-CITE-
21 USC CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
-HEAD-
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
-MISC1-
SUBCHAPTER I - SHORT TITLE
Sec.
301. Short title.
SUBCHAPTER II - DEFINITIONS
321. Definitions; generally.
321a. "Butter" defined.
321b. "Package" defined.
321c. Nonfat dry milk; "milk" defined.
321d. Market names for catfish and ginseng.
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
331. Prohibited acts.
332. Injunction proceedings.
333. Penalties.
333a. Repealed.
334. Seizure.
335. Hearing before report of criminal violation.
335a. Debarment, temporary denial of approval, and
suspension.
335b. Civil penalties.
335c. Authority to withdraw approval of abbreviated drug
applications.
336. Report of minor violations.
337. Proceedings in name of United States; provision as to
subpoenas.
SUBCHAPTER IV - FOOD
341. Definitions and standards for food.
342. Adulterated food.
343. Misbranded food.
343-1. National uniform nutrition labeling.
343-2. Dietary supplement labeling exemptions.
343-3. Disclosure.
343a. Repealed.
344. Emergency permit control.
345. Regulations making exemptions.
346. Tolerances for poisonous or deleterious substances in
food; regulations.
346a. Tolerances and exemptions for pesticide chemical
residues.
346b. Authorization of appropriations.
347. Intrastate sales of colored oleomargarine.
347a. Congressional declaration of policy regarding
oleomargarine sales.
347b. Contravention of State laws.
348. Food additives.
349. Bottled drinking water standards; publication in
Federal Register.
350. Vitamins and minerals.
350a. Infant formulas.
350b. New dietary ingredients.
350c. Maintenance and inspection of records.
350d. Registration of food facilities.
350e. Sanitary transportation practices.
SUBCHAPTER V - DRUGS AND DEVICES
PART A - DRUGS AND DEVICES
351. Adulterated drugs and devices.
352. Misbranded drugs and devices.
353. Exemptions and consideration for certain drugs,
devices, and biological products.
353a. Pharmacy compounding.
354. Veterinary feed directive drugs.
355. New drugs.
355a. Pediatric studies of drugs.
355b. Adverse-event reporting.
355c. Research into pediatric uses for drugs and biological
products.
356. Fast track products.
356-1. Accelerated approval of priority countermeasures.
356a. Manufacturing changes.
356b. Reports of postmarketing studies.
356c. Discontinuance of life saving product.
357. Repealed.
358. Authority to designate official names.
359. Nonapplicability of subchapter to cosmetics.
360. Registration of producers of drugs or devices.
360a. Repealed.
360b. New animal drugs.
360c. Classification of devices intended for human use.
360d. Performance standards.
360e. Premarket approval.
360f. Banned devices.
360g. Judicial review.
360h. Notification and other remedies.
360i. Records and reports on devices.
360j. General provisions respecting control of devices
intended for human use.
360k. State and local requirements respecting devices.
360l. Postmarket surveillance.
360m. Accredited persons.
PART B - DRUGS FOR RARE DISEASES OR CONDITIONS
360aa. Recommendations for investigations of drugs for rare
diseases or conditions.
360bb. Designation of drugs for rare diseases or conditions.
360cc. Protection for drugs for rare diseases or conditions.
360dd. Open protocols for investigations of drugs for rare
diseases or conditions.
360ee. Grants and contracts for development of drugs for rare
diseases and conditions.
PART C - ELECTRONIC PRODUCT RADIATION CONTROL
360hh. Definitions.
360ii. Program of control.
360jj. Studies by Secretary.
360kk. Performance standards for electronic products.
360ll. Notification of defects in and repair or replacement
of electronic products.
360mm. Imports.
360nn. Inspection, records, and reports.
360oo. Prohibited acts.
360pp. Enforcement.
360qq. Repealed.
360rr. Federal-State cooperation.
360ss. State standards.
PART D - DISSEMINATION OF TREATMENT INFORMATION
360aaa. Requirements for dissemination of treatment
information on drugs or devices.
360aaa-1. Information authorized to be disseminated.
360aaa-2. Establishment of list of articles and publications
disseminated and list of providers that received
articles and reference publications.
360aaa-3. Requirement regarding submission of supplemental
application for new use; exemption from requirement.
360aaa-4. Corrective actions; cessation of dissemination.
360aaa-5. Definitions.
360aaa-6. Rules of construction.
PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES
360bbb. Expanded access to unapproved therapies and
diagnostics.
360bbb-1. Dispute resolution.
360bbb-2. Classification of products.
360bbb-3. Authorization for medical products for use in
emergencies.
360bbb-4. Technical assistance.
PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
360ccc. Conditional approval of new animal drugs for minor use
and minor species.
360ccc-1. Index of legally marketed unapproved new animal drugs
for minor species.
360ccc-2. Designated new animal drugs for minor use or minor
species.
SUBCHAPTER VI - COSMETICS
361. Adulterated cosmetics.
362. Misbranded cosmetics.
363. Regulations making exemptions.
364. Repealed.
SUBCHAPTER VII - GENERAL AUTHORITY
PART A - GENERAL ADMINISTRATIVE PROVISIONS
371. Regulations and hearings.
372. Examinations and investigations.
372a. Transferred.
373. Records.
374. Inspection.
374a. Inspections relating to food allergens.
375. Publicity.
376. Examination of sea food on request of packer; marking
food with results; fees; penalties.
377. Revision of United States Pharmacopoeia; development
of analysis and mechanical and physical tests.
378. Advertising of foods.
379. Confidential information.
379a. Presumption of existence of jurisdiction.
379b. Consolidated administrative and laboratory facility.
379c. Transferred.
379d. Automation of Food and Drug Administration.
PART B - COLORS
379e. Listing and certification of color additives for
foods, drugs, devices, and cosmetics.
PART C - FEES
SUBPART 1 - FREEDOM OF INFORMATION FEES
379f. Recovery and retention of fees for freedom of
information requests.
SUBPART 2 - FEES RELATING TO DRUGS
379g. Definitions.
379h. Authority to assess and use drug fees.
SUBPART 3 - FEES RELATING TO DEVICES
379i. Definitions.
379j. Authority to assess and use device fees.
SUBPART 4 - FEES RELATING TO ANIMAL DRUGS
379j-11. Definitions.
379j-12. Authority to assess and use animal drug fees.
PART D - INFORMATION AND EDUCATION
379k. Information system.
379l. Education.
PART E - ENVIRONMENTAL IMPACT REVIEW
379o. Environmental impact.
PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
379r. National uniformity for nonprescription drugs.
379s. Preemption for labeling or packaging of cosmetics.
PART G - SAFETY REPORTS
379v. Safety report disclaimers.
PART H - SERIOUS ADVERSE EVENT REPORTS
379aa. Serious adverse event reporting for nonprescription
drugs.
379aa-1. Serious adverse event reporting for dietary
supplements.
SUBCHAPTER VIII - IMPORTS AND EXPORTS
381. Imports and exports.
382. Exports of certain unapproved products.
383. Office of International Relations.
384. Importation of prescription drugs.
SUBCHAPTER IX - MISCELLANEOUS
391. Separability clause.
392. Exemption of meats and meat food products.
393. Food and Drug Administration.
393a. Office of Pediatric Therapeutics.
394. Scientific review groups.
395. Loan repayment program.
396. Practice of medicine.
397. Contracts for expert review.
398. Notices to States regarding imported food.
399. Grants to States for inspections.
-End-
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21 USC SUBCHAPTER I - SHORT TITLE 01/03/2007
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TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I - SHORT TITLE
-HEAD-
SUBCHAPTER I - SHORT TITLE
-End-
-CITE-
21 USC Sec. 301 01/03/2007
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TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I - SHORT TITLE
-HEAD-
Sec. 301. Short title
-STATUTE-
This chapter may be cited as the Federal Food, Drug, and Cosmetic
Act.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)
-MISC1-
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, Secs. 1, 2, 53 Stat. 853, 854,
provided that:
"[Sec. 1] (a) The effective date of the following provisions of
the Federal Food, Drug, and Cosmetic Act is hereby postponed until
January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k) of this title]; 501(a), (4) [351(a)(4) of this title];
502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this
title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this
title].
"(b) The Secretary of Agriculture shall promulgate regulations
further postponing to July 1, 1940 the effective date of the
provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g),
(h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of
this title] of such Act with respect to lithographed labeling which
was manufactured prior to February 1, 1939, and to containers
bearing labeling which, prior to February 1, 1939, was
lithographed, etched, stamped, pressed, printed, fused or blown on
or in such containers, where compliance with such provisions would
be unduly burdensome by reason of causing the loss of valuable
stocks of such labeling or containers, and where such postponement
would not prevent the public interest being adequately served:
Provided, That in no case shall such regulations apply to labeling
which would not have complied with the requirements of the Food and
Drugs Act of June 30, 1906, as amended.
"Sec. 2. (a) The provisions of section 8 [section 10 of this
title], paragraph fifth, under the heading 'In the case of food:',
of the Food and Drugs Act of June 30, 1906, as amended, and
regulations promulgated thereunder, and all other provisions of
such Act to the extent that they may relate to the enforcement of
such section 8 [section 10 of this title] and of such regulations,
shall remain in force until January 1, 1940.
"(b) The provisions of such Act of June 30, 1906, as amended,
[sections 1 to 5, 7 to 15, and 372a of this title] to the extent
that they impose, or authorize the imposition of, any requirement
imposed by section 403(k) of the Federal Food, Drug, and Cosmetic
Act [section 343(k) of this title], shall remain in force until
January 1, 1940.
"(c) Notwithstanding the provisions of section 1 of this Act,
such section shall not apply -
"(1) to the provisions of section 502(d) and (e) of the Federal
Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar
as such provisions relate to any substance named in section 8
[section 10 of this title], paragraph second, under the heading
'In the case of drugs:', of the Food and Drugs Act of June 30,
1906, as amended, or a derivative of any such substance; or
"(2) to the provisions of section 502(b), (d), (e), (f), (g),
and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d)
to (h) of this title], insofar as such provisions relate to drugs
to which section 505 [355 of this title] of such Act applies."
EFFECTIVE DATE
Section 902(a) of act June 25, 1938, provided that: "This Act
[enacting this chapter and repealing sections 1 to 5 and 7 to 15 of
this title], shall take effect twelve months after the date of its
enactment [June 25, 1938]. The Federal Food and Drugs Act of June
30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15),
shall remain in force until such effective date, and, except as
otherwise provided in this subsection, is hereby repealed effective
upon such date: Provided, That the provisions of section 701
[section 371 of this title] shall become effective on the enactment
of this Act, and thereafter the Secretary is authorized hereby to
(1) conduct hearings and to promulgate regulations which shall
become effective on or after the effective date of this Act as the
Secretary shall direct, and (2) designate prior to the effective
date of this Act food having common or usual names and exempt such
food from the requirements of clause (2) of section 403(i) [section
343(i) of this title] for a reasonable time to permit the
formulation, promulgation, and effective application of definitions
and standards of identity therefor as provided by section 401
[section 341 of this title]: Provided further, That sections
502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively
of this title], and all other provisions of this Act to the extent
that they may relate to the enforcement of such sections, shall
take effect on the date of the enactment of this Act, except that
in the case of a cosmetic to which the proviso of section 601(a)
[section 361(a) of this title], relates, such cosmetic shall not,
prior to the ninetieth day after such date of enactment, be deemed
adulterated by reason of the failure of its label to bear the
legend prescribed in such proviso: Provided further, That the Act
of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a
of this title]; 42 Stat. 1500, ch. 268), defining butter and
providing a standard therefor; the Act of July 24, 1919 (U.S.C.,
1934 ed., title 21, sec. 10 [section 321b of this title]; 41 Stat.
271, ch. 26], defining wrapped meats as in package form; and the
amendment to the Food and Drugs Act, section 10A, approved August
27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section
372a of this title]) shall remain in force and effect and be
applicable to the provisions of this Act."
SHORT TITLE OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 1, Dec. 22, 2006, 120 Stat. 3469, provided
that: "This Act [enacting sections 379aa and 379aa-1 of this title,
amending sections 331, 343, 352, and 381 of this title, and
enacting provisions set out as notes under sections 331, 343, 352,
379aa, and 381 of this title] may be cited as the 'Dietary
Supplement and Nonprescription Drug Consumer Protection Act'."
SHORT TITLE OF 2005 AMENDMENTS
Pub. L. 109-59, title VII, Sec. 7201, Aug. 10, 2005, 119 Stat.
1911, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
of title VII of Pub. L. 109-59, enacting section 350e of this
title, amending sections 331, 342, and 373 of this title and
section 5701 of Title 49, Transportation, omitting sections 5702 to
5714 of Title 49, and enacting provisions set out as a note under
section 331 of this title] may be cited as the 'Sanitary Food
Transportation Act of 2005'."
Pub. L. 109-43, Sec. 1, Aug. 1, 2005, 119 Stat. 439, provided
that: "This Act [amending sections 352 and 379j of this title,
enacting provisions set out as a note under section 352 of this
title, and amending provisions set out as notes under sections 352
and 379i of this title] may be cited as the 'Medical Device User
Fee Stabilization Act of 2005'."
SHORT TITLE OF 2004 AMENDMENTS
Pub. L. 108-282, title I, Sec. 101, Aug. 2, 2004, 118 Stat. 891,
provided that: "This title [enacting sections 360ccc to 360ccc-2 of
this title, amending sections 321, 331, 352, 353, 354, and 360b of
this title, enacting provisions set out as notes under sections
360ccc and 393 of this title, and amending provisions set out as a
note under section 360b of this title] may be cited as the 'Minor
Use and Minor Species Animal Health Act of 2004'."
Pub. L. 108-282, title II, Sec. 201, Aug. 2, 2004, 118 Stat. 905,
provided that: "This title [enacting section 374a of this title and
section 242r of Title 42, The Public Health and Welfare, amending
sections 321, 343, and 343-1 of this title, and enacting provisions
set out as notes under sections 321 and 343 of this title and
sections 243 and 300d-2 of Title 42] may be cited as the 'Food
Allergen Labeling and Consumer Protection Act of 2004'."
Pub. L. 108-214, Sec. 1, Apr. 1, 2004, 118 Stat. 572, provided
that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i,
and 379j of this title and provisions set out as notes under
sections 352, 360l, and 379j of this title] may be cited as the
'Medical Devices Technical Corrections Act'."
SHORT TITLE OF 2003 AMENDMENTS
Pub. L. 108-155, Sec. 1, Dec. 3, 2003, 117 Stat. 1936, provided
that: "This Act [enacting section 355c of this title, 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 355c of this title, and
amending provisions set out as notes under section 355a of this
title and section 284m of Title 42] may be cited as the 'Pediatric
Research Equity Act of 2003'."
Pub. L. 108-130, Sec. 1, Nov. 18, 2003, 117 Stat. 1361, provided
that: "This Act [enacting sections 379j-11 and 379j-12 of this
title and provisions set out as notes under section 379j-11 of this
title] may be cited as the 'Animal Drug User Fee Act of 2003'."
SHORT TITLE OF 2002 AMENDMENTS
Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided
that: "This Act [amending sections 360cc and 360ee of this title
and enacting provisions set out as a note under section 360ee of
this title] may be cited as the 'Rare Diseases Orphan Product
Development Act of 2002'."
Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588,
provided that: "This Act [enacting sections 379i and 379j of this
title and section 289g-3 of Title 42, The Public Health and
Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360,
360c, 360e, 360m, and 374 of this title, and enacting provisions
set out as notes under sections 352, 360e, 360j, 360l, 379i, and
379j of this title and section 289g-3 of Title 42] may be cited as
the 'Medical Device User Fee and Modernization Act of 2002'."
Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,
provided that: "This subtitle [subtitle A (Secs. 501-509) of title
V of Pub. L. 107-188, amending sections 356b, 379g, and 379h of
this title and enacting provisions set out as notes under sections
356b and 379g of this title] may be cited as the 'Prescription Drug
User Fee Amendments of 2002'."
Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided
that: "This Act [enacting sections 355b and 393a of this title and
section 284m of Title 42, The Public Health and Welfare, amending
sections 321, 355, 355a, and 379h of this title and sections 282,
284k, 284l, 285a-2, and 290b of Title 42, and enacting provisions
set out as notes under sections 355 and 355a of this title and
sections 284m and 289 of Title 42] may be cited as the 'Best
Pharmaceuticals for Children Act'."
SHORT TITLE OF 2000 AMENDMENT
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(a)], Oct. 28,
2000, 114 Stat. 1549, 1549A-35, provided that: "This section
[enacting section 384 of this title, amending sections 331, 333,
and 381 of this title, and enacting provisions set out as a note
under section 384 of this title] may be cited as the 'Medicine
Equity and Drug Safety Act of 2000'."
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(a)], Oct. 28,
2000, 114 Stat. 1549, 1549A-40, provided that: "This section
[amending section 381 of this title and enacting provisions set out
as a note under section 381 of this title] may be cited as the
'Prescription Drug Import Fairness Act of 2000'."
SHORT TITLE OF 1998 AMENDMENT
Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided
that: "This Act [amending sections 321 and 346a of this title] may
be cited as the 'Antimicrobial Regulation Technical Corrections Act
of 1998'."
SHORT TITLE OF 1997 AMENDMENT
Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296,
provided that: "This Act [enacting sections 343-3, 353a, 355a, 356
to 356c, 360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l,
379o, 379r, 379s, 379v, 396, and 397 of this title and sections
247b-8 and 299a-3 of Title 42, The Public Health and Welfare,
amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355,
360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee,
371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title,
section 45C of Title 26, Internal Revenue Code, section 156 of
Title 35, Patents, section 8126 of Title 38, Veterans' Benefits,
and sections 262, 263a, and 282 of Title 42, repealing sections 356
and 357 of this title, and enacting provisions set out as notes
under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l,
360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and
sections 247b-8 and 282 of Title 42] may be cited as the 'Food and
Drug Administration Modernization Act of 1997'."
SHORT TITLE OF 1996 AMENDMENTS
Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151,
provided that: "This Act [enacting section 354 of this title,
amending sections 331, 353, and 360b of this title, and enacting
provisions set out as notes under section 360b of this title] may
be cited as the 'Animal Drug Availability Act of 1996'."
Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.
1513, provided that: "This title [amending sections 321, 331, 333,
342, and 346a of this title] may be cited as the 'Food Quality
Protection Act of 1996'."
[Another "Food Quality Protection Act of 1996", was enacted by
Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note
under section 136 of Title 7, Agriculture.]
Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.
1321-313, provided that: "This chapter [chapter 1A (Secs. 2101-
2105) of title II of Pub. L. 104-134, enacting section 382 of this
title and amending sections 331 and 381 of this title and section
262 of Title 42, The Public Health and Welfare] may be cited as the
'FDA Export Reform and Enhancement Act of 1996'."
SHORT TITLE OF 1994 AMENDMENTS
Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325,
provided that: "This Act [enacting sections 343-2 and 350b of this
title and section 287c-11 of Title 42, The Public Health and
Welfare, amending sections 321, 331, 342, 343, and 350 of this
title and section 281 of Title 42, and enacting provisions set out
as notes under sections 321 and 343 of this title] may be cited as
the 'Dietary Supplement Health and Education Act of 1994'."
Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided
that: "This Act [amending sections 331, 343-1, 360b, and 371 of
this title and enacting provisions set out as notes under section
360b of this title] may be cited as the 'Animal Medicinal Drug Use
Clarification Act of 1994'."
SHORT TITLE OF 1993 AMENDMENT
Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided
that: "This Act [amending sections 321, 331 to 333, 334, 335b, 341
to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,
360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this
title and section 263b of Title 42, The Public Health and Welfare,
and enacting provisions set out as a note under section 343 of this
title] may be cited as the 'Nutrition Labeling and Education Act
Amendments of 1993'."
SHORT TITLE OF 1992 AMENDMENTS
Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.
4491, provided that: "This title [enacting sections 379g and 379h
of this title, transferring sections 372a, 376, and 379c of this
title to sections 376, 379e and 379f, respectively, of this title,
amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361,
362, 453, 601, and 1033 of this title, enacting provisions set out
as notes under section 379g of this title, and amending provisions
set out as notes under sections 343 and 343-1 of this title] may be
cited as the 'Prescription Drug User Fee Act of 1992'."
Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat.
4500, provided that: "This title [enacting provisions set out as
notes under sections 343 and 393 of this title and amending
provisions set out as notes under sections 343 and 343-1 of this
title] may be cited as the 'Dietary Supplement Act of 1992'."
Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941,
provided that: "This Act [amending sections 333, 353, and 381 of
this title and enacting provisions set out as a note under section
353 of this title] may be cited as the 'Prescription Drug
Amendments of 1992'."
Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238,
provided that: "This Act [amending sections 321, 331, 334, 346a,
352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to
372a, 376, and 381 of this title and section 262 of Title 42, The
Public Health and Welfare and enacting and amending provisions set
out as notes under section 360i of this title] may be cited as the
'Medical Device Amendments of 1992'."
Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided
that: "This Act [enacting sections 335a to 335c of this title,
amending sections 321, 336, 337, and 355 of this title, and
enacting provisions set out as notes under section 335a of this
title] may be cited as the 'Generic Drug Enforcement Act of 1992'."
SHORT TITLE OF 1990 AMENDMENTS
Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583,
provided that: "This Act [enacting sections 379b to 379d and 394 of
this title] may be cited as the 'Food and Drug Administration
Revitalization Act'."
Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511,
provided that: "This Act [enacting sections 360l and 383 of this
title, amending sections 321, 333, 351, 353, and 360c to 360j of
this title and sections 263b to 263n of Title 42, The Public Health
and Welfare, redesignating sections 263b to 263n of Title 42 as
sections 360gg to 360ss of this title, repealing section 263b of
Title 42, and enacting provisions set out as notes under sections
333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as
the 'Safe Medical Devices Act of 1990'."
Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353,
provided that: "This Act [enacting section 343-1 of this title,
amending sections 321, 337, 343, 345, and 371 of this title, and
enacting provisions set out as notes under sections 343 and 343-1
of this title] may be cited as the 'Nutrition Labeling and
Education Act of 1990'."
SHORT TITLE OF 1988 AMENDMENTS
Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971,
provided that: "This Act [amending sections 321, 353, and 360b of
this title, section 2201 of Title 28, Judiciary and Judicial
Procedure, and sections 156 and 271 of Title 35, Patents, and
enacting provisions set out as notes under section 360b of this
title] may be cited as the 'Generic Animal Drug and Patent Term
Restoration Act'."
Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,
provided that: "This title [enacting section 393 of this title,
amending sections 5315 and 5316 of Title 5, Government Organization
and Employees, and enacting provisions set out as notes under
section 393 of this title] may be cited as the 'Food and Drug
Administration Act of 1988'."
Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided
that: "This Act [amending sections 331, 333, 353, and 381 of this
title and enacting provisions set out as notes under section 353 of
this title] may be cited as the 'Prescription Drug Marketing Act of
1987'."
Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided
that: "This Act [amending sections 360bb and 360ee of this title,
enacting provisions set out as a note under section 360aa of this
title, and amending provisions set out as a note under section 236
of Title 42, The Public Health and Welfare] may be cited as the
'Orphan Drug Amendments of 1988'."
SHORT TITLE OF 1986 AMENDMENT
Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat.
3743, provided that: "This title [enacting section 382 of this
title, amending sections 241 and 262 of Title 42, The Public Health
and Welfare, and enacting provisions set out as notes under section
333 of this title and section 262 of Title 42] may be cited as the
'Drug Export Amendments Act of 1986'."
SHORT TITLE OF 1985 AMENDMENT
Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided
that: "This Act [amending sections 360aa to 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 360aa of this title and section 236 of Title 42] may be
cited as the 'Orphan Drug Amendments of 1985'."
SHORT TITLE OF 1984 AMENDMENT
Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:
"That this Act [enacting section 156 of Title 35, Patents, amending
sections 355 and 360cc of this title, sections 68b, 68c, and 70b of
Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary
and Judicial Procedure, and sections 271 and 282 of Title 35, and
enacting provisions set out as notes under section 355 of this
title and section 68b of Title 15] may be cited as the 'Drug Price
Competition and Patent Term Restoration Act of 1984'."
SHORT TITLE OF 1983 AMENDMENTS
Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided:
"That this Act [amending provisions set out as a note under section
348 of this title] may be cited as the 'Saccharin Study and
Labeling Act Amendment of 1983'."
Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided
that: "This Act [enacting part B of subchapter V of chapter 9 of
this title, section 44H of Title 26, Internal Revenue Code, section
155 of Title 35, Patents, and sections 236, 255, and 298b-4 of
Title 42, The Public Health and Welfare, amending sections 1274,
1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and
Trade, section 904 of this title, sections 280C and 6096 of Title
26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o,
254p, 256, 294j, 295g-1, 295g-4, 295h, 295h-1a, 297-1, 300, 300a-1,
300a-3, 300b, 300e-1, 300m, 300n-5, 300q-2, 300u-5, 300w-3, 300x-1,
300x-4, 300y-11, 4577, and 4588 of Title 42, enacting provisions
set out as notes under section 360aa of this title, section 44H of
Title 26, and sections 241, 255, 287i, and 300x-1 of Title 42, and
repealing provisions set out as a note under section 300t-11 of
Title 42] may be cited as the 'Orphan Drug Act'."
SHORT TITLE OF 1981 AMENDMENT
Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided:
"That this Act [amending provisions set out as a note under section
348 of this title] may be cited as the 'Saccharin Study and
Labeling Act Amendment of 1981'."
SHORT TITLE OF 1980 AMENDMENT
Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:
"That this Act [enacting section 350a of this title, amending
sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and
enacting a provision set out as a note under section 350a of this
title] may be cited as the 'Infant Formula Act of 1980'."
SHORT TITLE OF 1977 AMENDMENT
Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided
that: "This Act [enacting section 343a of this title, amending
sections 321 and 343 of this title, enacting provisions set out as
notes under sections 343 and 348 of this title, and amending
provisions set out as notes under sections 218 and 289l-1 of Title
42, The Public Health and Welfare] may be cited as the 'Saccharin
Study and Labeling Act'."
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'."
SHORT TITLE OF 1972 AMENDMENT
Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided
that: "This Act [amending sections 331, 335, and 360 of this title
and enacting provisions set out as notes under section 360 of this
title] may be cited as the 'Drug Listing Act of 1972'."
SHORT TITLE OF 1968 AMENDMENTS
Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided
that: "This Act [enacting provisions now comprising part C (Secs.
360hh-360ss) of subchapter III of this chapter and provisions set
out as notes under section 360hh of this title] may be cited as the
'Radiation Control for Health and Safety Act of 1968'."
Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:
"That this Act [enacting section 360b of this title, amending
sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title,
and enacting provisions set out as a note under section 360b of
this title] may be cited as the 'Animal Drug Amendments of 1968'."
SHORT TITLE OF 1965 AMENDMENT
Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided:
"That this Act [amending sections 321, 331, 333, 334, 360, and 372
of this title and section 1114 of Title 18, Crimes and Criminal
Procedure, and enacting provisions set out as notes under sections
321 and 352 of this title] may be cited as the 'Drug Abuse Control
Amendments of 1965'."
SHORT TITLE OF 1962 AMENDMENT
Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in
part that such Act [enacting sections 358 to 360 of this title,
amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
374, 379e, and 381 of this title, and enacting provisions set out
as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374
of this title] may be cited as the 'Drug Amendments of 1962'."
SHORT TITLE OF 1960 AMENDMENT
Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:
"That this Act [amending sections 321, 331, 333, 342, 346, 351,
352, 361, 362, 371, and 379e of this title, repealing sections 354
and 364 of this title, and enacting notes set out under this
section] may be cited as the 'Color Additive Amendments of 1960'."
SHORT TITLE OF 1958 AMENDMENT
Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:
"That this Act [amending sections 321, 331, 342, 346, 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, 342,
and 451 of this title] may be cited as the 'Food Additives
Amendment of 1958'."
HAZARDOUS SUBSTANCES
Federal Hazardous Substances Act as not modifying this chapter,
see Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out
as an Effect Upon Federal and State Laws note under section 1261 of
Title 15, Commerce and Trade.
-End-
-CITE-
21 USC SUBCHAPTER II - DEFINITIONS 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
SUBCHAPTER II - DEFINITIONS
-End-
-CITE-
21 USC Sec. 321 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321. Definitions; generally
-STATUTE-
For the purposes of this chapter -
(a)(1) The term "State", except as used in the last sentence of
section 372(a) of this title, means any State or Territory of the
United States, the District of Columbia, and the Commonwealth of
Puerto Rico.
(2) The term "Territory" means any Territory or possession of the
United States, including the District of Columbia, and excluding
the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce between any
State or Territory and any place outside thereof, and (2) commerce
within the District of Columbia or within any other Territory not
organized with a legislative body.
(c) The term "Department" means Department of Health and Human
Services.
(d) The term "Secretary" means the Secretary of Health and Human
Services.
(e) The term "person" includes individual, partnership,
corporation, and association.
(f) The term "food" means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article.
(g)(1) The term "drug" means (A) articles recognized in the
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary,
or any supplement to any of them; and (B) articles intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any article specified in clause (A), (B), or (C). A food or
dietary supplement for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug solely
because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and
not misleading statement is made in accordance with section
343(r)(6) of this title is not a drug under clause (C) solely
because the label or the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or
device, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and which
thereby falsely purports or is represented to be the product of, or
to have been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor.
(h) The term "device" (except when used in paragraph (n) of this
section and in sections 331(i), 343(f), 352(c), and 362(c) of this
title) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
(3) intended to affect the structure or any function of the
body of man or other animals, and
which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement
of its primary intended purposes.
(i) The term "cosmetic" means (1) articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such
articles; except that such term shall not include soap.
(j) The term "official compendium" means the official United
States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States, official National Formulary, or any supplement to
any of them.
(k) The term "label" means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this chapter that any
word, statement, or other information appear on the label shall not
be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper,
if any there be, of the retail package of such article, or is
easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package
liners.
(m) 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.
(n) If an article is alleged to be misbranded because the
labeling or advertising is misleading, then in determining whether
the labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations
or material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates
under the conditions of use prescribed in the labeling or
advertising thereof or under such conditions of use as are
customary or usual.
(o) The representation of a drug, in its labeling, as an
antiseptic shall be considered to be a representation that it is a
germicide, except in the case of a drug purporting to be, or
represented as, an antiseptic for inhibitory use as a wet dressing,
ointment, dusting powder, or such other use as involves prolonged
contact with the body.
(p) The term "new drug" means -
(1) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug is not generally recognized, among experts
qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, as safe and effective for use
under the conditions prescribed, recommended, or suggested in the
labeling thereof, except that such a drug not so recognized shall
not be deemed to be a "new drug" if at any time prior to June 25,
1938, it was subject to the Food and Drugs Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such
conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under such conditions.
(q)(1)(A) Except as provided in clause (B), the term "pesticide
chemical" means any substance that is a pesticide within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
[7 U.S.C. 136 et seq.], including all active and inert ingredients
of such pesticide. Notwithstanding any other provision of law, the
term "pesticide" within such meaning includes ethylene oxide and
propylene oxide when such substances are applied on food.
(B) In the case of the use, with respect to food, of a substance
described in clause (A) to prevent, destroy, repel, or mitigate
microorganisms (including bacteria, viruses, fungi, protozoa,
algae, and slime), the following applies for purposes of clause
(A):
(i) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is
applied for such use on food, or the substance is included for
such use in water that comes into contact with the food, in the
preparing, packing, or holding of the food for commercial
purposes. The substance is not excluded under this subclause from
such definition if the substance is ethylene oxide or propylene
oxide, and is applied for such use on food. The substance is not
so excluded if the substance is applied for such use on a raw
agricultural commodity, or the substance is included for such use
in water that comes into contact with the commodity, as follows:
(I) The substance is applied in the field.
(II) The substance is applied at a treatment facility where
raw agricultural commodities are the only food treated, and the
treatment is in a manner that does not change the status of the
food as a raw agricultural commodity (including treatment
through washing, waxing, fumigating, and packing such
commodities in such manner).
(III) The substance is applied during the transportation of
such commodity between the field and such a treatment facility.
(ii) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is a
food contact substance as defined in section 348(h)(6) of this
title, and any of the following circumstances exist: The
substance is included for such use in an object that has a food
contact surface but is not intended to have an ongoing effect on
any portion of the object; the substance is included for such use
in an object that has a food contact surface and is intended to
have an ongoing effect on a portion of the object but not on the
food contact surface; or the substance is included for such use
in or is applied for such use on food packaging (without regard
to whether the substance is intended to have an ongoing effect on
any portion of the packaging). The food contact substance is not
excluded under this subclause from such definition if any of the
following circumstances exist: The substance is applied for such
use on a semipermanent or permanent food contact surface (other
than being applied on food packaging); or the substance is
included for such use in an object that has a semipermanent or
permanent food contact surface (other than being included in food
packaging) and the substance is intended to have an ongoing
effect on the food contact surface.
With respect to the definition of the term "pesticide" that is
applicable to the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.], this clause does not exclude any
substance from such definition.
(2) The term "pesticide chemical residue" means a residue in or
on raw agricultural commodity or processed food of -
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
(3) Notwithstanding subparagraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of
"pesticide chemical" or "pesticide chemical residue" if -
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be
regulated under one or more provisions of this chapter other than
sections 342(a)(2)(B) and 346a of this title.
(r) The term "raw agricultural commodity" means any food in its
raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior
to marketing.
(s) The term "food additive" means any substance the intended use
of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or, in
the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on common
use in food) to be safe under the conditions of its intended use;
except that such term does not include -
(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or
approval granted prior to September 6, 1958, pursuant to this
chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
seq.] or the Meat Inspection Act of March 4, 1907, as amended and
extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended
for use in, a dietary supplement.
(t)(1) The term "color additive" means a material which -
(A) is a dye, pigment, or other substance made by a process of
synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change
of identity, from a vegetable, animal, mineral, or other source,
and
(B) when added or applied to a food, drug, or cosmetic, or to
the human body or any part thereof, is capable (alone or through
reaction with other substance) of imparting color thereto;
except that such term does not include any material which the
Secretary, by regulation, determines is used (or intended to be
used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate
grays.
(3) Nothing in subparagraph (1) of this paragraph shall be
construed to apply to any pesticide chemical, soil or plant
nutrient, or other agricultural chemical solely because of its
effect in aiding, retarding, or otherwise affecting, directly or
indirectly, the growth or other natural physiological processes of
produce of the soil and thereby affecting its color, whether before
or after harvest.
(u) The term "safe" as used in paragraph (s) of this section and
in sections 348, 360b, 360ccc, and 379e of this title, has
reference to the health of man or animal.
(v) The term "new animal drug" means any drug intended for use
for animals other than man, including any drug intended for use in
animal feed but not including such animal feed, -
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof; except that such a drug not so recognized shall not be
deemed to be a "new animal drug" if at any time prior to June 25,
1938, it was subject to the Food and Drug Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and
effectiveness for use under such conditions, has become so
recognized but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.
Provided that any drug intended for minor use or use in a minor
species that is not the subject of a final regulation published by
the Secretary through notice and comment rulemaking finding that
the criteria of paragraphs (1) and (2) have not been met (or that
the exception to the criterion in paragraph (1) has been met) is a
new animal drug.
(w) The term "animal feed", as used in paragraph (w) (!1) of this
section, in section 360b of this title, and in provisions of this
chapter referring to such paragraph or section, means an article
which is intended for use for food for animals other than man and
which is intended for use as a substantial source of nutrients in
the diet of the animal, and is not limited to a mixture intended to
be the sole ration of the animal.
(x) The term "informal hearing" means a hearing which is not
subject to section 554, 556, or 557 of title 5 and which provides
for the following:
(1) The presiding officer in the hearing shall be designated by
the Secretary from officers and employees of the Department who
have not participated in any action of the Secretary which is the
subject of the hearing and who are not directly responsible to an
officer or employee of the Department who has participated in any
such action.
(2) Each party to the hearing shall have the right at all times
to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be
given reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for the
action taken or proposed by the Secretary which is the subject of
the hearing and a general summary of the information which will
be presented by the Secretary at the hearing in support of such
action.
(4) At the hearing the parties to the hearing shall have the
right to hear a full and complete statement of the action of the
Secretary which is the subject of the hearing together with the
information and reasons supporting such action, to conduct
reasonable questioning, and to present any oral or written
information relevant to such action.
(5) The presiding officer in such hearing shall prepare a
written report of the hearing to which shall be attached all
written material presented at the hearing. The participants in
the hearing shall be given the opportunity to review and correct
or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A
party to the hearing shall have the right to have the hearing
transcribed at his expense. Any transcription of a hearing shall
be included in the presiding officer's report of the hearing.
(y) The term "saccharin" includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to be
or is represented for special dietary use solely as a food for
infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an application
submitted under section 355(j) of this title for the approval of a
drug that relies on the approved application of another drug with
the same active ingredient to establish safety and efficacy, and -
(1) in the case of section 335a of this title, includes a
supplement to such an application for a different or additional
use of the drug but does not include a supplement to such an
application for other than a different or additional use of the
drug, and
(2) in the case of sections 335b and 335c of this title,
includes any supplement to such an application.
(bb) The term "knowingly" or "knew" means that a person, with
respect to information -
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the
truth or falsity of the information.
(cc) For purposes of section 335a of this title, the term "high
managerial agent" -
(1) means -
(A) an officer or director of a corporation or an
association,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation,
association, or partnership,
having duties such that the conduct of such officer, director,
partner, employee, or agent may fairly be assumed to represent
the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility for -
(A) submissions to the Food and Drug Administration regarding
the development or approval of any drug product,
(B) production, quality assurance, or quality control of any
drug product, or
(C) research and development of any drug product.
(dd) For purposes of sections 335a and 335b of this title, the
term "drug product" means a drug subject to regulation under
section 355, 360b, or 382 of this title or under section 262 of
title 42.
(ee) The term "Commissioner" means the Commissioner of Food and
Drugs.
(ff) The term "dietary supplement" -
(1) means a product (other than tobacco) intended to supplement
the diet that bears or contains one or more of the following
dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet
by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B),
(C), (D), or (E);
(2) means a product that -
(A)(i) is intended for ingestion in a form described in
section 350(c)(1)(B)(i) of this title; or
(ii) complies with section 350(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a
sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does -
(A) include an article that is approved as a new drug under
section 355 of this title or licensed as a biologic under
section 262 of title 42 and was, prior to such approval,
certification, or license, marketed as a dietary supplement or
as a food unless the Secretary has issued a regulation, after
notice and comment, finding that the article, when used as or
in a dietary supplement under the conditions of use and dosages
set forth in the labeling for such dietary supplement, is
unlawful under section 342(f) of this title; and
(B) not include -
(i) an article that is approved as a new drug under section
355 of this title, certified as an antibiotic under section
357 of this title, or licensed as a biologic under section
262 of title 42, or
(ii) an article authorized for investigation as a new drug,
antibiotic, or biological for which substantial clinical
investigations have been instituted and for which the
existence of such investigations has been made public,
which was not before such approval, certification, licensing, or
authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, finding that the article
would be lawful under this chapter.
Except for purposes of paragraph (g), a dietary supplement shall be
deemed to be a food within the meaning of this chapter.
(gg) The term "processed food" means any food other than a raw
agricultural commodity and includes any raw agricultural commodity
that has been subject to processing, such as canning, cooking,
freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the
United States Environmental Protection Agency.
(ii) The term "compounded positron emission tomography drug" -
(1) means a drug that -
(A) exhibits spontaneous disintegration of unstable nuclei by
the emission of positrons and is used for the purpose of
providing dual photon positron emission tomographic diagnostic
images; and
(B) has been compounded by or on the order of a practitioner
who is licensed by a State to compound or order compounding for
a drug described in subparagraph (A), and is compounded in
accordance with that State's law, for a patient or for
research, teaching, or quality control; and
(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program to
be used in the preparation of such a drug.
(jj) The term "antibiotic drug" means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other drug intended for human
use containing any quantity of any chemical substance which is
produced by a micro-organism and which has the capacity to inhibit
or destroy micro-organisms in dilute solution (including a
chemically synthesized equivalent of any such substance) or any
derivative thereof.
(kk) Priority supplement. - The term "priority supplement" means
a drug application referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997 (111 Stat. 2298).
(ll)(1) The term "single-use device" means a device that is
intended for one use, or on a single patient during a single
procedure.
(2)(A) The term "reprocessed", with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed
within the meaning of this definition.
(B) A single-use device that meets the definition under clause
(A) shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term
"recycled" rather than the term "reprocessed".
(3) The term "original device" means a new, unused single-use
device.
(mm)(1) The term "critical reprocessed single-use device" means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
(2) The term "semi-critical reprocessed single-use device" means
a reprocessed single-use device that is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the
body.
(nn) The term "major species" means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary may
add species to this definition by regulation.
(oo) The term "minor species" means animals other than humans
that are not major species.
(pp) The term "minor use" means the intended use of a drug in a
major species for an indication that occurs infrequently and in
only a small number of animals or in limited geographical areas and
in only a small number of animals annually.
(qq) The term "major food allergen" means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(2) A food ingredient that contains protein derived from a food
specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in
paragraph (1) and any ingredient derived from such highly
refined oil.
(B) A food ingredient that is exempt under paragraph (6) or
(7) of section 343(w) of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-
516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title
V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295,
Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203,
Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, Sec. 3,
Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, Sec.
107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, Sec.
5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec. 16(b),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May 13,
1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-
170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-
115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111
Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30,
1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4,
2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct.
26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, Sec. 102(b)(1),
(5)(A), (B), title II, Sec. 203(c)(1), Aug. 2, 2004, 118 Stat. 891,
902, 908.)
-REFTEXT-
REFERENCES IN TEXT
The Food and Drugs Act of June 30, 1906, as amended, referred to
in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
amended, referred to in par. (v)(1), is act June 30, 1906, ch.
3915, 34 Stat. 768, as amended, which was classified to subchapter
I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except
for section 14a which was transferred to section 372a of this
title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,
and is covered by this chapter.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in par. (q)(1), 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 Poultry Products Inspection Act, referred to in par. (s)(4),
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 Meat Inspection Act of March 4, 1907, as amended and
extended, referred to in par. (s)(4), 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.
Section 101(4) of the Food and Drug Administration Modernization
Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
105-115, which is set out as a note under section 379g of this
title.
-MISC1-
AMENDMENTS
2004-Par. (u). Pub. L. 108-282, Sec. 102(b)(5)(A), substituted
"360b, 360ccc" for "360b".
Par. (v). Pub. L. 108-282, Sec. 102(b)(5)(B), inserted concluding
provisions.
Pars. (nn) to (pp). Pub. L. 108-282, Sec. 102(b)(1), added pars.
(nn) to (pp).
Par. (qq). Pub. L. 108-282, Sec. 203(c)(1), added par. (qq).
2002 - Par. (kk). Pub. L. 107-109 added par. (kk).
Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)
and struck out former subpar. (1) which read as follows: "The term
'pesticide chemical' means any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide, and Rodenticide
Act, including all active and inert ingredients of such pesticide."
Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
"subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
introductory provisions.
1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
"or 357" after "section 355(j)".
Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
after "section 355,".
Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
", certified as an antibiotic under section 357 of this title,"
before "or licensed as a biologic".
Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)
generally. Prior to amendment, par. (q) read as follows: "The term
'pesticide chemical' means any substance which, alone, in chemical
combination or in formulation with one or more other substances, is
'a pesticide' within the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act as now in force or as hereafter
amended, and which is used in the production, storage, or
transportation of raw agricultural commodities."
Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
(1) and (2) generally. Prior to amendment, subpars. (1) and (2)
read as follows:
"(1) a pesticide chemical in or on a raw agricultural commodity;
or
"(2) a pesticide chemical to the extent that it is intended for
use or is used in the production, storage, or transportation of any
raw agricultural commodity; or".
Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
and (hh).
1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last
sentence generally. Prior to amendment, last sentence read as
follows: "A food for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug under
clause (B) solely because the label or labeling contains such a
claim."
Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture".
Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
(w) to (ff) as (v) to (ee), respectively.
1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), 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 notes below.
Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
103-80, Sec. 4(b), substituted "its primary" for "any of its
principal" in two places in concluding provisions.
Par. (u). Pub. L. 102-571 substituted "379e" for "376".
Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
Health, Education, and Welfare" after "employees of the
Department".
Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
but does not include devices or their components, parts, or
accessories" after "clause (A), (B), or (C)".
Pub. L. 101-535 inserted at end "A food for which a claim,
subject to sections 343(r)(1)(B) and 343(r)(3) of this title or
sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
accordance with the requirements of section 343(r) of this title is
not a drug under clause (B) solely because the label or labeling
contains such a claim."
Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the
amendment of subpar. (3) by substituting "its primary" for "any of
its principal", could not be executed because "any of its
principal" did not appear in subpar. (3).
1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which
read as follows: "which drug is composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, or bacitracin, or any derivative thereof, except
when there is in effect a published order of the Secretary
declaring such drug not to be a new animal drug on the grounds that
(A) the requirement of certification of batches of such drug, as
provided for in section 360b(n) of this title, is not necessary to
insure that the objectives specified in paragraph (3) thereof are
achieved and (B) that neither subparagraph (1) nor (2) of this
paragraph (w) applies to such drug."
1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
1977 - Par. (z). Pub. L. 95-203 added par. (z).
1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded
definition of "device" to include implements, machines, implants,
in vitro reagents, and other similar or related articles, added
recognition in the National Formulary or the United States
Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,
to the enumeration of conditions under which a device may qualify
for inclusion under this chapter, and inserted requirements that a
device be one which does not achieve any of its principal intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.
Par. (n). Pub. L. 94-278 inserted "or advertising" after
"labeling" wherever appearing.
Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
1972 - Par. (q). Pub. L. 92-516 substituted reference to
pesticide for reference to economic poison.
1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out
reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,
337, 360, 360a, 372, 373, 374, and 375 of this title as they apply
to depressant or stimulant drugs.
Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
defined "depressant or stimulant drug".
1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended
provisions to cover depressant and stimulant drugs, the containers
thereof, and equipment used in manufacturing, compounding, or
processing such drugs, to the Canal Zone.
Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted "(except a
new animal drug or an animal feed bearing or containing a new
animal drug)" after "Any drug" in subpars. (1) and (2),
respectively.
Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
section 360b of this title.
Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
lysergic acid diethylamide.
Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
(x).
1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing
provisions as subpar. (1), redesignated cls. (1) to (4) thereof as
(A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)"
and added subpar. (2).
Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
and the", and added subpar. (1).
Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
effectiveness" after "to evaluate the safety", and "and effective"
after "as safe".
Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
effectiveness" after "safety".
1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
additives from definition of "food additive".
Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
par. (t) redesignated (u).
Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
(u) and inserted reference to section 376 of this title.
1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
(r).
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-282, title II, Sec. 203(d), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 343 and 343-1 of this title] shall apply
to any food that is labeled on or after January 1, 2006."
EFFECTIVE DATE OF 1997 AMENDMENT
Section 501 of Pub. L. 105-115 provided that: "Except as
otherwise provided in this Act [see Short Title of 1997 Amendment
note set out under section 301 of this title], this Act and the
amendments made by this Act, other than the provisions of and the
amendments made by sections 111, 121, 125, and 307 [enacting
section 355a of this title, amending this section and sections 331,
335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,
and 382 of this title, section 45C of Title 26, Internal Revenue
Code, section 156 of Title 35, Patents, and section 8126 of Title
38, Veterans' Benefits, repealing sections 356 and 357 of this
title, and enacting provisions set out as notes under sections 351
and 355 of this title], shall take effect 90 days after the date of
enactment of this Act [Nov. 21, 1997]."
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective six months after the date
of the promulgation of final regulations to implement section
343(r) of this title, or if such regulations are not promulgated,
the date proposed regulations are to be considered as such final
regulations (Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined by the
Secretary under section 343(r)(2)(A)(i) of this title, see section
10(a) of Pub. L. 101-535, set out as a note under section 343 of
this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
1972, except if regulations are necessary for the implementation of
any provision that becomes effective on Oct. 21, 1972, and
continuation in effect of subchapter I of chapter 6 of Title 7, and
regulations thereunder, relating to the control of economic
poisons, as in existence prior to Oct. 21, 1972, until superseded
by provisions of Pub. L. 92-516, and regulations thereunder, see
section 4 of Pub. L. 92-516, set out as an Effective Date note
under section 136 of Title 7, Agriculture.
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 AMENDMENTS; TRANSITIONAL PROVISIONS
Section 6 of Pub. L. 90-639 provided that: "The amendments made
by this Act [amending this section, sections 331, 333, 334, and
360a of this title, and provisions set out as a note under section
289a of Title 42, The Public Health and Welfare] shall apply only
with respect to violations of the Federal Food, Drug, and Cosmetic
Act [this chapter] committed after the date of the enactment of
this Act [Oct. 24, 1968]."
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, except that in the case of a
drug (other than one subject to section 360b(n) of this title)
intended for use in animals other than man which, on Oct. 9, 1962,
was commercially used or sold in the United States, was not a new
drug as defined in par. (p) of this section then in force, and was
not covered by an effective application under section 355 of this
title, the words "effectiveness" and "effective" contained in par.
(v) of this section not applicable to such drug when intended
solely for use under conditions prescribed, recommended, or
suggested in labeling with respect to such drug on that day, see
section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an
Effective Date and Transitional Provisions note under section 360b
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Section 11 of Pub. L. 89-74 provided that: "The foregoing
provisions of this Act [see Short Title of 1965 Amendment note set
out under section 301 of this title] shall take effect on the first
day of the seventh calendar month [Feb. 1, 1966] following the
month in which this Act is enacted [July 15, 1965]; except that (1)
the Secretary shall permit persons, owning or operating any
establishment engaged in manufacturing, preparing, propagating,
compounding, processing, wholesaling, jobbing, or distributing any
depressant or stimulant drug, as referred to in the amendments made
by section 4 of this Act to section 510 of the Federal Food, Drug,
and Cosmetic Act [section 360 of this title], to register their
name, places of business, and establishments, and other information
prescribed by such amendments, with the Secretary prior to such
effective date, and (2) sections 201(v) and 511(g) of the Federal
Food, Drug, and Cosmetic Act, as added by this act [par. (v) of
this section and par. (g) of section 360a of this title], and the
provisions of sections 8 [amending section 372 of this title and
section 1114 of Title 18, Crimes and Criminal Procedure] and 10
[set out as a note under this section] shall take effect upon the
date of enactment of this Act [July 15, 1965]."
EFFECTIVE DATE OF 1962 AMENDMENT
Section 107 of Pub. L. 87-781 provided that:
"(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections of this part A [amending this
section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of
this title, and enacting provisions set out as a note under section
355 of this title] shall take effect on the date of enactment of
this Act [Oct. 10, 1962].
"(b) The amendments made by sections 101, 103, 105, and 106 of
this part A [amending sections 331, 332, 351, 352, 355, and 357 of
this title] shall, with respect to any drug, take effect on the
first day of the seventh calendar month following the month in
which this Act is enacted [Oct. 1962].
"(c)(1) As used in this subsection, the term 'enactment date'
means the date of enactment of this Act; and the term 'basic Act'
means the Federal Food, Drug, and Cosmetic Act [this chapter].
"(2) An application filed pursuant to section 505(b) of the basic
Act [section 355(b) of this title] which was 'effective' within the
meaning of that Act on the day immediately preceding the enactment
date shall be deemed as of the enactment date, to be an application
'approved' by the Secretary within the meaning of the basic Act as
amended by this Act.
"(3) In the case of any drug with respect to which an application
filed under section 505(b) of the basic Act is deemed to be an
approved application on the enactment date by virtue of paragraph
(2) of this subsection -
"(A) the amendments made by this Act to section 201(p), and to
subsections (b) and (d) of section 505, of the basic Act [par.
(p) of this section, and subsecs. (b) and (d) of section 355 of
this title], insofar as such amendments relate to the
effectiveness of drugs, shall not, so long as approval of such
application is not withdrawn or suspended pursuant to section
505(e) of that Act [section 355(e) of this title], apply to such
drug when intended solely for use under conditions prescribed,
recommended, or suggested in labeling covered by such approved
application, but shall apply to any changed use, or conditions of
use, prescribed, recommended, or suggested in its labeling,
including such conditions of use as are the subject of an
amendment or supplement to such application pending on, or filed
after, the enactment date; and
"(B) clause (3) of the first sentence of section 505(e) of the
basic Act, as amended by this Act [section 355(e) of this title],
shall not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling
covered by such approved application (except with respect to such
use, or conditions of use, as are the subject of an amendment or
supplement to such approved application, which amendment or
supplement has been approved after the enactment date under
section 505 of the basic Act as amended by this Act [section 355
of this title]) until whichever of the following first occurs:
(i) the expiration of the two-year period beginning with the
enactment date; (ii) the effective date of an order under section
505(e) of the basic Act [section 355(e) of this title], other
than clause (3) of the first sentence of such section 505(e)
[section 355(e) of this title], withdrawing or suspending the
approval of such application.
"(4) In the case of any drug which, on the day immediately
preceding the enactment date, (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 as then in force [par. (p) of this
section], and (C) was not covered by an effective application under
section 505 of that Act [section 355 of this title], the amendments
to section 201(p) [par. (p) of this section] made by this Act 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."
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
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 OF 1958 AMENDMENT
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
EFFECTIVE DATE OF 1954 AMENDMENT
For effective date of amendment by act July 22, 1954, see section
5 of that act, set out as a note under section 342 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.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and 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
Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.
2, Oct. 26, 1974, 88 Stat. 1455, provided that:
"(a) Prosecutions for any violation of law occurring prior to the
effective date [see Effective Date of 1970 Amendment note above] of
section 701 [repealing section 360a of this title, and 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] shall
not be affected by the repeals or amendments made by such section,
or abated by reason thereof.
"(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 701 shall not be
affected by the repeals or amendments made by such section, or
abated by reason thereof.
"(c) All administrative proceedings pending before the Bureau of
Narcotics and Dangerous Drugs [now the Drug Enforcement
Administration] on the date of enactment of this Act [Oct. 27,
1970] shall be continued and brought to final determination in
accord with laws and regulations in effect prior to such date of
enactment. Where a drug is finally determined under such
proceedings to be a depressant or stimulant drug, as defined in
section 201(v) of the Federal Food, Drug, and Cosmetic Act [par.
(v) of this section], such drug shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings and listed in the
appropriate schedule after he has obtained the recommendation of
the Secretary. Any drug with respect to which such a final
determination has been made prior to the date of enactment of this
Act which is not listed in section 202 [section 812 of this title]
within schedules I through V shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings, and be listed in the
appropriate schedule, after he has obtained the recommendations of
the Secretary.
"(d) Notwithstanding subsection (a) of this section or section
1103 [of Pub. L. 91-513, set out as a note under sections 171 to
174 of this title], section 4202 of title 18, United States Code,
shall apply to any individual convicted under any of the laws
repealed by this title or title III [subchapter I or subchapter II
of chapter 13 of this title] without regard to the terms of any
sentence imposed on such individual under such 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.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Federal Food, Drug, and Cosmetic
Act, to the extent such functions related to administration and
enforcement of the Poison Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.), transferred to Consumer Product Safety
Commission by section 2079 of Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Drug Abuse Control Amendments of
1965 [see Short Title of 1965 Amendment note set out under section
301 of this title] transferred to Attorney General except function
of regulating counterfeiting of those drugs which are not
"depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
of 1968, set out in the Appendix to Title 5, Government
Organization and Employees.
Functions of Federal Security Administrator transferred to
Secretary of Health, Education, and Welfare and all agencies of
Federal Security Agency transferred to Department of Health,
Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,
set out in the Appendix to Title 5, Government Organization and
Employees. Federal Security Agency and office of Administrator
abolished by section 8 of Reorg. Plan No. 1 of 1953.
Food and Drug Administration in Department of Agriculture and its
functions, except those functions relating to administration of
Insecticide Act of 1910 and Naval Stores Act, transferred to
Federal Security Agency, to be administered under direction and
supervision of Federal Security Administrator, by Reorg. Plan No.
IV of 1940, set out in the Appendix to Title 5.
-MISC2-
REGULATION OF TOBACCO
Section 422 of Pub. L. 105-115 provided that: "Nothing in this
Act [see Short Title of 1997 Amendment note set out under section
301 of this title] or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health
and Human Services has any authority to regulate any tobacco
product, tobacco ingredient, or tobacco additive. Such authority,
if any, shall be exercised under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
the date of the enactment of this Act [Nov. 21, 1997]."
CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417
Section 2 of Pub. L. 103-417 provided that: "Congress finds that -
"(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
"(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have been
documented increasingly in scientific studies;
"(3)(A) there is a link between the ingestion of certain
nutrients or dietary supplements and the prevention of chronic
diseases such as cancer, heart disease, and osteoporosis; and
"(B) clinical research has shown that several chronic diseases
can be prevented simply with a healthful diet, such as a diet
that is low in fat, saturated fat, cholesterol, and sodium, with
a high proportion of plant-based foods;
"(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
"(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
"(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
"(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
"(7) there is a growing need for emphasis on the dissemination
of information linking nutrition and long-term good health;
"(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
"(9) national surveys have revealed that almost 50 percent of
the 260,000,000 Americans regularly consume dietary supplements
of vitamins, minerals, or herbs as a means of improving their
nutrition;
"(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and to
obtain more holistic consideration of their needs;
"(11) the United States will spend over $1,000,000,000,000 on
health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts
are undertaken to reverse the increase;
"(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
"(B) the industry consistently projects a positive trade
balance; and
"(C) the estimated 600 dietary supplement manufacturers in the
United States produce approximately 4,000 products, with total
annual sales of such products alone reaching at least
$4,000,000,000;
"(13) although the Federal Government should take swift action
against products that are unsafe or adulterated, the Federal
Government should not take any actions to impose unreasonable
regulatory barriers limiting or slowing the flow of safe products
and accurate information to consumers;
"(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
"(15)(A) legislative action that protects the right of access
of consumers to safe dietary supplements is necessary in order to
promote wellness; and
"(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements."
DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE
Section 5 of Pub. L. 90-639 provided that: "It is the sense of
the Congress that, because of the inadequate knowledge on the part
of the people of the United States of the substantial adverse
effects of misuse of depressant and stimulant drugs, and of other
drugs liable to abuse, on the individual, his family, and the
community, the highest priority should be given to Federal programs
to disseminate information which may be used to educate the public,
particularly young persons, regarding the dangers of drug abuse."
CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY
Section 2 of Pub. L. 89-74 provided that: "The Congress hereby
finds and declares that there is a widespread illicit traffic in
depressant and stimulant drugs moving in or otherwise affecting
interstate commerce; that the use of such drugs, when not under the
supervision of a licensed practitioner, often endangers safety on
the highways (without distinction of interstate and intrastate
traffic thereon) and otherwise has become a threat to the public
health and safety, making additional regulation of such drugs
necessary regardless of the intrastate or interstate origin of such
drugs; that in order to make regulation and protection of
interstate commerce in such drugs effective, regulation of
intrastate commerce is also necessary because, among other things,
such drugs, when held for illicit sale, often do not bear labeling
showing their place of origin and because in the form in which they
are so held or in which they are consumed a determination of their
place of origin is often extremely difficult or impossible; and
that regulation of interstate commerce without the regulation of
intrastate commerce in such drugs, as provided in this Act [see
Short Title of 1965 Amendment note set out under section 301 of
this title], would discriminate against and adversely affect
interstate commerce in such drugs."
EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS
Section 10 of Pub. L. 89-74 provided that:
"(a) Nothing in this Act [enacting section 360a of this title,
amending sections 321, 331, 333, 334, 360, and 372 of this title
and section 1114 of Title 18, Crimes and Criminal Procedure, and
enacting provisions set out as notes under sections 321, 352, and
360a of this title] shall be construed as authorizing the
manufacture, compounding, processing, possession, sale, delivery,
or other disposal of any drug in any State in contravention of the
laws of such State.
"(b) No provision of this Act nor any amendment made by it shall
be construed as indicating an intent on the part of the Congress to
occupy the field in which such provision or amendment operates to
the exclusion of any State law on the same subject matter, unless
there is a direct and positive conflict between such provision or
amendment and such State law so that the two cannot be reconciled
or consistently stand together.
"(c) No amendment made by this Act shall be construed to prevent
the enforcement in the courts of any State of any statute of such
State prescribing any criminal penalty for any act made criminal by
any such amendment."
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
Section 202 of Pub. L. 87-781 provided that: "Nothing in the
amendments made by this Act [enacting sections 358 to 360, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
and 381 of this title, and enacting provisions set out as notes
under sections 321, 331, 332, 352, 355, 360, and 374 of this title]
to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be
construed as invalidating any provision of State law which would be
valid in the absence of such amendments unless there is a direct
and positive conflict between such amendments and such provision of
State law."
-CROSS-
DEFINITIONS
Section 2 of Pub. L. 105-115 provided that: "In this Act [see
Short Title of 1997 Amendment note set out under section 301 of
this title], the terms 'drug', 'device', 'food', and 'dietary
supplement' have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
-FOOTNOTE-
(!1) So in original. Probably should be paragraph "(v)".
-End-
-CITE-
21 USC Sec. 321a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321a. "Butter" defined
-STATUTE-
For the purposes of the Food and Drug Act of June 30, 1906
(Thirty-fourth Statutes at Large, page 768) "butter" shall be
understood to mean the food product usually known as butter, and
which is made exclusively from milk or cream, or both, with or
without common salt, and with or without additional coloring
matter, and containing not less than 80 per centum by weight of
milk fat, all tolerances having been allowed for.
-SOURCE-
(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)
-REFTEXT-
REFERENCES IN TEXT
The Food and Drug Act of June 30, 1906, referred to in text, is
act June 30, 1906, ch. 3915, 34 Stat. 768, as amended, which was
classified to subchapter I (Sec. 1 et seq.) of chapter 1 of this
title, was repealed (except for section 14a which was transferred
to section 376 of this title) by act June 25, 1938, ch. 675, Sec.
902(a), 52 Stat. 1059, and is covered by this chapter.
-COD-
CODIFICATION
Section, which was not enacted as part of the Federal Food, Drug,
and Cosmetic Act which comprises this chapter, was formerly
classified to section 6 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 this section should remain in force and
effect and be applicable to the provisions of this chapter.
-End-
-CITE-
21 USC Sec. 321b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321b. "Package" defined
-STATUTE-
The word "package" where it occurs the second and last time in
the act entitled "An act to amend section 8 of an act entitled, 'An
act for preventing the manufacture, sale, or transportation of
adulterated or misbranded or poisonous deleterious foods, drugs,
medicines, and liquors, and for regulating traffic therein, and for
other purposes,' " approved March 3, 1913, shall include and shall
be construed to include wrapped meats inclosed in papers or other
materials as prepared by the manufacturers thereof for sale.
-SOURCE-
(July 24, 1919, ch. 26, 41 Stat. 271.)
-REFTEXT-
REFERENCES IN TEXT
An act approved March 3, 1913, referred to in text, is act Mar.
3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this
title. For complete classification of this Act to the Code, see
Tables.
"An act for preventing the manufacture, sale, or transportation
of adulterated or misbranded or poisonous deleterious foods, drugs,
medicines, and liquors, and for regulating traffic therein, and for
other purposes,", referred to in text, is act June 30, 1906, ch.
3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et
seq.) of chapter 1 of this title, was repealed (except for section
14a which was transferred to section 376 of this title) by act June
25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059, and is covered by
this chapter.
-COD-
CODIFICATION
Section, which was not enacted as part of the Federal Food, Drug,
and Cosmetic Act which comprises this chapter, was formerly
classified to the last sentence of paragraph third of section 10 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
this section should remain in force and effect and be applicable to
the provisions of this chapter.
-End-
-CITE-
21 USC Sec. 321c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321c. Nonfat dry milk; "milk" defined
-STATUTE-
For the purposes of the Federal Food, Drug, and Cosmetic Act of
June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et
seq.] nonfat dry milk is the product resulting from the removal of
fat and water from milk, and contains the lactose, milk proteins,
and milk minerals in the same relative proportions as in the fresh
milk from which made. It contains not over 5 per centum by weight
of moisture. The fat content is not over 1 1/2 per centum by
weight unless otherwise indicated.
The term "milk", when used herein, means sweet milk of cows.
-SOURCE-
(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70
Stat. 486.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch.
675, sec. 1, 52 Stat. 1040), referred to in text, probably means
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to this chapter (Sec. 301 et seq.). For
complete classification of this Act to the Code, see section 301 of
this title and Tables.
-COD-
CODIFICATION
Section was not enacted as a part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter, but was made applicable
thereto.
-MISC1-
AMENDMENTS
1956 - Act July 2, 1956, substituted "nonfat dry milk" for
"nonfat dry milk solids or defatted milk solids".
-End-
-CITE-
21 USC Sec. 321d 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321d. Market names for catfish and ginseng
-STATUTE-
(a) Catfish labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -
(A) the term "catfish" may only be considered to be a common
or usual name (or part thereof) for fish classified within the
family Ictaluridae; and
(B) only labeling or advertising for fish classified within
that family may include the term "catfish".
(2) Omitted
(b) Ginseng labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -
(A) the term "ginseng" may only be considered to be a common
or usual name (or part thereof) for any herb or herbal
ingredient derived from a plant classified within the genus
Panax; and
(B) only labeling or advertising for herbs or herbal
ingredients classified within that genus may include the term
"ginseng".
(2) Omitted
-SOURCE-
(Pub. L. 107-171, title X, Sec. 10806, May 13, 2002, 116 Stat.
526.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(a)(1), (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 is comprised of section 10806 of Pub. L. 107-171.
Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107-171
amended section 343 of this title.
Section was enacted as part of the Farm Security and Rural
Investment Act of 2002, and not as part of Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-End-
-CITE-
21 USC Sec. 331 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 331. Prohibited acts
-STATUTE-
The following acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or
cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device,
or cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate
commerce of any article in violation of section 344, 355, or 360bbb-
3 of this title.
(e) The refusal to permit access to or copying of any record as
required by section 350a, 350c, 350e, 354, 360bbb-3, 373, 374(a),
379aa, or 379aa-1 of this title; or the failure to establish or
maintain any record, or make any report, required under section
350a, 350c(b), 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j),
(l) or (m), 360ccc-1(i).,(!1) 360e(f), 360i, 360bbb-3, 379aa, or
379aa-1 of this title, or the refusal to permit access to or
verification or copying of any such required record.
(f) The refusal to permit entry or inspection as authorized by
section 374 of this title.
(g) The manufacture within any Territory of any food, drug,
device, or cosmetic that is adulterated or misbranded.
(h) The giving of a guaranty or undertaking referred to in
section 333(c)(2) of this title, which guaranty or undertaking is
false, except by a person who relied upon a guaranty or undertaking
to the same effect signed by, and containing the name and address
of, the person residing in the United States from whom he received
in good faith the food, drug, device, or cosmetic; or the giving of
a guaranty or undertaking referred to in section 333(c)(3) of this
title, which guaranty or undertaking is false.
(i)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp,
tag, label, or other identification device authorized or required
by regulations promulgated under the provisions of section 344 or
379e of this title.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing 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 drug.
(3) The doing of any act which causes a drug to be a counterfeit
drug, or the sale or dispensing, or the holding for sale or
dispensing, of a counterfeit drug.
(j) The using by any person to his own advantage, or revealing,
other than to the Secretary or officers or employees of the
Department, or to the courts when relevant in any judicial
proceeding under this chapter, any information acquired under
authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-
2.,(!1) 374, 379, or 379e of this title concerning any method or
process which as a trade secret is entitled to protection; or the
violating of section 346a(i)(2) of this title or any regulation
issued under that section..(!1) This paragraph does not authorize
the withholding of information from either House of Congress or
from, to the extent of matter within its jurisdiction, any
committee or subcommittee of such committee or any joint committee
of Congress or any subcommittee of such joint committee.
(k) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to, a food, drug, device, or
cosmetic, if such act is done while such article is held for sale
(whether or not the first sale) after shipment in interstate
commerce and results in such article being adulterated or
misbranded.
(l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
111 Stat. 2380.
(m) The sale or offering for sale of colored oleomargarine or
colored margarine, or the possession or serving of colored
oleomargarine or colored margarine in violation of subsections (b)
or (c) of section 347 of this title.
(n) The using, in labeling, advertising or other sales promotion
of any reference to any report or analysis furnished in compliance
with section 374 of this title.
(o) In the case of a prescription drug distributed or offered for
sale in interstate commerce, the failure of the manufacturer,
packer, or distributor thereof to maintain for transmittal, or to
transmit, to any practitioner licensed by applicable State law to
administer such drug who makes written request for information as
to such drug, true and correct copies of all printed matter which
is required to be included in any package in which that drug is
distributed or sold, or such other printed matter as is approved by
the Secretary. Nothing in this paragraph shall be construed to
exempt any person from any labeling requirement imposed by or under
other provisions of this chapter.
(p) The failure to register in accordance with section 360 of
this title, the failure to provide any information required by
section 360(j) or 360(k) of this title, or the failure to provide a
notice required by section 360(j)(2) of this title.
(q)(1) The failure or refusal to (A) comply with any requirement
prescribed under section 360h or 360j(g) of this title, (B) furnish
any notification or other material or information required by or
under section 360i or 360j(g) of this title, or (C) comply with a
requirement under section 360l of this title.
(2) With respect to any device, the submission of any report that
is required by or under this chapter that is false or misleading in
any material respect.
(r) The movement of a device in violation of an order under
section 334(g) of this title or the removal or alteration of any
mark or label required by the order to identify the device as
detained.
(s) The failure to provide the notice required by section 350a(c)
or 350a(e) of this title, the failure to make the reports required
by section 350a(f)(1)(B) of this title, the failure to retain the
records required by section 350a(b)(4) of this title, or the
failure to meet the requirements prescribed under section
350a(f)(3) of this title.
(t) The importation of a drug in violation of section 381(d)(1)
of this title, the sale, purchase, or trade of a drug or drug
sample or the offer to sell, purchase, or trade a drug or drug
sample in violation of section 353(c) of this title, the sale,
purchase, or trade of a coupon, the offer to sell, purchase, or
trade such a coupon, or the counterfeiting of such a coupon in
violation of section 353(c)(2) of this title, the distribution of a
drug sample in violation of section 353(d) of this title or the
failure to otherwise comply with the requirements of section 353(d)
of this title, or the distribution of drugs in violation of section
353(e) of this title or the failure to otherwise comply with the
requirements of section 353(e) of this title.
(u) The failure to comply with any requirements of the provisions
of, or any regulations or orders of the Secretary, under section
360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
(v) The introduction or delivery for introduction into interstate
commerce of a dietary supplement that is unsafe under section 350b
of this title.
(w) The making of a knowingly false statement in any statement,
certificate of analysis, record, or report required or requested
under section 381(d)(3) of this title; the failure to submit a
certificate of analysis as required under such section; the failure
to maintain records or to submit records or reports as required by
such section; the release into interstate commerce of any article
or portion thereof imported into the United States under such
section or any finished product made from such article or portion,
except for export in accordance with section 381(e) or 382 of this
title, or with section 262(h) of title 42; or the failure to so
export or to destroy such an article or portions thereof, or such a
finished product.
(x) The falsification of a declaration of conformity submitted
under section 360d(c) of this title or the failure or refusal to
provide data or information requested by the Secretary under
paragraph (3) of such section.
(y) In the case of a drug, device, or food -
(1) the submission of a report or recommendation by a person
accredited under section 360m of this title that is false or
misleading in any material respect;
(2) the disclosure by a person accredited under section 360m of
this title of confidential commercial information or any trade
secret without the express written consent of the person who
submitted such information or secret to such person; or
(3) the receipt by a person accredited under section 360m of
this title of a bribe in any form or the doing of any corrupt act
by such person associated with a responsibility delegated to such
person under this chapter.
(z) The dissemination of information in violation of section
360aaa of this title.
(aa) The importation of a prescription drug in violation of
section 384 of this title, the falsification of any record required
to be maintained or provided to the Secretary under such section,
or any other violation of regulations under such section.
(bb) The transfer of an article of food in violation of an order
under section 334(h) of this title, or the removal or alteration of
any mark or label required by the order to identify the article as
detained.
(cc) The importing or offering for import into the United States
of an article of food by, with the assistance of, or at the
direction of, a person debarred under section 335a(b)(3) of this
title.
(dd) The failure to register in accordance with section 350d of
this title.
(ee) The importing or offering for import into the United States
of an article of food in violation of the requirements under
section 381(m) of this title.
(ff) The importing or offering for import into the United States
of a drug or device with respect to which there is a failure to
comply with a request of the Secretary to submit to the Secretary a
statement under section 381(o) of this title.
(gg) The knowing failure to comply with paragraph (7)(E) of
section 374(g) of this title; the knowing inclusion by a person
accredited under paragraph (2) of such section of false information
in an inspection report under paragraph (7)(A) of such section; or
the knowing failure of such a person to include material facts in
such a report.
(hh) The failure by a shipper, carrier by motor vehicle or rail
vehicle, receiver, or any other person engaged in the
transportation of food to comply with the sanitary transportation
practices prescribed by the Secretary under section 350e of this
title.
(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 379aa
or 379aa-1 of this title) or the falsification of a serious adverse
event report (as defined under section 379aa or 379aa-1 of this
title) submitted to the Secretary.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,
ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59
Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,
1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.
3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;
Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-
618, title I, Secs. 104, 105(a), July 12, 1960, 74 Stat. 403; Pub.
L. 87-781, title I, Secs. 103(c), 104(e)(1), 106(c), 114(a), title
III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795;
Pub. L. 89-74, Secs. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;
Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L. 90-
639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,
title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92-
387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295, Secs.
3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L.
96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99-570,
title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; Pub.
L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508,
title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub.
L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-
571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499;
Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L.
103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-
417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104-134,
title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319; Pub. L. 104-
170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104-
250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105-115,
title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Secs. 204(b),
210(c), title IV, Secs. 401(b), 421, Nov. 21, 1997, 111 Stat. 2325,
2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a) [title VII, Sec.
745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107-
188, title III, Secs. 303(b), 304(d), 305(b), 306(c), 307(b),
321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670,
672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 26,
2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, Sec.
1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI,
Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214,
Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282,
title I, Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub.
L. 109-59, title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat.
1913; Pub. L. 109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120
Stat. 3472, 3475.)
-STATAMEND-
AMENDMENT OF SECTION
For termination of amendment by section 401(e) of Pub. L. 105-
115, see Effective and Termination Dates of 1997 Amendment note
below.
-MISC1-
AMENDMENTS
2006 - Par. (e). Pub. L. 109-462, Sec. 3(b), substituted "374(a),
379aa, or 379aa-1" for "374(a), or 379aa" and "360bbb-3, 379aa, or
379aa-1" for "360bbb-3, or 379aa".
Pub. L. 109-462, Sec. 2(c), substituted ", 374(a), or 379aa" for
", or 374(a)" and ", 360bbb-3, or 379aa" for ", or 360bbb-3".
Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
2005 - Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted "350e,"
before "354," in two places.
Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
2004 - Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which
directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m),
360ccc-1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed
by making the substitution for "360b(a)(4)(C), 360b(j), (l), or
(m)", to reflect the probable intent of Congress.
Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted "360j,
360ccc, 360ccc-1, 360ccc-2." for "360j".
Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to
amendment, text read as follows: "The knowing failure of a person
accredited under paragraph (2) of section 374(g) of this title to
comply with paragraph (7)(E) of such section; the knowing inclusion
by such a person of false information in an inspection report under
paragraph (7)(A) of such section; or the knowing failure of such a
person to include material facts in such a report."
2003 - Par. (d). Pub. L. 108-136 substituted "section 344, 355,
or 360bbb-3" for "section 344 or 355".
Par. (e). Pub. L. 108-136 inserted "360bbb-3," after "350c, 354,"
and substituted "360i, or 360bbb-3" for "or 360i".
Par. (aa). Pub. L. 108-173 substituted "prescription drug in
violation of section 384" for "covered product in violation of
section 384".
2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted "by
section 350a, 350c, 354, 373, or 374(a) of this title" for "by
section 350a, 354, or 373 of this title" and "under section 350a,
350c(b)" for "under section 350a".
Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted "350c," after
"350a,".
Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)
generally. Prior to amendment, par. (w) read as follows: "The
making of a knowingly false statement in any record or report
required or requested under subparagraph (A) or (B) of section
381(d)(3) of this title, the failure to submit or maintain records
as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this
title, the release into interstate commerce of any article imported
into the United States under section 381(d)(3) of this title or any
finished product made from such article (except for export in
accordance with section 381(e) or 382 of this title or section
262(h) of title 42), or the failure to export or destroy any
component, part or accessory not incorporated into a drug,
biological product or device that will be exported in accordance
with section 381(e) or 382 of this title or section 262(h) of title
42."
Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
Par. (gg). Pub. L. 107-250 added par. (gg).
2000 - Par. (aa). Pub. L. 106-387 added par. (aa).
1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out
"357(d) or (g)," after "355(i) or (k),".
Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ",
356, 357," before "or 379e of this title".
Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out "356,
357," before "360,".
Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which
read as follows: "The using, on the labeling of any drug or device
or in any advertising relating to such drug or device, of any
representation or suggestion that approval of an application with
respect to such drug or device is in effect under section 355,
360e, or 360j(g) of this title, as the case may be, or that such
drug or device complies with the provisions of such section."
Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
Par. (z). Pub. L. 105-115, Sec. 401(b), (e), temporarily added
par. (z). See Effective and Termination Dates of 1997 Amendment
note below.
1996 - Par. (e). Pub. L. 104-250 inserted ", 354," before "or 373
of this title" and "354," before "355(i) or (k)".
Par. (j). Pub. L. 104-170 inserted before period at end of first
sentence "; or the violating of section 346a(i)(2) of this title or
any regulation issued under that section."
Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating
to introduction into interstate commerce of unsafe dietary
supplement as (v) and added par. (w).
1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted
"357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".
Par. (u). Pub. L. 103-417 added par. (u) relating to introduction
into interstate commerce of unsafe dietary supplement.
Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to
failure to comply with regulations or orders of Secretary.
1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted "379,
or 379e" for "379e, or 379".
Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted "350a(e)" for
"350a(d)".
1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted "379e" for
"376".
Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
1990 - Par. (e). Pub. L. 101-502 substituted "or (k)" for "or
(j)".
Par. (j). Pub. L. 101-508 inserted at end "This paragraph does
not authorize the withholding of information from either House of
Congress or from, to the extent of matter within its jurisdiction,
any committee or subcommittee of such committee or any joint
committee of Congress or any subcommittee of such joint committee."
1988 - Par. (t). Pub. L. 100-293 added par. (t).
1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior
to amendment, par. (s) read as follows: "The failure to provide the
notice required by section 350a(b) or 350a(c), the failure to make
the reports required by section 350a(d)(1)(B), or the failure to
meet the requirements prescribed under section 350a(d)(2)."
1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to
section 350a of this title in two places.
Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to
section 350a of this title.
Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted
references to sections 360e(f) and 360i of this title.
Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to
sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of
this title.
Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted "drug or
device" for "drug" wherever appearing, and inserted references to
sections 360e and 360j(g) of this title.
Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted "section
360(j) or 360(k) of this title," for "section 360(j) of this
title,".
Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
1972 - Par. (p). Pub. L. 92-387 added failure to provide
information required by section 360(j) of this title, and failure
to provide notice required by section 360(j)(2) of this title as
prohibited acts.
1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out
penalties for illegal manufacture, sale, disposition, possession
and other traffic in stimulant and depressant drugs. See section
801 et seq. of this title.
1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference
to section 360b(j), (l), and (m) of this title.
Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to
section 360b of this title.
Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply
to possession in violation of section 360a(c) of this title, into
subcls. (A) and (B) which refer, respectively, to possession in
violation of section 360a(c)(1) of this title and possession in
violation of section 360a(c)(2) of this title.
1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing
provisions as subpar. (1) and added subpars. (2) and (3).
Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
1962 - Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited
the failure to establish or maintain any record, or make any
report, required under sections 355(i) or (j) and 507(d) or (g) of
this title, or the refusal to permit access to, or verification or
copying of, any such required record.
Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted "approval of"
before "an application", and substituted "in effect" for
"effective".
Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out
references to sections 346(b), 354, and 364 of this title and
inserted reference to section 376 of this title.
Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section
376 of this title.
1958 - Par. (j). Pub. L. 85-929, inserted reference to section
348 of this title.
1953 - Par. (n). Act Aug. 7, 1953, added par. (n).
1950 - Par. (m). Act Mar. 16, 1950, added par. (m).
1948 - Par. (k). Act June 24, 1948, inserted "(whether or not the
first sale)" so as to make it clear that this subsection is not
limited to the case where the act occurs while the article is held
for the first sale after interstate shipment, and extended coverage
of subsection to acts which result in adulteration.
1947 - Par. (j). Act Mar. 10, 1947, inserted reference to
sections 356 and 357 of this title.
1945 - Par. (i). Act July 6, 1945, inserted reference to section
357 of this title.
1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section
356 of this title.
EFFECTIVE DATE OF 2006 AMENDMENT
Amendment by section 2(c) of Pub. L. 109-462 effective 1 year
after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set
out as a note under section 352 of this title.
Amendment by section 3(b) of Pub. L. 109-462 effective 1 year
after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set
out as a note under section 343 of this title.
Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475,
provided that: "The amendment 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 2005 AMENDMENT
Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat.
1914, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
of title VII of Pub. L. 109-59, enacting section 350e of this
title, amending this section, sections 342 and 373 of this title,
and section 5701 of Title 49, Transportation, omitting sections
5702 to 5714 of Title 49, and enacting provisions set out as a note
under section 301 of this title] takes effect on October 1, 2005."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.
676, provided that: "The amendments made by this section [amending
this section and sections 360 and 381 of this title] take effect
upon the expiration of the 180-day period beginning on the date of
the enactment of this Act [June 12, 2002]."
Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.
678, provided that: "The amendments made by this section [amending
this section and section 381 of this title] take effect upon the
expiration of the 90-day period beginning on the date of the
enactment of this Act [June 12, 2002]."
EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
Amendment by sections 204, 210, and 421 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.
Amendment by section 401(b) of Pub. L. 105-115 effective 1 year
after Nov. 21, 1997, or upon Secretary's issuance of final
regulations pursuant to section 401(c) of Pub. L. 105-115,
whichever is sooner, and ceases to be effective Sept. 30, 2006, or
7 years after date Secretary promulgates regulations under section
401(c) of Pub. L. 105-115, whichever is later, see section 401(d),
(e) of Pub. L. 105-115, set out as an Effective and Termination
Dates note under section 360aaa of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-396 effective upon adoption of final
regulations under section 2(c) of Pub. L. 103-396, set out as a
Regulations note under section 360b of this title, see section 2(d)
of Pub. L. 103-396, set out as a note under section 360b of this
title.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
made by that section is effective as if included in subtitle D of
title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.
101-239, title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,
see 42 U.S.C. 300aa-1 note, 300aa-10 note.
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 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 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 AMENDMENTS
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.
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by sections 103(c) and 106(c) of Pub. L. 87-781
effective on first day of seventh calendar month following Oct.
1962, and amendment by section 104(e)(1) of 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.
Section 114(b) 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]."
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
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 OF 1958 AMENDMENT
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950, see
section 7 of that act, set out as an Effective Date note under
section 347 of this title.
REGULATIONS
Secretary of Health and Human Services to promulgate regulations
to implement amendments made by section 401 of Pub. L. 105-115 not
later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.
L. 105-115, set out as a note under section 360aaa of this title.
SAVINGS PROVISION
Amendment by Pub. L. 91-513 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 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.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188
Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.
675, provided that: "Nothing in this title [enacting sections 350c,
350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319,
and 8320 of Title 7, Agriculture, and section 247b-20 of Title 42,
The Public Health and Welfare, amending this section, sections 334,
335a, 342, 343, 360, 372, 374, and 381 of this title, and section
43 of Title 18, Crimes and Criminal Procedure, and enacting
provisions set out as notes under this section and sections 341,
350c, 350d, and 381 of this title], or an amendment made by this
title, shall be construed to alter the jurisdiction between the
Secretaries of Agriculture and of Health and Human Services, under
applicable statutes and regulations."
-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.
-End-
-CITE-
21 USC Sec. 332 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 332. Injunction proceedings
-STATUTE-
(a) Jurisdiction of courts
The district courts of the United States and the United States
courts of the Territories shall have jurisdiction, for cause shown
(!1) to restrain violations of section 331 of this title, except
paragraphs (h), (i), and (j).
(b) Violation of injunction
In case of violation of an injunction or restraining order issued
under this section, which also constitutes a violation of this
chapter, trial shall be by the court, or, upon demand of the
accused, by a jury.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 302, 52 Stat. 1043; Pub. L. 87-781,
title I, Sec. 103(d), title II, Sec. 201(c), Oct. 10, 1962, 76
Stat. 784, 793; Pub. L. 103-80, Sec. 3(d), Aug. 13, 1993, 107 Stat.
775.)
-MISC1-
AMENDMENTS
1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(d)(1), struck out ",
and subject to the provisions of section 17 (relating to notice to
opposite party) of the Act entitled 'An Act to supplement existing
laws against unlawful restraints and monopolies, and for other
purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed.,
title 28, sec. 381)," after "for cause shown".
Subsec. (b). Pub. L. 103-80, Sec. 3(d)(2), struck out at end
"Such trial shall be conducted in accordance with the practice and
procedure applicable in the case of proceedings subject to the
provisions of section 22 of such Act of October 15, 1914, as
amended (U.S.C., 1934 ed., title 28, sec. 387)."
1962 - Subsec. (a). Pub. L. 87-781, Sec. 103(d), struck out
"(e)," after "paragraphs".
Pub. L. 87-781, Sec. 201(c), struck out "(f)," after
"paragraphs".
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by section 103(c) of 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.
Section 203 of title II of Pub. L. 87-781 provided that: "The
amendments made by this title [amending this section and section
374 of this title and enacting provisions set out as notes under
sections 321 and 374 of this title] shall take effect on the date
of enactment of this Act [Oct. 10, 1962]."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 333 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 333. Penalties
-STATUTE-
(a) Violation of section 331 of this title; second violation;
intent to defraud or mislead
(1) Any person who violates a provision of section 331 of this
title shall be imprisoned for not more than one year or fined not
more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section,(!1) if any person commits such a violation after a
conviction of him under this section has become final, or commits
such a violation with the intent to defraud or mislead, such person
shall be imprisoned for not more than three years or fined not more
than $10,000, or both.
(b) Prescription drug marketing violations
(1) Notwithstanding subsection (a) of this section, any person
who violates section 331(t) of this title by -
(A) knowingly importing a drug in violation of section
381(d)(1) of this title,
(B) knowingly selling, purchasing, or trading a drug or drug
sample or knowingly offering to sell, purchase, or trade a drug
or drug sample, in violation of section 353(c)(1) of this title,
(C) knowingly selling, purchasing, or trading a coupon,
knowingly offering to sell, purchase, or trade such a coupon, or
knowingly counterfeiting such a coupon, in violation of section
353(c)(2) of this title, or
(D) knowingly distributing drugs in violation of section
353(e)(2)(A) of this title,
shall be imprisoned for not more than 10 years or fined not more
than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug samples
by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or distributor,
violated section 331(t) of this title because of a violation of
section 353(c)(1) of this title or violated any State law
prohibiting the sale, purchase, or trade of a drug sample subject
to section 353(b) of this title or the offer to sell, purchase, or
trade such a drug sample shall, upon conviction of the
representative for such violation, be subject to the following
civil penalties:
(A) A civil penalty of not more than $50,000 for each of the
first two such violations resulting in a conviction of any
representative of the manufacturer or distributor in any 10-year
period.
(B) A civil penalty of not more than $1,000,000 for each
violation resulting in a conviction of any representative after
the second conviction in any 10-year period.
For the purposes of this paragraph, multiple convictions of one or
more persons arising out of the same event or transaction, or a
related series of events or transactions, shall be considered as
one violation.
(3) Any manufacturer or distributor who violates section 331(t)
of this title because of a failure to make a report required by
section 353(d)(3)(E) of this title shall be subject to a civil
penalty of not more than $100,000.
(4)(A) If a manufacturer or distributor or any representative of
such manufacturer or distributor provides information leading to
the institution of a criminal proceeding against, and conviction
of, any representative of that manufacturer or distributor for a
violation of section 331(t) of this title because of a sale,
purchase, or trade or offer to purchase, sell, or trade a drug
sample in violation of section 353(c)(1) of this title or for a
violation of State law prohibiting the sale, purchase, or trade or
offer to sell, purchase, or trade a drug sample, the conviction of
such representative shall not be considered as a violation for
purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the sale,
purchase, or trade of a drug or the offer to sell, purchase, or
trade a drug, it is shown, by clear and convincing evidence -
(i) that the manufacturer or distributor conducted, before the
institution of a criminal proceeding against such representative
for the violation which resulted in such conviction, an
investigation of events or transactions which would have led to
the reporting of information leading to the institution of a
criminal proceeding against, and conviction of, such
representative for such purchase, sale, or trade or offer to
purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function, despite
diligent implementation by the manufacturer or distributor of an
independent audit and security system designed to detect such a
violation, the manufacturer or distributor could not reasonably
have been expected to have detected such violation,
the conviction of such representative shall not be considered as a
conviction for purposes of paragraph (2).
(5) If a person provides information leading to the institution
of a criminal proceeding against, and conviction of, a person for a
violation of section 331(t) of this title because of the sale,
purchase, or trade of a drug sample or the offer to sell, purchase,
or trade a drug sample in violation of section 353(c)(1) of this
title, such person shall be entitled to one-half of the criminal
fine imposed and collected for such violation but not more than
$125,000.
(6) Notwithstanding subsection (a) of this section, any person
who is a manufacturer or importer of a prescription drug under
section 384(b) of this title and knowingly fails to comply with a
requirement of section 384(e) of this title that is applicable to
such manufacturer or importer, respectively, shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both.
(c) Exceptions in certain cases of good faith, etc.
No person shall be subject to the penalties of subsection (a)(1)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such
delivery or proffer was made in good faith, unless he refuses to
furnish on request of an officer or employee duly designated by the
Secretary the name and address of the person from whom he purchased
or received such article and copies of all documents, if any there
be, pertaining to the delivery of the article to him; or (2) for
having violated section 331(a) or (d) of this title, if he
establishes a guaranty or undertaking signed by, and containing the
name and address of, the person residing in the United States from
whom he received in good faith the article, to the effect, in case
of an alleged violation of section 331(a) of this title, that such
article is not adulterated or misbranded, within the meaning of
this chapter designating this chapter or to the effect, in case of
an alleged violation of section 331(d) of this title, that such
article is not an article which may not, under the provisions of
section 344 or 355 of this title, be introduced into interstate
commerce; or (3) for having violated section 331(a) of this title,
where the violation exists because the article is adulterated by
reason of containing a color additive not from a batch certified in
accordance with regulations promulgated by the Secretary under this
chapter, if such person establishes a guaranty or undertaking
signed by, and containing the name and address of, the manufacturer
of the color additive, to the effect that such color additive was
from a batch certified in accordance with the applicable
regulations promulgated by the Secretary under this chapter; or (4)
for having violated section 331(b), (c) or (k) of this title by
failure to comply with section 352(f) of this title in respect to
an article received in interstate commerce to which neither section
353(a) nor 353(b)(1) of this title is applicable, if the delivery
or proffered delivery was made in good faith and the labeling at
the time thereof contained the same directions for use and warning
statements as were contained in the labeling at the time of such
receipt of such article; or (5) for having violated section
331(i)(2) of this title if such person acted in good faith and had
no reason to believe that use of the punch, die, plate, stone, or
other thing involved would result in a drug being a counterfeit
drug, or for having violated section 331(i)(3) of this title if the
person doing the act or causing it to be done acted in good faith
and had no reason to believe that the drug was a counterfeit drug.
(d) Exceptions involving misbranded food
No person shall be subject to the penalties of subsection (a)(1)
of this section for a violation of section 331 of this title
involving misbranded food if the violation exists solely because
the food is misbranded under section 343(a)(2) of this title
because of its advertising.
(e) Prohibited distribution of human growth hormone
(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human growth
hormone for any use in humans other than the treatment of a disease
or other recognized medical condition, where such use has been
authorized by the Secretary of Health and Human Services under
section 355 of this title and pursuant to the order of a physician,
is guilty of an offense punishable by not more than 5 years in
prison, such fines as are authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and
such offense involves an individual under 18 years of age is
punishable by not more than 10 years imprisonment, such fines as
are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of
this subsection shall be considered a felony violation of the
Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes
of forfeiture under section 413 of such Act [21 U.S.C. 853].
(4) As used in this subsection the term "human growth hormone"
means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f) Redesignated (g)
(g) Violations related to devices
(1)(A) Except as provided in subparagraph (B), any person who
violates a requirement of this chapter which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated in a single
proceeding. For purposes of the preceding sentence, a person
accredited under paragraph (2) of section 374(g) of this title who
is substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to public
health or fails to act in a manner that is consistent with the
purposes of such section, shall be considered to have violated a
requirement of this chapter that relates to devices.
(B) Subparagraph (A) shall not apply -
(i) to any person who violates the requirements of section
360i(a) or 360j(f) of this title unless such violation
constitutes (I) a significant or knowing departure from such
requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of section
360i(e) or 360i(f) of this title (only with respect to correction
reports) if such person demonstrates substantial compliance with
such section, or
(iii) to violations of section 351(a)(2)(A) of this title which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article of
food that is adulterated within the meaning of section 342(a)(2)(B)
of this title shall be subject to a civil money penalty of not more
than $50,000 in the case of an individual and $250,000 in the case
of any other person for such introduction or delivery, not to
exceed $500,000 for all such violations adjudicated in a single
proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses a
civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this section
to sanction such person for the introduction or delivery for
introduction into interstate commerce of the article of food that
is adulterated. If the Secretary assesses a civil penalty against
any person under this paragraph, the Secretary may not use the
seizure authorities of section 334 of this title or the injunction
authorities of section 332 of this title with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this paragraph,
the presiding officer shall have the same authority with regard to
compelling testimony or production of documents as a presiding
officer has under section 346a(g)(2)(B) of this title. The third
sentence of paragraph (3)(A) shall not apply to any investigation
under this paragraph.
(3)(A) A civil penalty under paragraph (1) or (2) shall be
assessed by the Secretary by an order made on the record after
opportunity for a hearing provided in accordance with this
subparagraph and section 554 of title 5. Before issuing such an
order, the Secretary shall give written notice to the person to be
assessed a civil penalty under such order of the Secretary's
proposal to issue such order and provide such person an opportunity
for a hearing on the order. In the course of any investigation, the
Secretary may issue subpoenas requiring the attendance and
testimony of witnesses and the production of evidence that relates
to the matter under investigation.
(B) In determining the amount of a civil penalty, the Secretary
shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the
violator, ability to pay, effect on ability to continue to do
business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1) or (2). The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person
charged.
(4) Any person who requested, in accordance with paragraph
(3)(A), a hearing respecting the assessment of a civil penalty and
who is aggrieved by an order assessing a civil penalty may file a
petition for judicial review of such order with the United States
Court of Appeals for the District of Columbia Circuit or for any
other circuit in which such person resides or transacts business.
Such a petition may only be filed within the 60-day period
beginning on the date the order making such assessment was issued.
(5) If any person fails to pay an assessment of a civil penalty -
(A) after the order making the assessment becomes final, and if
such person does not file a petition for judicial review of the
order in accordance with paragraph (4), or
(B) after a court in an action brought under paragraph (4) has
entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (4) or the
date of such final judgment, as the case may be) in an action
brought in any appropriate district court of the United States. In
such an action, the validity, amount, and appropriateness of such
penalty shall not be subject to review.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
2469.)
-REFTEXT-
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (e)(3), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, which is classified principally to subchapter I (Sec. 801
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
801 of this title and Tables.
-MISC1-
AMENDMENTS
2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
of subsec. (a)(6) by substituting "prescription drug under section
384(b)" for "covered product pursuant to section 384(a)", was
executed by making the substitution in subsec. (b)(6), to reflect
the probable intent of Congress.
2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "For
purposes of the preceding sentence, a person accredited under
paragraph (2) of section 374(g) of this title who is substantially
not in compliance with the standards of accreditation under such
section, or who poses a threat to public health or fails to act in
a manner that is consistent with the purposes of such section,
shall be considered to have violated a requirement of this chapter
that relates to devices."
2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
par. (2). Former par. (2) redesignated (3).
Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
par. (2) as (3) and substituted "paragraph (1) or (2)" for
"paragraph (1)" in subpars. (A) and (C). Former par. (3)
redesignated (4).
Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
(2)(A)". Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
wherever appearing.
1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
Pub. L. 101-647. See 1990 Amendment note below.
1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
amendment of this section by redesignating the second subsec. (e)
and subsec. (f) as subsecs. (f) and (g), respectively, could only
be executed by designating subsec. (f) as (g) because this section
did not contain a second subsec. (e) subsequent to amendment of
Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
notes for subsec. (e) under this section.
1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Notwithstanding subsection (a) of this section, any person who
violates section 331(t) of this title because of an importation of
a drug in violation of section 381(d)(1) of this title, because of
a sale, purchase, or trade of a drug or drug sample or the offer to
sell, purchase, or trade a drug or drug sample in violation of
section 353(c) of this title, because of the sale, purchase, or
trade of a coupon, the offer to sell, purchase, or trade such a
coupon, or the counterfeiting of such a coupon in violation of
section 353(c)(2) of this title, or the distribution of drugs in
violation of section 353(e)(2)(A) of this title shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both."
Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
"the institution of a criminal proceeding against, and conviction
of," for "the arrest and conviction of".
Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
substituted "before the institution of a criminal proceeding
against" for "before the arrest of" and "the institution of a
criminal proceeding against, and conviction of," for "the arrest
and conviction of".
Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
institution of a criminal proceeding against, and conviction of,"
for "the arrest and conviction of".
Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section".
Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section" and struck out ", and no person shall be subject to the
penalties of subsection (b) of this section for such a violation
unless the violation is committed with the intent to defraud or
mislead" after "advertising".
1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
322, amended subsec. (e) generally. Prior to amendment, subsec.
(e) read as follows:
"(e)(1) Except as provided in paragraph (2), any person who
distributes or possesses with the intent to distribute any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than three years or fined under title 18, or both.
"(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than six years or fined under title 18, or both."
Subsec. (f). Pub. L. 101-629 added subsec. (f).
1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
substituted "paragraph (1)" for "subsection (a)" in par. (2), and
added subsec. (b).
Subsec. (e). Pub. L. 100-690 added subsec. (e).
1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
subsec. (b) and transferred to subsec. (b) provisions covering
second offenses and offenses committed with intent to defraud or
mislead.
Subsec. (b). Pub. L. 91-513 inserted provisions covering second
offenses and offenses committed with intent to defraud or mislead
formerly set out in subsec. (a) and struck out provisions covering
violations involving depressant and stimulant drugs. See section
801 et seq. of this title.
1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
in the penalties prescribed for offenses involving depressant or
stimulant drugs, set a fine of not to exceed $10,000 or
imprisonment of not more than 5 years for offenses involving the
unlawful manufacturing of, sale, or disposal of, or possession with
intent to sell, a depressant or stimulant drug or involving
counterfeit depressant or stimulant drugs, stiffened the penalties
for unlawful sales or other disposals by persons over 18 to persons
under 21, and set new penalties for possession of a depressant or
stimulant drug for purposes other than sale or other disposal.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
limiting the penalties for depressant or stimulant drug violations
to two years imprisonment or $5,000 fine or both for first offense
and to two years imprisonment or $15,000 fine or both for
subsequent offenses.
Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
exception provision.
Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
additive" for "a coal-tar color", "the color additive" for "the
coal-tar color" and "such color additive was" for "such color was".
1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330015 of Pub. L. 103-322 provided that the amendment
made by that section is effective as of the date on which section
1904 of Pub. L. 101-647, which amended this section, took effect.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 17(b) of Pub. L. 101-629 provided that:
"(b) Effective Date of Application to Device User Facilities. -
"(1) The Secretary of Health and Human Services shall conduct a
study to determine whether there has been substantial compliance
with the requirements of section 519(b) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
facilities (as defined in section 519(b)(5)(A) of such Act). The
Secretary shall report the results of the study to the Congress
after the expiration of 45 months after the date of the enactment
of this Act [Nov. 28, 1990].
"(2)(A) If upon the expiration of 48 months after the date of
the enactment of this Act [Nov. 28, 1990] the Secretary has not
made the report required by paragraph (1), section 303(f) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
by the amendment made by subsection (a), shall take effect with
respect to device user facilities (as defined in section
519(b)(5)(A) of such Act). [Secretary of Health and Human
Services had not made the report required by par. (1) on the
expiration of 48 months after Nov. 28, 1990.]
"(B) If in the report under paragraph (1) the Secretary reports
that there has been substantial compliance with the requirements
of such section 519(b) by a type of device user facility and if
the Secretary does not make a determination under subparagraph
(C) with respect to such type of facility, such section 303(f)
shall not take effect with respect to such type of facility.
"(C) If the Secretary determines in the report under paragraph
(1) that there is not substantial compliance with the
requirements of such section 519(b) by a type of device user
facility or if the Secretary makes such a determination after
making the report under paragraph (1), such section 303(f) shall
take effect with respect to such type of facility upon the
effective date of the report."
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 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 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 by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, 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 OF 1951 AMENDMENT
Section 3 of act Oct. 26, 1951, provided that: "The provisions of
this Act [amending this section and section 353 of this title]
shall take effect six months after the date of its enactment [Oct.
26, 1951]."
SAVINGS PROVISION
Amendment by Pub. L. 91-513 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 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.
-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-
ENFORCEMENT
Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
provided that: "For the fines authorized to be imposed under
section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
333], see section 3623 of title 18, United States Code, for the
period ending October 31, 1986 [probably should be October 31,
1987], and sections 3559 and 3571 of such title for the period
beginning November 1, 1986 [probably should be November 1, 1987]."
-FOOTNOTE-
(!1) So in original. Words "of this section" probably should not
appear.
-End-
-CITE-
21 USC Sec. 333a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 333a. Repealed.
-MISC1-
Sec. 333a. Repealed. Pub. L. 101-647, title XIX, Sec. 1905, Nov.
29, 1990, 104 Stat. 4853.
Section, Pub. L. 100-690, title II, Sec. 2401, Nov. 18, 1988, 102
Stat. 4230, related to forfeiture and illegal trafficking in
steroids or human growth hormones.
-End-
-CITE-
21 USC Sec. 334 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 334. Seizure
-STATUTE-
(a) Grounds and jurisdiction
(1) Any article of food, drug, or cosmetic that is adulterated or
misbranded when introduced into or while in interstate commerce or
while held for sale (whether or not the first sale) after shipment
in interstate commerce, or which may not, under the provisions of
section 344 or 355 of this title, be introduced into interstate
commerce, shall be liable to be proceeded against while in
interstate commerce, or at any time thereafter, on libel of
information and condemned in any district court of the United
States or United States court of a Territory within the
jurisdiction of which the article is found. No libel for
condemnation shall be instituted under this chapter, for any
alleged misbranding if there is pending in any court a libel for
condemnation proceeding under this chapter based upon the same
alleged misbranding, and not more than one such proceeding shall be
instituted if no such proceeding is so pending, except that such
limitations shall not apply (A) when such misbranding has been the
basis of a prior judgment in favor of the United States, in a
criminal, injunction, or libel for condemnation proceeding under
this chapter, or (B) when the Secretary has probable cause to
believe from facts found, without hearing, by him or any officer or
employee of the Department that the misbranded article is dangerous
to health, or that the labeling of the misbranded article is
fraudulent, or would be in a material respect misleading to the
injury or damage of the purchaser or consumer. In any case where
the number of libel for condemnation proceedings is limited as
above provided the proceeding pending or instituted shall, on
application of the claimant, seasonably made, be removed for trial
to any district agreed upon by stipulation between the parties, or,
in case of failure to so stipulate within a reasonable time, the
claimant may apply to the court of the district in which the
seizure has been made, and such court (after giving the United
States attorney for such district reasonable notice and opportunity
to be heard) shall by order, unless good cause to the contrary is
shown, specify a district of reasonable proximity to the claimant's
principal place of business, to which the case shall be removed for
trial.
(2) The following shall be liable to be proceeded against at any
time on libel of information and condemned in any district court of
the United States or United States court of a Territory within the
jurisdiction of which they are found: (A) Any drug that is a
counterfeit drug, (B) Any container of a counterfeit drug, (C) Any
punch, die, plate, stone, labeling, container, or other thing used
or designed for use in making a counterfeit drug or drugs, and (D)
Any adulterated or misbranded device.
(3)(A) Except as provided in subparagraph (B), no libel for
condemnation may be instituted under paragraph (1) or (2) against
any food which -
(i) is misbranded under section 343(a)(2) of this title because
of its advertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated by a
manufacturer, packer, or distributor of the food.
(B) A libel for condemnation may be instituted under paragraph
(1) or (2) against a food described in subparagraph (A) if -
(i)(I) the food's advertising which resulted in the food being
misbranded under section 343(a)(2) of this title was disseminated
in the establishment in which the food is being held for sale to
the ultimate consumer,
(II) such advertising was disseminated by, or under the
direction of, the owner or operator of such establishment, or
(III) all or part of the cost of such advertising was paid by
such owner or operator; and
(ii) the owner or operator of such establishment used such
advertising in the establishment to promote the sale of the food.
(b) Procedure; multiplicity of pending proceedings
The article, equipment, or other thing proceeded against shall be
liable to seizure by process pursuant to the libel, and the
procedure in cases under this section shall conform, as nearly as
may be, to the procedure in admiralty; except that on demand of
either party any issue of fact joined in any such case shall be
tried by jury. When libel for condemnation proceedings under this
section, involving the same claimant and the same issues of
adulteration or misbranding, are pending in two or more
jurisdictions, such pending proceedings, upon application of the
claimant seasonably made to the court of one such jurisdiction,
shall be consolidated for trial by order of such court, and tried
in (1) any district selected by the claimant where one of such
proceedings is pending; or (2) a district agreed upon by
stipulation between the parties. If no order for consolidation is
so made within a reasonable time, the claimant may apply to the
court of one such jurisdiction and such court (after giving the
United States attorney for such district reasonable notice and
opportunity to be heard) shall by order, unless good cause to the
contrary is shown, specify a district of reasonable proximity to
the claimant's principal place of business, in which all such
pending proceedings shall be consolidated for trial and tried. Such
order of consolidation shall not apply so as to require the removal
of any case the date for trial of which has been fixed. The court
granting such order shall give prompt notification thereof to the
other courts having jurisdiction of the cases covered thereby.
(c) Availability of samples of seized goods prior to trial
The court at any time after seizure up to a reasonable time
before trial shall by order allow any party to a condemnation
proceeding, his attorney or agent, to obtain a representative
sample of the article seized and a true copy of the analysis, if
any, on which the proceeding is based and the identifying marks or
numbers, if any, of the packages from which the samples analyzed
were obtained.
(d) Disposition of goods after decree of condemnation; claims for
remission or mitigation of forfeitures
(1) Any food, drug, device, or cosmetic condemned under this
section shall, after entry of the decree, be disposed of by
destruction or sale as the court may, in accordance with the
provisions of this section, direct and the proceeds thereof, if
sold, less the legal costs and charges, shall be paid into the
Treasury of the United States; but such article shall not be sold
under such decree contrary to the provisions of this chapter or the
laws of the jurisdiction in which sold. After entry of the decree
and upon the payment of the costs of such proceedings and the
execution of a good and sufficient bond conditioned that such
article shall not be sold or disposed of contrary to the provisions
of this chapter or the laws of any State or Territory in which
sold, the court may by order direct that such article be delivered
to the owner thereof to be destroyed or brought into compliance
with the provisions of this chapter, under the supervision of an
officer or employee duly designated by the Secretary, and the
expenses of such supervision shall be paid by the person obtaining
release of the article under bond. If the article was imported into
the United States and the person seeking its release establishes
(A) that the adulteration, misbranding, or violation did not occur
after the article was imported, and (B) that he had no cause for
believing that it was adulterated, misbranded, or in violation
before it was released from customs custody, the court may permit
the article to be delivered to the owner for exportation in lieu of
destruction upon a showing by the owner that all of the conditions
of section 381(e) of this title can and will be met. The provisions
of this sentence shall not apply where condemnation is based upon
violation of section 342(a)(1), (2), or (6), section 351(a)(3),
section 352(j), or section 361(a) or (d) of this title. Where such
exportation is made to the original foreign supplier, then
subparagraphs (A) and (B) of section 381(e)(1) of this title and
the preceding sentence shall not be applicable; and in all cases of
exportation the bond shall be conditioned that the article shall
not be sold or disposed of until the applicable conditions of
section 381(e) of this title have been met. Any person seeking to
export an imported article pursuant to any of the provisions of
this subsection shall establish that the article was intended for
export at the time the article entered commerce. Any article
condemned by reason of its being an article which may not, under
section 344 or 355 of this title, be introduced into interstate
commerce, shall be disposed of by destruction.
(2) The provisions of paragraph (1) of this subsection shall, to
the extent deemed appropriate by the court, apply to any equipment
or other thing which is not otherwise within the scope of such
paragraph and which is referred to in paragraph (2) of subsection
(a) of this section.
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a) of this section, the condemnation
of any equipment or thing (other than a drug) is decreed, the court
shall allow the claim of any claimant, to the extent of such
claimant's interest, for remission or mitigation of such forfeiture
if such claimant proves to the satisfaction of the court (i) that
he has not committed or caused to be committed any prohibited act
referred to in such paragraph (2) and has no interest in any drug
referred to therein, (ii) that he has an interest in such equipment
or other thing as owner or lienor or otherwise, acquired by him in
good faith, and (iii) that he at no time had any knowledge or
reason to believe that such equipment or other thing was being or
would be used in, or to facilitate, the violation of laws of the
United States relating to counterfeit drugs.
(e) Costs
When a decree of condemnation is entered against the article,
court costs and fees, and storage and other proper expenses, shall
be awarded against the person, if any, intervening as claimant of
the article.
(f) Removal of case for trial
In the case of removal for trial of any case as provided by
subsection (a) or (b) of this section -
(1) The clerk of the court from which removal is made shall
promptly transmit to the court in which the case is to be tried
all records in the case necessary in order that such court may
exercise jurisdiction.
(2) The court to which such case was removed shall have the
powers and be subject to the duties, for purposes of such case,
which the court from which removal was made would have had, or to
which such court would have been subject, if such case had not
been removed.
(g) Administrative restraint; detention orders
(1) If during an inspection conducted under section 374 of this
title of a facility or a vehicle, a device which the officer or
employee making the inspection has reason to believe is adulterated
or misbranded is found in such facility or vehicle, such officer or
employee may order the device detained (in accordance with
regulations prescribed by the Secretary) for a reasonable period
which may not exceed twenty days unless the Secretary determines
that a period of detention greater than twenty days is required to
institute an action under subsection (a) of this section or section
332 of this title, in which case he may authorize a detention
period of not to exceed thirty days. Regulations of the Secretary
prescribed under this paragraph shall require that before a device
may be ordered detained under this paragraph the Secretary or an
officer or employee designated by the Secretary approve such order.
A detention order under this paragraph may require the labeling or
marking of a device during the period of its detention for the
purpose of identifying the device as detained. Any person who would
be entitled to claim a device if it were seized under subsection
(a) of this section may appeal to the Secretary a detention of such
device under this paragraph. Within five days of the date an appeal
of a detention is filed with the Secretary, the Secretary shall
after affording opportunity for an informal hearing by order
confirm the detention or revoke it.
(2)(A) Except as authorized by subparagraph (B), a device subject
to a detention order issued under paragraph (1) shall not be moved
by any person from the place at which it is ordered detained until -
(i) released by the Secretary, or
(ii) the expiration of the detention period applicable to such
order,
whichever occurs first.
(B) A device subject to a detention order under paragraph (1) may
be moved -
(i) in accordance with regulations prescribed by the Secretary,
and
(ii) if not in final form for shipment, at the discretion of
the manufacturer of the device for the purpose of completing the
work required to put it in such form.
(h) Administrative detention of foods
(1) Detention authority
(A) In general
An officer or qualified employee of the Food and Drug
Administration may order the detention, in accordance with this
subsection, of any article of food that is found during an
inspection, examination, or investigation under this chapter
conducted by such officer or qualified employee, if the officer
or qualified employee has credible evidence or information
indicating that such article presents a threat of serious
adverse health consequences or death to humans or animals.
(B) Secretary's approval
An article of food may be ordered detained under subparagraph
(A) only if the Secretary or an official designated by the
Secretary approves the order. 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.
(2) Period of detention
An article of food may be detained under paragraph (1) for a
reasonable period, not to exceed 20 days, unless a greater
period, not to exceed 30 days, is necessary, to enable the
Secretary to institute an action under subsection (a) of this
section or section 332 of this title. The Secretary shall by
regulation provide for procedures for instituting such action on
an expedited basis with respect to perishable foods.
(3) Security of detained article
An order under paragraph (1) with respect to an article of food
may require that such article be labeled or marked as detained,
and shall require that the article be removed to a secure
facility, as appropriate. An article subject to such an order
shall not be transferred by any person from the place at which
the article is ordered detained, or from the place to which the
article is so removed, as the case may be, until released by the
Secretary or until the expiration of the detention period
applicable under such order, whichever occurs first. This
subsection may not be construed as authorizing the delivery of
the article pursuant to the execution of a bond while the article
is subject to the order, and section 381(b) of this title does
not authorize the delivery of the article pursuant to the
execution of a bond while the article is subject to the order.
(4) Appeal of detention order
(A) In general
With respect to an article of food ordered detained under
paragraph (1), any person who would be entitled to be a
claimant for such article if the article were seized under
subsection (a) of this section may appeal the order to the
Secretary. Within five days after such an appeal is filed, the
Secretary, after providing opportunity for an informal hearing,
shall confirm or terminate the order involved, and such
confirmation by the Secretary shall be considered a final
agency action for purposes of section 702 of title 5. If during
such five-day period the Secretary fails to provide such an
opportunity, or to confirm or terminate such order, the order
is deemed to be terminated.
(B) Effect of instituting court action
The process under subparagraph (A) for the appeal of an order
under paragraph (1) terminates if the Secretary institutes an
action under subsection (a) of this section or section 332 of
this title regarding the article of food involved.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948,
ch. 613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67
Stat. 477; Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89-
74, Sec. 6, July 15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec.
4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91-513, title II, Sec.
701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94-278,
title V, Sec. 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-
295, Secs. 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L.
102-300, Sec. 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105-115, title IV,
Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-188, title
III, Sec. 303(a), June 12, 2002, 116 Stat. 663.)
-MISC1-
AMENDMENTS
2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).
1997 - Subsec. (d)(1). Pub. L. 105-115 substituted "subparagraphs
(A) and (B) of section 381(e)(1) of this title" for "paragraphs (1)
and (2) of section 381(e) of this title" and inserted "Any person
seeking to export an imported article pursuant to any of the
provisions of this subsection shall establish that the article was
intended for export at the time the article entered commerce."
before "Any article condemned by reason".
1993 - Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted
"found. No libel" for "found: Provided, however, That no libel".
Subsec. (d)(1). Pub. L. 103-80, Sec. 3(f)(2), substituted "sold.
After entry" for "sold: Provided, That after entry", "met. The
provisions of this sentence" for "met: Provided, however, That the
provisions of this sentence", "title. Where such exportation" for
"title: And provided further, That where such exportation", and
"the preceding sentence shall not be applicable" for "the foregoing
proviso shall not be applicable".
1992 - Subsec. (d)(1). Pub. L. 102-300 substituted "381(e)" for
"381(d)" in three places and "paragraphs" for "clauses" before "(1)
and (2) of section 381(e)".
1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 3(c)(1), struck out
"device," after "Any article of food, drug,".
Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)
covering adulterated or misbranded devices.
Subsec. (a)(3). Pub. L. 94-278 added par. (3).
Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).
1970 - Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out
cls. (A) and (D) which dealt with depressant or stimulant drugs,
struck out reference to depressant or stimulant drugs in cl. (C),
and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C),
respectively.
Subsec. (d)(3)(iii). Pub. L. 91-513, Sec. 701(d), struck out
reference to depressant or stimulant drugs.
1968 - Subsec. (a). Pub. L. 90-639 inserted references to the
United States courts of Territories.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 6(a), designated existing
provisions as par. (1), redesignated cls. (1) and (2) of proviso as
(A) and (B), and added par. (2).
Subsec. (b). Pub. L. 89-74, Sec. 6(b)(1), inserted "equipment, or
other thing proceeded against" after "article" in first sentence.
Subsec. (d). Pub. L. 89-74, Sec. 6(b)(2), designated existing
provisions as par. (1), redesignated cls. (1) and (2) of the second
sentence thereof as (A) and (B), and added pars. (2) and (3).
1957 - Subsec. (d). Pub. L. 85-250 permitted, under certain
circumstances, reexportation of articles condemned at places other
than original port of entry.
1953 - Subsec. (c). Act Aug. 7, 1953, provided that a true copy
of the analysis in any case shall be furnished the owner.
1948 - Subsec. (a). Act June 24, 1948, inserted "or while held
for sale (whether or not the first sale) after shipment in
interstate commerce" to make this subsection coextensive with
section 331(k) of this title.
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 1976 AMENDMENT
Section 502(c) of Pub. L. 94-278 provided that: "The amendments
made by subsection (a) [amending this section and sections 321,
333, and 343 of this title] shall take effect 180 days after the
date of the enactment of this Act [Apr. 22, 1976]."
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 by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective 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.
-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. 335 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335. Hearing before report of criminal violation
-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 appropriate notice and an opportunity to present his
views, either orally or in writing, with regard to such
contemplated proceeding.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 305, 52 Stat. 1045.)
-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. 335a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335a. Debarment, temporary denial of approval, and suspension
-STATUTE-
(a) Mandatory debarment; certain drug applications
(1) Corporations, partnerships, and associations
If the Secretary finds that a person other than an individual
has been convicted, after May 13, 1992, of a felony under Federal
law for conduct relating to the development or approval,
including the process for development or approval, of any
abbreviated drug application, the Secretary shall debar such
person from submitting, or assisting in the submission of, any
such application.
(2) Individuals
If the Secretary finds that an individual has been convicted of
a felony under Federal law for conduct -
(A) relating to the development or approval, including the
process for development or approval, of any drug product, or
(B) otherwise relating to the regulation of any drug product
under this chapter,
the Secretary shall debar such individual from providing services
in any capacity to a person that has an approved or pending drug
product application.
(b) Permissive debarment; certain drug applications; food imports
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (2), debar -
(A) a person other than an individual from submitting or
assisting in the submission of any abbreviated drug
application,
(B) an individual from providing services in any capacity to
a person that has an approved or pending drug product
application, or
(C) a person from importing an article of food or offering
such an article for import into the United States.
(2) Persons subject to permissive debarment; certain drug
applications
The following persons are subject to debarment under
subparagraph (A) or (B) of paragraph (1):
(A) Corporations, partnerships, and associations
Any person other than an individual that the Secretary finds
has been convicted -
(i) for conduct that -
(I) relates to the development or approval, including the
process for the development or approval, of any abbreviated
drug application; and
(II) is a felony under Federal law (if the person was
convicted before May 13, 1992), a misdemeanor under Federal
law, or a felony under State law, or
(ii) of a conspiracy to commit, or aiding or abetting, a
criminal offense described in clause (i) or a felony
described in subsection (a)(1) of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(B) Individuals
(i) Any individual whom the Secretary finds has been
convicted of -
(I) a misdemeanor under Federal law or a felony under State
law for conduct relating to the development or approval,
including the process for development or approval, of any
drug product or otherwise relating to the regulation of drug
products under this chapter, or
(II) a conspiracy to commit, or aiding or abetting, such
criminal offense or a felony described in subsection (a)(2)
of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(ii) Any individual whom the Secretary finds has been
convicted of -
(I) a felony which is not described in subsection (a)(2) of
this section or clause (i) of this subparagraph and which
involves bribery, payment of illegal gratuities, fraud,
perjury, false statement, racketeering, blackmail, extortion,
falsification or destruction of records, or interference
with, obstruction of an investigation into, or prosecution
of, any criminal offense, or
(II) a conspiracy to commit, or aiding or abetting, such
felony,
if the Secretary finds, on the basis of the conviction of such
individual and other information, that such individual has
demonstrated a pattern of conduct sufficient to find that there
is reason to believe that such individual may violate
requirements under this chapter relating to drug products.
(iii) Any individual whom the Secretary finds materially
participated in acts that were the basis for a conviction for
an offense described in subsection (a) of this section or in
clause (i) or (ii) for which a conviction was obtained, if the
Secretary finds, on the basis of such participation and other
information, that such individual has demonstrated a pattern of
conduct sufficient to find that there is reason to believe that
such individual may violate requirements under this chapter
relating to drug products.
(iv) Any high managerial agent whom the Secretary finds -
(I) worked for, or worked as a consultant for, the same
person as another individual during the period in which such
other individual took actions for which a felony conviction
was obtained and which resulted in the debarment under
subsection (a)(2) of this section, or clause (i), of such
other individual,
(II) had actual knowledge of the actions described in
subclause (I) of such other individual, or took action to
avoid such actual knowledge, or failed to take action for the
purpose of avoiding such actual knowledge,
(III) knew that the actions described in subclause (I) were
violative of law, and
(IV) did not report such actions, or did not cause such
actions to be reported, to an officer, employee, or agent of
the Department or to an appropriate law enforcement officer,
or failed to take other appropriate action that would have
ensured that the process for the regulation of drugs was not
undermined, within a reasonable time after such agent first
knew of such actions,
if the Secretary finds that the type of conduct which served as
the basis for such other individual's conviction undermines the
process for the regulation of drugs.
(3) Persons subject to permissive debarment; food importation
A person is subject to debarment under paragraph (1)(C) if -
(A) the person has been convicted of a felony for conduct
relating to the importation into the United States of any food;
or
(B) the person has engaged in a pattern of importing or
offering for import adulterated food that presents a threat of
serious adverse health consequences or death to humans or
animals.
(4) Stay of certain orders
An order of the Secretary under clause (iii) or (iv) of
paragraph (2)(B) shall not take effect until 30 days after the
order has been issued.
(c) Debarment period and considerations
(1) Effect of debarment
The Secretary -
(A) shall not accept or review (other than in connection with
an audit under this section) any abbreviated drug application
submitted by or with the assistance of a person debarred under
subsection (a)(1) or (b)(2)(A) of this section during the
period such person is debarred,
(B) shall, during the period of a debarment under subsection
(a)(2) or (b)(2)(B) of this section, debar an individual from
providing services in any capacity to a person that has an
approved or pending drug product application and shall not
accept or review (other than in connection with an audit under
this section) an abbreviated drug application from such
individual, and
(C) shall, if the Secretary makes the finding described in
paragraph (6) or (7) of section 335b(a) of this title, assess a
civil penalty in accordance with section 335b of this title.
(2) Debarment periods
(A) In general
The Secretary shall debar a person under subsection (a) or
(b) of this section for the following periods:
(i) The period of debarment of a person (other than an
individual) under subsection (a)(1) of this section shall not
be less than 1 year or more than 10 years, but if an act
leading to a subsequent debarment under subsection (a) of
this section occurs within 10 years after such person has
been debarred under subsection (a)(1) of this section, the
period of debarment shall be permanent.
(ii) The debarment of an individual under subsection (a)(2)
of this section shall be permanent.
(iii) The period of debarment of any person under paragraph
(2) or (3) of subsection (b) of this section shall not be
more than 5 years.
The Secretary may determine whether debarment periods shall run
concurrently or consecutively in the case of a person debarred
for multiple offenses.
(B) Notification
Upon a conviction for an offense described in subsection (a)
or (b) of this section or upon execution of an agreement with
the United States to plead guilty to such an offense, the
person involved may notify the Secretary that the person
acquiesces to debarment and such person's debarment shall
commence upon such notification.
(3) Considerations
In determining the appropriateness and the period of a
debarment of a person under subsection (b) of this section and
any period of debarment beyond the minimum specified in
subparagraph (A)(i) of paragraph (2), the Secretary shall
consider where applicable -
(A) the nature and seriousness of any offense involved,
(B) the nature and extent of management participation in any
offense involved, whether corporate policies and practices
encouraged the offense, including whether inadequate
institutional controls contributed to the offense,
(C) the nature and extent of voluntary steps to mitigate the
impact on the public of any offense involved, including the
recall or the discontinuation of the distribution of suspect
drugs, full cooperation with any investigations (including the
extent of disclosure to appropriate authorities of all
wrongdoing), the relinquishing of profits on drug approvals
fraudulently obtained, and any other actions taken to
substantially limit potential or actual adverse effects on the
public health,
(D) whether the extent to which changes in ownership,
management, or operations have corrected the causes of any
offense involved and provide reasonable assurances that the
offense will not occur in the future,
(E) whether the person to be debarred is able to present
adequate evidence that current production of drugs subject to
abbreviated drug applications and all pending abbreviated drug
applications are free of fraud or material false statements,
and
(F) prior convictions under this chapter or under other Acts
involving matters within the jurisdiction of the Food and Drug
Administration.
(d) Termination of debarment
(1) Application
Any person that is debarred under subsection (a) of this
section (other than a person permanently debarred) or any person
that is debarred under subsection (b) of this section may apply
to the Secretary for termination of the debarment under this
subsection. Any information submitted to the Secretary under this
paragraph does not constitute an amendment or supplement to
pending or approved abbreviated drug applications.
(2) Deadline
The Secretary shall grant or deny any application respecting a
debarment which is submitted under paragraph (1) within 180 days
of the date the application is submitted.
(3) Action by the Secretary
(A) Corporations
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of a person under subsection (a)(1) of this section
or paragraph (2)(A) or (3) of subsection (b) of this section
is reversed, the Secretary shall withdraw the order of
debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of a person if the
Secretary finds that -
(I) changes in ownership, management, or operations have
fully corrected the causes of the offense involved and
provide reasonable assurances that the offense will not
occur in the future, and
(II) in applicable cases, sufficient audits, conducted by
the Food and Drug Administration or by independent experts
acceptable to the Food and Drug Administration, demonstrate
that pending applications and the development of drugs
being tested before the submission of an application are
free of fraud or material false statements.
In the case of persons debarred under subsection (a)(1) of
this section, such termination shall take effect no earlier
than the expiration of one year from the date of the
debarment.
(B) Individuals
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of an individual under subsection (a)(2) of this
section or clause (i), (ii), (iii), or (iv) of subsection
(b)(2)(B) or subsection (b)(3) of this section is reversed,
the Secretary shall withdraw the order of debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of an individual who
has been debarred under subsection (b)(2)(B) or subsection
(b)(3) of this section if such termination serves the
interests of justice and adequately protects the integrity of
the drug approval process or the food importation process, as
the case may be.
(4) Special termination
(A) Application
Any person that is debarred under subsection (a)(1) of this
section (other than a person permanently debarred under
subsection (c)(2)(A)(i) of this section) or any individual who
is debarred under subsection (a)(2) of this section may apply
to the Secretary for special termination of debarment under
this subsection. Any information submitted to the Secretary
under this subparagraph does not constitute an amendment or
supplement to pending or approved abbreviated drug
applications.
(B) Corporations
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that -
(i) the person making the application under subparagraph
(A) has demonstrated that the felony conviction which was the
basis for such person's debarment involved the commission of
an offense which was not authorized, requested, commanded,
performed, or recklessly tolerated by the board of directors
or by a high managerial agent acting on behalf of the person
within the scope of the board's or agent's office or
employment,
(ii) all individuals who were involved in the commission of
the offense or who knew or should have known of the offense
have been removed from employment involving the development
or approval of any drug subject to sections (!1) 355 of this
title,
(iii) the person fully cooperated with all investigations
and promptly disclosed all wrongdoing to the appropriate
authorities, and
(iv) the person acted to mitigate any impact on the public
of any offense involved, including the recall, or the
discontinuation of the distribution, of any drug with respect
to which the Secretary requested a recall or discontinuation
of distribution due to concerns about the safety or efficacy
of the drug.
(C) Individuals
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that such
individual has provided substantial assistance in the
investigations or prosecutions of offenses which are described
in subsection (a) or (b) of this section or which relate to any
matter under the jurisdiction of the Food and Drug
Administration.
(D) Secretarial action
The action referred to in subparagraphs (B) and (C) is -
(i) in the case of a person other than an individual -
(I) terminating the debarment immediately, or
(II) limiting the period of debarment to less than one
year, and
(ii) in the case of an individual, limiting the period of
debarment to less than permanent but to no less than 1 year,
whichever best serves the interest of justice and protects the
integrity of the drug approval process.
(e) Publication and list of debarred persons
The Secretary shall publish in the Federal Register the name of
any person debarred under subsection (a) or (b) of this section,
the effective date of the debarment, and the period of the
debarment. The Secretary shall also maintain and make available to
the public a list, updated no less often than quarterly, of such
persons, of the effective dates and minimum periods of such
debarments, and of the termination of debarments.
(f) Temporary denial of approval
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (3), refuse by
order, for the period prescribed by paragraph (2), to approve any
abbreviated drug application submitted by any person -
(A) if such person is under an active Federal criminal
investigation in connection with an action described in
subparagraph (B),
(B) if the Secretary finds that such person -
(i) has bribed or attempted to bribe, has paid or attempted
to pay an illegal gratuity, or has induced or attempted to
induce another person to bribe or pay an illegal gratuity to
any officer, employee, or agent of the Department of Health
and Human Services or to any other Federal, State, or local
official in connection with any abbreviated drug application,
or has conspired to commit, or aided or abetted, such
actions, or
(ii) has knowingly made or caused to be made a pattern or
practice of false statements or misrepresentations with
respect to material facts relating to any abbreviated drug
application, or the production of any drug subject to an
abbreviated drug application, to any officer, employee, or
agent of the Department of Health and Human Services, or has
conspired to commit, or aided or abetted, such actions, and
(C) if a significant question has been raised regarding -
(i) the integrity of the approval process with respect to
such abbreviated drug application, or
(ii) the reliability of data in or concerning such person's
abbreviated drug application.
Such an order may be modified or terminated at any time.
(2) Applicable period
(A) In general
Except as provided in subparagraph (B), a denial of approval
of an application of a person under paragraph (1) shall be in
effect for a period determined by the Secretary but not to
exceed 18 months beginning on the date the Secretary finds that
the conditions described in subparagraphs (A), (B), and (C) of
paragraph (1) exist. The Secretary shall terminate such denial -
(i) if the investigation with respect to which the finding
was made does not result in a criminal charge against such
person, if criminal charges have been brought and the charges
have been dismissed, or if a judgment of acquittal has been
entered, or
(ii) if the Secretary determines that such finding was in
error.
(B) Extension
If, at the end of the period described in subparagraph (A),
the Secretary determines that a person has been criminally
charged for an action described in subparagraph (B) of
paragraph (1), the Secretary may extend the period of denial of
approval of an application for a period not to exceed 18
months. The Secretary shall terminate such extension if the
charges have been dismissed, if a judgment of acquittal has
been entered, or if the Secretary determines that the finding
described in subparagraph (A) was in error.
(3) Informal hearing
Within 10 days of the date an order is issued under paragraph
(1), the Secretary shall provide such person with an opportunity
for an informal hearing, to be held within such 10 days, on the
decision of the Secretary to refuse approval of an abbreviated
drug application. Within 60 days of the date on which such
hearing is held, the Secretary shall notify the person given such
hearing whether the Secretary's refusal of approval will be
continued, terminated, or otherwise modified. Such notification
shall be final agency action.
(g) Suspension authority
(1) In general
If -
(A) the Secretary finds -
(i) that a person has engaged in conduct described in
subparagraph (B) of subsection (f)(1) of this section in
connection with 2 or more drugs under abbreviated drug
applications, or
(ii) that a person has engaged in flagrant and repeated,
material violations of good manufacturing practice or good
laboratory practice in connection with the development,
manufacturing, or distribution of one or more drugs approved
under an abbreviated drug application during a 2-year period,
and -
(I) such violations may undermine the safety and efficacy
of such drugs, and
(II) the causes of such violations have not been
corrected within a reasonable period of time following
notice of such violations by the Secretary, and
(B) such person is under an active investigation by a Federal
authority in connection with a civil or criminal action
involving conduct described in subparagraph (A),
the Secretary shall issue an order suspending the distribution of
all drugs the development or approval of which was related to
such conduct described in subparagraph (A) or suspending the
distribution of all drugs approved under abbreviated drug
applications of such person if the Secretary finds that such
conduct may have affected the development or approval of a
significant number of drugs which the Secretary is unable to
identify. The Secretary shall exclude a drug from such order if
the Secretary determines that such conduct was not likely to have
influenced the safety or efficacy of such drug.
(2) Public health waiver
The Secretary shall, on the Secretary's own initiative or in
response to a petition, waive the suspension under paragraph (1)
(involving an action described in paragraph (1)(A)(i)) with
respect to any drug if the Secretary finds that such waiver is
necessary to protect the public health because sufficient
quantities of the drug would not otherwise be available. The
Secretary shall act on any petition seeking action under this
paragraph within 180 days of the date the petition is submitted
to the Secretary.
(h) Termination of suspension
The Secretary shall withdraw an order of suspension of the
distribution of a drug under subsection (g) of this section if the
person with respect to whom the order was issued demonstrates in a
petition to the Secretary -
(1)(A) on the basis of an audit by the Food and Drug
Administration or by experts acceptable to the Food and Drug
Administration, or on the basis of other information, that the
development, approval, manufacturing, and distribution of such
drug is in substantial compliance with the applicable
requirements of this chapter, and
(B) changes in ownership, management, or operations -
(i) fully remedy the patterns or practices with respect to
which the order was issued, and
(ii) provide reasonable assurances that such actions will not
occur in the future, or
(2) the initial determination was in error.
The Secretary shall act on a submission of a petition under this
subsection within 180 days of the date of its submission and the
Secretary may consider the petition concurrently with the
suspension proceeding. Any information submitted to the Secretary
under this subsection does not constitute an amendment or
supplement to a pending or approved abbreviated drug application.
(i) Procedure
The Secretary may not take any action under subsection (a), (b),
(c), (d)(3), (g), or (h) of this section with respect to any person
unless the Secretary has issued an order for such action made on
the record after opportunity for an agency hearing on disputed
issues of material fact. In the course of any investigation or
hearing under this subsection, the Secretary may administer oaths
and affirmations, examine witnesses, receive evidence, and issue
subpoenas requiring the attendance and testimony of witnesses and
the production of evidence that relates to the matter under
investigation.
(j) Judicial review
(1) In general
Except as provided in paragraph (2), any person that is the
subject of an adverse decision under subsection (a), (b), (c),
(d), (f), (g), or (h) of this section may obtain a review of such
decision by the United States Court of Appeals for the District
of Columbia or for the circuit in which the person resides, by
filing in such court (within 60 days following the date the
person is notified of the Secretary's decision) a petition
requesting that the decision be modified or set aside.
(2) Exception
Any person that is the subject of an adverse decision under
clause (iii) or (iv) of subsection (b)(2)(B) of this section may
obtain a review of such decision by the United States District
Court for the District of Columbia or a district court of the
United States for the district in which the person resides, by
filing in such court (within 30 days following the date the
person is notified of the Secretary's decision) a complaint
requesting that the decision be modified or set aside. In such an
action, the court shall determine the matter de novo.
(k) Certification
Any application for approval of a drug product shall include -
(1) a certification that the applicant did not and will not use
in any capacity the services of any person debarred under
subsection (a) or (b) of this section, in connection with such
application, and
(2) if such application is an abbreviated drug application, a
list of all convictions, described in subsections (a) and (b) of
this section which occurred within the previous 5 years, of the
applicant and affiliated persons responsible for the development
or submission of such application.
(l) Applicability
(1) Conviction
For purposes of this section, a person is considered to have
been convicted of a criminal offense -
(A) when a judgment of conviction has been entered against
the person by a Federal or State court, regardless of whether
there is an appeal pending,
(B) when a plea of guilty or nolo contendere by the person
has been accepted by a Federal or State court, or
(C) when the person has entered into participation in a first
offender, deferred adjudication, or other similar arrangement
or program where judgment of conviction has been withheld.
(2) Effective dates
Subsection (a) of this section, subparagraph (A) of subsection
(b)(2) of this section, clauses (i) and (ii) of subsection
(b)(2)(B) of this section, and subsection (b)(3)(A) of this
section shall not apply to a conviction which occurred more than
5 years before the initiation of an agency action proposed to be
taken under subsection (a) or (b) of this section. Clauses (iii)
and (iv) of subsection (b)(2)(B) of this section, subsection
(b)(3)(B) of this section, and subsections (f) and (g) of this
section shall not apply to an act or action which occurred more
than 5 years before the initiation of an agency action proposed
to be taken under subsection (b), (f), or (g) of this section.
Clause (iv) of subsection (b)(2)(B) of this section shall not
apply to an action which occurred before June 1, 1992. Subsection
(k) of this section shall not apply to applications submitted to
the Secretary before June 1, 1992.
(m) Devices; mandatory debarment regarding third-party inspections
and reviews
(1) In general
If the Secretary finds that a person has been convicted of a
felony under section 331(gg) of this title, the Secretary shall
debar such person from being accredited under section 360m(b) or
374(g)(2) of this title and from carrying out activities under an
agreement described in section 383(b) of this title.
(2) Debarment period
The Secretary shall debar a person under paragraph (1) for the
following periods:
(A) The period of debarment of a person (other than an
individual) shall not be less than 1 year or more than 10
years, but if an act leading to a subsequent debarment under
such paragraph occurs within 10 years after such person has
been debarred under such paragraph, the period of debarment
shall be permanent.
(B) The debarment of an individual shall be permanent.
(3) Termination of debarment; judicial review; other matters
Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this
section apply with respect to a person (other than an individual)
or an individual who is debarred under paragraph (1) to the same
extent and in the same manner as such subsections apply with
respect to a person who is debarred under subsection (a)(1) of
this section, or an individual who is debarred under subsection
(a)(2) of this section, respectively.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec.
2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,
Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188,
title III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub.
L. 107-250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)
-MISC1-
PRIOR PROVISIONS
A prior section 306 of act June 25, 1938, was renumbered section
309 and is classified to section 336 of this title.
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted
"Mandatory debarment; certain drug applications" for "Mandatory
debarment" in heading.
Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted
"Permissive debarment; certain drug applications; food imports" for
"Permissive debarment" in heading.
Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.
(C).
Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted
"permissive debarment; certain drug applications" for "permissive
debarment" in heading.
Pub. L. 107-188, Sec. 304(a)(2)(A), inserted "subparagraph (A) or
(B) of" before "paragraph (1)" in introductory provisions.
Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C),
added par. (3) and redesignated former par. (3) as (4).
Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3),
substituted "paragraph (2) or (3) of subsection (b)" for
"subsection (b)(2)".
Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),
substituted "subsection (a)(1) of this section or paragraph (2)(A)
or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".
Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),
inserted "in applicable cases," before "sufficient audits".
Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C),
inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".
Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),
inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and
"or the food importation process, as the case may be" before
period.
Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence
struck out "and" after "subsection (b)(2) of this section," and
inserted ", and subsection (b)(3)(A) of this section" after
"subsection (b)(2)(B) of this section" and in second sentence
inserted ", subsection (b)(3)(B) of this section," after
"subsection (b)(2)(B) of this section".
Subsec. (m). Pub. L. 107-250 added subsec. (m).
1997 - Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out "or 357"
after "355".
CONSTRUCTION
Section 7 of Pub. L. 102-282 provided that: "No amendment made by
this Act [enacting this section and sections 335b and 335c of this
title and amending sections 321, 336, 337, and 355 of this title]
shall 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 this Act."
CONGRESSIONAL FINDINGS
Section 1(c) of Pub. L. 102-282 provided that: "The Congress
finds that -
"(1) there is substantial evidence that significant corruption
occurred in the Food and Drug Administration's process of
approving drugs under abbreviated drug applications,
"(2) there is a need to establish procedures designed to
restore and to ensure the integrity of the abbreviated drug
application approval process and to protect the public health,
and
"(3) there is a need to establish procedures to bar individuals
who have been convicted of crimes pertaining to the regulation of
drug products from working for companies that manufacture or
distribute such products."
-FOOTNOTE-
(!1) So in original. Probably should be "section".
-End-
-CITE-
21 USC Sec. 335b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335b. Civil penalties
-STATUTE-
(a) In general
Any person that the Secretary finds -
(1) knowingly made or caused to be made, to any officer,
employee, or agent of the Department of Health and Human
Services, a false statement or misrepresentation of a material
fact in connection with an abbreviated drug application,
(2) bribed or attempted to bribe or paid or attempted to pay an
illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services in connection with an
abbreviated drug application,
(3) destroyed, altered, removed, or secreted, or procured the
destruction, alteration, removal, or secretion of, any material
document or other material evidence which was the property of or
in the possession of the Department of Health and Human Services
for the purpose of interfering with that Department's discharge
of its responsibilities in connection with an abbreviated drug
application,
(4) knowingly failed to disclose, to an officer or employee of
the Department of Health and Human Services, a material fact
which such person had an obligation to disclose relating to any
drug subject to an abbreviated drug application,
(5) knowingly obstructed an investigation of the Department of
Health and Human Services into any drug subject to an abbreviated
drug application,
(6) is a person that has an approved or pending drug product
application and has knowingly -
(A) employed or retained as a consultant or contractor, or
(B) otherwise used in any capacity the services of,
a person who was debarred under section 335a of this title, or
(7) is an individual debarred under section 335a of this title
and, during the period of debarment, provided services in any
capacity to a person that had an approved or pending drug product
application,
shall be liable to the United States for a civil penalty for each
such violation in an amount not to exceed $250,000 in the case of
an individual and $1,000,000 in the case of any other person.
(b) Procedure
(1) In general
(A) Action by the Secretary
A civil penalty under subsection (a) of this section shall be
assessed by the Secretary on a person by an order made on the
record after an opportunity for an agency hearing on disputed
issues of material fact and the amount of the penalty. In the
course of any investigation or hearing under this subparagraph,
the Secretary may administer oaths and affirmations, examine
witnesses, receive evidence, and issue subpoenas requiring the
attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
(B) Action by the Attorney General
In lieu of a proceeding under subparagraph (A), the Attorney
General may, upon request of the Secretary, institute a civil
action to recover a civil money penalty in the amount and for
any of the acts set forth in subsection (a) of this section.
Such an action may be instituted separately from or in
connection with any other claim, civil or criminal, initiated
by the Attorney General under this chapter.
(2) Amount
In determining the amount of a civil penalty under paragraph
(1), the Secretary or the court shall take into account the
nature, circumstances, extent, and gravity of the act subject to
penalty, the person's ability to pay, the effect on the person's
ability to continue to do business, any history of prior, similar
acts, and such other matters as justice may require.
(3) Limitation on actions
No action may be initiated under this section -
(A) with respect to any act described in subsection (a) of
this section that occurred before May 13, 1992, or
(B) more than 6 years after the date when facts material to
the act are known or reasonably should have been known by the
Secretary but in no event more than 10 years after the date the
act took place.
(c) Judicial review
Any person that is the subject of an adverse decision under
subsection (b)(1)(A) of this section may obtain a review of such
decision by the United States Court of Appeals for the District of
Columbia or for the circuit in which the person resides, by filing
in such court (within 60 days following the date the person is
notified of the Secretary's decision) a petition requesting that
the decision be modified or set aside.
(d) Recovery of penalties
The Attorney General may recover any civil penalty (plus interest
at the currently prevailing rates from the date the penalty became
final) assessed under subsection (b)(1)(A) of this section in an
action brought in the name of the United States. The amount of such
penalty may be deducted, when the penalty has become final, from
any sums then or later owing by the United States to the person
against whom the penalty has been assessed. In an action brought
under this subsection, the validity, amount, and appropriateness of
the penalty shall not be subject to judicial review.
(e) Informants
The Secretary may award to any individual (other than an officer
or employee of the Federal Government or a person who materially
participated in any conduct described in subsection (a) of this
section) who provides information leading to the imposition of a
civil penalty under this section an amount not to exceed -
(1) $250,000, or
(2) one-half of the penalty so imposed and collected,
whichever is less. The decision of the Secretary on such award
shall not be reviewable.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec.
3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g),
Aug. 13, 1993, 107 Stat. 776.)
-MISC1-
PRIOR PROVISIONS
A prior section 307 of act June 25, 1938, was renumbered section
310 and is classified to section 337 of this title.
AMENDMENTS
1993 - Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment
to reference to May 13, 1992, to reflect correction of
corresponding provision of original act.
CONSTRUCTION
This section 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.
-End-
-CITE-
21 USC Sec. 335c 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335c. Authority to withdraw approval of abbreviated drug
applications
-STATUTE-
(a) In general
The Secretary -
(1) shall withdraw approval of an abbreviated drug application
if the Secretary finds that the approval was obtained, expedited,
or otherwise facilitated through bribery, payment of an illegal
gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug application if
the Secretary finds that the applicant has repeatedly
demonstrated a lack of ability to produce the drug for which the
application was submitted in accordance with the formulations or
manufacturing practice set forth in the abbreviated drug
application and has introduced, or attempted to introduce, such
adulterated or misbranded drug into commerce.
(b) Procedure
The Secretary may not take any action under subsection (a) of
this section with respect to any person unless the Secretary has
issued an order for such action made on the record after
opportunity for an agency hearing on disputed issues of material
fact. In the course of any investigation or hearing under this
subsection, the Secretary may administer oaths and affirmations,
examine witnesses, receive evidence, and issue subpoenas requiring
the attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
(c) Applicability
Subsection (a) of this section shall apply with respect to
offenses or acts regardless of when such offenses or acts occurred.
(d) Judicial review
Any person that is the subject of an adverse decision under
subsection (a) of this section may obtain a review of such decision
by the United States Court of Appeals for the District of Columbia
or for the circuit in which the person resides, by filing in such
court (within 60 days following the date the person is notified of
the Secretary's decision) a petition requesting that the decision
be modified or set aside.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec.
4, May 13, 1992, 106 Stat. 160.)
-MISC1-
CONSTRUCTION
This section 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.
-End-
-CITE-
21 USC Sec. 336 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 336. Report of minor violations
-STATUTE-
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 or warning.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 309, formerly Sec. 306, 52 Stat.
1045; renumbered Sec. 309, Pub. L. 102-282, Sec. 2, May 13, 1992,
106 Stat. 150.)
-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. 337 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 337. Proceedings in name of United States; provision as to
subpoenas
-STATUTE-
(a) Except as provided in subsection (b) of this section, all
such proceedings for the enforcement, or to restrain violations, of
this chapter shall be by and in the name of the United States.
Subpoenas for witnesses who are required to attend a court of the
United States, in any district, may run into any other district in
any proceeding under this section.
(b)(1) A State may bring in its own name and within its
jurisdiction proceedings for the civil enforcement, or to restrain
violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f),
343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if
the food that is the subject of the proceedings is located in the
State.
(2) No proceeding may be commenced by a State under paragraph (1)
-
(A) before 30 days after the State has given notice to the
Secretary that the State intends to bring such proceeding,
(B) before 90 days after the State has given notice to the
Secretary of such intent if the Secretary has, within such 30
days, commenced an informal or formal enforcement action
pertaining to the food which would be the subject of such
proceeding, or
(C) if the Secretary is diligently prosecuting a proceeding in
court pertaining to such food, has settled such proceeding, or
has settled the informal or formal enforcement action pertaining
to such food.
In any court proceeding described in subparagraph (C), a State may
intervene as a matter of right.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 310, formerly Sec. 307, 52 Stat.
1046; Sept. 3, 1954, ch. 1263, Sec. 37, 68 Stat. 1239; Pub. L. 101-
535, Sec. 4, Nov. 8, 1990, 104 Stat. 2362; renumbered Sec. 310,
Pub. L. 102-282, Sec. 2, May 13, 1992, 106 Stat. 150.)
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-535 substituted "(a) Except as provided in
subsection (b) of this section, all" for "All" and "any proceeding
under this section" for "any such proceeding" and added subsec.
(b).
1954 - Act Sept. 3, 1954, struck out reference to section 654 of
title 28.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,
1990, except that such amendment effective Dec. 31, 1993, with
respect to dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances, see section 10(a)(1)(C) of
Pub. L. 101-535, set out as a note under section 343 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and 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.
-End-
-CITE-
21 USC SUBCHAPTER IV - FOOD 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
SUBCHAPTER IV - FOOD
-End-
-CITE-
21 USC Sec. 341 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 341. Definitions and standards for food
-STATUTE-
Whenever in the judgment of the Secretary such action will
promote honesty and fair dealing in the interest of consumers, he
shall promulgate regulations fixing and establishing for any food,
under its common or usual name so far as practicable, a reasonable
definition and standard of identity, a reasonable standard of
quality, or reasonable standards of fill of container. No
definition and standard of identity and no standard of quality
shall be established for fresh or dried fruits, fresh or dried
vegetables, or butter, except that definitions and standards of
identity may be established for avocadoes, cantaloupes, citrus
fruits, and melons. In prescribing any standard of fill of
container, the Secretary shall give due consideration to the
natural shrinkage in storage and in transit of fresh natural food
and to need for the necessary packing and protective material. In
the prescribing of any standard of quality for any canned fruit or
canned vegetable, consideration shall be given and due allowance
made for the differing characteristics of the several varieties of
such fruit or vegetable. In prescribing a definition and standard
of identity for any food or class of food in which optional
ingredients are permitted, the Secretary shall, for the purpose of
promoting honesty and fair dealing in the interest of consumers,
designate the optional ingredients which shall be named on the
label. Any definition and standard of identity prescribed by the
Secretary for avocadoes, cantaloupes, citrus fruits, or melons
shall relate only to maturity and to the effects of freezing.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954,
ch. 143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70
Stat. 919; Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat.
776.)
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 substituted "or reasonable standards of
fill of container. No definition" for "and/or reasonable standards
of fill of container: Provided, That no definition".
1956 - Act Aug. 1, 1956, designated provisions constituting
subsec. (a) as entire section and repealed subsec. (b) which
provided the procedure for establishment of regulations and is
covered by section 371(e) of this title.
1954 - Act Apr. 15, 1954, designated existing provisions as
subsec. (a) and added subsec. (b).
SAVINGS PROVISION
Section 3 of act Aug. 1, 1956, provided that: "In any case in
which, prior to the enactment of this Act [Aug. 1, 1956], a public
hearing has been begun in accordance with section 401 of the
Federal Food, Drug, and Cosmetic Act [341 of this title] upon a
proposal to issue, amend, or repeal any regulation contemplated by
such section, or has been begun in accordance with section 701(e)
of such Act [section 371(e) of this title] upon a proposal to
issue, amend, or repeal any regulation contemplated by section
403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604
of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d),
352(h), 354, or 364 of this title], the provisions of such section
401 or 701(e), as the case may be, as in force immediately prior to
the date of the enactment of this Act [Aug. 1, 1956], shall be
applicable as though this Act [amending this section and section
371(e) of this title] had not been enacted."
-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-
FOOD SAFETY AND SECURITY STRATEGY
Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat.
662, provided that:
"(a) In General. - The President's Council on Food Safety (as
established by Executive Order No. 13100 [set out below]) shall, in
consultation with the Secretary of Transportation, the Secretary of
the Treasury, other relevant Federal agencies, the food industry,
consumer and producer groups, scientific organizations, and the
States, develop a crisis communications and education strategy with
respect to bioterrorist threats to the food supply. Such strategy
shall address threat assessments; technologies and procedures for
securing food processing and manufacturing facilities and modes of
transportation; response and notification procedures; and risk
communications to the public.
"(b) Authorization of Appropriations. - For the purpose of
implementing the strategy developed under subsection (a), there are
authorized to be appropriated $750,000 for fiscal year 2002, and
such sums as may be necessary for each subsequent fiscal year."
FOOD SAFETY COMMISSION
Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat.
527, provided that:
"(a) Establishment. -
"(1) In general. - There is established a commission to be
known as the 'Food Safety Commission' (referred to in this
section as the 'Commission').
"(2) Membership. -
"(A) Composition. - The Commission shall be composed of 15
members (including a Chairperson, appointed by the
President[)].
"(B) Eligibility. -
"(i) In general. - Members of the Commission -
"(I) shall have specialized training or significant experience
in matters under the jurisdiction of the Commission; and
"(II) shall represent, at a minimum -
"(aa) consumers;
"(bb) food scientists;
"(cc) the food industry; and
"(dd) health professionals.
"(ii) Federal employees. - Not more than 3 members of the
Commission may be Federal employees.
"(C) Date of appointments. - The appointment of the members
of the Commission shall be made as soon as practicable after
the date on which funds authorized to be appropriated under
subsection (e)(1) are made available.
"(D) Vacancies. - A vacancy on the Commission -
"(i) shall not affect the powers of the Commission; and
"(ii) shall be filled -
"(I) not later than 60 days after the date on which the
vacancy occurs; and
"(II) in the same manner as the original appointment was made.
"(3) Meetings. -
"(A) Initial meeting. - The initial meeting of the Commission
shall be conducted not later than 30 days after the date of
appointment of the final member of the Commission.
"(B) Other meetings. - The Commission shall meet at the call
of the Chairperson.
"(4) Quorum; standing rules. -
"(A) Quorum. - A majority of the members of the Commission
shall constitute a quorum to conduct business.
"(B) Standing rules. - At the first meeting of the
Commission, the Commission shall adopt standing rules of the
Commission to guide the conduct of business and decisionmaking
of the Commission.
"(b) Duties. -
"(1) Recommendations. - The Commission shall make specific
recommendations to enhance the food safety system of the United
States, including a description of how each recommendation would
improve food safety.
"(2) Components. - Recommendations made by the Commission under
paragraph (1) shall address all food available commercially in
the United States.
"(3) Report. - Not later than 1 year after the date on which
the Commission first meets, the Commission shall submit to the
President and Congress -
"(A) the findings, conclusions, and recommendations of the
Commission, including a description of how each recommendation
would improve food safety;
"(B) a summary of any other material used by the Commission
in the preparation of the report under this paragraph; and
"(C) if requested by 1 or more members of the Commission, a
statement of the minority views of the Commission.
"(c) Powers of the Commission. -
"(1) Hearings. - The Commission may, for the purpose of
carrying out this section, hold such hearings, meet and act at
such times and places, take such testimony, and receive such
evidence as the Commission considers advisable.
"(2) Information from federal agencies. -
"(A) In general. - The Commission may secure directly, from
any Federal agency, such information as the Commission
considers necessary to carry out this section.
"(B) Provision of information. -
"(i) In general. - Subject to subparagraph (C), on the
request of the Commission, the head of a Federal agency
described in subparagraph (A) may furnish information
requested by the Commission to the Commission.
"(ii) Administration. - The furnishing of information by a
Federal agency to the Commission shall not be considered a
waiver of any exemption available to the agency under section
552 of title 5, United States Code.
"(C) Information to be kept confidential. -
"(i) In general. - For purposes of section 1905 of title
18, United States Code -
"(I) the Commission shall be considered an agency of the
Federal Government; and
"(II) any individual employed by an individual, entity, or
organization that is a party to a contract with the
Commission under this section shall be considered an employee
of the Commission.
"(ii) Prohibition on disclosure. - Information obtained by
the Commission, other than information that is available to
the public, shall not be disclosed to any person in any
manner except to an employee of the Commission as described
in clause (i), for the purpose of receiving, reviewing, or
processing the information.
"(d) Commission Personnel Matters. -
"(1) Members. -
"(A) Compensation. - A member of the Commission shall serve
without compensation for the services of the member on the
Commission.
"(B) Travel expenses. - A member of the Commission shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for an employee of an agency
under subchapter I of chapter 57 of title 5, United States
Code, while away from the home or regular place of business of
the member in the performance of the duties of the Commission.
"(2) Staff. -
"(A) In general. - The Chairperson of the Commission may,
without regard to the civil service laws (including
regulations), appoint and terminate the appointment of an
executive director and such other additional personnel as are
necessary to enable the Commission to perform the duties of the
Commission.
"(B) Confirmation of executive director. - The employment of
an executive director shall be subject to confirmation by the
Commission.
"(C) Compensation. -
"(i) In general. - Except as provided in clause (ii), the
Chairperson of the Commission may fix the compensation of the
executive director and other personnel without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of
title 5, United States Code, relating to classification of
positions and General Schedule pay rates.
"(ii) Maximum rate of pay. - The rate of pay for the
executive director and other personnel shall not exceed the
rate payable for level II of the Executive Schedule under
section 5316 of title 5, United States Code.
"(3) Detail of federal government employees. -
"(A) In general. - An employee of the Federal Government may
be detailed to the Commission, without reimbursement, for such
period of time as is permitted by law.
"(B) Civil service status. - The detail of the employee shall
be without interruption or loss of civil service status or
privilege.
"(4) Procurement of temporary and intermittent services. - The
Chairperson of the Commission may procure temporary and
intermittent services in accordance with section 3109(b) of title
5, United States Code, at rates for individuals that do not
exceed the daily equivalent of the annual rate of basic pay
prescribed for level II of the Executive Schedule under section
5316 of that title.
"(e) Authorization of Appropriations. -
"(1) In general. - There is authorized to be appropriated such
sums as are necessary to carry out this section.
"(2) Limitation. - No payment may be made under subsection (d)
except to the extent provided for in advance in an appropriations
Act.
"(f) Termination. - The Commission shall terminate on the date
that is 60 days after the date on which the Commission submits the
recommendations and report under subsection (b)(3)."
-EXEC-
EX. ORD. NO. 13100. PRESIDENT'S COUNCIL ON FOOD SAFETY
Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by
Ex. Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623,
provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, and in order to
improve the safety of the food supply through science-based
regulation and well-coordinated inspection, enforcement, research,
and education programs, it is hereby ordered as follows:
Section 1. Establishment of President's Council on Food Safety.
(a) There is established the President's Council on Food Safety
("Council"). The Council shall comprise the Secretaries of
Agriculture, Commerce, Health and Human Services, and Homeland
Security, the Director of the Office of Management and Budget
(OMB), the Administrator of the Environmental Protection Agency,
the Assistant to the President for Science and Technology/Director
of the Office of Science and Technology Policy, the Assistant to
the President for Domestic Policy, and the Director of the National
Partnership for Reinventing Government. The Council shall consult
with other Federal agencies and State, local, and tribal government
agencies, and consumer, producer, scientific, and industry groups,
as appropriate.
(b) The Secretaries of Agriculture and of Health and Human
Services and the Assistant to the President for Science and
Technology/Director of the Office of Science and Technology Policy
shall serve as Joint Chairs of the Council.
Sec. 2. Purpose. The purpose of the Council shall be to develop a
comprehensive strategic plan for Federal food safety activities,
taking into consideration the findings and recommendations of the
National Academy of Sciences report "Ensuring Safe Food from
Production to Consumption" and other input from the public on how
to improve the effectiveness of the current food safety system. The
Council shall make recommendations to the President on how to
advance Federal efforts to implement a comprehensive science-based
strategy to improve the safety of the food supply and to enhance
coordination among Federal agencies, State, local, and tribal
governments, and the private sector. The Council shall advise
Federal agencies in setting priority areas for investment in food
safety.
Sec. 3. Specific Activities and Functions. (a) The Council shall
develop a comprehensive strategic Federal food safety plan that
contains specific recommendations on needed changes, including
measurable outcome goals. The principal goal of the plan should be
the establishment of a seamless, science-based food safety system.
The plan should address the steps necessary to achieve this goal,
including the key public health, resource, and management issues
regarding food safety. The planning process should consider both
short-term and long-term issues including new and emerging threats
and the special needs of vulnerable populations such as children
and the elderly. In developing this plan, the Council shall consult
with all interested parties, including State and local agencies,
tribes, consumers, producers, industry, and academia.
(b) Consistent with the comprehensive strategic Federal food
safety plan described in section 3(a) of this order, the Council
shall advise agencies of priority areas for investment in food
safety and ensure that Federal agencies annually develop
coordinated food safety budgets for submission to the OMB that
sustain and strengthen existing capacities, eliminate duplication,
and ensure the most effective use of resources for improving food
safety. The Council shall also ensure that Federal agencies
annually develop a unified budget for submission to the OMB for the
President's Food Safety Initiative and such other food safety
issues as the Council determines appropriate.
(c) The Council shall ensure that the Joint Institute for Food
Safety Research (JIFSR), in consultation with the National Science
and Technology Council, establishes mechanisms to guide Federal
research efforts toward the highest priority food safety needs. The
JIFSR shall report to the Council on a regular basis on its
efforts: (i) to develop a strategic plan for conducting food safety
research activities consistent with the President's Food Safety
Initiative and such other food safety activities as the JIFSR
determines appropriate; and (ii) to coordinate efficiently, within
the executive branch and with the private sector and academia, all
Federal food safety research.
Sec. 4. Cooperation. All actions taken by the Council shall, as
appropriate, promote partnerships and cooperation with States,
tribes, and other public and private sector efforts wherever
possible to improve the safety of the food supply.
Sec. 5. General Provisions. This order is intended only to
improve the internal management of the executive branch and is not
intended to, nor does it, create any right or benefit, substantive
or procedural, enforceable at law by a party against the United
States, its agencies, its officers or any person. Nothing in this
order shall affect or alter the statutory responsibilities of any
Federal agency charged with food safety responsibilities.
-End-
-CITE-
21 USC Sec. 342 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 342. Adulterated food
-STATUTE-
A food shall be deemed to be adulterated -
(a) Poisonous, insanitary, etc., ingredients
(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 food shall not be
considered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to
health.(!1) (2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a
pesticide chemical residue in or on a raw agricultural commodity or
processed food, a food additive, a color additive, or a new animal
drug) that is unsafe within the meaning of section 346 of this
title; or (B) if it bears or contains a pesticide chemical residue
that is unsafe within the meaning of section 346a(a) of this title;
or (C) if it is or if it bears or contains (i) any food additive
that is unsafe within the meaning of section 348 of this title; or
(ii) a new animal drug (or conversion product thereof) that is
unsafe within the meaning of section 360b of this title; or (3) if
it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food; or (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; or (5) if it
is, in whole or in part, the product of a diseased animal or of an
animal which has died otherwise than by slaughter; or (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; or (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.
(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or
inferiority has been concealed in any manner; or (4) 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.
(c) Color additives
If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 379e(a) of this title.
(d) Confectionery containing alcohol or nonnutritive substance
If it is confectionery, and -
(1) has partially or completely imbedded therein any
nonnutritive object, except that this subparagraph shall not
apply in the case of any nonnutritive object if, in the judgment
of the Secretary as provided by regulations, such object is of
practical functional value to the confectionery product and would
not render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in
excess of one-half of 1 per centum by volume derived solely from
the use of flavoring extracts, except that this clause shall not
apply to confectionery which is introduced or delivered for
introduction into, or received or held for sale in, interstate
commerce if the sale of such confectionery is permitted under the
laws of the State in which such confectionery is intended to be
offered for sale;
(3) bears or contains any nonnutritive substance, except that
this subparagraph shall not apply to a safe nonnutritive
substance which is in or on confectionery by reason of its use
for some practical functional purpose in the manufacture,
packaging, or storage of such confectionery if the use of the
substance does not promote deception of the consumer or otherwise
result in adulteration or misbranding in violation of any
provision of this chapter, except that the Secretary may, for the
purpose of avoiding or resolving uncertainty as to the
application of this subparagraph, issue regulations allowing or
prohibiting the use of particular nonnutritive substances.
(e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw
material used therein consisted in whole or in part of any filthy,
putrid, or decomposed substance, or such oleomargarine or margarine
or butter is otherwise unfit for food.
(f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary
ingredient that -
(A) presents a significant or unreasonable risk of illness or
injury under -
(i) conditions of use recommended or suggested in labeling,
or
(ii) if no conditions of use are suggested or recommended in
the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate
information to provide reasonable assurance that such ingredient
does not present a significant or unreasonable risk of illness or
injury;
(C) the Secretary declares to pose an imminent hazard to public
health or safety, except that the authority to make such
declaration shall not be delegated and the Secretary shall
promptly after such a declaration initiate a proceeding in
accordance with sections 554 and 556 of title 5 to affirm or
withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary
supplement.
In any proceeding under this subparagraph, the United States shall
bear the burden of proof on each element to show that a dietary
supplement is adulterated. The court shall decide any issue under
this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a
violation of paragraph (!2) (1)(A) for a civil proceeding, the
person against whom such proceeding would be initiated shall be
given appropriate notice and the opportunity to present views,
orally and in writing, at least 10 days before such notice, with
regard to such proceeding.
(g) Dietary supplement: manufacturing practices
(1) If it is a dietary supplement and it has been prepared,
packed, or held under conditions that do not meet current good
manufacturing practice regulations, including regulations
requiring, when necessary, expiration date labeling, issued by the
Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing
practices for dietary supplements. Such regulations shall be
modeled after current good manufacturing practice regulations for
food and may not impose standards for which there is no current and
generally available analytical methodology. No standard of current
good manufacturing practice may be imposed unless such standard is
included in a regulation promulgated after notice and opportunity
for comment in accordance with chapter 5 of title 5.
(h) Reoffer of food previously denied admission
If it is an article of food imported or offered for import into
the United States and the article of food has previously been
refused admission under section 381(a) of this title, unless the
person reoffering the article affirmatively establishes, at the
expense of the owner or consignee of the article, that the article
complies with the applicable requirements of this chapter, as
determined by the Secretary.
(i) Noncompliance with sanitary transportation practices
If it is transported or offered for transport by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other
person engaged in the transportation of food under conditions that
are not in compliance with regulations promulgated under section
350e of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,
ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68
Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,
Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.
17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Secs. 102(a)(1),
(2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477,
June 29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13,
1968, 82 Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100
Stat. 35; Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106
Stat. 4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat.
776; Pub. L. 103-417, Secs. 4, 9, Oct. 25, 1994, 108 Stat. 4328,
4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat.
1514; Pub. L. 107-188, title III, Sec. 309, June 12, 2002, 116
Stat. 673; Pub. L. 109-59, title VII, Sec. 7202(a), Aug. 10, 2005,
119 Stat. 1911.)
-MISC1-
AMENDMENTS
2005 - Par. (i). Pub. L. 109-59 added par. (i).
2002 - Par. (h). Pub. L. 107-188 added par. (h).
1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
former subpar. (2) which read as follows: "(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; (iii) a color
additive; or (iv) a new animal drug) which is unsafe within the
meaning of section 346 of this title, or (B) if it is a raw
agricultural commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning of section 346a(a) of
this title, or (C) if it is, or if it bears or contains, any food
additive which is unsafe within the meaning of section 348 of this
title: Provided, That where a pesticide chemical has been used in
or on a raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 346a of this title
and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or
milling, the residue of such pesticide chemical remaining in or on
such processed food shall, notwithstanding the provisions of
sections 346 and 348 of this title, not be deemed unsafe if such
residue in or on the raw agricultural commodity has been removed to
the extent possible in good manufacturing practice and the
concentration of such residue in the processed food when ready to
eat is not greater than the tolerance prescribed for the raw
agricultural commodity, or (D) if it is, or it bears or contains, a
new animal drug (or conversion product thereof) which is unsafe
within the meaning of section 360b of this title;". That part of
Pub. L. 104-170 which directed the substitution of "or (3) if it
consists" for "(3) if it consists" was executed by making the
substitution for "(3) If it consists" to reflect the probable
intent of Congress.
1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a
period for "; or" at end of subpar. (1) and "If it" for "if it" at
beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1),
which directed the substitution of a period for "; or" at end of
subpar. (2) could not be executed because "; or" did not appear.
Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ", except
that this subparagraph" for ": Provided, That this clause".
Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ", except
that this subparagraph shall not apply" for ": Provided, That this
clause shall not apply" and ", except that the Secretary may, for
the purpose of avoiding or resolving uncertainty as to the
application of this subparagraph" for ": And provided further, That
the Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this clause".
1992 - Par. (c). Pub. L. 102-571 substituted "379e(a)" for
"376(a)".
1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this
clause not apply to confectionery introduced or delivered for
introduction into or received or held for sale in, interstate
commerce if the sale is permitted under the laws of the State in
which the confectionery is intended to be offered for sale.
1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of
nonnutritive objects in confectionery foods if in the judgment of
the Secretary of Health, Education, and Welfare, as provided by
regulation, the imbedding of the object is of practical functional
value to the confectionery product and would not render it
injurious or hazardous to health, raised to one-half of 1 per
centum by volume the upper limit for the allowable use of alcohol
derived solely from the use of flavoring extracts, allowed the use
of safe nonnutritive substances in and on confectionery foods by
reason of their use for some practical and functional purpose in
the manufacture, packaging, or storage of the confectionery foods
if the use of the substances does not promote deception of the
consumer or otherwise result in adulteration or misbranding,
authorized the Secretary to issue regulations on the use of
particular nonnutritive substances, and removed reference to
nonnutritive masticatory substances added to chewing gum and
harmless flavoring, harmless resinous glaze not in excess of four-
tenths of 1 per centum, natural gum, authorized coloring, and
pectin.
1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted
"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" for "(except a pesticide chemical in or on a raw
agricultural commodity and except a food additive)" in cl. (2)(A).
Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
generally, substituting provisions deeming a food adulterated if it
is, or it bears or contains, a color additive which is unsafe
within the meaning of section 376 of this title for provisions
which related to food that 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 346 of this title, and struck
out provisos which related to the use of color on oranges.
Par. (d). Pub. L. 86-618, Sec. 105(c), substituted "authorized
coloring" for "harmless coloring".
1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May
1, 1959, the period during which subsection is inapplicable to
oranges which have been colored with F.D. & C. Red 32, and inserted
proviso requiring Secretary to establish regulations prescribing
the conditions under which Citrus Red No. 2 may be safely used in
coloring certain mature oranges, and providing for separately
listing and for certification of batches of such color.
1958 - Par. (a). Pub. L. 85-929, among other changes, inserted
cl. (2)(C) relating to food additive unsafe within the meaning of
section 348 of this title, and to pesticide chemical, and added cl.
(7) relating to radiated food.
1956 - Par. (c). Act July 9, 1956, inserted second proviso
relating to coloring of oranges.
1954 - Par. (a)(2). Act July 22, 1954, provided in the case of
any raw agricultural commodity bearing or containing a pesticide
chemical, that such commodity shall be deemed to be adulterated if
such pesticide chemical is unsafe within the meaning of section
346a of this title.
1950 - Par. (e). Act Mar. 16, 1950, added par. (e).
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 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 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 OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
DESICCANT AMENDMENT OF 1959
Effective date of par. (a)(2) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural
commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
139, Aug. 7, 1959, 73 Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
Stat. 1002, provided that:
"(a) Except as provided in subsections (b) and (c) of this
section, this Act [amending this section, sections 321, 331, 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 451 of this title] shall take effect on the date
of its enactment [Sept. 6, 1958].
"(b) Except as provided in subsection (c) of this section,
section 3 of this Act [amending this section and section 346 of
this title] shall take effect on the one hundred and eightieth day
after the date of enactment of this Act [Sept. 6, 1958].
"(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1,
1958, section 3 of this Act [amending this section and section 346
of this title] shall take effect -
"(1) Either (A) one year after the effective date established
in subsection (b) of this section, or (B) at the end of such
additional period (but not later than two years from such
effective date established in subsection (b)) as the Secretary of
Health, Education, and Welfare [now Health and Human Services]
may prescribe on the basis of a finding that such extension
involves no undue risk to the public health and that conditions
exist which necessitate the prescribing of such an additional
period, or
"(2) on the date on which an order with respect to such use
under section 409 of the Federal Food, Drug, and Cosmetic Act
[section 348 of this title] becomes effective,
whichever date first occurs. Whenever the Secretary has, pursuant
to clause (1)(B) of this subsection, extended the effective date of
section 3 of this Act [amending this section] to March 5, 1961, or
has on that date a request for such extension pending before him,
with respect to any such particular use of a food additive, he may,
notwithstanding the parenthetical time limitation in that clause,
further extend such effective date, not beyond June 30, 1964, under
the authority of that clause (but subject to clause (2)) with
respect to such use of the additive (or a more limited specified
use or uses thereof) if, in addition to making the findings
required by clause (1)(B), he finds (i) that bona fide action to
determine the applicability of such section 409 [section 348 of
this title] to such use or uses, or to develop the scientific data
necessary for action under such section, was commenced by an
interested person before March 6, 1960, and was thereafter pursued
with reasonable diligence, and (ii) that in the Secretary's
judgment such extension is consistent with the objective of
carrying to completion in good faith, as soon as reasonably
practicable, the scientific investigations necessary as a basis for
action under such section 409 [section 348 of this title]:
Provided, That if the Secretary has, pursuant to this sentence,
granted an extension to June 30, 1964, he may, upon making the
findings required by clause (1)(B) of this subsection and clauses
(i) and (ii) of this sentence, further extend such effective date,
but not beyond December 31, 1965. The Secretary may at any time
terminate an extension so granted if he finds that it should not
have been granted, or that by reason of a change in circumstances
the basis for such extension 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
extension."
EFFECTIVE DATE OF 1954 AMENDMENT
Section 5 of act July 22, 1954, provided that: "This Act
[amending this section and section 321 of this title and enacting
sections 346a and 346b of this title] shall take effect upon the
date of its enactment [July 22, 1954], except that with respect to
pesticide chemicals for which tolerances or exemptions have not
been established under section 408 of the Federal Food, Drug, and
Cosmetic Act [section 346a of this title], the amendment to section
402(a) of such Act [par. (a) of this section] made by section 2 of
this Act shall not be effective -
"(1) for the period of one year following the date of the
enactment of this Act [July 22, 1954]; or
"(2) for such additional period following such period of one
year, but not extending beyond two years after the date of the
enactment of this Act [July 22, 1954] as the Secretary of Health,
Education, and Welfare [now Health and Human Services] may
prescribe on the basis of a finding that conditions exist which
necessitate the prescribing of such additional period."
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950, see
section 7 of act Mar. 16, 1950, set out as an Effective Date note
under section 347 of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (c) 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.
SHORT TITLE
Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
"That this Act [amending provisions set out as a note under this
section and section 135 of Title 7, Agriculture] may be cited as
the 'Food Additives Transitional Provisions Amendment of 1964'."
-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-
DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS
OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY
PURCHASE PROGRAMS
Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.
1601, provided that: "Hereafter, notwithstanding any other
provision of law, any domestic fish or fish product produced in
compliance with food safety standards or procedures accepted by the
Food and Drug Administration as satisfying the requirements of the
'Procedures for the Safe and Sanitary Processing and Importing of
Fish and Fish Products' (published by the Food and Drug
Administration as a final regulation in the Federal Register of
December 18, 1995), shall be deemed to have met any inspection
requirements of the Department of Agriculture or other Federal
agency for any Federal commodity purchase program, including the
program authorized under section 32 of the Act of August 24, 1935
(7 U.S.C. 612c) except that the Department of Agriculture or other
Federal agency may utilize lot inspection to establish a reasonable
degree of certainty that fish or fish products purchased under a
Federal commodity purchase program, including the program
authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.
612c), meet Federal product specifications."
-FOOTNOTE-
(!1) So in original. The period probably should be "; or".
(!2) So in original. Probably should be "subparagraph".
-End-
-CITE-
21 USC Sec. 343 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343. Misbranded food
-STATUTE-
A food shall be deemed to be misbranded -
(a) False or misleading label
If (1) its labeling is false or misleading in any particular, or
(2) in the case of a food to which section 350 of this title
applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 350(b)(2) of
this title.
(b) Offer for sale under another name
If it is offered for sale under the name of another food.
(c) Imitation of another food
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.
(d) Misleading container
If its container is so made, formed, or filled as to be
misleading.
(e) Package form
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, except
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.
(f) 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.
(g) Representation as to definition and standard of identity
If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by
regulations as provided by section 341 of this title, unless (1) it
conforms to such definition and standard, and (2) 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.
(h) Representation as to standards of quality and fill of container
If it purports to be or is represented as -
(1) a food for which a standard of quality has been prescribed
by regulations as provided by section 341 of this title, and its
quality falls below such standard, unless its label bears, in
such manner and form as such regulations specify, a statement
that it falls below such standard;
(2) a food for which a standard or standards of fill of
container have been prescribed by regulations as provided by
section 341 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; or
(3) a food that is pasteurized unless -
(A) such food has been subjected to a safe process or
treatment that is prescribed as pasteurization for such food in
a regulation promulgated under this chapter; or
(B)(i) such food has been subjected to a safe process or
treatment that -
(I) is reasonably certain to achieve destruction or
elimination in the food of the most resistant microorganisms
of public health significance that are likely to occur in the
food;
(II) is at least as protective of the public health as a
process or treatment described in subparagraph (A);
(III) is effective for a period that is at least as long as
the shelf life of the food when stored under normal and
moderate abuse conditions; and
(IV) is the subject of a notification to the Secretary,
including effectiveness data regarding the process or
treatment; and
(ii) at least 120 days have passed after the date of receipt
of such notification by the Secretary without the Secretary
making a determination that the process or treatment involved
has not been shown to meet the requirements of subclauses (I)
through (III) of clause (i).
For purposes of paragraph (3), a determination by the Secretary
that a process or treatment has not been shown to meet the
requirements of subclauses (I) through (III) of subparagraph (B)(i)
shall constitute final agency action under such subclauses.
(i) Label where no representation as to definition and standard of
identity
Unless its label bears (1) the common or usual name of the food,
if any there be, and (2) in case it is fabricated from two or more
ingredients, the common or usual name of each such ingredient and
if the food purports to be a beverage containing vegetable or fruit
juice, a statement with appropriate prominence on the information
panel of the total percentage of such fruit or vegetable juice
contained in the food; except that spices, flavorings, and colors
not required to be certified under section 379e(c) of this title
(!1) unless sold as spices, flavorings, or such colors, may be
designated as spices, flavorings, and colorings without naming
each. To the extent that compliance with the requirements of clause
(2) of this paragraph is impracticable, or results in deception or
unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) Representation for special dietary use
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 determines
to be, and by regulations prescribes as, necessary in order fully
to inform purchasers as to its value for such uses.
(k) Artificial flavoring, artificial coloring, or chemical
preservatives
If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling
stating that fact, except that to the extent that compliance with
the requirements of this paragraph is impracticable, exemptions
shall be established by regulations promulgated by the Secretary.
The provisions of this paragraph and paragraphs (g) and (i) with
respect to artificial coloring shall not apply in the case of
butter, cheese, or ice cream. The provisions of this paragraph with
respect to chemical preservatives shall not apply to a pesticide
chemical when used in or on a raw agricultural commodity which is
the produce of the soil.
(l) Pesticide chemicals on raw agricultural commodities
If it is a raw agricultural commodity which is the produce of the
soil, bearing or containing a pesticide chemical applied after
harvest, unless the shipping container of such commodity bears
labeling which declares the presence of such chemical in or on such
commodity and the common or usual name and the function of such
chemical, except that no such declaration shall be required while
such commodity, having been removed from the shipping container, is
being held or displayed for sale at retail out of such container in
accordance with the custom of the trade.
(m) Color additives
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.
(n) Packaging or labeling of drugs in violation of regulations
If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
(o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
Dec. 21, 2000, 114 Stat. 2763, 2763A-73
(p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
(q) Nutrition information
(1) Except as provided in subparagraphs (3), (4), and (5), if it
is a food intended for human consumption and is offered for sale,
unless its label or labeling bears nutrition information that
provides -
(A)(i) the serving size which is an amount customarily consumed
and which is expressed in a common household measure that is
appropriate to the food, or
(ii) if the use of the food is not typically expressed in a
serving size, the common household unit of measure that expresses
the serving size of the food,
(B) the number of servings or other units of measure per
container,
(C) the total number of calories -
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, saturated
fat, cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein contained
in each serving size or other unit of measure,
(E) any vitamin, mineral, or other nutrient required to be
placed on the label and labeling of food under this chapter
before October 1, 1990, if the Secretary determines that such
information will assist consumers in maintaining healthy dietary
practices.
The Secretary may by regulation require any information required to
be placed on the label or labeling by this subparagraph or
subparagraph (2)(A) to be highlighted on the label or labeling by
larger type, bold type, or contrasting color if the Secretary
determines that such highlighting will assist consumers in
maintaining healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than a
nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
be included in the label or labeling of food subject to
subparagraph (1) for purposes of providing information regarding
the nutritional value of such food that will assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation require that information relating to such additional
nutrient be included in the label or labeling of such food.
(B) If the Secretary determines that the information relating to
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
clause (A) of this subparagraph to be included in the label or
labeling of food is not necessary to assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation remove information relating to such nutrient from such
requirement.
(3) For food that is received in bulk containers at a retail
establishment, the Secretary may, by regulation, provide that the
nutrition information required by subparagraphs (1) and (2) be
displayed at the location in the retail establishment at which the
food is offered for sale.
(4)(A) The Secretary shall provide for furnishing the nutrition
information required by subparagraphs (1) and (2) with respect to
raw agricultural commodities and raw fish by issuing voluntary
nutrition guidelines, as provided by clause (B) or by issuing
regulations that are mandatory as provided by clause (D).
(B)(i) Upon the expiration of 12 months after November 8, 1990,
the Secretary, after providing an opportunity for comment, shall
issue guidelines for food retailers offering raw agricultural
commodities or raw fish to provide nutrition information specified
in subparagraphs (1) and (2). Such guidelines shall take into
account the actions taken by food retailers during such 12-month
period to provide to consumers nutrition information on raw
agricultural commodities and raw fish. Such guidelines shall only
apply -
(I) in the case of raw agricultural commodities, to the 20
varieties of vegetables most frequently consumed during a year
and the 20 varieties of fruit most frequently consumed during a
year, and
(II) to the 20 varieties of raw fish most frequently consumed
during a year.
The vegetables, fruits, and raw fish to which such guidelines apply
shall be determined by the Secretary by regulation and the
Secretary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after November 8, 1990, the
Secretary shall issue a final regulation defining the circumstances
that constitute substantial compliance by food retailers with the
guidelines issued under subclause (i). The regulation shall provide
that there is not substantial compliance if a significant number of
retailers have failed to comply with the guidelines. The size of
the retailers and the portion of the market served by retailers in
compliance with the guidelines shall be considered in determining
whether the substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after November 8, 1990,
the Secretary shall issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw
agricultural commodities and raw fish under the guidelines issued
under clause (A). Such report shall include a determination of
whether there is substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance
with the guidelines, the Secretary shall issue a report and make a
determination of the type required in subclause (i) every two
years.
(D)(i) If the Secretary determines that there is not substantial
compliance with the guidelines issued under clause (A), the
Secretary shall at the time such determination is made issue
proposed regulations requiring that any person who offers raw
agricultural commodities or raw fish to consumers provide, in a
manner prescribed by regulations, the nutrition information
required by subparagraphs (1) and (2). The Secretary shall issue
final regulations imposing such requirements 6 months after issuing
the proposed regulations. The final regulations shall become
effective 6 months after the date of their promulgation.
(ii) Regulations issued under subclause (i) may require that the
nutrition information required by subparagraphs (1) and (2) be
provided for more than 20 varieties of vegetables, 20 varieties of
fruit, and 20 varieties of fish most frequently consumed during a
year if the Secretary finds that a larger number of such products
are frequently consumed. Such regulations shall permit such
information to be provided in a single location in each area in
which raw agricultural commodities and raw fish are offered for
sale. Such regulations may provide that information shall be
expressed as an average or range per serving of the same type of
raw agricultural commodity or raw fish. The Secretary shall develop
and make available to the persons who offer such food to consumers
the information required by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the
required information to be provided in each area of an
establishment in which raw agricultural commodities and raw fish
are offered for sale. The regulations shall permit food retailers
to display the required information by supplying copies of the
information provided by the Secretary, by making the information
available in brochure, notebook or leaflet form, or by posting a
sign disclosing the information. Such regulations shall also permit
presentation of the required information to be supplemented by a
video, live demonstration, or other media which the Secretary
approves.
(E) For purposes of this subparagraph, the term "fish" includes
freshwater or marine fin fish, crustaceans, and mollusks, including
shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw fish
to consumers may be prosecuted for minor violations of this
subparagraph if there has been substantial compliance with the
requirements of this paragraph.
(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
food -
(i) which is served in restaurants or other establishments in
which food is served for immediate human consumption or which is
sold for sale or use in such establishments,
(ii) which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which is of
the type described in subclause (i), and which is offered for
sale to consumers but not for immediate human consumption in such
establishment and which is not offered for sale outside such
establishment,
(iii) which is an infant formula subject to section 350a of
this title,
(iv) which is a medical food as defined in section 360ee(b) of
this title, or
(v) which is described in section 345(2) of this title.
(B) Subparagraphs (1) and (2) shall not apply to the label of a
food if the Secretary determines by regulations that compliance
with such subparagraphs is impracticable because the package of
such food is too small to comply with the requirements of such
subparagraphs and if the label of such food does not contain any
nutrition information.
(C) If a food contains insignificant amounts, as determined by
the Secretary, of all the nutrients required by subparagraphs (1)
and (2) to be listed in the label or labeling of food, the
requirements of such subparagraphs shall not apply to such food if
the label, labeling, or advertising of such food does not make any
claim with respect to the nutritional value of such food. If a food
contains insignificant amounts, as determined by the Secretary, of
more than one-half the nutrients required by subparagraphs (1) and
(2) to be in the label or labeling of the food, the Secretary shall
require the amounts of such nutrients to be stated in a simplified
form prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales
made or business done in sales to consumers which is not more than
$500,000 or has annual gross sales made or business done in sales
of food to consumers which is not more than $50,000, the
requirements of subparagraphs (1), (2), (3), and (4) shall not
apply with respect to food sold by such person to consumers unless
the label or labeling of food offered by such person provides
nutrition information or makes a nutrition claim.
(E)(i) During the 12-month period for which an exemption from
subparagraphs (1) and (2) is claimed pursuant to this subclause,
the requirements of such subparagraphs shall not apply to any food
product if -
(I) the labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r),
(II) the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 100 full-
time equivalent employees,
(III) such person provided the notice described in subclause
(iii), and
(IV) in the case of a food product which was sold in the 12-
month period preceding the period for which an exemption was
claimed, fewer than 100,000 units of such product were sold in
the United States during such preceding period, or in the case of
a food product which was not sold in the 12-month period
preceding the period for which such exemption is claimed, fewer
than 100,000 units of such product are reasonably anticipated to
be sold in the United States during the period for which such
exemption is claimed.
(ii) During the 12-month period after the applicable date
referred to in this sentence, the requirements of subparagraphs (1)
and (2) shall not apply to any food product which was first
introduced into interstate commerce before May 8, 1994, if the
labeling for such product does not provide nutrition information or
make a claim subject to paragraph (r), if such person provided the
notice described in subclause (iii), and if -
(I) during the 12-month period preceding May 8, 1994, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 600,000 units of such product
were sold in the United States,
(II) during the 12-month period preceding May 8, 1995, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 400,000 units of such product
were sold in the United States, or
(III) during the 12-month period preceding May 8, 1996, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 200 full-time
equivalent employees and fewer than 200,000 units of such product
were sold in the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall be
given to the Secretary prior to the beginning of the period during
which the exemption under subclause (i) or (ii) is to be in effect,
shall state that the person claiming such exemption for a food
product has complied with the applicable requirements of subclause
(i) or (ii), and shall -
(I) state the average number of full-time equivalent employees
such person employed during the 12 months preceding the date such
person claims such exemption,
(II) state the approximate number of units the person claiming
the exemption sold in the United States,
(III) if the exemption is claimed for a food product which was
sold in the 12-month period preceding the period for which the
exemption was claimed, state the approximate number of units of
such product which were sold in the United States during such
preceding period, and, if the exemption is claimed for a food
product which was not sold in such preceding period, state the
number of units of such product which such person reasonably
anticipates will be sold in the United States during the period
for which the exemption was claimed, and
(IV) contain such information as the Secretary may require to
verify the information required by the preceding provisions of
this subclause if the Secretary has questioned the validity of
such information.
If a person is not an importer, has fewer than 10 full-time
equivalent employees, and sells fewer than 10,000 units of any food
product in any year, such person is not required to file a notice
for such product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption, the
number of full-time equivalent employees of such person exceeds the
number in such subclause or if the number of food products sold in
the United States exceeds the number in such subclause, such
exemption shall extend to the expiration of 18 months after the
date the number of full-time equivalent employees or food products
sold exceeded the applicable number.
(v) For any food product first introduced into interstate
commerce after May 8, 2002, the Secretary may by regulation lower
the employee or units of food products requirement of subclause (i)
if the Secretary determines that the cost of compliance with such
lower requirement will not place an undue burden on persons subject
to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -
(I) the term "unit" means the packaging or, if there is no
packaging, the form in which a food product is offered for sale
to consumers,
(II) the term "food product" means food in any sized package
which is manufactured by a single manufacturer or which bears the
same brand name, which bears the same statement of identity, and
which has similar preparation methods, and
(III) the term "person" in the case of a corporation includes
all domestic and foreign affiliates of the corporation.
(F) A dietary supplement product (including a food to which
section 350 of this title applies) shall comply with the
requirements of subparagraphs (1) and (2) in a manner which is
appropriate for the product and which is specified in regulations
of the Secretary which shall provide that -
(i) nutrition information shall first list those dietary
ingredients that are present in the product in a significant
amount and for which a recommendation for daily consumption has
been established by the Secretary, except that a dietary
ingredient shall not be required to be listed if it is not
present in a significant amount, and shall list any other dietary
ingredient present and identified as having no such
recommendation;
(ii) the listing of dietary ingredients shall include the
quantity of each such ingredient (or of a proprietary blend of
such ingredients) per serving;
(iii) the listing of dietary ingredients may include the source
of a dietary ingredient; and
(iv) the nutrition information shall immediately precede the
ingredient information required under subclause (i), except that
no ingredient identified pursuant to subclause (i) shall be
required to be identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
which is sold by a food distributor if the food distributor
principally sells food to restaurants or other establishments in
which food is served for immediate human consumption and does not
manufacture, process, or repackage the food it sells.
(r) Nutrition levels and health-related claims
(1) Except as provided in clauses (A) through (C) of subparagraph
(5), if it is a food intended for human consumption which is
offered for sale and for which a claim is made in the label or
labeling of the food which expressly or by implication -
(A) characterizes the level of any nutrient which is of the
type required by paragraph (q)(1) or (q)(2) to be in the label or
labeling of the food unless the claim is made in accordance with
subparagraph (2), or
(B) characterizes the relationship of any nutrient which is of
the type required by paragraph (q)(1) or (q)(2) to be in the
label or labeling of the food to a disease or a health-related
condition unless the claim is made in accordance with
subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as
part of the nutrition information required or permitted by such
paragraph is not a claim which is subject to this paragraph and a
claim subject to clause (A) is not subject to clause (B).
(2)(A) Except as provided in subparagraphs (4)(A)(ii) and
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
claim described in subparagraph (1)(A) -
(i) may be made only if the characterization of the level made
in the claim uses terms which are defined in regulations of the
Secretary,
(ii) may not state the absence of a nutrient unless -
(I) the nutrient is usually present in the food or in a food
which substitutes for the food as defined by the Secretary by
regulation, or
(II) the Secretary by regulation permits such a statement on
the basis of a finding that such a statement would assist
consumers in maintaining healthy dietary practices and the
statement discloses that the nutrient is not usually present in
the food,
(iii) may not be made with respect to the level of cholesterol
in the food if the food contains, as determined by the Secretary
by regulation, fat or saturated fat in an amount which increases
to persons in the general population the risk of disease or a
health related condition which is diet related unless -
(I) the Secretary finds by regulation that the level of
cholesterol is substantially less than the level usually
present in the food or in a food which substitutes for the food
and which has a significant market share, or the Secretary by
regulation permits a statement regarding the absence of
cholesterol on the basis of a finding that cholesterol is not
usually present in the food and that such a statement would
assist consumers in maintaining healthy dietary practices and
the regulation requires that the statement disclose that
cholesterol is not usually present in the food, and
(II) the label or labeling of the food discloses the level of
such fat or saturated fat in immediate proximity to such claim
and with appropriate prominence which shall be no less than one-
half the size of the claim with respect to the level of
cholesterol,
(iv) may not be made with respect to the level of saturated fat
in the food if the food contains cholesterol unless the label or
labeling of the food discloses the level of cholesterol in the
food in immediate proximity to such claim and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of saturated fat,
(v) may not state that a food is high in dietary fiber unless
the food is low in total fat as defined by the Secretary or the
label or labeling discloses the level of total fat in the food in
immediate proximity to such statement and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation prohibits
the claim because the claim is misleading in light of the level
of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a
determination that the food contains a nutrient at a level that
increases to persons in the general population the risk of a
disease or health-related condition that is diet related, the label
or labeling of such food shall contain, prominently and in
immediate proximity to such claim, the following statement: "See
nutrition information for ___ content." The blank shall identify
the nutrient associated with the increased disease or health-
related condition risk. In making the determination described in
this clause, the Secretary shall take into account the significance
of the food in the total daily diet.
(C) Subparagraph (2)(A) does not apply to a claim described in
subparagraph (1)(A) and contained in the label or labeling of a
food if such claim is contained in the brand name of such food and
such brand name was in use on such food before October 25, 1989,
unless the brand name contains a term defined by the Secretary
under subparagraph (2)(A)(i). Such a claim is subject to paragraph
(a).
(D) Subparagraph (2) does not apply to a claim described in
subparagraph (1)(A) which uses the term "diet" and is contained in
the label or labeling of a soft drink if (i) such claim is
contained in the brand name of such soft drink, (ii) such brand
name was in use on such soft drink before October 25, 1989, and
(iii) the use of the term "diet" was in conformity with section
105.66 of title 21 of the Code of Federal Regulations. Such a claim
is subject to paragraph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not
apply to a statement in the label or labeling of food which
describes the percentage of vitamins and minerals in the food in
relation to the amount of such vitamins and minerals recommended
for daily consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage
level of a dietary ingredient for which the Secretary has not
established a reference daily intake, daily recommended value, or
other recommendation for daily consumption.
(G) A claim of the type described in subparagraph (1)(A) for a
nutrient, for which the Secretary has not promulgated a regulation
under clause (A)(i), shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, which identifies the nutrient level to which
the claim refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the nutrient level to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clauses (A) and (B), and are otherwise in
compliance with paragraph (a) and section 321(n) of this title;
and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(H) A claim submitted under the requirements of clause (G) may be
made until -
(i) such time as the Secretary issues a regulation -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (G) have not
been met, including finding that the petitioner had not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (G) have not been met.
(3)(A) Except as provided in subparagraph (5), a claim described
in subparagraph (1)(B) may only be made -
(i) if the claim meets the requirements of the regulations of
the Secretary promulgated under clause (B), and
(ii) if the food for which the claim is made does not contain,
as determined by the Secretary by regulation, any nutrient in an
amount which increases to persons in the general population the
risk of a disease or health-related condition which is diet
related, taking into account the significance of the food in the
total daily diet, except that the Secretary may by regulation
permit such a claim based on a finding that such a claim would
assist consumers in maintaining healthy dietary practices and
based on a requirement that the label contain a disclosure of the
type required by subparagraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing
claims of the type described in subparagraph (1)(B) only if the
Secretary determines, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant
scientific agreement, among experts qualified by scientific
training and experience to evaluate such claims, that the claim is
supported by such evidence.
(ii) A regulation described in subclause (i) shall describe -
(I) the relationship between a nutrient of the type required in
the label or labeling of food by paragraph (q)(1) or (q)(2) and a
disease or health-related condition, and
(II) the significance of each such nutrient in affecting such
disease or health-related condition.
(iii) A regulation described in subclause (i) shall require such
claim to be stated in a manner so that the claim is an accurate
representation of the matters set out in subclause (ii) and so that
the claim enables the public to comprehend the information provided
in the claim and to understand the relative significance of such
information in the context of a total daily diet.
(C) Notwithstanding the provisions of clauses (A)(i) and (B), a
claim of the type described in subparagraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in
accordance with clause (B) shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, about the relationship between a nutrient
and a disease or health-related condition to which the claim
refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the relationship between a nutrient and a disease or health-
related condition to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clause (A)(ii) and are otherwise in compliance
with paragraph (a) and section 321(n) of this title; and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(D) A claim submitted under the requirements of clause (C) may be
made until -
(i) such time as the Secretary issues a regulation under the
standard in clause (B)(i) -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (C) have not
been met, including finding that the petitioner has not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (C) have not been met.
(4)(A)(i) Any person may petition the Secretary to issue a
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
claim described in subparagraph (1)(A) or (1)(B). Not later than
100 days after the petition is received by the Secretary, the
Secretary shall issue a final decision denying the petition or file
the petition for further action by the Secretary. If the Secretary
does not act within such 100 days, the petition shall be deemed to
be denied unless an extension is mutually agreed upon by the
Secretary and the petitioner. If the Secretary denies the petition
or the petition is deemed to be denied, the petition shall not be
made available to the public. If the Secretary files the petition,
the Secretary shall deny the petition or issue a proposed
regulation to take the action requested in the petition not later
than 90 days after the date of such decision. If the Secretary does
not act within such 90 days, the petition shall be deemed to be
denied unless an extension is mutually agreed upon by the Secretary
and the petitioner. If the Secretary issues a proposed regulation,
the rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary. If the Secretary does not
issue a regulation within such 540 days, the Secretary shall
provide the Committee on Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate the
reasons action on the regulation did not occur within such 540
days.
(ii) Any person may petition the Secretary for permission to use
in a claim described in subparagraph (1)(A) terms that are
consistent with the terms defined by the Secretary under
subparagraph (2)(A)(i). Within 90 days of the submission of such a
petition, the Secretary shall issue a final decision denying the
petition or granting such permission.
(iii) Any person may petition the Secretary for permission to use
an implied claim described in subparagraph (1)(A) in a brand name.
After publishing notice of an opportunity to comment on the
petition in the Federal Register and making the petition available
to the public, the Secretary shall grant the petition if the
Secretary finds that such claim is not misleading and is consistent
with terms defined by the Secretary under subparagraph (2)(A)(i).
The Secretary shall grant or deny the petition within 100 days of
the date it is submitted to the Secretary and the petition shall be
considered granted if the Secretary does not act on it within such
100 days.
(B) A petition under clause (A)(i) respecting a claim described
in subparagraph (1)(A) or (1)(B) shall include an explanation of
the reasons why the claim meets the requirements of this paragraph
and a summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B)
relies on a report from an authoritative scientific body of the
United States, the Secretary shall consider such report and shall
justify any decision rejecting the conclusions of such report.
(5)(A) This paragraph does not apply to infant formulas subject
to section 350a(h) of this title and medical foods as defined in
section 360ee(b) of this title.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and
subparagraph (2)(B) do not apply to food which is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in
such establishments.
(C) A subparagraph (1)(A) claim made with respect to a food which
claim is required by a standard of identity issued under section
341 of this title shall not be subject to subparagraph (2)(A)(i) or
(2)(B).
(D) A subparagraph (1)(B) claim made with respect to a dietary
supplement of vitamins, minerals, herbs, or other similar
nutritional substances shall not be subject to subparagraph (3) but
shall be subject to a procedure and standard, respecting the
validity of such claim, established by regulation of the Secretary.
(6) For purposes of paragraph (r)(1)(B), a statement for a
dietary supplement may be made if -
(A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of such
disease in the United States, describes the role of a nutrient or
dietary ingredient intended to affect the structure or function
in humans, characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such structure or
function, or describes general well-being from consumption of a
nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
(C) the statement contains, prominently displayed and in
boldface type, the following: "This statement has not been
evaluated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of
diseases. If the manufacturer of a dietary supplement proposes to
make a statement described in the first sentence of this
subparagraph in the labeling of the dietary supplement, the
manufacturer shall notify the Secretary no later than 30 days after
the first marketing of the dietary supplement with such statement
that such a statement is being made.
(7) The Secretary may make proposed regulations issued under this
paragraph effective upon publication pending consideration of
public comment and publication of a final regulation if the
Secretary determines that such action is necessary -
(A) to enable the Secretary to review and act promptly on
petitions the Secretary determines provide for information
necessary to -
(i) enable consumers to develop and maintain healthy dietary
practices;
(ii) enable consumers to be informed promptly and effectively
of important new knowledge regarding nutritional and health
benefits of food; or
(iii) ensure that scientifically sound nutritional and health
information is provided to consumers as soon as possible; or
(B) to enable the Secretary to act promptly to ban or modify a
claim under this paragraph.
Such proposed regulations shall be deemed final agency action for
purposes of judicial review.
(s) Dietary supplements
If -
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list -
(i) the name of each ingredient of the supplement that is
described in section 321(ff) of this title; and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredients,
the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to
identify the product by using the term "dietary supplement",
which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section
321(ff)(1)(C) of this title, and the label or labeling of the
supplement fails to identify any part of the plant from which the
ingredient is derived;
(D) the supplement -
(i) is covered by the specifications of an official
compendium;
(ii) is represented as conforming to the specifications of an
official compendium; and
(iii) fails to so conform; or
(E) the supplement -
(i) is not covered by the specifications of an official
compendium; and
(ii)(I) fails to have the identity and strength that the
supplement is represented to have; or
(II) fails to meet the quality (including tablet or capsule
disintegration), purity, or compositional specifications, based
on validated assay or other appropriate methods, that the
supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings.
(t) Catfish
If it purports to be or is represented as catfish, unless it is
fish classified within the family Ictaluridae.
(u) Ginseng
If it purports to be or is represented as ginseng, unless it is
an herb or herbal ingredient derived from a plant classified within
the genus Panax.
(v) Failure to label; health threat
If -
(1) it fails to bear a label required by the Secretary under
section 381(n)(1) of this title (relating to food refused
admission into the United States);
(2) the Secretary finds that the food presents a threat of
serious adverse health consequences or death to humans or
animals; and
(3) upon or after notifying the owner or consignee involved
that the label is required under section 381 of this title, the
Secretary informs the owner or consignee that the food presents
such a threat.
(w) Major food allergen labeling requirements
(1) If it is not a raw agricultural commodity and it is, or it
contains an ingredient that bears or contains, a major food
allergen, unless either -
(A) the word "Contains", followed by the name of the food
source from which the major food allergen is derived, is printed
immediately after or is adjacent to the list of ingredients (in a
type size no smaller than the type size used in the list of
ingredients) required under subsections (g) and (i) of this
section; or
(B) the common or usual name of the major food allergen in the
list of ingredients required under subsections (g) and (i) of
this section is followed in parentheses by the name of the food
source from which the major food allergen is derived, except that
the name of the food source is not required when -
(i) the common or usual name of the ingredient uses the name
of the food source from which the major food allergen is
derived; or
(ii) the name of the food source from which the major food
allergen is derived appears elsewhere in the ingredient list,
unless the name of the food source that appears elsewhere in
the ingredient list appears as part of the name of a food
ingredient that is not a major food allergen under section
321(qq)(2)(A) or (B) of this title.
(2) As used in this subsection, the term "name of the food source
from which the major food allergen is derived" means the name
described in section 321(qq)(1) of this title; provided that in the
case of a tree nut, fish, or Crustacean shellfish, the term "name
of the food source from which the major food allergen is derived"
means the name of the specific type of nut or species of fish or
Crustacean shellfish.
(3) The information required under this subsection may appear in
labeling in lieu of appearing on the label only if the Secretary
finds that such other labeling is sufficient to protect the public
health. A finding by the Secretary under this paragraph (including
any change in an earlier finding under this paragraph) is effective
upon publication in the Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k) of this section,
or any other law, a flavoring, coloring, or incidental additive
that is, or that bears or contains, a major food allergen shall be
subject to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements of
subparagraph (A) or (B) of paragraph (1), or eliminate either the
requirement of subparagraph (A) or the requirements of subparagraph
(B) of paragraph (1), if the Secretary determines that the
modification or elimination of the requirement of subparagraph (A)
or the requirements of subparagraph (B) is necessary to protect the
public health.
(6)(A) Any person may petition the Secretary to exempt a food
ingredient described in section 321(qq)(2) of this title from the
allergen labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within 180
days of receipt of the petition or the petition shall be deemed
denied, unless an extension of time is mutually agreed upon by the
Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide scientific
evidence (including the analytical method used to produce the
evidence) that demonstrates that such food ingredient, as derived
by the method specified in the petition, does not cause an allergic
response that poses a risk to human health.
(D) A determination regarding a petition under this paragraph
shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all
petitions received under this paragraph within 14 days of receipt
and the Secretary shall promptly post the Secretary's response to
each.
(7)(A) A person need not file a petition under paragraph (6) to
exempt a food ingredient described in section 321(qq)(2) of this
title from the allergen labeling requirements of this subsection,
if the person files with the Secretary a notification containing -
(i) scientific evidence (including the analytical method used)
that demonstrates that the food ingredient (as derived by the
method specified in the notification, where applicable) does not
contain allergenic protein; or
(ii) a determination by the Secretary that the ingredient does
not cause an allergic response that poses a risk to human health
under a premarket approval or notification program under section
348 of this title.
(B) The food ingredient may be introduced or delivered for
introduction into interstate commerce as a food ingredient that is
not a major food allergen 90 days after the date of receipt of the
notification by the Secretary, unless the Secretary determines
within the 90-day period that the notification does not meet the
requirements of this paragraph, or there is insufficient scientific
evidence to determine that the food ingredient does not contain
allergenic protein or does not cause an allergenic response that
poses a risk to human health.
(C) The Secretary shall promptly post to a public site all
notifications received under this subparagraph within 14 days of
receipt and promptly post any objections thereto by the Secretary.
(x) Nonmajor food allergen labeling requirements
Notwithstanding subsection (g), (i), or (k) of this section, or
any other law, a spice, flavoring, coloring, or incidental additive
that is, or that bears or contains, a food allergen (other than a
major food allergen), as determined by the Secretary by regulation,
shall be disclosed in a manner specified by the Secretary by
regulation.
(y) Dietary supplements
If it is a dietary supplement that is marketed in the United
States, unless the label of such dietary supplement includes a
domestic address or domestic phone number through which the
responsible person (as described in section 379aa-1 of this title)
may receive a report of a serious adverse event with such dietary
supplement.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.
102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.
411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.
1452, 1453; Pub. L. 101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104
Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,
1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),
Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 2(b), 3(j),
Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Secs. 6, 7(a)-
(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104-
124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115, title
III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub. L. 106-
554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2),
(b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.
107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672; Pub.
L. 108-282, title II, Sec. 203(a), Aug. 2, 2004, 118 Stat. 906;
Pub. L. 109-462, Sec. 3(c), Dec. 22, 2006, 120 Stat. 3475.)
-MISC1-
AMENDMENTS
2006 - Par. (y). Pub. L. 109-462 added par. (y).
2004 - Pars. (w), (x). Pub. L. 108-282 added pars. (w) and (x).
2002 - Par. (h). Pub. L. 107-171, Sec. 10808(b), added subpar.
(3) and concluding provisions.
Par. (t). Pub. L. 107-171, Sec. 10806(a)(2), added par. (t).
Par. (u). Pub. L. 107-171, Sec. 10806(b)(2), added par. (u).
Par. (v). Pub. L. 107-188 added par. (v).
2000 - Par. (o). Pub. L. 106-554, which directed repeal of
section 403(o) of the Food, Drug, and Cosmetic Act, was executed by
repealing par. (o) of this section, which is section 403 of the
Federal Food, Drug, and Cosmetic Act, to reflect the probable
intent of Congress. Prior to repeal, par. (o) provided that a food
containing saccharin was to be deemed misbranded unless a specified
warning statement was placed in a conspicuous place on its label.
1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
generally. Prior to amendment, cl. (B) read as follows: "If a claim
described in subparagraph (1)(A) is made with respect to a nutrient
in a food, the label or labeling of such food shall contain,
prominently and in immediate proximity to such claim, the following
statement: 'See _____ for nutrition information.'. In the statement
-
"(i) the blank shall identify the panel on which the
information described in the statement may be found, and
"(ii) if the Secretary determines that the food contains a
nutrient at a level which increases to persons in the general
population the risk of a disease or health-related condition
which is diet related, taking into account the significance of
the food in the total daily diet, the statement shall also
identify such nutrient."
Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)
and (H).
Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)
and (D).
Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after
second sentence "If the Secretary does not act within such 100
days, the petition shall be deemed to be denied unless an extension
is mutually agreed upon by the Secretary and the petitioner.",
inserted "or the petition is deemed to be denied" after "If the
Secretary denies the petition", and inserted at end "If the
Secretary does not act within such 90 days, the petition shall be
deemed to be denied unless an extension is mutually agreed upon by
the Secretary and the petitioner. If the Secretary issues a
proposed regulation, the rulemaking shall be completed within 540
days of the date the petition is received by the Secretary. If the
Secretary does not issue a regulation within such 540 days, the
Secretary shall provide the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources of
the Senate the reasons action on the regulation did not occur
within such 540 days."
Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
1996 - Par. (p). Pub. L. 104-124 struck out par. (p), which
deemed products containing saccharin and offered for sale, but not
for immediate consumption, by retail establishment, to be
misbranded, unless notice of information required by subsec. (o)
was provided by manufacturer and prominently displayed near
product.
1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.
(F) generally. Prior to amendment, cl. (F) read as follows: "If a
food to which section 350 of this title applies (as defined in
section 350(c) of this title) contains one or more of the nutrients
required by subparagraph (1) or (2) to be in the label or labeling
of the food, the label or labeling of such food shall comply with
the requirements of subparagraphs (1) and (2) in a manner which is
appropriate for such food and which is specified in regulations of
the Secretary."
Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: "A
dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings."
Pub. L. 103-417, Sec. 7(a), added par. (s).
1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted
"count, except that" for "count: Provided, That".
Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted "unless sold
as spices, flavorings, or such colors" for ", other than those sold
as such" and "naming each. To the extent" for "naming each:
Provided, That, to the extent".
Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ", except
that" for ": Provided, That".
Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted "chemical,
except that" for "chemical: Provided, however, That".
Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)
and redesignated former cls. (E) and (F) as (F) and (G),
respectively.
Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted
"(5)(D)" for "5(D)".
Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
"paragraph" for "subsection".
1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
"379e(c)" for "376(c)".
Par. (m). Pub. L. 102-571, Sec. 107(6), substituted "379e" for
"376".
1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment
note below.
Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted "(D)" for
"(C)".
1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.
102-108, Sec. 2(c), substituted "Unless" for "If it is not subject
to the provisions of paragraph (g) unless", inserted "and if the
food purports to be a beverage containing vegetable or fruit juice,
a statement with appropriate prominence on the information panel of
the total percentage of such fruit or vegetable juice contained in
the food", and substituted "colors not required to be certified
under section 376(c) of this title" for "colorings" the first time
appearing.
Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
1976 - Par. (a). Pub. L. 94-278 inserted "(1)" after "If" and
inserted ", or (2) in the case of a food to which section 350 of
this title applies, its advertising is false or misleading in a
material respect or its labeling is in violation of section
350(b)(2) of this title" after "any particular".
1970 - Par. (n). Pub. L. 91-601 added par. (n).
1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
chemicals when used in or on a raw agricultural commodity which is
the produce of the soil.
Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
Par. (m). Pub. L. 86-618 added par. (m).
-CHANGE-
CHANGE OF NAME
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5, One Hundred
Seventh Congress, Jan. 3, 2001.
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 2006 AMENDMENT
Pub. L. 109-462, Sec. 3(d)(1), (2), Dec. 22, 2006, 120 Stat.
3475, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by this section [enacting section 379aa-1 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 403(y) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall
apply to any dietary supplement labeled on or after the date that
is 1 year after the date of enactment of this Act [Dec. 22, 2006]."
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-282 applicable to any food that is
labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
282, set out as a note under section 321 of this title.
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 7(e) of Pub. L. 103-417 provided that: "Dietary
supplements -
"(1) may be labeled after the date of the enactment of this Act
[Oct. 25, 1994] in accordance with the amendments made by this
section [amending this section and section 350 of this title],
and
"(2) shall be labeled after December 31, 1996, in accordance
with such amendments."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided
that:
"(1) Except as provided in paragraph (2) -
"(A) the amendments made by section 2 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of all final regulations
required to implement section 403(q) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 343(q)], or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347],
except that section 403(q)(4) of such Act shall take effect as
prescribed by such section,
"(B) the amendments made by section 3 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of final regulations to
implement section 403(r) of the Federal Food, Drug, and
Cosmetic Act, or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
person marketing a food the brand name of which contains a term
defined by the Secretary under section 403(r)(2)(A)(i) of the
Federal Food, Drug, and Cosmetic Act shall be given an
additional 6 months to comply with section 3,
"(C) the amendments made by section 4 [amending section 337 of
this title] shall take effect 24 months after the date of the
enactment of this Act [Nov. 8, 1990], except that such amendments
shall take effect with respect to such dietary supplements
[probably means dietary supplements of vitamins, minerals, herbs,
or other similar nutritional substances, see section 202(a)(1) of
Pub. L. 102-571, set out below] on December 31, 1993, and
"(D) the amendments made by section 5 [amending sections 321
and 345 of this title] shall take effect on the date the
amendments made by section 3 take effect.
"(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act
(as added by section 2) shall not apply with respect to food which
was labeled before the effective date of the amendments made by
section 2 and section 403(r) of the Federal Food, Drug, and
Cosmetic Act (as added by section 3) shall not apply with respect
to food which was labeled before the effective date of the
amendments made by section 3.
"(3)(A) If the Secretary finds that a person who is subject to
section 403(q)(4) of such Act is unable to comply with the
requirements of such section upon the effective date of final
regulations to implement section 403(q) of such Act or of proposed
regulations to be considered as such final regulations because the
Secretary has not made available to such person the information
required by such section, the Secretary shall delay the application
of such section to such person for such time as the Secretary may
require to provide such information.
"(B) If the Secretary finds that compliance with section 403(q)
or 403(r)(2) of such Act would cause an undue economic hardship,
the Secretary may delay the application of such sections for no
more than one year."
Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
"(1) Except as provided in paragraphs (2) and (3), the amendments
made by section 7 [amending this section] shall take effect one
year after the date of the enactment of this Act [Nov. 8, 1990].
"(2)(A) If a food subject to section 403(g) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or
more colors required to be certified under section 721(c) [of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a
label which was printed before July 1, 1991, and which is attached
to the food before May 8, 1993, such food shall not be subject to
the amendments made by section 7(1) and section 7(3) [amending this
section].
"(B) If a food described in subparagraph (A) -
"(i) bears a label which was printed after July 1, 1991, but
before the date the proposed regulation described in clause (ii)
takes effect as a final regulation and which was attached to the
food before May 8, 1993, and
"(ii) meets the requirements of the proposed regulation of the
Secretary of Health and Human Services published in 56 Fed. Reg.
28592-28636 (June 21, 1991) as it pertains to the amendments made
by this Act [see Short Title of 1990 Amendment note set out under
section 301 of this title],
such food shall not be subject to the amendments made by section
7(1) and section 7(3) [amending this section].
"(3) A food purported to be a beverage containing a vegetable or
fruit juice which bears a label attached to the food before May 8,
1993, shall not be subject to the amendments made by section 7(2)
[amending this section]."
EFFECTIVE DATE OF 1977 AMENDMENT
Section 4(a)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply only with
respect to food introduced or delivered for introduction in
interstate commerce on and after the 90th day after the date of the
enactment of this Act [Nov. 23, 1977]."
Section 4(b)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply with
respect to food which is sold in retail establishments on or after
the 90th day after the effective date of the regulations of the
Secretary of Health, Education, and Welfare [now Secretary of
Health and Human Services] under paragraph (p)(4) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 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 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
Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
subsections 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.
CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282
Pub. L. 108-282, title II, Sec. 203(b), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 321 and 343-1 of this title] that require
a label or labeling for major food allergens do not alter the
authority of the Secretary of Health and Human Services under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to
require a label or labeling for other food allergens."
CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188
Nothing in amendment by Pub. L. 107-188 to be construed to limit
authority of Secretary of Health and Human Services or Secretary of
the Treasury to require marking of articles of food imported or
offered for import into the United States which are refused
admission, see section 308(c) of Pub. L. 107-188, set out as a note
under section 381 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Section 9 of Pub. L. 101-535 provided that: "The amendments made
by this Act [enacting section 343-1 of this title and amending this
section and sections 321, 337, 345, and 371 of this title] shall
not 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.]."
FINDINGS
Pub. L. 108-282, title II, Sec. 202, Aug. 2, 2004, 118 Stat. 905,
provided that: "Congress finds that -
"(1) it is estimated that -
"(A) approximately 2 percent of adults and about 5 percent of
infants and young children in the United States suffer from
food allergies; and
"(B) each year, roughly 30,000 individuals require emergency
room treatment and 150 individuals die because of allergic
reactions to food;
"(2)(A) eight major foods or food groups - milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -
account for 90 percent of food allergies;
"(B) at present, there is no cure for food allergies; and
"(C) a food allergic consumer must avoid the food to which the
consumer is allergic;
"(3)(A) in a review of the foods of randomly selected
manufacturers of baked goods, ice cream, and candy in Minnesota
and Wisconsin in 1999, the Food and Drug Administration found
that 25 percent of sampled foods failed to list peanuts or eggs
as ingredients on the food labels; and
"(B) nationally, the number of recalls because of unlabeled
allergens rose to 121 in 2000 from about 35 a decade earlier;
"(4) a recent study shows that many parents of children with a
food allergy were unable to correctly identify in each of several
food labels the ingredients derived from major food allergens;
"(5)(A) ingredients in foods must be listed by their 'common or
usual name';
"(B) in some cases, the common or usual name of an ingredient
may be unfamiliar to consumers, and many consumers may not
realize the ingredient is derived from, or contains, a major food
allergen; and
"(C) in other cases, the ingredients may be declared as a
class, including spices, flavorings, and certain colorings, or
are exempt from the ingredient labeling requirements, such as
incidental additives; and
"(6)(A) celiac disease is an immune-mediated disease that
causes damage to the gastrointestinal tract, central nervous
system, and other organs;
"(B) the current recommended treatment is avoidance of glutens
in foods that are associated with celiac disease; and
"(C) a multicenter, multiyear study estimated that the
prevalence of celiac disease in the United States is 0.5 to 1
percent of the general population."
REGULATIONS
Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1) The Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(q) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months
after the date of the enactment of this Act [Nov. 8, 1990], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Not later than 24 months after the date
of the enactment of this Act, the Secretary shall issue final
regulations to implement the requirements of such section, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic] Such regulations shall -
"(A) require the required information to be conveyed to the
public in a manner which enables the public to readily observe
and comprehend such information and to understand its relative
significance in the context of a total daily diet,
"(B) include regulations which establish standards, in
accordance with paragraph (1)(A), to define serving size or other
unit of measure for food,
"(C) permit the label or labeling of food to include nutrition
information which is in addition to the information required by
such section 403(q) and which is of the type described in
subparagraph (1) or (2) of such section, and
"(D) permit the nutrition information on the label or labeling
of a food to remain the same or permit the information to be
stated as a range even though (i) there are minor variations in
the nutritional value of the food which occur in the normal
course of the production or processing of the food, or (ii) the
food is comprised of an assortment of similar foods which have
variations in nutritional value.
"(2) If the Secretary of Health and Human Services does not
promulgate final regulations under paragraph (1) upon the
expiration of 24 months after the date of the enactment of this
Act, the proposed regulations issued in accordance with paragraph
(1) shall be considered as the final regulations upon the
expiration of such 24 months, except that the proposed regulations
applicable to dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances shall not be considered to be
final regulations until December 31, 1993. There shall be promptly
published in the Federal Register notice of new status of the
proposed regulations [see 57 F.R. 56347].
"(3) If the Secretary of Health and Human Services does not
promulgate final regulations under section 403(q)(4) of the Federal
Food, Drug, and Cosmetic Act upon the expiration of 6 months after
the date on which the Secretary makes a finding that there has been
no substantial compliance with section 403(q)(4)(C) of such Act,
the proposed regulations issued in accordance with such section
shall be considered as the final regulations upon the expiration of
such 6 months. There shall be promptly published in the Federal
Register notice of new status of the proposed regulations."
[Section 202(a)(2)(C) of Pub. L. 102-571 provided that: "The
amendments made by subparagraph (B) [amending sections 2(b) and
3(b) of Pub. L. 101-535, set out above and below] shall not be
construed to modify the effective date of final regulations under
sections 2(b) and 3(b) of the Nutrition Labeling and Education Act
of 1990 [Pub. L. 101-535] (21 U.S.C. 343 note) with respect to
foods that are not such dietary supplements."]
Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1)(A) Within 12 months of the date of the enactment of this Act
[Nov. 8, 1990], the Secretary of Health and Human Services shall
issue proposed regulations to implement section 403(r) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Such regulations -
"(i) shall identify claims described in section 403(r)(1)(A) of
such Act which comply with section 403(r)(2) of such Act,
"(ii) shall identify claims described in section 403(r)(1)(B)
of such Act which comply with section 403(r)(3) of such Act,
"(iii) shall, in defining terms used to characterize the level
of any nutrient in food under section 403(r)(2)(A)(i) of such
Act, define -
"(I) free,
"(II) low,
"(III) light or lite,
"(IV) reduced,
"(V) less, and
"(VI) high,
unless the Secretary finds that the use of any such term would be
misleading,
"(iv) shall permit statements describing the amount and
percentage of nutrients in food which are not misleading and are
consistent with the terms defined in section 403(r)(2)(A)(i) of
such Act,
"(v) shall provide that if multiple claims subject to section
403(r)(1)(A) of such Act are made on a single panel of the food
label or page of a labeling brochure, a single statement may be
made to satisfy section 403(r)(2)(B) of such Act,
"(vi) shall determine whether claims respecting the following
nutrients and diseases meet the requirements of section 403(r)(3)
of such Act: Calcium and osteoporosis, dietary fiber and cancer,
lipids and cardiovascular disease, lipids and cancer, sodium and
hypertension, and dietary fiber and cardiovascular disease,
"(vii) shall not require a person who proposes to make a claim
described in section 403(r)(1)(B) of such Act which is in
compliance with such regulations to secure the approval of the
Secretary before making such claim,
"(viii) may permit a claim described in section 403(r)(1)(A) of
such Act to be made for butter,
"(ix) may, in defining terms under section 403(r)(2)(A)(i),
include similar terms which are commonly understood to have the
same meaning, and
"(x) shall establish, as required by section 403(r)(5)(D), the
procedure and standard respecting the validity of claims made
with respect to a dietary supplement of vitamins, minerals,
herbs, or other similar nutritional substances and shall
determine whether claims respecting the following nutrients and
diseases meet the requirements of section 403(r)(5)(D) of such
Act: folic acid and neural tube defects, antioxident [sic]
vitamins and cancer, zinc and immune function in the elderly, and
omega-3 fatty acids and heart disease.
"(B) Not later than 24 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic]
"(2) If the Secretary does not promulgate final regulations under
paragraph (1)(B) upon the expiration of 24 months after the date of
the enactment of this Act, the proposed regulations issued in
accordance with paragraph (1)(A) shall be considered as the final
regulations upon the expiration of such 24 months, except that the
proposed regulations applicable to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances shall not
be considered to be final regulations until December 31, 1993.
There shall be promptly published in the Federal Register notice of
the new status of the proposed regulations [see 57 F.R. 56347]."
[For construction of amendment made by section 202(a)(2)(B) of
Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,
see section 202(a)(2)(C) of Pub. L. 102-571 set out above following
section 2(b) of Pub. L. 101-535.]
-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.
-MISC3-
RULEMAKING ON LABELING
Pub. L. 108-282, title II, Sec. 206, Aug. 2, 2004, 118 Stat. 910,
provided that: "Not later than 2 years after the date of enactment
of this Act [Aug. 2, 2004], the Secretary of Health and Human
Services, in consultation with appropriate experts and
stakeholders, shall issue a proposed rule to define, and permit use
of, the term 'gluten-free' on the labeling of foods. Not later than
4 years after the date of enactment of this Act, the Secretary
shall issue a final rule to define, and permit use of, the term
'gluten-free' on the labeling of foods."
Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.
531, provided that: "The Secretary of Health and Human Services
(referred to in this section as the 'Secretary') shall publish a
proposed rule and, with due consideration to public comment, a
final rule to revise, as appropriate, the current regulation
governing the labeling of foods that have been treated to reduce
pest infestation or pathogens by treatment by irradiation using
radioactive isotope, electronic beam, or x-ray. Pending
promulgation of the final rule required by this subsection
[probably should be "this section"], any person may petition the
Secretary for approval of labeling, which is not false or
misleading in any material respect, of a food which has been
treated by irradiation using radioactive isotope, electronic beam,
or x-ray. The Secretary shall approve or deny such a petition
within 180 days of receipt of the petition, or the petition shall
be deemed denied, except to the extent additional agency review is
mutually agreed upon by the Secretary and the petitioner. Any
denial of a petition under this subsection shall constitute final
agency action subject to judicial review by the United States Court
of Appeals for the District of Columbia Circuit. Any labeling
approved through the foregoing petition process shall be subject to
the provisions of the final rule referred to in the first sentence
of the subparagraph on the effective date of such final rule."
COMMISSION ON DIETARY SUPPLEMENT LABELS
Section 12 of Pub. L. 103-417 provided that:
"(a) Establishment. - There shall be established as an
independent agency within the executive branch a commission to be
known as the Commission on Dietary Supplement Labels (hereafter in
this section referred to as the 'Commission').
"(b) Membership. -
"(1) Composition. - The Commission shall be composed of 7
members who shall be appointed by the President.
"(2) Expertise requirement. - The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of the
members of the Commission shall be qualified by scientific
training and experience to evaluate the benefits to health of the
use of dietary supplements and one of such three members shall
have experience in pharmacognosy, medical botany, traditional
herbal medicine, or other related sciences. Members and staff of
the Commission shall be without bias on the issue of dietary
supplements.
"(c) Functions of the Commission. - The Commission shall conduct
a study on, and provide recommendations for, the regulation of
label claims and statements for dietary supplements, including the
use of literature in connection with the sale of dietary
supplements and procedures for the evaluation of such claims. In
making such recommendations, the Commission shall evaluate how best
to provide truthful, scientifically valid, and not misleading
information to consumers so that such consumers may make informed
and appropriate health care choices for themselves and their
families.
"(d) Administrative Powers of the Commission. -
"(1) Hearings. - The Commission may hold 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) Information from federal agencies. - The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section.
"(3) Authorization of appropriations. - There are authorized to
be appropriated such sums as may be necessary to carry out this
section.
"(e) Reports and Recommendations. -
"(1) Final report required. - Not later than 24 months after
the date of enactment of this Act [Oct. 25, 1994], the Commission
shall prepare and submit to the President and to the Congress a
final report on the study required by this section.
"(2) Recommendations. - The report described in paragraph (1)
shall contain such recommendations, including recommendations for
legislation, as the Commission deems appropriate.
"(3) Action on recommendations. - Within 90 days of the
issuance of the report under paragraph (1), the Secretary of
Health and Human Services shall publish in the Federal Register a
notice of any recommendation of Commission for changes in
regulations of the Secretary for the regulation of dietary
supplements and shall include in such notice a notice of proposed
rulemaking on such changes together with an opportunity to
present views on such changes. Such rulemaking shall be completed
not later than 2 years after the date of the issuance of such
report. If such rulemaking is not completed on or before the
expiration of such 2 years, regulations of the Secretary
published in 59 FR 395-426 on January 4, 1994, shall not be in
effect."
EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED
PRIOR TO AUGUST 8, 1994
Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: "That
before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
provision of section 403(i) of such Act added by section 7(2) of
the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535],
shall not apply with respect to a food product which is contained
in a package for which the label was printed before May 8, 1994 (or
before August 8, 1994, in the case of a juice or milk food product
if the person responsible for the labeling of such food product
exercised due diligence in obtaining before such date labels which
are in compliance with such sections 403(q) and 403(r)(2) and such
provision of section 403(i)), if, before June 15, 1994, the person
who introduces or delivers for introduction such food product into
interstate commerce submits to the Secretary of Health and Human
Services a certification that such person will comply with this
section and will comply with such sections 403(q) and 403(r)(2) and
such provision of section 403(i) after August 8, 1994."
LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION
Section 2(a) of Pub. L. 103-80 provided that:
"(1) Before may 8, 1995. - Before May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in
accordance with the regulations of the Secretary of Health and
Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).
"(2) After may 8, 1995. - After May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act shall only be available with respect to food when it
is sold to consumers."
PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO
DIETARY SUPPLEMENTS
Section 202(a)(1) of Pub. L. 102-571 provided that:
"Notwithstanding any other provision of law and except as provided
in subsection (b) [set out as a note below] and in the amendment
made by paragraph (2)(A) [amending provisions set out as notes
above], the Secretary of Health and Human Services may not
implement the Nutrition Labeling and Education Act of 1990 (Public
Law 101-535; 104 Stat. 2353) [see Short Title of 1990 Amendments
note set out under section 301 of this title], or any amendment
made by such Act, earlier than December 15, 1993, with respect to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances."
HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS
Section 202(b) of Pub. L. 102-571 provided that: "Notwithstanding
section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions
set out as notes above and amending provisions set out as notes
above and under section 343-1 of this title], the Secretary of
Health and Human Services may, earlier than December 15, 1993,
approve claims made with respect to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
that are claims described in clauses (vi) and (x) of section
3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535] (21 U.S.C. 343 note)."
UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS
Section 203 of Pub. L. 102-571 provided that: "Notwithstanding
any other provision of Federal law, no regulations that require the
use of, or are based upon, recommended daily allowances of vitamins
or minerals may be promulgated before November 8, 1993 (other than
regulations establishing the United States recommended daily
allowances specified at section 101.9(c)(7)(iv) of title 21, Code
of Federal Regulations, as in effect on October 6, 1992, or
regulations under section 403(r)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such
recommended daily allowances)."
CONSUMER EDUCATION
Section 2(c) of Pub. L. 101-535 provided that: "The Secretary of
Health and Human Services shall carry out activities which educate
consumers about -
"(1) the availability of nutrition information in the label or
labeling of food, and
"(2) the importance of that information in maintaining healthy
dietary practices."
STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD
AND IMPURITIES IN AND TOXICITY OF SACCHARIN
Section 2 of Pub. L. 95-203 directed Secretary of Health,
Education, and Welfare to conduct a study concerning carcinogenic
and other toxic substances in food and impurities in and toxicity
of saccharin and make a report respecting the carcinogenic and
other substances to Committee on Human Resources of the Senate
within 12 months of Nov. 23, 1977, and a report respecting
saccharin to such committee within 15 months of Nov. 23, 1977.
REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT
TO FORMER PAR. (O)(2)
Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was
to report to specified congressional committees any action taken
under former par. (o)(2) of this section.
STATE OR TERRITORIAL REQUIREMENTS
Section 2 of Pub. L. 86-537 provided that: "Nothing in the
amendments made by the first section of this Act [amending this
section] shall affect any requirement of the laws of any State or
Territory."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 343-1 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-1. National uniform nutrition labeling
-STATUTE-
(a) Except as provided in subsection (b) of this section, no
State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as
to any food in interstate commerce -
(1) any requirement for a food which is the subject of a
standard of identity established under section 341 of this title
that is not identical to such standard of identity or that is not
identical to the requirement of section 343(g) of this title,
except that this paragraph does not apply to a standard of
identity of a State or political subdivision of a State for maple
syrup that is of the type required by sections 341 and 343(g) of
this title,
(2) any requirement for the labeling of food of the type
required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x)
of this title that is not identical to the requirement of such
section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that
is of the type required by section 343(c) of this title and that
is applicable to maple syrup,
(3) any requirement for the labeling of food of the type
required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or
343(k) of this title that is not identical to the requirement of
such section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that
is of the type required by section 343(h)(1) of this title and
that is applicable to maple syrup,
(4) any requirement for nutrition labeling of food that is not
identical to the requirement of section 343(q) of this title,
except a requirement for nutrition labeling of food which is
exempt under subclause (i) or (ii) of section 343(q)(5)(A) of
this title, or
(5) any requirement respecting any claim of the type described
in section 343(r)(1) of this title made in the label or labeling
of food that is not identical to the requirement of section
343(r) of this title, except a requirement respecting a claim
made in the label or labeling of food which is exempt under
section 343(r)(5)(B) of this title.
Paragraph (3) shall take effect in accordance with section 6(b) of
the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a
State, the Secretary may exempt from subsection (a) of this
section, under such conditions as may be prescribed by regulation,
any State or local requirement that -
(1) would not cause any food to be in violation of any
applicable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information
which need is not met by the requirements of the sections
referred to in subsection (a) of this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec.
6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec.
2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a),
Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108-282, title II, Sec.
203(c)(2), Aug. 2, 2004, 118 Stat. 908.)
-REFTEXT-
REFERENCES IN TEXT
Section 6(b) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535], referred to in subsec. (a), is set out below.
-MISC1-
AMENDMENTS
2004 - Subsec. (a)(2). Pub. L. 108-282 substituted "343(i)(2),
343(w), or 343(x)" for "or 343(i)(2)".
1994 - Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at
end "except that this paragraph does not apply to a standard of
identity of a State or political subdivision of a State for maple
syrup that is of the type required by sections 341 and 343(g) of
this title,".
Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end
"except that this paragraph does not apply to a requirement of a
State or political subdivision of a State that is of the type
required by section 343(c) of this title and that is applicable to
maple syrup,".
Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end
"except that this paragraph does not apply to a requirement of a
State or political subdivision of a State that is of the type
required by section 343(h)(1) of this title and that is applicable
to maple syrup,".
1991 - Subsec. (a)(5). Pub. L. 102-108 substituted "section
343(r)(5)(B) of this title" for "clause (B) of such section".
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-282 applicable to any food that is
labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
282, set out as a note under section 321 of this title.
EFFECTIVE DATE
Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106
Stat. 4499, 4501, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by section 6 [enacting this section] shall take
effect -
"(A) with respect to a requirement of a State or political
subdivision described in paragraph (1) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
section], on the date of the enactment of this Act [Nov. 8,
1990],
"(B) with respect to a requirement of a State or political
subdivision described in paragraph (2) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, one year after the date of
the enactment of this Act,
"(C) with respect to a requirement of a State or political
subdivision described in paragraph (3) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, as prescribed by section
6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L.
101-535, set out below],
"(D) with respect to a requirement of a State or political
subdivision described in paragraph (4) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(q) of such Act [21 U.S.C. 343(q)] take
effect, and
"(E) with respect to a requirement of a State or political
subdivision described in paragraph (5) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(r) of such Act take effect.
"(2) Exception. - If a State or political subdivision submits a
petition under section 403A(b) of the Federal Food, Drug, and
Cosmetic Act for a requirement described in section 403A(a) of such
Act within 18 months of the date of the enactment of this Act,
paragraphs (3) through (5) of such section 403A(a) shall not apply
with respect to such State or political subdivision requirement
until -
"(A) 24 months after the date of the enactment of this Act, or
"(B) action on the petition,
whichever occurs later.
"(3) Requirements pertaining to certain claims. - Notwithstanding
subparagraphs (D) and (E) of paragraph (1) and except with respect
to claims approved in accordance with section 202(b) of the Dietary
Supplement Act of 1992 [Pub. L. 102-571, set out as a note under
section 343 of this title], the requirements described in
paragraphs (4) and (5) of section 403A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4) and (5)) that pertain
to dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances shall not take effect until the date
final regulations take effect to implement subsection (q) or (r),
as appropriate, of section 403 of such Act with respect to such
dietary supplements."
Section 6(b) of Pub. L. 101-535 provided that:
"(1) For the purpose of implementing section 403A(a)(3) [21
U.S.C. 343-1(a)(3)], the Secretary of Health and Human Services
shall enter into a contract with a public or nonprofit private
entity to conduct a study of -
"(A) State and local laws which require the labeling of food
that is of the type required by sections 403(b), 403(d), 403(f),
403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
"(B) the sections of the Federal Food, Drug, and Cosmetic Act
referred to in subparagraph (A) and the regulations issued by the
Secretary to enforce such sections to determine whether such
sections and regulations adequately implement the purposes of
such sections.
"(2) The contract under paragraph (1) shall provide that the
study required by such paragraph shall be completed within 6 months
of the date of the enactment of this Act [Nov. 8, 1990].
"(3)(A) Within 9 months of the date of the enactment of this Act,
the Secretary shall publish a proposed list of sections which are
adequately being implemented by regulations as determined under
paragraph (1)(B) and sections which are not adequately being
implemented by regulations as so determined. After publication of
the lists, the Secretary shall provide 60 days for comments on such
lists.
"(B) Within 24 months of the date of the enactment of this Act,
the Secretary shall publish a final list of sections which are
adequately being implemented by regulations and a list of sections
which are not adequately being implemented by regulations. With
respect to a section which is found by the Secretary to be
adequately implemented, no State or political subdivision of a
State may establish or continue in effect as to any food in
interstate commerce any requirement which is not identical to the
requirement of such section.
"(C) Within 24 months of the date of the enactment of this Act,
the Secretary shall publish proposed revisions to the regulations
found to be inadequate under subparagraph (B) and within 30 months
of such date shall issue final revisions. Upon the effective date
of such final revisions, no State or political subdivision may
establish or continue in effect any requirement which is not
identical to the requirement of the section which had its
regulations revised in accordance with this subparagraph.
"(D)(i) If the Secretary does not issue a final list in
accordance with subparagraph (B), the proposed list issued under
subparagraph (A) shall be considered the final list and States and
political subdivisions shall be preempted with respect to sections
found to be adequate in such proposed list in accordance with
subparagraph (B).
"(ii) If the Secretary does not issue final revisions of
regulations in accordance with subparagraph (C), the proposed
revisions issued under such subparagraph shall be considered the
final revisions and States and political subdivisions shall be
preempted with respect to sections the regulations of which are
revised by the proposed revisions.
"(E) Subsection (b) of section 403A of the Federal Food, Drug,
and Cosmetic Act shall apply with respect to the prohibition
prescribed by subparagraphs (B) and (C)."
CONSTRUCTION OF PUB. L. 101-535
Section 6(c) of Pub. L. 101-535 provided that:
"(1) The Nutrition Labeling and Education Act of 1990 [Pub. L.
101-535, see Short Title of 1990 Amendment note set out under
section 301 of this title] shall not be construed to preempt any
provision of State law, unless such provision is expressly
preempted under section 403A of the Federal Food, Drug, and
Cosmetic Act [this section].
"(2) The amendment made by subsection (a) [enacting this section]
and the provisions of subsection (b) [set out as a note above]
shall not be construed to apply to any requirement respecting a
statement in the labeling of food that provides for a warning
concerning the safety of the food or component of the food.
"(3) The amendment made by subsection (a), the provisions of
subsection (b) and paragraphs (1) and (2) of this subsection shall
not be construed to affect preemption, express or implied, of any
such requirement of a State or political subdivision, which may
arise under the Constitution, any provision of the Federal Food,
Drug, and Cosmetic Act [this chapter] not amended by subsection
(a), any other Federal law, or any Federal regulation, order, or
other final agency action reviewable under chapter 7 of title 5,
United States Code."
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.
DELAYED APPLICABILITY OF CERTAIN PROVISIONS
Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat.
2090, provided that: "Notwithstanding any other provision of law,
section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343-1(a)(1)) shall not apply with respect to any requirement
of any State or political subdivision regarding maple syrup until
September 1, 1994."
-End-
-CITE-
21 USC Sec. 343-2 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-2. Dietary supplement labeling exemptions
-STATUTE-
(a) In general
A publication, including an article, a chapter in a book, or an
official abstract of a peer-reviewed scientific publication that
appears in an article and was prepared by the author or the editors
of the publication, which is reprinted in its entirety, shall not
be defined as labeling when used in connection with the sale of a
dietary supplement to consumers when it -
(1) is not false or misleading;
(2) does not promote a particular manufacturer or brand of a
dietary supplement;
(3) is displayed or presented, or is displayed or presented
with other such items on the same subject matter, so as to
present a balanced view of the available scientific information
on a dietary supplement;
(4) if displayed in an establishment, is physically separate
from the dietary supplements; and
(5) does not have appended to it any information by sticker or
any other method.
(b) Application
Subsection (a) of this section shall not apply to or restrict a
retailer or wholesaler of dietary supplements in any way whatsoever
in the sale of books or other publications as a part of the
business of such retailer or wholesaler.
(c) Burden of proof
In any proceeding brought under subsection (a) of this section,
the burden of proof shall be on the United States to establish that
an article or other such matter is false or misleading.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403B, as added Pub. L. 103-417, Sec.
5, Oct. 25, 1994, 108 Stat. 4328.)
-End-
-CITE-
21 USC Sec. 343-3 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-3. Disclosure
-STATUTE-
(a) No provision of section 321(n), 343(a), or 348 of this title
shall be construed to require on the label or labeling of a food a
separate radiation disclosure statement that is more prominent than
the declaration of ingredients required by section 343(i)(2) of
this title.
(b) In this section, the term "radiation disclosure statement"
means a written statement that discloses that a food has been
intentionally subject to radiation.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403C, as added Pub. L. 105-115, title
III, Sec. 306, Nov. 21, 1997, 111 Stat. 2353.)
-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. 343a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343a. Repealed.
-MISC1-
Sec. 343a. Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec.
517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73.
Section, Pub. L. 95-203, Sec. 4(c), (d), Nov. 23, 1977, 91 Stat.
1453, 1454, related to distribution of information on health risks
of saccharin.
-End-
-CITE-
21 USC Sec. 344 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 344. Emergency permit control
-STATUTE-
(a) Conditions on manufacturing, processing, etc., as health
measure
Whenever the Secretary finds after investigation that the
distribution in interstate commerce of any class of food may, by
reason of contamination with micro-organisms during the
manufacture, processing, or packing thereof in any locality, be
injurious to health, and that such injurious nature cannot be
adequately determined after such articles have entered interstate
commerce, he then, and in such case only, shall promulgate
regulations providing for the issuance, to manufacturers,
processors, or packers of such class of food in such locality, of
permits to which shall be attached such conditions governing the
manufacture, processing, or packing of such class of food, for such
temporary period of time, as may be necessary to protect the public
health; and after the effective date of such regulations, and
during such temporary period, no person shall introduce or deliver
for introduction into interstate commerce any such food
manufactured, processed, or packed by any such manufacturer,
processor, or packer unless such manufacturer, processor, or packer
holds a permit issued by the Secretary as provided by such
regulations.
(b) Violation of permit; suspension and reinstatement
The Secretary is authorized to suspend immediately upon notice
any permit issued under authority of this section if it is found
that any of the conditions of the permit have been violated. The
holder of a permit so suspended shall be privileged at any time to
apply for the reinstatement of such permit, and the Secretary
shall, immediately after prompt hearing and an inspection of the
establishment, reinstate such permit if it is found that adequate
measures have been taken to comply with and maintain the conditions
of the permit, as originally issued or as amended.
(c) Inspection of permit-holding establishments
Any officer or employee duly designated by the Secretary shall
have access to any factory or establishment, the operator of which
holds a permit from the Secretary, for the purpose of ascertaining
whether or not the conditions of the permit are being complied
with, and denial of access for such inspection shall be ground for
suspension of the permit until such access is freely given by the
operator.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 404, 52 Stat. 1048.)
-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. 345 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 345. Regulations making exemptions
-STATUTE-
The Secretary shall promulgate regulations exempting from any
labeling requirement of this chapter (1) small open containers of
fresh fruits and fresh vegetables and (2) food which is, 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 food is not adulterated or misbranded under the
provisions of this chapter upon removal from such processing,
labeling, or repacking establishment. This section does not apply
to the labeling requirements of sections 343(q) and 343(r) of this
title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 405, 52 Stat. 1049; Pub. L. 101-535,
Sec. 5(a), Nov. 8, 1990, 104 Stat. 2362.)
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-535 inserted at end "This section does not
apply to the labeling requirements of sections 343(q) and 343(r) of
this title."
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective six months after the date
of the promulgation of final regulations to implement section
343(r) of this title, or if such regulations are not promulgated,
the date proposed regulations are to be considered as such final
regulations (Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined by the
Secretary under section 343(r)(2)(A)(i) of this title, see section
10(a) of Pub. L. 101-535, set out as a note under section 343 of
this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and 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.
-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. 346 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346. Tolerances for poisonous or deleterious substances in
food; regulations
-STATUTE-
Any poisonous or deleterious substance added to any food, except
where such substance is required in the production thereof or
cannot be avoided by good manufacturing practice shall be deemed to
be unsafe for purposes of the application of clause (2)(A) of
section 342(a) of this title; but when such substance is so
required or cannot be so avoided, the Secretary shall promulgate
regulations limiting the quantity therein or thereon to such extent
as he finds necessary for the protection of public health, and any
quantity exceeding the limits so fixed shall also be deemed to be
unsafe for purposes of the application of clause (2)(A) of section
342(a) of this title. While such a regulation is in effect limiting
the quantity of any such substance in the case of any food, such
food shall not, by reason of bearing or containing any added amount
of such substance, be considered to be adulterated within the
meaning of clause (1) of section 342(a) of this title. In
determining the quantity of such added substance to be tolerated in
or on different articles of food the Secretary shall take into
account the extent to which the use of such substance is required
or cannot be avoided in the production of each such article, and
the other ways in which the consumer may be affected by the same or
other poisonous or deleterious substances.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,
Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,
Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)
-MISC1-
AMENDMENTS
1960 - Pub. L. 86-618 repealed subsec. (b) which required
Secretary to promulgate regulations for listing of coal-tar colors.
1958 - Subsec. (a). Pub. L. 85-929 substituted "clause (2)(A)"
for "clause (2)" in first sentence.
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 OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
DESICCANT AMENDMENT OF 1959
Effective date of subsec. (a) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural
commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
139, Aug. 7, 1959, 73 Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
For effective date of amendment by Pub. L. 85-929, see section
6(b), (c) of Pub. L. 85-929, set out as a note under section 342 of
this title.
-TRANS-
TRANSFER OF FUNCTIONS
Functions vested in Secretary of Health, Education, and Welfare
[now Health and Human Services] in establishing tolerances for
pesticide chemicals under this section together with authority to
monitor compliance with tolerances and effectiveness of
surveillance and enforcement and to provide technical assistance to
States and conduct research under this chapter and section 201 et
seq. of Title 42, The Public Health and Welfare, transferred to
Administrator of Environmental Protection Agency by Reorg. Plan No.
3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
2086, set out in the Appendix to Title 5, Government Organization
and Employees.
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 to Federal Security
Agency, see notes set out under section 321 of this title.
-End-
-CITE-
21 USC Sec. 346a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346a. Tolerances and exemptions for pesticide chemical
residues
-STATUTE-
(a) Requirement for tolerance or exemption
(1) General rule
Except as provided in paragraph (2) or (3), any pesticide
chemical residue in or on a food shall be deemed unsafe for the
purpose of section 342(a)(2)(B) of this title unless -
(A) a tolerance for such pesticide chemical residue in or on
such food is in effect under this section and the quantity of
the residue is within the limits of the tolerance; or
(B) an exemption from the requirement of a tolerance is in
effect under this section for the pesticide chemical residue.
For the purposes of this section, the term "food", when used as a
noun without modification, shall mean a raw agricultural
commodity or processed food.
(2) Processed food
Notwithstanding paragraph (1) -
(A) if a tolerance is in effect under this section for a
pesticide chemical residue in or on a raw agricultural
commodity, a pesticide chemical residue that is present in or
on a processed food because the food is made from that raw
agricultural commodity shall not be considered unsafe within
the meaning of section 342(a)(2)(B) of this title despite the
lack of a tolerance for the pesticide chemical residue in or on
the processed food if the pesticide chemical has been used in
or on the raw agricultural commodity in conformity with a
tolerance under this section, such residue in or on the raw
agricultural commodity has been removed to the extent possible
in good manufacturing practice, and the concentration of the
pesticide chemical residue in the processed food is not greater
than the tolerance prescribed for the pesticide chemical
residue in the raw agricultural commodity; or
(B) if an exemption for the requirement for a tolerance is in
effect under this section for a pesticide chemical residue in
or on a raw agricultural commodity, a pesticide chemical
residue that is present in or on a processed food because the
food is made from that raw agricultural commodity shall not be
considered unsafe within the meaning of section 342(a)(2)(B) of
this title.
(3) Residues of degradation products
If a pesticide chemical residue is present in or on a food
because it is a metabolite or other degradation product of a
precursor substance that itself is a pesticide chemical or
pesticide chemical residue, such a residue shall not be
considered to be unsafe within the meaning of section
342(a)(2)(B) of this title despite the lack of a tolerance or
exemption from the need for a tolerance for such residue in or on
such food if -
(A) the Administrator has not determined that the degradation
product is likely to pose any potential health risk from
dietary exposure that is of a different type than, or of a
greater significance than, any risk posed by dietary exposure
to the precursor substance;
(B) either -
(i) a tolerance is in effect under this section for
residues of the precursor substance in or on the food, and
the combined level of residues of the degradation product and
the precursor substance in or on the food is at or below the
stoichiometrically equivalent level that would be permitted
by the tolerance if the residue consisted only of the
precursor substance rather than the degradation product; or
(ii) an exemption from the need for a tolerance is in
effect under this section for residues of the precursor
substance in or on the food; and
(C) the tolerance or exemption for residues of the precursor
substance does not state that it applies only to particular
named substances and does not state that it does not apply to
residues of the degradation product.
(4) Effect of tolerance or exemption
While a tolerance or exemption from the requirement for a
tolerance is in effect under this section for a pesticide
chemical residue with respect to any food, the food shall not by
reason of bearing or containing any amount of such a residue be
considered to be adulterated within the meaning of section
342(a)(1) of this title.
(b) Authority and standard for tolerance
(1) Authority
The Administrator may issue regulations establishing,
modifying, or revoking a tolerance for a pesticide chemical
residue in or on a food -
(A) in response to a petition filed under subsection (d) of
this section; or
(B) on the Administrator's own initiative under subsection
(e) of this section.
As used in this section, the term "modify" shall not mean
expanding the tolerance to cover additional foods.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect a
tolerance for a pesticide chemical residue in or on a food
only if the Administrator determines that the tolerance is
safe. The Administrator shall modify or revoke a tolerance if
the Administrator determines it is not safe.
(ii) Determination of safety
As used in this section, the term "safe", with respect to a
tolerance for a pesticide chemical residue, means that the
Administrator has determined that there is a reasonable
certainty that no harm will result from aggregate exposure to
the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is
reliable information.
(iii) Rule of construction
With respect to a tolerance, a pesticide chemical residue
meeting the standard under clause (i) is not an eligible
pesticide chemical residue for purposes of subparagraph (B).
(B) Tolerances for eligible pesticide chemical residues
(i) Definition
As used in this subparagraph, the term "eligible pesticide
chemical residue" means a pesticide chemical residue as to
which -
(I) the Administrator is not able to identify a level of
exposure to the residue at which the residue will not cause
or contribute to a known or anticipated harm to human
health (referred to in this section as a "nonthreshold
effect");
(II) the lifetime risk of experiencing the nonthreshold
effect is appropriately assessed by quantitative risk
assessment; and
(III) with regard to any known or anticipated harm to
human health for which the Administrator is able to
identify a level at which the residue will not cause such
harm (referred to in this section as a "threshold effect"),
the Administrator determines that the level of aggregate
exposure is safe.
(ii) Determination of tolerance
Notwithstanding subparagraph (A)(i), a tolerance for an
eligible pesticide chemical residue may be left in effect or
modified under this subparagraph if -
(I) at least one of the conditions described in clause
(iii) is met; and
(II) both of the conditions described in clause (iv) are
met.
(iii) Conditions regarding use
For purposes of clause (ii), the conditions described in
this clause with respect to a tolerance for an eligible
pesticide chemical residue are the following:
(I) Use of the pesticide chemical that produces the
residue protects consumers from adverse effects on health
that would pose a greater risk than the dietary risk from
the residue.
(II) Use of the pesticide chemical that produces the
residue is necessary to avoid a significant disruption in
domestic production of an adequate, wholesome, and
economical food supply.
(iv) Conditions regarding risk
For purposes of clause (ii), the conditions described in
this clause with respect to a tolerance for an eligible
pesticide chemical residue are the following:
(I) The yearly risk associated with the nonthreshold
effect from aggregate exposure to the residue does not
exceed 10 times the yearly risk that would be allowed under
subparagraph (A) for such effect.
(II) The tolerance is limited so as to ensure that the
risk over a lifetime associated with the nonthreshold
effect from aggregate exposure to the residue is not
greater than twice the lifetime risk that would be allowed
under subparagraph (A) for such effect.
(v) Review
Five years after the date on which the Administrator makes
a determination to leave in effect or modify a tolerance
under this subparagraph, and thereafter as the Administrator
deems appropriate, the Administrator shall determine, after
notice and opportunity for comment, whether it has been
demonstrated to the Administrator that a condition described
in clause (iii)(I) or clause (iii)(II) continues to exist
with respect to the tolerance and that the yearly and
lifetime risks from aggregate exposure to such residue
continue to comply with the limits specified in clause (iv).
If the Administrator determines by such date that such
demonstration has not been made, the Administrator shall, not
later than 180 days after the date of such determination,
issue a regulation under subsection (e)(1) of this section to
modify or revoke the tolerance.
(vi) Infants and children
Any tolerance under this subparagraph shall meet the
requirements of subparagraph (C).
(C) Exposure of infants and children
In establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue, the
Administrator -
(i) shall assess the risk of the pesticide chemical residue
based on -
(I) available information about consumption patterns
among infants and children that are likely to result in
disproportionately high consumption of foods containing or
bearing such residue among infants and children in
comparison to the general population;
(II) available information concerning the special
susceptibility of infants and children to the pesticide
chemical residues, including neurological differences
between infants and children and adults, and effects of in
utero exposure to pesticide chemicals; and
(III) available information concerning the cumulative
effects on infants and children of such residues and other
substances that have a common mechanism of toxicity; and
(ii) shall -
(I) ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate
exposure to the pesticide chemical residue; and
(II) publish a specific determination regarding the
safety of the pesticide chemical residue for infants and
children.
The Secretary of Health and Human Services and the Secretary of
Agriculture, in consultation with the Administrator, shall
conduct surveys to document dietary exposure to pesticides
among infants and children. In the case of threshold effects,
for purposes of clause (ii)(I) an additional tenfold margin of
safety for the pesticide chemical residue and other sources of
exposure shall be applied for infants and children to take into
account potential pre- and post-natal toxicity and completeness
of the data with respect to exposure and toxicity to infants
and children. Notwithstanding such requirement for an
additional margin of safety, the Administrator may use a
different margin of safety for the pesticide chemical residue
only if, on the basis of reliable data, such margin will be
safe for infants and children.
(D) Factors
In establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue, the
Administrator shall consider, among other relevant factors -
(i) the validity, completeness, and reliability of the
available data from studies of the pesticide chemical and
pesticide chemical residue;
(ii) the nature of any toxic effect shown to be caused by
the pesticide chemical or pesticide chemical residue in such
studies;
(iii) available information concerning the relationship of
the results of such studies to human risk;
(iv) available information concerning the dietary
consumption patterns of consumers (and major identifiable
subgroups of consumers);
(v) available information concerning the cumulative effects
of such residues and other substances that have a common
mechanism of toxicity;
(vi) available information concerning the aggregate
exposure levels of consumers (and major identifiable
subgroups of consumers) to the pesticide chemical residue and
to other related substances, including dietary exposure under
the tolerance and all other tolerances in effect for the
pesticide chemical residue, and exposure from other non-
occupational sources;
(vii) available information concerning the variability of
the sensitivities of major identifiable subgroups of
consumers;
(viii) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects; and
(ix) safety factors which in the opinion of experts
qualified by scientific training and experience to evaluate
the safety of food additives are generally recognized as
appropriate for the use of animal experimentation data.
(E) Data and information regarding anticipated and actual
residue levels
(i) Authority
In establishing, modifying, leaving in effect, or revoking
a tolerance for a pesticide chemical residue, the
Administrator may consider available data and information on
the anticipated residue levels of the pesticide chemical in
or on food and the actual residue levels of the pesticide
chemical that have been measured in food, including residue
data collected by the Food and Drug Administration.
(ii) Requirement
If the Administrator relies on anticipated or actual
residue levels in establishing, modifying, or leaving in
effect a tolerance, the Administrator shall pursuant to
subsection (f)(1) of this section require that data be
provided five years after the date on which the tolerance is
established, modified, or left in effect, and thereafter as
the Administrator deems appropriate, demonstrating that such
residue levels are not above the levels so relied on. If such
data are not so provided, or if the data do not demonstrate
that the residue levels are not above the levels so relied
on, the Administrator shall, not later than 180 days after
the date on which the data were required to be provided,
issue a regulation under subsection (e)(1) of this section,
or an order under subsection (f)(2) of this section, as
appropriate, to modify or revoke the tolerance.
(F) Percent of food actually treated
In establishing, modifying, leaving in effect, or revoking a
tolerance for a pesticide chemical residue, the Administrator
may, when assessing chronic dietary risk, consider available
data and information on the percent of food actually treated
with the pesticide chemical (including aggregate pesticide use
data collected by the Department of Agriculture) only if the
Administrator -
(i) finds that the data are reliable and provide a valid
basis to show what percentage of the food derived from such
crop is likely to contain such pesticide chemical residue;
(ii) finds that the exposure estimate does not understate
exposure for any significant subpopulation group;
(iii) finds that, if data are available on pesticide use
and consumption of food in a particular area, the population
in such area is not dietarily exposed to residues above those
estimated by the Administrator; and
(iv) provides for the periodic reevaluation of the estimate
of anticipated dietary exposure.
(3) Detection methods
(A) General rule
A tolerance for a pesticide chemical residue in or on a food
shall not be established or modified by the Administrator
unless the Administrator determines, after consultation with
the Secretary, that there is a practical method for detecting
and measuring the levels of the pesticide chemical residue in
or on the food.
(B) Detection limit
A tolerance for a pesticide chemical residue in or on a food
shall not be established at or modified to a level lower than
the limit of detection of the method for detecting and
measuring the pesticide chemical residue specified by the
Administrator under subparagraph (A).
(4) International standards
In establishing a tolerance for a pesticide chemical residue in
or on a food, the Administrator shall determine whether a maximum
residue level for the pesticide chemical has been established by
the Codex Alimentarius Commission. If a Codex maximum residue
level has been established for the pesticide chemical and the
Administrator does not propose to adopt the Codex level, the
Administrator shall publish for public comment a notice
explaining the reasons for departing from the Codex level.
(c) Authority and standard for exemptions
(1) Authority
The Administrator may issue a regulation establishing,
modifying, or revoking an exemption from the requirement for a
tolerance for a pesticide chemical residue in or on food -
(A) in response to a petition filed under subsection (d) of
this section; or
(B) on the Administrator's initiative under subsection (e) of
this section.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect an
exemption from the requirement for a tolerance for a
pesticide chemical residue in or on food only if the
Administrator determines that the exemption is safe. The
Administrator shall modify or revoke an exemption if the
Administrator determines it is not safe.
(ii) Determination of safety
The term "safe", with respect to an exemption for a
pesticide chemical residue, means that the Administrator has
determined that there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.
(B) Factors
In making a determination under this paragraph, the
Administrator shall take into account, among other relevant
considerations, the considerations set forth in subparagraphs
(C) and (D) of subsection (b)(2) of this section.
(3) Limitation
An exemption from the requirement for a tolerance for a
pesticide chemical residue in or on food shall not be established
or modified by the Administrator unless the Administrator
determines, after consultation with the Secretary -
(A) that there is a practical method for detecting and
measuring the levels of such pesticide chemical residue in or
on food; or
(B) that there is no need for such a method, and states the
reasons for such determination in issuing the regulation
establishing or modifying the exemption.
(d) Petition for tolerance or exemption
(1) Petitions and petitioners
Any person may file with the Administrator a petition proposing
the issuance of a regulation -
(A) establishing, modifying, or revoking a tolerance for a
pesticide chemical residue in or on a food; or
(B) establishing, modifying, or revoking an exemption from
the requirement of a tolerance for such a residue.
(2) Petition contents
(A) Establishment
A petition under paragraph (1) to establish a tolerance or
exemption for a pesticide chemical residue shall be supported
by such data and information as are specified in regulations
issued by the Administrator, including -
(i)(I) an informative summary of the petition and of the
data, information, and arguments submitted or cited in
support of the petition; and
(II) a statement that the petitioner agrees that such
summary or any information it contains may be published as a
part of the notice of filing of the petition to be published
under this subsection and as part of a proposed or final
regulation issued under this section;
(ii) the name, chemical identity, and composition of the
pesticide chemical residue and of the pesticide chemical that
produces the residue;
(iii) data showing the recommended amount, frequency,
method, and time of application of that pesticide chemical;
(iv) full reports of tests and investigations made with
respect to the safety of the pesticide chemical, including
full information as to the methods and controls used in
conducting those tests and investigations;
(v) full reports of tests and investigations made with
respect to the nature and amount of the pesticide chemical
residue that is likely to remain in or on the food, including
a description of the analytical methods used;
(vi) a practical method for detecting and measuring the
levels of the pesticide chemical residue in or on the food,
or for exemptions, a statement why such a method is not
needed;
(vii) a proposed tolerance for the pesticide chemical
residue, if a tolerance is proposed;
(viii) if the petition relates to a tolerance for a
processed food, reports of investigations conducted using the
processing method(s) used to produce that food;
(ix) such information as the Administrator may require to
make the determination under subsection (b)(2)(C) of this
section;
(x) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects;
(xi) information regarding exposure to the pesticide
chemical residue due to any tolerance or exemption already
granted for such residue;
(xii) practical methods for removing any amount of the
residue that would exceed any proposed tolerance; and
(xiii) such other data and information as the Administrator
requires by regulation to support the petition.
If information or data required by this subparagraph is
available to the Administrator, the person submitting the
petition may cite the availability of the information or data
in lieu of submitting it. The Administrator may require a
petition to be accompanied by samples of the pesticide chemical
with respect to which the petition is filed.
(B) Modification or revocation
The Administrator may by regulation establish the
requirements for information and data to support a petition to
modify or revoke a tolerance or to modify or revoke an
exemption from the requirement for a tolerance.
(3) Notice
A notice of the filing of a petition that the Administrator
determines has met the requirements of paragraph (2) shall be
published by the Administrator within 30 days after such
determination. The notice shall announce the availability of a
description of the analytical methods available to the
Administrator for the detection and measurement of the pesticide
chemical residue with respect to which the petition is filed or
shall set forth the petitioner's statement of why such a method
is not needed. The notice shall include the summary required by
paragraph (2)(A)(i)(I).
(4) Actions by the Administrator
(A) In general
The Administrator shall, after giving due consideration to a
petition filed under paragraph (1) and any other information
available to the Administrator -
(i) issue a final regulation (which may vary from that
sought by the petition) establishing, modifying, or revoking
a tolerance for the pesticide chemical residue or an
exemption of the pesticide chemical residue from the
requirement of a tolerance (which final regulation shall be
issued without further notice and without further period for
public comment);
(ii) issue a proposed regulation under subsection (e) of
this section, and thereafter issue a final regulation under
such subsection; or
(iii) issue an order denying the petition.
(B) Priorities
The Administrator shall give priority to petitions for the
establishment or modification of a tolerance or exemption for a
pesticide chemical residue that appears to pose a significantly
lower risk to human health from dietary exposure than pesticide
chemical residues that have tolerances in effect for the same
or similar uses.
(C) Expedited review of certain petitions
(i) Date certain for review
If a person files a complete petition with the
Administrator proposing the issuance of a regulation
establishing a tolerance or exemption for a pesticide
chemical residue that presents a lower risk to human health
than a pesticide chemical residue for which a tolerance has
been left in effect or modified under subsection (b)(2)(B) of
this section, the Administrator shall complete action on such
petition under this paragraph within 1 year.
(ii) Required determinations
If the Administrator issues a final regulation establishing
a tolerance or exemption for a safer pesticide chemical
residue under clause (i), the Administrator shall, not later
than 180 days after the date on which the regulation is
issued, determine whether a condition described in subclause
(I) or (II) of subsection (b)(2)(B)(iii) of this section
continues to exist with respect to a tolerance that has been
left in effect or modified under subsection (b)(2)(B) of this
section. If such condition does not continue to exist, the
Administrator shall, not later than 180 days after the date
on which the determination under the preceding sentence is
made, issue a regulation under subsection (e)(1) of this
section to modify or revoke the tolerance.
(e) Action on Administrator's own initiative
(1) General rule
The Administrator may issue a regulation -
(A) establishing, modifying, suspending under subsection
(l)(3) of this section, or revoking a tolerance for a pesticide
chemical or a pesticide chemical residue;
(B) establishing, modifying, suspending under subsection
(l)(3) of this section, or revoking an exemption of a pesticide
chemical residue from the requirement of a tolerance; or
(C) establishing general procedures and requirements to
implement this section.
(2) Notice
Before issuing a final regulation under paragraph (1), the
Administrator shall issue a notice of proposed rulemaking and
provide a period of not less than 60 days for public comment on
the proposed regulation, except that a shorter period for comment
may be provided if the Administrator for good cause finds that it
would be in the public interest to do so and states the reasons
for the finding in the notice of proposed rulemaking.
(f) Special data requirements
(1) Requiring submission of additional data
If the Administrator determines that additional data or
information are reasonably required to support the continuation
of a tolerance or exemption that is in effect under this section
for a pesticide chemical residue on a food, the Administrator
shall -
(A) issue a notice requiring the person holding the pesticide
registrations associated with such tolerance or exemption to
submit the data or information under section 3(c)(2)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
136a(c)(2)(B)];
(B) issue a rule requiring that testing be conducted on a
substance or mixture under section 4 of the Toxic Substances
Control Act [15 U.S.C. 2603]; or
(C) publish in the Federal Register, after first providing
notice and an opportunity for comment of not less than 60 days'
duration, an order -
(i) requiring the submission to the Administrator by one or
more interested persons of a notice identifying the person or
persons who will submit the required data and information;
(ii) describing the type of data and information required
to be submitted to the Administrator and stating why the data
and information could not be obtained under the authority of
section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the
Toxic Substances Control Act [15 U.S.C. 2603];
(iii) describing the reports of the Administrator required
to be prepared during and after the collection of the data
and information;
(iv) requiring the submission to the Administrator of the
data, information, and reports referred to in clauses (ii)
and (iii); and
(v) establishing dates by which the submissions described
in clauses (i) and (iv) must be made.
The Administrator may under subparagraph (C) revise any such
order to correct an error. The Administrator may under this
paragraph require data or information pertaining to whether the
pesticide chemical may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen or
other endocrine effects.
(2) Noncompliance
If a submission required by a notice issued in accordance with
paragraph (1)(A), a rule issued under paragraph (1)(B), or an
order issued under paragraph (1)(C) is not made by the time
specified in such notice, rule, or order, the Administrator may
by order published in the Federal Register modify or revoke the
tolerance or exemption in question. In any review of such an
order under subsection (g)(2) of this section, the only material
issue shall be whether a submission required under paragraph (1)
was not made by the time specified.
(g) Effective date, objections, hearings, and administrative review
(1) Effective date
A regulation or order issued under subsection (d)(4), (e)(1),
or (f)(2) of this section shall take effect upon publication
unless the regulation or order specifies otherwise. The
Administrator may stay the effectiveness of the regulation or
order if, after issuance of such regulation or order, objections
are filed with respect to such regulation or order pursuant to
paragraph (2).
(2) Further proceedings
(A) Objections
Within 60 days after a regulation or order is issued under
subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
(n)(5)(C) of this section, any person may file objections
thereto with the Administrator, specifying with particularity
the provisions of the regulation or order deemed objectionable
and stating reasonable grounds therefor. If the regulation or
order was issued in response to a petition under subsection
(d)(1) of this section, a copy of each objection filed by a
person other than the petitioner shall be served by the
Administrator on the petitioner.
(B) Hearing
An objection may include a request for a public evidentiary
hearing upon the objection. The Administrator shall, upon the
initiative of the Administrator or upon the request of an
interested person and after due notice, hold a public
evidentiary hearing if and to the extent the Administrator
determines that such a public hearing is necessary to receive
factual evidence relevant to material issues of fact raised by
the objections. The presiding officer in such a hearing may
authorize a party to obtain discovery from other persons and
may upon a showing of good cause made by a party issue a
subpoena to compel testimony or production of documents from
any person. The presiding officer shall be governed by the
Federal Rules of Civil Procedure in making any order for the
protection of the witness or the content of documents produced
and shall order the payment of reasonable fees and expenses as
a condition to requiring testimony of the witness. On contest,
such a subpoena may be enforced by a Federal district court.
(C) Final decision
As soon as practicable after receiving the arguments of the
parties, the Administrator shall issue an order stating the
action taken upon each such objection and setting forth any
revision to the regulation or prior order that the
Administrator has found to be warranted. If a hearing was held
under subparagraph (B), such order and any revision to the
regulation or prior order shall, with respect to questions of
fact at issue in the hearing, be based only on substantial
evidence of record at such hearing, and shall set forth in
detail the findings of facts and the conclusions of law or
policy upon which the order or regulation is based.
(h) Judicial review
(1) Petition
In a case of actual controversy as to the validity of any
regulation issued under subsection (e)(1)(C) of this section, or
any order issued under subsection (f)(1)(C) or (g)(2)(C) of this
section, or any regulation that is the subject of such an order,
any person who will be adversely affected by such order or
regulation may obtain judicial review by filing in the United
States Court of Appeals for the circuit wherein that person
resides or has its principal place of business, or in the United
States Court of Appeals for the District of Columbia Circuit,
within 60 days after publication of such order or regulation, a
petition praying that the order or regulation be set aside in
whole or in part.
(2) Record and jurisdiction
A copy of the petition under paragraph (1) shall be forthwith
transmitted by the clerk of the court to the Administrator, or
any officer designated by the Administrator for that purpose, and
thereupon the Administrator shall file in the court the record of
the proceedings on which the Administrator based the order or
regulation, as provided in section 2112 of title 28. Upon the
filing of such a petition, the court shall have exclusive
jurisdiction to affirm or set aside the order or regulation
complained of in whole or in part. As to orders issued following
a public evidentiary hearing, the findings of the Administrator
with respect to questions of fact shall be sustained only if
supported by substantial evidence when considered on the record
as a whole.
(3) Additional evidence
If a party applies to the court for leave to adduce additional
evidence and shows to the satisfaction of the court that the
additional evidence is material and that there were reasonable
grounds for the failure to adduce the evidence in the proceeding
before the Administrator, the court may order that the additional
evidence (and evidence in rebuttal thereof) shall be taken before
the Administrator in the manner and upon the terms and conditions
the court deems proper. The Administrator may modify prior
findings as to the facts by reason of the additional evidence so
taken and may modify the order or regulation accordingly. The
Administrator shall file with the court any such modified
finding, order, or regulation.
(4) Final judgment; Supreme Court review
The judgment of the court affirming or setting aside, in whole
or in part, any regulation or any order and any regulation which
is the subject of such an order shall be final, subject to review
by the Supreme Court of the United States 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 a regulation or order.
(5) Application
Any issue as to which review is or was obtainable under this
subsection shall not be the subject of judicial review under any
other provision of law.
(i) Confidentiality and use of data
(1) General rule
Data and information that are or have been submitted to the
Administrator under this section or section 348 of this title in
support of a tolerance or an exemption from a tolerance shall be
entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the
same extent provided by sections 3 and 10 of the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a,
136h].
(2) Exceptions
(A) In general
Data and information that are entitled to confidential
treatment under paragraph (1) may be disclosed, under such
security requirements as the Administrator may provide by
regulation, to -
(i) employees of the United States authorized by the
Administrator to examine such data and information in the
carrying out of their official duties under this chapter or
other Federal statutes intended to protect the public health;
or
(ii) contractors with the United States authorized by the
Administrator to examine such data and information in the
carrying out of contracts under this chapter or such
statutes.
(B) Congress
This subsection does not authorize the withholding of data or
information from either House of Congress or from, to the
extent of matter within its jurisdiction, any committee or
subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee.
(3) Summaries
Notwithstanding any provision of this subsection or other law,
the Administrator may publish the informative summary required by
subsection (d)(2)(A)(i) of this section and may, in issuing a
proposed or final regulation or order under this section, publish
an informative summary of the data relating to the regulation or
order.
(j) Status of previously issued regulations
(1) Regulations under section 346
Regulations affecting pesticide chemical residues in or on raw
agricultural commodities promulgated, in accordance with section
371(e) of this title, under the authority of section 346(a) (!1)
of this title upon the basis of public hearings instituted before
January 1, 1953, shall be deemed to be regulations issued under
this section and shall be subject to modification or revocation
under subsections (d) and (e) of this section, and shall be
subject to review under subsection (q) of this section.
(2) Regulations under section 348
Regulations that established tolerances for substances that are
pesticide chemical residues in or on processed food, or that
otherwise stated the conditions under which such pesticide
chemicals could be safely used, and that were issued under
section 348 of this title on or before August 3, 1996, shall be
deemed to be regulations issued under this section and shall be
subject to modification or revocation under subsection (d) or (e)
of this section, and shall be subject to review under subsection
(q) of this section.
(3) Regulations under section 346a
Regulations that established tolerances or exemptions under
this section that were issued on or before August 3, 1996, shall
remain in effect unless modified or revoked under subsection (d)
or (e) of this section, and shall be subject to review under
subsection (q) of this section.
(4) Certain substances
With respect to a substance that is not included in the
definition of the term "pesticide chemical" under section
321(q)(1) of this title but was so included on the day before
October 30, 1998, the following applies as of October 30, 1998:
(A) Notwithstanding paragraph (2), any regulation applying to
the use of the substance that was in effect on the day before
October 30, 1998, and was on such day deemed in such paragraph
to have been issued under this section, shall be considered to
have been issued under section 348 of this title.
(B) Notwithstanding paragraph (3), any regulation applying to
the use of the substance that was in effect on such day and was
issued under this section (including any such regulation issued
before August 3, 1996) is deemed to have been issued under
section 348 of this title.
(k) Transitional provision
If, on the day before August 3, 1996, a substance that is a
pesticide chemical was, with respect to a particular pesticidal use
of the substance and any resulting pesticide chemical residue in or
on a particular food -
(1) regarded by the Administrator or the Secretary as generally
recognized as safe for use within the meaning of the provisions
of subsection (a) of this section or section 321(s) of this title
as then in effect; or
(2) regarded by the Secretary as a substance described by
section 321(s)(4) of this title;
such a pesticide chemical residue shall be regarded as exempt from
the requirement for a tolerance, as of August 3, 1996. The
Administrator shall by regulation indicate which substances are
described by this subsection. Any exemption under this subsection
may be modified or revoked as if it had been issued under
subsection (c) of this section.
(l) Harmonization with action under other laws
(1) Coordination with FIFRA
To the extent practicable and consistent with the review
deadlines in subsection (q) of this section, in issuing a final
rule under this subsection that suspends or revokes a tolerance
or exemption for a pesticide chemical residue in or on food, the
Administrator shall coordinate such action with any related
necessary action under the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136 et seq.].
(2) Revocation of tolerance or exemption following cancellation
of associated registrations
If the Administrator, acting under the Federal Insecticide,
Fungicide, and Rodenticide Act, cancels the registration of each
pesticide that contains a particular pesticide chemical and that
is labeled for use on a particular food, or requires that the
registration of each such pesticide be modified to prohibit its
use in connection with the production, storage, or transportation
of such food, due in whole or in part to dietary risks to humans
posed by residues of that pesticide chemical on that food, the
Administrator shall revoke any tolerance or exemption that allows
the presence of the pesticide chemical, or any pesticide chemical
residue that results from its use, in or on that food. Subsection
(e) of this section shall apply to actions taken under this
paragraph. A revocation under this paragraph shall become
effective not later than 180 days after -
(A) the date by which each such cancellation of a
registration has become effective; or
(B) the date on which the use of the canceled pesticide
becomes unlawful under the terms of the cancellation, whichever
is later.
(3) Suspension of tolerance or exemption following suspension of
associated registrations
(A) Suspension
If the Administrator, acting under the Federal Insecticide,
Fungicide, and Rodenticide Act, suspends the use of each
registered pesticide that contains a particular pesticide
chemical and that is labeled for use on a particular food, due
in whole or in part to dietary risks to humans posed by
residues of that pesticide chemical on that food, the
Administrator shall suspend any tolerance or exemption that
allows the presence of the pesticide chemical, or any pesticide
chemical residue that results from its use, in or on that food.
Subsection (e) of this section shall apply to actions taken
under this paragraph. A suspension under this paragraph shall
become effective not later than 60 days after the date by which
each such suspension of use has become effective.
(B) Effect of suspension
The suspension of a tolerance or exemption under subparagraph
(A) shall be effective as long as the use of each associated
registration of a pesticide is suspended under the Federal
Insecticide, Fungicide, and Rodenticide Act. While a suspension
of a tolerance or exemption is effective the tolerance or
exemption shall not be considered to be in effect. If the
suspension of use of the pesticide under that Act is
terminated, leaving the registration of the pesticide for such
use in effect under that Act, the Administrator shall rescind
any associated suspension of tolerance or exemption.
(4) Tolerances for unavoidable residues
In connection with action taken under paragraph (2) or (3), or
with respect to pesticides whose registrations were suspended or
canceled prior to August 3, 1996, under the Federal Insecticide,
Fungicide, and Rodenticide Act, if the Administrator determines
that a residue of the canceled or suspended pesticide chemical
will unavoidably persist in the environment and thereby be
present in or on a food, the Administrator may establish a
tolerance for the pesticide chemical residue. In establishing
such a tolerance, the Administrator shall take into account both
the factors set forth in subsection (b)(2) of this section and
the unavoidability of the residue. Subsection (e) of this section
shall apply to the establishment of such tolerance. The
Administrator shall review any such tolerance periodically and
modify it as necessary so that it allows no greater level of the
pesticide chemical residue than is unavoidable.
(5) Pesticide residues resulting from lawful application of
pesticide
Notwithstanding any other provision of this chapter, if a
tolerance or exemption for a pesticide chemical residue in or on
a food has been revoked, suspended, or modified under this
section, an article of that food shall not be deemed unsafe
solely because of the presence of such pesticide chemical residue
in or on such food if it is shown to the satisfaction of the
Secretary that -
(A) the residue is present as the result of an application or
use of a pesticide at a time and in a manner that was lawful
under the Federal Insecticide, Fungicide, and Rodenticide Act;
and
(B) the residue does not exceed a level that was authorized
at the time of that application or use to be present on the
food under a tolerance, exemption, food additive regulation, or
other sanction then in effect under this chapter;
unless, in the case of any tolerance or exemption revoked,
suspended, or modified under this subsection or subsection (d) or
(e) of this section, the Administrator has issued a determination
that consumption of the legally treated food during the period of
its likely availability in commerce will pose an unreasonable
dietary risk.
(6) Tolerance for use of pesticides under an emergency exemption
If the Administrator grants an exemption under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136p) for a pesticide chemical, the Administrator shall establish
a tolerance or exemption from the requirement for a tolerance for
the pesticide chemical residue. Such a tolerance or exemption
from a tolerance shall have an expiration date. The Administrator
may establish such a tolerance or exemption without providing
notice or a period for comment on the tolerance or exemption. The
Administrator shall promulgate regulations within 365 days after
August 3, 1996, governing the establishment of tolerances and
exemptions under this paragraph. Such regulations shall be
consistent with the safety standard under subsections (b)(2) and
(c)(2) of this section and with section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act.
(m) Fees
(1) Amount
The Administrator shall by regulation require the payment of
such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide,
equip, and maintain an adequate service for the performance of
the Administrator's functions under this section. Under the
regulations, the performance of the Administrator's services or
other functions under this section, including -
(A) the acceptance for filing of a petition submitted under
subsection (d) of this section;
(B) establishing, modifying, leaving in effect, or revoking a
tolerance or establishing, modifying, leaving in effect, or
revoking an exemption from the requirement for a tolerance
under this section;
(C) the acceptance for filing of objections under subsection
(g) of this section; or
(D) the certification and filing in court of a transcript of
the proceedings and the record under subsection (h) of this
section;
may be conditioned upon the payment of such fees. The regulations
may further provide for waiver or refund of fees in whole or in
part when in the judgment of the Administrator such a waiver or
refund is equitable and not contrary to the purposes of this
subsection.
(2) Deposit
All fees collected under paragraph (1) shall be deposited in
the Reregistration and Expedited Processing Fund created by
section 4(k) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136a-1(k)]. Such fees shall be
available to the Administrator, without fiscal year limitation,
for the performance of the Administrator's services or functions
as specified in paragraph (1).
(n) National uniformity of tolerances
(1) "Qualifying pesticide chemical residue" defined
For purposes of this subsection, the term "qualifying pesticide
chemical residue" means a pesticide chemical residue resulting
from the use, in production, processing, or storage of a food, of
a pesticide chemical that is an active ingredient and that -
(A) was first approved for such use in a registration of a
pesticide issued under section 3(c)(5) of the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
136a(c)(5)] on or after April 25, 1985, on the basis of data
determined by the Administrator to meet all applicable
requirements for data prescribed by regulations in effect under
that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or
(B) was approved for such use in a reregistration eligibility
determination issued under section 4(g) of that Act [7 U.S.C.
136a-1(g)] on or after August 3, 1996.
(2) "Qualifying Federal determination" defined
For purposes of this subsection, the term "qualifying Federal
determination" means a tolerance or exemption from the
requirement for a tolerance for a qualifying pesticide chemical
residue that -
(A) is issued under this section after August 3, 1996, and
determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in
the case of an exemption) of this section; or
(B)(i) pursuant to subsection (j) of this section is
remaining in effect or is deemed to have been issued under this
section, or is regarded under subsection (k) of this section as
exempt from the requirement for a tolerance; and
(ii) is determined by the Administrator to meet the standard
under subsection (b)(2)(A) (in the case of a tolerance) or
(c)(2) (in the case of an exemption) of this section.
(3) Limitation
The Administrator may make the determination described in
paragraph (2)(B)(ii) only by issuing a rule in accordance with
the procedure set forth in subsection (d) or (e) of this section
and only if the Administrator issues a proposed rule and allows a
period of not less than 30 days for comment on the proposed rule.
Any such rule shall be reviewable in accordance with subsections
(g) and (h) of this section.
(4) State authority
Except as provided in paragraphs (5), (6), and (8) no State or
political subdivision may establish or enforce any regulatory
limit on a qualifying pesticide chemical residue in or on any
food if a qualifying Federal determination applies to the
presence of such pesticide chemical residue in or on such food,
unless such State regulatory limit is identical to such
qualifying Federal determination. A State or political
subdivision shall be deemed to establish or enforce a regulatory
limit on a pesticide chemical residue in or on a food if it
purports to prohibit or penalize the production, processing,
shipping, or other handling of a food because it contains a
pesticide residue (in excess of a prescribed limit).
(5) Petition procedure
(A) In general
Any State may petition the Administrator for authorization to
establish in such State a regulatory limit on a qualifying
pesticide chemical residue in or on any food that is not
identical to the qualifying Federal determination applicable to
such qualifying pesticide chemical residue.
(B) Petition requirements
Any petition under subparagraph (A) shall -
(i) satisfy any requirements prescribed, by rule, by the
Administrator; and
(ii) be supported by scientific data about the pesticide
chemical residue that is the subject of the petition or about
chemically related pesticide chemical residues, data on the
consumption within such State of food bearing the pesticide
chemical residue, and data on exposure of humans within such
State to the pesticide chemical residue.
(C) Authorization
The Administrator may, by order, grant the authorization
described in subparagraph (A) if the Administrator determines
that the proposed State regulatory limit -
(i) is justified by compelling local conditions; and
(ii) would not cause any food to be a violation of Federal
law.
(D) Treatment
In lieu of any action authorized under subparagraph (C), the
Administrator may treat a petition under this paragraph as a
petition under subsection (d) of this section to modify or
revoke a tolerance or an exemption. If the Administrator
determines to treat a petition under this paragraph as a
petition under subsection (d) of this section, the
Administrator shall thereafter act on the petition pursuant to
subsection (d) of this section.
(E) Review
Any order of the Administrator granting or denying the
authorization described in subparagraph (A) shall be subject to
review in the manner described in subsections (g) and (h) of
this section.
(6) Urgent petition procedure
Any State petition to the Administrator pursuant to paragraph
(5) that demonstrates that consumption of a food containing such
pesticide residue level during the period of the food's likely
availability in the State will pose a significant public health
threat from acute exposure shall be considered an urgent
petition. If an order by the Administrator to grant or deny the
requested authorization in an urgent petition is not made within
30 days of receipt of the petition, the petitioning State may
establish and enforce a temporary regulatory limit on a
qualifying pesticide chemical residue in or on the food. The
temporary regulatory limit shall be validated or terminated by
the Administrator's final order on the petition.
(7) Residues from lawful application
No State or political subdivision may enforce any regulatory
limit on the level of a pesticide chemical residue that may
appear in or on any food if, at the time of the application of
the pesticide that resulted in such residue, the sale of such
food with such residue level was lawful under this section and
under the law of such State, unless the State demonstrates that
consumption of the food containing such pesticide residue level
during the period of the food's likely availability in the State
will pose an unreasonable dietary risk to the health of persons
within such State.
(8) Savings
Nothing in this chapter preempts the authority of any State or
political subdivision to require that a food containing a
pesticide chemical residue bear or be the subject of a warning or
other statement relating to the presence of the pesticide
chemical residue in or on such food.
(o) Consumer right to know
Not later than 2 years after August 3, 1996, and annually
thereafter, the Administrator shall, in consultation with the
Secretary of Agriculture and the Secretary of Health and Human
Services, publish in a format understandable to a lay person, and
distribute to large retail grocers for public display (in a manner
determined by the grocer), the following information, at a minimum:
(1) A discussion of the risks and benefits of pesticide
chemical residues in or on food purchased by consumers.
(2) A listing of actions taken under subparagraph (B) of
subsection (b)(2) of this section that may result in pesticide
chemical residues in or on food that present a yearly or lifetime
risk above the risk allowed under subparagraph (A) of such
subsection, and the food on which the pesticide chemicals
producing the residues are used.
(3) Recommendations to consumers for reducing dietary exposure
to pesticide chemical residues in a manner consistent with
maintaining a healthy diet, including a list of food that may
reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from
providing additional information.
(p) Estrogenic substances screening program
(1) Development
Not later than 2 years after August 3, 1996, the Administrator
shall in consultation with the Secretary of Health and Human
Services develop a screening program, using appropriate validated
test systems and other scientifically relevant information, to
determine whether certain substances may have an effect in humans
that is similar to an effect produced by a naturally occurring
estrogen, or such other endocrine effect as the Administrator may
designate.
(2) Implementation
Not later than 3 years after August 3, 1996, after obtaining
public comment and review of the screening program described in
paragraph (1) by the scientific advisory panel established under
section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136w(d)] or the science advisory board
established by section 4365 (!2) of title 42, the Administrator
shall implement the program.
(3) Substances
In carrying out the screening program described in paragraph
(1), the Administrator -
(A) shall provide for the testing of all pesticide chemicals;
and
(B) may provide for the testing of any other substance that
may have an effect that is cumulative to an effect of a
pesticide chemical if the Administrator determines that a
substantial population may be exposed to such substance.
(4) Exemption
Notwithstanding paragraph (3), the Administrator may, by order,
exempt from the requirements of this section a biologic substance
or other substance if the Administrator determines that the
substance is anticipated not to produce any effect in humans
similar to an effect produced by a naturally occurring estrogen.
(5) Collection of information
(A) In general
The Administrator shall issue an order to a registrant of a
substance for which testing is required under this subsection,
or to a person who manufactures or imports a substance for
which testing is required under this subsection, to conduct
testing in accordance with the screening program described in
paragraph (1), and submit information obtained from the testing
to the Administrator, within a reasonable time period that the
Administrator determines is sufficient for the generation of
the information.
(B) Procedures
To the extent practicable the Administrator shall minimize
duplicative testing of the same substance for the same
endocrine effect, develop, as appropriate, procedures for fair
and equitable sharing of test costs, and develop, as necessary,
procedures for handling of confidential business information.
(C) Failure of registrants to submit information
(i) Suspension
If a registrant of a substance referred to in paragraph
(3)(A) fails to comply with an order under subparagraph (A)
of this paragraph, the Administrator shall issue a notice of
intent to suspend the sale or distribution of the substance
by the registrant. Any suspension proposed under this
paragraph shall become final at the end of the 30-day period
beginning on the date that the registrant receives the notice
of intent to suspend, unless during that period a person
adversely affected by the notice requests a hearing or the
Administrator determines that the registrant has complied
fully with this paragraph.
(ii) Hearing
If a person requests a hearing under clause (i), the
hearing shall be conducted in accordance with section 554 of
title 5. The only matter for resolution at the hearing shall
be whether the registrant has failed to comply with an order
under subparagraph (A) of this paragraph. A decision by the
Administrator after completion of a hearing shall be
considered to be a final agency action.
(iii) Termination of suspensions
The Administrator shall terminate a suspension under this
subparagraph issued with respect to a registrant if the
Administrator determines that the registrant has complied
fully with this paragraph.
(D) Noncompliance by other persons
Any person (other than a registrant) who fails to comply with
an order under subparagraph (A) shall be liable for the same
penalties and sanctions as are provided under section 16 of the
Toxic Substances Control Act [15 U.S.C. 2615] in the case of a
violation referred to in that section. Such penalties and
sanctions shall be assessed and imposed in the same manner as
provided in such section 16.
(6) Agency action
In the case of any substance that is found, as a result of
testing and evaluation under this section, to have an endocrine
effect on humans, the Administrator shall, as appropriate, take
action under such statutory authority as is available to the
Administrator, including consideration under other sections of
this chapter, as is necessary to ensure the protection of public
health.
(7) Report to Congress
Not later than 4 years after August 3, 1996, the Administrator
shall prepare and submit to Congress a report containing -
(A) the findings of the Administrator resulting from the
screening program described in paragraph (1);
(B) recommendations for further testing needed to evaluate
the impact on human health of the substances tested under the
screening program; and
(C) recommendations for any further actions (including any
action described in paragraph (6)) that the Administrator
determines are appropriate based on the findings.
(q) Schedule for review
(1) In general
The Administrator shall review tolerances and exemptions for
pesticide chemical residues in effect on the day before August 3,
1996, as expeditiously as practicable, assuring that -
(A) 33 percent of such tolerances and exemptions are reviewed
within 3 years of August 3, 1996;
(B) 66 percent of such tolerances and exemptions are reviewed
within 6 years of August 3, 1996; and
(C) 100 percent of such tolerances and exemptions are
reviewed within 10 years of August 3, 1996.
In conducting a review of a tolerance or exemption, the
Administrator shall determine whether the tolerance or exemption
meets the requirements of subsections (!3) (b)(2) or (c)(2) of
this section and shall, by the deadline for the review of the
tolerance or exemption, issue a regulation under subsection
(d)(4) or (e)(1) of this section to modify or revoke the
tolerance or exemption if the tolerance or exemption does not
meet such requirements.
(2) Priorities
In determining priorities for reviewing tolerances and
exemptions under paragraph (1), the Administrator shall give
priority to the review of the tolerances or exemptions that
appear to pose the greatest risk to public health.
(3) Publication of schedule
Not later than 12 months after August 3, 1996, the
Administrator shall publish a schedule for review of tolerances
and exemptions established prior to August 3, 1996. The
determination of priorities for the review of tolerances and
exemptions pursuant to this subsection is not a rulemaking and
shall not be subject to judicial review, except that failure to
take final action pursuant to the schedule established by this
paragraph shall be subject to judicial review.
(r) Temporary tolerance or exemption
The Administrator may, upon the request of any person who has
obtained an experimental permit for a pesticide chemical under the
Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136
et seq.] or upon the Administrator's own initiative, establish a
temporary tolerance or exemption for the pesticide chemical residue
for the uses covered by the permit. Subsections (b)(2), (c)(2),
(d), and (e) of this section shall apply to actions taken under
this subsection.
(s) Savings clause
Nothing in this section shall be construed to amend or modify the
provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et
seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7
U.S.C. 136 et seq.].
-SOURCE-
(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,
Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28,
1958, 72 Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct.
30, 1970, 84 Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a),
Nov. 18, 1971, 85 Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21,
1972, 86 Stat. 998; Pub. L. 98-620, title IV, Sec. 402(25)(A), Nov.
8, 1984, 98 Stat. 3359; Pub. L. 102-300, Sec. 6(b)(1), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(7), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(k), Aug. 13, 1993,
107 Stat. 776; Pub. L. 104-170, title IV, Sec. 405, Aug. 3, 1996,
110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 30, 1998, 112
Stat. 3036.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Rules of Civil Procedure, referred to in subsec.
(g)(2)(B), are set out in the Appendix to Title 28, Judiciary and
Judicial Procedure.
Section 346 of this title, referred to in subsec. (j)(1),
originally consisted of subsecs. (a) and (b). Subsec. (a) was
redesignated as the entire section 346 and subsec. (b) was repealed
by Pub. L. 86-618, title I, Sec. 103(a)(1), 74 Stat. 398.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in subsecs. (l), (n)(1)(A), (r), and (s), 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.
Section 4365 of title 42, referred to in subsec. (p)(2), was in
the original "section 8 of the Environmental Research, Development,
and Demonstration Act of 1978", and was translated as meaning
section 8 of the Environmental Research, Development, and
Demonstration Authorization Act of 1978, to reflect the probable
intent of Congress.
The Toxic Substances Control Act, referred to in subsec. (s), is
Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is
classified generally to chapter 53 (Sec. 2601 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 2601 of Title 15
and Tables.
-COD-
CODIFICATION
August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A),
and (p)(1), (2), (7), was in the original references to the date of
enactment of this subsection and the date of enactment of this
section, which was translated as meaning the date of enactment of
Pub. L. 104-170, which amended this section generally, to reflect
the probable intent of Congress.
-MISC1-
AMENDMENTS
1998 - Subsec. (j)(4). Pub. L. 105-324 added par. (4).
1996 - Pub. L. 104-170 amended section generally, substituting,
in subsec. (a), provisions relating to requirement for tolerance or
exemption for provisions relating to conditions for safety; in
subsec. (b), provisions relating to authority and standard for
tolerance for provisions relating to establishment of tolerances;
in subsec. (c), provisions relating to authority and standard for
exemptions for provisions relating to exemptions; in subsec. (d),
provisions relating to petition for tolerance or exemption for
provisions relating to regulations pursuant to petition,
publication of notice, time for issuance, referral to advisory
committees, effective date, and hearings; in subsec. (e),
provisions relating to action on Administrator's own initiative for
provisions relating to regulations pursuant to Administrator's
proposals; in subsec. (f), provisions relating to special data
requirements for provisions relating to data submitted as
confidential; in subsec. (g), provisions relating to effective
date, objections, hearings, and administrative review for
provisions relating to advisory committees and their appointment,
composition, compensation, and clerical assistance; in subsec. (h),
provisions relating to judicial review for provisions relating to
right of consultation; in subsec. (i), provisions relating to
confidentiality and use of data for provisions relating to judicial
review; in subsec. (j), provisions relating to status of previously
issued regulations for provisions relating to temporary tolerances;
in subsec. (k), provisions relating to transitions for provisions
relating to regulations based on public hearings before January 1,
1953; in subsec. (l), provisions relating to harmonization with
action under other laws for provisions relating to pesticides under
Federal Insecticide, Fungicide, and Rodenticide Act, functions of
Administrator of Environmental Protection Agency, certifications,
hearings, time limitations, opinions, and regulations; in subsec.
(m), provisions relating to fees for provisions relating to
amendment of regulations; in subsec. (n), provisions relating to
national uniformity of tolerances for provisions relating to
guaranties; in subsec. (o), provisions relating to consumer right
to know for provisions relating to payment of fees, services or
functions conditioned on payment, and waiver or refund of fees; and
adding subsecs. (p) to (s).
1993 - Pub. L. 103-80, Sec. 3(k)(6), substituted "Administrator"
for "Secretary" wherever appearing except when followed by "of
Agriculture".
Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted
"Administrator of the Environmental Protection Agency (hereinafter
in this section referred to as the 'Administrator')" for "Secretary
of Health and Human Services".
Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted
"section 556(c) of title 5" for "section 7(c) of the Administrative
Procedure Act (5 U.S.C., sec. 1006(c))".
Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted "In the
event" for "It the event" before "a hearing is requested".
Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical
amendment to reference to section 333(c) of this title to reflect
amendment of corresponding provision of original act.
Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the
substitution of "Administrator" for "Secretary of Health and Human
Services" wherever appearing in the original text, was executed by
making the substitution in the first sentence before "shall by
regulation require", the only place "Secretary of Health and Human
Services" appeared in the original text.
1992 - Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-
300 substituted "Health and Human Services" for "Health,
Education, and Welfare" wherever appearing in the original
statutory text.
Subsec. (g). Pub. L. 102-571 substituted "379e" for "376".
1984 - Subsec. (i)(5). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the
disposition of all causes filed therein pursuant to this section.
1972 - Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted
references to pesticide for references to economic poison wherever
appearing therein.
1971 - Subsec. (g). Pub. L. 92-157 struck out ", which the
Secretary shall by rules and regulations prescribe," after "as
compensation for their services a reasonable per diem" prior to
amendment in 1970, by Pub. L. 91-515, which overlooked such
language when amending subsec. (g) as provided in 1970 Amendment
note.
1970 - Subsec. (g). Pub. L. 91-515 substituted provisions
authorizing members of an advisory committee to receive
compensation and travel expenses in accordance with section
376(b)(5)(D) of this title, 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.
1958 - Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first
sentence, substituted "transmitted by the clerk of the court to the
Secretary, or" for "served upon the Secretary, or upon",
substituted "file in the court the record of the proceedings" for
"certify and file in the court a transcript of the proceedings and
the record", and inserted "as provided in section 2112 of title
28", and which, in second sentence, substituted "the filing of such
petition" for "such filing".
Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,
substituted "transmitted by the clerk of the court to the Secretary
of Agriculture, or" for "served upon the Secretary of Agriculture,
or upon", substituted "file in the court the record of the
proceedings" for "certify and file in the court a transcript of the
proceedings and the record", and inserted "as provided in section
2112 of title 28", and, in second sentence, substituted "the filing
of such petition" for "such filing".
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98-620 not applicable to cases pending on
Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
Effective Date note under section 1657 of Title 28, Judiciary and
Judicial Procedure.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,
except if regulations are necessary for implementation of any
provision that becomes effective on Oct. 21, 1972, and continuation
in effect of subchapter I of chapter 6 of Title 7, Agriculture, and
regulations thereunder, relating to control of economic poisons, as
in existence prior to Oct. 21, 1972, until superseded by provisions
of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub.
L. 92-516, set out as an Effective Date note under section 136 of
Title 7.
TOLERANCE FEES
Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004,
118 Stat. 422, provided that: "Notwithstanding section 408(m)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)),
during the period beginning on October 1, 2003, and ending on
September 30, 2008, the Administrator of the Environmental
Protection Agency shall not collect any tolerance fees under that
section."
DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF INFANTS AND CHILDREN
Section 301 of Pub. L. 104-170 provided that:
"(a) In General. - The Secretary of Agriculture, in consultation
with the Administrator of the Environmental Protection Agency and
the Secretary of Health and Human Services, shall coordinate the
development and implementation of survey procedures to ensure that
adequate data on food consumption patterns of infants and children
are collected.
"(b) Procedures. - To the extent practicable, the procedures
referred to in subsection (a) shall include the collection of data
on food consumption patterns of a statistically valid sample of
infants and children.
"(c) Residue Data Collection. - The Secretary of Agriculture
shall ensure that the residue data collection activities conducted
by the Department of Agriculture in cooperation with the
Environmental Protection Agency and the Department of Health and
Human Services, provide for the improved data collection of
pesticide residues, including guidelines for the use of comparable
analytical and standardized reporting methods, and the increased
sampling of foods most likely consumed by infants and children."
-FOOTNOTE-
(!1) See References in Text note below.
(!2) See References in Text note below.
(!3) So in original. Probably should be "subsection".
-End-
-CITE-
21 USC Sec. 346b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346b. Authorization of appropriations
-STATUTE-
There are authorized to be appropriated, out of any moneys in the
Treasury not otherwise appropriated, such sums as may be necessary
for the purpose and administration of sections 321(q), (r),
342(a)(2), and 346a of this title.
-SOURCE-
(July 22, 1954, ch. 559, Sec. 4, 68 Stat. 517.)
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC Sec. 347 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347. Intrastate sales of colored oleomargarine
-STATUTE-
(a) Law governing
Colored oleomargarine or colored margarine which is sold in the
same State or Territory in which it is produced shall be subject in
the same manner and to the same extent to the provisions of this
chapter as if it had been introduced in interstate commerce.
(b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored oleomargarine or
colored margarine unless -
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any package sold in a
retail establishment is one pound or less,
(3) there appears on the label of the package (A) the word
"oleomargarine" or "margarine" in type or lettering at least as
large as any other type or lettering on such label, and (B) a
full and accurate statement of all the ingredients contained in
such oleomargarine or margarine, and
(4) each part of the contents of the package is contained in a
wrapper which bears the word "oleomargarine" or "margarine" in
type or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this chapter.
(c) Sales in public eating places
No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless
a notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner as
to render it likely to be read and understood by the ordinary
individual being served in such eating place or is printed or is
otherwise set forth on the menu in type or lettering not smaller
than that normally used to designate the serving of other food
items. No person shall serve colored oleomargarine or colored
margarine at a public eating place, whether or not any charge is
made therefor, unless (1) each separate serving bears or is
accompanied by labeling identifying it as oleomargarine or
margarine, or (2) each separate serving thereof is triangular in
shape.
(d) Exemption from labeling requirements
Colored oleomargarine or colored margarine when served with meals
at a public eating place shall at the time of such service be
exempt from the labeling requirements of section 343 of this title
(except paragraphs (a) and (f)) if it complies with the
requirements of subsection (b) of this section.
(e) Color content of oleomargarine
For the purpose of this section colored oleomargarine or colored
margarine is oleomargarine or margarine having a tint or shade
containing more than one and six-tenths degrees of yellow, or of
yellow and red collectively, but with an excess of yellow over red,
measured in terms of Lovibond tintometer scale or its equivalent.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 407, as added Mar. 16, 1950, ch. 61,
Sec. 3(c), 64 Stat. 20.)
-MISC1-
EFFECTIVE DATE
Section 7 of act Mar. 16, 1950, provided that: "This Act
[enacting this section and sections 347a and 347b of this title and
amending sections 331 and 342 of this title and sections 45 and 55
of Title 15, Commerce and Trade] shall become effective on July 1,
1950."
TRANSFER OF APPROPRIATIONS
Section 5 of act Mar. 16, 1950, provided that: "So much of the
unexpended balances of appropriations, allocations, or other funds
(including funds available for the fiscal year ending June 30,
1950) for the use of the Bureau of Internal Revenue of the Treasury
Department in the exercise of functions under the Oleomargarine Tax
Act (26 U.S.C., Sec. 2300, subchapter A) [now section 4591 et seq.
of Title 26, Internal Revenue Code], as the Director of the Bureau
of the Budget [now Director of the Office of Management and Budget]
may determine, shall be transferred to the Federal Security Agency
(Food and Drug Administration) [now the Department of Health and
Human Services] for use in the enforcement of this Act [see
Effective Date note above]."
-End-
-CITE-
21 USC Sec. 347a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347a. Congressional declaration of policy regarding
oleomargarine sales
-STATUTE-
The Congress finds and declares that the sale, or the serving in
public eating places, of colored oleomargarine or colored margarine
without clear identification as such or which is otherwise
adulterated or misbranded within the meaning of this chapter
depresses the market in interstate commerce for butter and for
oleomargarine or margarine clearly identified and neither
adulterated nor misbranded, and constitutes a burden on interstate
commerce in such articles. Such burden exists, irrespective of
whether such oleomargarine or margarine originates from an
interstate source or from the State in which it is sold.
-SOURCE-
(Mar. 16, 1950, ch. 61, Sec. 3(a), 64 Stat. 20.)
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-MISC1-
EFFECTIVE DATE
Section effective July 1, 1950, see section 7 of act Mar. 16,
1950, set out as a note under section 347 of this title.
-End-
-CITE-
21 USC Sec. 347b 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347b. Contravention of State laws
-STATUTE-
Nothing in this Act shall be construed as authorizing the
possession, sale, or serving of colored oleomargarine or colored
margarine in any State or Territory in contravention of the laws of
such State or Territory.
-SOURCE-
(Mar. 16, 1950, ch. 61, Sec. 6, 64 Stat. 22.)
-REFTEXT-
REFERENCES IN TEXT
This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64
Stat. 20, which is classified to sections 331, 342, 347 to 347b of
this title, and sections 45 and 55 of Title 15, Commerce and Trade.
For complete classification of this Act to the Code, see Tables.
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-MISC1-
EFFECTIVE DATE
Section effective July 1, 1950, see section 7 of act Mar. 16,
1950, set out as a note under section 347 of this title.
-End-
-CITE-
21 USC Sec. 348 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 348. Food additives
-STATUTE-
(a) Unsafe food additives; exception for conformity with exemption
or regulation
A food additive shall, with respect to any particular use or
intended use of such additives, be deemed to be unsafe for the
purposes of the application of clause (2)(C) of section 342(a) of
this title, unless -
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (j) of this
section;
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may be
safely used; or
(3) in the case of a food additive as defined in this chapter
that is a food contact substance, there is -
(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
(B) a notification submitted under subsection (h) of this
section that is effective.
While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) of this section relating to a
food additive that is a food contact substance, is in effect, and
has not been revoked pursuant to subsection (i) of this section, a
food shall not, by reason of bearing or containing such a food
additive in accordance with the regulation or notification, be
considered adulterated under section 342(a)(1) of this title.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls;
samples; notice of regulation
(1) Any person may, with respect to any intended use of a food
additive, file with the Secretary a petition proposing the issuance
of a regulation prescribing the conditions under which such
additive may be safely used.
(2) Such petition shall, in addition to any explanatory or
supporting data, contain -
(A) the name and all pertinent information concerning such food
additive, including, where available, its chemical identity and
composition;
(B) a statement of the conditions of the proposed use of such
additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and including
specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other
technical effect such additive is intended to produce, and the
quantity of such additive required to produce such effect;
(D) a description of practicable methods for determining the
quantity of such additive in or on food, and any substance formed
in or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as to
the methods and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive,
the petitioner shall have the manufacturer of such additive
furnish, without disclosure to the petitioner) a full description
of the methods used in, and the facilities and controls used for,
the production of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as
components thereof, and of the food in or on which the additive is
proposed to be used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
(1) The Secretary shall -
(A) by order establish a regulation (whether or not in accord
with that proposed by the petitioner) prescribing, with respect
to one or more proposed uses of the food additive involved, the
conditions under which such additive may be safely used
(including, but not limited to, specifications as to the
particular food or classes of food in or in which such additive
may be used, the maximum quantity which may be used or permitted
to remain in or on such food, the manner in which such additive
may be added to or used in or on such food, and any directions or
other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and shall
notify the petitioner of such order and the reasons for such
action; or
(B) by order deny the petition, and shall notify the petitioner
of such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this
subsection shall be issued within ninety days after the date of
filing of the petition, 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.
(3) No such regulation shall issue if a fair evaluation of the
data before the Secretary -
(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe: Provided, That no additive shall be
deemed to be safe if it is found to induce cancer when ingested
by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal, except that this proviso shall
not apply with respect to the use of a substance as an ingredient
of feed for animals which are raised for food production, if the
Secretary finds (i) 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 (ii) 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 subsections (f) and (g) of
this section) in any edible portion of such animal after
slaughter or in any food yielded by or derived from the living
animal; or
(B) shows that the proposed use of the additive would promote
deception of the consumer in violation of this chapter or would
otherwise result in adulteration or in misbranding of food within
the meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is
required in order to assure that the proposed use of an additive
will be safe, the Secretary -
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
(B) shall not establish a regulation for such proposed use if
he finds upon a fair evaluation of the data before him that such
data do not establish that such use would accomplish the intended
physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall
consider among other relevant factors -
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet of man
or animals, taking into account any chemically or
pharmacologically related substance or substances in such diet;
and
(C) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of
animal experimentation data.
(d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose
the issuance of a regulation prescribing, with respect to any
particular use of a food additive, the conditions under which such
additive may be safely used, and the reasons therefor. After the
thirtieth day following publication of such a proposal, the
Secretary may by order establish a regulation based upon the
proposal.
(e) Publication and effective date of orders
Any order, including any regulation established by such order,
issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the
Secretary may stay such effectiveness if, after issuance of such
order, a hearing is sought with respect to such order pursuant to
subsection (f) of this section.
(f) Objections and public hearing; basis and contents of order;
statement
(1) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person
adversely affected by such an order may file objections thereto
with the Secretary, specifying with particularity the provisions of
the order deemed objectionable, stating reasonable grounds
therefor, and requesting a public hearing upon such objections. The
Secretary shall, after due notice, as promptly as possible hold
such public hearing for the purpose of receiving evidence relevant
and material to the issues raised by such objections. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the
entire record at such hearing, and shall include a statement
setting forth in detail the findings and conclusions upon which the
order is based.
(3) 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.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any
order issued under subsection (f) of this section, including any
order thereunder with respect to amendment or repeal of a
regulation issued under this section, any person who will be
adversely affected by such order may obtain judicial review by
filing in the United States Court of Appeals for the circuit
wherein such person 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 petition praying that the order be set aside in whole or in part.
(2) 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 file in the
court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28. Upon the filing of such
petition the court shall have jurisdiction, which upon the filing
of the record with it shall be exclusive, to affirm or set aside
the order complained of in whole or in part. Until the filing of
the record the Secretary may modify or set aside his order. The
findings of the Secretary with respect to questions of fact shall
be sustained if based upon a fair evaluation of the entire record
at such hearing.
(3) The court, on such judicial review, shall not sustain the
order of the Secretary if he failed to comply with any requirement
imposed on him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce
additional evidence, 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, if such evidence is material and there were
reasonable grounds for failure to adduce such evidence in the
proceedings below. The Secretary may modify his findings as to the
facts and order by reason of the additional evidence so taken, and
shall file with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section 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 section shall not,
unless specifically ordered by the court to the contrary, operate
as a stay of an order.
(h) Notification relating to food contact substance
(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact
substance may, at least 120 days prior to the introduction or
delivery for introduction into interstate commerce of the food
contact substance, notify the Secretary of the identity and
intended use of the food contact substance, and of the
determination of the manufacturer or supplier that the intended use
of such food contact substance is safe under the standard described
in subsection (c)(3)(A) of this section. The notification shall
contain the information that forms the basis of the determination
and all information required to be submitted by regulations
promulgated by the Secretary.
(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and
the food contact substance may be introduced or delivered for
introduction into interstate commerce, unless the Secretary makes a
determination within the 120-day period that, based on the data and
information before the Secretary, such use of the food contact
substance has not been shown to be safe under the standard
described in subsection (c)(3)(A) of this section, and informs the
manufacturer or supplier of such determination.
(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
(C) In this paragraph, the term "food contact substance" means
the substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical
substance manufactured or prepared by a person other than the
manufacturer identified in the notification.
(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where
the Secretary determines that submission and review of a petition
under subsection (b) of this section is necessary to provide
adequate assurance of safety, or where the Secretary and any
manufacturer or supplier agree that such manufacturer or supplier
may submit a petition under subsection (b) of this section.
(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b) of this section, and shall consider criteria such as
the probable consumption of such food contact substance and
potential toxicity of the food contact substance in determining the
circumstances in which a petition shall be filed under subsection
(b) of this section.
(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days after
receipt by the Secretary of the notification. After the expiration
of such 120 days, the information shall be available to any
interested party except for any matter in the notification that is
a trade secret or confidential commercial information.
(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iv) is made for such fiscal year for
carrying out such program in such fiscal year; and
(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds the
amount appropriated for the Center for fiscal year 1997,
excluding any amount appropriated for new programs.
(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the
notification program established under this subsection if -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iii) is made for the last six months of
fiscal year 1999 for carrying out such program during such
period; and
(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition
of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds an
amount equivalent to one-half the amount appropriated for the
Center for fiscal year 1997, excluding any amount appropriated
for new programs.
(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in
the budget request of the President for the six-month period
involved for carrying out the notification program in fiscal year
1999, whichever is less.
(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal
year involved for carrying out the notification program under this
subsection, whichever is less.
(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1999 through
fiscal year 2003, except that such authorization of appropriations
is not effective for a fiscal year for any amount that is less than
the applicable amount under clause (iii) or (iv) of subparagraph
(A), whichever is applicable.
(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to
the Committees on Appropriations of the House of Representatives
and the Senate, the Committee on Commerce of the House of
Representatives, and the Committee on Labor and Human Resources of
the Senate that provides an estimate of the Secretary of the costs
of carrying out the notification program established under this
subsection for the next fiscal year.
(6) In this section, the term "food contact substance" means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.
(i) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by
which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform to the
procedure provided in this section for the promulgation of such
regulations. The Secretary shall by regulation prescribe the
procedure by which the Secretary may deem a notification under
subsection (h) of this section to no longer be effective.
(j) Exemptions for investigational use
Without regard to subsections (b) to (i), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
food 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. 409, as added Pub. L. 85-929, Sec. 4,
Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June
29, 1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1),
Oct. 10, 1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec.
402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105-115, title
III, Sec. 309, Nov. 21, 1997, 111 Stat. 2354.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing
provisions, substituted "While such a regulation relating to a food
additive, or such a notification under subsection (h)(1) of this
section relating to a food additive that is a food contact
substance, is in effect, and has not been revoked pursuant to
subsection (i) of this section, a food shall not, by reason of
bearing or containing such a food additive in accordance with the
regulation or notification, be considered adulterated under section
342(a)(1) of this title." for "While such a regulation relating to
a food additive is in effect, a food shall not, by reason of
bearing or containing such an additive in accordance with the
regulation, be considered adulterated within the meaning of clause
(1) of section 342(a) of this title."
Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted
"subsection (j)" for "subsection (i)".
Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3),
added par. (3).
Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).
Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated
subsec. (h) as (i) and inserted at end "The Secretary shall by
regulation prescribe the procedure by which the Secretary may deem
a notification under subsection (h) of this section to no longer be
effective."
Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated
subsec. (i) as (j) and substituted "subsections (b) to (i)" for
"subsections (b) to (h)".
1984 - Subsec. (g)(2). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the
disposition of all causes filed therein pursuant to this section.
1962 - Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
applying to use of a substance as an ingredient of feed for animals
raised for food production, if under 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 - Subsec. (g)(2). Pub. L. 86-546 substituted "forthwith
transmitted by the clerk of the court to the Secretary, or any
officer" for "served upon the Secretary, or upon any officer",
"shall file in the court the record of the proceedings on which he
based his order, as provided in section 2112 of title 28" for
"shall certify and file in the court a transcript of the
proceedings and the record on which he based his order", and "Upon
the filing of such petition the court shall have jurisdiction,
which upon the filing of the record with it shall be exclusive,"
for "Upon such filing, the court shall have exclusive
jurisdiction", and inserted sentence authorizing the Secretary to
modify or set aside his order until the filing of the record.
-CHANGE-
CHANGE OF NAME
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5, One Hundred
Seventh Congress, Jan. 3, 2001.
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
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
Amendment by Pub. L. 98-620 not applicable to cases pending on
Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
Effective Date note under section 1657 of Title 28, Judiciary and
Judicial Procedure.
EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as an Effective Date of 1962
Amendment note under section 321 of this title.
EFFECTIVE DATE
Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-
929, set out as an Effective Date of 1958 Amendment note under
section 342 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
Functions vested in Secretary of Health, Education, and Welfare
[now Health and Human Services] in establishing tolerances for
pesticide chemicals under this section together with authority to
monitor compliance with tolerances and effectiveness of
surveillance and enforcement and to provide technical assistance to
States and conduct research under this chapter and section 201 et
seq. of Title 42, The Public Health and Welfare, transferred to
Administrator of Environmental Protection Agency by Reorg. Plan No.
3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
2086, set out in the Appendix to Title 5, Government Organization
and Employees.
-MISC3-
GLASS AND CERAMIC WARE
Section 308 of Pub. L. 105-115 provided that:
"(a) In General. - The Secretary may not implement any
requirement which would ban, as an unapproved food additive, lead
and cadmium based enamel in the lip and rim area of glass and
ceramic ware before the expiration of one year after the date such
requirement is published.
"(b) Lead and Cadmium Based Enamel. - Unless the Secretary
determines, based on available data, that lead and cadmium based
enamel on glass and ceramic ware -
"(1) which has less than 60 millimeters of decorating area
below the external rim, and
"(2) which is not, by design, representation, or custom of
usage intended for use by children,
is unsafe, the Secretary shall not take any action before January
1, 2003, to ban lead and cadmium based enamel on such glass and
ceramic ware. Any action taken after January 1, 2003, to ban such
enamel on such glass and ceramic ware as an unapproved food
additive shall be taken by regulation and such regulation shall
provide that such products shall not be removed from the market
before 1 year after publication of the final regulation."
MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN
Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42,
Sec. 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr.
22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81;
Pub. L. 100-71, title I, Sec. 101, July 11, 1987, 101 Stat. 431;
Pub. L. 102-142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L.
104-180, title VI, Sec. 602, Aug. 6, 1996, 110 Stat. 1594, provided
that: "During the period ending May 1, 2002, the Secretary -
"(1) may not amend or revoke the interim food additive
regulation of the Food and Drug Administration of the Department
of Health and Human Services applicable to saccharin and
published on March 15, 1977 (section 180.37 of part 180,
subchapter B, chapter 1, title 21, Code of Federal Regulations
(42 Fed. Reg. 14638)), or
"(2) may, except as provided in section 4 [enacting section
343a of this title, amending sections 321 and 343 of this title,
and enacting provisions set out as notes under section 343 of
this title] and the amendments made by such section, not take any
other action under the Federal Food, Drug, and Cosmetic Act [this
chapter] to prohibit or restrict the sale or distribution of
saccharin, any food permitted by such interim food additive
regulation to contain saccharin, or any drug or cosmetic
containing saccharin,
solely on the basis of the carcinogenic or other toxic effect of
saccharin as determined by any study made available to the
Secretary before the date of the enactment of this Act [Nov. 23,
1977] which involved human studies or animal testing, or both."
For definition of "saccharin" as used in this note, see section
2(d) of Pub. L. 95-203.
-End-
-CITE-
21 USC Sec. 349 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 349. Bottled drinking water standards; publication in Federal
Register
-STATUTE-
(a) Except as provided in subsection (b) of this section,
whenever the Administrator of the Environmental Protection Agency
prescribes interim or revised national primary drinking water
regulations under section 1412 of the Public Health Service Act [42
U.S.C. 300g-1], the Secretary shall consult with the Administrator
and within 180 days after the promulgation of such drinking water
regulations either promulgate amendments to regulations under this
chapter applicable to bottled drinking water or publish in the
Federal Register his reasons for not making such amendments.
(b)(1) Not later than 180 days before the effective date of a
national primary drinking water regulation promulgated by the
Administrator of the Environmental Protection Agency for a
contaminant under section 1412 of the Safe Drinking Water Act (42
U.S.C. 300g-1), the Secretary shall promulgate a standard of
quality regulation under this subsection for that contaminant in
bottled water or make a finding that such a regulation is not
necessary to protect the public health because the contaminant is
contained in water in public water systems (as defined under
section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water
used for bottled drinking water. The effective date for any such
standard of quality regulation shall be the same as the effective
date for such national primary drinking water regulation, except
for any standard of quality of regulation promulgated by the
Secretary before August 6, 1996, for which (as of August 6, 1996)
an effective date had not been established. In the case of a
standard of quality regulation to which such exception applies, the
Secretary shall promulgate monitoring requirements for the
contaminants covered by the regulation not later than 2 years after
August 6, 1996.
(2) A regulation issued by the Secretary as provided in this
subsection shall include any monitoring requirements that the
Secretary determines appropriate for bottled water.
(3) A regulation issued by the Secretary as provided in this
subsection shall require the following:
(A) In the case of contaminants for which a maximum contaminant
level is established in a national primary drinking water
regulation under section 1412 of the Safe Drinking Water Act (42
U.S.C. 300g-1), the regulation under this subsection shall
establish a maximum contaminant level for the contaminant in
bottled water which is no less stringent than the maximum
contaminant level provided in the national primary drinking water
regulation.
(B) In the case of contaminants for which a treatment technique
is established in a national primary drinking water regulation
under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-
1), the regulation under this subsection shall require that
bottled water be subject to requirements no less protective of
the public health than those applicable to water provided by
public water systems using the treatment technique required by
the national primary drinking water regulation.
(4)(A) If the Secretary does not promulgate a regulation under
this subsection within the period described in paragraph (1), the
national primary drinking water regulation referred to in paragraph
(1) shall be considered, as of the date on which the Secretary is
required to establish a regulation under paragraph (1), as the
regulation applicable under this subsection to bottled water.
(B) In the case of a national primary drinking water regulation
that pursuant to subparagraph (A) is considered to be a standard of
quality regulation, the Secretary shall, not later than the
applicable date referred to in such subparagraph, publish in the
Federal Register a notice -
(i) specifying the contents of such regulation, including
monitoring requirements; and
(ii) providing that for purposes of this paragraph the
effective date for such regulation is the same as the effective
date for the regulation for purposes of the Safe Drinking Water
Act [42 U.S.C. 300f et seq.] (or, if the exception under
paragraph (1) applies to the regulation, that the effective date
for the regulation is not later than 2 years and 180 days after
August 6, 1996).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4,
Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III,
Sec. 305, Aug. 6, 1996, 110 Stat. 1684.)
-REFTEXT-
REFERENCES IN TEXT
The Safe Drinking Water Act, referred to in subsec.
(b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16,
1974, Pub. L. 93-523, Sec. 2(a), 88 Stat. 1660, as amended, which
is classified generally to subchapter XII (Sec. 300f et seq.) 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.
-MISC1-
AMENDMENTS
1996 - Pub. L. 104-182 substituted "(a) Except as provided in
subsection (b) of this section, whenever" for "Whenever" and added
subsec. (b).
BOTTLED WATER STUDY
Section 114(b) of Pub. L. 104-182 provided that: "Not later than
18 months after the date of enactment of this Act [Aug. 6, 1996],
the Administrator of the Food and Drug Administration, in
consultation with the Administrator of the Environmental Protection
Agency, shall publish for public notice and comment a draft study
on the feasibility of appropriate methods, if any, of informing
customers of the contents of bottled water. The Administrator of
the Food and Drug Administration shall publish a final study not
later than 30 months after the date of enactment of this Act."
-End-
-CITE-
21 USC Sec. 350 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350. Vitamins and minerals
-STATUTE-
(a) Authority and limitations of Secretary; applicability
(1) Except as provided in paragraph (2) -
(A) the Secretary may not establish, under section 321(n), 341,
or 343 of this title, maximum limits on the potency of any
synthetic or natural vitamin or mineral within a food to which
this section applies;
(B) the Secretary may not classify any natural or synthetic
vitamin or mineral (or combination thereof) as a drug solely
because it exceeds the level of potency which the Secretary
determines is nutritionally rational or useful;
(C) the Secretary may not limit, under section 321(n), 341, or
343 of this title, the combination or number of any synthetic or
natural -
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin,
mineral, other ingredient of food, or food, which is represented
for use by individuals in the treatment or management of specific
diseases or disorders, by children, or by pregnant or lactating
women. For purposes of this subparagraph,(!1) the term "children"
means individuals who are under the age of twelve years.
(b) Labeling and advertising requirements for foods
(1) A food to which this section applies shall not be deemed
under section 343 of this title to be misbranded solely because its
label bears, in accordance with section 343(i)(2) of this title,
all the ingredients in the food or its advertising contains
references to ingredients in the food which are not vitamins or
minerals.
(2) The labeling for any food to which this section applies may
not list its ingredients which are not dietary supplement
ingredients described in section 321(ff) of this title (i) except
as a part of a list of all the ingredients of such food, and (ii)
unless such ingredients are listed in accordance with applicable
regulations under section 343 of this title. To the extent that
compliance with clause (i) of this subparagraph is impracticable or
results in deception or unfair competition, exemptions shall be
established by regulations promulgated by the Secretary.
(c) Definitions
(1) For purposes of this section, the term "food to which this
section applies" means a food for humans which is a food for
special dietary use -
(A) which is or contains any natural or synthetic vitamin or
mineral, and
(B) which -
(i) is intended for ingestion in tablet, capsule, powder,
softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not
represented as conventional food and is not represented for use
as a sole item of a meal or of the diet.
(2) For purposes of paragraph (1)(B)(i), a food shall be
considered as intended for ingestion in liquid form only if it is
formulated in a fluid carrier and it is intended for ingestion in
daily quantities measured in drops or similar small units of
measure.
(3) For purposes of paragraph (1) and of section 343(j) of this
title insofar as that section is applicable to food to which this
section applies, the term "special dietary use" as applied to food
used by man means a particular use for which a food purports or is
represented to be used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason of a
physical, physiological, pathological, or other condition,
including but not limited to the condition of disease,
convalescence, pregnancy, lactation, infancy, allergic
hypersensitivity to food, underweight, overweight, or the need to
control the intake of sodium.
(B) Supplying a vitamin, mineral, or other ingredient for use
by man to supplement his diet by increasing the total dietary
intake.
(C) Supplying a special dietary need by reason of being a food
for use as the sole item of the diet.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title
V, Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103-
417, Secs. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)
-MISC1-
AMENDMENTS
1994 - Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated
subpar. (A) as par. (2), substituted "dietary supplement
ingredients described in section 321(ff) of this title" for
"vitamins or minerals", and struck out former subpar. (B), which
read as follows: "Notwithstanding the provisions of subparagraph
(A), the labeling and advertising for any food to which this
section applies may not give prominence to or emphasize ingredients
which are not -
"(i) vitamins,
"(ii) minerals, or
"(iii) represented as a source of vitamins or minerals."
Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted
"powder, softgel, gelcap," after "capsule,".
Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out
"does not simulate and" after "in such a form,".
EFFECTIVE DATE OF 1994 AMENDMENT
For provision that dietary supplements may be labeled after Oct.
25, 1994, in accordance with amendments made by section 7(d) of
Pub. L. 103-417, and shall be so labeled after Dec. 31, 1996, see
section 7(e) of Pub. L. 103-417, set out as a note under section
343 of this title.
AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY
Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,
title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that:
"The Secretary of Health and Human Services shall amend any
regulation promulgated under the Federal Food, Drug, and Cosmetic
Act [this chapter] which is inconsistent with section 411 of such
Act [section 350 of this title] (as added by subsection (a)) and
such amendments shall be promulgated in accordance with section 553
of title 5, United States Code."
-FOOTNOTE-
(!1) So in original. Probably should be "paragraph".
-End-
-CITE-
21 USC Sec. 350a 01/03/2007
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350a. Infant formulas
-STATUTE-
(a) Adulteration
An infant formula, including an infant formula powder, shall be
deemed to be adulterated if -
(1) such infant formula does not provide nutrients as required
by subsection (i) of this section,
(2) such infant formula does not meet the quality factor
requirements prescribed by the Secretary under subsection (b)(1)
of this section, or
(3) the processing of such infant formula is not in compliance
with the good manufacturing practices and the quality control
procedures prescribed by the Secretary under subsection (b)(2) of
this section.
(b) Requirements for quality factors, good manufacturing practices,
and retention of records
(1) The Secretary shall by regulation establish requirements for
quality factors for infant formulas to the extent possible
consistent with current scientific knowledge, including quality
factor requirements for the nutrients required by subsection (i) of
this section.
(2)(A) The Secretary shall by regulation establish good
manufacturing practices for infant formulas, including quality
control procedures that the Secretary determines are necessary to
assure that an infant formula provides nutrients in accordance with
this subsection and subsection (i) of this section and is
manufactured in a manner designed to prevent adulteration of the
infant formula.
(B) The good manufacturing practices and quality control
procedures prescribed by the Secretary under subparagraph (A) shall
include requirements for -
(i) the testing, in accordance with paragraph (3) and by the
manufacturer of an infant formula or an agent of such
manufacturer, of each batch of infant formula for each nutrient
required by subsection (i) of this section before the
distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an
infant formula or an agent of such manufacturer, of samples of
infant formulas during the shelf life of such formulas to ensure
that such formulas are in compliance with this section,
(iii) in-process controls including, where necessary, testing
required by good manufacturing practices designed to prevent
adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula or an
agent of such manufacturer of regularly scheduled audits to
determine that such manufacturer has complied with the
regulations prescribed under subparagraph (A).
In prescribing requirements for audits under clause (iv), the
Secretary shall provide that such audits be conducted by
appropriately trained individuals who do not have any direct
responsibility for the manufacture or production of infant formula.
(3)(A) At the final product stage, each batch of infant formula
shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E
to ensure that such infant formula is in compliance with the
requirements of this subsection and subsection (i) of this section
relating to such vitamins.
(B) Each nutrient premix used in the manufacture of an infant
formula shall be tested for each relied upon nutrient required by
subsection (i) of this section which is contained in such premix to
ensure that such premix is in compliance with its specifications or
certifications by a premix supplier.
(C) During the manufacturing process or at the final product
stage and before distribution of an infant formula, an infant
formula shall be tested for all nutrients required to be included
in such formula by subsection (i) of this section for which testing
has not been conducted pursuant to subparagraph (A) or (B). Testing
under this subparagraph shall be conducted to -
(i) ensure that each batch of such infant formula is in
compliance with the requirements of subsection (i) of this
section relating to such nutrients, and
(ii) confirm that nutrients contained in any nutrient premix
used in such infant formula are present in each batch of such
infant formula in the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in
the table in subsection (i) of this section, the Secretary shall by
regulation require that the manufacturer of an infant formula test
each batch of such formula for such new nutrient in accordance with
subparagraph (A), (B), or (C).
(E) For purposes of this paragraph, the term "final product
stage" means the point in the manufacturing process, before
distribution of an infant formula, at which an infant formula is
homogenous and is not subject to further degradation.
(4)(A) The Secretary shall by regulation establish requirements
respecting the retention of records. Such requirements shall
provide for -
(i) the retention of all records necessary to demonstrate
compliance with the good manufacturing practices and quality
control procedures prescribed by the Secretary under paragraph
(2), including records containing the results of all testing
required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of
analysis by premix suppliers,
(iii) the retention by a premix supplier of all records
necessary to confirm the accuracy of all premix certifications
and guarantees of analysis,
(iv) the retention of -
(I) all records pertaining to the microbiological quality and
purity of raw materials used in infant formula powder and in
finished infant formula, and
(II) all records pertaining to food packaging materials which
show that such materials do not cause an infant formula to be
adulterated within the meaning of section 342(a)(2)(C) of this
title,
(v) the retention of all records of the results of regularly
scheduled audits conducted pursuant to the requirements
prescribed by the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of
files with respect to, and the review of, complaints concerning
infant formulas which may reveal the possible existence of a
hazard to health.
(B)(i) Records required under subparagraph (A) with respect to an
infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Except as
provided in clause (ii), such records shall be made available to
the Secretary for review and duplication upon request of the
Secretary.
(ii) A manufacturer need only provide written assurances to the
Secretary that the regularly scheduled audits required by paragraph
(2)(B)(iv) are being conducted by the manufacturer, and need not
make available to the Secretary the actual written reports of such
audits.
(c) Registration of persons distributing new infant formula
(1) No person shall introduce or deliver for introduction into
interstate commerce any new infant formula unless -
(A) such person has, before introducing such new infant
formula, or delivering such new infant formula for introduction,
into interstate commerce, registered with the Secretary the name
of such person, the place of business of such person, and all
establishments at which such person intends to manufacture such
new infant formula, and
(B) such person has at least 90 days before marketing such new
infant formula, made the submission to the Secretary required by
subsection (c)(1) of this section.
(2) For purposes of paragraph (1), the term "new infant formula"
includes -
(A) an infant formula manufactured by a person which has not
previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has
previously manufactured infant formula and in which there is a
major change, in processing or formulation, from a current or any
previous formulation produced by such manufacturer.
For purposes of this paragraph, the term "major change" has the
meaning given to such term in section 106.30(c)(2) of title 21,
Code of Federal Regulations (as in effect on August 1, 1986), and
guidelines issued thereunder.
(d) Submission of information about new infant formula required
(1) A person shall, with respect to any infant formula subject to
subsection (c) of this section, make a submission to the Secretary
which shall include -
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or change
in processing of the infant formula,
(C) assurances that the infant formula will not be marketed
unless it meets the requirements of subsections (b)(1) and (i) of
this section, as demonstrated by the testing required under
subsection (b)(3) of this section, and
(D) assurances that the processing of the infant formula
complies with subsection (b)(2) of this section.
(2) After the first production of an infant formula subject to
subsection (c) of this section, and before the introduction into
interstate commerce of such formula, the manufacturer of such
formula shall submit to the Secretary, in such form as may be
prescribed by the Secretary, a written verification which
summarizes test results and records demonstrating that such formula
complies with the requirements of subsections (b)(1), (b)(2)(A),
(b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this
section.
(3) If the manufacturer of an infant formula for commercial or
charitable distribution for human consumption determines that a
change in the formulation of the formula or a change in the
processing of the formula may affect whether the formula is
adulterated under subsection (a) of this section, the manufacturer
shall, before the first processing of such formula, make the
submission to the Secretary required by paragraph (1).
(e) Additional notice requirements for manufacturer
(1) If the manufacturer of an infant formula has knowledge which
reasonably supports the conclusion that an infant formula which has
been processed by the manufacturer and which has left an
establishment subject to the control of the manufacturer -
(A) may not provide the nutrients required by subsection (i) of
this section, or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such
knowledge. If the Secretary determines that the infant formula
presents a risk to human health, the manufacturer shall immediately
take all actions necessary to recall shipments of such infant
formula from all wholesale and retail establishments, consistent
with recall regulations and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term "knowledge" as
applied to a manufacturer means (A) the actual knowledge that the
manufacturer had, or (B) the knowledge which a reasonable person
would have had under like circumstances or which would have been
obtained upon the exercise of due care.
(f) Procedures applicable to recalls by manufacturer; regulatory
oversight
(1) If a recall of infant formula is begun by a manufacturer, the
recall shall be carried out in accordance with such requirements as
the Secretary shall prescribe under paragraph (2) and -
(A) the Secretary shall, not later than the 15th day after the
beginning of such recall and at least once every 15 days
thereafter until the recall is terminated, review the actions
taken under the recall to determine whether the recall meets the
requirements prescribed under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day after
the beginning of such recall and at least once every 14 days
thereafter until the recall is terminated, report to the
Secretary the actions taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and
extent of recalls of infant formulas necessary and appropriate for
the degree of risks to human health presented by the formula
subject to the recall.
(3) The Secretary shall by regulation require each manufacturer
of an infant formula who begins a recall of such formula because of
a risk to human health to request each retail establishment at
which such formula is sold or available for sale to post at the
point of purchase of such formula a notice of such recall at such
establishment for such time that the Secretary determines necessary
to inform the public of such recall.
(g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement
(1) Each manufacturer of an infant formula shall make and retain
such records respecting the distribution of the infant formula
through any establishment owned or operated by such manufacturer as
may be necessary to effect and monitor recalls of the formula. Such
records shall be retained for at least one year after the
expiration of the shelf life of the infant formula.
(2) To the extent that the Secretary determines that records are
not being made or maintained in accordance with paragraph (1), the
Secretary may by regulation prescribe the records required to be
made under paragraph (1) and requirements respecting the retention
of such records under such paragraph. Such regulations shall take
effect on such date as the Secretary prescribes but not sooner than
the 180th day after the date such regulations are promulgated. Such
regulations shall apply only with respect to distributions of
infant formulas made after such effective date.
(h) Exemptions; regulatory oversight
(1) Any infant formula which is represented and labeled for use
by an infant -
(A) who has an inborn error of metabolism or a low birth
weight, or
(B) who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c) of
this section. The manufacturer of an infant formula exempt under
this paragraph shall, in the case of the exempt formula, be
required to provide the notice required by subsection (e)(1) of
this section only with respect to adulteration or misbranding
described in subsection (e)(1)(B) of this section and to comply
with the regulations prescribed by the Secretary under paragraph
(2).
(2) The Secretary may by regulation establish terms and
conditions for the exemption of an infant formula from the
requirements of subsections (a), (b), and (c) of this section. An
exemption of an infant formula under paragraph (1) may be withdrawn
by the Secretary if such formula is not in compliance with
applicable terms and conditions prescribed under this paragraph.
(i) Nutrient requirements
(1) An infant formula shall contain nutrients in accordance with
the table set out in this subsection or, if revised by the
Secretary under paragraph (2), as so revised.
(2) The Secretary may by regulation -
(A) revise the list of nutrients in the table in this
subsection, and
(B) revise the required level for any nutrient required by the
table.
NUTRIENTS
--------------------------------------------------------------------
Nutrient Minimum Maximum
a a
--------------------------------------------------------------------
Protein (gm) 1.8 4.5.
b
Fat:
gm 3.3 6.0.
percent cal 30.0 54.0.
Essential fatty acids
(linoeate):
percent cal 2.7
mg 300.0
Vitamins:
A (IU) 250.0 (75 750.0 (225
µg µ
)c ;g).c
D (IU) 40.0 100.0.
K (µg) 4.0
E (IU) 0.7 (with 0.7
IU/gm
linoleic acid)
C (ascorbic acid) (mg) 8.0
B1 (thiamine) 40.0
(µg)
B2 (riboflavin) 60.0
(µg)
B6 (pyridoxine) 35.0 (with 15
(µg) µg/gm
of protein in
formula)
B12 (µg) 0.15
Niacin (µg) 250.0
Folic acid (µg) 4.0
Pantothenic acid (µg) 300.0
Biotin (µg) 1.5
d
Choline (mg) 7.0
d
Inositol (mg) 4.0
d
Minerals:
Calcium (mg) 50.0
e
Phosphorus (mg) 25.0
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
-End-
-CITE-
21 USC Sec. 381 01/03/2007
-EXPCITE-
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-