In general
(i) In general
In addition to awarding grants under paragraph (1), to
stimulate the development of coalitions in sparsely populated
and rural areas, the Administrator, in consultation with the
Advisory Commission, may award a grant in accordance with
this section to a coalition that represents a county with a
population that does not exceed 30,000 individuals. In
awarding a grant under this paragraph, the Administrator may
waive any requirement under subsection (a) of this section if
the Administrator considers that waiver to be appropriate.
(ii) Matching requirement
Subject to subparagraph (C), for a fiscal year, the
Administrator may grant to an eligible coalition under this
paragraph, an amount not to exceed the amount of non-Federal
funds raised by the coalition, including in-kind
contributions, for that fiscal year.
(iii) Suspension of grants
If such grant recipient fails to continue to meet any
criteria specified in subsection (a) of this section that has
not been waived by the Administrator pursuant to clause (i),
the Administrator may suspend the grant, after providing
written notice to the grant recipient and an opportunity to
appeal.
(B) Renewal grants
The Administrator may award a renewal grant to an eligible
coalition that is a grant recipient under this paragraph for
each fiscal year following the fiscal year for which an initial
grant is awarded, in an amount not to exceed the amount of non-
Federal funds raised by the coalition, including in-kind
contributions, during the 4-year period following the period of
the initial grant.
(C) Limitations
(i) Amount
The amount of a grant award under this paragraph shall not
exceed $125,000 for a fiscal year.
(ii) Awards
With respect to a county referred to in subparagraph (A),
the Administrator may award a grant under this section to not
more than 1 eligible coalition that represents the county.
(3) Additional grants
(A) In general
Subject to subparagraph (F), the Administrator may award an
additional grant under this paragraph to an eligible coalition
awarded a grant under paragraph (1) or (2) for any first fiscal
year after the end of the 4-year period following the period of
the initial grant under paragraph (1) or (2), as the case may
be.
(B) Scope of grants
A coalition awarded a grant under paragraph (1) or (2),
including a renewal grant under such paragraph, may not be
awarded another grant under such paragraph, and is eligible for
an additional grant under this section only under this
paragraph.
(C) No priority for applications
The Administrator may not afford a higher priority in the
award of an additional grant under this paragraph than the
Administrator would afford the applicant for the grant if the
applicant were submitting an application for an initial grant
under paragraph (1) or (2) rather than an application for a
grant under this paragraph.
(D) Renewal grants
Subject to subparagraph (F), the Administrator may award a
renewal grant to a grant recipient under this paragraph for
each of the fiscal years of the 4-fiscal-year period following
the fiscal year for which the initial additional grant under
subparagraph (A) is awarded in an amount not to exceed amounts
as follows:
(i) For the first and second fiscal years of that 4-fiscal-
year period, the amount equal to 80 percent of the non-
Federal funds, including in-kind contributions, raised by
the coalition for the applicable fiscal year.
(ii) For the third and fourth fiscal years of that 4-fiscal-
year period, the amount equal to 67 percent of the non-
Federal funds, including in-kind contributions, raised by
the coalition for the applicable fiscal year.
(E) Suspension
If a grant recipient under this paragraph fails to continue
to meet the criteria specified in subsection (a) of this
section, the Administrator may suspend the grant, after
providing written notice to the grant recipient and an
opportunity to appeal.
(F) Limitation
The amount of a grant award under this paragraph may not
exceed $125,000 for a fiscal year.
(4) Process for suspension
A grantee shall not be suspended or terminated under paragraph
(1)(A)(ii), (2)(A)(iii), or (3)(E) unless that grantee is
afforded a fair, timely, and independent appeal prior to such
suspension or termination.
(c) Treatment of funds for coalitions representing certain
organizations
Funds appropriated for the substance abuse activities of a
coalition that includes a representative of the Bureau of Indian
Affairs, the Indian Health Service, or a tribal government agency
with expertise in the field of substance abuse may be counted as
non-Federal funds raised by the coalition for purposes of this
section.
(d) Priority in awarding grants
In awarding grants under subsection (b)(1)(A)(i) of this section,
priority shall be given to a coalition serving economically
disadvantaged areas.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1032, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 227; amended Pub. L. 107-82, Sec.
1(d), (g), (h), Dec. 14, 2001, 115 Stat. 818, 819; Pub. L. 109-469,
title VIII, Secs. 802(a), 803, 804, Dec. 29, 2006, 120 Stat. 3535.)
-COD-
CODIFICATION
Pub. L. 109-469, Secs. 802(a), 803, 804, which directed amendment
of section 1032 of the "Drug-Free Communities Act of 1997", were
executed to this section, which is section 1032 of the National
Narcotics Leadership Act of 1988, to reflect the probable intent of
Congress. See 2006 Amendment notes below.
-MISC1-
AMENDMENTS
2006 - Subsec. (a)(7). Pub. L. 109-469, Sec. 804, added par. (7).
See Codification note above.
Subsec. (b)(1)(A)(iv), (2)(C)(i), (3)(F). Pub. L. 109-469, Sec.
803, substituted "$125,000" for "$100,000". See Codification note
above.
Subsec. (b)(4). Pub. L. 109-469, Sec. 802(a), added par. (4). See
Codification note above.
2001 - Subsec. (b)(3). Pub. L. 107-82, Sec. 1(d), added par. (3).
Subsec. (c). Pub. L. 107-82, Sec. 1(g), added subsec. (c).
Subsec. (d). Pub. L. 107-82, Sec. 1(h), added subsec. (d).
REPORT TO CONGRESS
Pub. L. 109-469, title VIII, Sec. 802(b), Dec. 29, 2006, 120
Stat. 3535, provided that: "Not later than 60 days after the date
of enactment of this Act [Dec. 29, 2006], the Director of the
Office of National Drug Control Policy shall submit to Congress a
report detailing the appeals process required by section 1032(b)(4)
of the Drug-Free Communities Act of 1997 [probably means 21 U.S.C.
1532(b)(4)], as added by subsection (a) [see 2006 Amendments note
above]."
-End-
-CITE-
21 USC Sec. 1533 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
Sec. 1533. Information collection and dissemination with respect to
grant recipients
-STATUTE-
(a) Coalition information
(1) General auditing authority
For the purpose of audit and examination, the Administrator -
(A) shall have access to any books, documents, papers, and
records that are pertinent to any grant or grant renewal
request under this subchapter; and
(B) may periodically request information from a grant
recipient to ensure that the grant recipient meets the
applicable criteria under section 1532(a) of this title.
(2) Application process
The Administrator shall issue a request for proposal regarding,
with respect to the grants awarded under section 1532 of this
title, the application process, grant renewal, and suspension or
withholding of renewal grants. Each application under this
paragraph shall be in writing and shall be subject to review by
the Administrator.
(3) Reporting
The Administrator shall, to the maximum extent practicable and
in a manner consistent with applicable law, minimize reporting
requirements by a grant recipient and expedite any application
for a renewal grant made under this part.
(b) Data collection and dissemination
(1) In general
The Administrator may collect data from -
(A) national substance abuse organizations that work with
eligible coalitions, community anti-drug coalitions,
departments or agencies of the Federal Government, or State or
local governments and the governing bodies of Indian tribes;
and
(B) any other entity or organization that carries out
activities that relate to the purposes of the Program.
(2) Activities of Administrator
The Administrator may -
(A) evaluate the utility of specific initiatives relating to
the purposes of the Program;
(B) conduct an evaluation of the Program; and
(C) disseminate information described in this subsection to -
(i) eligible coalitions and other substance abuse
organizations; and
(ii) the general public.
(3) Consultation
The Administrator shall carry out activities under this
subsection in consultation with the Advisory Commission and the
National Community Antidrug Coalition Institute.
(4) Limitation on use of certain funds for evaluation of Program
Amounts for activities under paragraph (2)(B) may not be
derived from amounts under section 1524(a) of this title except
for amounts that are available under section 1524(b) of this
title for administrative costs.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1033, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 230; amended Pub. L. 107-82, Sec.
1(e), (f), Dec. 14, 2001, 115 Stat. 818.)
-MISC1-
AMENDMENTS
2001 - Subsec. (b)(3). Pub. L. 107-82, Sec. 1(e), added par. (3).
Subsec. (b)(4). Pub. L. 107-82, Sec. 1(f), added par. (4).
-End-
-CITE-
21 USC Sec. 1534 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
Sec. 1534. Technical assistance and training
-STATUTE-
(a) In general
(1) Technical assistance and agreements
With respect to any grant recipient or other organization, the
Administrator may -
(A) offer technical assistance and training; and
(B) enter into contracts and cooperative agreements.
(2) Coordination of programs
The Administrator may facilitate the coordination of programs
between a grant recipient and other organizations and entities.
(b) Training
The Administrator may provide training to any representative
designated by a grant recipient in -
(1) coalition building;
(2) task force development;
(3) mediation and facilitation, direct service, assessment and
evaluation; or
(4) any other activity related to the purposes of the Program.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1034, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 231.)
-End-
-CITE-
21 USC Sec. 1535 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part A - Drug-Free Communities Support Program
-HEAD-
Sec. 1535. Supplemental grants for coalition mentoring activities
-STATUTE-
(a) Authority to make grants
As part of the program established under section 1531 of this
title, the Director may award an initial grant under this
subsection, and renewal grants under subsection (f) of this
section, to any coalition awarded a grant under section 1532 of
this title that meets the criteria specified in subsection (d) of
this section in order to fund coalition mentoring activities by
such coalition in support of the program.
(b) Treatment with other grants
(1) Supplement
A grant awarded to a coalition under this section is in
addition to any grant awarded to the coalition under section 1532
of this title.
(2) Requirement for basic grant
A coalition may not be awarded a grant under this section for a
fiscal year unless the coalition was awarded a grant or renewal
grant under section 1532(b) of this title for that fiscal year.
(c) Application
A coalition seeking a grant under this section shall submit to
the Administrator an application for the grant in such form and
manner as the Administrator may require.
(d) Criteria
A coalition meets the criteria specified in this subsection if
the coalition -
(1) has been in existence for at least 5 years;
(2) has achieved, by or through its own efforts, measurable
results in the prevention and treatment of substance abuse among
youth;
(3) has staff or members willing to serve as mentors for
persons seeking to start or expand the activities of other
coalitions in the prevention and treatment of substance abuse;
(4) has demonstrable support from some members of the community
in which the coalition mentoring activities to be supported by
the grant under this section are to be carried out; and
(5) submits to the Administrator a detailed plan for the
coalition mentoring activities to be supported by the grant under
this section.
(e) Use of grant funds
A coalition awarded a grant under this section shall use the
grant amount for mentoring activities to support and encourage the
development of new, self-supporting community coalitions that are
focused on the prevention and treatment of substance abuse in such
new coalitions' communities. The mentoring coalition shall
encourage such development in accordance with the plan submitted by
the mentoring coalition under subsection (d)(5) of this section.
(f) Renewal grants
The Administrator may make a renewal grant to any coalition
awarded a grant under subsection (a) of this section, or a previous
renewal grant under this subsection, if the coalition, at the time
of application for such renewal grant -
(1) continues to meet the criteria specified in subsection (d)
of this section; and
(2) has made demonstrable progress in the development of one or
more new, self-supporting community coalitions that are focused
on the prevention and treatment of substance abuse.
(g) Grant amounts
(1) In general
Subject to paragraphs (2) and (3), the total amount of grants
awarded to a coalition under this section for a fiscal year may
not exceed the amount of non-Federal funds raised by the
coalition, including in-kind contributions, for that fiscal year.
Funds appropriated for the substance abuse activities of a
coalition that includes a representative of the Bureau of Indian
Affairs, the Indian Health Service, or a tribal government agency
with expertise in the field of substance abuse may be counted as
non-Federal funds raised by the coalition.
(2) Initial grants
The amount of the initial grant awarded to a coalition under
subsection (a) of this section may not exceed $75,000.
(3) Renewal grants
The total amount of renewal grants awarded to a coalition under
subsection (f) of this section for any fiscal year may not exceed
$75,000.
(h) Fiscal year limitation on amount available for grants
The total amount available for grants under this section,
including renewal grants under subsection (f) of this section, in
any fiscal year may not exceed the amount equal to five percent of
the amount authorized to be appropriated by section 1524(a) of this
title for that fiscal year.
(i) Priority in awarding initial grants
In awarding initial grants under this section, priority shall be
given to a coalition that expressly proposes to provide mentorship
to a coalition or aspiring coalition serving economically
disadvantaged areas.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1035, as added Pub. L. 107-82, Sec.
2, Dec. 14, 2001, 115 Stat. 819.)
-End-
-CITE-
21 USC Part B - Advisory Commission 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
PART B - ADVISORY COMMISSION
-End-
-CITE-
21 USC Sec. 1541 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1541. Establishment of Advisory Commission
-STATUTE-
(a) Establishment
There is established a commission to be known as the "Advisory
Commission on Drug-Free Communities".
(b) Purpose
The Advisory Commission shall advise, consult with, and make
recommendations to the Director concerning matters related to the
activities carried out under the Program.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1041, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 231.)
-End-
-CITE-
21 USC Sec. 1542 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1542. Duties
-STATUTE-
(a) In general
The Advisory Commission -
(1) shall, not later than 30 days after its first meeting, make
recommendations to the Director regarding the selection of an
Administrator;
(2) may make recommendations to the Director regarding any
grant, contract, or cooperative agreement made by the Program;
(3) may make recommendations to the Director regarding the
activities of the Program;
(4) may make recommendations to the Director regarding any
policy or criteria established by the Director to carry out the
Program;
(5) may -
(A) collect, by correspondence or by personal investigation,
information concerning initiatives, studies, services,
programs, or other activities of coalitions or organizations
working in the field of substance abuse in the United States or
any other country; and
(B) with the approval of the Director, make the information
referred to in subparagraph (A) available through appropriate
publications or other methods for the benefit of eligible
coalitions and the general public; and
(6) may appoint subcommittees and convene workshops and
conferences.
(b) Recommendations
If the Director rejects any recommendation of the Advisory
Commission under subsection (a)(1) of this section, the Director
shall notify the Advisory Commission in writing of the reasons for
the rejection not later than 15 days after receiving the
recommendation.
(c) Conflict of interest
A member of the Advisory Commission shall recuse himself or
herself from any decision that would constitute a conflict of
interest.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1042, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 231.)
-End-
-CITE-
21 USC Sec. 1543 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1543. Membership
-STATUTE-
(a) In general
The President shall appoint 11 members to the Advisory Commission
as follows:
(1) four members shall be appointed from the general public and
shall include leaders -
(A) in fields of youth development, public policy, law, or
business; or
(B) of nonprofit organizations or private foundations that
fund substance abuse programs.
(2) four members shall be appointed from the leading
representatives of national substance abuse reduction
organizations, of which no fewer than three members shall have
extensive training or experience in drug prevention.
(3) three members shall be appointed from the leading
representatives of State substance abuse reduction organizations.
(b) Chairperson
The Advisory Commission shall elect a chairperson or co-
chairpersons from among its members.
(c) Ex officio members
The ex officio membership of the Advisory Commission shall
consist of any two officers or employees of the United States that
the Director determines to be necessary for the Advisory Commission
to effectively carry out its functions.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1043, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 232.)
-End-
-CITE-
21 USC Sec. 1544 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1544. Compensation
-STATUTE-
(a) In general
Members of the Advisory Commission who are officers or employees
of the United States shall not receive any additional compensation
for service on the Advisory Commission. The remaining members of
the Advisory Commission shall receive, for each day (including
travel time) that they are engaged in the performance of the
functions of the Advisory Commission, compensation at rates not to
exceed the daily equivalent to the annual rate of basic pay payable
for grade GS-10 of the General Schedule.
(b) Travel expenses
Each member of the Advisory Commission shall receive travel
expenses, including per diem in lieu of subsistence, in accordance
with sections 5702 and 5703 of title 5.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1044, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 232.)
-REFTEXT-
REFERENCES IN TEXT
Grade GS-10 of the General Schedule, referred to in subsec. (a),
is set out under section 5332 of Title 5, Government Organization
and Employees.
-End-
-CITE-
21 USC Sec. 1545 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1545. Terms of office
-STATUTE-
(a) In general
Subject to subsection (b) of this section, the term of office of
a member of the Advisory Commission shall be 3 years, except that,
as designated at the time of appointment -
(1) of the initial members appointed under section 1543(a)(1)
of this title, two shall be appointed for a term of 2 years;
(2) of the initial members appointed under section 1543(a)(2)
of this title, two shall be appointed for a term of 2 years; and
(3) of the initial members appointed under section 1543(a)(3)
of this title, one shall be appointed for a term of 1 year.
(b) Vacancies
Any member appointed to fill a vacancy for an unexpired term of a
member shall serve for the remainder of the unexpired term. A
member of the Advisory Commission may serve after the expiration of
such member's term until a successor has been appointed and taken
office.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1045, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 233.)
-End-
-CITE-
21 USC Sec. 1546 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1546. Meetings
-STATUTE-
(a) In general
After its initial meeting, the Advisory Commission shall meet,
with the advanced approval of the Administrator, at the call of the
Chairperson (or Co-chairpersons) of the Advisory Commission or a
majority of its members or upon the request of the Director or
Administrator of the Program.
(b) Quorum
Six members of the Advisory Commission shall constitute a quorum.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1046, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 233.)
-End-
-CITE-
21 USC Sec. 1547 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1547. Staff
-STATUTE-
The Administrator shall make available to the Advisory Commission
adequate staff, information, and other assistance.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1047, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 233.)
-End-
-CITE-
21 USC Sec. 1548 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 20 - NATIONAL DRUG CONTROL PROGRAM
SUBCHAPTER II - DRUG-FREE COMMUNITIES
Part B - Advisory Commission
-HEAD-
Sec. 1548. Termination
-STATUTE-
The Advisory Commission shall terminate at the end of fiscal year
2007.
-SOURCE-
(Pub. L. 100-690, title I, Sec. 1048, as added Pub. L. 105-20, Sec.
2(a)(2), June 27, 1997, 111 Stat. 234; amended Pub. L. 107-82, Sec.
3, Dec. 14, 2001, 115 Stat. 820.)
-MISC1-
AMENDMENTS
2001 - Pub. L. 107-82 substituted "2007" for "2002".
-End-
-CITE-
21 USC CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-MISC1-
Sec.
1601. Findings.
1602. Definitions.
1603. General requirements; applicability; preemption.
1604. Liability of biomaterials suppliers.
1605. Procedures for dismissal of civil actions against
biomaterials suppliers.
1606. Subsequent impleader of dismissed biomaterials
supplier.
-End-
-CITE-
21 USC Sec. 1601 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1601. Findings
-STATUTE-
The Congress finds that -
(1) each year millions of citizens of the United States depend
on the availability of lifesaving or life-enhancing medical
devices, many of which are permanently implantable within the
human body;
(2) a continued supply of raw materials and component parts is
necessary for the invention, development, improvement, and
maintenance of the supply of the devices;
(3) most of the medical devices are made with raw materials and
component parts that -
(A) move in interstate commerce;
(B) are not designed or manufactured specifically for use in
medical devices; and
(C) come in contact with internal human tissue;
(4) the raw materials and component parts also are used in a
variety of nonmedical products;
(5) because small quantities of the raw materials and component
parts are used for medical devices, sales of raw materials and
component parts for medical devices constitute an extremely small
portion of the overall market for the raw materials and component
parts;
(6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) manufacturers of medical devices are required to
demonstrate that the medical devices are safe and effective,
including demonstrating that the products are properly designed
and have adequate warnings or instructions;
(7) notwithstanding the fact that raw materials and component
parts suppliers do not design, produce, or test a final medical
device, the suppliers have been the subject of actions alleging
inadequate -
(A) design and testing of medical devices manufactured with
materials or parts supplied by the suppliers; or
(B) warnings related to the use of such medical devices;
(8) even though suppliers of raw materials and component parts
have very rarely been held liable in such actions, such suppliers
have ceased supplying certain raw materials and component parts
for use in medical devices for a number of reasons, including
concerns about the costs of such litigation;
(9) unless alternate sources of supply can be found, the
unavailability of raw materials and component parts for medical
devices will lead to unavailability of lifesaving and life-
enhancing medical devices;
(10) because other suppliers of the raw materials and component
parts in foreign nations are refusing to sell raw materials or
component parts for use in manufacturing certain medical devices
in the United States, the prospects for development of new
sources of supply for the full range of threatened raw materials
and component parts for medical devices are remote;
(11) it is unlikely that the small market for such raw
materials and component parts in the United States could support
the large investment needed to develop new suppliers of such raw
materials and component parts;
(12) attempts to develop such new suppliers would raise the
cost of medical devices;
(13) courts that have considered the duties of the suppliers of
the raw materials and component parts have generally found that
the suppliers do not have a duty -
(A) to evaluate the safety and efficacy of the use of a raw
material or component part in a medical device; or
(B) to warn consumers concerning the safety and effectiveness
of a medical device;
(14) because medical devices and the raw materials and
component parts used in their manufacture move in interstate
commerce, a shortage of such raw materials and component parts
affects interstate commerce;
(15) in order to safeguard the availability of a wide variety
of lifesaving and life-enhancing medical devices, immediate
action is needed -
(A) to clarify the permissible bases of liability for
suppliers of raw materials and component parts for medical
devices; and
(B) to provide expeditious procedures to dispose of
unwarranted suits against the suppliers in such manner as to
minimize litigation costs;
(16) the several States and their courts are the primary
architects and regulators of our tort system; Congress, however,
must, in certain circumstances involving the national interest,
address tort issues, and a threatened shortage of raw materials
and component parts for lifesaving medical devices is one such
circumstance; and
(17) the protections set forth in this chapter are needed to
assure the continued supply of materials for lifesaving medical
devices, although such protections do not protect negligent
suppliers.
-SOURCE-
(Pub. L. 105-230, Sec. 2, Aug. 13, 1998, 112 Stat. 1519.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in par.
(6), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of
this title. For complete classification of this Act to the Code,
see section 301 of this title and Tables.
-MISC1-
EFFECTIVE DATE
Pub. L. 105-230, Sec. 8, Aug. 13, 1998, 112 Stat. 1529, provided
that: "This Act [enacting this chapter] shall apply to all civil
actions covered under this Act that are commenced on or after the
date of enactment of this Act [Aug. 13, 1998], including any such
action with respect to which the harm asserted in the action or the
conduct that caused the harm occurred before the date of enactment
of this Act."
SHORT TITLE
Pub. L. 105-230, Sec. 1, Aug. 13, 1998, 112 Stat. 1519, provided
that: "This Act [enacting this chapter] may be cited as the
'Biomaterials Access Assurance Act of 1998'."
-End-
-CITE-
21 USC Sec. 1602 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1602. Definitions
-STATUTE-
As used in this chapter:
(1) Biomaterials supplier
(A) In general
The term "biomaterials supplier" means an entity that
directly or indirectly supplies a component part or raw
material for use in the manufacture of an implant.
(B) Persons included
Such term includes any person who -
(i) has submitted master files to the Secretary for
purposes of premarket approval of a medical device; or
(ii) licenses a biomaterials supplier to produce component
parts or raw materials.
(2) Claimant
(A) In general
The term "claimant" means any person who brings a civil
action, or on whose behalf a civil action is brought, arising
from harm allegedly caused directly or indirectly by an
implant, including a person other than the individual into
whose body, or in contact with whose blood or tissue, the
implant is placed, who claims to have suffered harm as a result
of the implant.
(B) Action brought on behalf of an estate
With respect to an action brought on behalf of or through the
estate of a deceased individual into whose body, or in contact
with whose blood or tissue the implant was placed, such term
includes the decedent that is the subject of the action.
(C) Action brought on behalf of a minor or incompetent
With respect to an action brought on behalf of or through a
minor or incompetent, such term includes the parent or guardian
of the minor or incompetent.
(D) Exclusions
Such term does not include -
(i) a provider of professional health care services in any
case in which -
(I) the sale or use of an implant is incidental to such
services; and
(II) the essence of the professional health care services
provided is the furnishing of judgment, skill, or services;
(ii) a person acting in the capacity of a manufacturer,
seller, or biomaterials supplier; or
(iii) a person alleging harm caused by either the silicone
gel or the silicone envelope utilized in a breast implant
containing silicone gel, except that -
(I) neither the exclusion provided by this clause nor any
other provision of this chapter may be construed as a
finding that silicone gel (or any other form of silicone)
may or may not cause harm; and
(II) the existence of the exclusion under this clause may
not -
(aa) be disclosed to a jury in any civil action or
other proceeding; and
(bb) except as necessary to establish the applicability
of this chapter, otherwise be presented in any civil
action or other proceeding.
(3) Component part
(A) In general
The term "component part" means a manufactured piece of an
implant.
(B) Certain components
Such term includes a manufactured piece of an implant that -
(i) has significant non-implant applications; and
(ii) alone, has no implant value or purpose, but when
combined with other component parts and materials,
constitutes an implant.
(4) Harm
(A) In general
The term "harm" means -
(i) any injury to or damage suffered by an individual;
(ii) any illness, disease, or death of that individual
resulting from that injury or damage; and
(iii) any loss to that individual or any other individual
resulting from that injury or damage.
(B) Exclusion
The term does not include any commercial loss or loss of or
damage to an implant.
(5) Implant
The term "implant" means -
(A) a medical device that is intended by the manufacturer of
the device -
(i) to be placed into a surgically or naturally formed or
existing cavity of the body for a period of at least 30 days;
or
(ii) to remain in contact with bodily fluids or internal
human tissue through a surgically produced opening for a
period of less than 30 days; and
(B) suture materials used in implant procedures.
(6) Manufacturer
The term "manufacturer" means any person who, with respect to
an implant -
(A) is engaged in the manufacture, preparation, propagation,
compounding, or processing (as defined in section 360(a)(1) of
this title) of the implant; and
(B) is required -
(i) to register with the Secretary pursuant to section 360
of this title and the regulations issued under such section;
and
(ii) to include the implant on a list of devices filed with
the Secretary pursuant to section 360(j) of this title and
the regulations issued under such section.
(7) Medical device
The term "medical device" means a device, as defined in section
321(h) of this title, and includes any device component of any
combination product as that term is used in section 353(g) of
this title.
(8) Raw material
The term "raw material" means a substance or product that -
(A) has a generic use; and
(B) may be used in an application other than an implant.
(9) Secretary
The term "Secretary" means the Secretary of Health and Human
Services.
(10) Seller
(A) In general
The term "seller" means a person who, in the course of a
business conducted for that purpose, sells, distributes,
leases, packages, labels, or otherwise places an implant in the
stream of commerce.
(B) Exclusions
The term does not include -
(i) a seller or lessor of real property;
(ii) a provider of professional health care services in any
case in which -
(I) the sale or use of the implant is incidental to such
services; and
(II) the essence of the professional health care services
provided is the furnishing of judgment, skill, or services;
or
(iii) any person who acts in only a financial capacity with
respect to the sale of an implant.
-SOURCE-
(Pub. L. 105-230, Sec. 3, Aug. 13, 1998, 112 Stat. 1520.)
-End-
-CITE-
21 USC Sec. 1603 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1603. General requirements; applicability; preemption
-STATUTE-
(a) General requirements
(1) In general
In any civil action covered by this chapter, a biomaterials
supplier may -
(A) raise any exclusion from liability set forth in section
1604 of this title; and
(B) make a motion for dismissal or for summary judgment as
set forth in section 1605 of this title.
(2) Procedures
Notwithstanding any other provision of law, a Federal or State
court in which an action covered by this chapter is pending
shall, in connection with a motion under section 1605 or 1606 of
this title, use the procedures set forth in this chapter.
(b) Applicability
(1) In general
Except as provided in paragraph (2), this chapter applies to
any civil action brought by a claimant, whether in a Federal or
State court, on the basis of any legal theory, for harm allegedly
caused, directly or indirectly, by an implant.
(2) Exclusion
A civil action brought by a purchaser of a medical device,
purchased for use in providing professional health care services,
for loss or damage to an implant or for commercial loss to the
purchaser -
(A) shall not be considered an action that is subject to this
chapter; and
(B) shall be governed by applicable commercial or contract
law.
(c) Scope of preemption
(1) In general
This chapter supersedes any State law regarding recovery for
harm caused by an implant and any rule of procedure applicable to
a civil action to recover damages for such harm only to the
extent that this chapter establishes a rule of law applicable to
the recovery of such damages.
(2) Applicability of other laws
Any issue that arises under this chapter and that is not
governed by a rule of law applicable to the recovery of damages
described in paragraph (1) shall be governed by applicable
Federal or State law.
(d) Statutory construction
Nothing in this chapter may be construed -
(1) to affect any defense available to a defendant under any
other provisions of Federal or State law in an action alleging
harm caused by an implant; or
(2) to create a cause of action or Federal court jurisdiction
pursuant to section 1331 or 1337 of title 28 that otherwise would
not exist under applicable Federal or State law.
-SOURCE-
(Pub. L. 105-230, Sec. 4, Aug. 13, 1998, 112 Stat. 1523.)
-End-
-CITE-
21 USC Sec. 1604 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1604. Liability of biomaterials suppliers
-STATUTE-
(a) In general
Except as provided in section 1606 of this title, a biomaterials
supplier shall not be liable for harm to a claimant caused by an
implant unless such supplier is liable -
(1) as a manufacturer of the implant, as provided in subsection
(b) of this section;
(2) as a seller of the implant, as provided in subsection (c)
of this section; or
(3) for furnishing raw materials or component parts for the
implant that failed to meet applicable contractual requirements
or specifications, as provided in subsection (d) of this section.
(b) Liability as manufacturer
(1) In general
A biomaterials supplier may, to the extent required and
permitted by any other applicable law, be liable for harm to a
claimant caused by an implant if the biomaterials supplier is the
manufacturer of the implant.
(2) Grounds for liability
The biomaterials supplier may be considered the manufacturer of
the implant that allegedly caused harm to a claimant only if the
biomaterials supplier -
(A)(i) registered or was required to register with the
Secretary pursuant to section 360 of this title and the
regulations issued under such section; and
(ii) included or was required to include the implant on a
list of devices filed with the Secretary pursuant to section
360(j) of this title and the regulations issued under such
section;
(B) is the subject of a declaration issued by the Secretary
pursuant to paragraph (3) that states that the supplier, with
respect to the implant that allegedly caused harm to the
claimant, was required to -
(i) register with the Secretary under section 360 of this
title, and the regulations issued under such section, but
failed to do so; or
(ii) include the implant on a list of devices filed with
the Secretary pursuant to section 360(j) of this title and
the regulations issued under such section, but failed to do
so; or
(C) is related by common ownership or control to a person
meeting all the requirements described in subparagraph (A) or
(B), if the court deciding a motion to dismiss in accordance
with section 1605(c)(3)(B)(i) of this title finds, on the basis
of affidavits submitted in accordance with section 1605 of this
title, that it is necessary to impose liability on the
biomaterials supplier as a manufacturer because the related
manufacturer meeting the requirements of subparagraph (A) or
(B) lacks sufficient financial resources to satisfy any
judgment that the court feels it is likely to enter should the
claimant prevail.
(3) Administrative procedures
(A) In general
The Secretary may issue a declaration described in paragraph
(2)(B) on the motion of the Secretary or on petition by any
person, after providing -
(i) notice to the affected persons; and
(ii) an opportunity for an informal hearing.
(B) Docketing and final decision
Immediately upon receipt of a petition filed pursuant to this
paragraph, the Secretary shall docket the petition. Not later
than 120 days after the petition is filed, the Secretary shall
issue a final decision on the petition.
(C) Applicability of statute of limitations
Any applicable statute of limitations shall toll during the
period from the time a claimant files a petition with the
Secretary under this paragraph until such time as either (i)
the Secretary issues a final decision on the petition, or (ii)
the petition is withdrawn.
(D) Stay pending petition for declaration
If a claimant has filed a petition for a declaration with
respect to a defendant, and the Secretary has not issued a
final decision on the petition, the court shall stay all
proceedings with respect to that defendant until such time as
the Secretary has issued a final decision on the petition.
(c) Liability as seller
A biomaterials supplier may, to the extent required and permitted
by any other applicable law, be liable as a seller for harm to a
claimant caused by an implant only if -
(1) the biomaterials supplier -
(A) held title to the implant and then acted as a seller of
the implant after its initial sale by the manufacturer; or
(B) acted under contract as a seller to arrange for the
transfer of the implant directly to the claimant after the
initial sale by the manufacturer of the implant; or
(2) the biomaterials supplier is related by common ownership or
control to a person meeting all the requirements described in
paragraph (1), if a court deciding a motion to dismiss in
accordance with section 1605(c)(3)(B)(ii) of this title finds, on
the basis of affidavits submitted in accordance with section 1605
of this title, that it is necessary to impose liability on the
biomaterials supplier as a seller because the related seller
meeting the requirements of paragraph (1) lacks sufficient
financial resources to satisfy any judgment that the court feels
it is likely to enter should the claimant prevail.
(d) Liability for failure to meet applicable contractual
requirements or specifications
A biomaterials supplier may, to the extent required and permitted
by any other applicable law, be liable for harm to a claimant
caused by an implant if the claimant in an action shows, by a
preponderance of the evidence, that -
(1) the biomaterials supplier supplied raw materials or
component parts for use in the implant that either -
(A) did not constitute the product described in the contract
between the biomaterials supplier and the person who contracted
for the supplying of the product; or
(B) failed to meet any specifications that were -
(i) accepted, pursuant to applicable law, by the
biomaterials supplier;
(ii) published by the biomaterials supplier;
(iii) provided by the biomaterials supplier to the person
who contracted for such product;
(iv) contained in a master file that was submitted by the
biomaterials supplier to the Secretary and that is currently
maintained by the biomaterials supplier for purposes of
premarket approval of medical devices; or
(v) included in the submissions for purposes of premarket
approval or review by the Secretary under section 360, 360c,
360e, or 360j of this title, and received clearance from the
Secretary if such specifications were accepted, pursuant to
applicable law, by the biomaterials supplier; and
(2) such failure to meet applicable contractual requirements or
specifications was an actual and proximate cause of the harm to
the claimant.
-SOURCE-
(Pub. L. 105-230, Sec. 5, Aug. 13, 1998, 112 Stat. 1524.)
-End-
-CITE-
21 USC Sec. 1605 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1605. Procedures for dismissal of civil actions against
biomaterials suppliers
-STATUTE-
(a) Motion to dismiss
A defendant may, at any time during which a motion to dismiss may
be filed under applicable law, move to dismiss an action against it
on the grounds that the defendant is a biomaterials supplier and
one or more of the following:
(1) The defendant is not liable as a manufacturer, as provided
in section 1604(b) of this title.
(2) The defendant is not liable as a seller, as provided in
section 1604(c) of this title.
(3) The defendant is not liable for furnishing raw materials or
component parts for the implant that failed to meet applicable
contractual requirements or specifications, as provided in
section 1604(d) of this title.
(4) The claimant did not name the manufacturer as a party to
the action, as provided in subsection (b) of this section.
(b) Manufacturer of implant shall be named a party
In any civil action covered by this chapter, the claimant shall
be required to name the manufacturer of the implant as a party to
the action, unless -
(1) the manufacturer is subject to service of process solely in
a jurisdiction in which the biomaterials supplier is not
domiciled or subject to a service of process; or
(2) a claim against the manufacturer is barred by applicable
law or rule of practice.
(c) Proceeding on motion to dismiss
The following rules shall apply to any proceeding on a motion to
dismiss filed by a defendant under this section:
(1) Effect of motion to dismiss on discovery
(A) In general
Except as provided in subparagraph (B), if a defendant files
a motion to dismiss under subsection (a) of this section, no
discovery shall be permitted in connection with the action that
is the subject of the motion, other than discovery necessary to
determine a motion to dismiss for lack of jurisdiction, until
such time as the court rules on the motion to dismiss.
(B) Discovery
If a defendant files a motion to dismiss under subsection
(a)(3) of this section on the grounds that it did not furnish
raw materials or component parts for the implant that failed to
meet applicable contractual requirements or specifications, the
court may permit discovery limited to issues that are directly
relevant to -
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(2) Affidavits
(A) Defendant
A defendant may submit affidavits supporting the grounds for
dismissal contained in its motion to dismiss under subsection
(a) of this section. If the motion is made under subsection
(a)(1) of this section, the defendant may submit an affidavit
demonstrating that the defendant has not included the implant
on a list, if any, filed with the Secretary pursuant to section
360(j) of this title.
(B) Claimant
In response to a motion to dismiss, the claimant may submit
affidavits demonstrating that -
(i) the Secretary has, with respect to the defendant and
the implant that allegedly caused harm to the claimant,
issued a declaration pursuant to section 1604(b)(2)(B) of
this title; or
(ii) the defendant is a seller of the implant who is liable
under section 1604(c) of this title.
(3) Basis of ruling on motion to dismiss
The court shall rule on a motion to dismiss filed under
subsection (a) of this section solely on the basis of the
pleadings and affidavits of the parties made pursuant to this
subsection. The court shall grant a motion to dismiss filed under
subsection (a) of this section -
(A) unless the claimant submits a valid affidavit that
demonstrates that the defendant is not a biomaterials supplier;
(B) unless the court determines, to the extent raised in the
pleadings and affidavits, that one or more of the following
apply:
(i) the defendant may be liable as a manufacturer, as
provided in section 1604(b) of this title;
(ii) the defendant may be liable as a seller, as provided
in section 1604(c) of this title; or
(iii) the defendant may be liable for furnishing raw
materials or component parts for the implant that failed to
meet applicable contractual requirements or specifications,
as provided in section 1604(d) of this title; or
(C) if the claimant did not name the manufacturer as a party
to the action, as provided in subsection (b) of this section.
(4) Treatment of motion as motion for summary judgment
The court may treat a motion to dismiss as a motion for summary
judgment subject to subsection (d) of this section in order to
determine whether the pleadings and affidavits, in connection
with such action, raise genuine issues of material fact
concerning whether the defendant furnished raw materials or
component parts of the implant that failed to meet applicable
contractual requirements or specifications as provided in section
1604(d) of this title.
(d) Summary judgment
(1) In general
(A) Basis for entry of judgment
If a motion to dismiss of a biomaterials supplier is to be
treated as a motion for summary judgment under subsection
(c)(4) of this section or if a biomaterials supplier moves for
summary judgment, the biomaterials supplier shall be entitled
to entry of judgment without trial if the court finds there is
no genuine issue of material fact for each applicable element
set forth in paragraphs (1) and (2) of section 1604(d) of this
title.
(B) Issues of material fact
With respect to a finding made under subparagraph (A), the
court shall consider a genuine issue of material fact to exist
only if the evidence submitted by the claimant would be
sufficient to allow a reasonable jury to reach a verdict for
the claimant if the jury found the evidence to be credible.
(2) Discovery made prior to a ruling on a motion for summary
judgment
If, under applicable rules, the court permits discovery prior
to a ruling on a motion for summary judgment governed by section
1604(d) of this title, such discovery shall be limited solely to
establishing whether a genuine issue of material fact exists as
to the applicable elements set forth in paragraphs (1) and (2) of
section 1604(d) of this title.
(3) Discovery with respect to a biomaterials supplier
A biomaterials supplier shall be subject to discovery in
connection with a motion seeking dismissal or summary judgment on
the basis of the inapplicability of section 1604(d) of this title
or the failure to establish the applicable elements of section
1604(d) of this title solely to the extent permitted by the
applicable Federal or State rules for discovery against
nonparties.
(e) Dismissal with prejudice
An order granting a motion to dismiss or for summary judgment
pursuant to this section shall be entered with prejudice, except
insofar as the moving defendant may be rejoined to the action as
provided in section 1606 of this title.
(f) Manufacturer conduct of litigation
The manufacturer of an implant that is the subject of an action
covered under this chapter shall be permitted to conduct litigation
on any motion for summary judgment or dismissal filed by a
biomaterials supplier who is a defendant under this section on
behalf of such supplier if the manufacturer and any other defendant
in such action enter into a valid and applicable contractual
agreement under which the manufacturer agrees to bear the cost of
such litigation or to conduct such litigation.
-SOURCE-
(Pub. L. 105-230, Sec. 6, Aug. 13, 1998, 112 Stat. 1526.)
-End-
-CITE-
21 USC Sec. 1606 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE
-HEAD-
Sec. 1606. Subsequent impleader of dismissed biomaterials supplier
-STATUTE-
(a) Impleading of dismissed defendant
A court, upon motion by a manufacturer or a claimant within 90
days after entry of a final judgment in an action by the claimant
against a manufacturer, and notwithstanding any otherwise
applicable statute of limitations, may implead a biomaterials
supplier who has been dismissed from the action pursuant to this
chapter if -
(1) the manufacturer has made an assertion, either in a motion
or other pleading filed with the court or in an opening or
closing statement at trial, or as part of a claim for
contribution or indemnification, and the court finds based on the
court's independent review of the evidence contained in the
record of the action, that under applicable law -
(A) the negligence or intentionally tortious conduct of the
dismissed supplier was an actual and proximate cause of the
harm to the claimant; and
(B) the manufacturer's liability for damages should be
reduced in whole or in part because of such negligence or
intentionally tortious conduct; or
(2) the claimant has moved to implead the supplier and the
court finds, based on the court's independent review of the
evidence contained in the record of the action, that under
applicable law -
(A) the negligence or intentionally tortious conduct of the
dismissed supplier was an actual and proximate cause of the
harm to the claimant; and
(B) the claimant is unlikely to be able to recover the full
amount of its damages from the remaining defendants.
(b) Standard of liability
Notwithstanding any preliminary finding under subsection (a) of
this section, a biomaterials supplier who has been impleaded into
an action covered by this chapter, as provided for in this section -
(1) may, prior to entry of judgment on the claim against it,
supplement the record of the proceeding that was developed prior
to the grant of the motion for impleader under subsection (a) of
this section; and
(2) may be found liable to a manufacturer or a claimant only to
the extent required and permitted by any applicable State or
Federal law other than this chapter.
(c) Discovery
Nothing in this section shall give a claimant or any other party
the right to obtain discovery from a biomaterials supplier at any
time prior to grant of a motion for impleader beyond that allowed
under section 1605 of this title.
-SOURCE-
(Pub. L. 105-230, Sec. 7, Aug. 13, 1998, 112 Stat. 1528.)
-End-
-CITE-
21 USC CHAPTER 22 - NATIONAL DRUG CONTROL POLICY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-MISC1-
Sec.
1701. Definitions.
1702. Office of National Drug Control Policy.
1703. Appointment and duties of Director and Deputy
Directors.
1704. Coordination with National Drug Control Program
agencies in demand reduction, supply reduction, and
State and local affairs.
1705. Development, submission, implementation, and
assessment of National Drug Control Strategy.
1706. High Intensity Drug Trafficking Areas Program.
1707. Counter-Drug Technology Assessment Center.
1708. National youth anti-drug media campaign.
1708a. Annual report requirement.
1709. Repealed.
1710. Drug Interdiction Coordinator and Committee.
1710a. Requirement for disclosure of Federal sponsorship of
all Federal advertising or other communication
materials.
1711. Authorization of appropriations.
1712. Termination of Office of National Drug Control Policy.
1713. Authorization of use of environmentally-approved
herbicides to eliminate illicit narcotics crops.
1714. Awards for demonstration programs by local
partnerships to coerce abstinence in chronic
hard-drug users under community supervision through
the use of drug testing and sanctions.
-End-
-CITE-
21 USC Sec. 1701 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1701. Definitions
-STATUTE-
In this chapter:
(1) Demand reduction
The term "demand reduction" means any activity conducted by a
National Drug Control Program agency, other than an enforcement
activity, that is intended to reduce the use of drugs, including -
(A) drug abuse education;
(B) drug abuse prevention;
(C) drug abuse treatment;
(D) drug abuse research;
(E) drug abuse rehabilitation;
(F) drug-free workplace programs;
(G) drug testing, including the testing of employees;
(H) interventions for drug abuse and dependence;
(I) international drug control coordination and cooperation
with respect to activities described in this paragraph; and
(J) international drug abuse education, prevention,
treatment, research, rehabilitation activities, and
interventions for drug abuse and dependence.
(2) Director
The term "Director" means the Director of National Drug Control
Policy.
(3) Drug
The term "drug" has the meaning given the term "controlled
substance" in section 802(6) of this title.
(4) Drug control
The term "drug control" means any activity conducted by a
National Drug Control Program agency involving supply reduction
or demand reduction.
(5) Fund
The term "Fund" means the fund established under section
1702(d) of this title.
(6) National Drug Control Program
The term "National Drug Control Program" means programs,
policies, and activities undertaken by National Drug Control
Program agencies pursuant to the responsibilities of such
agencies under the National Drug Control Strategy, including any
activities involving supply reduction, demand reduction, or
State, local, and tribal affairs.
(7) National Drug Control Program agency
The term "National Drug Control Program agency" means any
agency that is responsible for implementing any aspect of the
National Drug Control Strategy, including any agency that
receives Federal funds to implement any aspect of the National
Drug Control Strategy, but does not include any agency that
receives funds for drug control activity solely under the
National Intelligence Program, the Joint Military Intelligence
Program or Tactical Intelligence and Related Activities, or (for
purposes of section 1703(d) of this title) an agency that is
described in section 530C(a) of title 28, unless such agency has
been designated -
(A) by the President; or
(B) jointly by the Director and the head of the agency.
(8) National Drug Control Strategy
The term "National Drug Control Strategy" means the strategy
developed and submitted to Congress under section 1705 of this
title.
(9) Office
Unless the context clearly indicates otherwise, the term
"Office" means the Office of National Drug Control Policy
established under section 1702(a) of this title.
(10) State, local, and tribal affairs
The term "State, local, and tribal affairs" means domestic
activities conducted by a National Drug Control Program agency
that are intended to reduce the availability and use of illegal
drugs, including -
(A) coordination and enhancement of Federal, State, local,
and tribal law enforcement drug control efforts;
(B) coordination and enhancement of efforts among National
Drug Control Program agencies and State, local, and tribal
demand reduction and supply reduction agencies;
(C) coordination and enhancement of Federal, State, local,
and tribal law enforcement initiatives to gather, analyze, and
disseminate information and law enforcement intelligence
relating to drug control among domestic law enforcement
agencies; and
(D) other coordinated and joint initiatives among Federal,
State, local, and tribal agencies to promote comprehensive drug
control strategies designed to reduce the demand for, and the
availability of, illegal drugs.
(11) Supply reduction
The term "supply reduction" means any activity or program
conducted by a National Drug Control Program agency that is
intended to reduce the availability or use of illegal drugs in
the United States or abroad, including -
(A) law enforcement outside the United States;
(B) source country programs, including economic development
programs primarily intended to reduce the production or
trafficking of illicit drugs;
(C) activities to control international trafficking in, and
availability of, illegal drugs, including -
(i) accurate assessment and monitoring of international
drug production and interdiction programs and policies; and
(ii) coordination and promotion of compliance with
international treaties relating to the production,
transportation, or interdiction of illegal drugs;
(D) activities to conduct and promote international law
enforcement programs and policies to reduce the supply of
drugs; and
(E) activities to facilitate and enhance the sharing of
domestic and foreign intelligence information among National
Drug Control Program agencies, relating to the production and
trafficking of drugs in the United States and in foreign
countries.
(12) Appropriate congressional committees
Except where otherwise provided, the term "appropriate
congressional committees" means the Committee on the Judiciary,
the Committee on Appropriations, and the Caucus on International
Narcotics Control of the Senate and the Committee on Government
Reform, the Committee on the Judiciary, and the Committee on
Appropriations of the House of Representatives.
(13) Law enforcement
The term "law enforcement" or "drug law enforcement" means all
efforts by a Federal, State, local, or tribal government agency
to enforce the drug laws of the United States or any State,
including investigation, arrest, prosecution, and incarceration
or other punishments or penalties.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 702, Oct. 21, 1998, 112
Stat. 2681-670; Pub. L. 109-469, title I, Sec. 101, Dec. 29, 2006,
120 Stat. 3503.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
title", meaning title VII of div. C of Pub. L. 105-277, Oct. 21,
1998, 112 Stat. 2681-670, which is classified principally to this
chapter. For complete classification of title VII to the Code, see
Short Title note set out below and Tables.
-COD-
CODIFICATION
The repeal of this chapter and of the amendments made by this
chapter, effective Sept. 30, 2003, by section 1712 of this title,
as in effect on Sept. 30, 2003, has not been given effect in the
Code, to reflect the probable intent of Congress, because of the
amendment to section 1712 of this title by Pub. L. 109-469 which
substituted "September 30, 2010" for "September 30, 2003" as the
effective date of the repeal.
-MISC1-
AMENDMENTS
2006 - (1)(G). Pub. L. 109-469, Sec. 101(a)(2), substituted ",
including the testing of employees;" for period at end.
Par. (1)(H) to (J). Pub. L. 109-469, Sec. 101(a)(1), (3), added
subpars. (H) to (J).
Par. (6). Pub. L. 109-469, Sec. 101(b), inserted ", including any
activities involving supply reduction, demand reduction, or State,
local, and tribal affairs" before period at end.
Par. (7). Pub. L. 109-469, Sec. 101(c), in introductory
provisions, substituted "National Intelligence Program," for
"National Foreign Intelligence Program," and inserted "or (for
purposes of section 1703(d) of this title) an agency that is
described in section 530C(a) of title 28," after "Related
Activities,".
Par. (9). Pub. L. 109-469, Sec. 101(d), substituted "indicates"
for "implicates".
Par. (10). Pub. L. 109-469, Sec. 101(e), amended par. (10)
generally. Prior to amendment, text defined the term "State and
local affairs".
Par. (11). Pub. L. 109-469, Sec. 101(f), amended par. (11)
generally. Prior to amendment, text defined the term "supply
reduction".
Pars. (12), (13). Pub. L. 109-469, Sec. 101(g), added pars. (12)
and (13).
SHORT TITLE OF 2006 AMENDMENT
Pub. L. 109-469, Sec. 1(a), Dec. 29, 2006, 120 Stat. 3502,
provided that: "This Act [enacting sections 1708a, 1714, 2001 to
2003, and 2011 to 2014 of this title, amending this section,
sections 823, 1524, 1532, 1702 to 1708, 1710 to 1712 of this title,
and section 458 of Title 6, Domestic Security, repealing sections
1509, 1709, and 1801 to 1804 of this title, enacting provisions set
out as notes under this section, sections 1532, 1705, 1706, and
2001 of this title, and section 112 of Title 32, National Guard,
amending provisions set out as a note under section 1521 of this
title, and repealing provisions set out as a note under section
1801 of this title] may be cited as the 'Office of National Drug
Control Policy Reauthorization Act of 2006'."
Pub. L. 109-469, title III, Sec. 302(a), Dec. 29, 2006, 120 Stat.
3524, provided that: "This section [amending section 1706 of this
title and enacting provisions set out as a note under section 1706
of this title] may be cited as the 'Dawson Family Community
Protection Act'."
SHORT TITLE
Pub. L. 105-277, div. C, title VII, Sec. 701, Oct. 21, 1998, 112
Stat. 2681-670, provided that: "This title [enacting this chapter,
amending section 1509 of this title, sections 5312 to 5314 of Title
5, Government Organization and Employees, section 1105 of Title 31,
Money and Finance, and section 402 of Title 50, War and National
Defense] may be cited as the 'Office of National Drug Control
Policy Reauthorization Act of 1998'."
MODEL ACTS
Pub. L. 109-469, title XI, Sec. 1105, Dec. 29, 2006, 120 Stat.
3541, provided that:
"(a) In General. - The Director of the Office of National Drug
Control Policy shall provide for or shall enter into an agreement
with a non-profit corporation that is described in section
501(c)(3) of the Internal Revenue Code of 1986 [26 U.S.C.
501(c)(3)] and exempt from tax under section 501(a) of such Code to
-
"(1) advise States on establishing laws and policies to address
alcohol and other drug issues, based on the model State drug laws
developed by the President's Commission on Model State Drug Laws
in 1993; and
"(2) revise such model State drug laws and draft supplementary
model State laws to take into consideration changes in the
alcohol and drug abuse problems in the State involved.
"(b) Authorization of Appropriations. - There is authorized to be
appropriated to carry out this subsection [probably should be
"section"] $1,500,000 for each of fiscal years 2007 through 2011."
-EXEC-
EX. ORD. NO. 13165. WHITE HOUSE TASK FORCE ON DRUG USE IN SPORTS
AND UNITED STATES REPRESENTATIVE ON THE BOARD OF THE WORLD
ANTI-DOPING AGENCY
Ex. Ord. No. 13165, Aug. 9, 2000, 65 F.R. 49469, as amended by
Ex. Ord. No. 13286, Sec. 11, Feb. 28, 2003, 68 F.R. 10622,
provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, including the Office
of National Drug Control [Policy] Reauthorization Act of 1998, (21
U.S.C. 1701 et seq.), and in order to develop recommendations for
Federal agency actions to address the use of drugs in sports, in
particular among young people, it is hereby ordered as follows:
Section 1. Policy. The use of drugs in sports has reached a level
that endangers not just the legitimacy of athletic competition but
also the lives and health of athletes - from the elite ranks to
youth leagues. The National Household Survey on Drug Abuse issued
in 1999 found that in just 1 year's time the rate of steroid use
among young people rose roughly 50 percent among both sexes and
across all age groups. It is the policy of my Administration to
take the steps needed to help eliminate illicit or otherwise banned
drug use and doping in sports at the State, national, and
international level.
Sec. 2. Establishment of a White House Task Force on Drug Use in
Sports. (a) There is established a White House Task Force on Drug
Use in Sports (Task Force). The Task Force shall comprise the co-
vice chairs of the White House Olympic Task Force (the "Olympic
Task Force Vice Chairs"), and representatives designated by the
Office of National Drug Control Policy, the Department of Health
and Human Services, the Department of Labor, the President's
Council on Physical Fitness and Sports, the Office of Management
and Budget, the National Security Council, the Department of State,
the Department of the Treasury, the Department of Education, the
Department of Justice, the Department of Transportation, the
Department of Homeland Security, the National Institute on Drug
Abuse, and the Substance Abuse and Mental Health Services
Administration.
(b) The Task Force shall develop recommendations for the
President on further executive and legislative actions that can be
undertaken to address the problem of doping and drug use in sports.
In developing the recommendations, the Task Force shall consider,
among other things: (i) the health and safety of America's
athletes, in particular our Nation's young people; (ii) the
integrity of honest athletic competition; and (iii) the views and
recommendations of State and local governments, the private sector,
citizens, community groups, and nonprofit organizations, on actions
to address this threat. The Task Force, through its Chairs, shall
submit its recommendations to the President.
(c) The Director of the Office of National Drug Control Policy
(the Director), the Secretary of the Department of Health and Human
Services, and the Olympic Task Force Vice Chairs or their designees
shall serve as the Task Force Chairs.
(d) To the extent permitted by law and at the request of the
Chairs, agencies shall cooperate with and provide information to
the Task Force.
Sec. 3. Participation in the World Anti-Doping Agency. (a) As
part of my Administration's efforts to address the problem of drug
use in sports, the United States has played a leading role in the
formation of a World Anti-Doping Agency (WADA) by the Olympic and
sports community and the nations of the world. Through these
efforts, the United States has been selected to serve as a
governmental representative on the board of the WADA. This order
will authorize the Director to serve as the United States
Government's representative on the WADA board.
(b) Pursuant to 21 U.S.C. 1701 et seq., the Director, or in his
absence his designee, is hereby authorized to take all necessary
and proper actions to execute his responsibilities as United States
representative to the WADA.
(c) To assist the Director in carrying out these responsibilities
as the United States Government representative to the WADA and to
the extent permitted by law, Federal employees may serve in their
official capacity, inter alia, on WADA Committees or WADA advisory
committees, serving as experts to the WADA.
-End-
-CITE-
21 USC Sec. 1702 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1702. Office of National Drug Control Policy
-STATUTE-
(a) Establishment of Office
There is established in the Executive Office of the President an
Office of National Drug Control Policy, which shall -
(1) develop national drug control policy;
(2) coordinate and oversee the implementation of the national
drug control policy;
(3) assess and certify the adequacy of National Drug Control
Programs and the budget for those programs; and
(4) evaluate the effectiveness of the national drug control
policy and the National Drug Control Program agencies' programs,
by developing and applying specific goals and performance
measurements.
When developing the national drug control policy, any policy of the
Director relating to syringe exchange programs for intravenous drug
users shall be based on the best available medical and scientific
evidence regarding their effectiveness in promoting individual
health and preventing the spread of infectious disease, and their
impact on drug addiction and use. In making any policy relating to
syringe exchange programs, the Director shall consult with the
National Institutes of Health and the National Academy of Sciences.
(b) Director of National Drug Control Policy and Deputy Directors
(1) Director
There shall be a Director of National Drug Control Policy who
shall head the Office (referred to in this chapter as the
"Director") and shall hold the same rank and status as the head
of an executive department listed in section 101 of title 5.
(2) Deputy Director
There shall be a Deputy Director of National Drug Control
Policy who shall report directly to the Director (referred to in
this chapter as the "Deputy Director").
(3) Other Deputy Directors
(A) In general
There shall be a Deputy Director for Demand Reduction, a
Deputy Director for Supply Reduction, and a Deputy Director for
State, Local, and Tribal Affairs.
(B) Reporting
The Deputy Director for Demand Reduction, the Deputy Director
for Supply Reduction, and the Deputy Director for State, Local,
and Tribal Affairs shall report directly to the Deputy Director
of the Office of National Drug Control Policy.
(C) Deputy Director for Demand Reduction
The Deputy Director for Demand Reduction shall be responsible
for the activities in subparagraphs (A) through (H) of section
1701(1) (!1) of this title.
(D) Deputy Director for Supply Reduction
The Deputy Director for Supply Reduction shall -
(i) have substantial experience and expertise in drug
interdiction and other supply reduction activities; and
(ii) be responsible for the activities in subparagraphs (A)
through (C) in section 1701(11) of this title.
(E) Deputy Director for State, Local, and Tribal Affairs
The Deputy Director for State, Local, and Tribal Affairs
shall be responsible for the activities -
(i) in subparagraphs (A) through (D) of section 1701(10) of
this title;
(ii) in section 1706 of this title, the High Intensity Drug
Trafficking Areas Program; and
(iii) in section 1707 of this title, the Counterdrug
Technology Assessment Center.
(c) Access by Congress
The location of the Office in the Executive Office of the
President shall not be construed as affecting access by Congress,
or any committee of the House of Representatives or the Senate, to
any -
(1) information, document, or study in the possession of, or
conducted by or at the direction of the Director; or
(2) personnel of the Office.
(d) Office of National Drug Control Policy Gift Fund
(1) Establishment
There is established in the Treasury of the United States a
fund for the receipt of gifts, both real and personal, for the
purpose of aiding or facilitating the work of the Office under
section 1703(c) of this title.
(2) Contributions
The Office may accept, hold, and administer contributions to
the Fund.
(3) Use of amounts deposited
Amounts deposited in the Fund are authorized to be
appropriated, to remain available until expended for authorized
purposes at the discretion of the Director.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 703, Oct. 21, 1998, 112
Stat. 2681-672; Pub. L. 109-469, title I, Sec. 102, title XI, Sec.
1120, Dec. 29, 2006, 120 Stat. 3505, 3548.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in subsec. (b)(1), (2), was in the
original "this Act" and was translated as reading "this title",
meaning title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112
Stat. 2681-670, which is classified principally to this chapter, to
reflect the probable intent of Congress. For complete
classification of title VII to the Code, see Short Title note set
out under section 1701 of this title and Tables.
Section 1701(1) of this title, referred to in subsec. (b)(3)(C),
was in the original "section 702(l)", and was translated as reading
"section 702(1)", meaning section 702(1) of Pub. L. 105-277, to
reflect the probable intent of Congress, because section 702 of
Pub. L. 105-277 does not contain a subsec. (l).
-MISC1-
AMENDMENTS
2006 - Subsec. (a). Pub. L. 109-469, Sec. 1120, inserted
concluding provisions.
Pub. L. 109-469, Sec. 102(a), amended subsec. (a) generally.
Prior to amendment, subsec. (a) related to establishment of Office
of National Drug Control Policy.
Subsec. (b). Pub. L. 109-469, Sec. 102(b), amended subsec. (b)
generally. Prior to amendment, subsec. (b) related to Director and
Deputy Directors of National Drug Control Policy.
GIFTS TO OFFICE OF NATIONAL DRUG CONTROL POLICY
Pub. L. 109-115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475,
provided in part: "That the Office [of National Drug Control
Policy] is authorized to accept, hold, administer, and utilize
gifts, both real and personal, public and private, without fiscal
year limitation, for the purpose of aiding or facilitating the work
of the Office."
Similar provisions were contained in the following prior
appropriation acts:
Pub. L. 108-447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249.
Pub. L. 108-199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.
Pub. L. 108-7, div. J, title III, Feb. 20, 2003, 117 Stat. 446.
Pub. L. 107-67, title III, Nov. 12, 2001, 115 Stat. 530.
Pub. L. 106-554, Sec. 1(a)(3) [title III], Dec. 21, 2000, 114
Stat. 2763, 2763A-139.
Pub. L. 106-58, title III, Sept. 29, 1999, 113 Stat. 447.
Pub. L. 105-277, div. A, Sec. 101(h) [title III], Oct. 21, 1998,
112 Stat. 2681-480, 2681-496.
Pub. L. 105-61, title III, Oct. 10, 1997, 111 Stat. 1293.
Pub. L. 104-208, div. A, title I, Sec. 101(f) [title III], Sept.
30, 1996, 110 Stat. 3009-314, 3009-329.
Pub. L. 104-52, title III, Nov. 19, 1995, 109 Stat. 479.
Pub. L. 103-329, title III, Sept. 30, 1994, 108 Stat. 2394.
Pub. L. 103-123, title III, Oct. 28, 1993, 107 Stat. 1237.
Pub. L. 102-393, title III, Oct. 6, 1992, 106 Stat. 1741.
Pub. L. 102-141, title III, Oct. 28, 1991, 105 Stat. 847.
Pub. L. 101-509, title III, Nov. 5, 1990, 104 Stat. 1402.
Pub. L. 101-136, title III, Nov. 3, 1989, 103 Stat. 793.
-EXEC-
EX. ORD. NO. 12911. SEAL FOR OFFICE OF NATIONAL DRUG CONTROL POLICY
Ex. Ord. No. 12911, Apr. 25, 1994, 59 F.R. 21121 [22121],
provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, it is hereby ordered
as follows:
Section 1. There is approved for the Office of National Drug
Control Policy in the Executive Office of the President an official
seal described as follows:
On a blue disc the Arms of the United States proper above a
curved gold scroll inscribed "OFFICE OF NATIONAL DRUG CONTROL
POLICY" in blue letters, all within a white border edged in gold
and inscribed "EXECUTIVE OFFICE OF THE PRESIDENT OF THE UNITED
STATES" in blue letters.
This design is appropriate for the Office of National Drug
Control Policy. The dark blue in this seal is suggested by the Seal
of the President and denotes the direct organizational link of the
Office of National Drug Control Policy with the Presidential
office. The Arms of the United States refer to the entire Nation
and represent the involvement in drug control policies that are
necessary to assist the President in his role as Chief Executive of
the United States.
Sec. 2. The seal shall be of the design that is attached hereto
and made a part of this order.
William J. Clinton.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 1703 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1703. Appointment and duties of Director and Deputy Directors
-STATUTE-
(a) Appointment
(1) In general
The Director, the Deputy Director of National Drug Control
Policy, the Deputy Director for Demand Reduction, the Deputy
Director for Supply Reduction, and the Deputy Director for State
and Local Affairs, shall each be appointed by the President, by
and with the advice and consent of the Senate, and shall serve at
the pleasure of the President. In appointing the Deputy Director
for Demand Reduction under this paragraph, the President shall
take into consideration the scientific, educational or
professional background of the individual, and whether the
individual has experience in the fields of substance abuse
prevention, education, or treatment.
(2) Duties of Deputy Director of National Drug Control Policy
The Deputy Director of National Drug Control Policy shall -
(A) carry out the duties and powers prescribed by the
Director; and
(B) serve as the Director in the absence of the Director or
during any period in which the office of the Director is
vacant.
(3) Acting Director
If the Director dies, resigns, or is otherwise unable to
perform the functions and duties of the office, the Deputy
Director shall perform the functions and duties of the Director
temporarily in an acting capacity pursuant to subchapter III of
chapter 33 of title 5.
(4) Prohibition
No person shall serve as Director or a Deputy Director while
serving in any other position in the Federal Government.
(5) Prohibition on political campaigning
Any officer or employee of the Office who is appointed to that
position by the President, by and with the advice and consent of
the Senate, may not participate in Federal election campaign
activities, except that such official is not prohibited by this
paragraph from making contributions to individual candidates.
(b) Responsibilities
The Director -
(1) shall assist the President in the establishment of
policies, goals, objectives, and priorities for the National Drug
Control Program;
(2) shall promulgate the National Drug Control Strategy under
section 1705(a) of this title and each report under section
1705(b) of this title in accordance with section 1705 of this
title;
(3) shall coordinate and oversee the implementation by the
National Drug Control Program agencies of the policies, goals,
objectives, and priorities established under paragraph (1) and
the fulfillment of the responsibilities of such agencies under
the National Drug Control Strategy and make recommendations to
National Drug Control Program agency heads with respect to
implementation of Federal counter-drug programs;
(4) shall make such recommendations to the President as the
Director determines are appropriate regarding changes in the
organization, management, and budgets of National Drug Control
Program agencies, and changes in the allocation of personnel to
and within those departments and agencies, to implement the
policies, goals, priorities, and objectives established under
paragraph (1) and the National Drug Control Strategy;
(5) shall consult with and assist State and local governments
with respect to the formulation and implementation of National
Drug Control Policy and their relations with the National Drug
Control Program agencies;
(6) shall appear before duly constituted committees and
subcommittees of the House of Representatives and of the Senate
to represent the drug policies of the executive branch;
(7) shall notify any National Drug Control Program agency if
its policies are not in compliance with the responsibilities of
the agency under the National Drug Control Strategy, transmit a
copy of each such notification to the President and the
appropriate congressional committees, and maintain a copy of each
such notification;
(8) shall provide, by July 1 of each year, budget
recommendations, including requests for specific initiatives that
are consistent with the priorities of the President under the
National Drug Control Strategy, to the heads of departments and
agencies with responsibilities under the National Drug Control
Program, which recommendations shall -
(A) apply to the next budget year scheduled for formulation
under chapter 11 of title 31, and each of the 4 subsequent
fiscal years; and
(B) address funding priorities developed in the National Drug
Control Strategy;
(9) may serve as representative of the President in appearing
before Congress on all issues relating to the National Drug
Control Program;
(10) shall, in any matter affecting national security
interests, work in conjunction with the Assistant to the
President for National Security Affairs;
(11) may serve as spokesperson of the Administration on drug
issues;
(12) shall ensure that no Federal funds appropriated to the
Office of National Drug Control Policy shall be expended for any
study or contract relating to the legalization (for a medical use
or any other use) of a substance listed in schedule I of section
812 of this title and take such actions as necessary to oppose
any attempt to legalize the use of a substance (in any form) that
-
(A) is listed in schedule I of section 812 of this title; and
(B) has not been approved for use for medical purposes by the
Food and Drug Administration;
(13) shall require each National Drug Control Program agency to
submit to the Director on an annual basis an evaluation of
progress by the agency with respect to drug control program goals
using the performance measures for the agency developed under
section 1705(c) of this title, including progress with respect to
-
(A) success in reducing domestic and foreign sources of
illegal drugs;
(B) success in protecting the borders of the United States
(and in particular the Southwestern border of the United
States) from penetration by illegal narcotics;
(C) success in reducing violent crime associated with drug
use in the United States;
(D) success in reducing the negative health and social
consequences of drug use in the United States; and
(E) implementation of drug treatment and prevention programs
in the United States and improvements in the adequacy and
effectiveness of such programs;
(14) shall submit to the appropriate congressional committees
on an annual basis, not later than 60 days after the date of the
last day of the applicable period, a summary of -
(A) each of the evaluations received by the Director under
paragraph (13); and
(B) the progress of each National Drug Control Program agency
toward the drug control program goals of the agency using the
performance measures for the agency developed under section
1705(c) of this title;
(15) shall ensure that drug prevention and drug treatment
research and information is effectively disseminated by National
Drug Control Program agencies to State and local governments and
nongovernmental entities involved in demand reduction by -
(A) encouraging formal consultation between any such agency
that conducts or sponsors research, and any such agency that
disseminates information in developing research and information
product development agendas;
(B) encouraging such agencies (as appropriate) to develop and
implement dissemination plans that specifically target State
and local governments and nongovernmental entities involved in
demand reduction; and
(C) supporting the substance abuse information clearinghouse
administered by the Administrator of the Substance Abuse and
Mental Health Services Administration and established in
section 290aa(d)(16) of title 42 by -
(i) encouraging all National Drug Control Program agencies
to provide all appropriate and relevant information; and
(ii) supporting the dissemination of information to all
interested entities;
(16) shall coordinate with the private sector to promote
private research and development of medications to treat
addiction;
(17) shall seek the support and commitment of State, local, and
tribal officials in the formulation and implementation of the
National Drug Control Strategy;
(18) shall monitor and evaluate the allocation of resources
among Federal law enforcement agencies in response to significant
local and regional drug trafficking and production threats;
(19) shall submit an annual report to Congress detailing how
the Office of National Drug Control Policy has consulted with and
assisted State, local, and tribal governments with respect to the
formulation and implementation of the National Drug Control
Strategy and other relevant issues; and
(20) shall, within 1 year after December 29, 2006, report to
Congress on the impact of each Federal drug reduction strategy
upon the availability, addiction rate, use rate, and other harms
of illegal drugs.
(c) National Drug Control Program budget
(1) Responsibilities of National Drug Control Program agencies
(A) In general
For each fiscal year, the head of each department, agency, or
program of the Federal Government with responsibilities under
the National Drug Control Program Strategy shall transmit to
the Director a copy of the proposed drug control budget request
of the department, agency, or program at the same time as that
budget request is submitted to their superiors (and before
submission to the Office of Management and Budget) in the
preparation of the budget of the President submitted to
Congress under section 1105(a) of title 31.
(B) Submission of drug control budget requests
The head of each National Drug Control Program agency shall
ensure timely development and submission to the Director of
each proposed drug control budget request transmitted pursuant
to this paragraph, in such format as may be designated by the
Director with the concurrence of the Director of the Office of
Management and Budget.
(C) Content of drug control budget requests
A drug control budget request submitted by a department,
agency, or program under this paragraph shall include all
requests for funds for any drug control activity undertaken by
that department, agency, or program, including demand
reduction, supply reduction, and State, local, and tribal
affairs, including any drug law enforcement activities. If an
activity has both drug control and nondrug control purposes or
applications, the department, agency, or program shall estimate
by a documented calculation the total funds requested for that
activity that would be used for drug control, and shall set
forth in its request the basis and method for making the
estimate.
(2) National Drug Control Program budget proposal
For each fiscal year, following the transmission of proposed
drug control budget requests to the Director under paragraph (1),
the Director shall, in consultation with the head of each
National Drug Control Program agency and the head of each major
national organization that represents law enforcement officers,
agencies, or associations -
(A) develop a consolidated National Drug Control Program
budget proposal designed to implement the National Drug Control
Strategy and to inform Congress and the public about the total
amount proposed to be spent on all supply reduction, demand
reduction, State, local, and tribal affairs, including any drug
law enforcement, and other drug control activities by the
Federal Government, which shall conform to the content
requirements set forth in paragraph (1)(C);
(B) submit the consolidated budget proposal to the President;
and
(C) after submission under subparagraph (B), submit the
consolidated budget proposal to Congress.
(3) Review and certification of budget requests and budget
submissions of National Drug Control Program agencies
(A) In general
The Director shall review each drug control budget request
submitted to the Director under paragraph (1).
(B) Review of budget requests
(i) Inadequate requests
If the Director concludes that a budget request submitted
under paragraph (1) is inadequate, in whole or in part, to
implement the objectives of the National Drug Control
Strategy with respect to the department, agency, or program
at issue for the year for which the request is submitted, the
Director shall submit to the head of the applicable National
Drug Control Program agency a written description of funding
levels and specific initiatives that would, in the
determination of the Director, make the request adequate to
implement those objectives.
(ii) Adequate requests
If the Director concludes that a budget request submitted
under paragraph (1) is adequate to implement the objectives
of the National Drug Control Strategy with respect to the
department, agency, or program at issue for the year for
which the request is submitted, the Director shall submit to
the head of the applicable National Drug Control Program
agency a written statement confirming the adequacy of the
request.
(iii) Record
The Director shall maintain a record of each description
submitted under clause (i) and each statement submitted under
clause (ii).
(C) Specific requests
The Director shall not confirm the adequacy of any budget
request that -
(i) requests funding for Federal law enforcement activities
that do not adequately compensate for transfers of drug
enforcement resources and personnel to law enforcement and
investigation activities;
(ii) requests funding for law enforcement activities on the
borders of the United States that do not adequately direct
resources to drug interdiction and enforcement;
(iii) requests funding for drug treatment activities that
do not provide adequate results and accountability measures;
(iv) requests funding for any activities of the Safe and
Drug-Free Schools Program that do not include a clear anti-
drug message or purpose intended to reduce drug use;
(v) requests funding for drug treatment activities that do
not adequately support and enhance Federal drug treatment
programs and capacity;
(vi) requests funding for fiscal year 2007 for activities
of the Department of Education, unless it is accompanied by a
report setting forth a plan for providing expedited
consideration of student loan applications for all
individuals who submitted an application for any Federal
grant, loan, or work assistance that was rejected or denied
pursuant to 1091(r)(1) (!1) of title 20 by reason of a
conviction for a drug-related offense not occurring during a
period of enrollment for which the individual was receiving
any Federal grant, loan, or work assistance; and
(vii) requests funding for the operations and management of
the Department of Homeland Security that does not include a
specific request for funds for the Office of Counternarcotics
Enforcement to carry out its responsibilities under section
458 of title 6.
(D) Agency response
(i) In general
The head of a National Drug Control Program agency that
receives a description under subparagraph (B)(i) shall
include the funding levels and initiatives described by the
Director in the budget submission for that agency to the
Office of Management and Budget.
(ii) Impact statement
The head of a National Drug Control Program agency that has
altered its budget submission under this subparagraph shall
include as an appendix to the budget submission for that
agency to the Office of Management and Budget an impact
statement that summarizes -
(I) the changes made to the budget under this
subparagraph; and
(II) the impact of those changes on the ability of that
agency to perform its other responsibilities, including any
impact on specific missions or programs of the agency.
(iii) Congressional notification
The head of a National Drug Control Program agency shall
submit a copy of any impact statement under clause (ii) to
the Senate and the House of Representatives and the
appropriate congressional committees, at the time the budget
for that agency is submitted to Congress under section
1105(a) of title 31.
(E) Certification of budget submissions
(i) In general
At the time a National Drug Control Program agency submits
its budget request to the Office of Management and Budget,
the head of the National Drug Control Program agency shall
submit a copy of the budget request to the Director.
(ii) Certification
The Director -
(I) shall review each budget submission submitted under
clause (i); and
(II) based on the review under subclause (I), if the
Director concludes that the budget submission of a National
Drug Control Program agency does not include the funding
levels and initiatives described under subparagraph (B) -
(aa) may issue a written decertification of that
agency's budget; and
(bb) in the case of a decertification issued under item
(aa), shall submit to the Senate and the House of
Representatives and the appropriate congressional
committees, a copy of -
(aaa) the decertification issued under item (aa);
(bbb) the description made under subparagraph (B);
and
(ccc) the budget recommendations made under
subsection (b)(8) of this section.
(4) Reprogramming and transfer requests
(A) In general
No National Drug Control Program agency shall submit to
Congress a reprogramming or transfer request with respect to
any amount of appropriated funds in an amount exceeding
$1,000,000 that is included in the National Drug Control
Program budget unless the request has been approved by the
Director. If the Director has not responded to a request for
reprogramming subject to this subparagraph within 30 days after
receiving notice of the request having been made, the request
shall be deemed approved by the Director under this
subparagraph and forwarded to Congress.
(B) Appeal
The head of any National Drug Control Program agency may
appeal to the President any disapproval by the Director of a
reprogramming or transfer request under this paragraph.
(d) Powers of the Director
In carrying out subsection (b) of this section, the Director may -
(1) select, appoint, employ, and fix compensation of such
officers and employees of the Office as may be necessary to carry
out the functions of the Office under this chapter;
(2) subject to subsection (e)(3) of this section, request the
head of a department or agency, or program of the Federal
Government to place department, agency, or program personnel who
are engaged in drug control activities on temporary detail to
another department, agency, or program in order to implement the
National Drug Control Strategy, and the head of the department or
agency shall comply with such a request;
(3) use for administrative purposes, on a reimbursable basis,
the available services, equipment, personnel, and facilities of
Federal, State, and local agencies;
(4) procure the services of experts and consultants in
accordance with section 3109 of title 5, relating to appointments
in the Federal Service, at rates of compensation for individuals
not to exceed the daily equivalent of the rate of pay payable
under level IV of the Executive Schedule under section 5311 of
title 5;
(5) accept and use gifts and donations of property from
Federal, State, and local government agencies, and from the
private sector, as authorized in section 1702(d) of this title;
(6) use the mails in the same manner as any other department or
agency of the executive branch;
(7) monitor implementation of the National Drug Control
Program, including -
(A) conducting program and performance audits and
evaluations; and
(B) requesting assistance from the Inspector General of the
relevant agency in such audits and evaluations;
(8) transfer funds made available to a National Drug Control
Program agency for National Drug Control Strategy programs and
activities to another account within such agency or to another
National Drug Control Program agency for National Drug Control
Strategy programs and activities, except that -
(A) the authority under this paragraph may be limited in an
annual appropriations Act or other provision of Federal law;
(B) the Director may exercise the authority under this
paragraph only with the concurrence of the head of each
affected agency;
(C) in the case of an interagency transfer, the total amount
of transfers under this paragraph may not exceed 3 percent of
the total amount of funds made available for National Drug
Control Strategy programs and activities to the agency from
which those funds are to be transferred;
(D) funds transferred to an agency under this paragraph may
only be used to increase the funding for programs or activities
authorized by law; and
(E) the Director shall -
(i) submit to Congress, including to the Committees on
Appropriations of the Senate and the House of
Representatives, the authorizing committees for the Office,
and any other applicable committees of jurisdiction, a
reprogramming or transfer request in advance of any transfer
under this paragraph in accordance with the regulations of
the affected agency or agencies; and
(ii) annually submit to Congress a report describing the
effect of all transfers of funds made pursuant to this
paragraph or subsection (c)(4) of this section during the 12-
month period preceding the date on which the report is
submitted;
(9) issue to the head of a National Drug Control Program agency
a fund control notice described in subsection (f) of this section
to ensure compliance with the National Drug Control Program
Strategy and notify the appropriate congressional committees of
any fund control notice issued in accordance with subsection
(f)(5);
(10) participate in the drug certification process pursuant to
section 2291j of title 22 and section 2291j-1 of title 22.
(e) Personnel detailed to Office
(1) Evaluations
Notwithstanding any provision of chapter 43 of title 5, the
Director shall perform the evaluation of the performance of any
employee detailed to the Office for purposes of the applicable
performance appraisal system established under such chapter for
any rating period, or part thereof, that such employee is
detailed to such office.
(2) Compensation
(A) Bonus payments
Notwithstanding any other provision of law, the Director may
provide periodic bonus payments to any employee detailed to the
Office.
(B) Restrictions
An amount paid under this paragraph to an employee for any
period -
(i) shall not be greater than 20 percent of the basic pay
paid or payable to such employee for such period; and
(ii) shall be in addition to the basic pay of such
employee.
(C) Aggregate amount
The aggregate amount paid during any fiscal year to an
employee detailed to the Office as basic pay, awards, bonuses,
and other compensation shall not exceed the annual rate payable
at the end of such fiscal year for positions at level III of
the Executive Schedule.
(3) Maximum number of detailees
The maximum number of personnel who may be detailed to another
department or agency (including the Office) under subsection
(d)(2) of this section during any fiscal year is -
(A) for the Department of Defense, 50; and
(B) for any other department or agency, 10.
(f) Fund control notices
(1) In general
A fund control notice may direct that all or part of an amount
appropriated to the National Drug Control Program agency account
be obligated by -
(A) months, fiscal year quarters, or other time periods; and
(B) activities, functions, projects, or object classes.
(2) Unauthorized obligation or expenditure prohibited
An officer or employee of a National Drug Control Program
agency shall not make or authorize an expenditure or obligation
contrary to a fund control notice issued by the Director.
(3) Disciplinary action for violation
In the case of a violation of paragraph (2) by an officer or
employee of a National Drug Control Program agency, the head of
the agency, upon the request of and in consultation with the
Director, may subject the officer or employee to appropriate
administrative discipline, including, when circumstances warrant,
suspension from duty without pay or removal from office.
(4) (!2) Congressional notice
A copy of each fund control notice shall be transmitted to the
appropriate congressional committees.
(5) (!3) Restrictions
The Director shall not issue a fund control notice to direct
that all or part of an amount appropriated to the National Drug
Control Program agency account be obligated, modified, or altered
in any manner -
(A) contrary, in whole or in part, to a specific
appropriation; or
(B) contrary, in whole or in part, to the expressed intent of
Congress.
(4) (!2) Congressional notice. -
A copy of each fund control notice shall be transmitted to the
appropriate congressional committees.
(5) (!3) Restrictions
The Director shall not issue a fund control notice to direct
that all or part of an amount appropriated to the National Drug
Control Program agency account be obligated, modified, or altered
in any manner contrary, in whole or in part, to a specific
appropriation or statute.
(g) Inapplicability to certain programs
The provisions of this section shall not apply to the National
Intelligence Program, the Joint Military Intelligence Program, and
Tactical and Related Activities, unless such program or an element
of such program is designated as a National Drug Control Program -
(1) by the President; or
(2) jointly by -
(A) in the case of the National Intelligence Program, the
Director and the Director of National Intelligence; or
(B) in the case of the Joint Military Intelligence Program
and Tactical and Related Activities, the Director, the Director
of National Intelligence, and the Secretary of Defense.
(h) Construction
Nothing in this chapter shall be construed as derogating the
authorities and responsibilities of the Director of National
Intelligence or the Director of the Central Intelligence Agency
contained in the National Security Act of 1947 (50 U.S.C. 401 et
seq.), the Central Intelligence Agency Act of 1949 (50 U.S.C. 403a
et seq.), or any other law.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 704, Oct. 21, 1998, 112
Stat. 2681-672; Pub. L. 109-469, title I, Secs. 103(a)-(e), (f)(3),
105, Dec. 29, 2006, 120 Stat. 3506, 3507, 3510, 3511.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
Levels III and IV of the Executive Schedule, referred to in
subsecs. (d)(4) and (e)(2)(C), are set out in sections 5314 and
5315, respectively, of Title 5, Government Organization and
Employees.
This chapter, referred to in subsec. (h), was in the original
"this Act" and was translated as reading "this title", meaning
title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112 Stat. 2681-
670, which is classified principally to this chapter, to reflect
the probable intent of Congress. For complete classification of
title VII to the Code, see Short Title note set out under section
1701 of this title and Tables.
The National Security Act of 1947, referred to in subsec. (h), is
act July 26, 1947, ch. 343, 61 Stat. 495, as amended. For complete
classification of this Act to the Code, see Short Title note set
out under section 401 of Title 50, War and National Defense, and
Tables.
The Central Intelligence Agency Act of 1949, referred to in
subsec. (h), is act June 20, 1949, ch. 227, 63 Stat. 208, as
amended, which is classified generally to section 403a et seq. of
Title 50, War and National Defense. For complete classification of
this Act to the Code, see Short Title note set out under section
403a of Title 50 and Tables.
-COD-
CODIFICATION
In subsec. (b)(8)(A), "chapter 11 of title 31" substituted for
"the Budget and Accounting Act of 1921" on authority of Pub. L. 97-
258, Sec. 4(b), Sept. 13, 1982, 96 Stat. 1067, the first section
of which enacted Title 31, Money and Finance.
-MISC1-
AMENDMENTS
2006 - Subsec. (a)(3). Pub. L. 109-469, Sec. 103(a), amended par.
(3) generally. Prior to amendment, text read as follows: "In the
absence of the Deputy Director, or if the Office of the Deputy
Director is vacant, the Director shall designate such other
permanent employee of the Office to serve as the Director, if the
Director is absent or unable to serve."
Subsec. (b)(4). Pub. L. 109-469, Sec. 103(b)(1), substituted
"National Drug Control Program agencies" for "Federal departments
and agencies engaged in drug enforcement".
Subsec. (b)(7). Pub. L. 109-469, Sec. 103(b)(2), inserted "and
the appropriate congressional committees" after "President".
Subsec. (b)(13). Pub. L. 109-469, Sec. 103(b)(3), struck out
"(beginning in 1999)" after "basis" in introductory provisions.
Subsec. (b)(14). Pub. L. 109-469, Sec. 103(b)(4), added par. (14)
and struck out former par. (14) which read as follows: "shall
submit to the Appropriations committees and the authorizing
committees of jurisdiction of the House of Representatives and the
Senate on an annual basis, not later than 60 days after the date of
the last day of the applicable period, a summary of -
"(A) each of the evaluations received by the Director under
paragraph (13); and
"(B) the progress of each National Drug Control Program agency
toward the drug control program goals of the agency using the
performance measures for the agency developed under section
1705(c) of this title; and".
Subsec. (b)(15)(C). Pub. L. 109-469, Sec. 103(b)(5), added
subpar. (C) and struck out former subpar. (C) which read as
follows: "developing a single interagency clearinghouse for the
dissemination of research and information by such agencies to State
and local governments and nongovernmental agencies involved in
demand reduction."
Subsec. (b)(16) to (20). Pub. L. 109-469, Sec. 103(b)(6), added
pars. (16) to (20).
Subsec. (c)(1)(C). Pub. L. 109-469, Sec. 105(a), added subpar.
(C).
Subsec. (c)(2). Pub. L. 109-469, Sec. 105(b)(1), inserted "and
the head of each major national organization that represents law
enforcement officers, agencies, or associations" after "agency" in
introductory provisions.
Subsec. (c)(2)(A). Pub. L. 109-469, Sec. 105(b)(2), inserted "and
to inform Congress and the public about the total amount proposed
to be spent on all supply reduction, demand reduction, State,
local, and tribal affairs, including any drug law enforcement, and
other drug control activities by the Federal Government, which
shall conform to the content requirements set forth in paragraph
(1)(C)" before semicolon at end.
Subsec. (c)(3)(C). Pub. L. 109-469, Sec. 105(c)(2), added subpar.
(C). Former subpar. (C) redesignated (D).
Subsec. (c)(3)(C)(iii). Pub. L. 109-469, Sec. 103(c)(1), inserted
"and the appropriate congressional committees," after "House of
Representatives".
Subsec. (c)(3)(D). Pub. L. 109-469, Sec. 105(c)(1), redesignated
subpar. (C) as (D). Former subpar. (D) redesignated (E).
Subsec. (c)(3)(D)(ii)(II)(bb). Pub. L. 109-469, Sec. 103(c)(2),
inserted "and the appropriate congressional committees," after
"House of Representatives".
Subsec. (c)(3)(D)(iii). Pub. L. 109-469, Sec. 105(c)(3), which
directed amendment of cl. (iii) by inserting "and the appropriate
congressional committees," after "House of Representatives", was
not executed in view of the identical amendment made by Pub. L. 109-
469, Sec. 103(c)(1) to subpar. (C)(iii) prior to its redesignation
as (D)(iii). See above.
Subsec. (c)(3)(E). Pub. L. 109-469, Sec. 105(c)(1), redesignated
subpar. (D) as (E).
Subsec. (c)(3)(E)(ii)(II)(bb). Pub. L. 109-469, Sec. 105(c)(4),
which directed amendment of item (bb) by inserting "and the
appropriate congressional committees," after "House of
Representatives", was not executed in view of the identical
amendment made by Pub. L. 109-469, Sec. 103(c)(2) to subpar.
(D)(ii)(II)(bb) prior to its redesignation as (E)(ii)(II)(bb). See
above.
Subsec. (c)(4)(A). Pub. L. 109-469, Sec. 105(d), substituted
"$1,000,000" for "$5,000,000" and inserted at end "If the Director
has not responded to a request for reprogramming subject to this
subparagraph within 30 days after receiving notice of the request
having been made, the request shall be deemed approved by the
Director under this subparagraph and forwarded to Congress."
Subsec. (d)(8)(D). Pub. L. 109-469, Sec. 105(e)(1), substituted
"authorized by law;" for "have been authorized by Congress;".
Subsec. (d)(9). Pub. L. 109-469, Sec. 105(e)(2), which directed
the substitution of "Strategy and notify the appropriate
congressional committees of any fund control notice issued; and"
for "Strategy; and", could not be executed because the words
"Strategy; and" did not appear subsequent to amendment by Pub. L.
109-469, Sec. 103(d)(1). See below.
Pub. L. 109-469, Sec. 103(d)(1), substituted "Strategy and notify
the appropriate congressional committees of any fund control notice
issued in accordance with subsection (f)(5);" for "Strategy; and".
Subsec. (d)(10). Pub. L. 109-469, Secs. 103(d)(2) and 105(e)(3),
made identical amendments, inserting "and section 2291j-1 of title
22" before period at end.
Subsec. (f)(4), (5). Pub. L. 109-469, Sec. 105(f), added pars.
(4) and (5) set out second.
Pub. L. 109-469, Sec. 103(e), added pars. (4) and (5) set out
first.
Subsec. (g). Pub. L. 109-469, Sec. 103(f)(3)(A), amended subsec.
(g) generally. Prior to amendment, text read as follows: "The
provisions of this section shall not apply to the National Foreign
Intelligence Program, the Joint Military Intelligence Program and
Tactical Intelligence and Related Activities unless the agency that
carries out such program is designated as a National Drug Control
Program agency by the President or jointly by the Director and the
head of the agency."
Subsec. (h). Pub. L. 109-469, Sec. 103(f)(3)(B), amended subsec.
(h) generally. Prior to amendment, text read as follows: "Nothing
in this chapter shall be construed as derogating the authorities
and responsibilities of the Director of Central Intelligence
contained in sections 403-4 and 414 of title 50 or any other law."
REPORT ON STREAMLINING FEDERAL PREVENTION AND TREATMENT EFFORTS
Pub. L. 105-277, div. D, title II, Sec. 221, Oct. 21, 1998, 112
Stat. 2681-758, expressed sense of Congress that efforts of the
Federal Government to reduce demand for illegal drugs in United
States are frustrated by fragmentation of those efforts across
multiple departments and agencies, and improvement of those efforts
can best be achieved through consolidation and coordination, and
further provided that not later than 18 months after Oct. 21, 1998,
Director of the Office of National Drug Control Policy was to
prepare and submit to Congress a report evaluating options for
increasing efficacy of drug prevention and treatment programs,
including a thorough review of activities and potential
consolidation of existing Federal drug information clearinghouses.
-EXEC-
EX. ORD. NO. 12880. NATIONAL DRUG CONTROL PROGRAM
Ex. Ord. No. 12880, Nov. 16, 1993, 58 F.R. 60989, as amended by
Ex. Ord. No. 13008, June 3, 1996, 61 F.R. 28721, provided:
The Office of National Drug Control Policy has the lead
responsibility within the Executive Office of the President to
establish policies, priorities, and objectives for the Nation's
drug control program, with the goal of reducing the production,
availability, and use of illegal drugs. All lawful and reasonable
means must be used to ensure that the United States has a
comprehensive and effective National Drug Control Strategy.
Therefore, by the authority vested in me as President by the
Constitution and the laws of the United States of America,
including the National Narcotics Leadership Act of 1988, as amended
(former 21 U.S.C. 1501 et seq.), and in order to provide for the
effective management of the drug abuse policies of the United
States, it is hereby ordered as follows:
Section 1. General Provisions. (a) Because the United States
considers the operations of international criminal narcotics
syndicates as a national security threat requiring an extraordinary
and coordinated response by civilian and military agencies involved
in national security, the Director of the Office of National Drug
Control Policy (Director), in his role as the principal adviser to
the National Security Council on national drug control policy (50
U.S.C. 402(f)), shall provide drug policy guidance and direction in
the development of related national security programs.
(b) The Director shall provide oversight and direction for all
international counternarcotics policy development and
implementation, in coordination with other concerned Cabinet
members, as appropriate.
(c) An Interagency Working Group (IWG) on international
counternarcotics policy, chaired by the Office of National Drug
Control Policy, shall develop and ensure coordinated implementation
of an international counternarcotics policy. The IWG shall report
its activities and differences of views among agencies to the
Director for review, mediation, and resolution with concerned
Cabinet members, and if necessary, by the President.
(d) A coordinator for drug interdiction shall be designated by
the Director to ensure that assets dedicated by Federal drug
program agencies for interdiction are sufficient and that their use
is properly integrated and optimized. The coordinator shall ensure
that interdiction efforts and priorities are consistent with
overall U.S. international counternarcotics policy.
(e) The Director shall examine the number and structure of
command/control and drug intelligence centers operated by drug
control program agencies involved in international counter-
narcotics and suggest improvements to the current structure for
consideration by the President and concerned members of the
Cabinet.
(f) The Director, utilizing the services of the Drugs and Crime
Data Center and Department of Justice Clearinghouse, shall assist
in coordinating and enhancing the dissemination of statistics and
studies relating to anti-drug abuse policy.
(g) The Director shall provide advice to agencies regarding ways
to achieve efficiencies in spending and improvements to interagency
cooperation that could enhance the delivery of drug control
treatment and prevention services to the public. The Director may
request agencies to provide studies, information, and analyses in
support of this order.
Sec. 2. Goals, Direction, Duties and Responsibilities with
Respect to the National Drug Control Program. (a) Budget Matters.
(1) In addition to the budgetary authorities and responsibilities
provided to the Director by statute, [former] 21 U.S.C. 1502, for
those agency budget requests that are not certified as adequate to
implement the objectives of the National Drug Control Strategy, the
Director shall include in such certifications initiatives or
funding levels that would make such requests adequate.
(2) The Director shall provide, by July 1 of each year, budget
recommendations to the heads of departments and agencies with
responsibilities under the National Drug Control Program. The
recommendations shall apply to the second following fiscal year and
address funding priorities developed in the annual National Drug
Control Strategy.
(b) Measurement of National Drug Control Strategy Outcomes. (1)
The National Drug Control Strategy shall include long-range goals
for reducing drug use and the consequences of drug use in the
United States, including burdens on hospital emergency rooms, drug
use among arrestees, the extent of drug-related crime, high school
dropout rates, the number of infants exposed annually to illicit
drugs in utero, national drug abuse treatment capacity, and the
annual national health care costs of drug use.
(2) The National Drug Control Strategy shall also include an
assessment of the quality of techniques and instruments to measure
current drug use and supply and demand reduction activities, and
the adequacy of the coverage of existing national drug use
instruments and techniques to measure the total illicit drug user
population and groups at-risk for drug use.
(3) The Director shall coordinate an effort among the relevant
drug control program agencies to assess the quality, access,
management, effectiveness, and standards of accountability of drug
abuse treatment, prevention, education, and other demand reduction
activities.
(c) Provision of Reports. To the extent permitted by law, heads
of departments and agencies with responsibilities under the
National Drug Control Program shall make available to the Office of
National Drug Control Policy, appropriate statistics, studies, and
reports, pertaining to Federal drug abuse control.
William J. Clinton.
-FOOTNOTE-
(!1) So in original. Probably should be preceded by "section".
(!2) So in original. Two pars. (4) have been enacted.
(!3) So in original. Two pars. (5) have been enacted.
-End-
-CITE-
21 USC Sec. 1704 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1704. Coordination with National Drug Control Program agencies
in demand reduction, supply reduction, and State and local
affairs
-STATUTE-
(a) Access to information
(1) In general
Upon the request of the Director, the head of any National Drug
Control Program agency shall cooperate with and provide to the
Director any statistics, studies, reports, and other information
prepared or collected by the agency concerning the
responsibilities of the agency under the National Drug Control
Strategy that relate to -
(A) drug control; or
(B) the manner in which amounts made available to that agency
for drug control are being used by that agency.
(2) Protection of intelligence information
(A) In general
The authorities conferred on the Office and the Director by
this chapter shall be exercised in a manner consistent with
provisions of the National Security Act of 1947 (50 U.S.C. 401
et seq.). The Director of National Intelligence shall prescribe
such regulations as may be necessary to protect information
provided pursuant to this chapter regarding intelligence
sources and methods.
(B) Duties of Director
The Director of National Intelligence and the Director of the
Central Intelligence Agency shall, to the maximum extent
practicable in accordance with subparagraph (A), render full
assistance and support to the Office and the Director.
(3) Required reports
(A) Secretaries of the Interior and Agriculture
Not later than July 1 of each year, the Secretaries of
Agriculture and the Interior shall jointly submit to the
Director and the appropriate congressional committees an
assessment of the quantity of illegal drug cultivation and
manufacturing in the United States on lands owned or under the
jurisdiction of the Federal Government for the preceding year.
(B) Secretary of Homeland Security
Not later than July 1 of each year, the Secretary of Homeland
Security shall submit to the Director and the appropriate
congressional committees information for the preceding year
regarding -
(i) the number and type of seizures of drugs by each
component of the Department of Homeland Security seizing
drugs, as well as statistical information on the geographic
areas of such seizures; and
(ii) the number of air and maritime patrol hours primarily
dedicated to drug supply reduction missions undertaken by
each component of the Department of Homeland Security.
(C) Secretary of Defense
The Secretary of Defense shall, by July 1 of each year,
submit to the Director and the appropriate congressional
committees information for the preceding year regarding the
number of air and maritime patrol hours primarily dedicated to
drug supply reduction missions undertaken by each component of
the Department of Defense.
(D) Attorney General
The Attorney General shall, by July 1 of each year, submit to
the Director and the appropriate congressional committees
information for the preceding year regarding the number and
type of -
(i) arrests for drug violations;
(ii) prosecutions for drug violations by United States
Attorneys; and
(iii) seizures of drugs by each component of the Department
of Justice seizing drugs, as well as statistical information
on the geographic areas of such seizures.
(b) Certification of policy changes to Director
(1) In general
Subject to paragraph (2), the head of a National Drug Control
Program agency shall, unless exigent circumstances require
otherwise, notify the Director in writing regarding any proposed
change in policies relating to the activities of that agency
under the National Drug Control Program prior to implementation
of such change. The Director shall promptly review such proposed
change and certify to the head of that agency in writing whether
such change is consistent with the National Drug Control
Strategy.
(2) Exception
If prior notice of a proposed change under paragraph (1) is not
practicable -
(A) the head of the National Drug Control Program agency
shall notify the Director of the proposed change as soon as
practicable; and
(B) upon such notification, the Director shall review the
change and certify to the head of that agency in writing
whether the change is consistent with the National Drug Control
Strategy.
(c) General Services Administration
The Administrator of General Services shall provide to the
Director, on a reimbursable basis, such administrative support
services as the Director may request.
(d) Accounting of funds expended
The Director shall -
(A) require the National Drug Control Program agencies to
submit to the Director not later than February 1 of each year a
detailed accounting of all funds expended by the agencies for
National Drug Control Program activities during the previous
fiscal year, and require such accounting to be authenticated by
the Inspector General for each agency prior to submission to the
Director; and
(B) submit to Congress not later than April 1 of each year the
information submitted to the Director under subparagraph (A).
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 705, Oct. 21, 1998, 112
Stat. 2681-680; Pub. L. 109-469, title I, Sec. 104, Dec. 29, 2006,
120 Stat. 3510.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
The National Security Act of 1947, referred to in subsec.
(a)(2)(A), is act July 26, 1947, ch. 343, 61 Stat. 495, as amended.
For complete classification of this Act to the Code, see Short
Title note set out under section 401 of Title 50, War and National
Defense, and Tables.
-MISC1-
AMENDMENTS
2006 - Subsec. (a)(1)(A). Pub. L. 109-469, Sec. 104(1), struck
out "abuse" after "drug".
Subsec. (a)(2)(A). Pub. L. 109-469, Sec. 104(2), substituted
"Director of National Intelligence" for "Director of Central
Intelligence".
Subsec. (a)(2)(B). Pub. L. 109-469, Sec. 104(3), substituted
"Director of National Intelligence and the Director of the Central
Intelligence Agency" for "Director of Central Intelligence".
Subsec. (a)(3). Pub. L. 109-469, Sec. 104(4), amended par. (3)
generally. Prior to amendment, text read as follows: "The Secretary
of Agriculture shall annually submit to the Director an assessment
of the acreage of illegal drug cultivation in the United States."
Subsec. (b)(2)(B). Pub. L. 109-469, Sec. 104(5), substituted
"Strategy" for "Program".
Subsec. (c). Pub. L. 109-469, Sec. 104(6), substituted "on" for
"in".
-End-
-CITE-
21 USC Sec. 1705 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1705. Development, submission, implementation, and assessment
of National Drug Control Strategy
-STATUTE-
(a) Timing, contents, and process for development and submission of
National Drug Control Strategy
(1) Timing
Not later than February 1 of each year, the President shall
submit to Congress a National Drug Control Strategy, which shall
set forth a comprehensive plan for the year to reduce illicit
drug use and the consequences of such illicit drug use in the
United States by limiting the availability of, and reducing the
demand for, illegal drugs.
(2) Contents
(A) In general
The National Drug Control Strategy submitted under paragraph
(1) shall include the following:
(i) Comprehensive, research-based, long-range, quantifiable
goals for reducing illicit drug use and the consequences of
illicit drug use in the United States.
(ii) Annual quantifiable and measurable objectives and
specific targets to accomplish long-term quantifiable goals
that the Director determines may be achieved during each year
beginning on the date on which the National Drug Control
Strategy is submitted.
(iii) A 5-year projection for program and budget
priorities.
(iv) A review of international, State, local, and private
sector drug control activities to ensure that the United
States pursues coordinated and effective drug control at all
levels of government.
(v) An assessment of current illicit drug use (including
inhalants and steroids) and availability, impact of illicit
drug use, and treatment availability, which assessment shall
include -
(I) estimates of drug prevalence and frequency of use as
measured by national, State, and local surveys of illicit
drug use and by other special studies of nondependent and
dependent illicit drug use;
(II) illicit drug use in the workplace and the
productivity lost by such use; and
(III) illicit drug use by arrestees, probationers, and
parolees.
(vi) An assessment of the reduction of illicit drug
availability, as measured by -
(I) the quantities of cocaine, heroin, marijuana,
methamphetamine, ecstasy, and other drugs available for
consumption in the United States;
(II) the amount of marijuana, cocaine, heroin,
methamphetamine, ecstasy, and precursor chemicals and other
drugs entering the United States;
(III) the number of illicit drug manufacturing
laboratories seized and destroyed and the number of
hectares of marijuana, poppy, and coca cultivated and
destroyed domestically and in other countries;
(IV) the number of metric tons of marijuana, heroin,
cocaine, and methamphetamine seized and other drugs; and
(V) changes in the price and purity of heroin,
methamphetamine, and cocaine, changes in the price of
ecstasy, and changes in tetrahydrocannabinol level of
marijuana and other drugs.
(vii) An assessment of the reduction of the consequences of
illicit drug use and availability, which shall include -
(I) the burden illicit drug users placed on hospital
emergency departments in the United States, such as the
quantity of illicit drug-related services provided;
(II) the annual national health care cost of illicit drug
use; and
(III) the extent of illicit drug-related crime and
criminal activity.
(viii) A determination of the status of drug treatment in
the United States, by assessing -
(I) public and private treatment utilization; and
(II) the number of illicit drug users the Director
estimates meet diagnostic criteria for treatment.
(ix) A review of the research agenda of the Counterdrug
Technology Assessment Center to reduce the availability and
abuse of drugs.
(x) A summary of the efforts made to coordinate with
private sector entities to conduct private research and
development of medications to treat addiction by -
(I) screening chemicals for potential therapeutic value;
(II) developing promising compounds;
(III) conducting clinical trials;
(IV) seeking Food and Drug Administration approval for
drugs to treat addiction;
(V) marketing the drug for the treatment of addiction;
(VI) urging physicians to use the drug in the treatment
of addiction; and
(VII) encouraging insurance companies to reimburse the
cost of the drug for the treatment of addiction.
(xi) An assessment of Federal effectiveness in achieving
the National Drug Control Strategy for the previous year,
including a specific evaluation of whether the objectives and
targets for reducing illicit drug use for the previous year
were met and reasons for the success or failure of the
previous year's Strategy.
(xii) A general review of the status of, and trends in,
demand reduction activities by private sector entities and
community-based organizations, including faith-based
organizations, to determine their effectiveness and the
extent of cooperation, coordination, and mutual support
between such entities and organizations and Federal, State,
local, and tribal government agencies.
(xiii) Such additional statistical data and information as
the Director considers appropriate to demonstrate and assess
trends relating to illicit drug use, the effects and
consequences of illicit drug use (including the effects on
children of substance abusers), supply reduction, demand
reduction, drug-related law enforcement, and the
implementation of the National Drug Control Strategy.
(xiv) A supplement reviewing the activities of each
individual National Drug Control Program agency during the
previous year with respect to the National Drug Control
Strategy and the Director's assessment of the progress of
each National Drug Control Program agency in meeting its
responsibilities under the National Drug Control Strategy.
(B) Classified information
Any contents of the National Drug Control Strategy that
involve information properly classified under criteria
established by an Executive order shall be presented to
Congress separately from the rest of the National Drug Control
Strategy.
(C) Selection of data and information
In selecting data and information for inclusion under
subparagraph (A), the Director shall ensure -
(i) the inclusion of data and information that will permit
analysis of current trends against previously compiled data
and information where the Director believes such analysis
enhances long-term assessment of the National Drug Control
Strategy; and
(ii) the inclusion of data and information to permit a
standardized and uniform assessment of the effectiveness of
drug treatment programs in the United States.
(3) Process for development and submission
In developing and effectively implementing the National Drug
Control Strategy, the Director -
(A) shall consult with -
(i) the heads of the National Drug Control Program
agencies;
(ii) Congress;
(iii) State, local, and tribal officials;
(iv) private citizens and organizations, including
community and faith-based organizations with experience and
expertise in demand reduction;
(v) private citizens and organizations with experience and
expertise in supply reduction; and
(vi) appropriate representatives of foreign governments;
(B) in satisfying the requirements of subparagraph (A), shall
ensure, to the maximum extent possible, that State, local, and
tribal officials and relevant private organizations commit to
support and take steps to achieve the goals and objectives of
the National Drug Control Strategy;
(C) with the concurrence of the Attorney General, may require
the El Paso Intelligence Center to undertake specific tasks or
projects to support or implement the National Drug Control
Strategy; and
(D) with the concurrence of the Director of National
Intelligence and the Attorney General, may request that the
National Drug Intelligence Center undertake specific tasks or
projects to support or implement the National Drug Control
Strategy.
(b) Submission of revised strategy
The President may submit to Congress a revised National Drug
Control Strategy that meets the requirements of this section -
(1) at any time, upon a determination of the President, in
consultation with the Director, that the National Drug Control
Strategy in effect is not sufficiently effective; or
(2) if a new President or Director takes office.
(c) Performance measurement system
Not later than February 1 of each year, the Director shall submit
to Congress as part of the National Drug Control Strategy, a
description of a national drug control performance measurement
system, that -
(1) develops 2-year and 5-year performance measures and targets
for each National Drug Control Strategy goal and objective
established for reducing drug use, availability, and the
consequences of drug use;
(2) describes the sources of information and data that will be
used for each performance measure incorporated into the
performance measurement system;
(3) identifies major programs and activities of the National
Drug Control Program agencies that support the goals and annual
objectives of the National Drug Control Strategy;
(4) evaluates the contribution of demand reduction and supply
reduction activities as defined in section 1701 of this title
implemented by each National Drug Control Program agency in
support of the National Drug Control Strategy;
(5) monitors consistency between the drug-related goals and
objectives of the National Drug Control Program agencies and
ensures that each agency's goals and budgets support and are
fully consistent with the National Drug Control Strategy; and
(6) coordinates the development and implementation of national
drug control data collection and reporting systems to support
policy formulation and performance measurement, including an
assessment of -
(A) the quality of current drug use measurement instruments
and techniques to measure supply reduction and demand reduction
activities;
(B) the adequacy of the coverage of existing national drug
use measurement instruments and techniques to measure the
illicit drug user population, and groups that are at risk for
illicit drug use;
(C) the adequacy of the coverage of existing national
treatment outcome monitoring systems to measure the
effectiveness of drug abuse treatment in reducing illicit drug
use and criminal behavior during and after the completion of
substance abuse treatment; and
(D) the actions the Director shall take to correct any
deficiencies and limitations identified pursuant to
subparagraphs (A) and (B) of this subsection.
(d) Modifications
A description of any modifications made during the preceding year
to the national drug performance measurement system described in
subsection (c) shall be included in each report submitted under
subsection (b).
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 706, Oct. 21, 1998, 112
Stat. 2681-681; Pub. L. 109-469, title II, Secs. 201, 202, Dec. 29,
2006, 120 Stat. 3513, 3517.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469, Sec. 201, amended section generally.
Prior to amendment, section related to development, submission,
implementation, and assessment of National Drug Control Strategy.
Subsecs. (c), (d). Pub. L. 109-469, Sec. 202, added subsecs. (c)
and (d).
REQUIREMENT FOR SOUTHWEST BORDER COUNTERNARCOTICS STRATEGY
Pub. L. 109-469, title XI, Sec. 1110, Dec. 29, 2006, 120 Stat.
3543, provided that:
"(a) In General. - Not later than 120 days after the date of
enactment of this Act [Dec. 29, 2006], and every 2 years
thereafter, the Director of National Drug Control Policy shall
submit to the Congress a Southwest Border Counternarcotics
Strategy.
"(b) Purposes. - The Southwest Border Counternarcotics Strategy
shall -
"(1) set forth the Government's strategy for preventing the
illegal trafficking of drugs across the international border
between the United States and Mexico, including through ports of
entry and between ports of entry on that border;
"(2) state the specific roles and responsibilities of the
relevant National Drug Control Program agencies (as defined in
section 702 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1701)) for implementing
that strategy; and
"(3) identify the specific resources required to enable the
relevant National Drug Control Program agencies to implement that
strategy.
"(c) Specific Content Related to Drug Tunnels Between the United
States and Mexico. - The Southwest Border Counternarcotics Strategy
shall include -
"(1) a strategy to end the construction and use of tunnels and
subterranean passages that cross the international border between
the United States and Mexico for the purpose of illegal
trafficking of drugs across such border; and
"(2) recommendations for criminal penalties for persons who
construct or use such a tunnel or subterranean passage for such a
purpose.
"(d) Consultation With Other Agencies. - The Director shall issue
the Southwest Border Counternarcotics Strategy in consultation with
the heads of the relevant National Drug Control Program agencies.
"(e) Limitation. - The Southwest Border Counternarcotics Strategy
shall not change existing agency authorities or the laws governing
interagency relationships, but may include recommendations about
changes to such authorities or laws.
"(f) Report to Congress. - The Director shall provide a copy of
the Southwest Border Counternarcotics Strategy to the appropriate
congressional committees (as defined in section 702 of the Office
of National Drug Control Policy Reauthorization Act of 1998 (21
U.S.C. 1701)), and to the Committee on Armed Services and the
Committee on Homeland Security of the House of Representatives, and
the Committee on Homeland Security and Governmental Affairs and the
Committee on Armed Services of the Senate.
"(g) Treatment of Classified or Law Enforcement Sensitive
Information. - Any content of the Southwest Border Counternarcotics
Strategy that involves information classified under criteria
established by an Executive order, or whose public disclosure, as
determined by the Director or the head of any relevant National
Drug Control Program agency, would be detrimental to the law
enforcement or national security activities of any Federal, State,
local, or tribal agency, shall be presented to Congress separately
from the rest of the strategy."
-End-
-CITE-
21 USC Sec. 1706 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1706. High Intensity Drug Trafficking Areas Program
-STATUTE-
(a) Establishment
(1) In general
There is established in the Office a program to be known as the
High Intensity Drug Trafficking Areas Program (in this section
referred to as the "Program").
(2) Purpose
The purpose of the Program is to reduce drug trafficking and
drug production in the United States by -
(A) facilitating cooperation among Federal, State, local, and
tribal law enforcement agencies to share information and
implement coordinated enforcement activities;
(B) enhancing law enforcement intelligence sharing among
Federal, State, local, and tribal law enforcement agencies;
(C) providing reliable law enforcement intelligence to law
enforcement agencies needed to design effective enforcement
strategies and operations; and
(D) supporting coordinated law enforcement strategies which
maximize use of available resources to reduce the supply of
illegal drugs in designated areas and in the United States as a
whole.
(b) Designation
(1) In general
The Director, in consultation with the Attorney General, the
Secretary of the Treasury, the Secretary of Homeland Security,
heads of the National Drug Control Program agencies, and the
Governor of each applicable State, may designate any specified
area of the United States as a high intensity drug trafficking
area.
(2) Activities
After making a designation under paragraph (1) and in order to
provide Federal assistance to the area so designated, the
Director may -
(A) obligate such sums as are appropriated for the Program;
(B) direct the temporary reassignment of Federal personnel to
such area, subject to the approval of the head of the
department or agency that employs such personnel;
(C) take any other action authorized under section 1703 of
this title to provide increased Federal assistance to those
areas; and
(D) coordinate activities under this section (specifically
administrative, recordkeeping, and funds management activities)
with State, local, and tribal officials.
(c) Petitions for designation
The Director shall establish regulations under which a coalition
of interested law enforcement agencies from an area may petition
for designation as a high intensity drug trafficking area. Such
regulations shall provide for a regular review by the Director of
the petition, including a recommendation regarding the merit of the
petition to the Director by a panel of qualified, independent
experts.
(d) Factors for consideration
In considering whether to designate an area under this section as
a high intensity drug trafficking area, the Director shall
consider, in addition to such other criteria as the Director
considers to be appropriate, the extent to which -
(1) the area is a significant center of illegal drug
production, manufacturing, importation, or distribution;
(2) State, local, and tribal law enforcement agencies have
committed resources to respond to the drug trafficking problem in
the area, thereby indicating a determination to respond
aggressively to the problem;
(3) drug-related activities in the area are having a
significant harmful impact in the area, and in other areas of the
country; and
(4) a significant increase in allocation of Federal resources
is necessary to respond adequately to drug-related activities in
the area.
(e) Organization of high intensity drug trafficking areas
(1) Executive Board and officers
To be eligible for funds appropriated under this section, each
high intensity drug trafficking area shall be governed by an
Executive Board. The Executive Board shall designate a chairman,
vice chairman, and any other officers to the Executive Board that
it determines are necessary.
(2) Responsibilities
The Executive Board of a high intensity drug trafficking area
shall be responsible for -
(A) providing direction and oversight in establishing and
achieving the goals of the high intensity drug trafficking
area;
(B) managing the funds of the high intensity drug trafficking
area;
(C) reviewing and approving all funding proposals consistent
with the overall objective of the high intensity drug
trafficking area; and
(D) reviewing and approving all reports to the Director on
the activities of the high intensity drug trafficking area.
(3) Board representation
None of the funds appropriated under this section may be
expended for any high intensity drug trafficking area, or for a
partnership or region of a high intensity drug trafficking area,
if the Executive Board for such area, region, or partnership,
does not apportion an equal number of votes between
representatives of participating Federal agencies and
representatives of participating State, local, and tribal
agencies. Where it is impractical for an equal number of
representatives of Federal agencies and State, local, and tribal
agencies to attend a meeting of an Executive Board in person, the
Executive Board may use a system of proxy votes or weighted votes
to achieve the voting balance required by this paragraph.
(4) No agency relationship
The eligibility requirements of this section are intended to
ensure the responsible use of Federal funds. Nothing in this
section is intended to create an agency relationship between
individual high intensity drug trafficking areas and the Federal
Government.
(f) Use of funds
The Director shall ensure that no Federal funds appropriated for
the Program are expended for the establishment or expansion of drug
treatment programs, and shall ensure that not more than 5 percent
of the Federal funds appropriated for the Program are expended for
the establishment of drug prevention programs.
(g) Counterterrorism activities
(1) Assistance authorized
The Director may authorize use of resources available for the
Program to assist Federal, State, local, and tribal law
enforcement agencies in investigations and activities related to
terrorism and prevention of terrorism, especially but not
exclusively with respect to such investigations and activities
that are also related to drug trafficking.
(2) Limitation
The Director shall ensure -
(A) that assistance provided under paragraph (1) remains
incidental to the purpose of the Program to reduce drug
availability and carry out drug-related law enforcement
activities; and
(B) that significant resources of the Program are not
redirected to activities exclusively related to terrorism,
except on a temporary basis under extraordinary circumstances,
as determined by the Director.
(h) Role of Drug Enforcement Administration
The Director, in consultation with the Attorney General, shall
ensure that a representative of the Drug Enforcement Administration
is included in the Intelligence Support Center for each high
intensity drug trafficking area.
(i) Annual HIDTA Program budget submissions
As part of the documentation that supports the President's annual
budget request for the Office, the Director shall submit to
Congress a budget justification that includes -
(1) the amount proposed for each high intensity drug
trafficking area, conditional upon a review by the Office of the
request submitted by the HIDTA and the performance of the HIDTA,
with supporting narrative descriptions and rationale for each
request;
(2) a detailed justification that explains -
(A) the reasons for the proposed funding level; how such
funding level was determined based on a current assessment of
the drug trafficking threat in each high intensity drug
trafficking area;
(B) how such funding will ensure that the goals and
objectives of each such area will be achieved; and
(C) how such funding supports the National Drug Control
Strategy; and
(3) the amount of HIDTA funds used to investigate and prosecute
organizations and individuals trafficking in methamphetamine in
the prior calendar year, and a description of how those funds
were used.
(j) Emerging threat response fund
(1) In general
Subject to the availability of appropriations, the Director may
expend up to 10 percent of the amounts appropriated under this
section on a discretionary basis, to respond to any emerging drug
trafficking threat in an existing high intensity drug trafficking
area, or to establish a new high intensity drug trafficking area
or expand an existing high intensity drug trafficking area, in
accordance with the criteria established under paragraph (2).
(2) Consideration of impact
In allocating funds under this subsection, the Director shall
consider -
(A) the impact of activities funded on reducing overall drug
traffic in the United States, or minimizing the probability
that an emerging drug trafficking threat will spread to other
areas of the United States; and
(B) such other criteria as the Director considers
appropriate.
(k) Evaluation
(1) Initial report
Not later than 90 days after December 29, 2006, the Director
shall, after consulting with the Executive Boards of each
designated high intensity drug trafficking area, submit a report
to Congress that describes, for each designated high intensity
drug trafficking area -
(A) the specific purposes for the high intensity drug
trafficking area;
(B) the specific long-term and short-term goals and
objectives for the high intensity drug trafficking area;
(C) the measurements that will be used to evaluate the
performance of the high intensity drug trafficking area in
achieving the long-term and short-term goals; and
(D) the reporting requirements needed to evaluate the
performance of the high intensity drug trafficking area in
achieving the long-term and short-term goals.
(2) Evaluation of HIDTA Program as part of National Drug Control
Strategy
For each designated high intensity drug trafficking area, the
Director shall submit, as part of the annual National Drug
Control Strategy report, a report that -
(A) describes -
(i) the specific purposes for the high intensity drug
trafficking area; and
(ii) the specific long-term and short-term goals and
objectives for the high intensity drug trafficking area; and
(B) includes an evaluation of the performance of the high
intensity drug trafficking area in accomplishing the specific
long-term and short-term goals and objectives identified under
paragraph (1)(B).
(l) Assessment of drug enforcement task forces in high intensity
drug trafficking areas
Not later than 1 year after December 29, 2006, and as part of
each subsequent annual National Drug Control Strategy report, the
Director shall submit to Congress a report -
(1) assessing the number and operation of all federally funded
drug enforcement task forces within each high intensity drug
trafficking area; and
(2) describing -
(A) each Federal, State, local, and tribal drug enforcement
task force operating in the high intensity drug trafficking
area;
(B) how such task forces coordinate with each other, with any
high intensity drug trafficking area task force, and with
investigations receiving funds from the Organized Crime and
Drug Enforcement Task Force;
(C) what steps, if any, each such task force takes to share
information regarding drug trafficking and drug production with
other federally funded drug enforcement task forces in the high
intensity drug trafficking area;
(D) the role of the high intensity drug trafficking area in
coordinating the sharing of such information among task forces;
(E) the nature and extent of cooperation by each Federal,
State, local, and tribal participant in ensuring that such
information is shared among law enforcement agencies and with
the high intensity drug trafficking area;
(F) the nature and extent to which information sharing and
enforcement activities are coordinated with joint terrorism
task forces in the high intensity drug trafficking area; and
(G) any recommendations for measures needed to ensure that
task force resources are utilized efficiently and effectively
to reduce the availability of illegal drugs in the high
intensity drug trafficking areas.
(m) Assessment of law enforcement intelligence sharing in High
Intensity Drug Trafficking Areas Program
Not later than 180 days after December 29, 2006, and as part of
each subsequent annual National Drug Control Strategy report, the
Director, in consultation with the Director of National
Intelligence, shall submit to Congress a report -
(1) evaluating existing and planned law enforcement
intelligence systems supported by each high intensity drug
trafficking area, or utilized by task forces receiving any
funding under the Program, including the extent to which such
systems ensure access and availability of law enforcement
intelligence to Federal, State, local, and tribal law enforcement
agencies within the high intensity drug trafficking area and
outside of it;
(2) the extent to which Federal, State, local, and tribal law
enforcement agencies participating in each high intensity drug
trafficking area are sharing law enforcement intelligence
information to assess current drug trafficking threats and design
appropriate enforcement strategies; and
(3) the measures needed to improve effective sharing of
information and law enforcement intelligence regarding drug
trafficking and drug production among Federal, State, local, and
tribal law enforcement participating in a high intensity drug
trafficking area, and between such agencies and similar agencies
outside the high intensity drug trafficking area.
(n) Coordination of Law enforcement intelligence sharing with
Organized Crime Drug Enforcement Task Force program
The Director, in consultation with the Attorney General, shall
ensure that any drug enforcement intelligence obtained by the
Intelligence Support Center for each high intensity drug
trafficking area is shared, on a timely basis, with the drug
intelligence fusion center operated by the Organized Crime Drug
Enforcement Task Force of the Department of Justice.
(o) Use of funds to combat methamphetamine trafficking
(1) Requirement
As part of the documentation that supports the President's
annual budget request for the Office, the Director shall submit
to Congress a report describing the use of HIDTA funds to
investigate and prosecute organizations and individuals
trafficking in methamphetamine in the prior calendar year.
(2) Contents
The report shall include -
(A) the number of methamphetamine manufacturing facilities
discovered through HIDTA-funded initiatives in the previous
fiscal year;
(B) the amounts of methamphetamine or listed chemicals (as
that term is defined in section 802(33) of this title (!1)
seized by HIDTA-funded initiatives in the area during the
previous year; and
(C) law enforcement intelligence and predictive data from the
Drug Enforcement Administration showing patterns and trends in
abuse, trafficking, and transportation in methamphetamine and
listed chemicals.
(3) Certification
Before the Director awards any funds to a high intensity drug
trafficking area, the Director shall certify that the law
enforcement entities participating in that HIDTA are providing
laboratory seizure data to the national clandestine laboratory
database at the El Paso Intelligence Center.
(p) Authorization of appropriations
There is authorized to be appropriated to the Office of National
Drug Control Policy to carry out this section -
(1) $240,000,000 for fiscal year 2007;
(2) $250,000,000 for fiscal year 2008;
(3) $260,000,000 for fiscal year 2009;
(4) $270,000,000 for fiscal year 2010; and
(5) $280,000,000 for each of (!2) fiscal year 2011.
(q) Specific purposes
(1) In general
The Director shall ensure that, of the amounts appropriated for
a fiscal year for the Program, at least $7,000,000 is used in
high intensity drug trafficking areas with severe neighborhood
safety and illegal drug distribution problems.
(2) Required uses
The funds used under paragraph (1) shall be used -
(A) to ensure the safety of neighborhoods and the protection
of communities, including the prevention of the intimidation of
potential witnesses of illegal drug distribution and related
activities; and
(B) to combat illegal drug trafficking through such methods
as the Director considers appropriate, such as establishing or
operating (or both) a toll-free telephone hotline for use by
the public to provide information about illegal drug-related
activities.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 707, Oct. 21, 1998, 112
Stat. 2681-686; Pub. L. 109-469, title III, Secs. 301, Sec. 302(c),
Dec. 29, 2006, 120 Stat. 3518, 3525.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
December 29, 2006, referred to in subsecs. (k)(1), (l), and (m)
was in the original "the date of the enactment of this section",
which was translated as meaning the date of enactment of Pub. L.
109-469, which amended this section generally, to reflect the
probable intent of Congress.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469, Sec. 301, amended section generally.
Prior to amendment, section related to the High Intensity Drug
Trafficking Areas Program.
Subsec. (q). Pub. L. 109-469, Sec. 302(c), added subsec. (q).
FINDINGS
Pub. L. 109-469, title III, Sec. 302(b), Dec. 29, 2006, 120 Stat.
3524, provided that: "Congress finds the following:
"(1) In the early morning hours of October 16, 2002, the home
of Carnell and Angela Dawson was firebombed in apparent
retaliation for Mrs. Dawson's notification to police about
persistent drug distribution activity in their East Baltimore
City neighborhood.
"(2) The arson claimed the lives of Mr. and Mrs. Dawson and
their 5 young children, aged 9 to 14.
"(3) The horrific murder of the Dawson family is a stark
example of domestic narco-terrorism.
"(4) In all phases of counternarcotics law enforcement - from
prevention to investigation to prosecution to reentry - the
voluntary cooperation of ordinary citizens is a critical
component.
"(5) Voluntary cooperation is difficult for law enforcement
officials to obtain when citizens feel that cooperation carries
the risk of violent retaliation by illegal drug trafficking
organizations and their affiliates.
"(6) Public confidence that law enforcement is doing all it can
to make communities safe is a prerequisite for voluntary
cooperation among people who may be subject to intimidation or
reprisal (or both).
"(7) Witness protection programs are insufficient on their own
to provide security because many individuals and families who
strive every day to make distressed neighborhoods livable for
their children, other relatives, and neighbors will resist or
refuse offers of relocation by local, State, and Federal
prosecutorial agencies and because, moreover, the continued
presence of strong individuals and families is critical to
preserving and strengthening the social fabric in such
communities.
"(8) Where (as in certain sections of Baltimore City)
interstate trafficking of illegal drugs has severe ancillary
local consequences within areas designated as high intensity drug
trafficking areas, it is important that supplementary High
Intensity Drug Trafficking Areas Program funds be committed to
support initiatives aimed at making the affected communities safe
for the residents of those communities and encouraging their
cooperation with tribal, local, State, and Federal law
enforcement efforts to combat illegal drug trafficking."
COMBATING METHAMPHETAMINE AND AMPHETAMINE IN HIGH INTENSITY DRUG
TRAFFICKING AREAS
Pub. L. 106-310, div. B, title XXXVI, Sec. 3624, Oct. 17, 2000,
114 Stat. 1232, provided that:
"(a) In General. -
"(1) In general. - The Director of National Drug Control Policy
shall use amounts available under this section to combat the
trafficking of methamphetamine and amphetamine in areas
designated by the Director as high intensity drug trafficking
areas.
"(2) Activities. - In meeting the requirement in paragraph (1),
the Director shall transfer funds to appropriate Federal, State,
and local governmental agencies for employing additional Federal
law enforcement personnel, or facilitating the employment of
additional State and local law enforcement personnel, including
agents, investigators, prosecutors, laboratory technicians,
chemists, investigative assistants, and drug-prevention
specialists.
"(b) Authorization of Appropriations. - There is authorized to be
appropriated to carry out this section -
"(1) $15,000,000 for fiscal year 2000; and
"(2) such sums as may be necessary for each of fiscal years
2001 through 2004.
"(c) Apportionment of Funds. -
"(1) Factors in apportionment. - The Director shall apportion
amounts appropriated for a fiscal year pursuant to the
authorization of appropriations in subsection (b) for activities
under subsection (a) among and within areas designated by the
Director as high intensity drug trafficking areas based on the
following factors:
"(A) The number of methamphetamine manufacturing facilities
and amphetamine manufacturing facilities discovered by Federal,
State, or local law enforcement officials in the previous
fiscal year.
"(B) The number of methamphetamine prosecutions and
amphetamine prosecutions in Federal, State, or local courts in
the previous fiscal year.
"(C) The number of methamphetamine arrests and amphetamine
arrests by Federal, State, or local law enforcement officials
in the previous fiscal year.
"(D) The amounts of methamphetamine, amphetamine, or listed
chemicals (as that term is defined in section 102(33) of the
Controlled Substances Act (21 U.S.C. 802(33)) seized by
Federal, State, or local law enforcement officials in the
previous fiscal year.
"(E) Intelligence and predictive data from the Drug
Enforcement Administration and the Department of Health and
Human Services showing patterns and trends in abuse,
trafficking, and transportation in methamphetamine,
amphetamine, and listed chemicals (as that term is so defined).
"(2) Certification. - Before the Director apportions any funds
under this subsection to a high intensity drug trafficking area,
the Director shall certify that the law enforcement entities
responsible for clandestine methamphetamine and amphetamine
laboratory seizures in that area are providing laboratory seizure
data to the national clandestine laboratory database at the El
Paso Intelligence Center.
"(d) Limitation on Administrative Costs. - Not more than 5
percent of the amount appropriated in a fiscal year pursuant to the
authorization of appropriations for that fiscal year in subsection
(b) may be available in that fiscal year for administrative costs
associated with activities under subsection (a)."
FUNDING FOR HIGH INTENSITY DRUG TRAFFICKING AREAS PROGRAM
Pub. L. 106-58, title III, Sept. 29, 1999, 113 Stat. 448,
provided in part: "That, hereafter, of the amount appropriated for
fiscal year 2000 or any succeeding fiscal year for the High
Intensity Drug Trafficking Areas Program, the funds to be obligated
or expended during such fiscal year for programs addressing the
treatment or prevention of drug use as part of the approved
strategy for a designated High Intensity Drug Trafficking Area
(HIDTA) shall not be less than the funds obligated or expended for
such programs during fiscal year 1999 for each designated HIDTA
without the prior approval of the Committees on Appropriations".
-FOOTNOTE-
(!1) So in original. There probably should be a closing parenthesis.
(!2) So in original.
-End-
-CITE-
21 USC Sec. 1707 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1707. Counter-Drug Technology Assessment Center
-STATUTE-
(a) Establishment
There is established within the Office the Counter-Drug
Technology Assessment Center (referred to in this section as the
"Center"). The Center shall operate under the authority of the
Director of National Drug Control Policy and shall serve as the
central counter-drug technology research and development
organization of the United States Government.
(b) Chief Scientist
There shall be at the head of the Center the Chief Scientist, who
shall be appointed by the Director from among individuals qualified
and distinguished in the area of science, medicine, engineering, or
technology.
(c) Research and development responsibilities
The Director, acting through the Chief Scientist, shall -
(1) identify and define the short-, medium-, and long-term
scientific and technological needs of Federal, State, local, and
tribal drug supply reduction agencies, including -
(A) advanced surveillance, tracking, and radar imaging;
(B) electronic support measures;
(C) communications;
(D) data fusion, advanced computer systems, and artificial
intelligence; and
(E) chemical, biological, radiological (including neutron and
electron), and other means of detection;
(2) identify demand reduction basic and applied research needs
and initiatives, in consultation with affected National Drug
Control Program agencies, including -
(A) improving treatment through neuroscientific advances;
(B) improving the transfer of biomedical research to the
clinical setting; and
(C) in consultation with the National Institute of Drug Abuse
and the Substance Abuse and Mental Health Services
Administration, and through interagency agreements or grants,
examining addiction and rehabilitation research and the
application of technology to expanding the effectiveness and
availability of drug treatment;
(3) make a priority ranking of such needs identified in
paragraphs (1) and (2) according to fiscal and technological
feasibility, as part of a National Counterdrug Research and
Development Program;
(4) oversee and coordinate counterdrug technology initiatives
with related activities of other Federal civilian and military
departments;
(5) provide support to the development and implementation of
the national drug control performance measurement system
established under subsection (c) of section 1705 of this title;
and
(6) pursuant to the authority of the Director of National Drug
Control Policy under section 1703 of this title, submit requests
to Congress for the reprogramming or transfer of funds
appropriated for counterdrug technology research and development.
(d) Limitation on authority
The authority granted to the Director under this section shall
not extend to the awarding of contracts, management of individual
projects, or other operational activities.
(e) Assistance and support to the Office of National Drug Control
Policy
The Secretary of Defense, the Secretary of Homeland Security, and
the Secretary of Health and Human Services shall, to the maximum
extent practicable, render assistance and support to the Office and
to the Director in the conduct of counterdrug technology
assessment.
(f) Technology transfer program
(1) Program
The Chief Scientist, with the advice and counsel of experts
from State, local, and tribal law enforcement agencies, shall be
responsible to the Director for coordination and implementation
of a counterdrug technology transfer program.
(2) Purpose
The purpose of the Technology Transfer Program shall be for the
Counterdrug Technology Assessment Center to transfer technology
and associated training directly to State, local, and tribal law
enforcement agencies.
(3) Priority of receipts
Transfers shall be made in priority order based on -
(A) the need of potential recipients for such technology;
(B) the effectiveness of the technology to enhance current
counterdrug activities of potential recipients; and
(C) the ability and willingness of potential recipients to
evaluate transferred technology.
(4) Agreement authority
The Director may enter into an agreement with the Secretary of
Homeland Security to transfer technology with both counterdrug
and homeland security applications to State, local, and tribal
law enforcement agencies on a reimbursable basis.
(5) Report
On or before July 1 of each year, the Director shall submit a
report to the appropriate congressional committees that addresses
the following:
(A) The number of requests received during the previous 12
months, including the identity of each requesting agency and
the type of technology requested.
(B) The number of requests fulfilled during the previous 12
months, including the identity of each recipient agency and the
type of technology transferred.
(C) A summary of the criteria used in making the
determination on what requests were funded and what requests
were not funded, except that such summary shall not include
specific information on any individual requests.
(D) A general assessment of the future needs of the program,
based on expected changes in threats, expected technologies,
and likely need from potential recipients.
(E) An assessment of the effectiveness of the technologies
transferred, based in part on the evaluations provided by the
recipients, with a recommendation whether the technology should
continue to be offered through the program.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 708, Oct. 21, 1998, 112
Stat. 2681-687; Pub. L. 109-469, title IV, Sec. 401, Dec. 29, 2006,
120 Stat. 3525.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-MISC1-
AMENDMENTS
2006 - Subsec. (b). Pub. L. 109-469, Sec. 401(a), amended subsec.
(b) generally. Prior to amendment, text read as follows: "There
shall be at the head of the Center the Director of Technology, who
shall be appointed by the Director of National Drug Control Policy
from among individuals qualified and distinguished in the area of
science, medicine, engineering, or technology."
Subsec. (c). Pub. L. 109-469, Sec. 401(b)(1)(B), added subsec.
(c) and struck out former subsec. (c) which related to additional
responsibilities of the Director of National Drug Control Policy.
Subsec. (d). Pub. L. 109-469, Sec. 401(c), which directed
insertion of ", the Secretary of Homeland Security," after "The
Secretary of Defense", could not be executed because the words "The
Secretary of Defense" did not appear subsequent to amendment by
Pub. L. 109-469, Sec. 401(b)(1). See below.
Pub. L. 109-469, Sec. 401(b)(1)(B), added subsec. (d). Former
subsec. (d) redesignated (e).
Subsec. (e). Pub. L. 109-469, Sec. 401(b)(2), amended subsec. (e)
generally. Prior to amendment, text read as follows: "The Secretary
of Defense and the Secretary of Health and Human Services shall, to
the maximum extent practicable, render assistance and support to
the Office and to the Director in the conduct of counter-drug
technology assessment."
Pub. L. 109-469, Sec. 401(b)(1)(A), redesignated subsec. (d) as
(e).
Subsec. (f). Pub. L. 109-469, Sec. 401(b)(3), added subsec. (f).
-End-
-CITE-
21 USC Sec. 1708 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1708. National youth anti-drug media campaign
-STATUTE-
(a) In general
The Director shall conduct a national youth anti-drug media
campaign (referred to in this chapter (!1) as the "national media
campaign") in accordance with this section for the purposes of -
(1) preventing drug abuse among young people in the United
States;
(2) increasing awareness of adults of the impact of drug abuse
on young people; and
(3) encouraging parents and other interested adults to discuss
with young people the dangers of illegal drug use.
(b) Use of funds
(1) In general
Amounts made available to carry out this section for the
national media campaign may only be used for the following:
(A) The purchase of media time and space, including the
strategic planning for, and accounting of, such purchases.
(B) Creative and talent costs, consistent with paragraph
(2)(A).
(C) Advertising production costs.
(D) Testing and evaluation of advertising.
(E) Evaluation of the effectiveness of the national media
campaign.
(F) The negotiated fees for the winning bidder on requests
for proposals issued either by the Office or its designee to
enter into contracts to carry out activities authorized by this
section.
(G) Partnerships with professional and civic groups,
community-based organizations, including faith-based
organizations, and government organizations related to the
national media campaign.
(H) Entertainment industry outreach, interactive outreach,
media projects and activities, public information, news media
outreach, and corporate sponsorship and participation.
(I) Operational and management expenses.
(2) Specific requirements
(A) Creative services
(i) In using amounts for creative and talent costs under
paragraph (1)(B), the Director shall use creative services
donated at no cost to the Government (including creative
services provided by the Partnership for a Drug-Free America)
wherever feasible and may only procure creative services for
advertising -
(I) responding to high-priority or emergent campaign needs
that cannot timely be obtained at no cost; or
(II) intended to reach a minority, ethnic, or other special
audience that cannot reasonably be obtained at no cost; or
(III) the Director determines that the Partnership for a
Drug-Free America is unable to provide, pursuant to
subsection (d)(2)(B).
(ii) Subject to the availability of appropriations, no more
than $1,500,000 may be expended under this section each fiscal
year on creative services, except that the Director may expend
up to $2,000,000 in a fiscal year on creative services to meet
urgent needs of the national media campaign with advance
approval from the Committee on Appropriations of the Senate and
of the House of Representatives upon a showing of the
circumstances causing such urgent needs of the national media
campaign.
(B) Testing and evaluation of advertising
In using amounts for testing and evaluation of advertising
under paragraph (1)(D), the Director shall test all
advertisements prior to use in the national media campaign to
ensure that the advertisements are effective and meet industry-
accepted standards. The Director may waive this requirement
for advertisements using no more than 10 percent of the
purchase of advertising time purchased under this section in a
fiscal year and no more than 10 percent of the advertising
space purchased under this section in a fiscal year, if the
advertisements respond to emergent and time-sensitive campaign
needs or the advertisements will not be widely utilized in the
national media campaign.
(C) Evaluation of effectiveness of media campaign
In using amounts for the evaluation of the effectiveness of
the national media campaign under paragraph (1)(E), the
Director shall -
(i) designate an independent entity to evaluate by April 20
of each year the effectiveness of the national media campaign
based on data from -
(I) the Monitoring the Future Study published by the
Department of Health and Human Services;
(II) the Attitude Tracking Study published by the
Partnership for a Drug-Free America;
(III) the National Household Survey on Drug Abuse; and
(IV) other relevant studies or publications, as
determined by the Director, including tracking and
evaluation data collected according to marketing and
advertising industry standards; and
(ii) ensure that the effectiveness of the national media
campaign is evaluated in a manner that enables consideration
of whether the national media campaign has contributed to
reduction of illicit drug use among youth and such other
measures of evaluation as the Director determines are
appropriate.
(3) Purchase of advertising time and space
Subject to the availability of appropriations, for each fiscal
year, not less than 77 percent of the amounts appropriated under
this section shall be used for the purchase of advertising time
and space for the national media campaign, subject to the
following exceptions:
(A) In any fiscal year for which less than $125,000,000 is
appropriated for the national media campaign, not less than 72
percent of the amounts appropriated under this section shall be
used for the purchase of advertising time and space for the
national media campaign.
(B) In any fiscal year for which more than $195,000,000 is
appropriated under this section, not less than 82 percent shall
be used for advertising production costs and the purchase of
advertising time and space for the national media campaign.
(c) Advertising
In carrying out this section, the Director shall ensure that
sufficient funds are allocated to meet the stated goals of the
national media campaign.
(d) Division of responsibilities and functions under the program
(1) In general
The Director, in consultation with the Partnership for a Drug-
Free America, shall determine the overall purposes and strategy
of the national media campaign.
(2) Responsibilities
(A) Director
The Director shall be responsible for implementing a focused
national media campaign to meet the purposes set forth in
subsection (a), and shall approve -
(i) the strategy of the national media campaign;
(ii) all advertising and promotional material used in the
national media campaign; and
(iii) the plan for the purchase of advertising time and
space for the national media campaign.
(B) The Partnership for a Drug-Free America
The Director shall request that the Partnership for a Drug-
Free America -
(i) develop and recommend strategies to achieve the goals
of the national media campaign, including addressing national
and local drug threats in specific regions or States, such as
methamphetamine and ecstasy;
(ii) create all advertising to be used in the national
media campaign, except advertisements that are -
(I) provided by other nonprofit entities pursuant to
subsection (f);
(II) intended to respond to high-priority or emergent
campaign needs that cannot timely be obtained at no cost
(not including production costs and talent reuse payments),
provided that any such advertising material is reviewed by
the Partnership for a Drug-Free America;
(III) intended to reach a minority, ethnic, or other
special audience that cannot be obtained at no cost (not
including production costs and talent reuse payments),
provided that any such advertising material is reviewed by
the Partnership for a Drug-Free America; or
(IV) any other advertisements that the Director
determines that the Partnership for a Drug-Free America is
unable to provide or if the Director determines that
another entity is more appropriate, subject to the
requirements of subsection (b)(2)(A).
If the Director determines that another entity is more
appropriate under clause (ii)(IV), the Director shall notify
Congress, through the committees of jurisdiction in the House
and Senate, in writing, not less than 30 days prior to
contracting with a party other than the Partnership for a Drug-
Free America.
(C) Media buying contractor
The Director shall enter into a contract with a media buying
contractor to plan and purchase advertising time and space for
the national media campaign. The media buying contractor shall
not provide any other service or material, or conduct any other
function or activity which the Director determines should be
provided by the Partnership for a Drug-Free America.
(e) Prohibitions
None of the amounts made available under subsection (b) may be
obligated or expended for any of the following:
(1) To supplant current anti-drug community-based coalitions.
(2) To supplant pro bono public service time donated by
national and local broadcasting networks for other public service
campaigns.
(3) For partisan political purposes, or express advocacy in
support of or to defeat any clearly identified candidate, clearly
identified ballot initiative, or clearly identified legislative
or regulatory proposal.
(4) To fund advertising that features any elected officials,
persons seeking elected office, cabinet level officials, or other
Federal officials employed pursuant to section 213 of Schedule C
of title 5, Code of Federal Regulations.
(5) To fund advertising that does not contain a primary message
intended to reduce or prevent illicit drug use.
(6) To fund advertising containing a primary message intended
to promote support for the media campaign or private sector
contributions to the media campaign.
(f) Matching requirement
(1) In general
Amounts made available under subsection (b) for media time and
space shall be matched by an equal amount of non-Federal funds
for the national media campaign, or be matched with in-kind
contributions of the same value.
(2) No-cost match advertising direct relationship requirement
The Director shall ensure that at least 70 percent of no-cost
match advertising provided directly relates to substance abuse
prevention consistent with the specific purposes of the national
media campaign, except that in any fiscal year in which less than
$125,000,000 is appropriated to the national media campaign, the
Director shall ensure that at least 85 percent of no-cost match
advertising directly relates to substance abuse prevention
consistent with the specific purposes of the national media
campaign.
(3) No-cost match advertising not directly related
The Director shall ensure that no-cost match advertising that
does not directly relate to substance abuse prevention consistent
with the purposes of the national media campaign includes a clear
anti-drug message. Such message is not required to be the primary
message of the match advertising.
(g) Financial and performance accountability
The Director shall cause to be performed -
(1) audits and reviews of costs of the national media campaign
pursuant to section 254d of title 41; and
(2) an audit to determine whether the costs of the national
media campaign are allowable under section 256 of title 41.
(h) Report to Congress
The Director shall submit on an annual basis a report to Congress
that describes -
(1) the strategy of the national media campaign and whether
specific objectives of the media campaign were accomplished;
(2) steps taken to ensure that the national media campaign
operates in an effective and efficient manner consistent with the
overall strategy and focus of the national media campaign;
(3) plans to purchase advertising time and space;
(4) policies and practices implemented to ensure that Federal
funds are used responsibly to purchase advertising time and space
and eliminate the potential for waste, fraud, and abuse; and
(5) all contracts entered into with a corporation, partnership,
or individual working on behalf of the national media campaign.
(i) Local target requirement
The Director shall, to the maximum extent feasible, use amounts
made available under this section for media that focuses on, or
includes specific information on, prevention or treatment resources
for consumers within specific local areas.
(j) Prevention of marijuana use
(1) Findings
The Congress finds the following:
(A) 60 percent of adolescent admissions for drug treatment
are based on marijuana use.
(B) Potency levels of contemporary marijuana, particularly
hydroponically grown marijuana, are significantly higher than
in the past, rising from under 1 percent of THC in the mid-
1970s to as high as 30 percent today.
(C) Contemporary research has demonstrated that youths
smoking marijuana early in life may be up to 5 times more
likely to use hard drugs.
(D) Contemporary research has demonstrated clear detrimental
effects in adolescent educational achievement resulting from
marijuana use.
(E) Contemporary research has demonstrated clear detrimental
effects in adolescent brain development resulting from
marijuana use.
(F) An estimated 9,000,000 Americans a year drive while under
the influence of illegal drugs, including marijuana.
(G) Marijuana smoke contains 50 to 70 percent more of certain
cancer causing chemicals than tobacco smoke.
(H) Teens who use marijuana are up to 4 times more likely to
have a teen pregnancy than teens who have not.
(I) Federal law enforcement agencies have identified clear
links suggesting that trade in hydroponic marijuana facilitates
trade by criminal organizations in hard drugs, including
heroin.
(J) Federal law enforcement agencies have identified possible
links between trade in cannabis products and financing for
terrorist organizations.
(2) Emphasis on prevention of youth marijuana use
In conducting advertising and activities otherwise authorized
under this section, the Director may emphasize prevention of
youth marijuana use.
(k) Prevention of methamphetamine abuse and other emerging drug
abuse threats
(1) Requirement to use 10 percent of funds for methamphetamine
abuse prevention
The Director shall ensure that, of the amounts appropriated
under this section for the national media campaign for a fiscal
year, not less than 10 percent shall be expended solely for the
activities described in subsection (b)(1) with respect to
advertisements specifically intended to reduce the use of
methamphetamine.
(2) Authority to use funds for other drug abuse upon
certification that methamphetamine abuse fell during fiscal
year 2007
With respect to fiscal year 2008 and any fiscal year
thereafter, if the Director certifies in writing to Congress that
domestic methamphetamine laboratory seizures (as reported to the
El Paso Intelligence Center of the Drug Enforcement
Administration) decreased to at least 75 percent of the 2006
level, or the Director has documented a highly, statistically
significant increase in a specific drug, from a baseline
determined by locally collected data, that can be defined as a
local drug crisis, the Director may apply paragraph (1)(A) for
that fiscal year with respect to advertisements specifically
intended to reduce the use of such other drugs.
(l) Authorization of appropriations
There is authorized to be appropriated to the Office to carry out
this section, $195,000,000 for each of fiscal years 2007 and 2008
and $210,000,000 for each of fiscal years 2009 through 2011.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 709, Oct. 21, 1998, 112
Stat. 2681-688; Pub. L. 109-469, title V, Sec. 501(a), Dec. 29,
2006, 120 Stat. 3527.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in subsec. (a), was in the original
"this subtitle" and was translated as reading "this title", meaning
title VII of Pub. L. 105-277, div. C, Oct. 21, 1998, 112 Stat. 2681-
670, which is classified principally to this chapter, to reflect
the probable intent of Congress. Title VII does not contain
subtitles. For complete classification of title VII to the Code,
see Short Title note set out under section 1701 of this title and
Tables.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469 amended section catchline and text
generally. Prior to amendment, section related to the President's
Council on Counter-Narcotics.
-EXEC-
EX. ORD. NO. 12992. PRESIDENT'S COUNCIL ON COUNTER-NARCOTICS
Ex. Ord. No. 12992, Mar. 15, 1996, 61 F.R. 11287, as amended by
Ex. Ord. No. 13023, Secs. 2, 3, Nov. 6, 1996, 61 F.R. 57767; Ex.
Ord. No. 13284, Sec. 8, Jan. 23, 2003, 68 F.R. 4076, provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, including section 301
of title 3, United States Code, it is hereby ordered as follows:
Section 1. Establishment. There is established the President's
Drug Policy Council ("Council").
Sec. 2. Membership. The Council shall comprise the:
(a) President, who shall serve as Chairman of the Council;
(b) Vice President;
(c) Secretary of State;
(d) Secretary of the Treasury;
(e) Secretary of Defense;
(f) Attorney General;
(g) Secretary of the Interior;
(h) Secretary of Agriculture;
(i) Secretary of Health and Human Services;
(j) Secretary of Housing and Urban Development;
(k) Secretary of Transportation;
(l) Secretary of Education;
(m) Secretary of Veterans Affairs;
(n) Secretary of Homeland Security;
(o) Representative of the United States of America to the United
Nations;
(p) Director of the Office of Management and Budget;
(q) Chief of Staff to the President;
(r) Director of National Drug Control Policy;
(s) Director of Central Intelligence;
(t) Assistant to the President for National Security Affairs;
(u) Counsel to the President;
(v) Chairman, Joint Chiefs of Staff;
(w) National Security Advisor to the Vice President; and
(x) Assistant to the President for Domestic Policy.
As applicable, the Council shall also comprise such other
officials of the departments and agencies as the President may,
from time to time, designate.
Sec. 3. Meetings of the Council. The President, or upon his
direction, the Vice President, may convene meetings of the Council.
The President shall preside over meetings of the Council, provided
that in his absence, the Vice President will preside. The Council
will meet at least quarterly.
Sec. 4. Functions. (a) The functions of the Council are to advise
and assist the President in: (1) providing direction and oversight
for the national drug control strategy, including relating drug
control policy to other national security interests and
establishing priorities; and (2) ensuring coordination among
departments and agencies concerning implementation of the
President's national drug control strategy.
(b) The Director of National Drug Control Policy will continue to
be the senior drug control policy official in the executive branch
and the President's chief drug control policy spokesman.
(c) In matters affecting national security interests, the
Director of National Drug Control Policy shall work in conjunction
with the Assistant to the President for National Security Affairs.
Sec. 5. Administration. (a) The Council may utilize established
or ad hoc committees, task forces, or interagency groups chaired by
the Director of National Drug Control Policy or his representative,
in carrying out its functions under this order.
(b) The staff of the Office of National Drug Control Policy, in
coordination with the staffs of the Vice President and the
Assistant to the President for National Security Affairs, shall act
as staff for the Council.
(c) All executive departments and agencies shall cooperate with
the Council and provide such assistance, information, and advice as
the Council may request, to the extent permitted by law.
EX. ORD. NO. 13023. EXPANDING AND CHANGING NAME OF PRESIDENT'S
COUNCIL ON COUNTER-NARCOTICS
Ex. Ord. No. 13023, Nov. 6, 1996, 61 F.R. 57767, provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, including section 301
of title 3, United States Code, and in order to change the name of
the "President's Council on Counter-Narcotics" to the "President's
Drug Policy Council" and to make the Secretaries of the Interior,
Agriculture, Health and Human Services, Housing and Urban
Development, Education, Veterans Affairs, and the Assistant to the
President for Domestic Policy, permanent members of the Council, it
is hereby ordered as follows:
Section 1. The Council established by Executive Order 12992 [set
out above] shall henceforth be called the "President's Drug Policy
Council."
[Secs. 2, 3. Amended Ex. Ord. No. 12992, set out above.]
William J. Clinton.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 1708a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1708a. Annual report requirement
-STATUTE-
(a) In general
On or before February 1 of each year, the Director shall submit a
report to Congress that describes -
(1) the strategy of the national media campaign and whether
specific objectives of the campaign were accomplished;
(2) steps taken to ensure that the national media campaign
operates in an effective and efficient manner consistent with the
overall strategy and focus of the campaign;
(3) plans to purchase advertising time and space;
(4) policies and practices implemented to ensure that Federal
funds are used responsibly to purchase advertising time and space
and eliminate the potential for waste, fraud, and abuse;
(5) all contracts entered into with a corporation, partnership,
or individual working on behalf of the national media campaign;
(6) specific policies and steps implemented to ensure
compliance with title IV of this Act;
(7) steps taken to ensure that the national media campaign will
secure, to the maximum extent possible, no cost matches of
advertising time and space or in-kind contributions that are
directly related to the campaign in accordance with title IV of
this Act; and
(8) a review and evaluation of the effectiveness of the
national media campaign strategy for the past year.
(b) Audit
The Government Accountability Office shall, at a frequency of not
less than once per year -
(1) conduct and supervise an audit and investigation relating
to the programs and operations of the -
(A) Office; or
(B) certain programs within the Office, including -
(i) the High Intensity Drug Trafficking Areas Program;
(ii) the Counterdrug Technology Assessment Center; or
(iii) the National Youth Anti-drug Media Campaign; and
(2) provide the Director and the appropriate congressional
committees with a report containing an evaluation of and
recommendations on the -
(A) policies and activities of the programs and operations
subject to the audit and investigation;
(B) economy, efficiency, and effectiveness in the
administration of the reviewed programs and operations; and
(C) policy or management changes needed to prevent and detect
fraud and abuse in such programs and operations.
-SOURCE-
(Pub. L. 109-469, title II, Sec. 203, Dec. 29, 2006, 120 Stat.
3517.)
-REFTEXT-
REFERENCES IN TEXT
Title IV of this Act, referred to in subsec. (a)(6), (7), is
title IV of Pub. L. 109-469, Dec. 29, 2006, 120 Stat. 3525, which
amended section 1707 of this title.
-COD-
CODIFICATION
Section was enacted as part of the Office of National Drug
Control Policy Reauthorization Act of 2006, and not as part of the
Office of National Drug Control Policy Reauthorization Act of 1998
which comprises this chapter.
-End-
-CITE-
21 USC Sec. 1709 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1709. Repealed.
-MISC1-
Sec. 1709. Repealed. Pub. L. 109-469, title XI, Sec. 1101(a), Dec.
29, 2006, 120 Stat. 3539.
Section, Pub. L. 105-277, div. C, title VII, Sec. 710, Oct. 21,
1998, 112 Stat. 2681-689, related to Parents Advisory Council on
Youth Drug Abuse.
-End-
-CITE-
21 USC Sec. 1710 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1710. Drug Interdiction Coordinator and Committee
-STATUTE-
(a) United States Interdiction Coordinator
(1) In general
The United States Interdiction Coordinator shall perform the
duties of that position described in paragraph (2) and such other
duties as may be determined by the Director with respect to
coordination of efforts to interdict illicit drugs from entering
the United States.
(2) Responsibilities
The United States Interdiction Coordinator shall be responsible
to the Director for -
(A) coordinating the interdiction activities of the National
Drug Control Program agencies to ensure consistency with the
National Drug Control Strategy;
(B) on behalf of the Director, developing and issuing, on or
before March 1 of each year and in accordance with paragraph
(3), a National Interdiction Command and Control Plan to ensure
the coordination and consistency described in subparagraph (A);
(C) assessing the sufficiency of assets committed to illicit
drug interdiction by the relevant National Drug Control Program
agencies; and
(D) advising the Director on the efforts of each National
Drug Control Program agency to implement the National
Interdiction Command and Control Plan.
(3) Staff
The Director shall assign such permanent staff of the Office as
he considers appropriate to assist the United States Interdiction
Coordinator to carry out the responsibilities described in
paragraph (2), and may also, at his discretion, request that
appropriate National Drug Control Program agencies detail or
assign staff to the Office of Supply Reduction for that purpose.
(4) National Interdiction Command and Control Plan
(A) Purposes
The National Interdiction Command and Control Plan shall -
(i) set forth the Government's strategy for drug
interdiction;
(ii) state the specific roles and responsibilities of the
relevant National Drug Control Program agencies for
implementing that strategy; and
(iii) identify the specific resources required to enable
the relevant National Drug Control Program agencies to
implement that strategy.
(B) Consultation with other agencies
The United States Interdiction Coordinator shall issue the
National Interdiction Command and Control Plan in consultation
with the other members of the Interdiction Committee described
in subsection (b).
(C) Limitation
The National Interdiction Command and Control Plan shall not
change existing agency authorities or the laws governing
interagency relationships, but may include recommendations
about changes to such authorities or laws.
(D) Report to Congress
On or before March 1 of each year, the United States
Interdiction Coordinator shall provide a report on behalf of
the Director to the appropriate congressional committees, to
the Committee on Armed Services and the Committee on Homeland
Security of the House of Representatives, and to the Committee
on Homeland Security and Governmental Affairs and the Committee
on Armed Services of the Senate, which shall include -
(i) a copy of that year's National Interdiction Command and
Control Plan;
(ii) information for the previous 10 years regarding the
number and type of seizures of drugs by each National Drug
Control Program agency conducting drug interdiction
activities, as well as statistical information on the
geographic areas of such seizures; and
(iii) information for the previous 10 years regarding the
number of air and maritime patrol hours undertaken by each
National Drug Control Program agency conducting drug
interdiction activities, as well as statistical information
on the geographic areas in which such patrol hours took
place.
(E) Treatment of classified or law enforcement sensitive
information
Any content of the report described in subparagraph (D) that
involves information classified under criteria established by
an Executive order, or the public disclosure of which, as
determined by the Director, the Director of National
Intelligence, or the head of any Federal Government agency the
activities of which are described in the plan, would be
detrimental to the law enforcement or national security
activities of any Federal, State, or local agency, shall be
presented to Congress separately from the rest of the report.
(b) Interdiction Committee
(1) In general
The Interdiction Committee shall meet to -
(A) discuss and resolve issues related to the coordination,
oversight and integration of international, border, and
domestic drug interdiction efforts in support of the National
Drug Control Strategy;
(B) review the annual National Interdiction Command and
Control Plan, and provide advice to the Director and the United
States Interdiction Coordinator concerning that plan; and
(C) provide such other advice to the Director concerning drug
interdiction strategy and policies as the committee determines
is appropriate.
(2) Chairman
The Director shall designate one of the members of the
Interdiction Committee to serve as chairman.
(3) Meetings
The members of the Interdiction Committee shall meet, in person
and not through any delegate or representative, at least once per
calendar year, prior to March 1. At the call of either the
Director or the current chairman, the Interdiction Committee may
hold additional meetings, which shall be attended by the members
either in person, or through such delegates or representatives as
they may choose.
(4) Report
Not later than September 30 of each year, the chairman of the
Interdiction Committee shall submit a report to the Director and
to the appropriate congressional committees describing the
results of the meetings and any significant findings of the
Committee during the previous 12 months. Any content of such a
report that involves information classified under criteria
established by an Executive order, or whose public disclosure, as
determined by the Director, the chairman, or any member, would be
detrimental to the law enforcement or national security
activities of any Federal, State, local, or tribal agency, shall
be presented to Congress separately from the rest of the report.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 711, Oct. 21, 1998, 112
Stat. 2681-691; Pub. L. 109-469, title I, Sec. 103(f)(1), Dec. 29,
2006, 120 Stat. 3507.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469, which directed that section 711 of Office
of National Drug Control Policy Reauthorization Act of 1998 (Pub.
L. 105-277, div. C, title VII) be amended by "adding at the end" a
new section 711, was executed by substituting the new section 711
for this section which was the existing section 711 of the Act, to
reflect the probable intent of Congress. Prior to amendment, this
section related to drug interdiction.
-End-
-CITE-
21 USC Sec. 1710a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1710a. Requirement for disclosure of Federal sponsorship of
all Federal advertising or other communication materials
-STATUTE-
(a) Requirement
Each advertisement or other communication paid for by the Office,
either directly or through a contract awarded by the Office, shall
include a prominent notice informing the target audience that the
advertisement or other communication is paid for by the Office.
(b) Advertisement or other communication
In this section, the term "advertisement or other communication"
includes -
(1) an advertisement disseminated in any form, including print
or by any electronic means; and
(2) a communication by an individual in any form, including
speech, print, or by any electronic means.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 712, as added Pub. L. 109-
469, title XI, Sec. 1118, Dec. 29, 2006, 120 Stat. 3546.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-COD-
CODIFICATION
Another section 712 of title VII of div. C of Pub. L. 105-277
amended former section 1509 of this title.
-End-
-CITE-
21 USC Sec. 1711 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1711. Authorization of appropriations
-STATUTE-
There are authorized to be appropriated to carry out this chapter
except activities otherwise specified, to remain available until
expended, such sums as may be necessary for each of fiscal years
2006 through 2010.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 714, Oct. 21, 1998, 112
Stat. 2681-693; Pub. L. 109-469, title VI, Sec. 601, Dec. 29, 2006,
120 Stat. 3533.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
title", meaning title VII of Pub. L. 105-277, div. C, Oct. 21,
1998, 112 Stat. 2681-670, which is classified principally to this
chapter. For complete classification of title VII to the Code, see
Short Title note set out under section 1701 of this title and
Tables.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469 substituted "chapter except activities
otherwise specified," for "chapter," and "2006 through 2010" for
"1999 through 2003".
APPROPRIATIONS
Provisions appropriating funds to carry out activities authorized
by the Office of National Drug Control Policy Reauthorization Act
of 1998, which enacted this chapter, notwithstanding section 1712
of this title, were contained in the following appropriation acts:
Pub. L. 109-115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.
Pub. L. 108-447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249,
3250.
Pub. L. 108-199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.
-End-
-CITE-
21 USC Sec. 1712 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1712. Termination of Office of National Drug Control Policy
-STATUTE-
(a) In general
Except as provided in subsection (b) of this section, effective
on September 30, 2010, this chapter and the amendments made to this
chapter are repealed.
(b) Exception
Subsection (a) of this section does not apply to section 713 or
the amendments made by that section.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 715, Oct. 21, 1998, 112
Stat. 2681-693; Pub. L. 109-469, title VI, Sec. 602, Dec. 29, 2006,
120 Stat. 3533.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in subsec. (a), was in the original
"this title", meaning title VII of Pub. L. 105-277, div. C, Oct.
21, 1998, 112 Stat. 2681-670, which is classified principally to
this chapter. For complete classification of title VII to the Code,
see Short Title note set out under section 1701 of this title and
Tables.
Section 713, referred to in subsec. (b), is section 713 of Pub.
L. 105-277, div. C, title VII, Oct. 21, 1998, 112 Stat. 2681-693,
which amended sections 5312 to 5314 of Title 5, Government
Organization and Employees, section 1105 of Title 31, Money and
Finance, and section 402 of Title 50, War and National Defense.
-COD-
CODIFICATION
The repeal of this chapter and of the amendments made by this
chapter, effective Sept. 30, 2003, by this section, as in effect on
Sept. 30, 2003, has not been given effect in the Code, to reflect
the probable intent of Congress, because of the amendment to this
section by Pub. L. 109-469 which substituted "September 30, 2010"
for "September 30, 2003" as the effective date of the repeal. See
2006 Amendment note below.
-MISC1-
AMENDMENTS
2006 - Pub. L. 109-469 substituted "September 30, 2010, this
chapter and the amendments made to this chapter" for "September 30,
2003, this chapter and the amendments made by this chapter".
-End-
-CITE-
21 USC Sec. 1713 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1713. Authorization of use of environmentally-approved
herbicides to eliminate illicit narcotics crops
-STATUTE-
The Secretary of State, the Attorney General, the Secretary of
Agriculture, the Secretary of Defense, the Director of the Office
of National Drug Control Policy, and the Administrator of the
Environmental Protection Agency are authorized to support the
development and use of environmentally-approved herbicides to
eliminate illicit narcotics crops, including coca, cannabis, and
opium poppy, both in the United States and in foreign countries.
-SOURCE-
(Pub. L. 105-277, div. C, title VIII, Sec. 834, Oct. 21, 1998, 112
Stat. 2681-702.)
-COD-
CODIFICATION
Section was enacted as part of the Western Hemisphere Drug
Elimination Act, and not as part of the Office of National Drug
Control Policy Reauthorization Act of 1998 which comprises this
chapter.
-End-
-CITE-
21 USC Sec. 1714 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 22 - NATIONAL DRUG CONTROL POLICY
-HEAD-
Sec. 1714. Awards for demonstration programs by local partnerships
to coerce abstinence in chronic hard-drug users under community
supervision through the use of drug testing and sanctions
-STATUTE-
(a) Awards required
The Director shall make competitive awards to fund demonstration
programs by eligible partnerships for the purpose of reducing the
use of illicit drugs by chronic hard-drug users living in the
community while under the supervision of the criminal justice
system.
(b) Use of award amounts
Award amounts received under this section shall be used -
(1) to support the efforts of the agencies, organizations, and
researchers included in the eligible partnership;
(2) to develop and field a drug testing and graduated sanctions
program for chronic hard-drug users living in the community under
criminal justice supervision; and
(3) to assist individuals described in subsection (a) by
strengthening rehabilitation efforts through such means as job
training, drug treatment, or other services.
(c) Eligible partnership defined
In this section, the term "eligible partnership" means a working
group whose application to the Director -
(1) identifies the roles played, and certifies the involvement
of, two or more agencies or organizations, which may include -
(A) State, local, or tribal agencies (such as those carrying
out police, probation, prosecution, courts, corrections,
parole, or treatment functions);
(B) Federal agencies (such as the Drug Enforcement Agency,
the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and
United States Attorney offices); and
(C) community-based organizations;
(2) includes a qualified researcher;
(3) includes a plan for using judicial or other criminal
justice authority to administer drug tests to individuals
described in subsection (a) at least twice a week, and to swiftly
and certainly impose a known set of graduated sanctions for non-
compliance with community-release provisions relating to drug
abstinence (whether imposed as a pre-trial, probation, or parole
condition or otherwise);
(4) includes a strategy for responding to a range of substance
use and abuse problems and a range of criminal histories;
(5) includes a plan for integrating data infrastructure among
the agencies and organizations included in the eligible
partnership to enable seamless, real-time tracking of individuals
described in subsection (a);
(6) includes a plan to monitor and measure the progress toward
reducing the percentage of the population of individuals
described in subsection (a) who, upon being summoned for a drug
test, either fail to show up or who test positive for drugs.
(d) Reports to Congress
(1) Interim report
Not later than June 1, 2009, the Director shall submit to
Congress a report that identifies the best practices in reducing
the use of illicit drugs by chronic hard-drug users, including
the best practices identified through the activities funded under
this section.
(2) Final report
Not later than June 1, 2010, the Director shall submit to
Congress a report on the demonstration programs funded under this
section, including on the matters specified in paragraph (1).
(e) Authorization of appropriations
There is authorized to be appropriated to carry out this section
$4,900,000 for each of fiscal years 2007 through 2009.
-SOURCE-
(Pub. L. 105-277, div. C, title VII, Sec. 716, as added Pub. L. 109-
469, title XI, Sec. 1119, Dec. 29, 2006, 120 Stat. 3547.)
-STATAMEND-
REPEAL OF SECTION
For repeal of section on Sept. 30, 2010, see section 1712 of this
title.
-End-
-CITE-
21 USC CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA
CAMPAIGN 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN
-HEAD-
CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN
-End-
-CITE-
21 USC Secs. 1801 to 1804 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 23 - NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN
-HEAD-
Secs. 1801 to 1804. Repealed.
-MISC1-
Secs. 1801 to 1804. Repealed. Pub. L. 109-469, title V, Sec.
501(b), Dec. 29, 2006, 120 Stat. 3533.
Section 1801, Pub. L. 105-277, div. D, title I, Sec. 102, Oct.
21, 1998, 112 Stat. 2681-752, related to requirement to conduct
national media campaign.
Section 1802, Pub. L. 105-277, div. D, title I, Sec. 103, Oct.
21, 1998, 112 Stat. 2681-752, related to use of funds.
Section 1803, Pub. L. 105-277, div. D, title I, Sec. 104, Oct.
21, 1998, 112 Stat. 2681-753, related to reports to Congress.
Section 1804, Pub. L. 105-277, div. D, title I, Sec. 105, Oct.
21, 1998, 112 Stat. 2681-753, related to authorization of
appropriations.
SHORT TITLE
Pub. L. 105-277, div. D, Sec. 1(a), Oct. 21, 1998, 112 Stat. 2681-
751, provided that: "This division [enacting this chapter and
section 7144 of Title 20, Education, and enacting provisions set
out as notes under this section, section 1703 of this title,
section 6301 of Title 20, and section 3751 of Title 42, The Public
Health and Welfare] may be cited as the 'Drug Demand Reduction
Act'."
Pub. L. 105-277, div. D, title I, Sec. 101, Oct. 21, 1998, 112
Stat. 2681-752, which provided that subtitle A (Secs. 101-105) of
title I of div. D of Pub. L. 105-277, enacting this chapter, was to
be cited as the "Drug-Free Media Campaign Act of 1998", was
repealed by Pub. L. 109-469, title V, Sec. 501(b), Dec. 29, 2006,
120 Stat. 3533.
-End-
-CITE-
21 USC CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-MISC1-
Sec.
1901. Findings and policy.
1902. Purpose.
1903. Public identification of significant foreign narcotics
traffickers and required reports.
1904. Blocking assets and prohibiting transactions.
1905. Authorities.
1906. Enforcement.
1907. Definitions.
1908. Judicial Review Commission on Foreign Asset Control.
-End-
-CITE-
21 USC Sec. 1901 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1901. Findings and policy
-STATUTE-
(a) Findings
Congress makes the following findings:
(1) Presidential Decision Directive 42, issued on October 21,
1995, ordered agencies of the executive branch of the United
States Government to, inter alia, increase the priority and
resources devoted to the direct and immediate threat
international crime presents to national security, work more
closely with other governments to develop a global response to
this threat, and use aggressively and creatively all legal means
available to combat international crime.
(2) Executive Order No. 12978 of October 21, 1995, provides for
the use of the authorities in the International Emergency
Economic Powers Act (IEEPA) (50 U.S.C. 1701 et seq.) to target
and apply sanctions to four international narcotics traffickers
and their organizations that operate from Colombia.
(3) IEEPA was successfully applied to international narcotics
traffickers in Colombia and based on that successful case study,
Congress believes similar authorities should be applied
worldwide.
(4) There is a national emergency resulting from the activities
of international narcotics traffickers and their organizations
that threatens the national security, foreign policy, and economy
of the United States.
(b) Policy
It shall be the policy of the United States to apply economic and
other financial sanctions to significant foreign narcotics
traffickers and their organizations worldwide to protect the
national security, foreign policy, and economy of the United States
from the threat described in subsection (a)(4) of this section.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 802, Dec. 3, 1999, 113 Stat.
1626.)
-REFTEXT-
REFERENCES IN TEXT
Executive Order No. 12978, referred to in subsec. (a)(2), is Ex.
Ord. No. 12978, Oct. 21, 1995, 60 F.R. 54579, which is listed in a
table under section 1701 of Title 50, War and National Defense.
The International Emergency Economic Powers Act, referred to in
subsec. (a)(2), is title II of Pub. L. 95-223, Dec. 28, 1977, 91
Stat. 1626, as amended, which is classified generally to chapter 35
(Sec. 1701 et seq.) of Title 50, War and National Defense. For
complete classification of this Act to the Code, see Short Title
note set out under section 1701 of Title 50 and Tables.
-MISC1-
EFFECTIVE DATE
Pub. L. 106-120, title VIII, Sec. 811, Dec. 3, 1999, 113 Stat.
1636, provided that: "This title [see Short Title note set out
below] shall take effect on the date of the enactment of this Act
[Dec. 3, 1999]."
SHORT TITLE
Pub. L. 106-120, title VIII, Sec. 801, Dec. 3, 1999, 113 Stat.
1626, provided that: "This title [enacting this chapter and
amending section 1182 of Title 8, Aliens and Nationality] may be
cited as the 'Foreign Narcotics Kingpin Designation Act'."
-End-
-CITE-
21 USC Sec. 1902 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1902. Purpose
-STATUTE-
The purpose of this chapter is to provide authority for the
identification of, and application of sanctions on a worldwide
basis to, significant foreign narcotics traffickers, their
organizations, and the foreign persons who provide support to those
significant foreign narcotics traffickers and their organizations,
whose activities threaten the national security, foreign policy,
and economy of the United States.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 803, Dec. 3, 1999, 113 Stat.
1626.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
title", meaning title VIII of Pub. L. 106-120, Dec. 3, 1999, 113
Stat. 1626, which is classified generally to this chapter. For
complete classification of this Act to the Code, see Short Title
note set out under section 1901 of this title and Tables.
-End-
-CITE-
21 USC Sec. 1903 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1903. Public identification of significant foreign narcotics
traffickers and required reports
-STATUTE-
(a) Provision of information to the President
The Secretary of the Treasury, the Attorney General, the
Secretary of Defense, the Secretary of State, and the Director of
Central Intelligence shall consult among themselves and provide the
appropriate and necessary information to enable the President to
submit the report under subsection (b) of this section. This
information shall also be provided to the Director of the Office of
National Drug Control Policy.
(b) Public identification and sanctioning of significant foreign
narcotics traffickers
Not later than June 1, 2000, and not later than June 1 of each
year thereafter, the President shall submit a report to the
Permanent Select Committee on Intelligence, and the Committees on
the Judiciary, International Relations, Armed Services, and Ways
and Means of the House of Representatives; and to the Select
Committee on Intelligence, and the Committees on the Judiciary,
Foreign Relations, Armed Services, and Finance of the Senate -
(1) identifying publicly the foreign persons that the President
determines are appropriate for sanctions pursuant to this
chapter; and
(2) detailing publicly the President's intent to impose
sanctions upon these significant foreign narcotics traffickers
pursuant to this chapter.
The report required in this subsection shall not include
information on persons upon which United States sanctions imposed
under this chapter, or otherwise on account of narcotics
trafficking, are already in effect.
(c) Unclassified report required
The report required by subsection (b) of this section shall be
submitted in unclassified form and made available to the public.
(d) Classified report
(1) Not later than July 1, 2000, and not later than July 1 of
each year thereafter, the President shall provide the Permanent
Select Committee on Intelligence of the House of Representatives
and the Select Committee on Intelligence of the Senate with a
report in classified form describing in detail the status of the
sanctions imposed under this chapter, including the personnel and
resources directed towards the imposition of such sanctions during
the preceding fiscal year, and providing background information
with respect to newly-identified significant foreign narcotics
traffickers and their activities.
(2) Such classified report shall describe actions the President
intends to undertake or has undertaken with respect to such
significant foreign narcotics traffickers.
(3) The report required under this subsection is in addition to
the President's obligations to keep the intelligence committees of
Congress fully and currently informed pursuant to the provisions of
the National Security Act of 1947.
(e) Exclusion of certain information
(1) Intelligence
Notwithstanding any other provision of this section, the
reports described in subsections (b) and (d) of this section
shall not disclose the identity of any person, if the Director of
Central Intelligence determines that such disclosure could
compromise an intelligence operation, activity, source, or method
of the United States.
(2) Law enforcement
Notwithstanding any other provision of this section, the
reports described in subsections (b) and (d) of this section
shall not disclose the name of any person if the Attorney
General, in coordination as appropriate with the Director of the
Federal Bureau of Investigation, the Administrator of the Drug
Enforcement Administration, and the Secretary of the Treasury,
determines that such disclosure could reasonably be expected to -
(A) compromise the identity of a confidential source,
including a State, local, or foreign agency or authority or any
private institution that furnished information on a
confidential basis;
(B) jeopardize the integrity or success of an ongoing
criminal investigation or prosecution;
(C) endanger the life or physical safety of any person; or
(D) cause substantial harm to physical property.
(f) Notification required
(1) Whenever either the Director of Central Intelligence or the
Attorney General makes a determination under subsection (e) of this
section, the Director of Central Intelligence or the Attorney
General shall notify the Permanent Select Committee on Intelligence
of the House of Representatives and the Select Committee on
Intelligence of the Senate, and explain the reasons for such
determination.
(2) The notification required under this subsection shall be
submitted to the Permanent Select Committee on Intelligence of the
House of Representatives and the Select Committee on Intelligence
of the Senate not later than July 1, 2000, and on an annual basis
thereafter.
(g) Determinations not to apply sanctions
(1) The President may waive the application to a significant
foreign narcotics trafficker of any sanction authorized by this
chapter if the President determines that the application of
sanctions under this chapter would significantly harm the national
security of the United States.
(2) When the President determines not to apply sanctions that are
authorized by this chapter to any significant foreign narcotics
trafficker, the President shall notify the Permanent Select
Committee on Intelligence, and the Committees on the Judiciary,
International Relations, Armed Services, and Ways and Means of the
House of Representatives, and the Select Committee on Intelligence,
and the Committees on the Judiciary, Foreign Relations, Armed
Services, and Finance of the Senate not later than 21 days after
making such determination.
(h) Changes in determinations to impose sanctions
(1) Additional determinations
(A) If at any time after the report required under subsection
(b) of this section the President finds that a foreign person is
a significant foreign narcotics trafficker and such foreign
person has not been publicly identified in a report required
under subsection (b) of this section, the President shall submit
an additional public report containing the information described
in subsection (b) of this section with respect to such foreign
person to the Permanent Select Committee on Intelligence, and the
Committees on the Judiciary, International Relations, Armed
Services, and Ways and Means of the House of Representatives, and
the Select Committee on Intelligence, and the Committees on the
Judiciary, Foreign Relations, Armed Services, and Finance of the
Senate.
(B) The President may apply sanctions authorized under this
chapter to the significant foreign narcotics trafficker
identified in the report submitted under subparagraph (A) as if
the trafficker were originally included in the report submitted
pursuant to subsection (b) of this section.
(C) The President shall notify the Secretary of the Treasury of
any determination made under this paragraph.
(2) Revocation of determination
(A) Whenever the President finds that a foreign person that has
been publicly identified as a significant foreign narcotics
trafficker in the report required under subsection (b) of this
section or this subsection no longer engages in those activities
for which sanctions under this chapter may be applied, the
President shall issue public notice of such a finding.
(B) Not later than the date of the public notice issued
pursuant to subparagraph (A), the President shall notify, in
writing and in classified or unclassified form, the Permanent
Select Committee on Intelligence, and the Committees on the
Judiciary, International Relations, Armed Services, and Ways and
Means of the House of Representatives, and the Select Committee
on Intelligence, and the Committees on the Judiciary, Foreign
Relations, Armed Services, and Finance of the Senate of actions
taken under this paragraph and a description of the basis for
such actions.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 804, Dec. 3, 1999, 113 Stat.
1626.)
-REFTEXT-
REFERENCES IN TEXT
The National Security Act of 1947, referred to in subsec. (d)(3),
is act July 26, 1947, ch. 343, 61 Stat. 495, as amended. For
complete classification of this Act to the Code, see Short Title
note set out under section 401 of Title 50, War and National
Defense, and Tables.
-CHANGE-
CHANGE OF NAME
Reference to the Director of Central Intelligence or the Director
of the Central Intelligence Agency in the Director's capacity as
the head of the intelligence community deemed to be a reference to
the Director of National Intelligence. Reference to the Director of
Central Intelligence or the Director of the Central Intelligence
Agency in the Director's capacity as the head of the Central
Intelligence Agency deemed to be a reference to the Director of the
Central Intelligence Agency. See section 1081(a), (b) of Pub. L.
108-458, set out as a note under section 401 of Title 50, War and
National Defense.
-TRANS-
DELEGATION OF FUNCTIONS
For delegation of Congressional reporting functions of President
under subsec. (d) of this section, see section 1 of Ex. Ord. No.
13313, July 31, 2003, 68 F.R. 46075, set out as a note under
section 301 of Title 3, The President.
-End-
-CITE-
21 USC Sec. 1904 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1904. Blocking assets and prohibiting transactions
-STATUTE-
(a) Applicability of sanctions
A significant foreign narcotics trafficker publicly identified in
the report required under subsection (b) or (h)(1) of section 1903
of this title and foreign persons designated by the Secretary of
the Treasury pursuant to subsection (b) of this section shall be
subject to any and all sanctions as authorized by this chapter. The
application of sanctions on any foreign person pursuant to
subsection (b) or (h)(1) of section 1903 of this title or
subsection (b) of this section shall remain in effect until revoked
pursuant to section 1903(h)(2) of this title or subsection
(e)(1)(A) of this section or waived pursuant to section 1903(g)(1)
of this title.
(b) Blocking of assets
Except to the extent provided in regulations, orders,
instructions, licenses, or directives issued pursuant to this
chapter, and notwithstanding any contract entered into or any
license or permit granted prior to the date on which the President
submits the report required under subsection (b) or (h)(1) of
section 1903 of this title, there are blocked as of such date, and
any date thereafter, all such property and interests in property
within the United States, or within the possession or control of
any United States person, which are owned or controlled by -
(1) any significant foreign narcotics trafficker publicly
identified by the President in the report required under
subsection (b) or (h)(1) of section 1903 of this title;
(2) any foreign person that the Secretary of the Treasury, in
consultation with the Attorney General, the Director of Central
Intelligence, the Director of the Federal Bureau of
Investigation, the Administrator of the Drug Enforcement
Administration, the Secretary of Defense, and the Secretary of
State, designates as materially assisting in, or providing
financial or technological support for or to, or providing goods
or services in support of, the international narcotics
trafficking activities of a significant foreign narcotics
trafficker so identified in the report required under subsection
(b) or (h)(1) of section 1903 of this title, or foreign persons
designated by the Secretary of the Treasury pursuant to this
subsection;
(3) any foreign person that the Secretary of the Treasury, in
consultation with the Attorney General, the Director of Central
Intelligence, the Director of the Federal Bureau of
Investigation, the Administrator of the Drug Enforcement
Administration, the Secretary of Defense, and the Secretary of
State, designates as owned, controlled, or directed by, or acting
for or on behalf of, a significant foreign narcotics trafficker
so identified in the report required under subsection (b) or
(h)(1) of section 1903 of this title, or foreign persons
designated by the Secretary of the Treasury pursuant to this
subsection; and
(4) any foreign person that the Secretary of the Treasury, in
consultation with the Attorney General, the Director of Central
Intelligence, the Director of the Federal Bureau of
Investigation, the Administrator of the Drug Enforcement
Administration, the Secretary of Defense, and the Secretary of
State, designates as playing a significant role in international
narcotics trafficking.
(c) Prohibited transactions
Except to the extent provided in regulations, orders,
instructions, licenses, or directives issued pursuant to this
chapter, and notwithstanding any contract entered into or any
license or permit granted prior to the date on which the President
submits the report required under subsection (b) or (h)(1) of
section 1903 of this title, the following transactions are
prohibited:
(1) Any transaction or dealing by a United States person, or
within the United States, in property or interests in property of
any significant foreign narcotics trafficker so identified in the
report required pursuant to subsection (b) or (h)(1) of section
1903 of this title, and foreign persons designated by the
Secretary of the Treasury pursuant to subsection (b) of this
section.
(2) Any transaction or dealing by a United States person, or
within the United States, that evades or avoids, or has the
effect of evading or avoiding, and any endeavor, attempt, or
conspiracy to violate, any of the prohibitions contained in this
chapter.
(d) Law enforcement and intelligence activities not affected
Nothing in this chapter prohibits or otherwise limits the
authorized law enforcement or intelligence activities of the United
States, or the law enforcement activities of any State or
subdivision thereof.
(e) Implementation
(1) The Secretary of the Treasury, in consultation with the
Attorney General, the Director of Central Intelligence, the
Director of the Federal Bureau of Investigation, the Administrator
of the Drug Enforcement Administration, the Secretary of Defense,
and the Secretary of State, is authorized to take such actions as
may be necessary to carry out this chapter, including -
(A) making those designations authorized by paragraphs (2),
(3), and (4) of subsection (b) of this section and revocation
thereof;
(B) promulgating rules and regulations permitted under this
chapter; and
(C) employing all powers conferred on the Secretary of the
Treasury under this chapter.
(2) Each agency of the United States shall take all appropriate
measures within its authority to carry out the provisions of this
chapter.
(3) Section 552(a)(3) of title 5 shall not apply to any record or
information obtained or created in the implementation of this
chapter.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 805, Dec. 3, 1999, 113 Stat.
1629; Pub. L. 107-108, title III, Sec. 307, Dec. 28, 2001, 115
Stat. 1399.)
-MISC1-
AMENDMENTS
2001 - Subsec. (f). Pub. L. 107-108 struck out heading and text
of subsec. (f). Text read as follows: "The determinations,
identifications, findings, and designations made pursuant to
section 1903 of this title and subsection (b) of this section shall
not be subject to judicial review."
-CHANGE-
CHANGE OF NAME
Reference to the Director of Central Intelligence or the Director
of the Central Intelligence Agency in the Director's capacity as
the head of the intelligence community deemed to be a reference to
the Director of National Intelligence. Reference to the Director of
Central Intelligence or the Director of the Central Intelligence
Agency in the Director's capacity as the head of the Central
Intelligence Agency deemed to be a reference to the Director of the
Central Intelligence Agency. See section 1081(a), (b) of Pub. L.
108-458, set out as a note under section 401 of Title 50, War and
National Defense.
-End-
-CITE-
21 USC Sec. 1905 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1905. Authorities
-STATUTE-
(a) In general
To carry out the purposes of this chapter, the Secretary of the
Treasury may, under such regulations as he may prescribe, by means
of instructions, licenses, or otherwise -
(1) investigate, regulate, or prohibit -
(A) any transactions in foreign exchange, currency, or
securities; and
(B) transfers of credit or payments between, by, through, or
to any banking institution, to the extent that such transfers
or payments involve any interests of any foreign country or a
national thereof; and
(2) investigate, block during the pendency of an investigation,
regulate, direct and compel, nullify, void, prevent, or prohibit
any acquisition, holding, withholding, use, transfer, withdrawal,
transportation, placement into foreign or domestic commerce of,
or dealing in, or exercising any right, power, or privilege with
respect to, or transactions involving, any property in which any
foreign country or a national thereof has any interest,
by any person, or with respect to any property, subject to the
jurisdiction of the United States.
(b) Recordkeeping
Pursuant to subsection (a) of this section, the Secretary of the
Treasury may require recordkeeping, reporting, and production of
documents to carry out the purposes of this chapter.
(c) Defenses
(1) Full and actual compliance with any regulation, order,
license, instruction, or direction issued under this chapter shall
be a defense in any proceeding alleging a violation of any of the
provisions of this chapter.
(2) No person shall be held liable in any court for or with
respect to anything done or omitted in good faith in connection
with the administration of, or pursuant to, and in reliance on this
chapter, or any regulation, instruction, or direction issued under
this chapter.
(d) Rulemaking
The Secretary of the Treasury may issue such other regulations or
orders, including regulations prescribing recordkeeping, reporting,
and production of documents, definitions, licenses, instructions,
or directions, as may be necessary for the exercise of the
authorities granted by this chapter.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 806, Dec. 3, 1999, 113 Stat.
1631.)
-End-
-CITE-
21 USC Sec. 1906 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1906. Enforcement
-STATUTE-
(a) Criminal penalties
(1) Whoever willfully violates the provisions of this chapter, or
any license rule, or regulation issued pursuant to this chapter, or
willfully neglects or refuses to comply with any order of the
President issued under this chapter shall be -
(A) imprisoned for not more than 10 years,
(B) fined in the amount provided in title 18 or, in the case of
an entity, fined not more than $10,000,000,
or both.
(2) Any officer, director, or agent of any entity who knowingly
participates in a violation of the provisions of this chapter shall
be imprisoned for not more than 30 years, fined not more than
$5,000,000, or both.
(b) Civil penalties
A civil penalty not to exceed $1,000,000 may be imposed by the
Secretary of the Treasury on any person who violates any license,
order, rule, or regulation issued in compliance with the provisions
of this chapter.
(c) Judicial review of civil penalty
Any penalty imposed under subsection (b) of this section shall be
subject to judicial review only to the extent provided in section
702 of title 5.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 807, Dec. 3, 1999, 113 Stat.
1631.)
-End-
-CITE-
21 USC Sec. 1907 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1907. Definitions
-STATUTE-
As used in this chapter:
(1) Entity
The term "entity" means a partnership, joint venture,
association, corporation, organization, network, group, or
subgroup, or any form of business collaboration.
(2) Foreign person
The term "foreign person" means any citizen or national of a
foreign state or any entity not organized under the laws of the
United States, but does not include a foreign state.
(3) Narcotics trafficking
The term "narcotics trafficking" means any illicit activity to
cultivate, produce, manufacture, distribute, sell, finance, or
transport narcotic drugs, controlled substances, or listed
chemicals, or otherwise endeavor or attempt to do so, or to
assist, abet, conspire, or collude with others to do so.
(4) Narcotic drug; controlled substance; listed chemical
The terms "narcotic drug", "controlled substance", and "listed
chemical" have the meanings given those terms in section 802 of
this title.
(5) Person
The term "person" means an individual or entity.
(6) United States person
The term "United States person" means any United States citizen
or national, permanent resident alien, an entity organized under
the laws of the United States (including its foreign branches),
or any person within the United States.
(7) Significant foreign narcotics trafficker
The term "significant foreign narcotics trafficker" means any
foreign person that plays a significant role in international
narcotics trafficking, that the President has determined to be
appropriate for sanctions pursuant to this chapter, and that the
President has publicly identified in the report required under
subsection (b) or (h)(1) of section 1903 of this title.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 808, Dec. 3, 1999, 113 Stat.
1632.)
-End-
-CITE-
21 USC Sec. 1908 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 24 - INTERNATIONAL NARCOTICS TRAFFICKING
-HEAD-
Sec. 1908. Judicial Review Commission on Foreign Asset Control
-STATUTE-
(a) Establishment
There is established a commission to be known as the "Judicial
Review Commission on Foreign Asset Control" (in this section
referred to as the "Commission").
(b) Membership and procedural matters
(1) The Commission shall be composed of five members, as follows:
(A) One member shall be appointed by the Chairman of the Select
Committee on Intelligence of the Senate.
(B) One member shall be appointed by the Vice Chairman of the
Select Committee on Intelligence of the Senate.
(C) One member shall be appointed by the Chairman of the
Permanent Select Committee on Intelligence of the House of
Representatives.
(D) One member shall be appointed by the Ranking Minority
Member of the Permanent Select Committee on Intelligence of the
House of Representatives.
(E) One member shall be appointed jointly by the members
appointed under subparagraphs (A) through (D).
(2) Each member of the Commission shall, for purposes of the
activities of the Commission under this section, possess or obtain
an appropriate security clearance in accordance with applicable
laws and regulations regarding the handling of classified
information.
(3) The members of the Commission shall choose the chairman of
the Commission from among the members of the Commission.
(4) The members of the Commission shall establish rules governing
the procedures and proceedings of the Commission.
(c) Duties
The Commission shall have as its duties the following:
(1) To conduct a review of the current judicial, regulatory,
and administrative authorities relating to the blocking of assets
of foreign persons by the United States Government.
(2) To conduct a detailed examination and evaluation of the
remedies available to United States persons affected by the
blocking of assets of foreign persons by the United States
Government.
(d) Powers
(1) The Commission may hold such hearings, sit and act at such
times and places, take such testimony, and receive such evidence as
the Commission considers advisable to carry out the purposes of
this section.
(2) The Commission may secure directly from any executive
department, agency, bureau, board, commission, office, independent
establishment, or instrumentality of the Government information,
suggestions, estimates, and statistics for the purposes of this
section. Each such department, agency, bureau, board, commission,
office, establishment, or instrumentality shall, to the extent
authorized by law, furnish such information, suggestions,
estimates, and statistics directly to the Commission, upon request
of the chairman of the Commission. The Commission shall handle and
protect all classified information provided to it under this
section in accordance with applicable statutes and regulations.
(3) The Attorney General and the Secretary of the Treasury shall
provide to the Commission, on a nonreimbursable basis, such
administrative services, funds, facilities, and other support
services as are necessary for the performance of the Commission's
duties under this section.
(4) The Commission shall receive the full and timely cooperation
of any official, department, or agency of the United States
Government whose assistance is necessary for the fulfillment of the
duties of the Commission under this section, including the
provision of full and current briefings and analyses.
(5) No department or agency of the Government may withhold
information from the Commission on the grounds that providing the
information to the Commission would constitute the unauthorized
disclosure of classified information or information relating to
intelligence sources or methods.
(6) The Commission may use the United States mails in the same
manner and under the same conditions as the departments and
agencies of the United States.
(e) Staff
(1) Subject to paragraph (2), the chairman of the Commission, in
accordance with rules agreed upon by the Commission, shall appoint
and fix the compensation of a staff director and such other
personnel as may be necessary to enable the Commission to carry out
its duties, without regard to the provisions of title 5 governing
appointments in the competitive service, and without regard to the
provisions of chapter 51 and subchapter III or (!1) chapter 53 of
such title relating to classification and General Schedule pay
rates, except that no rate of pay fixed under this subsection may
exceed the equivalent of that payable to a person occupying a
position at level V of the Executive Schedule under section 5316 of
such title.
(2)(A) Any employee of a department or agency referred to in
subparagraph (B) may be detailed to the Commission without
reimbursement from the Commission, and such detailee shall retain
the rights, status, and privileges of his or her regular employment
without interruption.
(B) The departments and agencies referred to in this subparagraph
are as follows:
(i) The Department of Justice.
(ii) The Department of the Treasury.
(iii) The Central Intelligence Agency.
(3) All staff of the Commission shall possess a security
clearance in accordance with applicable laws and regulations
concerning the handling of classified information.
(f) Compensation and travel expenses
(1)(A) Except as provided in subparagraph (B), each member of the
Commission may be compensated at not to exceed the daily equivalent
of the annual rate of basic pay in effect for a position at level
IV of the Executive Schedule under section 5315 of title 5 for each
day during which that member is engaged in the actual performance
of the duties of the Commission under this section.
(B) Members of the Commission who are officers or employees of
the United States shall receive no additional pay by reason of
their service on the Commission.
(2) While away from their homes or regular places of business in
the performance of services for the Commission, members of the
Commission may be allowed travel expenses, including per diem in
lieu of subsistence, in the same manner as persons employed
intermittently in the Government service are allowed expenses under
section 5703(b) (!2) of title 5.
(g) Report
(1) Not later than 1 year after December 3, 1999, the Commissions
(!3) shall submit to the committees of Congress referred to in
paragraph (4) a report on the activities of the Commission under
this section, including the findings, conclusions, and
recommendations, if any, of the Commission as a result of the
review under subsection (c)(1) of this section and the examination
and evaluation under subsection (c)(2) of this section.
(2) The report under paragraph (1) shall include any additional
or dissenting views of a member of the Commission upon the request
of the member.
(3) The report under paragraph (1) shall be submitted in
unclassified form, but may include a classified annex.
(4) The committees of Congress referred to in this paragraph are
the following:
(A) The Select Committee on Intelligence and the Committees on
Foreign Relations and the Judiciary of the Senate.
(B) The Permanent Select Committee on Intelligence and the
Committees on International Relations and the Judiciary of the
House of Representatives.
(h) Termination
The Commission shall terminate at the end of the 60-day period
beginning on the date on which the report required by subsection
(g) of this section is submitted to the committees of Congress
referred to in that subsection.
(i) Inapplicability of certain administrative provisions
(1) The provisions of the Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the activities of the Commission
under this section.
(2) The provisions of section 552 of title 5 (commonly referred
to as the Freedom of Information Act) shall not apply to the
activities, records, and proceedings of the Commission under this
chapter.
(j) Funding
The Attorney General shall, from amounts authorized to be
appropriated to the Attorney General by this Act, make available to
the Commission $1,000,000 for purposes of the activities of the
Commission under this section. Amounts made available to the
Commission under the preceding sentence shall remain available
until expended.
-SOURCE-
(Pub. L. 106-120, title VIII, Sec. 810, Dec. 3, 1999, 113 Stat.
1633.)
-REFTEXT-
REFERENCES IN TEXT
The provisions of title 5 governing appointments in the
competitive service, referred to in subsec. (e)(1), are classified
generally to section 3301 et seq. of Title 5, Government
Organization and Employees.
The Federal Advisory Committee Act, referred to in subsec. (i),
is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is
set out in the Appendix to Title 5, Government Organization and
Employees.
This Act, referred to in subsec. (j), is Pub. L. 106-120, Dec. 3,
1999, 113 Stat. 1606, known as the Intelligence Authorization Act
for Fiscal Year 2000. For complete classification of this Act to
the Code, see Tables.
-FOOTNOTE-
(!1) So in original. Probably should be "of".
(!2) So in original. Section 5703 of title 5 does not contain a
subsec. (b).
(!3) So in original. Probably should be "Commission".
-End-
-CITE-
21 USC CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE
PROVISIONS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
-HEAD-
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
-MISC1-
SUBCHAPTER I - ANTI-DOPING AGENCY
Sec.
2001. Designation of United States Anti-Doping Agency.
2002. Records, audit, and report.
2003. Authorization of appropriations.
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
2011. Definitions.
2012. Establishment of clearinghouse and advisory council.
2013. NMIC requirements and review.
2014. Authorization of appropriations.
-End-
-CITE-
21 USC SUBCHAPTER I - ANTI-DOPING AGENCY 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER I - ANTI-DOPING AGENCY
-HEAD-
SUBCHAPTER I - ANTI-DOPING AGENCY
-End-
-CITE-
21 USC Sec. 2001 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER I - ANTI-DOPING AGENCY
-HEAD-
Sec. 2001. Designation of United States Anti-Doping Agency
-STATUTE-
(a) Definitions
In this subchapter:
(1) United States Olympic Committee
The term "United States Olympic Committee" means the
organization established by the "Ted Stevens Olympic and Amateur
Sports Act" (36 U.S.C. 220501 et seq.).
(2) Amateur athletic competition
The term "amateur athletic competition" means a contest, game,
meet, match, tournament, regatta, or other event in which amateur
athletes compete (36 U.S.C. 220501(b)(2)).
(3) Amateur athlete
The term "amateur athlete" means an athlete who meets the
eligibility standards established by the national governing body
or paralympic sports organization for the sport in which the
athlete competes (36 U.S.C. 22501(b)(1)).(!1)
(4) Gene doping
The term "gene doping" means the nontherapeutic use of cells,
genes, genetic elements, or of the modulation of gene expression,
having the capacity to enhance athletic performance.
(b) In general
The United States Anti-Doping Agency shall -
(1) serve as the independent anti-doping organization for the
amateur athletic competitions recognized by the United States
Olympic Committee;
(2) ensure that athletes participating in amateur athletic
activities recognized by the United States Olympic Committee are
prevented from using performance-enhancing drugs, or performance-
enhancing genetic modifications accomplished through gene-
doping;
(3) implement anti-doping education, research, testing, and
adjudication programs to prevent United States Amateur Athletes
participating in any activity recognized by the United States
Olympic Committee from using performance-enhancing drugs, or
performance-enhancing genetic modifications accomplished through
gene-doping;
(4) serve as the United States representative responsible for
coordination with other anti-doping organizations coordinating
amateur athletic competitions recognized by the United States
Olympic Committee to ensure the integrity of athletic
competition, the health of the athletes and the prevention of use
of performance-enhancing drugs, or performance-enhancing genetic
modifications accomplished through gene-doping by United States
amateur athletes; and
(5) permanently include "gene doping" among any list of
prohibited substances adopted by the Agency.
-SOURCE-
(Pub. L. 109-469, title VII, Sec. 701, Dec. 29, 2006, 120 Stat.
3533.)
-REFTEXT-
REFERENCES IN TEXT
The Ted Stevens Olympic and Amateur Sports Act, referred to in
subsec. (a)(1), is chapter 2205 of Title 36, Patriotic and National
Observances, Ceremonies, and Organizations.
-MISC1-
SHORT TITLE
Pub. L. 109-469, title X, Sec. 1001, Dec. 29, 2006, 120 Stat.
3537, provided that: "This title [enacting subchapter II of this
chapter] may be cited as the 'National Methamphetamine Information
Clearinghouse Act of 2006'."
-FOOTNOTE-
(!1) So in original. Probably should be "220501(b)(1))."
-End-
-CITE-
21 USC Sec. 2002 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER I - ANTI-DOPING AGENCY
-HEAD-
Sec. 2002. Records, audit, and report
-STATUTE-
(a) Records
The United States Anti-Doping Agency shall keep correct and
complete records of account.
(b) Report
The United States Anti-Doping Agency shall submit an annual
report to Congress which shall include -
(1) an audit conducted and submitted in accordance with section
10101 of title 36; and
(2) a description of the activities of the agency.
-SOURCE-
(Pub. L. 109-469, title VII, Sec. 702, Dec. 29, 2006, 120 Stat.
3534.)
-End-
-CITE-
21 USC Sec. 2003 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER I - ANTI-DOPING AGENCY
-HEAD-
Sec. 2003. Authorization of appropriations
-STATUTE-
There are authorized to be appropriated to the United States Anti-
Doping Agency -
(1) for fiscal year 2007, $9,700,000;
(2) for fiscal year 2008, $10,300,000;
(3) for fiscal year 2009, $10,600,000;
(4) for fiscal year 2010, $11,000,000; and
(5) for fiscal year 2011, $11,500,000.
-SOURCE-
(Pub. L. 109-469, title VII, Sec. 703, Dec. 29, 2006, 120 Stat.
3534.)
-End-
-CITE-
21 USC SUBCHAPTER II - NATIONAL METHAMPHETAMINE
INFORMATION CLEARINGHOUSE 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-HEAD-
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-End-
-CITE-
21 USC Sec. 2011 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-HEAD-
Sec. 2011. Definitions
-STATUTE-
In this subchapter -
(1) the term "Council" means the National Methamphetamine
Advisory Council established under section 2012(b)(1) of this
title;
(2) the term "drug endangered children" means children whose
physical, mental, or emotional health are at risk because of the
production, use, or other effects of methamphetamine production
or use by another person;
(3) the term "National Methamphetamine Information
Clearinghouse" or "NMIC" means the information clearinghouse
established under section 2012(a) of this title; and
(4) the term "qualified entity" means a State, local, or tribal
government, school board, or public health, law enforcement,
nonprofit, community anti-drug coalition, or other
nongovernmental organization providing services related to
methamphetamines.
-SOURCE-
(Pub. L. 109-469, title X, Sec. 1002, Dec. 29, 2006, 120 Stat.
3537.)
-End-
-CITE-
21 USC Sec. 2012 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-HEAD-
Sec. 2012. Establishment of clearinghouse and advisory council
-STATUTE-
(a) Clearinghouse
There is established, under the supervision of the Attorney
General of the United States, an information clearinghouse to be
known as the National Methamphetamine Information Clearinghouse.
(b) Advisory council
(1) In general
There is established an advisory council to be known as the
National Methamphetamine Advisory Council.
(2) Membership
The Council shall consist of 10 members appointed by the
Attorney General -
(A) not fewer than 3 of whom shall be representatives of law
enforcement agencies;
(B) not fewer than 4 of whom shall be representatives of
nongovernmental and nonprofit organizations providing services
or training and implementing programs or strategies related to
methamphetamines; and
(C) 1 of whom shall be a representative of the Department of
Health and Human Services.
(3) Period of appointment; vacancies
Members shall be appointed for 3 years. Any vacancy in the
Council shall not affect its powers, but shall be filled in the
same manner as the original appointment.
(4) Personnel matters
(A) Travel expenses
The members of the Council shall be allowed travel expenses,
including per diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I of chapter 57 of
title 5, while away from their homes or regular places of
business in the performance of services for the Council.
(B) No compensation
The members of the Council shall not receive compensation for
the performance of the duties of a member of the Council.
-SOURCE-
(Pub. L. 109-469, title X, Sec. 1003, Dec. 29, 2006, 120 Stat.
3538.)
-End-
-CITE-
21 USC Sec. 2013 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-HEAD-
Sec. 2013. NMIC requirements and review
-STATUTE-
(a) In general
The NMIC shall promote sharing information regarding successful
law enforcement, treatment, environmental, prevention, social
services, and other programs related to the production, use, or
effects of methamphetamine and grants available for such programs.
(b) Components
The NMIC shall include -
(1) a toll-free number; and
(2) a website that provides a searchable database, which -
(A) provides information on the short-term and long-term
effects of methamphetamine use;
(B) provides information regarding methamphetamine treatment
and prevention programs and strategies and programs for drug
endangered children, including descriptions of successful
programs and strategies and contact information for such
programs and strategies;
(C) provides information regarding grants for methamphetamine-
related programs, including contact information and links to
websites;
(D) allows a qualified entity to submit items to be posted on
the website regarding successful public or private programs or
other useful information related to the production, use, or
effects of methamphetamine;
(E) includes a restricted section that may only be accessed
by a law enforcement organization that contains successful
strategies, training techniques, and other information that the
Council determines helpful to law enforcement agency efforts to
identify or combat the production, use, or effects of
methamphetamine;
(F) allows public access to all information not in a
restricted section; and
(G) contains any additional information the Council
determines may be useful in identifying or combating the
production, use, or effects of methamphetamine.
Thirty days after the website in paragraph (2) is operational, no
funds shall be expended to continue the website methresources.gov.
(c) Review of posted information
(1) In general
Not later than 30 days after the date of submission of an item
by a qualified entity, the Council shall review an item submitted
for posting on the website described in subsection (b)(2) -
(A) to evaluate and determine whether the item, as submitted
or as modified, meets the requirements for posting; and
(B) in consultation with the Attorney General, to determine
whether the item should be posted in a restricted section of
the website.
(2) Determination
Not later than 45 days after the date of submission of an item,
the Council shall -
(A) post the item on the website described in subsection
(b)(2); or
(B) notify the qualified entity that submitted the item
regarding the reason such item shall not be posted and
modifications, if any, that the qualified entity may make to
allow the item to be posted.
-SOURCE-
(Pub. L. 109-469, title X, Sec. 1004, Dec. 29, 2006, 120 Stat.
3538.)
-End-
-CITE-
21 USC Sec. 2014 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 25 - MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
SUBCHAPTER II - NATIONAL METHAMPHETAMINE INFORMATION CLEARINGHOUSE
-HEAD-
Sec. 2014. Authorization of appropriations
-STATUTE-
There are authorized to be appropriated -
(1) for fiscal year 2007 -
(A) $500,000 to establish the NMIC and Council; and
(B) such sums as are necessary for the operation of the NMIC
and Council; and
(2) for each of fiscal years 2008 and 2009, such sums as are
necessary for the operation of the NMIC and Council.
-SOURCE-
(Pub. L. 109-469, title X, Sec. 1005, Dec. 29, 2006, 120 Stat.
3539.)
-End-