21CFR CONTROLLED SUBSTANCES ACT
PART 1310--RECORDS
[Code of Federal Regulations]
[Title 21, Volume 9, Parts 1300 to end]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1310]
[Page 107-117]
TITLE 21-FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
Sec.
1310.01 Definitions.
1310.02 Substances covered.
1310.03 Persons required to keep records and file reports.
1310.04 Maintenance of records.
1310.05 Reports.
1310.06 Content of records and reports.
1310.07 Proof of identity.
1310.08 Excluded transactions.
1310.09 Temporary exemption from registration.
1310.10 Removal of the exemption of drugs distributed under the Food,
Drug and Cosmetic Act.
1310.11 Reinstatement of exemption for drug products distributed under
the Food, Drug and Cosmetic Act.
1310.14 Exemption of drug products containing ephedrine and
therapeutically significant quantities of another active
medicinal ingredient.
1310.15 Exempt drug products containing ephedrine and therapeutically
significant quantities of another active medicinal ingredient.
Authority: 21 U.S.C. 802, 830, 871(b).
Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
Sec. 1310.01 Definitions.
Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13968, Mar. 24, 1997]
Sec. 1310.02 Substances covered.
The following chemicals have been specifically designated by the
Administrator of the Drug Enforcement Administration as the listed
chemicals subject to the provisions of this part and parts 1309 and 1313
of this chapter. Each chemical has been assigned the DEA Chemical Code
Number set forth opposite it.
(a) List I chemicals
(1) Anthranilic acid, its esters, and its salts.....................8530
(2) Benzyl cyanide..................................................8735
(3) Ephedrine, its salts, optical isomers, and salts of optical isomers
8113
(4) Ergonovine and its salts........................................8675
(5) Ergotamine and its salts........................................8676
(6) N-Acetylanthranilic acid, its esters, and its salts.............8522
(7) Norpseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8317
(8) Phenylacetic acid, its esters, and its salts....................8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts of
optical isomers.....................................................1225
(10) Piperidine and its salts.......................................2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers.............................................................8112
(12) 3,4-Methylenedioxyphenyl-2-propanone...........................8502
(13) Methylamine and its salts......................................8520
(14) Ethylamine and its salts.......................................8678
(15) Propionic anhydride............................................8328
(16) Isosafrole.....................................................8704
(17) Safrole........................................................8323
(18) Piperonal......................................................8750
[[Page 108]]
(19) N-Methylephedrine, its salts, optical isomers, and salts of optical
isomers (N-Methylephedrine).........................................8115
(20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of
optical isomers.....................................................8119
(21) Hydriodic Acid.................................................6695
(22) Benzaldehyde...................................................8256
(23) Nitroethane....................................................6724
(b) List II chemicals:
(1) Acetic anhydride................................................8519
(2) Acetone.........................................................6532
(3) Benzyl chloride.................................................8570
(4) Ethyl ether.....................................................6584
(5) Potassium permanganate..........................................6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)......................6714
(7) Toluene.........................................................6594
(8) Hydrochloric acid...............................................6545
(9) Sulfuric acid...................................................6552
(10) Methyl Isobutyl Ketone (MIBK)..................................6715
(c) The Administrator may add or delete a substance as a listed
chemical by publishing a final rule in the Federal Register following a
proposal which shall be published at least 30 days prior to the final
rule.
(d) Any person may petition the Administrator to have any substance
added or deleted from paragraphs (a) or (b) of this section.
(e) Any petition under this section shall contain the following
information:
(1) The name and address of the petitioner;
(2) The name of the chemical to which the petition pertains;
(3) The name and address of the manufacturer(s) of the chemical (if
known);
(4) A complete statement of the facts which the petitioner believes
justifies the addition or deletion of the substance from paragraphs (a)
or (b) of this section;
(5) The date of the petition.
(f) The Administrator may require the petitioner to submit such
documents or written statements of fact relevant to the petition as he
deems necessary in making a determination.
(g) Within a reasonable period of time after the receipt of the
petition, the Administrator shall notify the petitioner of his decision
and the reason therefor. The Administrator need not accept a petition if
any of the requirements prescribed in paragraph (e) of this section or
requested pursuant to paragraph (f) of this section are lacking or are
not clearly set forth as to be readily understood. If the petitioner
desires, he may amend and resubmit the petition to meet the requirements
of paragraphs (e) and (f) of this section.
(h) If a petition is granted or the Administrator, upon his own
motion, proposes to add or delete substances as listed chemicals as set
forth in paragraph (c) of this section, he shall issue and publish in
the Federal Register a proposal to add or delete a substance as a listed
chemical. The Administrator shall permit any interested person to file
written comments regarding the proposal within 30 days of the date of
publication of his order in the Federal Register. The Administrator will
consider any comments filed by interested persons and publish a final
rule in accordance with his decision in the matter.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991;
57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460,
June 22, 1995; 62 FR 5917, Feb. 10, 1997]
Sec. 1310.03 Persons required to keep records and file reports.
(a) Each regulated person who engages in a regulated transaction
involving a listed chemical, a tableting machine, or an encapsulating
machine shall keep a record of the transaction as specified by
Sec. 1310.04 and file reports as specified by Sec. 1310.05. However, a
non-regulated person who acquires listed chemicals for internal
consumption or ``end use'' and becomes a regulated person by virtue of
infrequent or rare distribution of a listed chemical from inventory,
shall not be required to maintain receipt records of listed chemicals
under this section.
(b) Each regulated person who manufactures a List I or List II
chemical shall file reports regarding such manufacture as specified in
Section 1310.05.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61
FR 14023, Mar. 29, 1996]
Sec. 1310.04 Maintenance of records.
(a) Every record required to be kept subject to Sec. 1310.03 for a
List I chemical, a tableting machine, or an encapsulating machine shall
be kept by the
[[Page 109]]
regulated person for 2 years after the date of the transaction.
(b) Every record required to be kept subject to Section 1310.03 for
List II chemical shall be kept by the regulated person for two years
after the date of the transaction.
(c) A record under this section shall be kept at the regulated
person's place of business where the transaction occurred, except that
records may be kept at a single, central location of the regulated
person if the regulated person has notified the Administration of the
intention to do so. Written notification must be submitted by registered
or certified mail, return receipt requested, to the Special Agent in
Charge of the DEA Divisional Office for the area in which the records
are required to be kept.
(d) The records required to be kept under this section shall be
readily retrievable and available for inspection and copying by
authorized employees of the Administration under the provisions of 21
U.S.C. 880.
(e) The regulated person with more than one place of business where
records are required to be kept shall devise a system to detect any
party purchasing from several individual locations of the regulated
person thereby seeking to avoid the application of the cumulative
threshold or evading the requirements of the Act.
(f) For those listed chemicals for which thresholds have been
established, the quantitative threshold or the cumulative amount for
multiple transactions within a calendar month, to be utilized in
determining whether a receipt, sale, importation or exportation is a
regulated transaction is as follows:
(1) List I Chemicals:
------------------------------------------------------------------------
Chemical Threshold by base weight
------------------------------------------------------------------------
(i) Anthranilic acid and its salts... 30 kilograms.
(ii) Benzyl cyanide.................. 1 kilogram.
(iii) Ergonovine and its salts....... 10 grams.
(iv) Ergotamine and its salts........ 20 grams.
(v) N-Acetylanthranilic acid and its 40 kilograms
salts.
(vi) Norpseudoephedrine, its salts, 2.5 kilograms.
optical isomers, and salts of
optical isomers.
(vii) Phenylacetic acid and its salts 1 kilogram.
(viii) Phenylpropanolamine, its 2.5 kilograms.
salts, optical isomers, and salts of
optical isomers.
(ix) Piperidine and its salts........ 500 grams.
(x) Pseudoephedrine, its salts, 1 kilogram
optical isomers, and salts of
optical isomers.
(xi) 3, 4-Methylenedioxyphenyl-2- 4 kilograms.
propanone.
(xii) Methylamine and its salts...... 1 kilogram.
(xiii) Ethylamine and its salts...... 1 kilogram.
(xiv) Propionic anhydride............ 1 gram.
(xv) Isosafrole...................... 4 kilograms.
(xvi) Safrole........................ 4 kilograms.
(xvii) Piperonal..................... 4 kilograms.
(xviii) N-Methylephedrine, its salts, 1 kilogram.
optical isomers, and salts of
optical isomers.
(xix) N-Methylpseudoephedrine, its 1 kilogram.
salts, optical isomers, and salts of
optical isomers.
(xx) Hydriotic acid (57%)............ 1.7 kilograms (or 1 liter by
volume).
(xxi) Benzaldehyde................... 4 Kilograms.
(xxii) Nitroethane................... 2.5 Kilograms.
------------------------------------------------------------------------
(2) List II Chemicals:
(i) Imports and Exports
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 500 gallons........................ 1,500 kilograms.
(C) Benzyl chloride.................... N/A................................ 4 kilograms.
(D) Ethyl ether........................ 500 gallons........................ 1,364 kilograms.
(E) Potassium permanganate............. N/A................................ 500 kilograms.
(F) 2-Butanone (MEK)................... 500 gallons........................ 1,455 kilograms.
(G) Toluene............................ 500 gallons........................ 1,591 kilograms.
----------------------------------------------------------------------------------------------------------------
(ii) Domestic Sales
[[Page 110]]
----------------------------------------------------------------------------------------------------------------
Chemical Threshold by volume Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride................... 250 gallons........................ 1,023 kilograms.
(B) Acetone............................ 50 gallons......................... 150 kilograms.
(C) Benzyl chloride.................... N/A................................ 1 kilogram.
(D) Ethyl ether........................ 50 gallons......................... 135.8 kilograms.
(E) Potassium permanganate............. N/A................................ 55 kilograms.
(F) 2-Butanone (MEK)................... 50 gallons......................... 145 kilograms.
(G) Toluene............................ 50 gallons......................... 159 kilograms.
----------------------------------------------------------------------------------------------------------------
(iii) The cumulative threshold is not applicable to domestic sales
of Acetone, 2-Butanone (MEK), and Toluene.
(iv) Exports, transshipments and international transactions to
Designated Countries set forth in Sec. 1310.08(b)
(v) Export and International Transactions to Designated Countries,
and Importations for Transshipment or Transfer to Designated Countries
------------------------------------------------------------------------
Threshold by
Chemical volume Threshold by weight
------------------------------------------------------------------------
(A) Methyl Isobutyl Ketone 500 gallons....... 1523 kilograms.
(MIBK).
(B) Reserved.
------------------------------------------------------------------------
(g) For listed chemicals for which no thresholds have been
established, the size of the transaction is not a factor in determining
whether the transaction meets the definition of a regulated transaction
as set forth in Sec. 1310.01(f). All such transactions, regardless of
size, are subject to recordkeeping and reporting requirements as set
forth in this part 1310 and notification provisions as set forth in part
1313 of this chapter.
(1) Listed Chemicals For Which No Thresholds Have Been Established:
(i) Ephedrine, its salts, optical isomers, and salts of optical
isomers
(ii) [Reserved]
(2) [Reserved]
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991;
57 FR 43615, Sept. 22, 1992; 59 FR 51367, Oct. 11, 1994; 60 FR 19510,
Apr. 19, 1995; 60 FR 32460, June 22, 1995; 60 FR 42436, Aug. 16, 1995;
62 FR 5917, Feb. 10, 1997]
Sec. 1310.05 Reports.
(a) Each regulated person shall report to the Special Agent in
Charge of the DEA Divisional Office for the area in which the regulated
person making the report is located, as follows:
(1) Any regulated transaction involving an extraordinary quantity of
a listed chemical, an uncommon method of payment or delivery, or any
other circumstance that the regulated person believes may indicate that
the listed chemical will be used in violation of this part.
(2) Any proposed regulated transaction with a person whose
description or other identifying characteristic the Administration has
previously furnished to the regulated person.
(3) Any unusual or excessive loss or disappearance of a listed
chemical under the control of the regulated person. The regulated person
responsible for reporting a loss in-transit is the supplier.
(4) Any domestic regulated transaction in a tableting machine or an
encapsulating machine.
(b) Each report submitted pursuant to paragraph (a) of this section
shall, whenever possible, be made orally to the DEA Divisional Office
for the area in which the regulated person making the report is located
at the earliest practicable opportunity after the regulated person
becomes aware of the circumstances involved and as much in advance of
the conclusion of the transaction as possible. Written reports of
transactions listed in paragraphs (a)(1), (a)(3) and (a)(4) of this
section will subsequently be filed as set forth in Sec. 1310.06 within
15 days after the regulated person becomes aware of the circumstances of
the event. A transaction may not be completed with a person whose
description or identifying characteristic has previously been furnished
to the regulated person by the Administration unless the transaction is
approved by the Administration.
(c) Each regulated person who imports or exports a tableting
machine, or encapsulation machine, shall file a report (not a 486) of
such importation or exportation with the Administration at the following
address on or before the date of importation or exportation:
[[Page 111]]
Drug Enforcement Administration, P.O. Box 28346, Washington, DC 20038.
In order to facilitate the importation or exportation of any tableting
machine or encapsulating machine and implement the purpose of the Act,
regulated persons may wish to report to the Administration as far in
advance as possible. A copy of the report may be transmitted directly to
the Drug Enforcement Administration through electronic facsimile media.
Any tableting machine or encapsulating machine may be imported or
exported if that machine is needed for medical, commercial, scientific,
or other legitimate uses. However, an importation or exportation of a
tableting machine or encapsulating machine may not be completed with a
person whose description or identifying characteristic has previously
been furnished to the regulated person by the Administration unless the
transaction is approved by the Administration.
(d) Each regulated bulk manufacturer of a listed chemical shall
submit manufacturing, inventory and use data on an annual basis as set
forth in Sec. 1310.06(h). This data shall be submitted annually to the
Drug and Chemical Evaluation Section, Drug Enforcement Administration
(DEA), Washington, D.C. 20537, on or before the 15th day of March of the
year immediately following the calendar year for which submitted. A
business entity which manufactures a listed chemical may elect to report
separately by individual location or report as an aggregate amount for
the entire business entity provided that they inform the DEA of which
method they will use. This reporting requirement does not apply to drug
or other products which are exempted under Secs. 1310.01(f)(1)(iv) or
1310.01(f)(1)(v) except as set forth in Sec. 1310.06(h)(5). Bulk
manufacturers that produce a listed chemical solely for internal
consumption shall not be required to report for that listed chemical.
For purposes of these reporting requirements, internal consumption shall
consist of any quantity of a listed chemical otherwise not available for
further resale or distribution. Internal consumption shall include (but
not be limited to) quantities used for quality control testing,
quantities consumed in-house or production losses. Internal consumption
does not include the quantities of a listed chemical consumed in the
production of exempted products. If an existing standard industry report
contains the information required in Sec. 1310.06(h) and such
information is separate or readily retrievable from the report, that
report may be submitted in satisfaction of this requirement. Each report
shall be submitted to the DEA under company letterhead and signed by an
appropriate, responsible official. For purposes of this paragraph only,
the term regulated bulk manufacturer of a listed chemical means a person
who manufactures a listed chemical by means of chemical synthesis or by
extraction from other substances. The term bulk manufacturer does not
include persons whose sole activity consists of the repackaging or
relabeling of listed chemical products or the manufacture of drug dosage
form products which contain a listed chemical.
[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61
FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar.
24, 1997]
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03 shall include the
following:
(1) The name, address, and, if required, DEA registration number of
each party to the regulated transaction.
(2) The date of the regulated transaction.
(3) The name, quantity and form of packaging of the listed chemical
or a description of the tableting machine or encapsulating machine
(including make, model and serial number).
(4) The method of transfer (company truck, picked up by customer,
etc.).
(5) The type of identification used by the purchaser and any unique
number on that identification.
(b) For purposes of this section, normal business records shall be
considered adequate if they contain the information listed in paragraph
(a) of this section and are readily retrievable from other business
records of the regulated person. For prescription drug products,
prescription and hospital
[[Page 112]]
records kept in the normal course of medical treatment shall be
considered adequate for satisfying the requirements of paragraph (a) of
this section with respect to dispensing to patients, and records
required to be maintained pursuant to the Federal Food and Drug
Administration regulations relating to the distribution of prescription
drugs, as set forth in 21 CFR part 205, shall be considered adequate for
satisfying the requirements of paragraph (a) of this section with
respect to distributions.
(c) Each report required by Section 1310.05(a) shall include the
information as specified by Section 1310.06(a) and, where obtainable,
the registration number of the other party, if such party is registered.
A report submitted pursuant to Sec. 1310.05(a)(1) or (a)(4) must also
include a description of the circumstances leading the regulated person
to make the report, such as the reason that the method of payment was
uncommon or the loss unusual. If the report is for a loss or
disappearance under Sec. 1310.05(a)(4), the circumstances of such loss
must be provided (in-transit, theft from premises, etc.)
(d) A suggested format for the reports is provided below:
Supplier:
Registration Number____________________________________________________
Name___________________________________________________________________
Business Address_______________________________________________________
City___________________________________________________________________
State__________________________________________________________________
Zip____________________________________________________________________
Business Phone_________________________________________________________
Purchaser:
Registration Number____________________________________________________
Name___________________________________________________________________
Business Address_______________________________________________________
City___________________________________________________________________
State__________________________________________________________________
Zip____________________________________________________________________
Business Phone_________________________________________________________
Identification_________________________________________________________
Shipping Address (if different than purchaser Address):
Street_________________________________________________________________
City___________________________________________________________________
State__________________________________________________________________
Zip____________________________________________________________________
Date of Shipment_______________________________________________________
Name of Listed Chemical(s)_____________________________________________
Quantity and Form of Packaging_________________________________________
Description of Machine:
Make___________________________________________________________________
Model__________________________________________________________________
Serial #_______________________________________________________________
Method of Transfer_____________________________________________________
If Loss or Disappearance:
Date of Loss___________________________________________________________
Type of Loss___________________________________________________________
Description of Circumstances___________________________________________
Public reporting burden for this collection of information is estimated
to average ten minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to the Drug Enforcement Administration, Records
Management Section, Washington, D.C. 20537; and to the Office of
Management and Budget, Paperwork Reduction Project No. 1117-0024,
Washington, D.C. 20503.
(e) Each report of an importation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c) shall include the
following information:
(1) The name, address, telephone number, tdlex number, and, where
available, the facsimile number of the regulated person; the name,
address, telephone number, telex number, and, where available, the
facsimile number of the import broker or forwarding agent, if any:
(2) The description of each machine (including make, model, and
serial number) and the number of machines being received;
(3) The proposed import date, and the first U.S. Customs Port of
Entry; and
(4) The name, address, telephone number, telex number, and, where
available, the facsimile number of the consignor in the foreign country
of exportation.
(f) Each report of an exportation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c) shall include the
following information:
(1) The name, address, telephone number, telex number, and, where
available, the facsimile number of the regulated person; the name,
address,
[[Page 113]]
telephone number, telex number, and, where available, the facsimile
number of the export broker, if any;
(2) The description of each machine (including make, model, and
serial number) and the number of machines being shipped;
(3) The proposed export date, the U.S. Customs Port of exportation,
and the foreign Port of Entry; and
(4) The name, address, telephone, telex, and, where available, the
facsimile number of the consignee in the country where the shipment is
destined; the name(s) and address(es) of any intermediate consignee(s).
(g) Declared exports of machines which are refused, rejected, or
otherwise deemed undeliverable may be returned to the U.S. exporter of
record. A brief written report outlining the circumstances must be sent
to the Drug Enforcement Administration, P.O. Box 28346, Washington, DC
20038, following the return within a reasonable time. This provision
does not apply to shipments that have cleared foreign customs, been
delivered, and accepted by the foreign consignee. Returns to third
parties in the United States will be regarded as imports.
(h) Each annual report required by Section 1310.05(d) shall provide
the following information for each listed chemical manufactured:
(1) The name, address and chemical registration number (if any) of
the manufacturer and person to contact for information.
(2) The aggregate quantity of each listed chemical that the company
manufactured during the preceding calendar year.
(3) The year-end inventory of each listed chemical as of the close
of business on the 31st day of December of each year. (For each listed
chemical, if the prior period's ending inventory has not previously been
reported to DEA, this report should also detail the beginning inventory
for the period.) For purposes of this requirement, inventory shall
reflect the quantity of listed chemicals, whether in bulk or non-exempt
product form, held in storage for later distribution. Inventory does not
include waste material for destruction, material stored as an in-process
intermediate or other in-process material.
(4) The aggregate quantity of each listed chemical used for internal
consumption during the preceding calendar year, unless the chemical is
produced solely for internal consumption.
(5) The aggregate quantity of each listed chemical manufactured
which becomes a component of a product exempted from Section
1310.01(f)(1)(iv) or 1310.01(f)(1)(v) during the preceding calendar
year.
(6) Data shall identify the specific isomer, salt or ester when
applicable but quantitative data shall be reported as anhydrous base or
acid in kilogram units of measure.
[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2462, Jan. 22, 1992; 59
FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, Mar.
29, 1996; 61 FR 32926, June 26, 1996]
Sec. 1310.07 Proof of identity.
(a) Each regulated person who engages in a regulated transaction
must identify the other party to the transaction. For domestic
transaction, this shall be accomplished by having the other party
present documents which would verify the identity, or registration
status if a registrant, of the other party to the regulated person at
the time the order is placed. For export transactions, this shall be
accomplished by good faith inquiry through reasonably available research
documents or publicly available information which would indicate the
existence of the foreign customer. No proof of identity is required for
foreign suppliers.
(b) The regulated person must verify the existence and apparent
validity of a business entity ordering a listed chemical, tableting
machine or encapsulating machine. For domestic transactions, this may be
accomplished by such methods as checking the telephone directory, the
local credit bureau, the local Chamber of Commerce or the local Better
Business Bureau, or, if the business entity is a registrant, by
verification of the registration. For export transactions, a good faith
inquiry to verify the existence and apparent validity of a foreign
business entity may be accomplished by such methods as verifying the
business telephone listing through international telephone
[[Page 114]]
information, the firm's listing in international or foreign national
chemical directories or other commerce directories or trade
publications, confirmation through foreign subsidiaries of the U.S.
regulated person, verification through the country of destination's
embassy Commercial Attache, or official documents provided by the
purchaser which confirm the existence and apparent validity of the
business entity.
(c) When transacting business with a new representative of a firm,
the regulated person must verify the claimed agency status of the
representative.
(d) For sales to individuals or cash purchasers, the type of
documents and other evidence of proof must consist of at least a
signature of the purchaser, a driver's license and one other form of
identification. Any exports to individuals or exports paid in cash are
suspect and should be handled as such. For such exports, the regulated
person shall diligently obtain from the purchaser or independently seek
to confirm clear documentation which proves the person is properly
identified such as through foreign identity documents, driver's license,
passport information and photograph, etc. Any regulated person who fails
to adequately prove the identity of the other party to the transaction
may be subject to the specific penalties provided for violations of law
related to regulated transactions in listed chemicals.
(e) For a new customer who is not an individual or cash customer,
the regulated person shall establish the identity of the authorized
purchasing agent or agents and have on file that person's signature,
electronic password, or other identification. Once the authorized
purchasing agent has been established, the agent list may be updated
annually rather than on each order. The regulated person must ensure
that shipments are not made unless the order is placed by an authorized
agent of record.
(f) With respect to electronic orders, the identity of the purchaser
shall consist of a computer password, identification number or some
other means of identification consistent with electronic orders and with
Sec. 1310.07(e).
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32461, June 22, 1995]
Sec. 1310.08 Excluded transactions.
Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following
transactions has been determined to be unnecessary for the enforcement
of the Chemical Diversion and Trafficking Act and, therefore, they have
been excluded from the definitions of regulated transactions:
(a) Domestic and import transactions of hydrochloric and sulfuric
acids.
(b) Exports, transshipments, and international transactions of
hydrochloric and sulfuric acids, except for exports, transshipments and
international transactions to the following countries:
(1) Argentina
(2) Bolivia
(3) Brazil
(4) Chile
(5) Colombia
(6) Ecuador
(7) French Guiana
(8) Guyana
(9) Panama
(10) Paraguay
(11) Peru
(12) Suriname
(13) Uruguay
(14) Venezuela
(c) Domestic transactions of Methyl Isobutyl Ketone (MIBK).
(d) Import transactions of Methyl Isobutyl Ketone (MIBK) destined
for the United States.
(e) Export transactions, international transactions, and import
transactions for transshipment or transfer of Methyl Isobutyl Ketone
(MIBK) destined for Canada or any country outside of the Western
Hemisphere.
[57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995;
60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997]
Sec. 1310.09 Temporary exemption from registration.
(a) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a combination
ephedrine product is temporarily exempted from the
[[Page 115]]
registration requirement, provided that the person submits a proper
application for registration on or before July 12, 1997. The exemption
will remain in effect for each person who has made such application
until the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309, 1310, and 1313 of this chapter
remain in full force and effect.
(b) Each person required by section 302 of the act (21 U.S.C. 822)
to obtain a registration to distribute, import, or export a drug product
that contains pseudoephedrine or phenylpropanolamine that is regulated
pursuant to Sec. 1300.02(b)(28)(1)(D) of this chapter is temporarily
exempted from the registration requirement, provided that the person
submits a proper application for registration on or before December 3,
1997. The exemption will remain in effect for each person who has made
such application until the Administration has approved or denied that
application. This exemption applies only to registration; all other
chemical control requirements set forth in parts 1309, 1310, and 1313 of
this chapter remain in full force and effect.
[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997]
Sec. 1310.10 Removal of the exemption of drugs distributed under the
Food, Drug and Cosmetic Act.
(a) The Administrator may remove from exemption under
Sec. 1310.01(b)(28)(i)(D) any drug or group of drugs that the
Administrator finds is being diverted to obtain a listed chemical for
use in the illicit production of a controlled substance. In removing a
drug or group of drugs from the exemption the Administrator shall
consider:
(1) The scope, duration, and significance of the diversion;
(2) Whether the drug or group of drugs is formulated in such a way
that it cannot be easily used in the illicit production of a controlled
substance; and
(3) Whether the listed chemical can be readily recovered from the
drug or group of drugs.
(b) Upon determining that a drug or group of drugs should be removed
from the exemption under paragraph (a) of this section, the
Administrator shall issue and publish in the Federal Register his
proposal to remove the drug or group of drugs from the exemption, which
shall include a reference to the legal authority under which the
proposal is based. The Administrator shall permit any interested person
to file written comments on or objections to the proposal. After
considering any comments or objections filed, the Administrator shall
publish in the Federal Register his final order.
(c) The Administrator shall limit the removal of a drug or group of
drugs from exemption under paragraph (a) of this section to the most
identifiable type of the drug or group of drugs for which evidence of
diversion exists unless there is evidence, based on the pattern of
diversion and other relevant factors, that the diversion will not be
limited to that particular drug or group of drugs.
(d) Any manufacturer seeking reinstatement of a particular drug
product that has been removed from an exemption under paragraph (a) of
this section, may apply to the Administrator for reinstatement of the
exemption for that particular drug product on the grounds that the
particular drug product is manufactured and distributed in a manner that
prevents diversion. In determining whether the exemption should be
reinstated the Administrator shall consider:
(1) The package sizes and manner of packaging of the drug product;
(2) The manner of distribution and advertising of the drug product;
(3) Evidence of diversion of the drug product;
(4) Any actions taken by the manufacturer to prevent diversion of
the drug product; and
(5) Such other factors as are relevant to and consistent with the
public health and safety, including the factors described in paragraph
(a) of this section as applied to the drug product.
(e) Within a reasonable period of time after receipt of the
application for reinstatement of the exemption, the
[[Page 116]]
Administrator shall notify the applicant of his acceptance or non-
acceptance of his application, and if not accepted, the reason therefor.
If the application is accepted for filing, the Administrator shall issue
and publish in the Federal Register his order on the reinstatement of
the exemption for the particular drug product, which shall include a
reference to the legal authority under which the order is based. This
order shall specify the date on which it shall take effect. The
Administrator shall permit any interested person to file written
comments on or objections to the order. If any such comments raise
significant issues regarding any finding of fact or conclusion of law
upon which the order is based, the Administrator shall immediately
suspend the effectiveness of the order until he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, revoke, or amend his original order
as he determines appropriate.
(f) Unless the Administrator has evidence that the drug product is
being diverted, as determined by applying the factors set forth in
paragraph (a) of this section, and the Administrator so notifies the
applicant, transactions involving a specific drug product will not be
considered regulated transactions during the following periods:
(1) While a bonafide application for reinstatement of exemption
under paragraph (d) of this section for the specific drug product is
pending resolution, provided that the application for reinstatement is
filed not later than 60 days after the publication of the final order
removing the exemption; and
(2) For a period of 60 days following the Administrator's denial of
an application for reinstatement.
(g) An order published by the Administrator in the Federal Register,
pursuant to paragraph (e) of this section, to reinstate an exemption may
be modified or revoked with respect to a particular drug product upon a
finding that:
(1) Applying the factors set forth in paragraph (a) of this section
to the particular drug product, the drug product is being diverted; or
(2) There is a significant change in the data that led to the
issuance of the final rule.
[60 FR 32461, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1310.11 Reinstatement of exemption for drug products distributed
under the Food, Drug and Cosmetic Act.
(a) The Administrator has reinstated the exemption for the drug
products listed in paragraph (e) of this section from application of
sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823,
830, and 957-958), to the extent described in paragraphs (b), (c), and
(d) of this section.
(b) No reinstated exemption granted pursuant to 1310.10 affects the
criminal liability for illegal possession or distribution of listed
chemicals contained in the exempt drug product.
(c) Changes in exempt drug product compositions: Any change in the
quantitative or qualitative composition, trade name or other designation
of an exempt drug product listed in paragraph (d) requires a new
application for reinstatement of the exemption.
(d) The following drug products, in the form and quantity listed in
the application submitted (indicated as the ``date'') are designated as
reinstated exempt drug products for the purposes set forth in this
section:
Exempt Drug Products
----------------------------------------------------------------------------------------------------------------
Supplier Product name Form Date
----------------------------------------------------------------------------------------------------------------
[Reserved]........................... ....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
[60 FR 32462, June 22, 1995]
Sec. 1310.14 Exemption of drug products containing ephedrine and
therapeutically significant quantities of another active
medicinal ingredient.
(a) Any manufacturer of a drug product containing ephedrine in
combination with another active medicinal ingredient, the product
formulation of which is not listed in the compendiums set forth in Sec.
1310.01(b)(28)(i)(D)(1), may request that the Administrator exempt the
product as one which contains ephedrine together with a therapeutically
significant quantity of another active medicinal ingredient.
[[Page 117]]
(b) An application for an exemption under this section shall contain
the following information:
(1) The name and address of the applicant;
(2) The exact trade name of the drug product for which exemption is
sought;
(3) The complete quantitative and qualitative composition of the
drug product;
(4) A brief statement of the facts which the applicant believes
justify the granting of an exemption under this section; and
(5) Certification by the applicant that the product may be lawfully
marketed or distributed under the Food, Drug, and Cosmetic Act.
(6) The identification of any information on the application which
is considered by the applicant to be a trade secret or confidential and
entitled to protection under U.S. laws restricting the public disclosure
of such information by government employees.
(c) The Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application which he deems necessary for determining if the application
should be granted.
(d) Within a reasonable period of time after the receipt of a
completed application for an exemption under this section, the
Administrator shall notify the applicant of acceptance or non-acceptance
of the application. If the application is not accepted, an explanation
will be provided. The Administrator is not required to accept an
application if any of the information required in paragraph (b) of this
section or requested pursuant to paragraph (c) of this section is
lacking or not readily understood. The applicant may, however, amend the
application to meet the requirements of paragraphs (b) and (c) of this
section. If the application is accepted for filing, the Administrator
shall issue and publish in the Federal Register an order on the
application, which shall include a reference to the legal authority
under which the order is based. This order shall specify the date on
which it shall take effect. The Administrator shall permit any
interested person to file written comments on or objections to the
order. If any comments or objections raise significant issues regarding
any findings of fact or law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Administrator shall reinstate, revoke,
or amend the original order as deemed appropriate.
[60 FR 32462, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Sec. 1310.15 Exempt drug products containing ephedrine and
therapeutically significant quantities of another active
medicinal ingredient.
(a) The drug products containing ephedrine and therapeutically
significant quantities of another active medicinal ingredient listed in
paragraph (e) of this section have been exempted by the Administrator
from application of sections 302, 303, 310, 1007, and 1008 of the Act
(21 U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs
(b), (c), and (d) of this section.
(b) No exemption granted pursuant to 1310.14 affects the criminal
liability for illegal possession or distribution of listed chemicals
contained in the exempt drug product.
(c) Changes in drug product compositions: Any change in the
quantitative or qualitative composition of an exempt drug product listed
in paragraph (d) requires a new application for exemption.
(d) In addition to the drug products listed in the compendium set
forth in Sec. 1310.01(b)(28)(i)(D)(1), the following drug products, in
the form and quantity listed in the application submitted (indicated as
the ``date'') are designated as exempt drug products for the purposes
set forth in this section:
Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal
Ingredient
----------------------------------------------------------------------------------------------------------------
Supplier Product name Form Date
----------------------------------------------------------------------------------------------------------------
[Reserved]........................... ....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
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