[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: 21CFR1300]

[Page 5-12]
 
                         TITLE 21-FOOD AND DRUGS
 
 CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1300--DEFINITIONS--Table of Contents


Sec.
1300.01  Definitions relating to controlled substances.
1300.02  Definitions relating to listed chemicals.

    Authority:  21 U.S.C. 802, 871(b), 951, 958(f)

    Source:  62 FR 13941, Mar. 24, 1997, unless otherwise noted.

Sec. 1300.01  Definitions relating to controlled substances.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1301 through 1308 and part 1312 of this 
chapter, the following terms shall have the meanings specified:
    (1) The term Act means the Controlled Substances Act, as amended (84 
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and 
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The term anabolic steroid means any drug or hormonal substance, 
chemically and pharmacologically related to testosterone (other than 
estrogens, progestins, and corticosteroids) that promotes muscle growth, 
and includes:
    (i) Boldenone;
    (ii) Chlorotestosterone (4-chlortestosterone);
    (iii) Clostebol;
    (iv) Dehydrochlormethyltestosterone;
    (v) Dihydrotestosterone (4-dihydrotestosterone);
    (vi) Drostanolone;
    (vii) Ethylestrenol;
    (viii) Fluoxymesterone;
    (ix) Formebulone (formebolone);
    (x) Mesterolone;
    (xi) Methandienone;
    (xii) Methandranone;
    (xiii) Methandriol;
    (xiv) Methandrostenolone;
    (xv) Methenolone;
    (xvi) Methyltestosterone;
    (xvii) Mibolerone;
    (xviii) Nandrolone;
    (xix) Norethandrolone;
    (xx) Oxandrolone;
    (xxi) Oxymesterone;
    (xxii) Oxymetholone;
    (xxiii) Stanolone;
    (xxiv) Stanozolol;
    (xxv) Testolactone;
    (xxvi) Testosterone;
    (xxvii) Trenbolone; and
    (xxviii) Any salt, ester, or isomer of a drug or substance described 
or listed in this paragraph, if that salt, ester, or isomer promotes 
muscle growth. Except such term does not include an anabolic steroid 
which is expressly intended for administration through implants to 
cattle or other nonhuman species and which has been approved by the 
Secretary of Health and Human Services for such administration. If any 
person prescribes, dispenses, or distributes such steroid for human use, 
such person shall be considered to have prescribed, dispensed, or 
distributed an anabolic steroid within the meaning of this paragraph.
    (5) The term basic class means, as to controlled substances listed 
in Schedules I and II:
    (i) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.11(b) of this 
chapter;
    (ii) Each of the opium derivatives, including its salts, isomers, 
and salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation, 
listed in Sec. 1308.11(c) of this chapter;
    (iii) Each of the hallucinogenic substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation, listed in Sec. 1308.11(d) of this chapter;
    (iv) Each of the following substances, whether produced directly or 
indirectly

[[Page 6]]

by extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (A) Opium, including raw opium, opium extracts, opium fluid 
extracts, powdered opium, granulated opium, deodorized opium and 
tincture of opium;
    (B) Apomorphine;
    (C) Codeine;
    (D) Etorphine hydrochloride;
    (E) Ethylmorphine;
    (F) Hydrocodone;
    (G) Hydromorphone;
    (H) Metopon;
    (I) Morphine;
    (J) Oxycodone;
    (K) Oxymorphone;
    (L) Thebaine;
    (M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this 
chapter;
    (N) Cocaine; and
    (O) Ecgonine;
    (v) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.12(c) of this 
chapter; and
    (vi) Methamphetamine, its salts, isomers, and salts of its isomers;
    (vii) Amphetamine, its salts, optical isomers, and salts of its 
optical isomers;
    (viii) Phenmetrazine and its salts;
    (ix) Methylphenidate;
    (x) Each of the substances having a depressant effect on the central 
nervous system, including its salts, isomers, and salts of isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation, listed in 
Sec. 1308.12(e) of this chapter.
    (6) The term commercial container means any bottle, jar, tube, 
ampule, or other receptacle in which a substance is held for 
distribution or dispensing to an ultimate user, and in addition, any box 
or package in which the receptacle is held for distribution or 
dispensing to an ultimate user. The term commercial container does not 
include any package liner, package insert or other material kept with or 
within a commercial container, nor any carton, crate, drum, or other 
package in which commercial containers are stored or are used for 
shipment of controlled substances.
    (7) The term compounder means any person engaging in maintenance or 
detoxification treatment who also mixes, prepares, packages or changes 
the dosage form of a narcotic drug listed in Schedules II, III, IV or V 
for use in maintenance or detoxification treatment by another narcotic 
treatment program.
    (8) The term controlled substance has the meaning given in section 
802(6) of Title 21, United States Code (U.S.C.).
    (9) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.
    (10) The term detoxification treatment means the dispensing, for a 
period of time as specified below, of a narcotic drug or narcotic drugs 
in decreasing doses to an individual to alleviate adverse physiological 
or psychological effects incident to withdrawal from the continuous or 
sustained use of a narcotic drug and as a method of bringing the 
individual to a narcotic drug-free state within such period of time. 
There are two types of detoxification treatment: Short-term 
detoxification treatment and long-term detoxification treatment.
    (i) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (ii) Long-term detoxification treatment is for a period more than 30 
days but not in excess of 180 days.
    (11) The term dispenser means an individual practitioner, 
institutional practitioner, pharmacy or pharmacist who dispenses a 
controlled substance.
    (12) The term export means, with respect to any article, any taking 
out or removal of such article from the jurisdiction of the United 
States (whether or not such taking out or removal constitutes an 
exportation within the meaning of the customs and related laws of the 
United States).
    (13) The term exporter includes every person who exports, or who 
acts as an export broker for exportation of, controlled substances 
listed in any schedule.
    (14) The term hearing means:
    (i) In part 1301 of this chapter, any hearing held for the granting, 
denial,

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revocation, or suspension of a registration pursuant to sections 303, 
304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (ii) In part 1303 of this chapter, any hearing held regarding the 
determination of aggregate production quota or the issuance, adjustment, 
suspension, or denial of a procurement quota or an individual 
manufacturing quota.
    (iii) In part 1308 of this chapter, any hearing held for the 
issuance, amendment, or repeal of any rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (15) The term import means, with respect to any article, any 
bringing in or introduction of such article into either the jurisdiction 
of the United States or the customs territory of the United States, and 
from the jurisdiction of the United States into the customs territory of 
the United States (whether or not such bringing in or introduction 
constitutes an importation within the meaning of the tariff laws of the 
United States).
    (16) The term importer includes every person who imports, or who 
acts as an import broker for importation of, controlled substances 
listed in any schedule.
    (17) The term individual practitioner means a physician, dentist, 
veterinarian, or other individual licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he/she 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacist, a pharmacy, or 
an institutional practitioner.
    (18) The term institutional practitioner means a hospital or other 
person (other than an individual) licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which it 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacy.
    (19) The term interested person means any person adversely affected 
or aggrieved by any rule or proposed rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (20) The term inventory means all factory and branch stocks in 
finished form of a basic class of controlled substance manufactured or 
otherwise acquired by a registrant, whether in bulk, commercial 
containers, or contained in pharmaceutical preparations in the 
possession of the registrant (including stocks held by the registrant 
under separate registration as a manufacturer, importer, exporter, or 
distributor).
    (21) The term isomer means the optical isomer, except as used in 
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in 
Sec. 1308.11(d) of this chapter, the term isomer means the optical, 
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this 
chapter, the term isomer means the optical or geometric isomer.
    (22) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (23) The term label means any display of written, printed, or 
graphic matter placed upon the commercial container of any controlled 
substance by any manufacturer of such substance.
    (24) The term labeling means all labels and other written, printed, 
or graphic matter:
    (i) Upon any controlled substance or any of its commercial 
containers or wrappers, or
    (ii) Accompanying such controlled substance.
    (25) The term Long Term Care Facility (LTCF) means a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients.
    (26) The term maintenance treatment means the dispensing for a 
period in excess of twenty-one days, of a narcotic drug or narcotic 
drugs in the treatment of an individual for dependence upon heroin or 
other morphine-like drug.
    (27) The term manufacture means the producing, preparation, 
propagation, compounding, or processing of a drug or other substance or 
the packaging or repackaging of such substance, or the labeling or 
relabeling of the commercial container of such substance, but does not 
include the activities of a practitioner who, as an incident to his/her 
administration or dispensing such

[[Page 8]]

substance in the course of his/her professional practice, prepares, 
compounds, packages or labels such substance. The term manufacturer 
means a person who manufactures a drug or other substance, whether under 
a registration as a manufacturer or under authority of registration as a 
researcher or chemical analyst.
    (28) The term mid-level practitioner means an individual 
practitioner, other than a physician, dentist, veterinarian, or 
podiatrist, who is licensed, registered, or otherwise permitted by the 
United States or the jurisdiction in which he/she practices, to dispense 
a controlled substance in the course of professional practice. Examples 
of mid-level practitioners include, but are not limited to, health care 
providers such as nurse practitioners, nurse midwives, nurse 
anesthetists, clinical nurse specialists and physician assistants who 
are authorized to dispense controlled substances by the state in which 
they practice.
    (29) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (30) The term narcotic drug means any of the following whether 
produced directly or indirectly by extraction from substances of 
vegetable origin or independently by means of chemical synthesis or by a 
combination of extraction and chemical synthesis:
    (i) Opium, opiates, derivatives of opium and opiates, including 
their isomers, esters, ethers, salts, and salts of isomers, esters, and 
ethers whenever the existence of such isomers, esters, ethers and salts 
is possible within the specific chemical designation. Such term does not 
include the isoquinoline alkaloids of opium.
    (ii) Poppy straw and concentrate of poppy straw.
    (iii) Coca leaves, except coca leaves and extracts of coca leaves 
from which cocaine, ecgonine and derivatives of ecgonine or their salts 
have been removed.
    (iv) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers.
    (v) Ecgonine, its derivatives, their salts, isomers and salts of 
isomers.
    (vi) Any compound, mixture, or preparation which contains any 
quantity of any of the substances referred to in paragraphs (b)(31)(i) 
through (v) of this section.
    (31) The term narcotic treatment program means a program engaged in 
maintenance and/or detoxification treatment with narcotic drugs.
    (32) The term net disposal means, for a stated period, the quantity 
of a basic class of controlled substance distributed by the registrant 
to another person, plus the quantity of that basic class used by the 
registrant in the production of (or converted by the registrant into) 
another basic class of controlled substance or a noncontrolled 
substance, plus the quantity of that basic class otherwise disposed of 
by the registrant, less the quantity of that basic class returned to the 
registrant by any purchaser, and less the quantity of that basic class 
distributed by the registrant to another registered manufacturer of that 
basic class for purposes other than use in the production of, or 
conversion into, another basic class of controlled substance or a 
noncontrolled substance or in the manufacture of dosage forms of that 
basic class.
    (33) The term pharmacist means any pharmacist licensed by a State to 
dispense controlled substances, and shall include any other person 
(e.g., pharmacist intern) authorized by a State to dispense controlled 
substances under the supervision of a pharmacist licensed by such State.
    (34) The term person includes any individual, corporation, 
government or governmental subdivision or agency, business trust, 
partnership, association, or other legal entity.
    (35) The term prescription means an order for medication which is 
dispensed to or for an ultimate user but does not include an order for 
medication which is dispensed for immediate administration to the 
ultimate user. (e.g., an order to dispense a drug to a bed patient for 
immediate administration in a hospital is not a prescription.)
    (36) The term proceeding means all actions taken for the issuance, 
amendment, or repeal of any rule issued pursuant to section 201 of the 
Act (21 U.S.C. 811), commencing with the publication by the 
Administrator of the

[[Page 9]]

proposed rule, amended rule, or repeal in the Federal Register.
    (37) The term purchaser means any registered person entitled to 
obtain and execute order forms pursuant to Secs. 1305.04 and 1305.06.
    (38) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or records 
are kept on which certain items are asterisked, redlined, or in some 
other manner visually identifiable apart from other items appearing on 
the records.
    (39) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 
or 957).
    (40) The term registrant means any person who is registered pursuant 
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    (41) The term supplier means any registered person entitled to fill 
order forms pursuant to Sec. 1305.08 of this chapter.

Sec. 1300.02  Definitions relating to listed chemicals.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1309, 1310, and 1313 of this chapter, the 
following terms shall have the meaning specified:
    (1) The term Act means the Controlled Substances Act, as amended (84 
Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and 
Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951) as amended.
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The terms broker and trader mean any individual, corporation, 
corporate division, partnership, association, or other legal entity 
which assists in arranging an international transaction in a listed 
chemical by--
    (i) Negotiating contracts;
    (ii) Serving as an agent or intermediary; or
    (iii) Fulfilling a formal obligation to complete the transaction by 
bringing together a buyer and seller, a buyer and transporter, or a 
seller and transporter, or by receiving any form of compensation for so 
doing.
    (5) The term chemical export means transferring ownership or 
control, or the sending or taking of threshold quantities of listed 
chemicals out of the United States (whether or not such sending or 
taking out constitutes an exportation within the meaning of the Customs 
and related laws of the United States).
    (6) The term chemical exporter is a regulated person who, as the 
principal party in interest in the export transaction, has the power and 
responsibility for determining and controlling the sending of the listed 
chemical out of the United States.
    (7) The term chemical import means with respect to a listed 
chemical, any bringing in or introduction of such listed chemical into 
either the jurisdiction of the United States or into the Customs 
territory of the United States (whether or not such bringing in or 
introduction constitutes an importation within the meaning of the tariff 
laws of the United States).
    (8) The term chemical importer is a regulated person who, as the 
principal party in interest in the import transaction, has the power and 
responsibility for determining and controlling the bringing in or 
introduction of the listed chemical into the United States.
    (9) The term chemical mixture means a combination of two or more 
chemical substances, at least one of which is not a listed chemical, 
except that such term does not include any combination of a listed 
chemical with another chemical that is present solely as an impurity or 
which has been created to evade the requirements of the Act.
    (10) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.

[[Page 10]]

    (11) The term encapsulating machine means any manual, semi-
automatic, or fully automatic equipment which may be used to fill shells 
or capsules with any powdered, granular, semi-solid, or liquid material.
    (12) The term established business relationship with a foreign 
customer means the regulated person has exported a listed chemical at 
least once within the past six months, or twice within the past twelve 
months to a foreign manufacturer, distributor, or end user of the 
chemical that has an established business in the foreign country with a 
fixed street address. A person or business which functions as a broker 
or intermediary is not a customer for purposes of this definition. The 
term also means that the regulated person has provided the 
Administration with the following information in accordance with the 
waiver of 15-day advance notice requirements of Sec. 1313.24 of this 
chapter:
    (i) The name and street address of the chemical exporter and of each 
regular customer;
    (ii) The telephone number, telex number, contact person, and where 
available, the facsimile number for the chemical exporter and for each 
regular customer;
    (iii) The nature of the regular customer's business (i.e., importer, 
exporter, distributor, manufacturer, etc.), and if known, the use to 
which the listed chemical or chemicals will be applied;
    (iv) The duration of the business relationship;
    (v) The frequency and number of transactions occurring during the 
preceding 12-month period;
    (vi) the amounts and the listed chemical or chemicals involved in 
regulated transactions between the chemical exporter and regular 
customer;
    (vii) The method of delivery (direct shipment or through a broker or 
forwarding agent); and
    (viii) Other information that the chemical exporter considers 
relevant for determining whether a customer is a regular customer.
    (13) The term established record as an importer means that the 
regulated person has imported a listed chemical at least once within the 
past six months, or twice within the past twelve months from a foreign 
supplier. The term also means that the regulated person has provided the 
Administration with the following information in accordance with the 
waiver of the 15-day advance notice requirements of Sec. 1313.15 of this 
chapter:
    (i) The name, DEA registration number (where applicable), street 
address, telephone number, telex number, and, where available, the 
facsimile number of the regulated person and of each foreign supplier; 
and
    (ii) The frequency and number of transactions occurring during the 
preceding 12 month period.
    (14) The term hearing means any hearing held for the granting, 
denial, revocation, or suspension of a registration pursuant to sections 
303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (15) The term international transaction means a transaction 
involving the shipment of a listed chemical across an international 
border (other than a United States border) in which a broker or trader 
located in the United States participates.
    (16) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (17) The term listed chemical means any List I chemical or List II 
chemical.
    (18) The term List I chemical means a chemical specifically 
designated by the Administrator in Sec. 1310.02(a) of this chapter that, 
in addition to legitimate uses, is used in manufacturing a controlled 
substance in violation of the Act and is important to the manufacture of 
a controlled substance.
    (19) The term List II chemical means a chemical, other than a List I 
chemical, specifically designated by the Administrator in 
Sec. 1310.02(b) of this chapter that, in addition to legitimate uses, is 
used in manufacturing a controlled substance in violation of the Act.
    (20) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (21) The term person includes any individual, corporation, 
government or

[[Page 11]]

governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    (22) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or records 
are kept on which certain items are asterisked, redlined, or in some 
other manner visually identifiable apart from other items appearing on 
the records.
    (23) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 
or 957).
    (24) The term registrant means any person who is registered pursuant 
to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    (25) The term regular customer means a person with whom the 
regulated person has an established business relationship for a 
specified listed chemical or chemicals that has been reported to the 
Administration subject to the criteria established in 
Sec. 1300.02(b)(12).
    (26) The term regular importer means, with respect to a listed 
chemical, a person that has an established record as an importer of that 
listed chemical that is reported to the Administrator.
    (27) The term regulated person means any individual, corporation, 
partnership, association, or other legal entity who manufactures, 
distributes, imports, or exports a listed chemical, a tableting machine, 
or an encapsulating machine, or who acts as a broker or trader for an 
international transaction involving a listed chemical, tableting 
machine, or encapsulating machine.
    (28) The term regulated transaction means:
    (i) A distribution, receipt, sale, importation, or exportation of a 
listed chemical, or an international transaction involving shipment of a 
listed chemical, or if the Administrator establishes a threshold amount 
for a specific listed chemical, a threshold amount as determined by the 
Administrator, which includes a cumulative threshold amount for multiple 
transactions, of a listed chemical, except that such term does not 
include:
    (A) A domestic lawful distribution in the usual course of business 
between agents or employees of a single regulated person; in this 
context, agents or employees means individuals under the direct 
management and control of the regulated person;
    (B) A delivery of a listed chemical to or by a common or contract 
carrier for carriage in the lawful and usual course of the business of 
the common or contract carrier, or to or by a warehouseman for storage 
in the lawful and usual course of the business of the warehouseman, 
except that if the carriage or storage is in connection with the 
distribution, importation, or exportation of a listed chemical to a 
third person, this paragraph does not relieve a distributor, importer, 
or exporter from compliance with parts 1309, 1310, and 1313 of this 
chapter;
    (C) Any category of transaction or any category of transaction for a 
specific listed chemical or chemicals specified by regulation of the 
Administrator as excluded from this definition as unnecessary for 
enforcement of the Act;
    (D) Any transaction in a listed chemical that is contained in a drug 
that may be marketed or distributed lawfully in the United States under 
the Federal Food, Drug, and Cosmetic Act unless--
    (1)(i) The drug contains ephedrine or its salts, optical isomers, or 
salts of optical isomers; or
    (ii) The Administrator has determined pursuant to the criteria in 
1310.10 that the drug or group of drugs is being diverted to obtain the 
listed chemical for use in the illicit production of a controlled 
substance; and
    (2) The quantity of ephedrine or other listed chemical contained in 
the drug included in the transaction or multiple transactions equals or 
exceeds the threshold established for that chemical.
    (E) Any transaction in a chemical mixture listed in Sec. 1310.13 of 
this chapter.
    (ii) A distribution, importation, or exportation of a tableting 
machine or encapsulating machine except that such term does not include 
a domestic lawful distribution in the usual course

[[Page 12]]

of business between agents and employees of a single regulated person; 
in this context, agents or employees means individuals under the direct 
management and control of the regulated person.
    (29) The term retail distributor means a grocery store, general 
merchandise store, drug store, or other entity or person whose 
activities as a distributor relating to drug products containing 
pseudoephedrine, phenylpropanolamine, or ephedrine are limited almost 
exclusively to sales for personal use, both in number of sales and 
volume of sales, either directly to walk-in customers or in face-to-face 
transactions by direct sales. For the purposes of this paragraph, sale 
for personal use means the distribution of below-threshold quantities in 
a single transaction to an individual for legitimate medical use. Also 
for the purposes of this paragraph, a grocery store is an entity within 
Standard Industrial Classification (SIC) code 5411, a general 
merchandise store is an entity within SIC codes 5300 through 5399 and 
5499, and a drug store is an entity within SIC code 5912.
    (30) The term tableting machine means any manual, semi-automatic, or 
fully automatic equipment which may be used for the compaction or 
molding of powdered or granular solids, or semi-solid material, to 
produce coherent solid tablets.
[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997]








[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: 21CFR1301]

[Page 12-40]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

                           General Information

Sec.
1301.01  Scope of this part 1301.
1301.02  Definitions.
1301.03  Information; special instructions.

                              Registration

1301.11  Persons required to register.
1301.12  Separate registrations for separate locations.
1301.13  Application for registration; time for application; expiration 
          date; registration for independent activities; application 
          forms, fees, contents and signature; coincident activities.
1301.14  Filing of application; acceptance for filing; defective 
          applications.
1301.15  Additional information.
1301.16  Amendments to and withdrawal of applications.
1301.17  Special procedures for certain applications.
1301.18  Research protocols.

                   Exceptions to Registration and Fees

1301.21  Exception from fees.
1301.22  Exemption of agents and employees; affiliated practitioners.
1301.23  Exemption of certain military and other personnel.
1301.24  Exemption of law enforcement officials.
1301.25  Registration regarding ocean vessels, aircraft, and other 
          entities.
1301.26  Exemptions from import or export requirements for personal 
          medical use.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration

1301.31  Administrative review generally.
1301.32  Action on applications for research in Schedule I substances.
1301.33  Application for bulk manufacture of Schedule I and II 
          substances.
1301.34  Application for importation of Schedule I and II substances.
1301.35  Certificate of registration; denial of registration.
1301.36  Suspension or revocation of registration; suspension of 
          registration pending final order; extension of registration 
          pending final order.
1301.37  Order to show cause.

                                Hearings

1301.41  Hearings generally.
1301.42  Purpose of hearing.
1301.43  Request for hearing or appearance; waiver.
1301.44  Burden of proof.
1301.45  Time and place of hearing.
1301.46  Final order.

         Modification, Transfer, and Termination of Registration

1301.51  Modification in registration.
1301.52  Termination of registration; transfer of registration; 
          distribution upon discontinuance of business.

                          Security Requirements

1301.71  Security requirements generally.
1301.72  Physical security controls for nonpractitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs; storage areas.
1301.73  Physical security controls for nonpractitioners; compounders 
          for narcotic treatment programs; manufacturing and compounding 
          areas.
1301.74  Other security controls for nonpractitioners; narcotic 
          treatment programs and compounders for narcotic

[[Page 13]]

          treatment programs.
1301.75  Physical security controls for practitioners.
1301.76  Other security controls for practitioners.

                  Employee Screening--Non-Practitioners

1301.90  Employee screening procedures.
1301.91  Employee responsibility to report drug diversion.
1301.92  Illicit activities by employees.
1301.93  Sources of information for employee checks.

    Authority:  21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.

    Source:  36 FR 7778, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information

Sec. 1301.01  Scope of this part 1301.

    Procedures governing the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances pursuant to sections 301-304 and 1007-1008 of the Act (21 
U.S.C. 821-824 and 957-958) are set forth generally by those sections 
and specifically by the sections of this part.
[62 FR 13945, Mar. 24, 1997]

Sec. 1301.02  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 13945, Mar. 24, 1997]

Sec. 1301.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Registration Unit, Drug Enforcement Administration, Department of 
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 23, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986]

                              Registration

Sec. 1301.11  Persons required to register.

    (a) Every person who manufactures, distributes, dispenses, imports, 
or exports any controlled substance or who proposes to engage in the 
manufacture, distribution, dispensing, importation or exportation of any 
controlled substance shall obtain a registration unless exempted by law 
or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged in 
such activities are required to obtain a registration; related or 
affiliated persons who are not engaged in such activities are not 
required to be registered. (For example, a stockholder or parent 
corporation of a corporation manufacturing controlled substances is not 
required to obtain a registration.)
    (b) [Reserved]
[62 FR 13945, Mar. 24, 1997]

Sec. 1301.12  Separate registrations for separate locations.

    (a) A separate registration is required for each principal place of 
business or professional practice at one general physical location where 
controlled substances are manufactured, distributed, imported, exported, 
or dispensed by a person.
    (b) The following locations shall be deemed not to be places where 
controlled substances are manufactured, distributed, or dispensed:
    (1) A warehouse where controlled substances are stored by or on 
behalf of a registered person, unless such substances are distributed 
directly from such warehouse to registered locations other than the 
registered location from which the substances were delivered or to 
persons not required to register by virtue of subsection 302(c)(2) or 
subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 
957(b)(1)(B));
    (2) An office used by agents of a registrant where sales of 
controlled substances are solicited, made, or supervised but which 
neither contains such substances (other than substances for display 
purposes or lawful distribution as samples only) nor serves as a 
distribution point for filling sales orders; and
    (3) An office used by a practitioner (who is registered at another 
location) where controlled substances are prescribed but neither 
administered nor otherwise dispensed as a regular part of

[[Page 14]]

the professional practice of the practitioner at such office, and where 
no supplies of controlled substances are maintained.
[62 FR 13945, Mar. 24, 1997]

Sec. 1301.13  Application for registration; time for application; 
          expiration date; registration for independent activities; 
          application forms, fees, contents and signature; coincident 
          activities.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is granted and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his/her registration, 
except that a bulk manufacturer of Schedule I or II controlled 
substances or an importer of Schedule I or II controlled substances may 
apply to be reregistered no more than 120 days before the expiration 
date of their registration.
    (c) At the time a manufacturer, distributor, researcher, analytical 
lab, importer, exporter or narcotic treatment program is first 
registered, that business activity shall be assigned to one of twelve 
groups, which shall correspond to the months of the year. The expiration 
date of the registrations of all registrants within any group will be 
the last date of the month designated for that group. In assigning any 
of the above business activities to a group, the Administration may 
select a group the expiration date of which is less than one year from 
the date such business activity was registered. If the business activity 
is assigned to a group which has an expiration date less than three 
months from the date of which the business activity is registered, the 
registration shall not expire until one year from that expiration date; 
in all other cases, the registration shall expire on the expiration date 
following the date on which the business activity is registered.
    (d) At the time a retail pharmacy, hospital/clinic, practitioner or 
teaching institution is first registered, that business activity shall 
be assigned to one of twelve groups, which shall correspond to the 
months of the year. The expiration date of the registrations of all 
registrants within any group will be the last day of the month 
designated for that group. In assigning any of the above business 
activities to a group, the Administration may select a group the 
expiration date of which is not less than 28 months nor more than 39 
months from the date such business activity was registered. After the 
initial registration period, the registration shall expire 36 months 
from the initial expiration date.
    (e) Any person who is required to be registered and who is not so 
registered, shall make application for registration for one of the 
following groups of controlled substances activities, which are deemed 
to be independent of each other. Application for each registration shall 
be made on the indicated form, and shall be accompanied by the indicated 
fee. Fee payments shall be made in the form of a personal, certified, or 
cashier's check or money order made payable to the ``Drug Enforcement 
Administration''. The application fees are not refundable. Any person, 
when registered to engage in the activities described in each 
subparagraph in this paragraph, shall be authorized to engage in the 
coincident activities described without obtaining a registration to 
engage in such coincident activities, provided that, unless specifically 
exempted, he/she complies with all requirements and duties prescribed by 
law for persons registered to engage in such coincident activities. Any 
person who engages in more than one group of independent activities 
shall obtain a separate registration for each group of activities, 
except as provided in this paragraph under coincident activities. A 
single registration to engage in any group of independent activities 
listed below may include one or more controlled substances listed in the 
schedules authorized in that group of independent activities. A person 
registered to conduct research with controlled substances listed in 
Schedule I may conduct research with any substances listed in Schedule I 
for which

[[Page 15]]

he/she has filed and had approved a research protocol.
    (1)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                 Application  Registration                      
   Business activity          Controlled        DEA application      fee         period          Coincident     
                              substances             forms        (dollars)      (years)     activities allowed 
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing        Schedules I through   New--225                 875            1    Schedules I through 
                          V                    Renewal--225a            875                  V: May distribute  
                                                                                             that substance or  
                                                                                             class for which    
                                                                                             registration was   
                                                                                             issued; may not    
                                                                                             distribute any     
                                                                                             substance or class 
                                                                                             for which not      
                                                                                             registered.        
                                                                                             Schedules II       
                                                                                             through V: May     
                                                                                             conduct chemical   
                                                                                             analysis and       
                                                                                             preclinical        
                                                                                             research (including
                                                                                             quality control    
                                                                                             analysis) with     
                                                                                             substances listed  
                                                                                             in those schedules 
                                                                                             for which          
                                                                                             authorization as a 
                                                                                             manufacturer was   
                                                                                             issued.            
(ii) Distributing        Schedules I through   New--225                 438            1    ....................
                          V                    Renewal--225a            438                                     
(iii) Dispensing or      Schedules II through  New--224                 210            3    May conduct research
 Instructing (Includes    V                    Renewal--224a            210                  and instructional  
 Practitioner Hospital/                                                                      activities with    
 Clinic, Retail                                                                              those substances   
 Pharmacy, Teaching                                                                          for which          
 Institution)                                                                                registration was   
                                                                                             granted, except    
                                                                                             that a mid-level   
                                                                                             practitioner may   
                                                                                             conduct such       
                                                                                             research only to   
                                                                                             the extent         
                                                                                             expressly          
                                                                                             authorized under   
                                                                                             state statute. A   
                                                                                             pharmacist may     
                                                                                             manufacture an     
                                                                                             aqueous or         
                                                                                             oleaginous solution
                                                                                             or solid dosage    
                                                                                             form containing a  
                                                                                             narcotic controlled
                                                                                             substance in       
                                                                                             Schedule II through
                                                                                             V in a proportion  
                                                                                             not exceeding 20   
                                                                                             percent of the     
                                                                                             complete solution, 
                                                                                             compound, or       
                                                                                             mixture.           
(iv) Research            Schedule I            New--225                  70            1    A researcher may    
                                               Renewal--225a             70                  manufacture or     
                                                                                             import the basic   
                                                                                             class of substance 
                                                                                             or substances for  
                                                                                             which registration 
                                                                                             was issued,        
                                                                                             provided that such 
                                                                                             manufacture or     
                                                                                             import is set forth
                                                                                             in the protocol    
                                                                                             required in Section
                                                                                             1301.18 and to     
                                                                                             distribute such    
                                                                                             class to persons   
                                                                                             registered or      
                                                                                             authorized to      
                                                                                             conduct research   
                                                                                             with such class of 
                                                                                             substance or       
                                                                                             registered or      
                                                                                             authorized to      
                                                                                             conduct chemical   
                                                                                             analysis with      
                                                                                             controlled         
                                                                                             substances.        
(v) Research             Schedules II through  New--225                  70            1    May conduct chemical
                          V                    Renewal--225a             70                  analysis with      
                                                                                             controlled         
                                                                                             substances in those
                                                                                             schedules for which
                                                                                             registration was   
                                                                                             issued; manufacture
                                                                                             such substances if 
                                                                                             and to the extent  
                                                                                             that such          
                                                                                             manufacture is set 
                                                                                             forth in a         
                                                                                             statement filed    
                                                                                             with the           
                                                                                             application for    
                                                                                             registration or    
                                                                                             reregistration and 
                                                                                             provided that the  
                                                                                             manufacture is not 
                                                                                             for the purposes of
                                                                                             dosage form        
                                                                                             development; import
                                                                                             such substances for
                                                                                             research purposes; 
                                                                                             distribute such    
                                                                                             substances to      
                                                                                             persons registered 
                                                                                             or authorized to   
                                                                                             conduct chemical   
                                                                                             analysis,          
                                                                                             instructional      
                                                                                             activities, or     
                                                                                             research with such 
                                                                                             substances, and to 
                                                                                             persons exempted   
                                                                                             from registration  
                                                                                             pursuant to Section
                                                                                             1301.24; and       
                                                                                             conduct            
                                                                                             instructional      
                                                                                             activities with    
                                                                                             controlled         
                                                                                             substances.        
(vi) Narcotic Treatment  Narcotic Drugs in     New--363                  70            1    ....................
 Program (including       Schedules II         Renewal--363a             70                                     
 compounder)              through V                                                                             

[[Page 16]]

                                                                                                                
(vii) Importing          Schedules I through   New--225                 438            1    May distribute that 
                          V                    Renewal--225a            438                  substance or class 
                                                                                             for which          
                                                                                             registration was   
                                                                                             issued; may not    
                                                                                             distribute any     
                                                                                             substance or class 
                                                                                             for which not      
                                                                                             registered.        
(viii) Exporting         Schedules I through   New--225                 438            1    ....................
                          V                    Renewal--225a            438                                     
(ix) Chemical Analysis   Schedules I through   New--225                  70            1    May manufacture and 
                          V                    Renewal--225a             70                  import controlled  
                                                                                             substances for     
                                                                                             analytical or      
                                                                                             instructional      
                                                                                             activities; may    
                                                                                             distribute such    
                                                                                             substances to      
                                                                                             persons registered 
                                                                                             or authorized to   
                                                                                             conduct chemical   
                                                                                             analysis,          
                                                                                             instructional      
                                                                                             activities, or     
                                                                                             research with such 
                                                                                             substances and to  
                                                                                             persons exempted   
                                                                                             from registration  
                                                                                             pursuant to Section
                                                                                             1301.24; may export
                                                                                             such substances to 
                                                                                             persons in other   
                                                                                             countries          
                                                                                             performing chemical
                                                                                             analysis or        
                                                                                             enforcing laws     
                                                                                             relating to        
                                                                                             controlled         
                                                                                             substances or drugs
                                                                                             in those countries;
                                                                                             and may conduct    
                                                                                             instructional      
                                                                                             activities with    
                                                                                             controlled         
                                                                                             substances.        
----------------------------------------------------------------------------------------------------------------

    (2) DEA Forms 224, 225, and 363 may be obtained at any area office 
of the Administration or by writing to the Registration Unit, Drug 
Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005.
    (3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, to 
each registered person approximately 60 days before the expiration date 
of his/her registration; if any registered person does not receive such 
forms within 45 days before the expiration date of his/her registration, 
he/she must promptly give notice of such fact and request such forms by 
writing to the Registration Unit of the Administration at the foregoing 
address.
    (f) Each application for registration to handle any basic class of 
controlled substance listed in Schedule I (except to conduct chemical 
analysis with such classes), and each application for registration to 
manufacture a basic class of controlled substance listed in Schedule II 
shall include the Administration Controlled Substances Code Number, as 
set forth in part 1308 of this chapter, for each basic class to be 
covered by such registration.
    (g) Each application for registration to import or export controlled 
substances shall include the Administration Controlled Substances Code 
Number, as set forth in part 1308 of this chapter, for each controlled 
substance whose importation or exportation is to be authorized by such 
registration. Registration as an importer or exporter shall not entitle 
a registrant to import or export any controlled substance not specified 
in such registration.
    (h) Each application for registration to conduct research with any 
basic class of controlled substance listed in Schedule II shall include 
the Administration Controlled Substances Code Number, as set forth in 
part 1308 of this chapter, for each such basic class to be manufactured 
or imported as a coincident activity of that registration. A statement 
listing the quantity of each such basic class of controlled substance to 
be imported or manufactured during the registration period for which 
application is being made shall be included with each such application. 
For purposes of this paragraph only, manufacturing is defined as the 
production of a controlled substance by synthesis, extraction or by 
agricultural/horticultural means.
    (i) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.

[[Page 17]]

    (j) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to do so, to sign applications for the 
applicant by filing with the Registration Unit of the Administration a 
power of attorney for each such individual. The power of attorney shall 
be signed by a person who is authorized to sign applications under this 
paragraph and shall contain the signature of the individual being 
authorized to sign applications. The power of attorney shall be valid 
until revoked by the applicant.
[62 FR 13946, Mar. 24, 1997]

Sec. 1301.14  Filing of application; acceptance for filing; defective 
          applications.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration, Department of 
Justice, Post Office Box 28083, Central Station, Washington, DC 20005. 
The appropriate registration fee and any required attachments must 
accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and should not refer to any accompanying application for 
required information.
    (c) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days following 
its receipt with a statement of the reason for not accepting the 
application for filing. A defective application may be corrected and 
resubmitted for filing at any time; the Administrator shall accept for 
filing any application upon resubmission by the applicant, whether 
complete or not.
    (d) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1301.15 
and has no bearing on whether the application will be granted.
[62 FR 13948, Mar. 24, 1997]

Sec. 1301.15  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he/she 
deems necessary to determine whether the application should be granted. 
The failure of the applicant to provide such documents or statements 
within a reasonable time after being requested to do so shall be deemed 
to be a waiver by the applicant of an opportunity to present such 
documents or facts for consideration by the Administrator in granting or 
denying the application.
[62 FR 13948, Mar. 24, 1997]

Sec. 1301.16  Amendments to and withdrawal of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administrator at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1301.37. An application 
may be amended or withdrawn with permission of the Administrator at any 
time where good cause is shown by the applicant or where the amendment 
or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, when sent 
by registered or certified mail, return receipt requested, shall be 
deemed to be a withdrawal of the application.
[62 FR 13949, Mar. 24, 1997]

Sec. 1301.17  Special procedures for certain applications.

    (a) If, at the time of application for registration of a new 
pharmacy, the pharmacy has been issued a license from the appropriate 
State licensing

[[Page 18]]

agency, the applicant may include with his/her application an affidavit 
as to the existence of the State license in the following form:

                       Affidavit for New Pharmacy

    I, ____________________, the ____________________ (Title of officer, 
official, partner, or other position) of ____________________ 
(Corporation, partnership, or sole proprietor), doing business as 
____________________ (Store name) at ____________________ (Number and 
Street), ____________________ (City) ____________ (State) ____________ 
(Zip code), hereby certify that said store was issued a pharmacy permit 
No. ________ by the ________________ (Board of Pharmacy or Licensing 
Agency) of the State of ____________ on ____________ (Date).
    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number. I understand that if any information 
is false, the Administration may immediately suspend the registration 
for this store and commence proceedings to revoke under 21 U.S.C. 824(a) 
because of the danger to public health and safety. I further understand 
that any false information contained in this affidavit may subject me 
personally and the above-named corporation/partnership/business to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.
 _______________________________________________________________________
Signature (Person who signs Application for Registration)
 State of_______________________________________________________________
 County of______________________________________________________________
    Subscribed to and sworn before me this ________ day of ________, 
19______.
 _______________________________________________________________________
Notary Public

    (b) Whenever the ownership of a pharmacy is being transferred from 
one person to another, if the transferee owns at least one other 
pharmacy licensed in the same State as the one the ownership of which is 
being transferred, the transferee may apply for registration prior to 
the date of transfer. The Administrator may register the applicant and 
authorize him to obtain controlled substances at the time of transfer. 
Such registration shall not authorize the transferee to dispense 
controlled substances until the pharmacy has been issued a valid State 
license. The transferee shall include with his/her application the 
following affidavit:

                   Affidavit for Transfer of Pharmacy

    I, ____________________, the ____________________ (Title of officer, 
official, partner or other position) of ____________________ 
(Corporation, partnership, or sole proprietor), doing business as 
____________________ (Store name) hereby certify:
    (1) That said company was issued a pharmacy permit No.____________by 
the ____________________ (Board of Pharmacy of Licensing Agency) of the 
State of ____________ and a DEA Registration Number ____________________ 
for a pharmacy located at ____________________ (Number and Street) 
____________ (City) ____________ (State) ____________ (Zip Code); and
    (2) That said company is acquiring the pharmacy business of 
____________________ (Name of Seller) doing business 
as____________________with DEA Registration Number ____________ on or 
about ____________ (Date of Transfer) and that said company has applied 
(or will apply on ____________ (Date) for a pharmacy permit from the 
board of pharmacy (or licensing agency) of the State of ____________ to 
do business as ____________________ (Store name) at ____________________ 
(Number and Street) ____________________ (City) ____________ (State) 
____________ (Zip Code).

    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number.

    I understand that if a DEA registration number is issued, the 
pharmacy may acquire controlled substances but may not dispense them 
until a pharmacy permit or license is issued by the State board of 
pharmacy or licensing agency.
    I understand that if any information is false, the Administration 
may immediately suspend the registration for this store and commence 
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to 
public health and safety. I further understand that any false 
information contained in this affidavit may subject me personally to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.

 _______________________________________________________________________
Signature (Person who signs Application for Registration)
 State of_______________________________________________________________
 County of______________________________________________________________
    Subscribed to and sworn before me this____day of____________, 
19____.
 _______________________________________________________________________
Notary Public

    (c) The Administrator shall follow the normal procedures for 
approving an application to verify the statements in

[[Page 19]]

the affidavit. If the statements prove to be false, the Administrator 
may revoke the registration on the basis of section 304(a)(1) of the Act 
(21 U.S.C. 824(a)(1)) and suspend the registration immediately by 
pending revocation on the basis of section 304(d) of the Act (21 U.S.C. 
824(d)). At the same time, the Administrator may seize and place under 
seal all controlled substances possessed by the applicant under section 
304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the 
affidavit procedure may subject the applicant to prosecution for fraud 
under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining 
controlled substances through registration by fraudulent means may 
subject the applicant to prosecution under section 403(a)(3) of the Act 
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense 
include imprisonment for up to 4 years, a fine not exceeding $30,000 or 
both.
[62 FR 13949, Mar. 24, 1997]

Sec. 1301.18  Research protocols.

    (a) A protocol to conduct research with controlled substances listed 
in Schedule I shall be in the following form and contain the following 
information where applicable:
    (1) Investigator:
    (i) Name, address, and DEA registration number; if any.
    (ii) Institutional affiliation.
    (iii) Qualifications, including a curriculum vitae and an 
appropriate bibliography (list of publications).
    (2) Research project:
    (i) Title of project.
    (ii) Statement of the purpose.
    (iii) Name of the controlled substances or substances involved and 
the amount of each needed.
    (iv) Description of the research to be conducted, including the 
number and species of research subjects, the dosage to be administered, 
the route and method of administration, and the duration of the project.
    (v) Location where the research will be conducted.
    (vi) Statement of the security provisions for storing the controlled 
substances (in accordance with Sec. 1301.75) and for dispensing the 
controlled substances in order to prevent diversion.
    (vii) If the investigator desires to manufacture or import any 
controlled substance listed in paragraph (a)(2)(iii) of this section, a 
statement of the quantity to be manufactured or imported and the sources 
of the chemicals to be used or the substance to be imported.
    (3) Authority:
    (i) Institutional approval.
    (ii) Approval of a Human Research Committee for human studies.
    (iii) Indication of an approved active Notice of Claimed 
Investigational Exemption for a New Drug (number).
    (iv) Indication of an approved funded grant (number), if any.
    (b) In the case of a clinical investigation with controlled 
substances listed in Schedule I, the applicant shall submit three copies 
of a Notice of Claimed Investigational Exemption for a New Drug (IND) 
together with a statement of the security provisions (as proscribed in 
paragraph (a)(2)(vi) of this section for a research protocol) to, and 
have such submission approved by, the Food and Drug Administration as 
required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission of 
this Notice and statement to the Food and Drug Administration shall be 
in lieu of a research protocol to the Administration as required in 
paragraph (a) of this section. The applicant, when applying for 
registration with the Administration, shall indicate that such notice 
has been submitted to the Food and Drug Administration by submitting to 
the Administration with his/her DEA Form 225 three copies of the 
following certificate:

    I hereby certify that on ____________________ (Date), pursuant to 21 
U.S.C. 355(i) and 21 CFR 130.3, I, ____________________ (Name and 
Address of IND Sponsor) submitted a Notice of Claimed Investigational 
Exemption for a New Drug (IND) to the Food and Drug Administration for:

 _______________________________________________________________________
(Name of Investigational Drug).

 _______________________________________________________________________
(Date)

 _______________________________________________________________________
(Signature of Applicant).

    (c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall

[[Page 20]]

submit a request to the Registration Unit, Drug Enforcement 
Administration, Post Office Box 28083, Central Station, Washington, DC 
20005, by registered mail, return receipt requested. The request shall 
contain the following information: DEA registration number; name of the 
controlled substance or substances and the quantity of each authorized 
in the approved protocol; and the additional quantity of each desired. 
Upon return of the receipt, the registrant shall be authorized to 
purchase the additional quantity of the controlled substance or 
substances specified in the request. The Administration shall review the 
letter and forward it to the Food and Drug Administration together with 
the Administration comments. The Food and Drug Administration shall 
approve or deny the request as an amendment to the protocol and so 
notify the registrant. Approval of the letter by the Food and Drug 
Administration shall authorize the registrant to use the additional 
quantity of the controlled substance in the research project.
    (d) In the event the registrant desires to conduct research beyond 
the variations provided in the registrant's approved protocol (excluding 
any increase in the quantity of the controlled substance requested for 
his/her research project as outlined in paragraph (c) of this section), 
he/she shall submit three copies of a supplemental protocol in 
accordance with paragraph (a) of this section describing the new 
research and omitting information in the supplemental protocol which has 
been stated in the original protocol. Supplemental protocols shall be 
processed and approved or denied in the same manner as original research 
protocols.
[62 FR 13949, Mar. 24, 1997]

                   Exceptions to Registration and Fees

Sec. 1301.21  Exemption from fees.

    (a) The Administrator shall exempt from payment of an application 
fee for registration or reregistration:
    (1) Any hospital or other institution which is operated by an agency 
of the United States (including the U.S. Army, Navy, Marine Corps., Air 
Force, and Coast Guard), of any State, or any political subdivision or 
agency thereof.
    (2) Any individual practitioner who is required to obtain an 
individual registration in order to carry out his or her duties as an 
official of an agency of the United States (including the U.S. Army, 
Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any 
political subdivision or agency thereof.
    (b) In order to claim exemption from payment of a registration or 
reregistration application fee, the registrant shall have completed the 
certification on the appropriate application form, wherein the 
registrant's superior (if the registrant is an individual) or officer 
(if the registrant is an agency) certifies to the status and address of 
the registrant and to the authority of the registrant to acquire, 
possess, or handle controlled substances.
    (c) Exemption from payment of a registration or reregistration 
application fee does not relieve the registrant of any other 
requirements or duties prescribed by law.
[62 FR 13950, Mar. 24, 1997]

Sec. 1301.22  Exemption of agents and employees; affiliated 
          practitioners.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if such agent or employee is acting in the usual 
course of his/her business or employment.
    (b) An individual practitioner who is an agent or employee of 
another practitioner (other than a mid-level practitioner) registered to 
dispense controlled substances may, when acting in the normal course of 
business or employment, administer or dispense (other than by issuance 
of prescription) controlled substances if and to the extent that such 
individual practitioner is authorized or permitted to do so by the 
jurisdiction in which he or she practices, under the registration of the 
employer or principal practitioner in lieu of being registered him/
herself.
    (c) An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course of 
business or employment, administer, dispense, or prescribe controlled 
substances under the registration of the hospital or other institution 
which is registered in lieu of

[[Page 21]]

being registered him/herself, provided that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his/her professional practice;
    (2) Such individual practitioner is authorized or permitted to do so 
by the jurisdiction in which he/she is practicing;
    (3) The hospital or other institution by whom he/she is employed has 
verified that the individual practitioner is so permitted to dispense, 
administer, or prescribe drugs within the jurisdiction;
    (4) Such individual practitioner is acting only within the scope of 
his/her employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist of 
numbers, letters, or a combination thereof and shall be a suffix to the 
institution's DEA registration number, preceded by a hyphen (e.g., 
APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other institution 
and is made available at all times to other registrants and law 
enforcement agencies upon request for the purpose of verifying the 
authority of the prescribing individual practitioner.
[62 FR 13950, Mar. 24, 1997]

Sec. 1301.23  Exemption of certain military and other personnel.

    (a) The requirement of registration is waived for any official of 
the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health 
Service, or Bureau of Prisons who is authorized to prescribe, dispense, 
or administer, but not to procure or purchase, controlled substances in 
the course of his/her official duties. Such officials shall follow 
procedures set forth in part 1306 of this chapter regarding 
prescriptions, but shall state the branch of service or agency (e.g., 
``U.S. Army'' or ``Public Health Service'') and the service 
identification number of the issuing official in lieu of the 
registration number required on prescription forms. The service 
identification number for a Public Health Service employee is his/her 
Social Security identification number.
    (b) The requirement of registration is waived for any official or 
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or 
Public Health Service who or which is authorized to import or export 
controlled substances in the course of his/her official duties.
    (c) If any official exempted by this section also engages as a 
private individual in any activity or group of activities for which 
registration is required, such official shall obtain a registration for 
such private activities.
[62 FR 13951, Mar. 24, 1997]

Sec. 1301.24  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, and any other Federal officer who is 
lawfully engaged in the enforcement of any Federal law relating to 
controlled substances, drugs or customs, and is duly authorized to 
possess or to import or export controlled substances in the course of 
his/her official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to controlled substances and is duly 
authorized to possess controlled substances in the course of his/her 
official duties.
    (b) Any official exempted by this section may, when acting in the 
course of his/her official duties, procure any controlled substance in 
the course of an inspection, in accordance with Sec. 1316.03(d) of this 
chapter, or in the course of any criminal investigation involving the 
person from whom the substance was procured, and may possess any 
controlled substance and distribute any such substance to any other 
official who is also exempted by

[[Page 22]]

this section and acting in the course of his/her official duties.
    (c) In order to enable law enforcement agency laboratories, 
including laboratories of the Administration, to obtain and transfer 
controlled substances for use as standards in chemical analysis, such 
laboratories shall obtain annually a registration to conduct chemical 
analysis. Such laboratories shall be exempted from payment of a fee for 
registration. Laboratory personnel, when acting in the scope of their 
official duties, are deemed to be officials exempted by this section and 
within the activity described in section 515(d) of the Act (21 U.S.C. 
885(d)). For purposes of this paragraph, laboratory activities shall not 
include field or other preliminary chemical tests by officials exempted 
by this section.
    (d) In addition to the activities authorized under a registration to 
conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix), 
laboratories of the Administration shall be authorized to manufacture or 
import controlled substances for any lawful purpose, to distribute or 
export such substances to any person, and to import and export such 
substances in emergencies without regard to the requirements of part 
1312 of this chapter if a report concerning the importation or 
exportation is made to the Drug Operations Section of the Administration 
within 30 days of such importation or exportation.
[62 FR 13951, Mar. 24, 1997]

Sec. 1301.25  Registration regarding ocean vessels, aircraft, and other 
          entities.

    (a) If acquired by and dispensed under the general supervision of a 
medical officer described in paragraph (b) of this section, or the 
master or first officer of the vessel under the circumstances described 
in paragraph (d) of this section, controlled substances may be held for 
stocking, be maintained in, and dispensed from medicine chests, first 
aid packets, or dispensaries:
    (1) On board any vessel engaged in international trade or in trade 
between ports of the United States and any merchant vessel belonging to 
the U.S. Government;
    (2) On board any aircraft operated by an air carrier under a 
certificate of permit issued pursuant to the Federal Aviation Act of 
1958 (49 U.S.C. 1301); and
    (3) In any other entity of fixed or transient location approved by 
the Administrator as appropriate for application of this section (e.g., 
emergency kits at field sites of an industrial firm).
    (b) A medical officer shall be:
    (1) Licensed in a state as a physician;
    (2) Employed by the owner or operator of the vessel, aircraft or 
other entity; and
    (3) Registered under the Act at either of the following locations:
    (i) The principal office of the owner or operator of the vessel, 
aircraft or other entity or
    (ii) At any other location provided that the name, address, 
registration number and expiration date as they appear on his/her 
Certificate of Registration (DEA Form 223) for this location are 
maintained for inspection at said principal office in a readily 
retrievable manner.
    (c) A registered medical officer may serve as medical officer for 
more than one vessel, aircraft, or other entity under a single 
registration, unless he/she serves as medical officer for more than one 
owner or operator, in which case he/she shall either maintain a separate 
registration at the location of the principal office of each such owner 
or operator or utilize one or more registrations pursuant to paragraph 
(b)(3)(ii) of this section.
    (d) If no medical officer is employed by the owner or operator of a 
vessel, or in the event such medical officer is not accessible and the 
acquisition of controlled substances is required, the master or first 
officer of the vessel, who shall not be registered under the Act, may 
purchase controlled substances from a registered manufacturer or 
distributor, or from an authorized pharmacy as described in paragraph 
(f) of this section, by following the procedure outlined below:
    (1) The master or first officer of the vessel must personally appear 
at the vendor's place of business, present proper identification (e.g., 
Seaman's photographic identification card) and a written requisition for 
the controlled substances.
    (2) The written requisition must be on the vessel's official 
stationery or

[[Page 23]]

purchase order form and must include the name and address of the vendor, 
the name of the controlled substance, description of the controlled 
substance (dosage form, strength and number or volume per container) 
number of containers ordered, the name of the vessel, the vessel's 
official number and country of registry, the owner or operator of the 
vessel, the port at which the vessel is located, signature of the 
vessel's officer who is ordering the controlled substances and the date 
of the requisition.
    (3) The vendor may, after verifying the identification of the 
vessel's officer requisitioning the controlled substances, deliver the 
control substances to that officer. The transaction shall be documented, 
in triplicate, on a record of sale in a format similar to that outlined 
in paragraph (d)(4) of this section. The vessel's requisition shall be 
attached to copy 1 of the record of sale and filed with the controlled 
substances records of the vendor, copy 2 of the record of sale shall be 
furnished to the officer of the vessel and retained aboard the vessel, 
copy 3 of the record of sale shall be forwarded to the nearest DEA 
Division Office within 15 days after the end of the month in which the 
sale is made.
    (4) The vendor's record of sale should be similar to, and must 
include all the information contained in, the below listed format.

                Sale of Controlled Substances to Vessels

 (Name of registrant)___________________________________________________

 (Address of registrant)________________________________________________

 (DEA registration number)______________________________________________

                                                                                                                                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of                                                Packages                      
                          Line No.                            packages ordered   Size of packages   Name of product     distributed     Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..........................................................  .................  .................  ................  .................  ................
2..........................................................  .................  .................  ................  .................  ................
3..........................................................  .................  .................  ................  .................  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.                                                                               

 Number of lines completed______________________________________________
 Name of vessel_________________________________________________________
 Vessel's official number_______________________________________________
 Vessel's country of registry___________________________________________
 Owner or operator of the vessel________________________________________

Name and title of vessel's officer who presented the requisition 
          ________
Signature of vessel's officer who presented the requisition ________

    (e) Any medical officer described in paragraph (b) of this section 
shall, in addition to complying with all requirements and duties 
prescribed for registrants generally, prepare an annual report as of the 
date on which his/her registration expires, which shall give in detail 
an accounting for each vessel, aircraft, or other entity, and a summary 
accounting for all vessels, aircraft, or other entities under his/her 
supervision for all controlled substances purchased, dispensed or 
disposed of during the year. The medical officer shall maintain this 
report with other records required to be kept under the Act and, upon 
request, deliver a copy of the report to the Administration. The medical 
officer need not be present when controlled substances are dispensed, if 
the person who actually dispensed the controlled substances is 
responsible to the medical officer to justify his/her actions.
    (f) Any registered pharmacy that wishes to distribute controlled 
substances pursuant to this section shall be authorized to do so, 
provided:
    (1) The registered pharmacy notifies the nearest Division Office of 
the Administration of its intention to so distribute controlled 
substances prior to the initiation of such activity. This notification 
shall be by registered mail and shall contain the name, address, and 
registration number of the pharmacy as well as the date upon which such 
activity will commence; and
    (2) Such activity is authorized by state law; and
    (3) The total number of dosage units of all controlled substances 
distributed by the pharmacy during any calendar year in which the 
pharmacy is registered to dispense does not exceed the limitations 
imposed upon such distribution by Sec. 1307.11(a)(4) and (b) of this 
chapter.

[[Page 24]]

    (g) Owners or operators of vessels, aircraft, or other entities 
described in this section shall not be deemed to possess or dispense any 
controlled substance acquired, stored and dispensed in accordance with 
this section. Additionally, owners or operators of vessels, aircraft, or 
other entities described in this section or in Article 32 of the Single 
Convention on Narcotic Drugs, 1961, or in Article 14 of the Convention 
on Psychotropic Substances, 1971, shall not be deemed to import or 
export any controlled substances purchased and stored in accordance with 
that section or applicable article.
    (h) The Master of a vessel shall prepare a report for each calendar 
year which shall give in detail an accounting for all controlled 
substances purchased, dispensed, or disposed of during the year. The 
Master shall file this report with the medical officer employed by the 
owner or operator of his/her vessel, if any, or, if not, he/she shall 
maintain this report with other records required to be kept under the 
Act and, upon request, deliver a copy of the report to the 
Administration.
    (i) Controlled substances acquired and possessed in accordance with 
this section shall not be distributed to persons not under the general 
supervision of the medical officer employed by the owner or operator of 
the vessel, aircraft, or other entity, except in accordance with 
Sec. 1307.21 of this chapter.
[62 FR 13951, Mar. 24, 1997]

Sec. 1301.26  Exemptions from import or export requirements for personal 
          medical use.

    Any individual who has in his/her possession a controlled substance 
listed in schedules II, III, IV, or V, which he/she has lawfully 
obtained for his/her personal medical use, or for administration to an 
animal accompanying him/her, may enter or depart the United States with 
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 
952-955), providing the following conditions are met:
    (a) The controlled substance is in the original container in which 
it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate official of 
the U.S. Customs Service stating:
    (1) That the controlled substance is possessed for his/her personal 
use, or for an animal accompanying him/her; and
    (2) The trade or chemical name and the symbol designating the 
schedule of the controlled substance if it appears on the container 
label, or, if such name does not appear on the label, the name and 
address of the pharmacy or practitioner who dispensed the substance and 
the prescription number, if any; and
    (c) The importation of the controlled substance for personal medical 
use is authorized or permitted under other Federal laws and state law.
[62 FR 13952, Mar. 24, 1997]

  Action on Application for Registration: Revocation or Suspension of 
                              Registration

Sec. 1301.31  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 
U.S.C. 958) of the Act have been met by the applicant.
[62 FR 13953, Mar. 24, 1997]

Sec. 1301.32  Action on applications for research in Schedule I 
          substances.

    (a) In the case of an application for registration to conduct 
research with controlled substances listed in Schedule I, the 
Administrator shall process the application and protocol and forward a 
copy of each to the Secretary of Health and Human Services (Secretary) 
within 7 days after receipt. The Secretary shall determine the 
qualifications and competency of the applicant, as well as the merits of 
the protocol (and shall notify the Administrator of his/her 
determination) within 21 days after receipt of the application and 
complete protocol, except that in the case of a clinical investigation, 
the Secretary shall have 30 days to make

[[Page 25]]

such determination and notify the Administrator. The Secretary, in 
determining the merits of the protocol, shall consult with the 
Administrator as to effective procedures to safeguard adequately against 
diversion of such controlled substances from legitimate medical or 
scientific use.
    (b) An applicant whose protocol is defective shall be notified by 
the Secretary within 21 days after receipt of such protocol from the 
Administrator (or in the case of a clinical investigation within 30 
days), and he/she shall be requested to correct the existing defects 
before consideration shall be given to his/her submission.
    (c) If the Secretary determines the applicant qualified and 
competent and the research protocol meritorious, he/she shall notify the 
Administrator in writing of such determination. The Administrator shall 
issue a certificate of registration within 10 days after receipt of this 
notice, unless he/she determines that the certificate of registration 
should be denied on a ground specified in section 304(a) of the Act (21 
U.S.C. 824(a)). In the case of a supplemental protocol, a replacement 
certificate of registration shall be issued by the Administrator.
    (d) If the Secretary determines that the protocol is not meritorious 
and/or the applicant is not qualified or competent, he/she shall notify 
the Administrator in writing setting forth the reasons for such 
determination. If the Administrator determines that grounds exist for 
the denial of the application, he/she shall within 10 days issue an 
order to show cause pursuant to Sec. 1301.37 and, if requested by the 
applicant, hold a hearing on the application pursuant to Sec. 1301.41. 
If the grounds for denial of the application include a determination by 
the Secretary, the Secretary or his duly authorized agent shall furnish 
testimony and documents pertaining to his determination at such hearing.
    (e) Supplemental protocols will be processed in the same manner as 
original research protocols. If the processing of an application or 
research protocol is delayed beyond the time limits imposed by this 
section, the applicant shall be so notified in writing.
[62 FR 13953, Mar. 24, 1997]

Sec. 1301.33  Application for bulk manufacture of Schedule I and II 
          substances.

    (a) In the case of an application for registration or reregistration 
to manufacture in bulk a basic class of controlled substance listed in 
Schedule I or II, the Administrator shall, upon the filing of such 
application, publish in the Federal Register a notice naming the 
applicant and stating that such applicant has applied to be registered 
as a bulk manufacturer of a basic class of narcotic or nonnarcotic 
controlled substance, which class shall be identified. A copy of said 
notice shall be mailed simultaneously to each person registered as a 
bulk manufacturer of that basic class and to any other applicant 
therefor. Any such person may, within 60 days from the date of 
publication of the notice in the Federal Register, file with the 
Administrator written comments on or objections to the issuance of the 
proposed registration.
    (b) In order to provide adequate competition, the Administrator 
shall not be required to limit the number of manufacturers in any basic 
class to a number less than that consistent with maintenance of 
effective controls against diversion solely because a smaller number is 
capable of producing an adequate and uninterrupted supply.
    (c) This section shall not apply to the manufacture of basic classes 
of controlled substances listed in Schedules I or II as an incident to 
research or chemical analysis as authorized in Sec. 1301.13(e)(1).
[62 FR 13953, Mar. 24, 1997]

Sec. 1301.34  Application for importation of Schedule I and II 
          substances.

    (a) In the case of an application for registration or reregistration 
to import a controlled substance listed in Schedule I or II, under the 
authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), 
the Administrator shall, upon the filing of such application, publish in 
the Federal Register a notice naming the applicant and stating that such 
applicant has applied to be registered as an importer of a Schedule I or 
II controlled substance, which substance shall be identified. A copy of 
said notice shall be mailed simultaneously to each person registered as 
a

[[Page 26]]

bulk manufacturer of that controlled substance and to any other 
applicant therefor. Any such person may, within 30 days from the date of 
publication of the notice in the Federal Register, file written comments 
on or objections to the issuance of the proposed registration, and may, 
at the same time, file a written request for a hearing on the 
application pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing on the application in accordance with 
Sec. 1301.41. Notice of the hearing shall be published in the Federal 
Register, and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any such person 
may participate in the hearing by filing a notice of appearance in 
accordance with Sec. 1301.43 of this chapter. Notice of the hearing 
shall contain a summary of all comments and objections filed regarding 
the application and shall state the time and place for the hearing, 
which shall not be less than 30 days after the date of publication of 
such notice in the Federal Register. A hearing pursuant to this section 
may be consolidated with a hearing held pursuant to Sec. 1301.35 or 
Sec. 1301.36 of this part.
    (b) The Administrator shall register an applicant to import a 
controlled substance listed in Schedule I or II if he/she determines 
that such registration is consistent with the public interest and with 
U.S. obligations under international treaties, conventions, or protocols 
in effect on May 1, 1971. In determining the public interest, the 
following factors shall be considered:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
Schedule I or II compounded therefrom into other than legitimate 
medical, scientific research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and uninterrupted 
supply of these substances under adequately competitive conditions for 
legitimate medical, scientific, research, and industrial purposes;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, and 
the existence in the establishment of effective control against 
diversion;
    (6) That the applicant will be permitted to import only:
    (i) Such amounts of crude opium, poppy straw, concentrate of poppy 
straw, and coca leaves as the Administrator finds to be necessary to 
provide for medical, scientific, or other legitimate purposes; or
    (ii) Such amounts of any controlled substances listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States 
during an emergency in which domestic supplies of such substances are 
found by the Administrator to be inadequate; or
    (iii) Such amounts of any controlled substance listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States in 
any case in which the Administrator finds that competition among 
domestic manufacturers of the controlled substance is inadequate and 
will not be rendered adequate by the registration of additional 
manufacturers under section 303 of the Act (21 U.S.C. 823); or
    (iv) Such limited quantities of any controlled substance listed in 
Schedule I or II as the Administrator shall find to be necessary for 
scientific, analytical or research uses; and
    (7) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (c) In determining whether the applicant can and will maintain 
effective controls against diversion within the meaning of paragraph (b) 
of this section, the Administrator shall consider among other factors:
    (1) Compliance with the security requirements set forth in 
Secs. 1301.71-1301.76; and

[[Page 27]]

    (2) Employment of security procedures to guard against in-transit 
losses within and without the jurisdiction of the United States.
    (d) In determining whether competition among the domestic 
manufacturers of a controlled substance is adequate within the meaning 
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section 
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator 
shall consider:
    (1) The extent of price rigidity in the light of changes in:
    (i) raw materials and other costs and
    (ii) conditions of supply and demand;
    (2) The extent of service and quality competition among the domestic 
manufacturers for shares of the domestic market including:
    (i) Shifts in market shares and
    (ii) Shifts in individual customers among domestic manufacturers;
    (3) The existence of substantial differentials between domestic 
prices and the higher of prices generally prevailing in foreign markets 
or the prices at which the applicant for registration to import is 
committed to undertake to provide such products in the domestic market 
in conformity with the Act. In determining the existence of substantial 
differentials hereunder, appropriate consideration should be given to 
any additional costs imposed on domestic manufacturers by the 
requirements of the Act and such other cost-related and other factors as 
the Administrator may deem relevant. In no event shall an importer's 
offering prices in the United States be considered if they are lower 
than those prevailing in the foreign market or markets from which the 
importer is obtaining his/her supply;
    (4) The existence of competitive restraints imposed upon domestic 
manufacturers by governmental regulations; and
    (5) Such other factors as may be relevant to the determinations 
required under this paragraph.
    (e) In considering the scope of the domestic market, consideration 
shall be given to substitute products which are reasonably 
interchangeable in terms of price, quality and use.
    (f) The fact that the number of existing manufacturers is small 
shall not demonstrate, in and of itself, that adequate competition among 
them does not exist.
[62 FR 13953, Mar. 24, 1997]

Sec. 1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 223) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of sections 
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the 
issuance of registration or reregistration is not required, the 
Administrator shall deny the application. Before denying any 
application, the Administrator shall issue an order to show cause 
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold 
a hearing on the application pursuant to Sec. 1301.41.
    (b) If in response to a show cause order a hearing is requested by 
an applicant for registration or reregistration to manufacture in bulk a 
basic class of controlled substance listed in Schedule I or II, notice 
that a hearing has been requested shall be published in the Federal 
Register and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any person 
entitled to file comments or objections to the issuance of the proposed 
registration pursuant to Sec. 1301.33(a) may participate in the hearing 
by filing notice of appearance in accordance with Sec. 1301.43. Such 
persons shall have 30 days to file a notice of appearance after the date 
of publication of the notice of a request for a hearing in the Federal 
Register.
    (c) The Certificate of Registration (DEA Form 223) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the schedules and/or Administration 
Controlled Substances Code Number (as set forth in part 1308 of this 
chapter) of the controlled substances which the registrant is authorized 
to handle, the amount of fee paid (or exemption), and the expiration 
date of the registration. The registrant shall maintain the certificate 
of registration at the registered location in a readily retrievable 
manner

[[Page 28]]

and shall permit inspection of the certificate by any official, agent or 
employee of the Administration or of any Federal, State, or local agency 
engaged in enforcement of laws relating to controlled substances.
[62 FR 13954, Mar. 24, 1997]

Sec. 1301.36  Suspension or revocation of registration; suspension of 
          registration pending final order; extension of registration 
          pending final order.

    (a) For any registration issued under section 303 of the Act (21 
U.S.C. 823), the Administrator may:
    (1) Suspend the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)) for any period of time.
    (2) Revoke the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)).
    (b) For any registration issued under section 1008 of the Act (21 
U.S.C. 958), the Administrator may:
    (1) Suspend the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) for any period of time.
    (2) Revoke the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) if he/she determines that such registration is 
inconsistent with the public interest as defined in section 1008 or with 
the United States obligations under international treaties, conventions, 
or protocols in effect on October 12, 1984.
    (c) The Administrator may limit the revocation or suspension of a 
registration to the particular controlled substance, or substances, with 
respect to which grounds for revocation or suspension exist.
    (d) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to 
Sec. 1301.37 and, if requested by the registrant, shall hold a hearing 
pursuant to Sec. 1301.41.
    (e) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he/she finds that there is an imminent 
danger to the public health or safety. If the Administrator so suspends, 
he/she shall serve with the order to show cause pursuant to Sec. 1301.37 
an order of immediate suspension which shall contain a statement of his 
findings regarding the danger to public health or safety.
    (f) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his/her 
Certificate of Registration, any order forms, and any import or export 
permits in his/her possession to the nearest office of the 
Administration. The suspension or revocation of a registration shall 
suspend or revoke any individual manufacturing or procurement quota 
fixed for the registrant pursuant to part 1303 of this chapter and any 
import or export permits issued to the registrant pursuant to part 1312 
of this chapter. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:
    (1) Deliver all controlled substances in his/her possession to the 
nearest office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all controlled substances in his/her possession under seal 
as described in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 
824(f) or 958(d)(6)).
    (g) In the event that revocation or suspension is limited to a 
particular controlled substance or substances, the registrant shall be 
given a new Certificate of Registration for all substances not affected 
by such revocation or suspension; no fee shall be required to be paid 
for the new Certificate of Registration. The registrant shall deliver 
the old Certificate of Registration and, if appropriate, any order forms 
in his/her possession to the nearest office of the Administration. The 
suspension or revocation of a registration, when limited to a particular 
basic class or classes of controlled substances, shall suspend or revoke 
any individual manufacturing or procurement quota fixed for the 
registrant for such class or classes pursuant to part 1303 of this 
chapter and any import or export permits issued to the registrant for 
such class or classes pursuant to part 1312 of this chapter. Also, upon 
service of the order of the Administrator revoking or suspending 
registration, the registrant

[[Page 29]]

shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular controlled 
substance or substances affected by the revocation or suspension which 
are in his/her possession; or
    (2) Place all of such substances under seal as described in sections 
304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).
    (h) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under paragraph (e) of this section may 
request a hearing on the revocation or suspension of his/her 
registration at a time earlier than specified in the order to show cause 
pursuant to Sec. 1301.37. This request shall be granted by the 
Administrator, who shall fix a date for such hearing as early as 
reasonably possible.
    (i) In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his/her order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.
[62 FR 13955, Mar. 24, 1997]

Sec. 1301.37  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 and/
or section 1008 of the Act (21 U.S.C. 823 and 958) to register the 
applicant, the Administrator shall serve upon the applicant an order to 
show cause why the registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the 
Administrator shall serve upon the registrant an order to show cause why 
the registration should not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon receipt of an order to show cause, the applicant or 
registrant must, if he/she desires a hearing, file a request for a 
hearing pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing at the time and place stated in the 
order, pursuant to Sec. 1301.41.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.
[62 FR 13955, Mar. 24, 1997]

                                Hearings

Sec. 1301.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefor, the procedures for such hearing 
shall be

[[Page 30]]

governed generally by the adjudication procedures set forth in the 
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by 
Secs. 1301.42-1301.46 of this part, and by the procedures for 
administrative hearings under the Act set forth in Secs. 1316.41-1316.67 
of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.
[62 FR 13956, Mar. 24, 1997]

Sec. 1301.42  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration, and the granting of any application for 
registration to import or to manufacture in bulk a basic class of 
controlled substance listed in Schedule I or II. Extensive argument 
should not be offered into evidence but rather presented in opening or 
closing statements of counsel or in memoranda or proposed findings of 
fact and conclusions of law.
[62 FR 13956, Mar. 24, 1997]

Sec. 1301.43  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. 1301.32 or 
Secs. 1301.34-1301.36 and desiring a hearing shall, within 30 days after 
the date of receipt of the order to show cause (or the date of 
publication of notice of the application for registration in the Federal 
Register in the case of Sec. 1301.34), file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to participate in a hearing pursuant to 
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30 
days of the date of publication of notice of the request for a hearing 
in the Federal Register, file with the Administrator a written notice of 
intent to participate in such hearing in the form prescribed in 
Sec. 1316.48 of this chapter. Any person filing a request for a hearing 
need not also file a notice of appearance.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the period 
permitted for filing a request for a hearing or a notice of appearance, 
file with the Administrator a waiver of an opportunity for a hearing or 
to participate in a hearing, together with a written statement regarding 
such person's position on the matters of fact and law involved in such 
hearing. Such statement, if admissible, shall be made a part of the 
record and shall be considered in light of the lack of opportunity for 
cross-examination in determining the weight to be attached to matters of 
fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 fails to file 
a request for a hearing or a notice of appearance, or if such person so 
files and fails to appear at the hearing, such person shall be deemed to 
have waived the opportunity for a hearing or to participate in the 
hearing, unless such person shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his/her final order pursuant to 
Sec. 1301.46 without a hearing.
[62 FR 13956, Mar. 24, 1997]

Sec. 1301.44  Burden of proof.

    (a) At any hearing on an application to manufacture any controlled 
substance listed in Schedule I or II, the applicant shall have the 
burden of proving that the requirements for such registration pursuant 
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.35(b) shall 
have the burden of proving any propositions of fact or law asserted by 
such person in the hearing.
    (b) At any hearing on the granting or denial of an applicant to be 
registered to conduct a narcotic treatment program or as a compounder, 
the applicant shall have the burden of proving

[[Page 31]]

that the requirements for each registration pursuant to section 303(g) 
of the Act (21 U.S.C. 823(g)) are satisfied.
    (c) At any hearing on the granting or denial of an application to be 
registered to import or export any controlled substance listed in 
Schedule I or II, the applicant shall have the burden of proving that 
the requirements for such registration pursuant to sections 1008(a) and 
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.34 shall have 
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
    (d) At any other hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 or section 1008(c) and (d) 
of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
    (e) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are 
satisfied.
[62 FR 13956, Mar. 24, 1997]

Sec. 1301.45  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter 
it may be moved to a different place and may be continued from day to 
day or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.
[62 FR 13956, Mar. 24, 1997]

Sec. 1301.46  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his/her order 
on the granting, denial, revocation, or suspension of registration. In 
the event that an application for registration to import or to 
manufacture in bulk a basic class of any controlled substance listed in 
Schedule I or II is granted, or any application for registration is 
denied, or any registration is revoked or suspended, the order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his/her order upon 
each party in the hearing.
[62 FR 13956, Mar. 24, 1997]

         Modification, Transfer and Termination of Registration

Sec. 1301.51  Modification in registration.

    Any registrant may apply to modify his/her registration to authorize 
the handling of additional controlled substances or to change his/her 
name or address, by submitting a letter of request to the Registration 
Unit, Drug Enforcement Administration, Department of Justice, Post 
Office Box 28083, Central Station, Washington, DC 20005. The letter 
shall contain the registrant's name, address, and registration number as 
printed on the certificate of registration, and the substances and/or 
schedules to be added to his/her registration or the new name or address 
and shall be signed in accordance with Sec. 1301.13(j). If the 
registrant is seeking to handle additional controlled substances listed 
in Schedule I for the purpose of research or instructional activities, 
he/she shall attach three copies of a research protocol describing each 
research project involving the additional substances, or two copies of a 
statement describing the nature, extent, and duration of such 
instructional activities, as appropriate. No fee shall be required to be 
paid for the modification. The request for modification shall be handled 
in the same manner as an application for registration. If the 
modification in registration is approved, the Administrator shall issue 
a new certificate of registration (DEA Form 223) to the registrant, who 
shall maintain it with the old certificate of registration until 
expiration.
[62 FR 13956, Mar. 24, 1997]

[[Page 32]]

Sec. 1301.52  Termination of registration; transfer of registration; 
          distribution upon discontinuance of business.

    (a) Except as provided in paragraph (b) of this section, the 
registration of any person shall terminate if and when such person dies, 
ceases legal existence, or discontinues business or professional 
practice. Any registrant who ceases legal existence or discontinues 
business or professional practice shall notify the Administrator 
promptly of such fact.
    (b) No registration or any authority conferred thereby shall be 
assigned or otherwise transferred except upon such conditions as the 
Administration may specifically designate and then only pursuant to 
written consent. Any person seeking authority to transfer a registration 
shall submit a written request, providing full details regarding the 
proposed transfer of registration, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Department of Justice, Washington, DC 20537.
    (c) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substances (without 
transferring such business activities to another person) shall return 
for cancellation his/her certificate of registration, and any unexecuted 
order forms in his/her possession, to the Registration Unit, Drug 
Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005. Any controlled substances 
in his/her possession may be disposed of in accordance with Sec. 1307.21 
of this chapter.
    (d) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substance (by transferring such 
business activities to another person) shall submit in person or by 
registered or certified mail, return receipt requested, to the Special 
Agent in Charge in his/her area, at least 14 days in advance of the date 
of the proposed transfer (unless the Special Agent in Charge waives this 
time limitation in individual instances), the following information:
    (1) The name, address, registration number, and authorized business 
activity of the registrant discontinuing the business (registrant-
transferor);
    (2) The name, address, registration number, and authorized business 
activity of the person acquiring the business (registrant-transferee);
    (3) Whether the business activities will be continued at the 
location registered by the person discontinuing business, or moved to 
another location (if the latter, the address of the new location should 
be listed);
    (4) Whether the registrant-transferor has a quota to manufacture or 
procure any controlled substance listed in Schedule I or II (if so, the 
basic class or class of the substance should be indicated); and
    (5) The date on which the transfer of controlled substances will 
occur.
    (e) Unless the registrant-transferor is informed by the Special 
Agent in Charge, before the date on which the transfer was stated to 
occur, that the transfer may not occur, the registrant-transferor may 
distribute (without being registered to distribute) controlled 
substances in his/her possession to the registrant-transferee in 
accordance with the following:
    (1) On the date of transfer of the controlled substances, a complete 
inventory of all controlled substances being transferred shall be taken 
in accordance with Sec. 1304.11 of this chapter. This inventory shall 
serve as the final inventory of the registrant-transferor and the 
initial inventory of the registrant-transferee, and a copy of the 
inventory shall be included in the records of each person. It shall not 
be necessary to file a copy of the inventory with the Administration 
unless requested by the Special Agent in Charge. Transfers of any 
substances listed in Schedule I or II shall require the use of order 
forms in accordance with part 1305 of this chapter.
    (2) On the date of transfer of the controlled substances, all 
records required to be kept by the registrant-transferor with reference 
to the controlled substances being transferred, under part 1304 of this 
chapter, shall be transferred to the registrant-transferee. 
Responsibility for the accuracy of records prior to the date of transfer 
remains with the transferor, but responsibility for custody and 
maintenance shall be upon the transferee.

[[Page 33]]

    (3) In the case of registrants required to make reports pursuant to 
part 1304 of this chapter, a report marked ``Final'' will be prepared 
and submitted by the registrant-transferor showing the disposition of 
all the controlled substances for which a report is required; no 
additional report will be required from him, if no further transactions 
involving controlled substances are consummated by him. The initial 
report of the registrant-transferee shall account for transactions 
beginning with the day next succeeding the date of discontinuance or 
transfer of business by the transferor-registrant and the substances 
transferred to him shall be reported as receipts in his/her initial 
report.
[62 FR 13957, Mar. 24, 1997]

                          Security Requirements

Sec. 1301.71  Security requirements generally.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of controlled 
substances. In order to determine whether a registrant has provided 
effective controls against diversion, the Administrator shall use the 
security requirements set forth in Secs. 1301.72-1301.76 as standards 
for the physical security controls and operating procedures necessary to 
prevent diversion. Materials and construction which will provide a 
structural equivalent to the physical security controls set forth in 
Secs. 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials 
and construction described in those sections.
    (b) Substantial compliance with the standards set forth in 
Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator 
after evaluation of the overall security system and needs of the 
applicant or registrant. In evaluating the overall security system of a 
registrant or applicant, the Administrator may consider any of the 
following factors as he may deem relevant to the need for strict 
compliance with security requirements:
    (1) The type of activity conducted (e.g., processing of bulk 
chemicals, preparing dosage forms, packaging, labeling, cooperative 
buying, etc.);
    (2) The type and form of controlled substances handled (e.g., bulk 
liquids or dosage units, usable powders or nonusable powders);
    (3) The quantity of controlled substances handled;
    (4) The location of the premises and the relationship such location 
bears on security needs;
    (5) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (6) The type of vault, safe, and secure enclosures or other storage 
system (e.g., automatic storage and retrieval system) used;
    (7) The type of closures on vaults, safes, and secure enclosures;
    (8) The adequacy of key control systems and/or combination lock 
control systems;
    (9) The adequacy of electric detection and alarm systems, if any 
including use of supervised transmittal lines and standby power sources;
    (10) The extent of unsupervised public access to the facility, 
including the presence and characteristics of perimeter fencing, if any;
    (11) The adequacy of supervision over employees having access to 
manufacturing and storage areas;
    (12) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel;
    (13) The availability of local police protection or of the 
registrant's or applicant's security personnel, and;
    (14) The adequacy of the registrant's or applicant's system for 
monitoring the receipt, manufacture, distribution, and disposition of 
controlled substances in its operations.
    (c) When physical security controls become inadequate as a result of 
a controlled substance being transferred to a different schedule, or as 
a result of a noncontrolled substance being listed on any schedule, or 
as a result of a significant increase in the quantity of controlled 
substances in the possession of the registrant during normal business 
operations, the physical security controls shall be expanded and 
extended accordingly. A registrant may adjust physical security controls 
within the requirements set forth in Secs. 1301.72-

[[Page 34]]

1301.76 when the need for such controls decreases as a result of a 
controlled substance being transferred to a different schedule, or a 
result of a controlled substance being removed from control, or as a 
result of a significant decrease in the quantity of controlled 
substances in the possession of the registrant during normal business 
operations.
    (d) Any registrant or applicant desiring to determine whether a 
proposed security system substantially complies with, or is the 
structural equivalent of, the requirements set forth in Secs. 1301.72-
1301.76 may submit any plans, blueprints, sketches or other materials 
regarding the proposed security system either to the Special Agent in 
Charge in the region in which the system will be used, or to the 
Diversion Operations Section, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (e) Physical security controls of locations registered under the 
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on 
April 30, 1971, shall be deemed to comply substantially with the 
standards set forth in Secs. 1301.72, 1301.73 and 1301.75. Any new 
facilities or work or storage areas constructed or utilized for 
controlled substances, which facilities or work or storage areas have 
not been previously approved by the Administration, shall not 
necessarily be deemed to comply substantially with the standards set 
forth in Secs. 1301.72, 1301.73 and 1301.75, notwithstanding that such 
facilities or work or storage areas have physical security controls 
similar to those previously approved by the Administration.
[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 
1982; 51 FR 5319, Feb. 13, 1986]

Sec. 1301.72  Physical security controls for non-practitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs; storage areas.

    (a) Schedules I and II. Raw materials, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedule I or II shall be stored in one of the 
following secure storage areas:
    (1) Where small quantities permit, a safe or steel cabinet;
    (i) Which safe or steel cabinet shall have the following 
specifications or the equivalent: 30 man-minutes against surreptitious 
entry, 10 man-minutes against forced entry, 20 man-hours against lock 
manipulation, and 20 man-hours against radiological techniques;
    (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, 
is bolted or cemented to the floor or wall in such a way that it cannot 
be readily removed; and
    (iii) Which safe or steel cabinet, if necessary, depending upon the 
quantities and type of controlled substances stored, is equipped with an 
alarm system which, upon attempted unauthorized entry, shall transmit a 
signal directly to a central protection company or a local or State 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant, or such other protection as the 
Administrator may approve.
    (2) A vault constructed before, or under construction on, September 
1, 1971, which is of substantial construction with a steel door, 
combination or key lock, and an alarm system; or
    (3) A vault constructed after September 1, 1971:
    (i) The walls, floors, and ceilings of which vault are constructed 
of at least 8 inches of reinforced concrete or other substantial 
masonry, reinforced vertically and horizontally with \1/2\-inch steel 
rods tied 6 inches on center, or the structural equivalent to such 
reinforced walls, floors, and ceilings;
    (ii) The door and frame unit of which vault shall conform to the 
following specifications or the equivalent: 30 man-minutes against 
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours 
against lock manipulation, and 20 man-hours against radiological 
techniques;
    (iii) Which vault, if operations require it to remain open for 
frequent access, is equipped with a ``day-gate'' which is self-closing 
and self-locking, or the equivalent, for use during the hours of 
operation in which the vault door is open;

[[Page 35]]

    (iv) The walls or perimeter of which vault are equipped with an 
alarm, which upon unauthorized entry shall transmit a signal directly to 
a central station protection company, or a local or State police agency 
which has a legal duty to respond, or a 24-hour control station operated 
by the registrant, or such other protection as the Administrator may 
approve, and, if necessary, holdup buttons at strategic points of entry 
to the perimeter area of the vault;
    (v) The door of which vault is equipped with contact switches; and
    (vi) Which vault has one of the following: Complete electrical 
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment 
within the vault; a sensitive sound accumulator system; or such other 
device designed to detect illegal entry as may be approved by the 
Administration.
    (b) Schedules III, IV and V. Raw materials, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedules III, IV and V shall be stored in the 
following secure storage areas:
    (1) A safe or steel cabinet as described in paragraph (a)(1) of this 
section;
    (2) A vault as described in paragraph (a)(2) or (3) of this section 
equipped with an alarm system as described in paragraph (b)(4)(v) of 
this section;
    (3) A building used for storage of Schedules III through V 
controlled substances with perhmeter security which limits access during 
working hours and provides security after working hours and meets the 
following specifications:
    (i) Has an electronic alarm system as described in paragraph 
(b)(4)(v) of this section,
    (ii) Is equipped with self-closing, self-locking doors constructed 
of substantial material commensurate with the type of building 
construction, provided, however, a door which is kept clored and locked 
at all times when not in use and when in use is kept under direct 
observation of a responsible employee or agent of the registrant is 
permitted in lieu of a self-closing, self-locking door. Doors may be 
sliding or hinged. Regarding hinged doors, where hinges are mounted on 
the outside, such hinges shall be sealed, welded or otherwise 
constructed to inhibit removal. Locking devices for such doors shall be 
either of the multiple-position combination or key lock type and:
    (a) In the case of key locks, shall require key control which limits 
access to a limited number of employees, or;
    (b) In the case of combination locks, the combination shall be 
limited to a minimum number of employees and can be changed upon 
termination of employment of an employee having knowledge of the 
combination;
    (4) A cage, located within a building on the premises, meeting the 
following specifications:
    (i) Having walls constructed of not less than No. 10 gauge steel 
fabric mounted on steel posts, which posts are:
    (a) At least one inch in diameter;
    (b) Set in concrete or installed with lag bolts that are pinned or 
brazed; and
    (c) Which are placed no more than ten feet apart with horizontal one 
and one-half inch reinforcements every sixty inches;
    (ii) Having a mesh construction with openings of not more than two 
and one-half inches across the square,
    (iii) Having a ceiling constructed of the same material, or in the 
alternative, a cage shall be erected which reaches and is securely 
attached to the structural ceiling of the building. A lighter gauge mesh 
may be used for the ceilings of large enclosed areas if walls are at 
least 14 feet in height,
    (iv) Is equipped with a door constructed of No. 10 gauge steel 
fabric on a metal door frame in a metal door flange, and in all other 
respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii), 
and
    (v) Is equipped with an alarm system which upon unauthorized entry 
shall transmit a signal directly to a central station protection agency 
or a local or state police agency, each having a legal duty to respond, 
or to a 24-hour control station operated by the registrant, or to such 
other source of protection as the Administrator may approve;
    (5) An enclosure of masonry or other material, approved in writing 
by the Administrator as providing security comparable to a cage;

[[Page 36]]

    (6) A building or enclosure within a building which has been 
inspected and approved by DEA or its predecessor agency, BNDD, and 
continues to provide adequate security against the diversion of Schedule 
III through V controlled substances, of which fact written 
acknowledgment has been made by the Special Agent in Charge of DEA for 
the area in which such building or enclosure is situated;
    (7) Such other secure storage areas as may be approved by the 
Administrator after considering the factors listed in Sec. 1301.71(b), 
(1) through (14);
    (8)(i) Schedule III through V controlled substances may be stored 
with Schedules I and II controlled substances under security measures 
provided by 21 CFR 1301.72(a);
    (ii) Non-controlled drugs, substances and other materials may be 
stored with Schedule III through V controlled substances in any of the 
secure storage areas required by 21 CFR 1301.72(b), provided that 
permission for such storage of non-controlled items is obtained in 
advance, in writing, from the Special Agent in Charge of DEA for the 
area in which such storage area is situated. Any such permission 
tendered must be upon the Special Agent in Charge's written 
determination that such non-segregated storage does not diminish 
security effectiveness for Schedules III through V controlled 
substances.
    (c) Multiple storage areas. Where several types or classes of 
controlled substances are handled separately by the registrant or 
applicant for different purposes (e.g., returned goods, or goods in 
process), the controlled substances may be stored separately, provided 
that each storage area complies with the requirements set forth in this 
section.
    (d) Accessibility to storage areas. The controlled substances 
storage areas shall be accessible only to an absolute minimum number of 
specifically authorized employees. When it is necessary for employee 
maintenance personnel, nonemployee maintenance personnel, business 
guests, or visitors to be present in or pass through controlled 
substances storage areas, the registrant shall provide for adequate 
observation of the area by an employee specifically authorized in 
writing.
[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, l973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1301.72, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1301.73  Physical security controls for non-practitioners; 
          compounders for narcotic treatment programs; manufacturing and 
          compounding areas.

    All manufacturing activities (including processing, packaging and 
labeling) involving controlled substances listed in any schedule and all 
activities of compounders shall be conducted in accordance with the 
following:
    (a) All in-process substances shall be returned to the controlled 
substances storage area at the termination of the process. If the 
process is not terminated at the end of a workday (except where a 
continuous process or other normal manufacturing operation should not be 
interrupted), the processing area or tanks, vessels, bins or bulk 
containers containing such substances shall be securely locked, with 
adequate security for the area or building. If such security requires an 
alarm, such alarm, upon unauthorized entry, shall transmit a signal 
directly to a central station protection company, or local or state 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant.
    (b) Manufacturing activities with controlled substances shall be 
conducted in an area or areas of clearly defined limited access which is 
under surveillance by an employee or employees designated in writing as 
responsible for the area. ``Limited access'' may be provided, in the 
absence of physical dividers such as walls or partitions, by traffic 
control lines or restricted space designation. The employee designated 
as responsible for the area may be engaged in the particular 
manufacturing operation being conducted: Provided, That he is able to 
provide continuous surveillance of the area in order that unauthorized 
persons may not enter or leave the area without his knowledge.
    (c) During the production of controlled substances, the 
manufacturing

[[Page 37]]

areas shall be accessible to only those employees required for efficient 
operation. When it is necessary for employee maintenance personnel, 
nonemployee maintenance personnel, business guests, or visitors to be 
present in or pass through manufacturing areas during production of 
controlled substances, the registrant shall provide for adequate 
observation of the area by an employee specifically authorized in 
writing.
[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973 and amended at 39 FR 37984, Oct. 25, 1974]

Sec. 1301.74  Other security controls for non-practitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs.

    (a) Before distributing a controlled substance to any person who the 
registrant does not know to be registered to possess the controlled 
substance, the registrant shall make a good faith inquiry either with 
the Administration or with the appropriate State controlled substances 
registration agency, if any, to determine that the person is registered 
to possess the controlled substance.
    (b) The registrant shall design and operate a system to disclose to 
the registrant suspicious orders of controlled substances. The 
registrant shall inform the Field Division Office of the Administration 
in his area of suspicious orders when discovered by the registrant. 
Suspicious orders include orders of unusual size, orders deviating 
substantially from a normal pattern, and orders of unusual frequency.
    (c) The registrant shall notify the Field Division Office of the 
Administration in his area of any theft or significant loss of any 
controlled substances upon discovery of such theft or loss. The supplier 
shall be responsible for reporting in-transit losses of controlled 
substances by the common or contract carrier selected pursuant to 
Sec. 1301.74(e), upon discovery of such theft or loss. The registrant 
shall also complete DEA Form 106 regarding such theft or loss. Thefts 
must be reported whether or not the controlled substances are 
subsequently recovered and/or the responsible parties are identified and 
action taken against them.
    (d) The registrant shall not distribute any controlled substance 
listed in Schedules II through V as a complimentary sample to any 
potential or current customer (1) without the prior written request of 
the customer, (2) to be used only for satisfying the legitimate medical 
needs of patients of the customer, and (3) only in reasonable 
quantities. Such request must contain the name, address, and 
registration number of the customer and the name and quantity of the 
specific controlled substance desired. The request shall be preserved by 
the registrant with other records of distribution of controlled 
substances. In addition, the requirements of part 1305 of the chapter 
shall be complied with for any distribution of a controlled substance 
listed in Schedule II. For purposes of this paragraph, the term 
``customer'' includes a person to whom a complimentary sample of a 
substance is given in order to encourage the prescribing or recommending 
of the substance by the person.
    (e) When shipping controlled substances, a registrant is responsible 
for selecting common or contract carriers which provide adequate 
security to guard against in-transit losses. When storing controlled 
substances in a public warehouse, a registrant is responsible for 
selecting a warehouseman which will provide adequate security to guard 
against storage losses; wherever possible, the registrant shall store 
controlled substances in a public warehouse which complies with the 
requirements set forth in Sec. 1301.72. In addition, the registrant 
shall employ precautions (e.g., assuring that shipping containers do not 
indicate that contents are controlled substances) to guard against 
storage or in-transit losses.
    (f) When distributing controlled substances through agents (e.g., 
detailmen), a registrant is responsible for providing and requiring 
adequate security to guard against theft and diversion while the 
substances are being stored or handled by the agent or agents.
    (g) Before the initial distribution of carfentanil etorphine 
hydrochloride and/or diprenorphine to any person, the registrant must 
verify that the person

[[Page 38]]

is authorized to handle the substances(s) by contacting the Drug 
Enforcement Administration.
    (h) The acceptance of delivery of narcotic substances by a narcotic 
treatment program shall be made only by a licensed practitioner employed 
at the facility or other authorized individuals designated in writing. 
At the time of delivery, the licensed practitioner or other authorized 
individual designated in writing (excluding persons currently or 
previously dependent on narcotic drugs), shall sign for the narcotics 
and place his specific title (if any) on any invoice. Copies of these 
signed invoices shall be kept by the distributor.
    (i) Narcotics dispensed or administered at a narcotic treatment 
program will be dispensed or administered directly to the patient by 
either (1) the licensed practitioner, (2) a registered nurse under the 
direction of the licensed practitioner, (3) a licensed practical nurse 
under the direction of the licensed practitioner, or (4) a pharmacist 
under the direction of the licensed practitioner.
    (j) Persons enrolled in a narcotic treatment program will be 
required to wait in an area physically separated from the narcotic 
storage and dispensing area. This requirement will be enforced by the 
program physician and employees.
    (k) All narcotic treatment programs must comply with standards 
established by the Secretary of Health and Human Services (after 
consultation with the Administration) respecting the quantities of 
narcotic drugs which may be provided to persons enrolled in a narcotic 
treatment program for unsupervised use.
    (l) DEA may exercise discretion regarding the degree of security 
required in narcotic treatment programs based on such factors as the 
location of a program, the number of patients enrolled in a program and 
the number of physicians, staff members and security guards. Similarly, 
such factors will be taken into consideration when evaluating existing 
security or requiring new security at a narcotic treatment program.
[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36 
FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, l973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1301.74, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1301.75  Physical security controls for practitioners.

    (a) Controlled substances listed in Schedule I shall be stored in a 
securely locked, substantially constructed cabinet.
    (b) Controlled substances listed in Schedules II, III, IV, and V 
shall be stored in a securely locked, substantially constructed cabinet. 
However, pharmacies and institutional practitioners may disperse such 
substances throughout the stock of noncontrolled substances in such a 
manner as to obstruct the theft or diversion of the controlled 
substances.
    (c) This section shall also apply to nonpractitioners authorized to 
conduct research or chemical analysis under another registration.
    (d) Carfentanil etorphine hydrochloride and diprenorphine shall be 
stored in a safe or steel cabinet equivalent to a U.S. Government Class 
V security container.
[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 
FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]

Sec. 1301.76  Other security controls for practitioners.

    (a) The registrant shall not employ, as an agent or employee who has 
access to controlled substances, any person who has been convicted of a 
felony offense relating to controlled substances or who, at any time, 
had an application for registration with the DEA denied, had a DEA 
registration revoked or has surrendered a DEA registration for cause. 
For purposes of this subsection, the term ``for cause'' means a 
surrender in lieu of, or as a consequence of, any federal or state 
administrative, civil or criminal action resulting from

[[Page 39]]

an investigation of the individual's handling of controlled substances.
    (b) The registrant shall notify the Field Division Office of the 
Administration in his area of the theft or significant loss of any 
controlled substances upon discovery of such loss or theft. The 
registrant shall also complete DEA (or BND) Form 106 regarding such loss 
or theft.
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor, as permitted in 
Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply 
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a), 
(b), and (e).
[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, l973; 
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, 
Mar. 24, 1997]

                 Employee Screening--Non- Practitioners

Sec. 1301.90  Employee screening procedures.

    It is the position of DEA that the obtaining of certain information 
by non-practitioners is vital to fairly assess the likelihood of an 
employee committing a drug security breach. The need to know this 
information is a matter of business necessity, essential to overall 
controlled substances security. In this regard, it is believed that 
conviction of crimes and unauthorized use of controlled substances are 
activities that are proper subjects for inquiry. It is, therefore, 
assumed that the following questions will become a part of an employer's 
comprehensive employee screening program:

    Question. Within the past five years, have you been convicted of a 
felony, or within the past two years, of any misdemeanor or are you 
presently formally charged with committing a criminal offense? (Do not 
include any traffic violations, juvenile offenses or military 
convictions, except by general court-martial.) If the answer is yes, 
furnish details of conviction, offense, location, date and sentence.

    Question. In the past three years, have you ever knowingly used any 
narcotics, amphetamines or barbiturates, other than those prescribed to 
you by a physician? If the answer is yes, furnish details.

    Advice. An authorization, in writing, that allows inquiries to be 
made of courts and law enforcement agencies for possible pending charges 
or convictions must be executed by a person who is allowed to work in an 
area where access to controlled substances clearly exists. A person must 
be advised that any false information or omission of information will 
jeopardize his or her position with respect to employment. The 
application for employment should inform a person that information 
furnished or recovered as a result of any inquiry will not necessarily 
preclude employment, but will be considered as part of an overall 
evaluation of the person's qualifications. The maintaining of fair 
employment practices, the protection of the person's right of privacy, 
and the assurance that the results of such inquiries will be treated by 
the employer in confidence will be explained to the employee.
[40 FR 17143, Apr. 17, 1975]

Sec. 1301.91  Employee responsibility to report drug diversion.

    Reports of drug diversion by fellow employees is not only a 
necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of drug diversion from his employer by a 
fellow employee has an obligation to report such information to a 
responsible security official of the employer. The employer shall treat 
such information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of drug 
diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in a drug security area. The 
employer shall inform all employees concerning this policy.
[40 FR 17143, Apr. 17, 1975]

Sec. 1301.92  Illicit activities by employees.

    It is the position of DEA that employees who possess, sell, use or 
divert controlled substances will subject themselves not only to State 
or Federal prosecution for any illicit activity, but shall also 
immediately become the subject of independent action regarding their 
continued employment. The employer will assess the seriousness of the 
employee's violation, the

[[Page 40]]

position of responsibility held by the employee, past record of 
employment, etc., in determining whether to suspend, transfer, terminate 
or take other action against the employee.
[40 FR 17143, Apr. 17, 1975]

Sec. 1301.93  Sources of information for employee checks.

    DEA recommends that inquiries concerning employees' criminal records 
be made as follows:

    Local inquiries. Inquiries should be made by name, date and place of 
birth, and other identifying information, to local courts and law 
enforcement agencies for records of pending charges and convictions. 
Local practice may require such inquiries to be made in person, rather 
than by mail, and a copy of an authorization from the employee may be 
required by certain law enforcement agencies.
    DEA inquiries. Inquiries supplying identifying information should 
also be furnished to DEA Field Division Offices along with written 
consent from the concerned individual for a check of DEA files for 
records of convictions. The Regional check will result in a national 
check being made by the Field Division Office.
[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]









[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: 21CFR1302]

[Page 40-41]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES

Sec.
1302.01  Scope of part 1302.
1302.02  Definitions.
1302.03  Symbol required; exceptions.
1302.04  Location and size of symbol on label and labeling.
1302.05  Effective dates of labeling requirements.
1302.06  Sealing of controlled substances.
1302.07  Labeling and packaging requirements for imported and exported 
          substances.

    Authority:  21 U.S.C. 821, 825, 871(b), 958(e).

    Source:  36 FR 7785, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

Sec. 1302.01  Scope of part 1302.

    Requirements governing the labeling and packaging of controlled 
substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 
825 and 958(d)) are set forth generally by those sections and 
specifically by the sections of this part.
[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973]

Sec. 1302.02  Definitions.

    Any term contained 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 13958, Mar. 24, 1997]

Sec. 1302.03  Symbol required; exceptions.

    (a) Each commercial container of a controlled substance (except for 
a controlled substance excepted by the Administrator pursuant to 
Sec. 1308.31 of this chapter) shall have printed on the label the symbol 
designating the schedule in which such controlled substance is listed. 
Each such commercial container, if it otherwise has no label, must bear 
a label complying with the requirement of this part.
    (b) Each manufacturer shall print upon the labeling of each 
controlled substance distributed by him the symbol designating the 
schedule in which such controlled substance is listed.
    (c) The following symbols shall designate the schedule corresponding 
thereto:

                                                                        
                                                                        
                 Schedule                                               
                                                                        
Schedule I................................  CI or C-I.                  
Schedule II...............................  CII or C-II.                
Schedule III..............................  CIII or C-III.              
Schedule IV...............................  CIV or C-IV.                
Schedule V................................  CV or C-V.                  
                                                                        


The word ``schedule'' need not be used. No distinction need be made 
between narcotic and nonnarcotic substances.
    (d) The symbol is not required on a carton or wrapper in which a 
commercial container is held if the symbol is easily legible through 
such carton or wrapper.
    (e) The symbol is not required on a commercial container too small 
or otherwise unable to accommodate a label, if the symbol is printed on 
the box or package from which the commercial container is removed upon 
dispensing to an ultimate user.
    (f) The symbol is not required on a commercial container containing, 
or

[[Page 41]]

on the labeling of, a controlled substance being utilized in clinical 
research involving blind and double blind studies.
[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1302.04  Location and size of symbol on label and labeling.

    The symbol shall be prominently located on the label or the labeling 
of the commercial container and/or the panel of the commercial container 
normally displayed to dispensers of any controlled substance. The symbol 
on labels shall be clear and large enough to afford easy identification 
of the schedule of the controlled substance upon inspection without 
removal from the dispenser's shelf. The symbol on all other labeling 
shall be clear and large enough to afford prompt identification of the 
controlled substance upon inspection of the labeling.
[62 FR 13958, Mar. 24, 1997]

Sec. 1302.05  Effective dates of labeling requirements.

    All labels on commercial containers of, and all labeling of, a 
controlled substance which either is transferred to another schedule or 
is added to any schedule shall comply with the requirements of 
Sec. 1302.03, on or before the effective date established in the final 
order for the transfer or addition.
[62 FR 13958, Mar. 24, 1997]

Sec. 1302.06  Sealing of controlled substances.

    On each bottle, multiple dose vial, or other commercial container of 
any controlled substance, there shall be securely affixed to the 
stopper, cap, lid, covering, or wrapper or such container a seal to 
disclose upon inspection any tampering or opening of the container.
[62 FR 13958, Mar. 24, 1997]

Sec. 1302.07  Labeling and packaging requirements for imported and 
          exported substances.

    (a) The symbol requirements of Secs. 1302.03-1302.05 apply to every 
commercial container containing, and to all labeling of, controlled 
substances imported into the jurisdiction of and/or the customs 
territory of the United States.
    (b) The symbol requirements of Secs. 1302.03-1302.05 do not apply to 
any commercial containers containing, or any labeling of, a controlled 
substance intended for export from the jurisdiction of the United 
States.
    (c) The sealing requirements of Sec. 1302.06 apply to every bottle, 
multiple dose vial, or other commercial container of any controlled 
substance listed in schedule I or II, or any narcotic controlled 
substance listed in schedule III or IV, imported into, exported from, or 
intended for export from, the jurisdiction of and/or the customs 
territory of the United States.
[62 FR 13958, Mar. 24, 1997]









[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: 21CFR1303]

[Page 41-50]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1303--QUOTAS

                           General Information

Sec.
1303.01  Scope of part 1303.
1303.02  Definitions.

               Aggregate Production and Procurement Quotas

1303.11  Aggregate production quotas.
1303.12  Procurement quotas.
1303.13  Adjustments of aggregate production quotas.

                     Individual Manufacturing Quotas

1303.21  Individual manufacturing quotas.
1303.22  Procedure for applying for individual manufacturing quotas.
1303.23  Procedure for fixing individual manufacturing quotas.
1303.24  Inventory allowance.
1303.25  Increase in individual manufacturing quotas.
1303.26  Reduction in individual manufacturing quotas.
1303.27  Abandonment of quota.

                                Hearings

1303.31  Hearings generally.
1303.32  Purpose of hearing.
1303.33  Waiver or modification of rules.
1303.34  Request for hearing or appearance; waiver.
1303.35  Burden of proof.
1303.36  Time and place of hearing.
1303.37  Final order.

    Authority:  21 U.S.C. 821, 826, 871(b).

[[Page 42]]

                           General Information

Sec. 1303.01  Scope of part 1303.

    Procedures governing the establishment of production and 
manufacturing quotas on basic classes of controlled substances listed in 
schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) 
are governed generally by that section and specifically by the sections 
of this part.
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.02  Definitions.

    Any term contained 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 13958, Mar. 24, 1997]

               Aggregate Production and Procurement Quotas

Sec. 1303.11  Aggregate production quotas.

    (a) The Administrator shall determine the total quantity of each 
basic class of controlled substance listed in Schedule I or II necessary 
to be manufactured during the following calendar year to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States, for lawful export requirements, and for the establishment 
and maintenance of reserve stocks.
    (b) In making his determinations, the Administrator shall consider 
the following factors:
    (1) Total net disposal of the class by all manufacturers during the 
current and 2 preceding years;
    (2) Trends in the national rate of net disposal of the class;
    (3) Total actual (or estimated) inventories of the class and of all 
substances manufactured from the class, and trends in inventory 
accumulation;
    (4) Projected demand for such class as indicated by procurement 
quotas requested pursuant to Sec. 1303.12; and
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (c) The Administrator shall, on or before May 1 of each year, 
publish in the Federal Register, general notice of an aggregate 
production quota for any basic class determined by him under this 
section. A copy of said notice shall be mailed simultaneously to each 
person registered as a bulk manufacturer of the basic class. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice the time during which such filings may be made. The Administrator 
may, but shall not be required to, hold a public hearing on one or more 
issues raised by the comments and objections filed with him. In the 
event the Administrator decides to hold such a hearing, he shall publish 
notice of the hearing in the Federal Register, which notice shall 
summarize the issues to be heard and shall set the time for the hearing 
which shall nnt be less than 30 days after the date of publication of 
the notice. After consideration of any comments or objections, or after 
a hearing if one is ordered by the Administrator, the Administrator 
shall issue and publish in the Federal Register his final order 
determining the aggregate production quota for the basic class of 
controlled substance. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The order shall 
specify the date on which it shall take effect. A copy of said order 
shall be mailed simultaneously to each person registered as a bulk 
manufacturer of the basic class.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.12  Procurement quotas.

    (a) In order to determine the estimated needs for, and to insure an 
adequate and uninterrupted supply of, basic classes of controlled 
substances

[[Page 43]]

listed in Schedules I and II (except raw opium being imported by the 
registrant pursuant to an import permit) the Administrator shall issue 
procurement quotas authorizing persons to procure and use quantities of 
each basic class of such substances for the purpose of manufacturing 
such class into dosage forms or into other substances.
    (b) Any person who is registered to manufacture controlled 
substances listed in any schedule and who desires to use during the next 
calendar year any basic class of controlled substances listed in 
Schedule I or II (except raw opium being imported by the registrant 
pursuant to an import permit) for purposes of manufacturing, shall apply 
on DEA Form 250 for a procurement quota for such basic class. A separate 
application must be made for each basic class desired to be procured or 
used. The applicant shall state whether he intends to manufacture the 
basic class himself or purchase it from another manufacturer. The 
applicant shall state separately each purpose for which the basic class 
is desired, the quantity desired for that purpose during the next 
calendar year, and the quantities used and estimated to be used, if any, 
for that purpose during the current and preceding 2 calendar years. If 
the purpose is to manufacture the basic class into dosage form, the 
applicant shall state the official name, common or usual name, chemical 
name, or brand name of that form. If the purpose is to manufacture 
another substance, the applicant shall state the official name, common 
or usual name, chemical name, or brand name of the substance, and, if a 
controlled substance listed in any schedule, the schedule number and 
Administration Controlled Substances Code Number, as set forth in part 
1308 of this chapter, of the substance. If the purpose is to manufacture 
another basic class of controlled substance listed in Schedule I or II, 
the applicant shall also state the quantity of the other basic class 
which the applicant has applied to manufacture pursuant to Sec. 1303.22 
and the quantity of the first basic class necessary to manufacture a 
specified unit of the second basic class. DEA Form 250 shall be filed on 
or before April 1 of the year preceding the calendar year for which the 
procurement quota is being applied. Copies of DEA Form 250 may be 
obtained from, and shall be filed with, the Drug & Chemical Evaluation 
Section, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537.
    (c) The Administrator shall, on or before July 1 of the year 
preceding the calendar year during which the quota shall be effective, 
issue to each qualified applicant a procurement quota authorizing him to 
procure and use:
    (1) All quantities of such class necessary to manufacture all 
quantities of other basic classes of controlled substances listed in 
Schedules I and II which the applicant is authorized to manufacture 
pursuant to Sec. 1303.23; and
    (2) Such other quantities of such class as the applicant has applied 
to procure and use and are consistent with his past use, his estimated 
needs, and the total quantity of such class that will be produced.
    (d) Any person to whom a procurement quota has been issued may at 
any time request an adjustment in the quota by applying to the 
Administrator with a statement showing the need for the adjustment. Such 
application shall be filed with the Drug & Chemical Evaluation Section, 
Drug Enforcement Administration, Department of Justice, Washington, DC 
20537. The Administrator shall increase or decrease the procurement 
quota of such person if and to the extent that he finds, after 
considering the factors enumerated in paragraph (c) of this section and 
any occurrences since the issuance of the procurement quota, that the 
need justifies an adjustment.
    (e) The following persons need not obtain a procurement quota:
    (1) Any person who is registered to manufacture a basic class of 
controlled substance listed in Schedule I or II and who uses all of the 
quantity he manufactures in the manufacture of a substance not 
controlled under the Act;
    (2) Any person who is registered or authorized to conduct chemical 
analysis with controlled substances (for controlled substances to be 
used in such analysis only); and
    (3) Any person who is registered to conduct research with a basic 
class of controlled substance listed in Schedule

[[Page 44]]

I or II and who is authorized to manufacture a quantity of such class 
pursuant to Sec. 1301.13 of this chapter.
    (f) Any person to whom a procurement quota has been issued, 
authorizing that person to procure and use a quantity of a basic class 
of controlled substances listed in Schedules I or II during the current 
calendar year, shall, at or before the time of giving an order to 
another manufacturer requiring the distribution of a quantity of such 
basic class, certify in writing to such other manufacturer that the 
quantity of such basic class ordered does not exceed the person's unused 
and available procurement quota of such basic class for the current 
calendar year. The written certification shall be executed by the same 
individual who signed the DEA Form 222 transmitting the order. 
Manufacturers shall not fill an order from persons required to apply for 
a procurement quota under paragraph (b) of this section unless the order 
is accompanied by a certification as required under this section. The 
certification required by this section shall contain the following: The 
date of the certification; the name and address of the bulk manufacturer 
to whom the certification is directed; a reference to the number of the 
DEA Form 222 to which the certification applies; the name of the person 
giving the order to which the certification applies; the name of the 
basic class specified in the DEA Form 222 to which the certification 
applies; the appropriate schedule within which is listed the basic class 
specified in the DEA Form 222 to which the certification applies; a 
statement that the quantity (expressed in grams) of the basic class 
specified in the DEA Form 222 to which the certification applies does 
not exceed the unused and available procurement quota of such basic 
class, issued to the person giving the order, for the current calendar 
year; and the signature of the individual who signed the DEA Form 222 to 
which the certification applies.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 
FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1303.12, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1303.13  Adjustments of aggregate production quotas.

    (a) The Administrator may at any time increase or reduce the 
aggregate production quota for a basic class of controlled substance 
listed in Schedule I or II which he has previously fixed pursuant to 
Sec. 1303.11.
    (b) In determining to adjust the aggregate production quota, the 
Administrator shall consider the following factors:
    (1) Changes in the demand for that class, changes in the national 
rate of net disposal of the class, and changes in the rate of net 
disposal of the class by registrants holding individual manufacturing 
quotas for that class;
    (2) Whether any increased demand for that class, the national and/or 
individual rates of net disposal of that class are temporary, short 
term, or long term;
    (3) Whether any increased demand for that class can be met through 
existing inventories, increased individual manufacturing quotas, or 
increased importation, without increasing the aggregate production 
quota, taking into account production delays and the probability that 
other individual manufacturing quotas may be suspended pursuant to 
Sec. 1303.24(b);
    (4) Whether any decreased demand for that class will result in 
excessive inventory accumulation by all persons registered to handle 
that class (including manufacturers, distributors, practitioners, 
importers, and exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to 
Sec. 1303.24(b) or abandoned pursuant to Sec. 1303.27;
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in

[[Page 45]]

manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) The Administrator in the event he determines to increase or 
reduce the aggregate production quota for a basic class of controlled 
substance, shall publish in the Federal Register general notice of an 
adjustment in the aggregate production quota for that class determined 
by him under this section. A copy of said notice shall be mailed 
simultaneously to each person registered as a bulk manufacturer of the 
basic class. The Administrator shall permit any interested person to 
file written comments on or objections to the proposal and shall 
designate in the notice the time during which such filings may be made. 
The Administrator may, but shall not be required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish notice of the hearing in the Federal Register, 
which notice shall summarize the issues to be heard and shall set the 
time for the hearing, which shall not be less than 10 days after the 
date of publication of the notice. After consideration of any comments 
or objections, or after a hearing if one is ordered by the 
Administrator, the Administrator shall issue and publish in the Federal 
Register his final order determining the aggregate production for the 
basic class of controlled substance. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The order shall specify the date on which it shall take effect. A copy 
of said order shall be mailed simultaneously to each person registered 
as a bulk manufacturer of the basic class.
[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

                     Individual Manufacturing Quotas

Sec. 1303.21  Individual manufacturing quotas.

    (a) The Administrator shall, on or before July 1 of each year, fix 
for and issue to each person who is registered to manufacture a basic 
class of controlled substance listed in Schedule I or II, and who 
applies for a manufacturing quota, an individual manufacturing quota 
authorizing that person to manufacture during the next calendar year a 
quantity of that basic class. Any manufacturing quota fixed and issued 
by the Administrator shall be subject to his authority to reduce or 
limit it at a later date pursuant to Sec. 1303.26 and to his authority 
to revoke or suspend it at any time pursuant to Secs. 1301.36 of this 
chapter.
    (b) No individual manufacturing quota shall be required for 
registrants listed in Sec. 1303.12(e).
[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13958, Mar. 24, 1997]

Sec. 1303.22  Procedure for applying for individual manufacturing 
          quotas.

    Any person who is registered to manufacture any basic class of 
controlled substance listed in Schedule I or II and who desires to 
manufacture a quantity of such class shall apply on DEA Form 189 for a 
manufacturing quota for such quantity of such class. Copies of DEA Form 
189 may be obtained from, and shall be filed (on or before May 1 of the 
year preceding the calendar year for which the manufacturing quota is 
being applied) with, the Drug & Chemical Evaluation Section, Drug 
Enforcement Administration, Department of Justice, Washington, D.C. 
20537. A separate application must be made for each basic class desired 
to be manufactured. The applicant shall state:
    (a) The name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the basic class.
    (b) For the basic class in each of the current and preceding 2 
calendar years,
    (1) The authorized individual manufacturing quota, if any;
    (2) The actual or estimated quantity manufactured;
    (3) The actual or estimated net disposal;
    (4) The actual or estimated inventory allowance pursuant to 
Sec. 1303.24; and
    (5) The actual or estimated inventory as of December 31;
    (c) For the basic class in the next calendar year,

[[Page 46]]

    (1) The desired individual manufacturing quota; and
    (2) Any additional factors which the applicant finds relevant to the 
fixing of his individual manufacturing quota, including the trend of 
(and recent changes in) his and the national rates of net disposal, his 
production cycle and current inventory position, the econolic and 
physical availability of raw materials for use in manufacturing and for 
inventory purposes, yield and stability problems, potential disruptions 
to production (including possible labor strikes) and recent unforeseen 
emergencies such as floods and fires.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37 
FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 
13958, Mar. 24, 1997]

Sec. 1303.23  Procedure for fixing individual manufacturing quotas.

    (a) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is currently manufacturing such class a 
quota equal to 100 percent of the estimated net disposal of that 
applicant for the next calendar year, adjusted--
    (1) By the amount necessary to increase or reduce the estimated 
inventory of the applicant on December 31 of the current year to his 
estimated inventory allowance for the next calendar year, pursuant to 
Sec. 1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) his and the national 
rates of net disposal, his production cycle and current inventory 
position, the economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes, yield and stability 
problems, potential disruptions to production (including possible labor 
strikes), and recent unforeseen emergencies such as floods and fires.
    (b) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is not currently manufacturing such class 
a quota equal to 100 percent of the reasonably estimated net disposal of 
that applicant for the next calendar year, as determined by the 
Administrator, adjusted--
    (1) By the amount necessary to provide the applicant his estimated 
inventory allowance for the next calendar year, pursuant to 
Sec. 1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) the national rate of net 
disposal, his production cycle and current inventory position, the 
economic and physical availability of raw materials for use in 
manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) The Administrator shall, on or before March 1 of each year, 
adjust the individual manufacturing quota allocated for that year to 
each applicant in paragraph (a) of this section by the amount necessary 
to increase or reduce the actual inventory of the applicant to December 
31 of the preceding year to his estimated inventory allowance for the 
current calendar year, pursuant to Sec. 1303.24.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.24  Inventory allowance.

    (a) For the purpose of determining individual manufacturing quotas 
pursuant to Sec. 1303.23, each registered manufacturer shall be allowed 
as a part of such quota an amount sufficient to maintain an inventory 
equal to,
    (1) For current manufacturers, 50 percent of his average estimated 
net disposal for the current calendar year and the last preceding 
calendar year; or
    (2) For new manufacturers, 50 percent of his reasonably estimated 
net disposal for the next calendar year as determined by the 
Administrator.
    (b) During each calendar year each registered manufacturer shall be 
allowed to maintain an inventory of a

[[Page 47]]

basic class not exceeding 65 percent of his estimated net disposal of 
that class for that year, as determined at the time his quota for that 
year was determined. At any time the inventory of a basic class held by 
a manufacturer exceeds 65 percent of his estimated net disposal, his 
quota for that class is automatically suspended and shall remain 
suspended until his inventory is less than 60 percent of his estimated 
net disposal. The Administrator may, upon application and for good cause 
shown, permit a manufacturer whose quota is, or is likely to be, 
suspended pursuant to this paragraph to continue manufacturing and to 
accumulate an inventory in excess of 65 percent of his estimated net 
disposal, upon such conditions and within such limitations as the 
Administrator may find necessary or desirable.
    (c) If, during a calendar year, a registrant has manufactured the 
entire quantity of a basic class allocated to him under an individual 
manufacturing quota, and his inventory of that class is less than 40 
percent of his estimated net disposal of that class for that year, the 
Administrator may, upon application pursuant to Sec. 1303.25, increase 
the quota of such registrant sufficiently to allow restoration of the 
inventory to 50 percent of the estimated net disposal for that year.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.25  Increase in individual manufacturing quotas.

    (a) Any registrant who holds an individual manufacturing quota for a 
basic class of controlled substance listed in Schedule I or II may file 
with the Administrator an application on Administration Form 189 for an 
increase in such quota in order for him to meet his estimated net 
disposal, inventory and other requirements during the remainder of such 
calendar year.
    (b) The Administrator, in passing upon a registrant's application 
for an increase in his individual manufacturing quota, shall take into 
consideration any occurrences since the filing of such registrant's 
initial quota application that may require an increased manufacturing 
rate by such registrant during the balance of the calendar year. In 
passing upon such application the Administrator may also take into 
consideration the amount, if any, by which his determination of the 
total quantity for the basic class of controlled substance to be 
manufactured under Sec. 1303.11 exceeds the aggregate of all the 
individual manufacturing quotas for the basic class of controlled 
substance, and the equitable distribution of such excess among other 
registrants.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.26  Reduction in individual manufacturing quotas.

    The Administrator may at any time reduce an individual manufacturing 
quota for a basic class of controlled substance listed in Schedule I or 
II which he has previously fixed in order to prevent the aggregate of 
the individual manufacturing quotas and import permits outstanding or to 
be granted from exceeding the aggregate production quota which has been 
established for that class pursuant of Sec. 1303.11, as adjusted 
pursuant to Sec. 1303.13. If a quota assigned to a new manufacturer 
pursuant to Sec. 1303.23(b), or if a quota assigned to any manufacturer 
is increased pursuant to Sec. 1303.24(c), or if an import permit issued 
to an importer pursuant to part 1312 of this chapter, causes the total 
quantity of a basic class to be manufactured and imported during the 
year to exceed the aggregate production quota which has been established 
for that class pursuant to Sec. 1303.11, as adjusted pursuant to 
Sec. 1303.13, the Administrator may proportionately reduce the 
individual manufacturing quotas and import permits of all other 
registrants to keep the aggregate production quota within the limits 
originally established, or, alternatively, the Administrator may reduce 
the individual manufacturing quota of any registrant whose quota is 
suspended pursuant to Sec. 1303.24(b) or Sec. 1301.36 of this chapter, 
or is abandoned pursuant to Sec. 1303.27.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]

[[Page 48]]

Sec. 1303.27  Abandonment of quota.

    Any manufacturer assigned an individual manufacturing quota for any 
basic class pursuant to Sec. 1303.23 may at any time abandon his right 
to manufacture all or any part of such quota by filing with the Drug & 
Chemical Evaluation Section a written notice of such abandonment, 
stating the name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the substance and the 
amount which he has chosen not to manufacture. The Administrator may, in 
his discretion, allocate such amount among the other manufacturers in 
proportion to their respective quotas.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, 
May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]

                                Hearings

Sec. 1303.31  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the determination of an aggregate production quota pursuant to 
Sec. 1303.11(c), or regarding the adjustment of an aggregate production 
quota pursuant to Sec. 1303.13(c), the procedures for such hearing shall 
be governed generally by the rule making procedures set forth in the 
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 306 of the Act (21 U.S.C. 826), by Secs. 1303.32-1303.37, and by 
the procedures for administrative hearings under the Act set forth in 
Secs. 1316.41-1316.67 of this chapter.
    (b) In any case where the Administrator shall hold a hearing 
regarding the issuance, adjustment, suspension, or denial of a 
procurement quota pursuant to Sec. 1303.12, or the issuance, adjustment, 
suspension, or denial of an individual manufacturing quota pursuant to 
Secs. 1303.21-1303.27, the procedures for such hearing shall be governed 
generally by the adjudication procedures set forth in the Administrative 
Procedures Act (5 U.S.C. 551-559) and specifically by section 306 of the 
Act (21 U.S.C. 826), by Secs. 1303.32-1303.37, and by the procedures for 
administrative hearings under the Act set forth in Secs. 1316.41-1316.67 
of this chapter.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.32  Purpose of hearing.

    (a) The Administrator may, in his sole discretion, hold a hearing 
for the purpose of receiving factual evidence regarding any one or more 
issues (to be specified by him) involved in the determination or 
adjustment of any aggregate production quota.
    (b) If requested by a person applying for or holding a procurement 
quota or an individual manufacturing quota, the Administrator shall hold 
a hearing for the purpose of receiving factual evidence regarding the 
issues involved in the issuance, adjustment, suspension, or denial of 
such quota to such person, but the Administrator need not hold a hearing 
on the suspension of a quota pursuant to Sec. 1301.36 of this chapter 
separate from a hearing on the suspension of registration pursuant to 
those sections.
    (c) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]

Sec. 1303.33  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.
[36 FR 7786, Apr. 24,1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

[[Page 49]]

Sec. 1303.34  Request for hearing or appearance; waiver.

    (a) Any applicant or registrant who desires a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota shall, within 30 days after the date of 
receipt of the issuance, adjustment, suspension, or denial of such 
quota, file with the Administrator a written request for a hearing in 
the form prescribed in Sec. 1316.47 of this chapter. Any interested 
person who desires a hearing on the determination of an aggregate 
production quota shall, within the time prescribed in Sec. 1303.11(c), 
file with the Administrator a written request for a hearing in the form 
prescribed in Sec. 1316.47 of this chapter, including in the request a 
statement of the grounds for a hearing.
    (b) Any interested person who desires to participate in a hearing on 
the determination or adjustment of an aggregate production quota, which 
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or 
Sec. 1303.13(c) may do so by filing with the Administrator, within 30 
days of the date of publication of notice of the hearing in the Federal 
Register, a written notice of his intention to participate in such 
hearing in the form prescribed in Sec. 1316.48 of this chapter.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to paragraph (b) of this section, may, within the period 
permitted for filing a request for a hearing of notice of appearance, 
file with the Administrator a waiver of an opportunity for a hearing or 
to participate in a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such statement, if admissible, shall be made a part of the record and 
shall be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact 
asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to paragraph (b) of this section, fails to file a 
request for a hearing or notice of appearance, or if he so files and 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing or to participate in the hearing, unless he 
shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to 
Sec. 1303.37 without a hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.35  Burden of proof.

    (a) At any hearing regarding the determination or adjustment of an 
aggregate production quota, each interested person participating in the 
hearing shall have the burden of proving any propositions of fact or law 
asserted by him in the hearing.
    (b) At any hearing regarding the issuance, adjustment, suspension, 
or denial of a procurement or individual manufacturing quota, the 
Administration shall have the burden of proving that the requirements of 
this part for such issuance, adjustment, suspension, or denial are 
satisfied.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]

Sec. 1303.36  Time and place of hearing.

    (a) If any applicant or registrant requests a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota pursuant to Sec. 1303.34, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant or registrant of the time and place at least 30 
days prior to the hearing, unless the applicant or registrant waives 
such notice and requests the hearing be held at an earlier time, in 
which case the Administrator shall fix a date for such hearing as early 
as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section or in the 
notice of hearing published in the Federal Register pursuant to 
Sec. 1303.11(c) or Sec. 1303.13 (c), but

[[Page 50]]

thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1303.37  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the determination or adjustment of the aggregate production quota or on 
the issuance, adjustment, suspension, or denial of the procurement quota 
or individual manufacturing quota, as case may be. The order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his order upon each 
party in the hearing.
[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]









[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: 21CFR1304]

[Page 50-62]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1304--RECORDS AND REPORTS OF REGISTRANTS

                           General Information

Sec.
1304.01  Scope of part 1304.
1304.02  Definitions.
1304.03  Persons required to keep records and file reports.
1304.04  Maintenance of records and inventories.

                         Inventory Requirements

1304.11  Inventory requirements.

                           Continuing Records

1304.21  General requirements for continuing records.
1304.22  Records for manufacturers, distributors, dispensers, 
          researchers, importers, and exporters.
1304.23  Records for chemical analysts.
1304.24  Records for maintenance treatment programs and detoxification 
          treatment programs.
1304.25  Records for treatment programs which compound narcotics for 
          treatment programs and other locations.

                                 Reports

1304.31  Reports from manufacturers importing narcotic raw material.
1304.32  Reports of manufacturers importing coca leaves.
1304.33  Reports to ARCOS.

    Authority:  21 U.S.C. 821, 827, 871(b), 958(e), 965, unless 
otherwise noted.

                           General Information

Sec. 1304.01  Scope of part 1304.

    Inventory and other records and reports required under section 307 
or section 1008(d) of the Act (21 U.S.C. 827 and 958(d)) shall be in 
accordance with, and contain the information required by, those sections 
and by the sections of this part.
[36 FR 7789, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1304.02  Definitions.

    Any term contained 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 13958, Mar. 24, 1997]

Sec. 1304.03  Persons required to keep records and file reports.

    (a) Each registrant shall maintain the records and inventories and 
shall file the reports required by this part, except as exempted by this 
section. Any registrant who is authorized to conduct other activities 
without being registered to conduct those activities, either pursuant to 
Sec. 1301.22(b) of this chapter or pursuant to Secs. 1307.11-1307.15 of 
this chapter, shall maintain the records and inventories and shall file 
the reports required by this part for persons registered to conduct such 
activities. This latter requirement should not be construed as requiring 
stocks of controlled substances being used in various activities under 
one registration to be stored separately, nor that separate records are 
required for each activity. The intent of the Administration is to 
permit the registrant to keep one set of records which are adapted by 
the registrant to account for controlled substances used in any 
activity. Also, the Administration does not wish to acquire separate 
stocks of the same substance to be purchased and stored

[[Page 51]]

for separate activities. Otherwise, there is no advantage gained by 
permitting several activities under one registration. Thus, when a 
researcher manufactures a controlled item, he must keep a record of the 
quantity manufactured; when he distributes a quantity of the item, he 
must use and keep invoices or order forms to document the transfer; when 
he imports a substance, he keeps as part of his records the 
documentation required of an importer; and when substances are used in 
chemical analysis, he need not keep a record of this because such a 
record would not be required of him under a registration to do chemical 
analysis. All of these records may be maintained in one consolidated 
record system. Similarly, the researcher may store all of his controlled 
items in one place, and every two years take inventory of all items on 
hand, regardless of whether the substances were manufactured by him, 
imported by him, or purchased domestically by him, of whether the 
substances will be administered to subjects, distributed to other 
researchers, or destroyed during chemical analysis.
    (b) A registered individual practitioner is required to keep 
records, as described in Sec. 1304.04, of controlled substances in 
Schedules II, III, IV, and V which are dispensed, other than by 
prescribing or administering in the lawful course of professional 
practice.
    (c) A registered individual practitioner is not required to keep 
records of controlled substances in Schedules II, III, IV, and V which 
are prescribed in the lawful course of professional practice, unless 
such substances are prescribed in the course of maintenance or 
detoxification treatment of an individual.
    (d) A registered individual practitioner is not required to keep 
records of controlled substances listed in Schedules II, III, IV and V 
which are administered in the lawful course of professional practice 
unless the practitioner regularly engages in the dispensing or 
administering of controlled substances and charges patients, either 
separately or together with charges for other professional services, for 
substances so dispensed or administered. Records are required to be kept 
for controlled substances administered in the course of maintenance or 
detoxification treatment of an individual.
    (e) Each registered mid-level practitioner shall maintain in a 
readily retrievable manner those documents required by the state in 
which he/she practices which describe the conditions and extent of his/
her authorization to dispense controlled substances and shall make such 
documents available for inspection and copying by authorized employees 
of the Administration. Examples of such documentation include protocols, 
practice guidelines or practice agreements.
    (f) Registered persons using any controlled substances while 
conducting preclinical research, in teaching at a registered 
establishment which maintains records with respect to such substances or 
conducting research in conformity with an exemption granted under 
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains 
records in accordance with either of those sections, are not required to 
keep records if he/she notifies the Administration of the name, address, 
and registration number of the establishment maintaining such records. 
This notification shall be given at the time the person applies for 
registration or reregistration and shall be made in the form of an 
attachment to the application, which shall be filed with the 
application.
[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51 
FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar. 
24, 1997]

Sec. 1304.04  Maintenance of records and inventories.

    (a) Every inventory and other records required to be kept under this 
part shall be kept by the registrant and be available, for at least 2 
years from the date of such inventory or records, for inspection and 
copying by authorized employees of the Administration, except that 
financial and shipping records (such as invoices and packing

[[Page 52]]

slips but not executed order forms subject to Sec. 1305.13 of this 
chapter) may be kept at a central location, rather than at the 
registered location, if the registrant has notified the Administration 
of his intention to keep central records. Written notification must be 
submitted by registered or certified mail, return receipt requested, in 
triplicate, to the Special Agent in Charge of the Administration in the 
area in which the registrant is located. Unless the registrant is 
informed by the Special Agent in Charge that permission to keep central 
records is denied, the registrant may maintain central records 
commencing 14 days after receipt of his notification by the Special 
Agent in Charge.

All notifications must include:
    (1) The nature of the records to be kept centrally.
    (2) The exact location where the records will be kept.
    (3) The name, address, DEA registration number and type of DEA 
registration of the registrant whose records are being maintained 
centrally.
    (4) Whether central records will be maintained in a manual, or 
computer readable form.
    (b) All registrants that are authorized to maintain a central 
recordkeeping system shall be subject to the following conditions:
    (1) The records to be maintained at the central record location 
shall not include executed order forms, prescriptions and/or inventories 
which shall be maintained at each registered location.
    (2) If the records are kept on microfilm, computer media or in any 
form requiring special equipment to render the records easily readable, 
the registrant shall provide access to such equipment with the records. 
If any code system is used (other than pricing information), a key to 
the code shall be provided to make the records understandable.
    (3) The registrant agrees to deliver all or any part of such records 
to the registered location within two business days upon receipt of a 
written request from the Administration for such records, and if the 
Administration chooses to do so in lieu of requiring delivery of such 
records to the registered location, to allow authorized employees of the 
Administration to inspect such records at the central location upon 
request by such employees without a warrant of any kind.
    (4) In the event that a registrant fails to comply with these 
conditions, the Special Agent in Charge may cancel such central 
recordkeeping authorization, and all other central recordkeeping 
authorizations held by the registrant without a hearing or other 
procedures. In the event of a cancellation of central recordkeeping 
authorizations under this paragraph the registrant shall, within the 
time specified by the Special Agent in Charge, comply with the 
requirements of this section that all records be kept at the registered 
location.
    (c) Registrants need not notify the Special Agent in Charge or 
obtain central recordkeeping approval in order to maintain records on an 
in-house computer system.
    (d) ARCOS participants who desire authorization to report from other 
than their registered locations must obtain a separate central reporting 
identifier. Request for central reporting identifiers will be submitted 
to: ARCOS Unit, P.O. Box 28293, Central Station, Washington, DC 20005.
    (e) All central recordkeeping permits previously issued by the 
Administration expired September 30, 1980.
    (f) Each registered manufacturer, distributor, importer, exporter, 
narcotic treatment program and compounder for narcotic treatment program 
shall maintain inventories and records of controlled substances as 
follows:
    (1) Inventories and records of controlled substances listed in 
Schedules I and II shall be maintained separately from all of the 
records of the registrant; and
    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the registrant or in such form that the information 
required is readily retrievable from the ordinary business records of 
the registrant.
    (g) Each registered individual practitioner required to keep records 
and institutional practitioner shall maintain inventories and records of 
controlled

[[Page 53]]

substances in the manner prescribed in paragraph (f) of this section.
    (h) Each registered pharmacy shall maintain the inventories and 
records of controlled substances as follows:
    (1) Inventories and records of all controlled substances listed in 
Schedules I and II shall be maintained separately from all other records 
of the pharmacy, and prescriptions for such substances shall be 
maintained in a separate prescription file; and
    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the pharmacy or in such form that the information 
required is readily retrievable from ordinary business records of the 
pharmacy, and prescriptions for such substances shall be maintained 
either in a separate prescription file for controlled substances listed 
in Schedules III, IV, and V only or in such form that they are readily 
retrievable from the other prescription records of the pharmacy. 
Prescriptions will be deemed readily retrievable if, at the time they 
are initially filed, the face of the prescription is stamped in red ink 
in the lower right corner with the letter ``C'' no less than 1 inch high 
and filed either in the prescription file for controlled substances 
listed in Schedules I and II or in the usual consecutively numbered 
prescription file for non-controlled substances. However, if a pharmacy 
employs an ADP system or other electronic recordkeeping system for 
prescriptions which permits identification by prescription number and 
retrieval of original documents by prescriber's name, patient's name, 
drug dispensed, and date filled, then the requirement to mark the hard 
copy prescription with a red ``C'' is waived.

(21 U.S.C. 821 and 871(b); 28 CFR 0.100)
[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 39 FR 37985, 
Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982; 
51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997]

                         Inventory Requirements

Sec. 1304.11  Inventory requirements.

    (a) General requirements. Each inventory shall contain a complete 
and accurate record of all controlled substances on hand on the date the 
inventory is taken, and shall be maintained in written, typewritten, or 
printed form at the registered location. An inventory taken by use of an 
oral recording device must be promptly transcribed. Controlled 
substances shall be deemed to be ``on hand'' if they are in the 
possession of or under the control of the registrant, including 
substances returned by a customer, ordered by a customer but not yet 
invoiced, stored in a warehouse on behalf of the registrant, and 
substances in the possession of employees of the registrant and intended 
for distribution as complimentary samples. A separate inventory shall be 
made for each registered location and each independent activity 
registered, except as provided in paragraph (e)(4) of this section. In 
the event controlled substances in the possession or under the control 
of the registrant are stored at a location for which he/she is not 
registered, the substances shall be included in the inventory of the 
registered location to which they are subject to control or to which the 
person possessing the substance is responsible. The inventory may be 
taken either as of opening of business or as of the close of business on 
the inventory date and it shall be indicated on the inventory.
    (b) Initial inventory date. Every person required to keep records 
shall take an inventory of all stocks of controlled substances on hand 
on the date he/she first engages in the manufacture, distribution, or 
dispensing of controlled substances, in accordance with paragraph (e) of 
this section as applicable. In the event a person commences business 
with no controlled substances on hand, he/she shall record this fact as 
the initial inventory.
    (c) Biennial inventory date. After the initial inventory is taken, 
the registrant shall take a new inventory of all stocks of controlled 
substances on hand at least every two years. The biennial inventory may 
be taken on any

[[Page 54]]

date which is within two years of the previous biennial inventory date.
    (d) Inventory date for newly controlled substances. On the effective 
date of a rule by the Administrator pursuant to Secs. 1308.45, 1308.46, 
or 1308.47 of this chapter adding a substance to any schedule of 
controlled substances, which substance was, immediately prior to that 
date, not listed on any such schedule, every registrant required to keep 
records who possesses that substance shall take an inventory of all 
stocks of the substance on hand. Thereafter, such substance shall be 
included in each inventory made by the registrant pursuant to paragraph 
(c) of this section.
    (e) Inventories of manufacturers, distributors, dispensers, 
researchers, importers, exporters and chemical analysts. Each person 
registered or authorized (by Sec. 1301.13 or Secs. 1307.11-1307.13 of 
this chapter) to manufacture, distribute, dispense, import, export, 
conduct research or chemical analysis with controlled substances and 
required to keep records pursuant to Sec. 1304.03 shall include in the 
inventory the information listed below.
    (1) Inventories of manufacturers. Each person registered or 
authorized to manufacture controlled substances shall include the 
following information in the inventory:
    (i) For each controlled substance in bulk form to be used in (or 
capable of use in) the manufacture of the same or other controlled or 
non-controlled substances in finished form, the inventory shall include:
    (A) The name of the substance and
    (B) The total quantity of the substance to the nearest metric unit 
weight consistent with unit size.
    (ii) For each controlled substance in the process of manufacture on 
the inventory date, the inventory shall include:
    (A) The name of the substance;
    (B) The quantity of the substance in each batch and/or stage of 
manufacture, identified by the batch number or other appropriate 
identifying number; and
    (C) The physical form which the substance is to take upon completion 
of the manufacturing process (e.g., granulations, tablets, capsules, or 
solutions), identified by the batch number or other appropriate 
identifying number, and if possible the finished form of the substance 
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce 
or milliliter) and the number or volume thereof.
    (iii) For each controlled substance in finished form the inventory 
shall include:
    (A) The name of the substance;
    (B) Each finished form of the substance (e.g., 10-milligram tablet 
or 10-milligram concentration per fluid ounce or milliliter);
    (C) The number of units or volume of each finished form in each 
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
    (D) The number of commercial containers of each such finished form 
(e.g. four 100-tablet bottles or six 3-milliliter vials).
    (iv) For each controlled substance not included in paragraphs (e)(1) 
(i), (ii) or (iii) of this section (e.g., damaged, defective or impure 
substances awaiting disposal, substances held for quality control 
purposes, or substances maintained for extemporaneous compoundings) the 
inventories shall include:
    (A) The name of the substance;
    (B) The total quantity of the substance to the nearest metric unit 
weight or the total number of units of finished form; and
    (C) The reason for the substance being maintained by the registrant 
and whether such substance is capable of use in the manufacture of any 
controlled substance in finished form.
    (2) Inventories of distributors. Each person registered or 
authorized to distribute controlled substances shall include in the 
inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1) (iii) and (iv) of this section.
    (3) Inventories of dispensers and researchers. Each person 
registered or authorized to dispense or conduct research with controlled 
substances shall include in the inventory the same information required 
of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this 
section. In determining the number of units of each finished form

[[Page 55]]

of a controlled substance in a commercial container which has been 
opened, the dispenser shall do as follows:
    (i) If the substance is listed in Schedule I or II, make an exact 
count or measure of the contents, or
    (ii) If the substance is listed in Schedule III, IV or V, make an 
estimated count or measure of the contents, unless the container holds 
more than 1,000 tablets or capsules in which case he/she must make an 
exact count of the contents.
    (4) Inventories of importers and exporters. Each person registered 
or authorized to import or export controlled substances shall include in 
the inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1) (iii) and (iv) of this section. Each such person who 
is also registered as a manufacturer or as a distributor shall include 
in his/her inventory as an importer or exporter only those stocks of 
controlled substances that are actually separated from his stocks as a 
manufacturer or as a distributor (e.g., in transit or in storage for 
shipment).
    (5) Inventories of chemical analysts. Each person registered or 
authorized to conduct chemical analysis with controlled substances shall 
include in his inventory the same information required of manufacturers 
pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to 
substances which have been manufactured, imported, or received by such 
person. If less than 1 kilogram of any controlled substance (other than 
a hallucinogenic controlled substance listed in Schedule I), or less 
than 20 grams of a hallucinogenic substance listed in Schedule I (other 
than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid 
diethylamide, is on hand at the time of inventory, that substance need 
not be included in the inventory. Laboratories of the Administration may 
possess up to 150 grams of any hallucinogenic substance in Schedule I 
without regard to a need for an inventory of those substances. No 
inventory is required of known or suspected controlled substances 
received as evidentiary materials for analysis.
[62 FR 13959, Mar. 24, 1997]

                           Continuing Records

Sec. 1304.21  General requirements for continuing records.

    (a) Every registrant required to keep records pursuant to 
Sec. 1304.03 shall maintain on a current basis a complete and accurate 
record of each such substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, except that no 
registrant shall be required to maintain a perpetual inventory.
    (b) Separate records shall be maintained by a registrant for each 
registered location except as provided in Sec. 1304.04 (a). In the event 
controlled substances are in the possession or under the control of a 
registrant at a location for which he is not registered, the substances 
shall be included in the records of the registered location to which 
they are subject to control or to which the person possessing the 
substance is responsible.
    (c) Separate records shall be maintained by a registrant for each 
independent activity for which he/she is registered, except as provided 
in Sec. 1304.22(d).
    (d) In recording dates of receipt, importation, distribution, 
exportation, or other transfers, the date on which the controlled 
substances are actually received, imported, distributed, exported, or 
otherwise transferred shall be used as the date of receipt or 
distribution of any documents of transfer (e.g., invoices or packing 
slips).
[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, 
Mar. 24, 1997]

Sec. 1304.22  Records for manufacturers, distributors, dispensers, 
          researchers, importers and exporters.

    Each person registered or authorized (by Sec. 1301.13(e) or 
Secs. 1307.11-1307.13 of this chapter) to manufacture, distribute, 
dispense, import, export or conduct research with controlled substances 
shall maintain records with the information listed below.
    (a) Records for manufacturers. Each person registered or authorized 
to manufacture controlled substances shall maintain records with the 
following information:

[[Page 56]]

    (1) For each controlled substance in bulk form to be used in, or 
capable of use in, or being used in, the manufacture of the same or 
other controlled or noncontrolled substances in finished form,
    (i) The name of the substance;
    (ii) The quantity manufactured in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch manufactured;
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the substance was received;
    (iv) The quantity imported directly by the registrant (under a 
registration as an importer) for use in manufacture by him/her, 
including the date, quantity, and import permit or declaration number 
for each importation;
    (v) The quantity used to manufacture the same substance in finished 
form, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The quantity used in the manufacture;
    (C) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter);
    (D) The number of units of finished form manufactured;
    (E) The quantity used in quality control;
    (F) The quantity lost during manufacturing and the causes therefore, 
if known;
    (G) The total quantity of the substance contained in the finished 
form;
    (H) The theoretical and actual yields; and
    (I) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vi) The quantity used to manufacture other controlled and 
noncontrolled substances, including the name of each substance 
manufactured and the information required in paragraph (a)(1)(v) of this 
section;
    (vii) The quantity distributed in bulk form to other persons, 
including the date and quantity of each distribution and the name, 
address, and registration number of each person to whom a distribution 
was made;
    (viii) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exportation;
    (ix) The quantity distributed or disposed of in any other manner by 
the registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity distributed or disposed; and
    (x) The originals of all written certifications of available 
procurement quotas submitted by other persons (as required by 
Sec. 1303.12(f) of this chapter) relating to each order requiring the 
distribution of a basic class of controlled substance listed in Schedule 
I or II.
    (2) For each controlled substance in finished form,
    (i) The name of the substance;
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (iii) The number of containers of each such commercial finished form 
manufactured from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(1)(v) of this section;
    (iv) The number of units of finished forms and/or commercial 
containers acquired from other persons, including the date of and number 
of units and/or commercial containers in each acquisition to inventory 
and the name, address, and registration number of the person from whom 
the units were acquired;
    (v) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;

[[Page 57]]

    (vi) The number of units and/or commercial containers manufactured 
by the registrant from units in finished form received from others or 
imported, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The operation performed (e.g., repackaging or relabeling);
    (C) The number of units of finished form used in the manufacture, 
the number manufactured and the number lost during manufacture, with the 
causes for such losses, if known; and
    (D) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vii) The number of commercial containers distributed to other 
persons, including the date of and number of containers in each 
reduction from inventory, and the name, address, and registration number 
of the person to whom the containers were distributed; (viii) The number 
of commercial containers exported directly by the registrant (under a 
registration as an exporter), including the date, number of containers 
and export permit or declaration number for each exportation; and
    (ix) The number of units of finished forms and/or commercial 
containers distributed or disposed of in any other manner by the 
registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity in finished form distributed or disposed.
    (b) Records for distributors. Each person registered or authorized 
to distribute controlled substances shall maintain records with the same 
information required of manufacturers pursuant to paragraphs (a)(2) (i), 
(ii), (iv), (v), (vii), (viii) and (ix) of this section.
    (c) Records for dispensers and researchers. Each person registered 
or authorized to dispense or conduct research with controlled substances 
shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2) (i), (ii), (iv), (vii), and 
(ix) of this section. In addition, records shall be maintained of the 
number of units or volume of such finished form dispensed, including the 
name and address of the person to whom it was dispensed, the date of 
dispensing, the number of units or volume dispensed, and the written or 
typewritten name or initials of the individual who dispensed or 
administered the substance on behalf of the dispenser.
    (d) Records for importers and exporters. Each person registered or 
authorized to import or export controlled substances shall maintain 
records with the same information required of manufacturers pursuant to 
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, 
the quantity disposed of in any other manner by the registrant (except 
quantities used in manufacturing by an importer under a registration as 
a manufacturer), which quantities are to be recorded pursuant to 
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or 
number of units or volume in finished form) exported, including the 
date, quantity (or number of units or volume), and the export permit or 
declaration number for each exportation, but excluding all quantities 
(and number of units and volumes) manufactured by an exporter under a 
registration as a manufacturer, which quantities (and numbers of units 
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or 
(a)(2)(xiii) of this section.
[62 FR 13960, Mar. 24, 1997]

Sec. 1304.23  Records for chemical analysts.

    (a) Each person registered or authorized (by Sec. 1301.22(b) of this 
chapter) to conduct chemical analysis with controlled substances shall 
maintain records with the following information (to the extent known and 
reasonably ascertainable by him) for each controlled substance:
    (1) The name of the substance;
    (2) The form or forms in which the substance is received, imported, 
or manufactured by the registrant (e.g., powder, granulation, tablet, 
capsule, or solution) and the concentration of the substance in such 
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram 
concentration per milliliter);

[[Page 58]]

    (3) The total number of the forms received, imported or manufactured 
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), 
including the date and quantity of each receipt, importation, or 
manufacture and the name, address, and registration number, if any, of 
the person from whom the substance was received;
    (4) The quantity distributed, exported, or destroyed in any manner 
by the registrant (except quantities used in chemical analysis or other 
laboratory work), including the date and manner of distribution, 
exportation, or destruction, and the name, address, and registration 
number, if any, of each person to whom the substance was distributed or 
exported.
    (b) Records of controlled substances used in chemical analysis or 
other laboratory work are not required.
    (c) Records relating to known or suspected controlled substances 
received as evidentiary material for analysis are not required under 
paragraph (a) of this section.
[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13961, Mar. 24, 1997]

Sec. 1304.24  Records for maintenance treatment programs and 
          detoxification treatment programs.

    (a) Each person registered or authorized (by Sec. 1301.22 of this 
chapter) to maintain and/or detoxify controlled substance users in a 
narcotic treatment program shall maintain records with the following 
information for each narcotic controlled substance:
    (1) Name of substance;
    (2) Strength of substance;
    (3) Dosage form;
    (4) Date dispensed;
    (5) Adequate identification of patient (consumer);
    (6) Amount consumed;
    (7) Amount and dosage form taken home by patient; and
    (8) Dispenser's initials.
    (b) The records required by paragraph (a) of this section will be 
maintained in a dispensing log at the narcotic treatment program site 
and will be maintained in compliance with Sec. 1304.22 without reference 
to Sec. 1304.03.
    (c) All sites which compound a bulk narcotic solution from bulk 
narcotic powder to liquid for on-site use must keep a separate batch 
record of the compounding.
    (d) Records of identity, diagnosis, prognosis, or treatment of any 
patients which are maintained in connection with the performance of a 
narcotic treatment program shall be confidential, except that such 
records may be disclosed for purposes and under the circumstances 
authorized by part 310 and 42 CFR part 2.
[39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961, 
Mar. 24, 1997]

Sec. 1304.25  Records for treatment programs which compound narcotics 
          for treatment programs and other locations.

    Each person registered or authorized by Sec. 1301.22 of this chapter 
to compound narcotic drugs for off-site use in a narcotic treatment 
program shall maintain records which include the following information 
for each narcotic drug:
    (a) For each narcotic controlled substance in bulk form to be used 
in, or capable of use in, or being used in, the compounding of the same 
or other noncontrolled substances in finished form:
    (1) The name of the substance;
    (2) The quantity compounded in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch compounded;
    (3) The quantity received from other persons, including the date and 
quantity of each receipt and the name, address and registration number 
of the other person from whom the substance was received;
    (4) The quantity imported directly by the registrant (under a 
registration as an importer) for use in compounding by him, including 
the date, quantity and import permit or declaration number of each 
importation;
    (5) The quantity used to compound the same substance in finished 
form, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The quantity used in the compound;

[[Page 59]]

    (iii) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter;
    (iv) The number of units of finished form compounded;
    (v) The quantity used in quality control;
    (vi) The quantity lost during compounding and the causes therefore, 
if known;
    (vii) The total quantity of the substance contained in the finished 
form;
    (viii) The theoretical and actual yields; and
    (ix) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured 
and the information required in paragraph (a)(5) of this section;
    (7) The quantity distributed in bulk form to other programs, 
including the date and quantity of each distribution and the name, 
address and registration number of each program to whom a distribution 
was made;
    (8) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exploration; and
    (9) The quantity disposed of by destruction, including the reason, 
date and manner of destruction. All other destruction of narcotic 
controlled substances will comply with Sec. 1307.22.
    (b) For each narcotic controlled substance in finished form:
    (1) The name of the substance;
    (2) Each finished form (e.g., 10-milligram tablet or 10 milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume or finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (3) The number of containers of each such commercial finished form 
compounded from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(5) of this section;
    (4) The number of units of finished forms and/or commercial 
containers received from other persons, including the date of and number 
of units and/or commercial containers in each receipt and the name, 
address and registration number of the person from whom the units were 
received;
    (5) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (6) The number of units and/or commercial containers compounded by 
the registrant from units in finished form received from others or 
imported, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The operation performed (e.g., repackaging or relabeling);
    (iii) The number of units of finished form used in the compound, the 
number compounded and the number lost during compounding, with the 
causes for such losses, if known; and
    (iv) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (7) The number of containers distributed to other programs, 
including the date, the number of containers in each distribution, and 
the name, address and registration number of the program to whom the 
containers were distributed;
    (8) The number of commercial containers exported directly by the 
registrant (under a registration as an exporter), including the date, 
number of containers and export permit or declaration number for each 
exportation; and
    (9) The number of units of finished forms and/or commercial 
containers destroyed in any manner by the registrant, including the 
reason, the date and manner of destruction. All other destruction of 
narcotic controlled substances will comply with Sec. 1307.22.
[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997]

[[Page 60]]

                                 Reports

Sec. 1304.31  Reports from manufacturers importing narcotic raw 
          material.

    (a) Every manufacturer which imports or manufactures from narcotic 
raw material (opium, poppy straw, and concentrate of poppy straw) shall 
submit information which accounts for the importation and for all 
manufacturing operations performed between importation and the 
production in bulk or finished marketable products, standardized in 
accordance with the U.S. Pharmacopeia, National Formulary or other 
recognized medical standards. Reports shall be signed by the authorized 
official and submitted quarterly on company letterhead to the Drug 
Enforcement Administration, Drug and Chemical Evaluation Section, 
Washington, D.C. 20537, on or before the 15th day of the month 
immediately following the period for which it is submitted.
    (b) The following information shall be submitted for each type of 
narcotic raw material (quantities are expressed as grams of anhydrous 
morphine alkaloid):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Imports;
    (4) Other receipts;
    (5) Quantity put into process;
    (6) Losses on reweighing;
    (7) Other dispositions and
    (8) Ending inventory.
    (c) The following information shall be submitted for each narcotic 
raw material derivative including morphine, codeine, thebaine, 
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude 
alkaloids and other derivatives (quantities are expressed as grams of 
anhydrous base or anhydrous morphine alkaloid for manufacturing opium 
and medicinal opium):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Quantity extracted from narcotic raw material;
    (4) Quantity produced/manufactured/synthesized;
    (5) Quantity sold;
    (6) Quantity returned to conversion processes for reworking;
    (7) Quantity used for conversion;
    (8) Quantity placed in process;
    (9) Other dispositions;
    (10) Losses on reweighing and
    (11) Ending inventory.
    (d) The following information shall be submitted for importation of 
each narcotic raw material:
    (1) Import permit number;
    (2) Date shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of morphine, codeine and thebaine and
    (5) Quantity shipped, expressed as anhydrous morphine alkaloid.
    (e) Upon importation of crude opium, samples will be selected and 
assays made by the importing manufacturer in the manner and according to 
the method specified in the U.S. Pharmacopoeia. Where final assay data 
is not determined at the time of rendering report, the report shall be 
made on the basis of the best data available, subject to adjustment, and 
the necessary adjusting entries shall be made on the next report.
    (f) Where factory procedure is such that partial withdrawals of 
opium are made from individual containers, there shall be attached to 
each container a stock record card on which shall be kept a complete 
record of all withdrawals therefrom.
    (g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.
[62 FR 13961, Mar. 24, 1997]

Sec. 1304.32  Reports of manufacturers importing coca leaves.

    (a) Every manufacturer importing or manufacturing from raw coca 
leaves shall submit information accounting for the importation and for 
all manufacturing operations performed between the importation and the 
manufacture of bulk or finished products standardized in accordance with 
U.S. Pharmacopoeia, National Formulary, or other recognized standards. 
The reports shall be submitted quarterly on

[[Page 61]]

company letterhead to the Drug Enforcement Administration, Drug and 
Chemical Evaluation Section, Washington, DC 20537, on or before the 15th 
day of the month immediately following the period for which it is 
submitted.
    (b) The following information shall be submitted for raw coca leaf, 
ecgonine, ecgonine for conversion or further manufacture, 
benzoylecgonine, manufacturing coca extracts (list for tinctures and 
extracts; and others separately), other crude alkaloids and other 
derivatives (quantities should be reported as grams of actual quantity 
involved and the cocaine alkaloid content or equivalency):
    (1) Beginning inventory;
    (2) Imports;
    (3) Gains on reweighing;
    (4) Quantity purchased;
    (5) Quantity produced;
    (6) Other receipts;
    (7) Quantity returned to processes for reworking;
    (8) Material used in purification for sale;
    (9) Material used for manufacture or production;
    (10) Losses on reweighing;
    (11) Material used for conversion;
    (12) Other dispositions and
    (13) Ending inventory.
    (c) The following information shall be submitted for importation of 
coca leaves:
    (1) Import permit number;
    (2) Date the shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of cocaine alkaloid and
    (5) Total cocaine alkaloid content.
    (d) Upon importation of coca leaves, samples will be selected and 
assays made by the importing manufacturer in accordance with recognized 
chemical procedures. These assays shall form the basis of accounting for 
such coca leaves, which shall be accounted for in terms of their cocaine 
alkaloid content or equivalency or their total anhydrous coca alkaloid 
content. Where final assay data is not determined at the time of 
submission, the report shall be made on the basis of the best data 
available, subject to adjustment, and the necessary adjusting entries 
shall be made on the next report.
    (e) Where factory procedure is such that partial withdrawals of 
medicinal coca leaves are made from individual containers, there shall 
be attached to the container a stock record card on which shall be kept 
a complete record of withdrawals therefrom.
    (f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.
[62 FR 13962, Mar. 24, 1997]

Sec. 1304.33  Reports to ARCOS.

    (a) Reports generally. All reports required by this section shall be 
filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 
20005 on DEA Form 333, or on media which contains the data required by 
DEA Form 333 and which is acceptable to the ARCOS Unit.
    (b) Frequency of reports. Acquisition/Distribution transaction 
reports shall be filed every quarter not later than the 15th day of the 
month succeeding the quarter for which it is submitted; except that a 
registrant may be given permission to file more frequently (but not more 
frequently than monthly), depending on the number of transactions being 
reported each time by that registrant. Inventories shall provide data on 
the stocks of each reported controlled substance on hand as of the close 
of business on December 31 of each year, indicating whether the 
substance is in storage or in process of manufacturing. These reports 
shall be filed not later than January 15 of the following year. 
Manufacturing transaction reports shall be filed annually for each 
calendar year not later than January 15 of the following year, except 
that a registrant may be given permission to file more frequently (but 
not more frequently than quarterly).
    (c) Persons reporting. For controlled substances in Schedules I, II 
or narcotic controlled substances in Schedule III, each person who is 
registered to

[[Page 62]]

manufacture in bulk or dosage form, or to package, repackage, label or 
relabel, and each person who is registered to distribute shall report 
acquisition/distribution transactions. In addition to reporting 
acquisition/distribution transactions, each person who is registered to 
manufacture controlled substances in bulk or dosage form shall report 
manufacturing transactions on controlled substances in Schedules I and 
II, each narcotic controlled substance listed in Schedules III, IV, and 
V, and on each psychotropic controlled substance listed in Schedules III 
and IV as identified in paragraph (d) of this section.
    (d) Substances covered. (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled 
substance listed in Schedules I and II and on each narcotic controlled 
substance listed in Schedule III (but not on any material, compound, 
mixture or preparation containing a quantity of a substance having a 
stimulant effect on the central nervous system, which material, 
compound, mixture or preparation is listed in Schedule III or on any 
narcotic controlled substance listed in Schedule V). Additionally, 
reports on manufacturing transactions shall include the following 
psychotropic controlled substances listed in Schedules III and IV:
    (i) Schedule III
    (A) Benzphetamine;
    (B) Cyclobarbital;
    (C) Methyprylon; and
    (D) Phendimetrazine.
    (ii) Schedule IV
    (A) Barbital;
    (B) Diethylpropion (Amfepramone);
    (C) Ethchlorvynol;
    (D) Ethinamate;
    (E) Lefetamine (SPA);
    (F) Mazindol;
    (G) Meprobamate;
    (H) Methylphenobarbital;
    (I) Phenobarbital;
    (J) Phentermine; and
    (K) Pipradrol.
    (2) Data shall be presented in such a manner as to identify the 
particular form, strength, and trade name, if any, of the product 
containing the controlled substance for which the report is being made. 
For this purpose, persons filing reports shall utilize the National Drug 
Code Number assigned to the product under the National Drug Code System 
of the Food and Drug Administration.
    (e) Transactions reported. Acquisition/distribution transaction 
reports shall provide data on each acquisition to inventory (identifying 
whether it is, e.g., by purchase or transfer, return from a customer, or 
supply by the Federal Government) and each reduction from inventory 
(identifying whether it is, e.g., by sale or transfer, theft, 
destruction or seizure by Government agencies). Manufacturing reports 
shall provide data on material manufactured, manufacture from other 
material, use in manufacturing other material and use in producing 
dosage forms.
    (f) Exceptions. A registered institutional practitioner who 
repackages or relabels exclusively for distribution or who distributes 
exclusively to (for dispensing by) agents, employees, or affiliated 
institutional practitioners of the registrant may be exempted from 
filing reports under this section by applying to the ARCOS Unit of the 
Administration.

(Approved by the Office of Management and Budget under control number 
1117-0003)

[62 FR 13962, Mar. 24, 1997]









[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: 21CFR1305]

[Page 62-68]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1305--ORDER FORMS

Sec.
1305.01  Scope of part 1305.
1305.02  Definitions.
1305.03  Distributions requiring order forms.
1305.04  Persons entitled to obtain and execute order forms.
1305.05  Procedure for obtaining order forms.
1305.06  Procedure for executing order forms.
1305.07  Power of attorney.
1305.08  Persons entitled to fill order forms.
1305.09  Procedure for filling order forms.
1305.10  Procedure for endorsing order forms.
1305.11  Unaccepted and defective order forms.
1305.12  Lost and stolen order forms.
1305.13  Preservation of order forms.
1305.14  Return of unused order forms.
1305.15  Cancellation and voiding of order forms.
1305.16  Special procedure for filling certain order forms.

    Authority:  21 U.S.C. 821, 828, 871(b), unless otherwise noted.

[[Page 63]]


    Source:  36 FR 7796, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

Sec. 1305.01  Scope of part 1305.

    Procedures governing the issuance, use, and preservation of order 
forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth 
generally by that section and specifically by the sections of this part.

Sec. 1305.02   Definitions.

    Any term contained 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 13963, Mar. 24, 1997]

Sec. 1305.03  Distributions requiring order forms.

    An order form (DEA Form 222) is required for each distribution of a 
Schedule I or II controlled substance except to persons exempted from 
registration under part 1301 of this chapter; which are exported from 
the United States in conformity with the Act; or for delivery to a 
registered analytical laboratory, or its agent approved by DEA.
[62 FR 13963, Mar. 24, 1997]

Sec. 1305.04  Persons entitled to obtain and execute order forms.

    (a) Order forms may be obtained only by persons who are registered 
under section 303 of the Act (21 U.S.C. 823) to handle controlled 
substances listed in Schedules I and II, and by persons who are 
registered under section 1008 of the Act (21 U.S.C. 958) to export such 
substances. Persons not registered to handle controlled substances 
listed in Schedule I or II and persons registered only to import 
controlled substances listed in any schedule are not entitled to obtain 
order forms.
    (b) An order form may be executed only on behalf of the registrant 
named thereon and only if his/her registration as to the substances 
being purchased has not expired or been revoked or suspended.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13964, Mar. 24, 1997]

Sec. 1305.05  Procedure for obtaining order forms.

    (a) Order Forms are issued in mailing envelopes containing either 
seven or fourteen forms, each form containing an original duplicate and 
triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, 
which is based on the business activity of the registrant, will be 
imposed on the number of order forms which will be furnished on any 
requisition unless additional forms are specifically requested and a 
reasonable need for such additional forms is shown.
    (b) Any person applying for a registration which would entitle him/
her to obtain order forms may requisition such forms by so indicating on 
the application form; order forms will be supplied upon the registration 
of the applicant. Any person holding a registration entitling him/her to 
obtain order forms may requisition such forms for the first time by 
contacting any Division Office or the Registration Unit of the 
Administration. Any person already holding order forms may requisition 
additional forms on DEA Form 222a which is mailed to a registrant 
approximately 30 days after each shipment of order forms to that 
registrant or by contacting any Division Office or the Registration Unit 
of the Administration. All requisition forms (DEA Form 222a) shall be 
submitted to the Registration Unit, Drug Enforcement Administration, 
Department of Justice, Post Office Box 28083, Central Station, 
Washington, DC 20005.
    (c) Each requisition shall show the name, address, and registration 
number of the registrant and the number of books of order forms desired. 
Each requisition shall be signed and dated by the same person who signed 
the most recent application for registration or for reregistration, or 
by any person authorized to obtain and execute order forms by a power of 
attorney pursuant to Sec. 1305.07.
    (d) Order forms will be serially numbered and issued with the name, 
address and registration number of the registrant, the authorized 
activity and schedules of the registrant. This information cannot be 
altered or changed by the registrant; any errors must be corrected by 
the Registration Unit of

[[Page 64]]

the Administration by returning the forms with notification of the 
error.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, 
Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988; 62 FR 13964, Mar. 24, 1997]

Sec. 1305.06  Procedure for executing order forms.

    (a) Order forms shall be prepared and executed by the purchaser 
simultaneously in triplicate by means of interleaved carbon sheets which 
are part of the DEA Form 222. Order forms shall be prepared by use of a 
typewriter, pen, or indelible pencil.
    (b) Only one item shall be entered on each numbered line. An item 
shall consist of one or more commercial or bulk containers of the same 
finished or bulk form and quantity of the same substance. The number of 
lines completed shall be noted on that form at the bottom of the form, 
in the space provided. Order forms for carfentanil, etorphine 
hydrochloride, and diprenorphine shall contain only these substances.
    (c) The name and address of the supplier from whom the controlled 
substances are being ordered shall be entered on the form. Only one 
supplier may be listed on any form.
    (d) Each order form shall be signed and dated by a person authorized 
to sign an application for registration. The name of the purchaser, if 
different from the individual signing the order form, shall also be 
inserted in the signature space. Unexecuted order forms may be kept and 
may be executed at a location other than the registered location printed 
on the form, provided that all unexecuted forms are delivered promptly 
to the registered location upon an inspection of such location by any 
officer authorized to make inspections, or to enforce, any Federal, 
State, or local law regarding controlled substances.
[62 FR 13963, Mar. 24, 1997]

Sec. 1305.07  Power of attorney.

    Any purchaser may authorize one or more individuals, whether or not 
located at the registered location of the purchaser, to obtain and 
execute order forms on his/her behalf by executing a power of attorney 
for each such individual. The power of attorney shall be signed by the 
same person who signed the most recent application for registration or 
reregistration and by the individual being authorized to obtain and 
execute order forms. The power of attorney shall be filed with the 
executed order forms of the purchaser, and shall be retained for the 
same period as any order form bearing the signature of the attorney. The 
power of attorney shall be available for inspection together with other 
order form records. Any power of attorney may be revoked at any time by 
executing a notice of revocation, signed by the person who signed (or 
was authorized to sign) the power of attorney or by a successor, whoever 
signed the most recent application for registration or reregistration, 
and filing it with the power of attorney being revoked. The form for the 
power of attorney and notice of revocation shall be similar to the 
following:

                  Power of Attorney for DEA Order Forms

__________ (Name of registrant)
__________ (Address of registrant)
__________ (DEA registration number)

    I, __________ (name of person granting power), the undersigned, who 
is authorized to sign the current application for registration of the 
above-named registrant under the Controlled Substances Act or Controlled 
Substances Import and Export Act, have made, constituted, and appointed, 
and by these presents, do make, constitute, and appoint __________ (name 
of attorney-in-fact), my true and lawful attorney for me in my name, 
place, and stead, to execute applications for books of official order 
forms and to sign such order forms in requisition for Schedule I and II 
controlled substances, in accordance with section 308 of the Controlled 
Substances Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of 
Federal Regulations. I hereby ratify and confirm all that said attorney 
shall lawfully do or cause to be done by virtue hereof.

 _______________________________________________________________________
(Signature of person granting power)

    I, __________ (name of attorney-in-fact), hereby affirm that I am 
the person named herein as attorney-in-fact and that the signature 
affixed hereto is my signature.

 _______________________________________________________________________
(Signature of attorney-in-fact)

    Witnesses:
    1. __________.
    2. __________.
    Signed and dated on the ______ day of __________, (year), at 
__________.

[[Page 65]]

                          Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act of the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-fact 
__________ this same day.

 _______________________________________________________________________
(Signature of person revoking power)
    Witnesses:
    1. __________.
    2. __________.
    Signed and dated on the ______ day of __________, (year), at 
__________.
[62 FR 13963, Mar. 24, 1997]

Sec. 1305.08  Persons entitled to fill order forms.

    An order form may be filled only by a person registered as a 
manufacturer or distributor of controlled substances listed in Schedule 
I or II under section 303 of the Act (21 U.S.C. 823) or as an importer 
of such substances under section 1008 of the Act (21 U.S.C. 958), except 
for the following:
    (a) A person registered to dispense such substances under section 
303 of the Act, or to export such substances under section 1008 of the 
Act, if he/she is discontinuing business or if his/her registration is 
expiring without reregistration, may dispose of any controlled 
substances listed in Schedule I or II in his/her possession pursuant to 
order forms in accordance with Sec. 1307.14 of this chapter;
    (b) A person who has obtained any controlled substance in Schedule I 
or II by order form may return such substance, or portion thereof, to 
the person from whom he obtained the substance or the manufacturer of 
the substance pursuant to the order form of the latter person;
    (c) A person registered to dispense such substances may distribute 
such substances to another dispenser pursuant to, and only in the 
circumstances described in, Sec. 1307.11 of this chapter; and
    (d) A person registered or authorized to conduct chemical analysis 
or research with controlled substances may distribute a controlled 
substance listed in Schedule I or II to another person registered or 
authorized to conduct chemical analysis, instructional activities, or 
research with such substances pursuant to the order form of the latter 
person, if such distribution is for the purpose of furthering such 
chemical analysis, instructional activities, or research.
    (e) A person registered as a compounder of narcotic substances for 
use at off-site locations in conjunction with a narcotic treatment 
program at the compounding location, who is authorized to handle 
Schedule II narcotics, is authorized to fill order forms for 
distribution of narcotic drugs to off-site narcotic treatment programs 
only.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18732, Sept. 21, 1971; 37 FR 15921, Aug. 8, 1972. Redesignated at 38 
FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1305.08, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1305.09  Procedure for filling order forms.

    (a) The purchaser shall submit Copy 1 and Copy 2 of the order form 
to the supplier, and retain Copy 3 in his own files.
    (b) The supplier shall fill the order, if possible and if he/she 
desires to do so, and record on Copies 1 and 2 the number of commercial 
or bulk containers furnished on each item and the date on which such 
containers are shipped to the purchaser. If an order cannot be filled in 
its entirety, it may be filled in part and the balance supplied by 
additional shipments within 60 days following the date of the order 
form. No order form shall be valid more than 60 days after its execution 
by the purchaser, except as specified in paragraph (f) of this section.
    (c) The controlled substances shall only be shipped to the purchaser 
and at the location printed by the Administration on the order form, 
except as specified in paragraph (f) of this section.
    (d) The supplier shall retain Copy 1 of the order form for his/her 
own files and forward Copy 2 to the Special Agent in Charge of the Drug 
Enforcement Administration in the area in which the

[[Page 66]]

supplier is located. Copy 2 shall be forwarded at the close of the month 
during which the order is filled; if an order is filled by partial 
shipments, Copy 2 shall be forwarded at the close of the month during 
which the final shipment is made or during which the 60-day validity 
period expires.
    (e) The purchaser shall record on Copy 3 of the order form the 
number of commercial or bulk containers furnished on each item and the 
dates on which such containers are received by the purchaser.
    (f) Order forms submitted by registered procurement officers of the 
Defense Personnel Support Center of Defense Supply Agency for delivery 
to armed services establishments within the United States may be shipped 
to locations other than the location printed on the order form, and in 
partial shipments at different times not to exceed six months from the 
date of the order, as designated by the procurement officer when 
submitting the order.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, 
Sept. 22, 1982; 62 FR 13964, Mar. 24, 1997]

Sec. 1305.10  Procedure for endorsing order forms.

    (a) An order form made out to any supplier who cannot fill all or a 
part of the order within the time limitation set forth in Sec. 1305.09 
may be endorsed to another supplier for filling. The endorsement shall 
be made only by the supplier to whom the order form was first made, 
shall state (in the spaces provided on the reverse sides of Copies 1 and 
2 of the order form) the name and address of the second supplier, and 
shall be signed by a person authorized to obtain and execute order forms 
on behalf of the first supplier. The first supplier may not fill any 
part of an order on an endorsed form. The second supplier shall fill the 
order, if possible and if he/she desires to do so, in accordance with 
Sec. 1305.09 (b), (c), and (d), including shipping all substances 
directly to the purchaser.
    (b) Distributions made on endorsed order forms shall be reported by 
the second supplier in the same manner as all other distributions except 
that where the name of the supplier is requested on the reporting form, 
the second supplier shall record the name, address and registration 
number of the first supplier.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13964, Mar. 24, 1997]

Sec. 1305.11  Unaccepted and defective order forms.

    (a) No order form shall be filled if it:
    (1) Is not complete, legible, or properly prepared, executed, or 
endorsed; or
    (2) Shows any alteration, erasure, or change of any description.
    (b) If an order form cannot be filled for any reason under this 
section, the supplier shall return Copies 1 and 2 to the purchaser with 
a statement as to the reason (e.g., illegible or altered). A supplier 
may for any reason refuse to accept any order and if a supplier refuses 
to accept the order, a statement that the order is not accepted shall be 
sufficient for purposes of this paragraph.
    (c) When received by the purchaser, Copies 1 and 2 of the order form 
and the statement shall be attached to Copy 3 and retained in the files 
of the purchaser in accordance with Sec. 1305.13. A defective order form 
may not be corrected; it must be replaced by a new order form in order 
for the order to be filled.

Sec. 1305.12  Lost and stolen order forms.

    (a) If a purchaser ascertains that an unfilled order form has been 
lost, he shall execute another in triplicate and a statement containing 
the serial number and date of the lost form, and stating that the goods 
covered by the first order form were not received through loss of that 
order form. Copy 3 of the second form and a copy of the statement shall 
be retained with Copy 3 of the order form first executed. A copy of the 
statement shall be attached to Copies 1 and 2 of the second order form 
sent to the supplier. If the first order form is subsequently received 
by the supplier to whom it was directed, the supplier shall mark upon 
the face thereof ``Not accepted'' and return Copies 1 and 2 to the 
purchaser, who shall attach it to Copy 3 and the statement.

[[Page 67]]

    (b) Whenever any used or unused order forms are stolen or lost 
(otherwise than in the course of transmission) by any purchaser or 
supplier, he/she shall immediately upon discovery of such theft or loss, 
report the same to the Special Agent in Charge of the Drug Enforcement 
Administration in the Divisional Office responsible for the area in 
which the registrant is located, stating the serial number of each form 
stolen or lost. If the theft or loss includes any original order forms 
received from purchasers and the supplier is unable to state the serial 
numbers of such order forms, he/she shall report the date or approximate 
date of receipt thereof and the names and addresses of the purchasers. 
If an entire book of order forms is lost or stolen, and the purchaser is 
unable to state the serial numbers of the order forms contained therein, 
he/she shall report, in lieu of the numbers of the forms contained in 
such book, the date or approximate date of issuance thereof. If any 
unused order form reported stolen or lost is subsequently recovered or 
found, the Special Agent in Charge of the Drug Enforcement 
Administration in the Divisional Office responsible for the area in 
which the registrant is located shall immediately be notified.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, 
Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997]

Sec. 1305.13  Preservation of order forms.

    (a) The purchaser shall retain Copy 3 of each order form which has 
been filled. He/She shall also retain in his files all copies of each 
unaccepted or defective order form and each statement attached thereto.
    (b) The supplier shall retain Copy 1 of each order form which he/she 
has filled.
    (c) Order forms must be maintained separately from all other records 
of the registrant. Order forms are required to be kept available for 
inspection for a period of 2 years. If a purchaser has several 
registered locations, he/she must retain Copy 3 of the executed order 
forms and any attached statements or other related documents (not 
including unexecuted order forms which may be kept elsewhere pursuant to 
Sec. 1305.06(d)) at the registered location printed on the order form.
    (d) The supplier of carfentanil etorphine hydrochloride and 
diprenorphine shall maintain order forms for these substances separately 
from all other order forms and records required to be maintained by the 
registrant.
[36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 17839, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 
FR 13964, Mar. 24, 1997]

Sec. 1305.14  Return of unused order forms.

    If the registration of any purchaser terminates (because the 
purchaser dies, ceases legal existence, discontinues business or 
professional practice, or changes his name or address as shown on his 
registration) or is suspended or revoked pursuant to Sec. 1301.36 of 
this chapter as to all controlled substances listed in Schedules I and 
II for which he/she is registered, he/she shall return all unused order 
forms for such substance to the nearest office of the Administration.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13964, 
Mar. 24, 1997]

Sec. 1305.15  Cancellation and voiding of order forms.

    (a) A purchaser may cancel part or all of an order on an order form 
by notifying the supplier in writing of such cancellation. The supplier 
shall indicate the cancellation on Copies 1 and 2 of the order form by 
drawing a line through the canceled items and printing ``canceled'' in 
the space provided for number of items shipped.
    (b) A supplier may void part or all of an order on an order form by 
notifying the purchaser in writing of such voiding. The supplier shall 
indicate the voiding in the manner prescribed for cancellation in 
paragraph (a) of this section.
    (c) No cancellation or voiding permitted by this section shall 
affect in any way contract rights of either the purchaser or the 
supplier.
[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

[[Page 68]]

Sec. 1305.16  Special procedure for filling certain order forms.

    (a) The purchaser of carfentanil etorphine hydrochloride or 
diprenorphine shall submit copy 1 and 2 of the order form to the 
supplier and retain copy 3 in his own files.
    (b) The supplier, if he/she determines that the purchaser is a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs and/or research and authorized by the Administrator 
to handle these substances shall fill the order in accordance with the 
procedures set forth in Sec. 1305.09 except that:
    (1) Order forms for carfentanil etorphine hydrochloride and 
diprenorphine shall only contain these substances in reasonable 
quantities and
    (2) The substances shall only be shipped to the purchaser at the 
location printed by the Administration upon the order form under secure 
conditions using substantial packaging material with no markings on the 
outside which would indicate the content.
[39 FR 17839, May 21, 1974, as amended at 54 FR 33674, Aug. 16, 1989; 62 
FR 13964, Mar. 24, 1997]









[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: 21CFR1306]

[Page 68-76]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1306--PRESCRIPTIONS

                           General Information

Sec.
1306.01  Scope of part 1306.
1306.02  Definitions.
1306.03  Persons entitled to issue prescriptions.
1306.04  Purpose of issue of prescription.
1306.05  Manner of issuance of prescriptions.
1306.06  Persons entitled to fill prescriptions.
1306.07  Administering or dispensing of narcotic drugs.

               Controlled Substances Listed in Schedule II

1306.11  Requirement of prescription.
1306.12  Refilling prescriptions.
1306.13  Partial filling of prescriptions.
1306.14  Labeling of substances and filling of prescriptions.

        Controlled Substances Listed in Schedules III, IV, and V

1306.21  Requirement of prescription.
1306.22  Refilling of prescriptions.
1306.23  Partial filling of prescriptions.
1306.24  Labeling of substances and filling of prescriptions.
1306.25  Transfer between pharmacies of presription information for 
          Schedules III, IV, and V controlled substances for refill 
          purposes.
1306.26  Dispensing without prescription.

    Authority:  21 U.S.C. 821, 829, 871(b), unless otherwise noted.

    Source:  36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, 
unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information

Sec. 1306.01  Scope of part 1306.

    Rules governing the issuance, filling and filing of prescriptions 
pursuant to section 309 of the Act (21 U.S.C. 829) are set forth 
generally in that section and specifically by the sections of this part.

Sec. 1306.02  Definitions.

    Any term contained 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 13964, Mar. 24, 1997]

Sec. 1306.03  Persons entitled to issue prescriptions.

    (a) A prescription for a controlled substance may be issued only by 
an individual practitioner who is:
    (1) authorized to prescribe controlled substances by the 
jurisdiction in which he is licensed to practice his profession and
    (2) either registered or exempted from registration pursuant to 
Secs. 1301.22(c) and 1301.23 of this chapter.
    (b) A prescription issued by an individual practitioner may be 
communicated to a pharmacist by an employee or agent of the individual 
practitioner.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, 
Mar. 24, 1997]

Sec. 1306.04  Purpose of issue of prescription.

    (a) A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice. The 
responsibility for the proper prescribing and dispensing of

[[Page 69]]

controlled substances is upon the prescribing practitioner, but a 
corresponding responsibility rests with the pharmacist who fills the 
prescription. An order purporting to be a prescription issued not in the 
usual course of professional treatment or in legitimate and authorized 
research is not a prescription within the meaning and intent of section 
309 of the Act (21 U.S.C. 829) and the person knowingly filling such a 
purported prescription, as well as the person issuing it, shall be 
subject to the penalties provided for violations of the provisions of 
law relating to controlled substances.
    (b) A prescription may not be issued in order for an individual 
practitioner to obtain controlled substances for supplying the 
individual practitioner for the purpose of general dispensing to 
patients.
    (c) A prescription may not be issued for the dispensing of narcotic 
drugs listed in any schedule for ``detoxification treatment'' or 
``maintenance treatment'' as defined in Section 102 of the Act (21 
U.S.C. 802).
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 37986, Oct. 25, 1974]

Sec. 1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use and the name, address and registration 
number of the practitioner. A practitioner may sign a prescription in 
the same manner as he would sign a check or legal document (e.g., J.H. 
Smith or John H. Smith). Where an oral order is not permitted, 
prescriptions shall be written with ink or indelible pencil or 
typewriter and shall be manually signed by the practitioner. The 
prescriptions may be prepared by the secretary or agent for the 
signature of a practitioner, but the prescribing practitioner is 
responsible in case the prescription does not conform in all essential 
respects to the law and regulations. A corresponding liability rests 
upon the pharmacist who fills a prescription not prepared in the form 
prescribed by these regulations.
    (b) An individual practitioner exempted from registration under 
Sec. 1301.22(c) of this chapter shall include on all prescriptions 
issued by him or her the registration number of the hospital or other 
institution and the special internal code number assigned to him or her 
by the hospital or other institution as provided in Sec. 1301.22(c) of 
this chapter, in lieu of the registration number of the practitioner 
required by this section. Each written prescription shall have the name 
of the physician stamped, typed, or handprinted on it, as well as the 
signature of the physician.
    (c) An official exempted from registration under Sec. 1301.22(c) 
shall include on all prescriptions issued by him his branch of service 
or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his 
service identification number, in lieu of the registration number of the 
practitioner required by this section. The service identification number 
for a Public Health Service employee is his Social Security 
identification number. Each prescription shall have the name of the 
officer stamped, typed, or handprinted on it, as well as the signature 
of the officer.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 56 FR 25026, 
June 3, 1991; 60 FR 36641, July 18, 1995; 62 FR 13966, Mar. 24, 1997]

Sec. 1306.06  Persons entitled to fill prescriptions.

    A prescription for controlled substances may only be filled by a 
pharmacist acting in the usual course of his professional practice and 
either registered individually or employed in a registered pharmacy or 
registered institutional practitioner.

Sec. 1306.07  Administering or dispensing of narcotic drugs.

    (a) The administering or dispensing directly (but not prescribing) 
of narcotic drugs listed in any schedule to a narcotic drug dependent 
person for ``detoxification treatment'' or ``maintenance treatment'' as 
defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be 
within the meaning of

[[Page 70]]

the term ``in the course of his professional practice or research'' in 
section 308(e) and section 102(20) of the Act (21 U.S.C. 828 (e)): 
Provided, That the practitioner is separately registered with the 
Attorney General as required by section 303(g) of the Act (21 U.S.C. 
823(g)) and then thereafter complies with the regulatory standards 
imposed relative to treatment qualification, security, records and 
unsupervised use of drugs pursuant to such Act.
    (b) Nothing in this section shall prohibit a physician who is not 
specifically registered to conduct a narcotic treatment program from 
administering (but not prescribing) narcotic drugs to a person for the 
purpose of relieving acute withdrawal symptoms when necessary while 
arrangements are being made for referral for treatment. Not more than 
one day's medication may be administered to the person or for the 
person's use at one time. Such emergency treatment may be carried out 
for not more than three days and may not be renewed or extended.
    (c) This section is not intended to impose any limitations on a 
physician or authorized hospital staff to administer or dispense 
narcotic drugs in a hospital to maintain or detoxify a person as an 
incidental adjunct to medical or surgical treatment of conditions other 
than addiction, or to administer or dispense narcotic drugs to persons 
with intractable pain in which no relief or cure is possible or none has 
been found after reasonable efforts.
[39 FR 37986, Oct. 25, 1974]

               Controlled Substances Listed in Schedule II

Sec. 1306.11  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule II, which is a prescription drug as determined under the 
Federal Food, Drug, and Cosmetic Act, only pursuant to a written 
prescription signed by the practitioner, except as provided in paragraph 
(d) of this section. A prescription for a Schedule II controlled 
substance may be transmitted by the practitioner or the practitioner's 
agent to a pharmacy via facsimile equipment, provided that the original 
written, signed prescription is presented to the pharmacist for review 
prior to the actual dispensing of the controlled substance, except as 
noted in paragraph (e), (f), or (g) of this section. The original 
prescription shall be maintained in accordance with Sec. 1304.04(h) of 
this chapter.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule II in the course of his 
professional practice without a prescription, subject to Sec. 1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
II only pursuant to a written prescription signed by the prescribing 
individual practitioner or to an order for medication made by an 
individual practitioner which is dispensed for immediate administration 
to the ultimate user.
    (d) In the case of an emergency situation, as defined by the 
Secretary in Sec. 290.10 of this title, a pharmacist may dispense a 
controlled substance listed in Schedule II upon receiving oral 
authorization of a prescribing individual practitioner, provided that:
    (1) The quantity prescribed and dispensed is limited to the amount 
adequate to treat the patient during the emergency period (dispensing 
beyond the emergency period must be pursuant to a written prescription 
signed by the prescribing individual practitioner);
    (2) The prescription shall be immediately reduced to writing by the 
pharmacist and shall contain all information required in Sec. 1306.05, 
except for the signature of the prescribing individual practitioner;
    (3) If the prescribing individual practitioner is not known to the 
pharmacist, he must make a reasonable effort to determine that the oral 
authorization came from a registered individual practitioner, which may 
include a callback to the prescribing individual practitioner using his 
phone number as listed in the telephone directory and/or other good 
faith efforts to insure his identity; and
    (4) Within 7 days after authorizing an emergency oral prescription, 
the prescribing individual practitioner shall cause a written 
prescription for the emergency quantity prescribed to be

[[Page 71]]

delivered to the dispensing pharmacist. In addition to conforming to the 
requirements of Sec. 1306.05, the prescription shall have written on its 
face ``Authorization for Emergency Dispensing,'' and the date of the 
oral order. The written prescription may be delivered to the pharmacist 
in person or by mail, but if delivered by mail it must be postmarked 
within the 7 day period. Upon receipt, the dispensing pharmacist shall 
attach this prescription to the oral emergency prescription which had 
earlier been reduced to writing. The pharmacist shall notify the nearest 
office of the Administration if the prescribing individual practitioner 
fails to deliver a written prescription to him; failure of the 
pharmacist to do so shall void the authority conferred by this paragraph 
to dispense without a written prescription of a prescribing individual 
practitioner.
    (e) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance to be compounded for the direct 
administration to a patient by parenteral, intravenous, intramuscular, 
subcutaneous or intraspinal infusion may be transmitted by the 
practitioner or the practitioner's agent to the pharmacy by facsimile. 
The facsimile serves as the original written prescription for purposes 
of this paragraph (e) and it shall be maintained in accordance with 
Sec. 1304.04(h) of this chapter.
    (f) A prescription prepared in accordance with Sec. 1306.05 written 
for Schedule II substance for a resident of a Long Term Care Facility 
may be transmitted by the practitioner or the practitioner's agent to 
the dispensing pharmacy by facsimile. The facsimile serves as the 
original written prescription for purposes of this paragraph (f) and it 
shall be maintained in accordance with Sec. 1304.04(h).
    (g) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance for a patient residing in a hospice 
certified by Medicare under Title XVIII or licensed by the state may be 
transmitted by the practitioner or the practitioner's agent to the 
dispensing pharmacy by facsimile. The practitioner or the practitioner's 
agent will note on the prescription that the patient is a hospice 
patient. The facsimile serves as the original written prescription for 
purposes of this paragraph (g) and it shall be maintained in accordance 
with Sec. 1304.04(h) of this chapter.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, 
Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62 
FR 13964, Mar. 24, 1997]

Sec. 1306.12  Refilling prescriptions.

    The refilling of a prescription for a controlled substance listed in 
Schedule II is prohibited.

Sec. 1306.13  Partial filling of prescriptions.

    (a) The partial filling of a prescription for a controlled substance 
listed in Schedule II is permissible, if the pharmacist is unable to 
supply the full quantity called for in a written or emergency oral 
prescription and he makes a notation of the quantity supplied on the 
face of the written prescription (or written record of the emergency 
oral prescription). The remaining portion of the prescription may be 
filled within 72 hours of the first partial filling; however, if the 
remaining portion is not or cannot be filled within the 72-hour period, 
the pharmacist shall so notify the prescribing individual practitioner. 
No further quantity may be supplied beyond 72 hours without a new 
prescription.
    (b) A prescription for a Schedule II controlled substance written 
for a patient in a Long Term Care Facility (LTCF) or for a patient with 
a medical diagnosis documenting a terminal illness may be filled in 
partial quantities to include individual dosage units. If there is any 
question whether a patient may be classified as having a terminal 
illness, the pharmacist must contact the practitioner prior to partially 
filling the prescription. Both the pharmacist and the prescribing 
practitioner have a corresponding responsibility to assure that the 
controlled substance is for a terminally ill patient. The pharmacist 
must record on the prescription whether the patient is ``terminally 
ill'' or an ``LTCF patient.'' A prescription that is partially filled 
and does not contain the notation ``terminally ill''

[[Page 72]]

or ``LTCF patient'' shall be deemed to have been filled in violation of 
the Act. For each partial filling, the dispensing pharmacist shall 
record on the back of the prescription (or on another appropriate 
record, uniformly maintained, and readily retrievable) the date of the 
partial filling, quantity dispensed, remaining quantity authorized to be 
dispensed, and the identification of the dispensing pharmacist. The 
total quantity of Schedule II controlled substances dispensed in all 
partial fillings must not exceed the total quantity prescribed. Schedule 
II prescriptions for patients in a LTCF or patients with a medical 
diagnosis documenting a terminal illness shall be valid for a period not 
to exceed 60 days from the issue date unless sooner terminated by the 
discontinuance of medication.
    (c) Information pertaining to current Schedule II prescriptions for 
patients in a LTCF or for patients with a medical diagnosis documenting 
a terminal illness may be maintained in a computerized system if this 
system has the capability to permit:
    (1) Output (display or printout) of the original prescription 
number, date of issue, identification of prescribing individual 
practitioner, identification of patient, address of the LTCF or address 
of the hospital or residence of the patient, identification of 
medication authorized (to include dosage, form, strength and quantity), 
listing of the partial fillings that have been dispensed under each 
prescription and the information required in Sec. 1306.13(b).
    (2) Immediate (real time) updating of the prescription record each 
time a partial filling of the prescription is conducted.
    (3) Retrieval of partially filled Schedule II prescription 
information is the same as required by Sec. 1306.22(b) (4) and (5) for 
Schedule III and IV prescription refill information.

(21 U.S.C. 801, et seq.)
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 
FR 13965, Mar. 24, 1997]

Sec. 1306.14  Labeling of substances and filling of prescriptions.

    (a) The pharmacist filling a written or emergency oral prescription 
for a controlled substance listed in Schedule II shall affix to the 
package a label showing date of filling, the pharmacy name and address, 
the serial number of the prescription, the name of the patient, the name 
of the prescribing practitioner, and directions for use and cautionary 
statements, if any, contained in such prescription or required by law.
    (b) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule II is prescribed for 
administration to an ultimate user who is institutionalized: Provided, 
That:
    (1) Not more than 7-day supply of the controlled substance listed in 
Schedule II is dispensed at one time;
    (2) The controlled substance listed in Schedule II is not in the 
possession of the ultimate user prior to the administration;
    (3) The institution maintains appropriate safeguards and records 
regarding the proper administration, control, dispensing, and storage of 
the controlled substance listed in Schedule II; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product, and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (c) All written prescriptions and written records of emergency oral 
prescriptions shall be kept in accordance with requirements of 
Sec. 1304.04(h) of this chapter.
[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965, 
Mar. 24, 1997]

        Controlled Substances Listed in Schedules III, IV, and V

Sec. 1306.21  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule III, IV, or V which is a prescription drug as determined 
under the Federal Food, Drug, and Cosmetic Act, only pursuant to either 
a written prescription signed by a practitioner or a facsimile of a 
written, signed prescription transmitted by the practitioner or

[[Page 73]]

the practitioner's agent to the pharmacy or pursuant to an oral 
prescription made by an individual practitioner and promptly reduced to 
writing by the pharmacist containing all information required in 
Sec. 1306.05, except for the signature of the practitioner.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule III, IV, or V in the course of 
his/her professional practice without a prescription, subject to 
Sec. 1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
III, IV, or V only pursuant to a written prescription signed by an 
individual practitioner, or pursuant to a facsimile of a written 
prescription or order for medication transmitted by the practitioner or 
the practitioner's agent to the institutional practitioner-pharmacist, 
or pursuant to an oral prescription made by an individual practitioner 
and promptly reduced to writing by the pharmacist (containing all 
information required in Section 1306.05 except for the signature of the 
individual practitioner), or pursuant to an order for medication made by 
an individual practitioner which is dispensed for immediate 
administration to the ultimate user, subject to Sec. 1306.07.
[62 FR 13965, Mar. 24, 1997]

Sec. 1306.22  Refilling of prescriptions.

    (a) No prescription for a controlled substance listed in Schedule 
III or IV shall be filled or refilled more than six months after the 
date on which such prescription was issued and no such prescription 
authorized to be refilled may be refilled more than five times. Each 
refilling of a prescription shall be entered on the back of the 
prescription or on another appropriate document. If entered on another 
document, such as a medication record, the document must be uniformly 
maintained and readily retrievable. The following information must be 
retrievable by the prescription number consisting of the name and dosage 
form of the controlled substance, the date filled or refilled, the 
quantity dispensed, initials of the dispensing pharmacist for each 
refill, and the total number of refills for that prescription. If the 
pharmacist merely initials and dates the back of the prescription it 
shall be deemed that the full face amount of the prescription has been 
dispensed. The prescribing practitioner may authorize additional refills 
of Schedule III or IV controlled substances on the original prescription 
through an oral refill authorization transmitted to the pharmacist 
provided the following conditions are met:
    (1) The total quantity authorized, including the amount of the 
original prescription, does not exceed five refills nor extend beyond 
six months from the date of issue of the original prescription.
    (2) The pharmacist obtaining the oral authorization records on the 
reverse of the original prescription the date, quantity of refill, 
number of additional refills authorized, and initials the prescription 
showing who received the authorization from the prescribing practitioner 
who issued the original prescription.
    (3) The quantity of each additional refill authorized is equal to or 
less than the quantity authorized for the initial filling of the 
original prescription.
    (4) The prescribing practitioner must execute a new and separate 
prescription for any additional quantities beyond the five refill, six-
month limitation.
    (b) As an alternative to the procedures provided by subsection (a), 
an automated data processing system may be used for the storage and 
retrieval of refill information for prescription orders for controlled 
substances in Schedule III and IV, subject to the following conditions:
    (1) Any such proposed computerized system must provide on-line 
retrieval (via CRT display or hard-copy printout) of original 
prescription order information for those prescription orders which are 
currently authorized for refilling. This shall include, but is not 
limited to, data such as the original prescription number, date of 
issuance of the original prescription order by the practitioner, full 
name and address of the patient, name, address, and DEA registration 
number of the practitioner, and the name, strength, dosage

[[Page 74]]

form, quantity of the controlled substance prescribed (and quantity 
dispensed if different from the quantity prescribed), and the total 
number of refills authorized by the prescribing practitioner.
    (2) Any such proposed computerized system must also provide on-line 
retrieval (via CRT display or hard-copy printout) of the current refill 
history for Schedule III or IV controlled substance prescription orders 
(those authorized for refill during the past six months.) This refill 
history shall include, but is not limited to, the name of the controlled 
substance, the date of refill, the quantity dispensed, the 
identification code, or name or initials of the dispensing pharmacist 
for each refill and the total number of refills dispensed to date for 
that prescription order.
    (3) Documentation of the fact that the refill information entered 
into the computer each time a pharmacist refills an original 
prescription order for a Schedule III or IV controlled substance is 
correct must be provided by the individual pharmacist who makes use of 
such a system. If such a system provides a hard-copy printout of each 
day's controlled substance prescription order refill data, that printout 
shall be verified, dated, and signed by the individual pharmacist who 
refilled such a prescription order. The individual pharmacist must 
verify that the data indicated is correct and then sign this document in 
the same manner as he would sign a check or legal document (e.g., J. H. 
Smith, or John H. Smith). This document shall be maintained in a 
separate file at that pharmacy for a period of two years from the 
dispensing date. This printout of the day's controlled substance 
prescription order refill data must be provided to each pharmacy using 
such a computerized system within 72 hours of the date on which the 
refill was dispensed. It must be verified and signed by each pharmacist 
who is involved with such dispensing. In lieu of such a printout, the 
pharmacy shall maintain a bound log book, or separate file, in which 
each individual pharmacist involved in such dispensing shall sign a 
statement (in the manner previously described) each day, attesting to 
the fact that the refill information entered into the computer that day 
has been reviewed by him and is correct as shown. Such a book or file 
must be maintained at the pharmacy employing such a system for a period 
of two years after the date of dispensing the appropriately authorized 
refill.
    (4) Any such computerized system shall have the capability of 
producing a printout of any refill data which the user pharmacy is 
responsible for maintaining under the Act and its implementing 
regulations. For example, this would include a refill-by-refill audit 
trail for any specified strength and dosage form of any controlled 
substance (by either brand or generic name or both). Such a printout 
must include name of the prescribing practitioner, name and address of 
the patient, quantity dispensed on each refill, date of dispensing for 
each refill, name or identification code of the dispensing pharmacist, 
and the number of the original prescription order. In any computerized 
system employed by a user pharmacy the central recordkeeping location 
must be capable of sending the printout to the pharmacy within 48 hours, 
and if a DEA Special Agent or Diversion Investigator requests a copy of 
such printout from the user pharmacy, it must, if requested to do so by 
the Agent or Investigator, verify the printout transmittal capability of 
its system by documentation (e.g., postmark).
    (5) In the event that a pharmacy which employs such a computerized 
system experiences system down-time, the pharmacy must have an auxiliary 
procedure which will be used for documentation of refills os Schedule 
III and IV controlled substance prescription orders. This auxiliary 
procedure must insure that refills are authorized by the original 
prescription order, that the maximum number of refills has not been 
exceeded, and that all of the appropriate data is retained for on-line 
data entry as soon as the computer system is available for use again.
    (c) When filing refill information for original prescription orders 
for Schedule III or IV controlled substances, a pharmacy may use only 
one of the two

[[Page 75]]

systems described in paragraphs (a) or (b) of this section.
[36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971. Redesignated at 
38 FR 26609, Sept. 24, 1973, and amended at 42 FR 28878, June 6, 1977; 
45 FR 44266, July 1, 1980; 52 FR 3605, Feb. 5, 1987; 62 FR 13966, Mar. 
24, 1997]

Sec. 1306.23  Partial filling of prescriptions.

    The partial filling of a prescription for a controlled substance 
listed in Schedule III, IV, or V is permissible, provided that:
    (a) Each partial filling is recorded in the same manner as a 
refilling,
    (b) The total quantity dispensed in all partial fillings does not 
exceed the total quantity prescribed, and
    (c) No dispensing occurs after 6 months after the date on which the 
prescription was issued.
[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, 
1997]

Sec. 1306.24  Labeling of substances and filing of prescriptions.

    (a) The pharmacist filling a prescription for a controlled substance 
listed in Schedule III, IV, or V shall affix to the package a label 
showing the pharmacy name and address, the serial number and date of 
initial filling, the name of the patient, the name of the practitioner 
issuing the prescription, and directions for use and cautionary 
statements, if any, contained in such prescription as required by law.
    (b) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule III, IV, or V is 
prescribed for administration to an ultimate user who is 
institutionalized: Provided, That:
    (1) Not more than a 34-day supply or 100 dosage units, whichever is 
less, of the controlled substance listed in Schedule III, IV, or V is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III, IV, or V is not 
in the possession of the ultimate user prior to administration;
    (3) The institution maintains appropriate safeguards and records the 
proper administration, control, dispensing, and storage of the 
controlled substance listed in Schedule III, IV, or V; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (c) All prescriptions for controlled substances listed in Schedules 
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this 
chapter.
[62 FR 13965, Mar. 24, 1997]

Sec. 1306.25  Transfer between pharmacies of prescription information 
          for Schedules III, IV, and V controlled substances for refill 
          purposes.

    (a) The transfer of original prescription information for a 
controlled substance listed in Schedules III, IV or V for the purpose of 
refill dispensing is permissible between pharmacies on a one time basis 
only. However, pharmacies electronically sharing a real-time, on-line 
database may transfer up to the maximum refills permitted by law and the 
prescriber's authorization. Transfers are subject to the following 
requirements:
    (1) The transfer is communicated directly between two licensed 
pharmacists and the transferring pharmacist records the following 
information:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription.
    (ii) Record on the reverse of the invalidated prescription the name, 
address and DEA registration number of the pharmacy to which it was 
transferred and the name of the pharmacist receiving the prescription 
information.
    (iii) Record the date of the transfer and the name of the pharmacist 
transferring the information.
    (b) The pharmacist receiving the transferred prescription 
information shall reduce to writing the following:
    (1) Write the word ``transfer'' on the face of the transferred 
prescription.
    (2) Provide all information required to be on a prescription 
pursuant to 21 CFR 1306.05 and include:
    (i) Date of issuance of original prescription;
    (ii) Original number of refills authorized on original prescription;

[[Page 76]]

    (iii) Date of original dispensing;
    (iv) Number of valid refills remaining and date(s) and locations of 
previous refill(s);
    (v) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription information was 
transferred;
    (vi) Name of pharmacist who transferred the prescription.
    (vii) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription was originally filled;
    (3) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
    (c) Pharmacies electronically accessing the same prescription record 
must satisfy all information requirements of a manual mode for 
prescription transferral.
    (d) The procedure allowing the transfer of prescription information 
for refill purposes is permissible only if allowable under existing 
state or other applicable law.
[46 FR 48919, Oct. 5, 1981. Redesignated and amended at 62 FR 13966, 
Mar. 24, 1997]

Sec. 1306.26  Dispensing without prescription.

    A controlled substance listed in Schedules II, III, IV, or V which 
is not a prescription drug as determined under the Federal Food, Drug, 
and Cosmetic Act, may be dispensed by a pharmacist without a 
prescription to a purchaser at retail, provided that:
    (a) Such dispensing is made only by a pharmacist (as defined in part 
1300 of this chapter), and not by a nonpharmacist employee even if under 
the supervision of a pharmacist (although after the pharmacist has 
fulfilled his professional and legal responsibilities set forth in this 
section, the actual cash, credit transaction, or delivery, may be 
completed by a nonpharmacist);
    (b) Not more than 240 cc. (8 ounces) of any such controlled 
substance containing opium, nor more than 120 cc. (4 ounces) of any 
other such controlled substance nor more than 48 dosage units of any 
such controlled substance containing opium, nor more than 24 dosage 
units of any other such controlled substance may be dispensed at retail 
to the same purchaser in any given 48-hour period;
    (c) The purchaser is at least 18 years of age;
    (d) The pharmacist requires every purchaser of a controlled 
substance under this section not known to him to furnish suitable 
identification (including proof of age where appropriate);
    (e) A bound record book for dispensing of controlled substances 
under this section is maintained by the pharmacist, which book shall 
contain the name and address of the purchaser, the name and quantity of 
controlled substance purchased, the date of each purchase, and the name 
or initials of the pharmacist who dispensed the substance to the 
purchaser (the book shall be maintained in accordance with the 
recordkeeping requirement of Sec. 1304.04 of this chapter); and
    (f) A prescription is not required for distribution or dispensing of 
the substance pursuant to any other Federal, State or local law.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesigated and 
amended at 62 FR 13966, Mar. 24, 1997]









[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: 21CFR1307]

[Page 76-79]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1307--MISCELLANEOUS

Sec.

                           General Information

1307.01  Definitions.
1307.02  Application of State law and other Federal law.
1307.03  Exceptions to regulations.

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances

1307.11  Distribution by dispenser to another practitioner.
1307.12  Distribution to supplier.
1307.13  Incidental manufacture of controlled substances.

                    Disposal of Controlled Substances

1307.21  Procedure for disposing of controlled substances.
1307.22  Disposal of controlled substances by the Administration.

                         Special Exempt Persons

1307.31  Native American Church.

    Authority:  21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.

[[Page 77]]


    Source:  36 FR 7801, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information

Sec. 1307.01  Definitions.

    Any term contained 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 13966, Mar. 24, 1997]

Sec. 1307.02  Application of State law and other Federal law.

    Nothing in this chapter shall be construed as authorizing or 
permitting any person to do any act which such person is not authorized 
or permitted to do under other Federal laws or obligations under 
international treaties, conventions or protocols, or under the law of 
the State in which he/she desires to do such act nor shall compliance 
with such parts be construed as compliance with other Federal or State 
laws unless expressly provided in such other laws.
[62 FR 13966, Mar. 24, 1997]

Sec. 1307.03  Exceptions to regulations.

    Any person may apply for an exception to the application of any 
provision of this chapter by filing a written request stating the 
reasons for such exception. Requests shall be filed with the 
Administrator, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537. The Administrator may grant an exception in his 
discretion, but in no case shall he/she be required to grant an 
exception to any person which is otherwise required by law or the 
regulations cited in this section.
[62 FR 13966, Mar. 24, 1997]

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances

Sec. 1307.11  Distribution by dispenser to another practitioner.

    (a) A practitioner who is registered to dispense a controlled 
substance may distribute (without being registered to distribute) a 
quantity of such substance to another practitioner for the purpose of 
general dispensing by the practitioner to his or its patients: Provided, 
That:
    (1) The practitioner to whom the controlled substance is to be 
distributed is registered under the Act to dispense that controlled 
substance;
    (2) The distribution is recorded by the distributing practitioner in 
accordance with Sec. 1304.22(c) of this chapter and by the receiving 
practitioner in accordance with Sec. 1304.22(c) of this chapter;
    (3) If the substance is listed in Schedule I or II, an order form is 
used as required in part 1305 of this chapter;
    (4) The total number of dosage units of all controlled substances 
distributed by the practitioner pursuant to this section and 
Sec. 1301.25 of this chapter during each calendar year in which the 
practitioner is registered to dispense does not exceed 5 percent of the 
total number of dosage units of all controlled substances distributed 
and dispensed by the practitioner during the same calendar year.
    (b) If, during any calendar year in which the practitioner is 
registered to dispense, the practitioner has reason to believe that the 
total number of dosage units of all controlled substances which will be 
distributed by him pursuant to this section and Sec. 1301.25 of this 
chapter will exceed 5 percent of the total number of dosage units of all 
controlled substances distributed and dispensed by him during that 
calendar year, the practitioner shall obtain a registration to 
distribute controlled substances.
[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, and amended at 50 FR 31590, Aug. 5, 1985; 62 FR 13967, Mar. 24, 
1997]

Sec. 1307.12  Distribution to supplier.

    Any person lawfully in possession of a controlled substance listed 
in any schedule may distribute (without being registered to distribute) 
that substance to the person from whom he obtained it or to the 
manufacturer of the substance, provided that a written record is 
maintained which indicates the date of the transaction, the name, form 
and quantity of the substance, the name, address, and registration 
number, if

[[Page 78]]

any, of the person making the distribution, and the name, address, and 
registration number, if known, of the supplier or manufacturer. In the 
case of returning a controlled substance listed in Schedule I or II, an 
order form shall be used in the manner prescribed in part 1305 of this 
chapter and be maintained as the written record of the transaction. Any 
person not required to register pursuant to sections 302(c) or 
1007(b)(1) of the Act (21 U.S.C. 823(c) or 957(b)(1)) shall be exempt 
from maintaining the records required by this section.
[36 FR 7801, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 
62 FR 13967, Mar. 24, 1997]

Sec. 1307.13  Incidental manufacture of controlled substances.

    Any registered manufacturer who, incidentally but necessarily, 
manufactures a controlled substance as a result of the manufacture of a 
controlled substance or basic class of controlled substance for which he 
is registered and has been issued an individual manufacturing quota 
pursuant to part 1303 of this chapter (if such substance or class is 
listed in Schedule I or II) shall be exempt from the requirement of 
registration pursuant to part 1301 of this <ls-thn-eq>chapter and, if 
such incidentally manufactured substance is listed in Schedule I or II, 
shall be exempt from the requirement of an individual manufacturing 
quota pursuant to part 1303 of this chapter, if such substances are 
disposed of in accordance with Sec. 1307.21.
[36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13967, Mar. 24, 1997]

                    Disposal of Controlled Substances

Sec. 1307.21  Procedure for disposing of controlled substances.

    (a) Any person in possession of any controlled substance and 
desiring or required to dispose of such substance may request assistance 
from the Special Agent in Charge of the Administration in the area in 
which the person is located for authority and instructions to dispose of 
such substance. The request should be made as follows:
    (1) If the person is a registrant, he/she shall list the controlled 
substance or substances which he/she desires to dispose of on DEA Form 
41, and submit three copies of that form to the Special Agent in Charge 
in his/her area; or
    (2) If the person is not a registrant, he/she shall submit to the 
Special Agent in Charge a letter stating:
    (i) The name and address of the person;
    (ii) The name and quantity of each controlled substance to be 
disposed of;
    (iii) How the applicant obtained the substance, if known; and
    (iv) The name, address, and registration number, if known, of the 
person who possessed the controlled substances prior to the applicant, 
if known.
    (b) The Special Agent in Charge shall authorize and instruct the 
applicant to dispose of the controlled substance in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substance;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By destruction in the presence of an agent of the Administration 
or other authorized person; or
    (4) By such other means as the Special Agent in Charge may determine 
to assure that the substance does not become available to unauthorized 
persons.
    (c) In the event that a registrant is required regularly to dispose 
of controlled substances, the Special Agent in Charge may authorize the 
registrant to dispose of such substances, in accordance with paragraph 
(b) of this section, without prior approval of the Administration in 
each instance, on the condition that the registrant keep records of such 
disposals and file periodic reports with the Special Agent in Charge 
summarizing the disposals made by the registrant. In granting such 
authority, the Special Agent in Charge may place such conditions as he 
deems proper on the disposal of controlled substances, including the 
method of disposal and the frequency and detail of reports.
    (d) This section shall not be construed as affecting or altering in 
any

[[Page 79]]

way the disposal of controlled substances through procedures provided in 
laws and regulations adopted by any State.
[36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, 
Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]

Sec. 1307.22  Disposal of controlled substances by the Administration.

    Any controlled substance delivered to the Administration under 
Sec. 1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 
881) may be delivered to any department, bureau, or other agency of the 
United States or of any State upon proper application addressed to the 
Administrator, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537 The application shall show the name, address, and 
official title of the person or agency to whom the controlled drugs are 
to be delivered, including the name and quantity of the substances 
desired and the purpose for which intended. The delivery of such 
controlled drugs shall be ordered by the Administrator, if, in his 
opinion, there exists a medical or scientific need therefor.
[38 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13967, Mar. 24, 1997]

                         Special Exempt Persons

Sec. 1307.31  Native American Church.

    The listing of peyote as a controlled substance in Schedule I does 
not apply to the nondrug use of peyote in bona fide religious ceremonies 
of the Native American Church, and members of the Native American Church 
so using peyote are exempt from registration. Any person who 
manufactures peyote for or distributes peyote to the Native American 
Church, however, is required to obtain registration annually and to 
comply with all other requirements of law.









[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: 21CFR1308]

[Page 79-97]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

                           General Information

Sec.
1308.01  Scope of part 1308.
1308.02  Definitions.
1308.03  Administration Controlled Substances Code Number.

                                Schedules

1308.11  Schedule I.
1308.12  Schedule II.
1308.13  Schedule III.
1308.14  Schedule IV.
1308.15  Schedule V.

                     Excluded Nonnarcotic Substances

1308.21  Application for exclusion of a nonnarcotic substance.
1308.22  Excluded substances.

                      Exempt Chemical Preparations

1308.23  Exemption of certain chemical preparations; application.
1308.24  Exemption chemical preparations.

          Excluded Veterinary Anabolic Steroid Implant Products

1308.25  Exclusion of a veterinary anabolic steroid implant product; 
          application.
1308.26  Excluded veterinary anabolic steroid implant products.

                     Exempted Prescription Products

1308.31  Application for exemption of a nonnarcotic prescription 
          product.
1308.32  Exempted prescription products.

                    Exempt Anabolic Steroid Products

1308.33  Exemption of certain anabolic steroid products; application.
1308.34  Exempt anabolic steroid products.

                                Hearings

1308.41  Hearings generally.
1308.42  Purpose of hearing.
1308.43  Initiation of proceedings for rule-making.
1308.44  Request for hearing or appearance; waiver.
1308.45  Final order.
1308.46  Control required under international treaty.
1308.47  Control of immediate precursors.
1308.49  Emergency scheduling.

    Authority:  21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    Source:  38 FR 8254, Mar. 30, 1973, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information

Sec. 1308.01  Scope of part 1308.

    Schedules of controlled substances established by section 202 of the 
Act (21 U.S.C. 812), as they are changed, updated, and republished from 
time to time, are set forth in this part.

[[Page 80]]

Sec. 1308.02  Definitions.

    Any term contained 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 13967, Mar. 24, 1997]

Sec. 1308.03  Administration Controlled Substances Code Number.

    (a) Each controlled substance, or basic class thereof, has been 
assigned an ``Administration Controlled Substances Code Number'' for 
purposes of identification of the substances or class on certain 
Certificates of Registration issued by the Administration pursuant to 
Secs. 1301.35 of this chapter and on certain order forms issued by the 
Administration pursuant to Sec. 1305.05(d) of this chapter. Applicants 
for procurement and/or individual manufacturing quotas must include the 
appropriate code number on the application as required in 
Secs. 1303.12(b) and 1303.22(a) of this chapter. Applicants for import 
and export permits must include the appropriate code number on the 
application as required in Secs. 1312.12(a) and 1312.22(a) of this 
chapter. Authorized registrants who desire to import or export a 
controlled substance for which an import or export permit is not 
required must include the appropriate Administration Controlled 
Substances Code Number beneath or beside the name of each controlled 
substance listed on the DEA Form 236 (Controlled Substance Import/Export 
Declaration) which is executed for such importation or exportation as 
required in Secs. 1312.18(c) and 1312.27(b) of this chapter.
    (b) Except as stated in paragraph (a) of this section, no applicant 
or registrant is required to use the Administration Controlled 
Substances Code Number for any purpose.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]

                                Schedules

Sec. 1308.11  Schedule I.

    (a) Schedule I shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Opiates. Unless specifically excepted or unless listed in 
another schedule, any of the following opiates, including their isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, whenever 
the existence of such isomers, esters, ethers and salts is possible 
within the specific chemical designation (for purposes of paragraph 
(b)(34) only, the term isomer includes the optical and geometric 
isomers):

                                                                        
                                                                        
                                                                        
(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-         
 piperidinyl]-N-phenylacetamide).................................   9815
(2) Acetylmethadol...............................................   9601
(3) Allylprodine.................................................   9602
(4) Alphacetylmethadol (except levo-alphacetylmethadol also known       
 as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM)....   9603
(5) Alphameprodine...............................................   9604
(6) Alphamethadol................................................   9605
(7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-       
 piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-            
 propanilido) piperidine)........................................   9814
(8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-         
 piperidinyl]-N-phenylpropanamide)...............................   9832
(9) Benzethidine.................................................   9606
(10) Betacetylmethadol...........................................   9607
(11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-              
 piperidinyl]-N-phenylpropanamide)...............................   9830
(12) Beta-hydroxy-3-methylfentanyl (other name: N-[1-(2-hydroxy-2-      
 phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide..........   9831
(13) Betameprodine...............................................   9608
(14) Betamethadol................................................   9609
(15) Betaprodine.................................................   9611
(16) Clonitazene.................................................   9612
(17) Dextromoramide..............................................   9613
(18) Diampromide.................................................   9615
(19) Diethylthiambutene..........................................   9616
(20) Difenoxin...................................................   9168
(21) Dimenoxadol.................................................   9617
(22) Dimepheptanol...............................................   9618
(23) Dimethylthiambutene.........................................   9619
(24) Dioxaphetyl butyrate........................................   9621
(25) Dipipanone..................................................   9622
(26) Ethylmethylthiambutene......................................   9623
(27) Etonitazene.................................................   9624
(28) Etoxeridine.................................................   9625
(29) Furethidine.................................................   9626
(30) Hydroxypethidine............................................   9627
(31) Ketobemidone................................................   9628
(32) Levomoramide................................................   9629
(33) Levophenacylmorphan.........................................   9631
(34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]-      
 N-phenylpropanamide)............................................   9813
(35) 3-methylthiofentanyl (N-[(3-methyl-1-(2-thienyl)ethyl-4-           
 piperidinyl]-N-phenylpropanamide)...............................   9833
(36) Morpheridine................................................   9632
(37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine).............   9661
(38) Noracymethadol..............................................   9633
(39) Norlevorphanol..............................................   9634
(40) Normethadone................................................   9635
(41) Norpipanone.................................................   9636
(42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4-      
 piperidinyl] propanamide........................................   9812
(43) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine........   9663

[[Page 81]]

                                                                        
(44) Phenadoxone.................................................   9637
(45) Phenampromide...............................................   9638
(46) Phenomorphan................................................   9647
(47) Phenoperidine...............................................   9641
(48) Piritramide.................................................   9642
(49) Proheptazine................................................   9643
(50) Properidine.................................................   9644
(51) Propiram....................................................   9649
(52) Racemoramide................................................   9645
(53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]-       
 propanamide.....................................................   9835
(54) Tilidine....................................................   9750
(55) Trimeperidine...............................................   9646
                                                                        

    (c) Opium derivatives. Unless specifically excepted or unless listed 
in another schedule, any of the following opium derivatives, its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

                                                                        
                                                                        
                                                                        
(1) Acetorphine..................................................   9319
(2) Acetyldihydrocodeine.........................................   9051
(3) Benzylmorphine...............................................   9052
(4) Codeine methylbromide........................................   9070
(5) Codeine-N-Oxide..............................................   9053
(6) Cyprenorphine................................................   9054
(7) Desomorphine.................................................   9055
(8) Dihydromorphine..............................................   9145
(9) Drotebanol...................................................   9335
(10) Etorphine (except hydrochloride salt).......................   9056
(11) Heroin......................................................   9200
(12) Hydromorphinol..............................................   9301
(13) Methyldesorphine............................................   9302
(14) Methyldihydromorphine.......................................   9304
(15) Morphine methylbromide......................................   9305
(16) Morphine methylsulfonate....................................   9306
(17) Morphine-N-Oxide............................................   9307
(18) Myrophine...................................................   9308
(19) Nicocodeine.................................................   9309
(20) Nicomorphine................................................   9312
(21) Normorphine.................................................   9313
(22) Pholcodine..................................................   9314
(23) Thebacon....................................................   9315
                                                                        

    (d) Hallucinogenic substances. Unless specifically excepted or 
unless listed in another schedule, any material, compound, mixture, or 
preparation, which contains any quantity of the following hallucinogenic 
substances, or which contains any of its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation (for 
purposes of this paragraph only, the term ``isomer'' includes the 
optical, position and geometric isomers):

                                                                        
                                                                        
                                                                        
(1) Alpha-ethyltryptamine........................................   7249
  Some trade or other names: etryptamine; Monase; <greek-a>-ethyl-      
   1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; <greek-a>-ET;       
   and AET.                                                             
(2) 4-bromo-2,5-dimethoxy-amphetamine............................   7391
  Some trade or other names: 4-bromo-2,5-dimethoxy-<greek-a>-           
   methylphenethylamine; 4-bromo-2,5-DMA                                
(3) 4-Bromo-2,5-dimethoxyphenethylamine..........................   7392
  Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-         
   aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.                       
(4) 2,5-dimethoxyamphetamine.....................................   7396
  Some trade or other names: 2,5-dimethoxy-<greek-a>-                   
   methylphenethylamine; 2,5-DMA                                        
(5) 2,5-dimethoxy-4-ethylamphet-amine............................   7399
  Some trade or other names: DOET                                       
(6) 4-methoxyamphetamine.........................................   7411
  Some trade or other names: 4-methoxy-<greek-a>-                       
   methylphenethylamine; paramethoxyamphetamine, PMA                    
(7) 5-methoxy-3,4-mdthylenedioxy-amphetamine.....................   7401
(8) 4-methyl-2,5-dimethoxy-amphetamine...........................   7395
  Some trade and other names: 4-methyl-2,5-dimethoxy-<greek-a>-         
   methylphenethylamine; ``DOM''; and ``STP''                           
(9) 3,4-methylenedioxy amphetamine...............................   7400
(10) 3,4-methylenedioxymethamphetamine (MDMA)....................   7405
(11) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl-      
 alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA,           
 MDE, MDEA.......................................................   7404
(12) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-          
 hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-         
 hydroxy MDA.....................................................   7402
(13) 3,4,5-trimethoxy amphetamine................................   7390
(14) Bufotenine..................................................   7433
  Some trade and other names: 3-(<greek-b> -Dimethylaminoethyl)-5-      
   hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-             
   dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine         
(15) Diethyltryptamine...........................................   7434
  Some trade and other names: N,N-Diethyltryptamine; DET                
(16) Dimethyltryptamine..........................................   7435
  Some trade or other names: DMT                                        
(17) Ibogaine....................................................   7260
  Some trade and other names: 7-Ethyl-6,6<greek-b>,7,8,9,10,12,13-      
   octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2] azepino       
   [5,4-b] indole; Tabernanthe iboga                                    
(18) Lysergic acid diethylamide..................................   7315
(19) Marihuana...................................................   7360
(20) Mescaline...................................................   7381
(21) Parahexyl--7374; some trade or other names: 3-Hexyl-1-             
 hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-                        
 dibenzo[b,d]pyran; Synhexyl.                                           
(22) Peyote......................................................   7415
  Meaning all parts of the plant presently classified botanically       
   as Lophophora williamsii Lemaire, whether growing or not, the        
   seeds thereof, any extract from any part of such plant, and          
   every compound, manufacture, salts, derivative, mixture, or          
   preparation of such plant, its seeds or extracts                     
  (Interprets 21 USC 812(c), Schedule I(c) (12))                        
(23) N-ethyl-3-piperidyl benzilate...............................   7482
(24) N-methyl-3-piperidyl benzilate..............................   7484
(25) Psilocybin..................................................   7437
(26) Psilocyn....................................................   7438
(27) Tetrahydrocannabinols.......................................   7370

[[Page 82]]

                                                                        
  Synthetic equivalents of the substances contained in the plant,       
   or in the resinous extractives of Cannabis, sp. and/or               
   synthetic substances, derivatives, and their isomers with            
   similar chemical structure and pharmacological activity such         
   as the following:                                                    
  <greek-D>1 cis or trans tetrahydrocannabinol, and their optical       
   isomers                                                              
  <greek-D>6 cis or trans tetrahydrocannabinol, and their optical       
   isomers                                                              
  <greek-D>3,4 cis or trans tetrahydrocannabinol, and its optical       
   isomers                                                              
  (Since nomenclature of these substances is not internationally        
   standardized, compounds of these structures, regardless of           
   numerical designation of atomic positions covered.)                  
(28) Ethylamine analog of phencyclidine..........................   7455
  Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-       
   phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine,       
   cyclohexamine, PCE                                                   
(29) Pyrrolidine analog of phencyclidine.........................   7458
  Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine,        
   PCPy, PHP                                                            
(30) Thiophene analog of phencyclidine...........................   7470
  Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-              
   piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP              
(31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine......................   7473
  Some other names: TCPy                                                
                                                                        

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation:

                                                                        
                                                                        
                                                                        
(1) Mecloqualone.................................................   2572
(2) Methaqualone.................................................   2565
                                                                        

    (f) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers:

                                                                        
                                                                        
                                                                        
(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-        
 oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)...............   1585
(2) Cathinone....................................................   1235
  Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-       
   aminopropiophenone, 2-aminopropiophenone, and norephedrone           
(3) Fenethylline.................................................   1503
(4) Methcathinone (Some other names: 2-(methylamino)-                   
 propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-      
 1-phenylpropan-1-one; alpha-N-methylaminopropiophenone;                
 monomethylpropion; ephedrone; N-methylcathinone;                       
 methylcathinone; AL-464; AL-422; AL-463 and UR1432), its salts,        
 optical isomers and salts of optical isomers....................   1237
(5) (<plus-minus>)cis-4-methylaminorex ((<plus-minus>)cis-4,5-          
 dihydro-4-methyl-5-phenyl-2-oxazolamine)........................   1590
(6) N-ethylamphetamine...........................................   1475
(7) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-         
 benzeneethanamine; N,N-alpha-trimethylphenethylamine)...........   1480
                                                                        

    (g) Temporary listing of substances subject to emergency scheduling. 
Any material, compound, mixture or preparation which contains any 
quantity of the following substances:

                                                                        
                                                                        
                                                                        
(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide                        
 (benzylfentanyl), its optical isomers, salts and salts of              
 isomers.........................................................   9818
(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide             
 (thenylfentanyl), its optical isolers, salts and salts of              
 isomers.........................................................   9834
                                                                        

[39 FR 22141, June 20, 1974]

    Editorial Note: For Federal Register citations affecting 
Sec. 1308.11, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1308.12  Schedule II.

    (a) Schedule II shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the Controlled Substances Code Number set forth opposite it.
    (b) Substances, vegetable origin or chemical synthesis. Unless 
specifically excepted or unless listed in another schedule, any of the 
following substances whether produced directly or indirectly by 
extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (1) Opium and opiate, and any salt, compound, derivative, or 
preparation of opium or opiate excluding apomorphine, thebaine-derived 
butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone, and 
naltrexone, and their respective salts, but including the following:

                                                                        
                                                                        
                                                                        
(1) Raw opium....................................................   9600
(2) Opium extracts...............................................   9610
(3) Opium fluid..................................................   9620

[[Page 83]]

                                                                        
(4) Powdered opium...............................................   9639
(5) Granulated opium.............................................   9640
(6) Tincture of opium............................................   9630
(7) Codeine......................................................   9050
(8) Ethylmorphine................................................   9190
(9) Etorphine hydrochloride......................................   9059
(10) Hydrocodone.................................................   9193
(11) Hydromorphone...............................................   9150
(12) Metopon.....................................................   9260
(13) Morphine....................................................   9300
(14) Oxycodone...................................................   9143
(15) Oxymorphone.................................................   9652
(16) Thebaine....................................................   9333
                                                                        

    (2) Any salt, compound, derivative, or preparation thereof which is 
chemically equivalent or identical with any of the substances referred 
to in paragraph (b) (1) of this section, except that these substances 
shall not include the isoquinoline alkaloids of opium.
    (3) Opium poppy and poppy straw.
    (4) Coca leaves (9040) and any salt, compound, derivative or 
preparation of coca leaves (including cocaine (9041) and ecgonine (9180) 
and their salts, isomers, derivatives and salts of isomers and 
derivatives), and any salt, compound, derivative, or preparation thereof 
which is chemically equivalent or identical with any of these 
substances, except that the substances shall not include decocainized 
coca leaves or extraction of coca leaves, whhch extractions do not 
contain cocaine or ecgonine.
    (5) Concentrate of poppy straw (the crude extract of poppy straw in 
either liquid, solid or powder form which contains the phenanthrene 
alkaloids of the opium poppy), 9670.
    (c) Opiates. Unless specifically excepted or unless in another 
schedule any of the following opiates, including its isomers, esters, 
ethers, salts and salts of isomers, esters and ethers whenever the 
existence of such isomers, esters, ethers, and salts is possible within 
the specific chemical designation, dextrorphan and levopropoxyphene 
excepted:

                                                                        
                                                                        
                                                                        
(1) Alfentanil...................................................   9737
(2) Alphaprodine.................................................   9010
(3) Anileridine..................................................   9020
(4) Bezitramide..................................................   9800
(5) Bulk dextropropoxyphene (non-dosage forms)...................   9273
(6) Carfentanil..................................................   9743
(7) Dihydrocodeine...............................................   9120
(8) Diphenoxylate................................................   9170
(9) Fentanyl.....................................................   9801
(10) Isomethadone................................................   9226
(11) Levo-alphacetylmethadol.....................................   9648
  [Some other names: levo-alpha-acetylmethadol, levomethadyl            
   acetate, LAAM]                                                       
(12) Levomethorphan..............................................   9210
(13) Levorphanol.................................................   9220
(14) Metazocine..................................................   9240
(15) Methadone...................................................   9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl       
 butane..........................................................   9254
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-                 
 diphenylpropane-carboxylic acid.................................   9802
(18) Pethidine (meperidine)......................................   9230
(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-                      
 phenylpiperidine................................................   9232
(20) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-              
 carboxylate.....................................................   9233
(21) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-           
 carboxylic acid.................................................   9234
(22) Phenazocine.................................................   9715
(23) Piminodine..................................................   9730
(24) Racemethorphan..............................................   9732
(25) Racemorphan.................................................   9733
(26) Remifentanil................................................   9739
(27) Sufentanil..................................................   9740
                                                                        

    (d) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system:

                                                                        
                                                                        
                                                                        
(1) Amphetamine, its salts, optical isomers, and salts of its           
 optical isomers.................................................   1100
(2) Methamphetamine, its salts, isomers, and salts of its isomers   1105
(3) Phenmetrazine and its salts..................................   1631
(4) Methylphenidate..............................................   1724
                                                                        

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation:

                                                                        
                                                                        
                                                                        
(1) Amobarbital..................................................   2125
(2) Glutethimide.................................................   2550
(3) Pentobarbital................................................   2270
(4) Phencyclidine................................................   7471
(5) Secobarbital.................................................   2315
                                                                        

    (f) Hallucinogenic substances.

                                                                        
                                                                        
                                                                        
(1) Dronabinol (synthetic) in sesame oil and encapsulated in a          
 soft gelatin capsule in a U.S. Food and Drug Administration            
 approved drug product...........................................   7369
  [Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-             
   tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol,       
   or (-)-delta-9-(trans)-tetrahydrocannabinol]                         
(2) Nabilone.....................................................   7379
  [Another name for nabilone: (<plus-minus>)-trans-3-(1,1-              
   dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-             
   dimethyl-9H-dibenzo[b,d]pyran-9-one]                                 
                                                                        

    (g) Immediate precursors. Unless specifically excepted or unless 
listed in

[[Page 84]]

another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances:
    (1) Immediate precursor to amphetamine and methamphetamine:

                                                                        
                                                                        
                                                                        
(i) Phenylacetone................................................   8501
  Some trade or other names: phenyl-2-propanone; P2P; benzyl            
   methyl ketone; methyl benzyl ketone;                                 
                                                                        

    (2) Immediate precursors to phencyclidine (PCP):

                                                                        
                                                                        
                                                                        
(i) 1-phenylcyclohexylamine......................................   7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)...................   8603
                                                                        

[39 FR 22142, June 20, 1974]

    Editorial Note: For Federal Register citations affecting 
Sec. 1308.12, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1308.13  Schedule III.

    (a) Schedule III shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous sxstem, including its salts, isomers 
(whether optical, position, or geometric), and salts of such isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation:

                                                                        
                                                                        
                                                                        
(1) Those compounds, mixtures, or preparations in dosage unit           
 form containing any stimulant substances listed in schedule II         
 which compounds, mixtures, or preparations were listed on August       
 25, 1971, as excepted compounds under Sec.  1308.32, and any           
 other drug of the quantitative composition shown in that list          
 for those drugs or which is the same except that it contains a         
 lesser quantity of controlled substances........................   1405
(2) Benzphetamine................................................   1228
(3) Chlorphentermine.............................................   1645
(4) Clortermine..................................................   1647
(5) Phendimetrazine..............................................   1615
                                                                        

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system:

                                                                        
                                                                        
                                                                        
(1) Any compound, mixture or preparation containing:                    
    (i) Amobarbital..............................................   2126
    (ii) Secobarbital............................................   2316
    (iii) Pentobarbital..........................................   2271
  or any salt thereof and one or more other active medicinal            
   ingredients which are not listed in any schedule.                    
(2) Any suppository dosage form containing:                             
    (i) Amobarbital..............................................   2126
    (ii) Secobarbital............................................   2316
    (iii) Pentobarbital..........................................   2271
  or any salt of any of these drugs and approved by the Food and        
   Drug Administration for marketing only as a suppository.             
(3) Any substance which contains any quantity of a derivative of        
 barbituric acid or any salt thereof.............................   2100
(4) Chlorhexadol.................................................   2510
(5) Lysergic acid................................................   7300
(6) Lysergic acid amide..........................................   7310
(7) Methyprylon..................................................   2575
(8) Sulfondiethylmethane.........................................   2600
(9) Sulfonethylmethane...........................................   2605
(10) Sulfonmethane...............................................   2610
(11) Tiletamine and zolazepam or any salt thereof................   7295
  Some trade or other names for a tiletamine-zolazepam                  
   combination product:                                                 
    Telazol......................................................       
  Some trade or other names for tiletamine:                             
    2-(ethylamino)-2-(2-thienyl)-cyclohexanone...................       
  Some trade or other names for zolazepam:                              
    4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-        
     e] [1,4]-diazepin-7(1H)-one, flupyrazapon...................       
                                                                        

    (d) Nalorphine 9400.
    (e) Narcotic Drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs, or their salts 
calculated as the free anhydrous base or alkaloid, in limited quantities 
as set forth below:

                                                                        
                                                                        
                                                                        
(1) Not more than 1.8 grams of codeine per 100 milliliters or not       
 more than 90 milligrams per dosage unit, with an equal or              
 greater quantity of an isoquinoline alkaloid of opium...........   9803
(2) Not more than 1.8 grams of codeine per 100 milliliters or not       
 more than 90 milligrams per dosage unit, with one or more              
 active, nonnarcotic ingredients in recognized therapeutic              
 amounts.........................................................   9804
(3) Not more than 300 milligrams of dihydrocodeinone                    
 (hydrocodone) per 100 milliliters or not more than 15 milligrams       
 per dosage unit, with a fourfold or greater quantity of an             
 isoquinoline alkaloid of opium..................................   9805
(4) Not more than 300 milligrams of dihydrocodeinone                    
 (hydrocodone) per 100 milliliters or not more than 15 milligrams       
 per dosage unit, with one or more active nonnarcotic ingredients       
 in recognized therapeutic amounts...............................   9806
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters       
 or not more than 90 milligrams per dosage unit, with one or more       
 active nonnarcotic ingredients in recognized therapeutic amounts   9807
(6) Not more than 300 milligrams of ethylmorphine per 100               
 milliliters or not more than 15 milligrams per dosage unit, with       
 one or more active, nonnarcotic ingredients in recognized              
 therapeutic amounts.............................................   9808

[[Page 85]]

                                                                        
(7) Not more than 500 milligrams of opium per 100 milliliters or        
 per 100 grams or not more than 25 milligrams per dosage unit,          
 with one or more active, nonnarcotic ingredients in recognized         
 therapeutic amounts.............................................   9809
(8) Not more than 50 milligrams of morphine per 100 milliliters         
 or per 100 grams, with one or more active, nonnarcotic                 
 ingredients in recognized therapeutic amounts...................   9810
                                                                        

    (f) Anabolic steroids. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture, or preparation 
containing any quantity of the following substances, including its 
salts, isomers, and salts of isomers whenever the existence of such 
salts of isomers is possible within the specific chemical designation:

(1) Anabolic Steroids...............................................4000

[39 FR 22142, June 20, 1974, as amended at 41 FR 43401, Oct. 1, 1976; 43 
FR 3359, Jan. 25, 1978; 44 FR 40888, July 13, l979; 46 FR 52334, Oct. 
27, 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. 21, 1987; 52 FR 
5952, Feb. 27, 1987; 56 FR 5754, Feb. 13, 1991; 56 FR 11932, Mar. 21, 
1991; 62 FR 13968, Mar. 24, 1997]

Sec. 1308.14  Schedule IV.

    (a) Schedule IV shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs, or their salts 
calculated as the free anhydrous base or alkaloid, in limited quantities 
as set forth below:

                                                                        
                                                                        
                                                                        
(1) Not more than 1 milligram of difenoxin and not less than 25         
 micrograms of atropine sulfate per dosage unit..................   9167
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-       
 methyl-2-propionoxybutane)......................................   9278
                                                                        

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

                                                                        
                                                                        
                                                                        
(1)  Alprazolam.................................................    2882
(2)  Barbital...................................................    2145
(3)  Bromazepam.................................................    2748
(4)  Camazepam..................................................    2749
(5)  Chloral betaine............................................    2460
(6)  Chloral hydrate............................................    2465
(7)  Chlordiazepoxide...........................................    2744
(8)  Clobazam...................................................    2751
(9)  Clonazepam.................................................    2737
(10) Clorazepate................................................    2768
(11) Clotiazepam................................................    2752
(12) Cloxazolam.................................................    2753
(13) Delorazepam................................................    2754
(14) Diazepam...................................................    2765
(15) Estazolam..................................................    2756
(16) Ethchlorvynol..............................................    2540
(17) Ethinamate.................................................    2545
(18) Ethyl loflazepate..........................................    2758
(19) Fludiazepam................................................    2759
(20) Flunitrazepam..............................................    2763
(21) Flurazepam.................................................    2767
(22) Halazepam..................................................    2762
(23) Haloxazolam................................................    2771
(24) Ketazolam..................................................    2772
(25) Loprazolam.................................................    2773
(26) Lorazepam..................................................    2885
(27) Lormetazepam...............................................    2774
(28) Mebutamate.................................................    2800
(29) Medazepam..................................................    2836
(30) Meprobamate................................................    2820
(31) Methohexital...............................................    2264
(32) Methylphenobarbital (mephobarbital)........................    2250
(33) Midazolam..................................................    2884
(34) Nimetazepam................................................    2837
(35) Nitrazepam.................................................    2834
(36) Nordiazepam................................................    2838
(37) Oxazepam...................................................    2835
(38) Oxazolam...................................................    2839
(39) Paraldehyde................................................    2585
(40) Petrichloral...............................................    2591
(41) Phenobarbital..............................................    2285
(42) Pinazepam..................................................    2883
(43) Prazepam...................................................    2764
(44) Quazepam...................................................    2881
(45) Temazepam..................................................    2925
(46) Tetrazepam.................................................    2886
(47) Triazolam..................................................    2887
(48) Zolpidem...................................................    2783
                                                                        

    (d) Fenfluramine. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers (whether optical, position, or geometric), and salts of 
such isomers, whenever the existence of such salts, isomers, and salts 
of isomers is possible:

                                                                        
                                                                        
                                                                        
(1) Fenfluramine.................................................   1670
                                                                        

    (e) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers and 
salts of isomers:

                                                                        
                                                                        
                                                                        
(1) Cathine ((+)-norpseudoephedrine).............................   1230
(2) Diethylpropion...............................................   1610

[[Page 86]]

                                                                        
(3) Fencamfamin..................................................   1760
(4) Fenproporex..................................................   1575
(5) Mazindol.....................................................   1605
(6) Mefenorex....................................................   1580
(7) Pemoline (including organometallic complexes and chelates           
 thereof)........................................................   1530
(8) Phentermine..................................................   1640
(9) Pipradrol....................................................   1750
(10) Sibutramine.................................................   1675
(11) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)...............   1635
                                                                        

    (f) Other substances. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture or preparation 
which contains any quantity of the following substances, including its 
salts:

                                                                        
                                                                        
                                                                        
(1) Pentazocine..................................................   9709
(2) Butorphanol (including its optical isomers)..................   9720
                                                                        

[39 FR 22143, June 20, 1974]

    Editorial Note: For Federal Register citations affecting 
Sec. 1308.14, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1308.15  Schedule V.

    (a) Schedule V shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs and their salts, as set 
forth below:

                                                                        
                                                                        
                                                                        
(1) Buprenorphine................................................   9064
                                                                        

    (c) Narcotic drugs containing non-narcotic active medicinal 
ingredients. Any compound, mixture, or preparation containing any of the 
following narcotic drugs, or their salts calculated as the free 
anhydrous base or alkaloid, in limited quantities as set forth below, 
which shall include one or more non-narcotic active medicinal 
ingredients in sufficient proportion to confer upon the compound, 
mixture, or preparation valuable medicinal qualities other than those 
possessed by narcotic drugs alone:
    (1) Not more than 200 milligrams of codeine per 100 milliliters or 
per 100 grams.
    (2) Not more than 100 milligrams of dihydrocodeine per 100 
milliliters or per 100 grams.
    (3) Not more than 100 milligrams of ethylmorphine per 100 
milliliters or per 100 grams.
    (4) Not more than 2.5 milligrams of diphenoxylate and not less than 
25 micrograms of atropine sulfate per dosage unit.
    (5) Not more than 100 milligrams of opium per 100 milliliters or per 
100 grams.
    (6) Not more than 0.5 milligram of difenoxin and not less than 25 
micrograms of atropine sulfate per dosage unit.
    (d) Stimulants. Unless specifically exempted or excluded or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances 
having a stimulant effect on the central nervous system, including its 
salts, isomers and salts of isomers:

(1) Pyrovalerone...................................................1485.
(2)  [Reserved]

[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 
44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 
28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 
61372, Dec. 3, 1991]

                     Excluded Nonnarcotic Substances

Sec. 1308.21  Application for exclusion of a nonnarcotic substance.

    (a) Any person seeking to have any nonnarcotic substance which may, 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be 
lawfully sold over the counter without a prescription, excluded from any 
schedule, pursuant to section 201(g) (1) of the Act (21 U.S.C. 811 (g) 
(1)), may apply to the Administrator, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (b) An application for an exclusion under this section shall contain 
the following information:
    (1) The name and address of the applicant;
    (2) The name of the substance for which exclusion is sought; and
    (3) The complete quantitative composition of the substance.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the

[[Page 87]]

Administrator shall notify the applicant of his acceptance or 
nonacceptance of his application, and if not accepted, the reason 
therefore. The Administrator need not accept an application for filing 
if any of the requirements prescribed in paragraph (b) of this section 
is lacking or is not set forth as to be readily understood. If the 
applicant desires, he may amend the application to meet the requirements 
of paragraph (b) of this section. If the application is accepted for 
filing, the Administrator shall issue and publish in the Federal 
Register his order on the application, which shall include a reference 
to the legal authority under which the order is issued and the findings 
of fact and conclusions of law upon 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 within 60 days of the date of publication of his 
order in the Federal Register. If any such comments or objections 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.
    (d) The Administrator may at any time revoke any exclusion granted 
pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exclusion which has been accepted for filing.

Sec. 1308.22  Excluded substances.

    The following nonnarcotic substances which may, under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the 
counter without a prescription, are excluded from all schedules pursuant 
to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

                                          Excluded Nonnarcotic Products                                         
----------------------------------------------------------------------------------------------------------------
                                                                                     Controlled       (mg or mg/
            Company                  Trade name         NDC code        Form          substance          ml)    
----------------------------------------------------------------------------------------------------------------
Bioline Laboratories...........  Theophed..........      00719-1945  TB          Phenobarbital.....         8.00
Goldline Laboratories..........  Guiaphed Elixir...      00182-1377  EL          Phenobarbital.....         4.00
Goldline Laboratories..........  Tedrigen Tablets..      00182-0134  TB          Phenobarbital.....         8.00
Hawthorne Products Inc.........  Choate's Leg        ..............  LQ          Chloral hydrate...       246.67
                                  Freeze.                                                                       
Parke-Davis & Co...............  Tedral............      00071-0230  TB          Phenobarbital.....         8.00
Parke-Davis & Co...............  Tedral Elixir.....      00071-0242  EX          Phenobarbital.....        40.00
Parke-Davis & Co...............  Tedral S.A........      00071-0231  TB          Phenobarbital.....         8.00
Parke-Davis & Co...............  Tedral Suspension.      00071-0237  SU          Phenobarbital.....        80.00
Parmed Pharmacy................  Asma-Ese..........      00349-2018  TB          Phenobarbital.....         8.10
Rondex Labs....................  Azma-Aids.........      00367-3153  TB          Phenobarbital.....         8.00
Smith Kline Consumer...........  Benzedrex.........      49692-0928  IN          Propylhexedrine...       250.00
Sterling Drug, Inc.............  Bronkolixir.......      00057-1004  EL          Phenobarbital.....         0.80
Sterling Drug, Inc.............  Bronkotabs........      00057-1005  TB          Phenobarbital.....         8.00
Vicks Chemical Co..............  Vicks Inhaler.....      23900-0010  IN          I-Desoxyephedrine.       113.00
White Hall Labs................  Primatene (P-           00573-2940  TB          Phenobarbital.....         8.00
                                  tablets).                                                                     
----------------------------------------------------------------------------------------------------------------

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, 
and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 
FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 
19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]

                      Exempt Chemical Preparations

Sec. 1308.23  Exemption of certain chemical preparations; application.

    (a) The Administrator may, by regulation, exempt from the 
application of all or any part of the Act any chemical preparation or 
mixture containing one or more controlled substances listed in any 
schedule, which preparation or mixture is intended for laboratory, 
industrial, educational, or special research purposes and not for 
general administration to a human being or other animal, if the 
preparation or mixture either:
    (1) Contains no narcotic controlled substance and is packaged in 
such a

[[Page 88]]

form or concentration that the packaged quantity does not present any 
significant potential for abuse (the type of packaging and the history 
of abuse of the same or similar preparations may be considered in 
determining the potential for abuse of the preparation or mixture); or
    (2) Contains either a narcotic or nonnarcotic controlled substance 
and one or more adulterating or denaturing agents in such a manner, 
combination, quantity, proportion, or concentration, that the 
preparation or mixture does not present any potential for abuse. If the 
preparation or mixture contains a narcotic controlled substance, the 
preparation or mixture must be formulated in such a manner that it 
incorporates methods of denaturing or other means so that the 
preparation or mixture is not liable to be abused or have ill effects, 
if abused, and so that the narcotic substance cannot in practice be 
removed.
    (b) Any person seeking to have any preparation or mixture containing 
a controlled substance and one or more noncontrolled substances exempted 
from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (c) An application for an exemption under this section shall contain 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The name, address, and registration number, if any, of the 
manufacturer or importer of the preparation or mixture, if not the 
applicant;
    (3) The exact trade name or other designation of the preparation or 
mixture;
    (4) The complete qualitative and quantitative composition of the 
preparation or mixture (including all active and inactive ingredients 
and all controlled and noncontrolled substances);
    (5) The form of the immediate container in which the preparation or 
mixture will be distributed with sufficient descriptive detail to 
identify the preparation or mixture (e.g., bottle, packet, vial, soft 
plastic pillow, agar gel plate, etc.);
    (6) The dimensions or capacity of the immediate container of the 
preparation or mixture;
    (7) The label and labeling, as defined in part 1300 of this chapter, 
of the immediate container and the commercial containers, if any, of the 
preparation or mixture;
    (8) A brief statement of the facts which the applicant believes 
justify the granting of an exemption under this paragraph, including 
information on the use to which the preparation or mixture will be put;
    (9) The date of the application; and
    (10) Which of the information submitted on the application, if any, 
is deemed by the applicant to be a trade secret or otherwise 
confidential and entitled to protection under subsection 402(a)(8) of 
the Act (21 U.S.C. 842(a) (8)) or any other law restricting public 
disclosure of information.
    (d) The Administrator may require the applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted.
    (e) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) or requested pursuant to paragraph (d) is 
lacking or is not set forth as to be readily understood. If the 
applicant desires, he may amend the application to meet the requirements 
of paragraphs (c) and (d) of this section. If the application is 
accepted for filing, the Administrator shall issue and publish in the 
Federal Register his 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 within 60 days of the date of 
publication of his order in the Federal

[[Page 89]]

Register. If any such comments or objections 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) The Administrator may at any time revoke or modify any exemption 
granted pursuant to this section by following the procedures set forth 
in paragraph (e) of this section for handling an application for an 
exemption which has been accepted for filing. The Administrator may also 
modify or revoke the criteria by which exemptions are granted (and 
thereby modify or revoke all preparations and mixtures granted under the 
old criteria) and modify the scope of exemptions at any time.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, 1997]

Sec. 1308.24  Exempt chemical preparations.

    (a) The chemical preparations and mixtures approved pursuant to 
Sec. 1308.23 are exempt from application of sections 302, 303, 305, 306, 
307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 825-
829, 952-954) and Sec. 1301.74 of this chapter, to the extent described 
in paragraphs (b) to (h) of this section. Substances set forth in 
paragraph (j) of this section shall be exempt from the application of 
sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 
U.S.C. 825-829, 952-954) and Secs. 1301.71--1301.73 and 1301.74 (a), 
(b), (d), (e) and (f) of this chapter to the extent as hereinafter may 
be provided.
    (b) Registration and security: Any person who manufactures an exempt 
chemical preparation or mixture must be registered under the Act and 
comply with all relevant security requirements regarding controlled 
substances being used in the manufacturing process until the preparation 
or mixture is in the form described in paragraph (i) of this section. 
Any other person who handles an exempt chemical preparation after it is 
in the form described in paragraph (i) of this section is not required 
to be registered under the Act to handle that preparation, and the 
preparation is not required to be stored in accordance with security 
requirements regarding controlled substances.
    (c) Labeling: In lieu of the requirements set forth in part 1302 of 
this chapter, the label and the labeling of an exempt chemical 
preparation must be prominently marked with its full trade name or other 
description and the name of the manufacturer or supplier as set forth in 
paragraph (i) of this section, in such a way that the product can be 
readily identified as an exempt chemical preparation. The label and 
labeling must also include in a prominent manner the statement ``For 
industrial use only'' or ``For chemical use only'' or ``For in vitro use 
only--not for human or animal use'' or ``Diagnostic reagent--for 
professional use only'' or a comparable statement warning the person 
reading it that human or animal use is not intended. The symbol 
designating the schedule of the controlled substance is not required on 
either the label or the labeling of the exempt chemical preparation, nor 
is it necessary to list all ingredients of the preparation.
    (d) Records and reports: Any person who manufactures an exempt 
chemical preparation or mixture must keep complete and accurate records 
and file all reports required under part 1304 of this chapter regarding 
all controlled substances being used in the manufacturing process until 
the preparation or mixture is in the form described in paragraph (i) of 
this section. In lieu of records and reports required under part 1304 of 
this chapter regarding exempt chemical preparations, the manufacturer 
need only record the name, address, and registration number, if any, of 
each person to whom the manufacturer distributes any exempt chemical 
preparation. Each importer or exporter of an exempt narcotic chemical 
preparation must submit a semiannual report of the total quantity of 
each substance imported or exported in each calendar half-year within 30 
days of the close of the period to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Department

[[Page 90]]

of Justice, Washington, DC 20537. Any other person who handles an exempt 
chemical preparation after it is in the form described in paragraph (i) 
of this section is not required to maintain records or file reports.
    (e) Quotas, order forms, prescriptions, import, export, and 
transshipment requirements: Once an exempt chemical preparation is in 
the form described in paragraph (i) of this section, the requirements 
regarding quotas, order forms, prescriptions, import permits and 
declarations, export permit and declarations, and transshipment and 
intransit permits and declarations do not apply. These requirements do 
apply, however, to any controlled substances used in manufacturing the 
exempt chemical preparation before it is in the form described in 
paragraph (i) of this section.
    (f) Criminal penalties: No exemption granted pursuant to 
Sec. 1308.23 affects the criminal liability for illegal manufacture, 
distribution, or possession of controlled substances contained in the 
exempt chemical preparation. Distribution, possession, and use of an 
exempt chemical preparation are lawful for registrants and 
nonregistrants only as long as such distribution, possession, or use is 
intended for laboratory, industrial, or educational purposes and not for 
immediate or subsequent administration to a human being or other animal.
    (g) Bulk materials: For materials exempted in bulk quantities, the 
Administrator may prescribe requirements other than those set forth in 
paragraphs (b) through (e) of this section on a case-by-case basis.
    (h) Changes in chemical preparations: Any change in the quantitative 
or qualitative composition of the preparation or mixture after the date 
of application, or change in the trade name or other designation of the 
preparation or mixture, set forth in paragraph (i) of this section, 
requires a new application for exemption.
    (i) A listing of exempt chemical preparations may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Washington, DC 20537.
    (j) The following substances are designated as exempt chemical 
preparations for the purposes set forth in this section.
    (1) Chloral. When packaged in a sealed, oxygen-free environment, 
under nitrogen pressure, safeguarded against exposure to the air.
    (2) Emit<SUP>R</SUP> Phenobarbital Enzyme Reagent B. In one liter 
quantities each with a 5 ml. retention sample for repackaging as an 
exempt chemical preparation only.
[38 FR 8255, Mar. 30, 1973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1308.24, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

          Excluded Veterinary Anabolic Steroid Implant Products

Sec. 1308.25  Exclusion of a veterinary anabolic steroid implant 
          product; application.

    (a) Any person seeking to have any anabolic steroid product, which 
is expressly intended for administration through implants to cattle or 
other nonhuman species and which has been approved by the Secretary of 
Health and Human Services for such administration, identified as being 
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act 
(21 U.S.C. 802(41)(B)(i)), may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) An application for any exclusion under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) A complete description of dosage and quantitative composition of 
the dosage form;.
    (5) The conditions of use including whether or not Federal law 
restricts this product to use by or on the order of a licensed 
veterinarian;
    (6) A description of the delivery system in which the dosage form 
will be distributed with sufficient detail to

[[Page 91]]

identify the product (e.g. 20 cartridge brown plastic belt);
    (7) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;.
    (8) The name and address of the manufacturer of the dosage form if 
different from that of the applicant; and
    (9) Evidence that the product has been approved by the Secretary of 
Health and Human Services for administration through implant to cattle 
or other nonhuman species.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. The applicant may amend 
the application to meet the requirements of paragraph (b) of this 
section. If the application is accepted for filing, the Administrator 
shall issue and have published in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued and the findings of fact and conclusions 
of law upon which the order is based. This order shall specify the date 
on which it will take effect. The Administrator shall permit any 
interested person to file written comments on or objections to the order 
within 60 days of the date of publication in the Federal Register. If 
any such comments or objections 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.
    (d) The Administrator may at any time revoke or modify any 
designation of excluded status granted pursuant to this section by 
following the procedures set forth in paragraph (c) of this section for 
handling an application for an exclusion which has been accepted for 
filing.
[56 FR 42936, Aug. 30, 1991]

Sec. 1308.26  Excluded veterinary anabolic steroid implant products.

    (a) Products containing an anabolic steroid, that are expressly 
intended for administration through implants to cattle or other nonhuman 
species and which have been approved by the Secretary of Health and 
Human Services for such administration are excluded from all schedules 
pursuant to section 102(41)(B)(I) of the Act (21 U.S.C. 802(41)(B)(I)). 
A listing of the excluded products may be obtained by submitting a 
written request to the Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington DC 20537.
    (b) In accordance with section 102(41)(B)(ii) of the Act (21 U.S.C. 
802(41)(B)(ii)) if any person prescribes, dispenses, or distributes a 
product listed in paragraph (a) of this section for human use, such 
person shall be considered to have prescribed, dispensed, or distributed 
an anabolic steroid within the meaning of section 102(41)(A) of the Act 
(21 U.S.C. 802(41)(A)).
[56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 
FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997]

                     Exempted Prescription Products

Sec. 1308.31  Application for exemption of a nonnarcotic prescription 
          product.

    (a) Any person seeking to have any compound, mixture, or preparation 
containing any nonnarcotic controlled substance listed in 
Sec. 1308.12(e), or in Sec. 1308.13 (b) or (c), or in Sec. 1308.14, or 
in Sec. 1308.15, exempted from application of all or any part of the Act 
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A). 
may apply to the Administrator, Drug Enforcement Administration, 
Washington, DC 20537, for such exemption.
    (b) An application for an exemption under this section shall contain 
the following information:
    (1) The complete quantitative composition of the dosage form.
    (2) Description of the unit dosage form together with complete 
labeling.

[[Page 92]]

    (3) A summary of the pharmacology of the product including animal 
investigations and clinical evaluations and studies, with emphasis on 
the psychic and/or physiological dependence liability (this must be done 
for each of the active ingredients separately and for the combination 
product).
    (4) Details of synergisms and antagonisms among ingredients.
    (5) Deterrent effects of the noncontrolled ingredients.
    (6) Complete copies of all literature in support of claims.
    (7) Reported instances of abuse.
    (8) Reported and anticipated adverse effects.
    (9) Number of dosage units produced for the past 2 years.
    (c) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or non-acceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (b) of this section is lacking or is not set 
forth so as to be readily understood. If the applicant desires, he may 
amend the application to meet the requirements of paragraph (b) of this 
section. If accepted for filing, the Administrator shall publish in the 
Federal Register general notice of this proposed rulemaking in granting 
or denying the application. Such notice shall include a reference to the 
legal authority under which the rule is proposed, a statement of the 
proposed rule granting or denying an exemption, and, in the discretion 
of the Administrator, a summary of the subjects and issues involved. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice of proposed rule making the time during which such filings may be 
made. After consideration of the application and any comments on or 
objections to his proposed rulemaking, the Administrator shall issue and 
publish in the Federal Register his final order on the application, 
which shall set forth the findings of fact and conclusions of law upon 
which the order is based. This order shall specify the date on which it 
shall take effect, which shall not be less than 30 days from the date of 
publication in the Federal Register unless the Administrator finds that 
conditions of public health or safety necessitate an earlier effective 
date, in which event the Administrator shall specify in the order his 
findings as to such conditions.
    (d) The Administrator may revoke any exemption granted pursuant to 
section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exemption which has been accepted for filing.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987]

Sec. 1308.32  Exempted prescription products.

    The compounds, mixtures, or preparations that contain a nonnarcotic 
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13 (b) or 
(c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of 
Exempted Prescription Products have been exempted by the Administrator 
from the application of sections 302 through 305, 307 through 309, 1002 
through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and 
Secs. 1301.13, 1301.22, and Secs. 1301.71 through 1301.76 of this 
chapter for administrative purposes only. An exception to the above is 
that those products containing butalbital shall not be exempt from the 
requirement of 21 U.S.C. 952-954 concerning importation, exportation, 
transshipment and in-transit shipment of controlled substances. Any 
deviation from the quantitative composition of any of the listed drugs 
shall require a petition of exemption in order for the product to be 
exempted. A listing of the Exempted Prescription Products may be 
obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration, Washington, DC 
20537.
[62 FR 13967, Mar. 24, 1997]

[[Page 93]]

                    Exempt Anabolic Steroid Products

Sec. 1308.33  Exemption of certain anabolic steroid products; 
          application.

    (a) The Administrator, upon the recommendation of the Secretary of 
Health and Human Services, may, by regulation, exempt from the 
application of all or any part of the Act any compound, mixture, or 
preparation containing an anabolic steroid as defined in part 1300 of 
this chapter if, because of its concentration, preparation, mixture or 
delivery system, it has no significant potential for abuse (Pub. L. 101-
647 section 1903(a)).
    (b) Any person seeking to have any compound, mixture, or preparation 
containing an anabolic steroid as defined in part 1300 of this chapter 
exempted from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (c) An application for an exemption under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) The complete description of dosage and quantitative composition 
of the dosage form;
    (5) A description of the delivery system, if applicable;
    (6) The indications and conditions for use in which species, 
including whether or not this product is a prescription drug;
    (7) Information to facilitate identification of the dosage form, 
such as shape, color, coating, and scoring;
    (8) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;
    (9) The units in which the dosage form is ordinarily available; and
    (10) The facts which the applicant believes justify:
    (i) A determination that the product has no significant potential 
for abuse and
    (ii) a granting of an exemption under this section.
    (d) Within a reasonable period of time after the receipt of the 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) of this section is lacking or is not set 
forth so as to be readily understood. The applicant may amend the 
application to meet the requirements of paragraph (c) of this section. 
If accepted for filing, the Administrator will request from the 
Secretary for Health and Human Services his recommendation, as to 
whether such product which contains an anabolic steroid should be 
considered for exemption from certain portions of the Controlled 
Substances Act. On receipt of the recommendation of the Secretary, the 
Administrator shall make a determination as to whether the evidence 
submitted or otherwise available sufficiently establishes that the 
product possesses no significant potential for abuse. The Administrator 
shall issue and publish in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued, and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it will take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections 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.
    (e) The Administrator may revoke any exemption granted pursuant to 
section 1903(a) of Public Law 101-647 by following the procedures set 
forth in

[[Page 94]]

paragraph (d) of this section for handling an application for an 
exemption which has been accepted for filing.
[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at 
62 FR 13968, Mar. 24, 1997]

Sec. 1308.34  Exempt anabolic steroid products.

    The list of compounds, mixtures, or preparations that contain an 
anabolic steroid that have been exempted by the Administrator from 
application of sections 302 through 309 and 1002 through 1004 of the Act 
(21 U.S.C. 822-829 and 952-954) and Secs. 1301.13, 1301.22, and 1301.71 
through 1301.76 of this chapter for administrative purposes only may be 
obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration, Washington, DC 
20537.
[62 FR 13967, Mar. 24, 1997]

                                Hearings

Sec. 1308.41  Hearings generally.

    In any case where the Administrator shall hold a hearing on the 
issuance, amendment, or repeal of rules pursuant to section 201 of the 
Act, the procedures for such hearing and accompanying proceedings shall 
be governed generally by the rulemaking procedures set forth in the 
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 201 of the Act (21 U.S.C. 811), by Secs. 1308.42-1308.51, and by 
Secs. 1316.41-1316.67 of this chapter.

Sec. 1308.42  Purpose of hearing.

    If requested by any interested person after proceedings are 
initiated pursuant to Sec. 1308.43, the Administrator shall hold a 
hearing for the purpose of receiving factual evidence and expert opinion 
regarding the issues involved in the issuance, amendment or repeal of a 
rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). 
Extensive argument should not be offered into evidence but rather 
presented in opening or closing statements of counsel or in memoranda or 
proposed findings of fact and conclusions of law. Additional information 
relating to hearings to include waivers or modification of rules, 
request for hearing, burden of proof, time and place, and final order 
are set forth in part 1316 of this chapter.
[62 FR 13968, Mar. 24, 1997]

Sec. 1308.43  Initiation of proceedings for rulemaking.

    (a) Any interested person may submit a petition to initiate 
proceedings for the issuance, amendment, or repeal of any rule or 
regulation issuable pursuant to the provisions of section 201 of the 
Act.
    (b) Petitions shall be submitted in quintuplicate to the 
Administrator in the following form:

 _______________________________________________________________________
(Date)
Administrator, Drug Enforcemen
Administration
Department of Justice,
Washington, DC 20537.
    Dear Sir: The undersigned -------------- hereby petitions the 
Administrator to initiate proceedings for the issuance (amendment or 
repeal) of a rule or regulation pursuant to section 201 of the 
Controlled Substances Act.
    Attached hereto and constituting a part of this petition are the 
following:
    (A) The proposed rule in the form proposed by the petitioner. (If 
the petitioner seeks the amendment or repeal of an existing rule, the 
existing rule, together with a reference to the section in the Code of 
Federal Regulations where it appears, should be included.)
    (B) A statement of the grounds which the petitioner relies for the 
issuance (amendment or repeal) of the rule. (Such grounds shall include 
a reasonably concise statement of the facts relied upon by the 
petitioner, including a summary of any relevant medical or scientific 
evidence known to the petitioner.)
    All notices to be sent regarding this petition should be addressed 
to:

 _______________________________________________________________________

                                 (Name)

 _______________________________________________________________________

                            (Street Address)

 _______________________________________________________________________

                            (City and State)

    Respectfully yours,

 _______________________________________________________________________

                        (Signature of petitioner)

    (c) Within a reasonable period of time after the receipt of a 
petition, the

[[Page 95]]

Administrator shall notify the petitioner of his acceptance or 
nonacceptance of the petition, and if not accepted, the reason therefor. 
The Administrator need not accept a petition for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth so as to be readily understood. If the petitioner 
desires, he may amend the petition to meet the requirements of paragraph 
(b) of this section. If accepted for filing, a petition may be denied by 
the Administrator within a reasonable period of time thereafter if he 
finds the grounds upon which the petitioner relies are not sufficient to 
justify the initiation of proceedings.
    (d) The Administrator shall, before initiating proceedings for the 
issuance, amendment, or repeal of any rule either to control a drug or 
other substance, or to transfer a drug or other substance from one 
schedule to another, or to remove a drug or other substance entirely 
from the schedules, and after gathering the necessary data, request from 
the Secretary a scientific and medical evaluation and the Secretary's 
recommendations as to whether such drug or other substance should be so 
controlled, transferred, or removed as a controlled substance. The 
recommendations of the Secretary to the Administrator shall be binding 
on the Administrator as to such scientific and medical matters, and if 
the Secretary recommends that a drug or other substance not be 
controlled, the Administrator shall not control that drug or other 
substance.
    (e) If the Administrator determines that the scientific and medical 
evaluation and recommendations of the Secretary and all other relevant 
data constitute substantial evidence of potential for abuse such as to 
warrant control or additional control over the drug or other substance, 
or substantial evidence that the drug or other substances should be 
subjected to lesser control or removed entirely from the schedules, he 
shall initiate proceedings for control, transfer, or removal as the case 
may be.
    (f) If and when the Administrator determines to initiate 
proceedings, he shall publish in the Federal Register general notice of 
any proposed rule making to issue, amend, or repeal any rule pursuant to 
section 201 of the Act. Such published notice shall include a statement 
of the time, place, and nature of any hearings on the proposal in the 
event a hearing is requested pursuant to Sec. 1308.44. Such hearings may 
not be commenced until after the expiration of at least 30 days from the 
date the general notice is published in the Federal Register. Such 
published notice shall also include a reference to the legal authority 
under which the rule is proposed, a statement of the proposed rule, and, 
in the discretion of the Administrator, a summary of the subjects and 
issues involved.
    (g) The Administrator may permit any interested persons to file 
written comments on or objections to the proposal and shall designate in 
the notice of proposed rule making the time during which such filings 
may be made.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]

Sec. 1308.44  Request for hearing or appearance; waiver.

    (a) Any interested person desiring a hearing on a proposed 
rulemaking, shall, within 30 days after the date of publication of 
notice of the proposed rulemaking in the Federal Register, file with the 
Administrator a written request for a hearing in the form prescribed in 
Sec. 1316.47 of this chapter.
    (b) Any interested person desiring to participate in a hearing 
pursuant to Sec. 1308.41 shall, within 30 days after the date of 
publication of the notice of hearing in the Federal Register, file with 
the Administrator a written notice of his intention to participate in 
such hearing in the form prescribed in Sec. 1316.48 of this chapter. Any 
person filing a request for a hearing need not also file a notice of 
appearance; the request for a hearing shall be deemed to be a notice of 
appearance.
    (c) Any interested person may, within the period permitted for 
filing a request for a hearing, file with the Administrator a waiver of 
an opportunity for a hearing or to participate in a hearing, together 
with a written statement regarding his position on the matters of fact 
and law involved in

[[Page 96]]

such hearing. Such statement, if admissible, shall be made a part of the 
record and shall be considered in light of the lack of opportunity for 
cross-examination in determining the weight to be attached to matters of 
fact asserted therein.
    (d) If any interested person fails to file a request for a hearing; 
or if he so files and fails to appear at the hearing, he shall be deemed 
to have waived his opportunity for the hearing or to participate in the 
hearing, unless he shows good cause for such failure.
    (e) If all interested persons waive or are deemed to waive their 
opportunity for the hearing or to participate in the hearing, the 
Administrator may cancel the hearing, if scheduled, and issue his final 
order pursuant to Sec. 1308.45 without a hearing.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]

Sec. 1308.45  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his order in the proceeding, which 
shall set forth the final rule and the findings of fact and conclusions 
of law upon which the rule is based. This order shall specify the date 
on which it shall take effect, which shall not be less than 30 days from 
the date of publication in the Federal Register unless the Administrator 
finds that conditions of public health or safety necessitate an earlier 
effective date, in which event the Administrator shall specify in the 
order his findings as to such conditions.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]

Sec. 1308.46  Control required under international treaty.

    Pursuant to section 201(d) of the Act (21 U.S.C. 811(d) ), where 
control of a substance is required by U.S. obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971, the Administrator shall issue and publish in the Federal Register 
an order controlling such substance under the schedule he deems most 
appropriate to carry out obligations. Issuance of such an order shall be 
without regard to the findings required by subsections 201(a) or 202(b) 
of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the 
procedures prescribed by Sec. 1308.41 or subsections 201 (a) and (b) of 
the Act (21 U.S.C. 811 (a) and (b)). An order controlling a substance 
shall become effective 30 days from the date of publication in the 
Federal Register, unless the Administrator finds that conditions of 
public health or safety necessitate an earlier effective date, in which 
event the Administrator shall specify in the order his findings as to 
such conditions.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]

Sec. 1308.47  Control of immediate precursors.

    Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the 
Administrator may, without regard to the findings required by subsection 
201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and without 
regard to the procedures prescribed by Sec. 1308.41 or subsections 201 
(a) and (b) of the Act (21 U.S.C. 811(a) and (b)), issue and publish in 
the Federal Register an order controlling an immediate precursor. The 
order shall designate the schedule in which the immediate precursor is 
to be placed, which shall be the same schedule in which the controlled 
substance of which it is an immediate precursor is placed or any other 
schedule with a higher numerical designation. An order controlling an 
immediate precursor shall become effective 30 days from the date of 
publication in the Federal Register, unless the Administrator finds that 
conditions of public health or safety necessitate an earlier effective 
date, in which event the Administrator shall specify in the order his 
findings as to such conditions.
[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]

Sec. 1308.49  Emergency scheduling.

    Pursuant to 21 U.S.C. 811(h) and without regard to the requirements 
of 21 U.S.C. 811(b) relating to the scientific

[[Page 97]]

and medical evaluation of the Secretary of Health and Human Services, 
the Administrator may place a substance into Schedule I on a temporary 
basis, if he determines that such action is necessary to avoid an 
imminent hazard to the public safety. An order issued under this section 
may not be effective before the expiration of 30 days from:
    (a) The date of publication by the Administrator of a notice in the 
Federal Register of his intention to issue such order and the grounds 
upon which such order is to be issued, and
    (b) The date the Administrator has transmitted notification to the 
Secretary of Health and Human Services of his intention to issue such 
order. An order issued under this section shall be vacated upon the 
conclusion of a subsequent rulemaking proceeding initiated under section 
201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end 
of one year from the effective date of the order scheduling the 
substance, except that during the pendency of proceedings under section 
201(a) (21 U.S.C. 811(a)) with respect to the substance, the 
Administrator may extend the temporary scheduling for up to six months.
[51 FR 15318, Apr. 23, 1986. Redesignated and amended at 62 FR 13968, 
Mar. 24, 1997]









[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: 21CFR1309]

[Page 97-107]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS

                           General Information

Sec.
1309.01  Scope of part 1309.
1309.02  Definitions.
1309.03  Information; special instructions.

                Fees for Registration and Reregistration

1309.11  Fee amounts.
1309.12  Time and method of payment; refund.

                      Requirements for Registration

1309.21  Persons required to register.
1309.22  Separate registration for independent activities.
1309.23  Separate registration for separate locations.
1309.24  Exemption of agents and employees.
1309.25  Exemption of certain controlled substance registrants.
1309.26  Exemption of law enforcement officials.
1309.27  Exemption of certain manufacturers.
1309.28  Exemption of distributors of regulated prescription drug 
          products.
1309.29  Exemption of retail distributors of regulated drug products.

                      Application for Registration

1309.31  Time for application for registration; expiration date.
1309.32  Application forms; contents, signature.
1309.33  Filing of application; joint filings.
1309.34  Acceptance for filing; defective applications.
1309.35  Additional information.
1309.36  Amendments to and withdrawals of applications.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration

1309.41  Administrative review generally.
1309.42  Certificate of registration; denial of registration.
1309.43  Suspension or revocation of registration.
1309.44  Suspension of registration pending final order.
1309.45  Extension of registration pending final order.
1309.46  Order to show cause.

                                Hearings

1309.51  Hearings generally.
1309.52  Purpose of hearing.
1309.53  Request for hearing or appearance; waiver.
1309.54  Burden of proof.
1309.55  Time and place of hearing.

         Modification, Transfer and Termination of Registration

1309.61  Modification in registration.
1309.62  Termination of registration.
1309.63  Transfer of registration.

                          Security Requirements

1309.71  General security requirements.
1309.72  Felony conviction; employer responsibilities.
1309.73  Employee responsibility to report diversion.

    Authority:  21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 
958.

    Source:  60 FR 32454, June 22, 1995, unless otherwise noted.

                           General Information

Sec. 1309.01  Scope of part 1309.

    Procedures governing the registration of manufacturers, 
distributors, importers and exporters of List I

[[Page 98]]

chemicals pursuant to Sections 102, 302, 303, 1007 and 1008 of the Act 
(21 U.S.C. 802, 822, 823, 957 and 958) are set forth generally by those 
sections and specifically by the sections of this part.

Sec. 1309.02  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. 1309.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Drug Enforcement Administration, Chemical Operations Section, Office 
of Diversion Control, Washington, D.C. 20537.

                Fees for Registration and Reregistration

Sec. 1309.11  Fee amounts.

    (a) For each initial registration to manufacture for distribution, 
distribute, import, or export, the applicant shall pay a fee of $595 for 
a annual registration.
    (b) For each reregistration to manufacture for distribution, 
distribute, import, or export, the registrant shall pay a fee of $477 
for an annual registration.
    (c) For each initial registration to conduct business as a retail 
distributor the applicant shall pay an application processing fee of $7 
and an investigation fee of $248, for an annual registration.
    (d) For each reregistration to conduct business as a retail 
distributor the registrant shall pay a fee of $116.

Sec. 1309.12  Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture for distribution, distribute, import, or export, the 
applicant shall pay the fee when the application for registration or 
reregistration is submitted for filing.
    (b) For retail the distributor initial applications, the applicant 
shall pay the application processing fee when the application for 
registration is submitted for filing. The investigation fee shall be 
paid within 30 days after DEA notifies the applicant that the 
preregistration investigation has been scheduled.
    (c) For retail distributor reregistration applications, the 
registrant shall pay the fee when the application for reregistration is 
submitted for filing.
    (d) Payments should be made in the form of a personal, certified, or 
cashier's check or money order made payable to ``Drug Enforcement 
Administration.'' Payments made in the form of stamps, foreign currency, 
or third party endorsed checks will not be accepted. These application 
fees are not refundable.
[60 FR 32454, June 22, 1995; 60 FR 35264, July 6, 1995]

                      Requirements for Registration

Sec. 1309.21  Persons required to register.

    (a) Every person who distributes, imports, or exports any List I 
chemical, other than those List I chemicals contained in a product 
exempted under Sec. 1310.01(b)(28)(i)(D) of this chapter, or who 
proposes to engage in the distribution, importation, or exportation of 
any List I chemical, shall obtain annually a registration specific to 
the List I chemicals to be handled, unless exempted by law or pursuant 
to Secs. 1309.24 through 1309.28 of this part. Only persons actually 
engaged in such activities are required to obtain a registration; 
related or affiliated persons who are not engaged in such activities are 
not required to be registered. (For example, a stockholder or parent 
corporation of a corporation distributing List I chemicals is not 
required to obtain a registration.)
    (b) Every person who distributes or exports a List I chemical they 
have manufactured, other than a List I chemical contained in a product 
exempted under Sec. 1310.01(b)(28)(i)(D) of this chapter, or proposes to 
distribute or export a List I chemical they have manufactured, shall 
obtain annually a registration specific to the List I

[[Page 99]]

chemicals to be handled, unless exempted by law or pursuant to 
Secs. 1309.24 through 1309.28 of this part.
[61 FR 32926, June 26, 1996, as amended at 62 FR 13968, Mar. 24, 1997]

Sec. 1309.22  Separate registration for independent activities.

    (a) The following groups of activities are deemed to be independent 
of each other:
    (1) Retail distributing of List I chemicals;
    (2) Non-Retail distributing of List I chemicals;
    (3) Importing List I chemicals; and
    (4) Exporting List I chemicals.
    (b) Every person who engages in more than one group of independent 
activities shall obtain a separate registration for each group of 
activities, unless otherwise exempted by the Act or Secs. 1309.24 
through 1309.28 of this part, except that a person registered to import 
any List I chemical shall be authorized to distribute that List I 
chemical after importation, but no other chemical that the person is not 
registered to import.
[60 FR 32454, June 22, 1995, as amended at 61 FR 32926, June 26, 1996]

Sec. 1309.23  Separate registration for separate locations.

    (a) A separate registration is required for each principal place of 
business at one general physical location where List I chemicals are 
distributed, imported, or exported by a person.
    (b) The following locations shall be deemed to be places not subject 
to the registration requirement:
    (1) A warehouse where List I chemicals are stored by or on behalf of 
a registered person, unless such chemicals are distributed directly from 
such warehouse to locations other than the registered location from 
which the chemicals were originally delivered; and
    (2) An office used by agents of a registrant where sales of List I 
chemicals are solicited, made, or supervised but which neither contains 
such chemicals (other than chemicals for display purposes) nor serves as 
a distribution point for filling sales orders.

Sec. 1309.24  Exemption of agents and employees.

    The requirement of registration is waived for any agent or employee 
of a person who is registered to engage in any group of independent 
activities, if such agent or employee is acting in the usual course of 
his or her business or employment.

Sec. 1309.25  Exemption of certain controlled substance registrants.

    (a) The requirement of registration is waived for any person who 
distributes a product containing a List I chemical that is regulated 
pursuant to Sec. 1310.01(b)(28)(i)(D), if that person is registered with 
the Administration to manufacture, distribute or dispense a controlled 
substance.
    (b) The requirement of registration is waived for any person who 
imports or exports a product containing a List I chemical that is 
regulated pursuant to Sec. 1310.01(b)(28)(i)(D), if that person is 
registered with the Administration to engage in the same activity with a 
controlled substance.
    (c) The Administrator may, upon finding that continuation of the 
waiver would not be in the public interest, suspend or revoke a person's 
waiver pursuant to the procedures set forth in Secs. 1309.43 through 
1309.46 and 1309.51 through 1309.57. In considering the revocation or 
suspension of a person's waiver, the Administrator shall also consider 
whether action to revoke or suspend the person's controlled substance 
registration pursuant to 21 U.S.C. 824 is warranted.
    (d) Any person exempted from the registration requirement under this 
section shall comply with the security requirements set forth in 
Sections 1309.71-1309.73 and the recordkeeping and reporting 
requirements set forth under Parts 1310 and 1313 of this chapter.
[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]

Sec. 1309.26  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:

[[Page 100]]

    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, any other Federal officer who is lawfully 
engaged in the enforcement of any Federal law relating to listed 
chemicals, controlled substances, drugs or customs, and is duly 
authorized to possess and distribute List I chemicals in the course of 
official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to listed chemicals and controlled 
substances and is duly authorized to possess and distribute List I 
chemicals in the course of his official duties.
    (b) Any official exempted by this section may, when acting in the 
course of official duties, possess any List I chemical and distribute 
any such chemical to any other official who is also exempted by this 
section and acting in the course of official duties.

Sec. 1309.27  Exemption of certain manufacturers.

    The requirement of registration is waived for any manufacturer of a 
List I chemical, if that chemical is produced solely for internal 
consumption by the manufacturer and there is no subsequent distribution 
or exportation of the List I chemical.

Sec. 1309.28  Exemption of distributors of regulated prescription drug 
          products.

    (a) The requirement of registration is waived for any person who 
distributes a prescription drug product containing a List I chemical 
that is regulated pursuant to Sec. 1310.01(f)(1)(iv) of this chapter.
    (b) If any person exempted by this section also engages in the 
distribution, importation or exportation of a List I chemical, other 
than as described in paragraph (a) of this section, the person shall 
obtain a registration for such activities, as required by Sec. 1309.21 
of this part.
    (c) The Administrator may, upon finding that continuation of the 
waiver granted in paragraph (a) of this section would not be in the 
public interest, suspend or revoke a person's waiver pursuant to the 
procedures set forth in Secs. 1309.43 through 1309.46 and 1309.51 
through 1309.57 of this part.
[61 FR 32926, June 26, 1996]

Sec. 1309.29  Exemption of retail distributors of regulated drug 
          products.

    The requirement of registration is waived for any retail distributor 
whose activities with respect to List I chemicals are restricted to the 
distribution of below-threshold quantities of a drug product that 
contains a List I chemical that is regulated pursuant to 
Sec. 1300.02(b)(28)(1)(D) of this chapter to an individual for 
legitimate medical use.
[62 FR 53960, Oct. 17, 1997]

                      Application for Registration

Sec. 1309.31  Time for application for registration; expiration date.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is approved and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his registration.
    (c) At the time a person is first registered, that person shall be 
assigned to one of twelve groups, which shall correspond to the months 
of the year. The expiration date of the registrations of all registrants 
within any group will be the last day of the month designated for that 
group. In assigning any of the above persons to a group, the 
Administration may select a group the expiration date of which is less 
than one year from the date such business activity was registered. If 
the person is assigned to a group which has an expiration date less than 
eleven months from the date of which the person is registered, the 
registration shall not expire until one year from that expiration date; 
in all other cases, the

[[Page 101]]

registration shall expire on the expiration date following the date on 
which the person is registered.

Sec. 1309.32  Application forms; contents; signature.

    (a) Any person who is required to be registered pursuant to 
Sec. 1309.21 and is not so registered, shall apply on DEA Form 510.
    (b) Any person who is registered pursuant to Section 1309.21, shall 
apply for reregistration on DEA Form 510a.
    (c) DEA Form 510 may be obtained at any divisional office of the 
Administration or by writing to the Registration Unit, Drug Enforcement 
Administration, Department of Justice, Post Office Box 28083, Central 
Station, Washington, DC 20005. DEA Form 510a will be mailed to each List 
I chemical registrant approximately 60 days before the expiration date 
of his or her registration; if any registered person does not receive 
such forms within 45 days before the expiration date of the 
registration, notice must be promptly given of such fact and DEA Form 
510a must be requested by writing to the Registration Unit of the 
Administration at the foregoing address.
    (d) Each application for registration shall include the 
Administration Chemical Code Number, as set forth in Sec. 1310.02 of 
this chapter, for each List I chemical to be distributed, imported, or 
exported.
    (e) Registration shall not entitle a person to engage in any 
activity with any List I chemical not specified in his or her 
application.
    (f) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.
    (g) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to do so, to sign applications for the 
applicant by filing with the application or other document a power of 
attorney for each such individual. The power of attorney shall be signed 
by a person who is authorized to sign applications under this paragraph 
and shall contain the signature of the individual being authorized to 
sign the application or other document. The power of attorney shall be 
valid until revoked by the applicant.

Sec. 1309.33  Filing of application; joint filings.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration, Chemical 
Registration/ODC, Post Office Box 2427, Arlington, Virginia 22202-2427. 
The appropriate registration fee and any required attachments must 
accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and must not refer to any accompanying application for required 
information.

Sec. 1309.34  Acceptance for filing; defective applications.

    (a) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days of receipt 
with a statement of the reason for not accepting the application for 
filing. A defective application may be corrected and resubmitted for 
filing at any time.
    (b) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1309.35 
and has no bearing on whether the application will be granted.

Sec. 1309.35  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he deems 
necessary to determine whether the application

[[Page 102]]

should be granted. The failure of the applicant to provide such 
documents or statements within a reasonable time after being requested 
to do so shall be deemed to be a waiver by the applicant of an 
opportunity to present such documents or facts for consideration by the 
Administrator in granting or denying the application.

Sec. 1309.36  Amendments to and withdrawals of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administration at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1309.46. An application 
may be amended or withdrawn with permission of the Administrator at any 
time where good cause is shown by the applicant or where the amendment 
or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, including 
a request that the applicant submit the required fee, when sent by 
registered or certified mail, return receipt requested, shall be deemed 
to be a withdrawal of the application.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration

Sec. 1309.41  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of Section 303 of the Act (21 U.S.C. 823) have been 
met by the applicant.

Sec. 1309.42  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 511) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of section 
303 of the Act (21 U.S.C. 823). In the event that the issuance of 
registration or reregistration is not required, the Administrator shall 
deny the application. Before denying any application, the Administrator 
shall issue an order to show cause pursuant to Section 1309.46 and, if 
requested by the applicant, shall hold a hearing on the application 
pursuant to Sec. 1309.51.
    (b) The Certificate of Registration (DEA Form 511) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the amount of fee paid, and the 
expiration date of the registration. The registrant shall maintain the 
certificate of registration at the registered location in a readily 
retrievable manner and shall permit inspection of the certificate by any 
official, agent or employee of the Administration or of any Federal, 
State, or local agency engaged in enforcement of laws relating to List I 
chemicals or controlled substances.

Sec. 1309.43  Suspension or revocation of registration.

    (a) The Administrator may suspend any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he 
determines.
    (b) The Administrator may revoke any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)).
    (c) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to Section 
1309.46 and, if requested by the registrant, shall hold a hearing 
pursuant to Section 1309.51. Notwithstanding the requirements of this 
Section, however, the Administrator may suspend any registration pending 
a final order pursuant to Sec. 1309.44.
    (d) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his or 
her Certificate of Registration to the nearest office of the 
Administration. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:

[[Page 103]]

    (1) Deliver all List I chemicals in his or her possession that were 
obtained under the authority of a registration or an exemption from 
registration granted by the Administrator by regulation, to the nearest 
office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all such List I chemicals in his or her possession under 
seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
    (e) In the event that revocation or suspension is limited to a 
particular chemical or chemicals, the registrant shall be given a new 
Certificate of Registration for all substances not affected by such 
revocation or suspension; no fee shall be required for the new 
Certificate of Registration. The registrant shall deliver the old 
Certificate of Registration to the nearest office of the Administration. 
Also, upon service of the order of the Administrator revoking or 
suspending registration with respect to a particular chemical or 
chemicals, the registrant shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation, which are affected by the revocation or 
suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]

Sec. 1309.44  Suspension of registration pending final order.

    (a) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he finds that there is an imminent danger 
to the public health or safety. If the Administrator so suspends, he 
shall serve with the order to show cause pursuant to Sec. 1309.46 an 
order of immediate suspension that shall contain a statement of his 
findings regarding the danger to public health or safety.
    (b) Upon service of the order of immediate suspension, the 
registrant shall promptly return his Certificate of Registration to the 
nearest office of the Administration. Also, upon service of the order of 
immediate suspension, the registrant shall, as instructed by the 
Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation, which are affected by the revocation or 
suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).
    (c) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under this section may request a hearing on 
the revocation or suspension of his registration at a time earlier than 
specified in the order to show cause pursuant to Section 1309.46, which 
request shall be granted by the Administrator, who shall fix a date for 
such hearing as early as reasonably possible.
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]

Sec. 1309.45  Extension of registration pending final order.

    In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so

[[Page 104]]

issues his order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.

Sec. 1309.46  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 of 
the Act (21 U.S.C. 823) to register the applicant, the Administrator 
shall serve upon the applicant an order to show cause why the 
application for registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 of the Act (21 U.S.C. 824), the Administrator shall serve 
upon the registrant an order to show cause why the registration should 
not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon Receipt of an order to show cause, the applicant or 
registrant must, if he desires a hearing, file a request for a hearing 
pursuant to Sec. 1309.54. If a hearing is requested, the Administrator 
shall hold a hearing at the time and place stated in the order, pursuant 
to Sec. 1309.51.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

                                Hearings

Sec. 1309.51  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefore, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303 and 304 of the Act (21 U.S.C. 823-824), by Secs. 1309.52 
through 1309.57, and by the procedures for administrative hearings under 
the Act set forth in Secs. 1316.41 through 1316.67 of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.

Sec. 1309.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration. Extensive argument should not be offered into 
evidence but rather presented in opening or closing statements of 
counsel or in memoranda or proposed findings of fact and conclusions of 
law.

Sec. 1309.53  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Secs. 1309.42 and 
1309.43 and desiring a hearing shall, within 30 days after the date of 
receipt of the order to show cause, file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to a hearing pursuant to Secs. 1309.42 and 
1309.43 may, within the period permitted for filing a request for a 
hearing, file with the Administrator a waiver of an opportunity for a 
hearing, together with a written statement regarding his position on the 
matters of fact and law involved in such hearing. Such statement, if 
admissible, shall be made a part of the record and shall be considered 
in light of the lack of opportunity for cross-examination in determining 
the weight

[[Page 105]]

to be attached to matters of fact asserted therein.
    (c) If any person entitled to a hearing pursuant to Secs. 1309.42 
and 1309.43 fails to file a request for a hearing, or if he so files and 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing, unless he shows good cause for such 
failure.
    (d) If any person entitled to a hearing waives or is deemed to waive 
his or her opportunity for the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to 
Sec. 1309.57 without a hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

Sec. 1309.54  Burden of proof.

    (a) At any hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 of the Act (21 U.S.C. 823) 
are not satisfied.
    (b) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) of the Act (21 U.S.C. 824(a)) are satisfied.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

Sec. 1309.55  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Section 1309.44(c)) but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

         Modification, Transfer and Termination of Registration

Sec. 1309.61  Modification in registration.

    Any registrant may apply to modify his or her registration to 
authorize the handling of additional List I chemicals or to change his 
or her name or address, by submitting a letter of request to the Drug 
Enforcement Administration, Chemical Registration/ODC, Post Office Box 
2427, Arlington, Virginia 22202-2427. The letter shall contain the 
registrant's name, address, and registration number as printed on the 
certificate of registration, and the List I chemicals to be added to his 
registration or the new name or address and shall be signed in 
accordance with Sec. 1309.32(g). No fee shall be required to be paid for 
the modification. The request for modification shall be handled in the 
same manner as an application for registration. If the modification in 
registration is approved, the Administrator shall issue a new 
certificate of registration (DEA Form 511) to the registrant, who shall 
maintain it with the old certificate of registration until expiration.

Sec. 1309.62  Termination of registration.

    (a) The registration of any person shall terminate if and when such 
person dies, ceases legal existence, or discontinues business or 
professional practice. Any registrant who cases legal existence or 
discontinues business or professional practice shall promptly notify the 
Special Agent in Charge of the Administration in the area in which the 
person is located of such fact and seek authority and instructions to 
dispose of any List I chemicals obtained under the authority of that 
registration.
    (b) The Special Agent in Charge shall authorize and instruct the 
person to dispose of the List I chemical in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substances;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By such other means as the Special Agent in Charge may determine 
to assure that the substance does not become available to unauthorized 
persons.
[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]

[[Page 106]]

Sec. 1309.63  Transfer of registration.

    No registration or any authority conferred thereby shall be assigned 
or otherwise transferred except upon such conditions as the 
Administrator may specifically designate and then only pursuant to his 
written consent.

                          Security Requirements

Sec. 1309.71  General security requirements.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of List I chemicals. 
Specific attention shall be paid to storage of and controlling access to 
List I chemicals as follows:
    (1) Chemicals shall be stored in containers sealed in such a manner 
as to indicate any attempts at tampering with the container. Where 
chemicals cannot be stored in sealed containers, access to the chemicals 
should be controlled through physical means or through human or 
electronic monitoring.
    (2) In retail settings open to the public where drugs containing 
List I chemicals that are regulated pursuant to 
Sec. 1310.01(b)(28)(i)(D) are distributed, such drugs will be stocked 
behind a counter where only employees have access.
    (b) In evaluating the effectiveness of security controls and 
procedures, the Administrator shall consider the following factors:
    (1) The type, form, and quantity of List I chemicals handled;
    (2) The location of the premises and the relationship such location 
bears on the security needs;
    (3) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (4) The availability of electronic detection and alarm systems;
    (5) the extent of unsupervised public access to the facility;
    (6) The adequacy of supervision over employees having access to List 
I chemicals;
    (7) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel in areas where 
List I chemicals are processed or stored;
    (8) The adequacy of the registrant's or applicant's systems for 
monitoring the receipt, distribution, and disposition of List I 
chemicals in its operations.
    (c) Any registrant or applicant desiring to determine whether a 
proposed system of security controls and procedures is adequate may 
submit materials and plans regarding the proposed security controls and 
procedures either to the Special Agent in Charge in the region in which 
the security controls and procedures will be used, or to the Chemical 
Operations Section Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537.
[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]

Sec. 1309.72  Felony conviction; employer responsibilities.

    (a) The registrant shall exercise caution in the consideration of 
employment of persons who will have access to listed chemicals, who have 
been convicted of a felony offense relating to controlled substances or 
listed chemicals, or who have, at any time, had an application for 
registration with the DEA denied, had a DEA registration revoked, or 
surrendered a DEA registration for cause. (For purposes of this 
subsection, the term ``for cause'' means a surrender in lieu of, or as a 
consequence of, any Federal or State administrative, civil or criminal 
action resulting from an investigation of the individual's handling of 
controlled substances or listed chemicals.) The registrant should be 
aware of the circumstances regarding the action against the potential 
employee and the rehabilitative efforts following the action. The 
registrant shall assess the risks involved in employing such persons, 
including the potential for action against the registrant pursuant to 
Sec. 1309.43, If such person is found to have diverted listed chemicals, 
and, in the event of employment, shall institute procedures to limit the 
potential for diversion of List I chemicals.
    (b) It is the position of DEA that employees who possess, sell, use 
or divert

[[Page 107]]

listed chemicals or controlled substances will subject themselves not 
only to State or Federal prosecution for any illicit activity, but shall 
also immediately become the subject of independent action regarding 
their continued employment. The employer will assess the seriousness of 
the employee's violation, the position of responsibility held by the 
employee, past record of employment, etc., in determining whether to 
suspend, transfer, terminate or take other action against the employee.

Sec. 1309.73  Employee responsibility to report diversion.

    Reports of listed chemical diversion by fellow employees is not only 
a necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of diversion from his employer by a fellow 
employee has an obligation to report such information to a responsible 
security official of the employer. The employer shall treat such 
information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of 
chemical diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in an area with access to 
chemicals. The employer shall inform all employees concerning this 
policy.









[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]...........................  .......................  .......................  .......................
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[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]









[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: 21CFR1312]

[Page 118-130]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

Sec.
1312.01  Scope of part 1312.
1312.02  Definitions.

                  Importation of Controlled Substances

1312.11  Requirement of authorization to import.
1312.12  Application for import permit.
1312.13  Issuance of import permit.
1312.14  Distribution of copies of import permit.
1312.15  Shipments in greater or less amount than authorized.
1312.16  Cancellation of permit; expiration date.
1312.17  Special report from importers.
1312.18  Contents of import declaration.
1312.19  Distribution of import declaration.

                  Exportation of Controlled Substances

1312.21  Requirement of authorization to export.
1312.22  Application for export permit.
1312.23  Issuance of export permit.
1312.24  Distribution of copies of export permit.
1312.25  Expiration date.
1312.26  Records required of exporter.
1312.27  Contents of special controlled substances invoice.
1312.28  Distribution of special controlled substances invoice.
1312.29  Domestic release prohibited.
1312.30  Schedule III, IV, and V non-narcotic controlled substances 
          requiring an import and export permit.

     Transshipment and In-Transit Shipment of Controlled Substances

1312.31  Schedule I: Application for prior written approval.
1312.32  Schedules II, III, IV: Advance notice.

                                Hearings

1312.41  Hearings generally.
1312.42  Purpose of hearing.
1312.43  Waiver or modification of rules.
1312.44  Request for hearing or appearance; waiver.
1312.45  Burden of proof.
1312.46  Time and place of hearing.
1312.47  Final order.

    Authority:  21 U.S.C. 952, 953, 954, 957, 958.

    Source:  36 FR 7815, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

Sec. 1312.01  Scope of part 1312.

    Procedures governing the importation, exportation, transshipment and 
intransit shipment of controlled substances pursuant to section 1002, 
1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed 
generally by those sections and specifically by the sections of this 
part.

Sec. 1312.02  Definitions.

    Any term contained 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 13969, Mar. 24, 1997]

                  Importation of Controlled Substances

Sec. 1312.11  Requirement of authorization to import.

    (a) No person shall import or cause to be imported any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III, IV or V or any non-narcotic controlled 
substance in Schedule III which the Administrator has specifically 
designated by regulation in Sec. 1312.30 of this part or any non-
narcotic controlled substance in Schedule IV or V which is also listed 
in Schedule I or II of the Convention on Psychotropic Substances unless 
and until such person is properly registered under the Act (or exempt 
from registration) and the Administrator has issued him a permit to do 
so pursuant to Sec. 1312.13 of this part.
    (b) No person shall import or cause to be imported any non-narcotic 
controlled substance listed in Schedule III, IV or V, excluding those 
described in paragraph (a) of this section, unless and until such person 
is properly registered under the Act (or exempt from registration) and 
has filed an import declaration to do so with the Administrator, 
pursuant to Sec. 1312.18 of this part.
    (c) When an import permit or declaration is required, a separate 
permit or declaration must be obtained for

[[Page 119]]

each consignment of controlled substances to be imported.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17289, 
May 7, 1987]

Sec. 1312.12  Application for import permit.

    (a) An application for a permit to import controlled substances 
shall be made on DEA Form 357. DEA Form 357 may be obtained from, and 
shall be filed with, the Drug Enforcement Administration, Drug 
Operations Section, Washington, DC 20537. Each application shall show 
the date of execution; the registration number of the importer; a 
detailed description of each controlled substance to be imported 
including the drug name, dosage form, National Drug Code (NDC) number, 
the Administration Controlled Substance Code Number as set forth in part 
1308 of this chapter, the number and size of packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the net quantity of any controlled substance 
(expressed in anhydrous acid, base or alkaloid) given in kilograms or 
parts thereof. The application shall also include the following:
    (1) The name, address, and business of the consignor, if known at 
the time application is submitted, but if unknown at that time, the fact 
should be indicated and the name and address afterwards furnished to the 
Administrator as soon as ascertained by the importer;
    (2) The foreign port of exportation (i.e., the place where the 
article will begin its journey of exportation to the United States);
    (3) The port of entry into the United States;
    (4) The latest date said shipment will leave said foreign port;
    (5) The stock on hand of the controlled substance desired to be 
imported;
    (6) The name of the importing carrier or vessel (if known, or if 
unknown it should be stated whether shipment will be made by express, 
freight, or otherwise, imports of controlled substances in Schedules I 
or II and narcotic drugs in Schedules III, IV, or V by mail being 
prohibited);
    (7) The total tentative allotment to the importer of such controlled 
substance for the current calendar year;
    (8) The total number of kilograms of said allotment for which 
permits have previously been issued and the total quantity of controlled 
substance actually imported during the current year to date.
    (b) If desired, alternative foreign ports of exportation within the 
same country may be indicated upon the application (e.g., (1) Calcutta, 
(2) Bombay). If a formal permit is issued pursuant to such application, 
it will bear the names of the two ports in the order given in the 
application and will authorize shipment from either port. Alternate 
ports in different countries will not be authorized in the same permit.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 43218, 
Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; 51 FR 5319 and 5320, Feb. 13, 
1986; 52 FR 17289, May 7, 1987; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.13  Issuance of import permit.

    (a) The Administrator may authorize importation of any controlled 
substance listed in Schedule I or II or any narcotic drug listed in 
Schedule III, IV, or V if he finds:
    (1) That the substance is crude opium, poppy straw, concentrate of 
poppy straw, or coca leaves, in such quantity as the Administrator finds 
necessary to provide for medical, scientific, or other legitimate 
purposes;
    (2) That the substance is necessary to provide for medical and 
scientific needs or other legitimate needs of the United States during 
an emergency where domestic supplies of such substance or drug are found 
to be inadequate, or in any case in which the Administrator finds that 
competition among domestic manufacturers of the controlled substance is 
inadequate and will not be rendered adequate by the registration of 
additional manufacturers under section 303 of the Controlled Substances 
Act (21 U.S.C. 823); or
    (3) That the domestic supply of any controlled substance is 
inadequate for scientific studies, and that the importation of that 
substance for scientific

[[Page 120]]

purposes is only for delivery to officials of the United Nations, of the 
United States, or of any State, or to any person registered or exempted 
from registration under sections 1007 and 1008 of the Act (21 U.S.C. 957 
and 958).
    (4) That the importation of the controlled substance is for 
ballistics or other analytical or scientific purposes, and that the 
importation of that substance is only for delivery to officials of the 
United Nations, of the United States, or of any State, or to any person 
registered or exempted from registration under sections 1007 and 1008 of 
the Act (21 U.S.C. 957 and 958).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as he shall designate by regulation in 
Sec. 1312.30 of this part be imported only pursuant to the issuance of 
an import permit. The Administrator may authorize the importation of 
such substances if he finds that the substance is being imported for 
medical, scientific or other legitimate uses.
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
1971, it shall be imported only pursuant to the issuance of an import 
permit. The Administrator may authorize the importation of such 
substances if it is found that the substance is being imported for 
medical, scientific or other legitimate uses.
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (e) Each import permit shall be issued in sextuplet and serially 
numbered, with all six copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. All copies of import permits shall bear the signature of 
the Director or his delegate, and facsimiles of signatures shall not be 
used. No permit shall be altered or changed by any person after being 
signed by the Administrator or his delegate and any change or alteration 
upon the face of any permit after it shall have been signed by the 
Administrator or his delegate shall render it void and of no effect. 
Permits are not transferable. Each copy of the permit shall have printed 
or stamped thereon the disposition to be made thereof. Each permit shall 
be dated and shall certify that the importer named therein is thereby 
permitted as a registrant under the Act, to import, throtgh the port 
named, one shipment of not to exceed the specified quantity of the named 
controlled substances, shipment to be made before a specified date. Not 
more than one shipment shall be made on a single import permit. The 
permit shall state that the Administrator is satisfied that the 
consignment proposed to be imported is required for legitimate purposes.
    (f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section, 
the Administrator shall permit, pursuant to 21 U.S.C. 952(a)(1) or 
(a)(2)(A), the importation of approved narcotic raw material (opium, 
poppy straw and concentrate of poppy straw) having as its source:
    (1) Turkey,
    (2) India,
    (3) Yugoslavia,
    (4) France,
    (5) Poland,
    (6) Hungary, and
    (7) Australia.
    (g) At least eighty (80) percent of the narcotic raw material 
imported into the United States shall have as its original source Turkey 
and India. Except under conditions of insufficient supplies of narcotic 
raw materials, not more than twenty (20) percent of the narcotic raw 
material imported into the United States annually shall have as its 
source Yugoslavia, France, Poland, Hungary and Australia.
[36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776, 
Aug. 18, 1981; 52 FR 17289, May 7, 1987]

[[Page 121]]

Sec. 1312.14  Distribution of copies of import permit.

    Copies of the import permit shall be distributed and serve purposes 
as follows:
    (a) The original and quintuplet copies (Copy 1 and Copy 5) shall be 
transmitted by the Administration to the importer, who shall retain the 
quintuplet copy (Copy 5) on file as his record of authority for the 
importation, and shall transmit the original copy (Copy 1) to the 
foreign exporter. The foreign exporter will submit the original copy 
(Copy 1) to the proper governmental authority in the exporting country, 
if required, as a prerequisite to the issuance of an export 
authorization. This copy of the permit will accompany the shipment. Upon 
arrival of the imported merchandise, the District Director of the U.S. 
Customs Service at the port of entry will, after appraising the 
merchandise, forward the original copy (Copy 1) to the Drug Operations 
Section with a report on the reverse side of such copy, showing the name 
of the port of importation, date prepared, name and net quantity of each 
substance, and report of analysis of the merchandise entered.
    (b) The duplicate copy (Copy 2) shall be forwarded by the 
Administration to the proper governmental authorities of the exporting 
country.
    (c) The quadruplet copy (Copy 4) shall be forwarded by the 
Administration to the District Director of the U.S. Customs Service at 
the U.S. port of entry, which shall be the customs port of destination 
in the case of shipments transported under immediate transportation 
entries, in order that the District Director may compare it with the 
original copy (Copy 1) and the bill of lading upon arrival of the 
merchandise. If a discrepancy is noted between corresponding items upon 
different copies of a permit bearing the same serial number when 
compared by the District Director, he shall refuse to permit entry of 
the merchandise until the facts are communicated to the Administration 
and further instructions are received.
    (d) The triplicate copy (Copy 3) and sextuplet copy (Copy 6) shall 
be retained by the Administration.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.15  Shipments in greater or less amount than authorized.

    (a) If the shipment made under an import permit is greater than the 
maximum amount authorized to be imported under the permit, as determined 
at the weighing by the District Director of the U.S. Customs Service, 
such difference shall be seized subject to forfeiture, pending an 
explanation; except that shipments of substances exceeding the maximum 
authorized amount by less than 1 percent may be released to the importer 
upon the filing by him of an amended import permit. If the substance is 
included in Schedule I, it will be summarily forfeited to the 
Government.
    (b) If the shipment made under the permit is less than the maximum 
amount authorized to be imported under the permit as determined at the 
weighing by the District Director of the U.S. Customs Service, such 
difference, when ascertained by the Administration, shall be recredited 
to the tentative allotment against which the quantity covered by the 
permit was charged, and the balance of any such tentative allotment with 
any such recredits will remain available to the importer to whom made 
(unless previously revoked in whole or in part), for importations 
pursuant to any permit or permits as are requested and issued during the 
remainder of the calendar year to which the allotment is applicable. No 
permit shall be issued for importation of a quantity of controlled 
substances as a charge against the tentative allotment for a given 
calendar year, after the close of such calendar year, unless the 
Director of the Administration decides to make an exception for good 
cause shown.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981]

[[Page 122]]

Sec. 1312.16  Cancellation of permit; expiration date.

    (a) A permit may be canceled after being issued, at the request of 
the importer, provided no shipment has been made thereunder. In the 
event that a permit is lost, the Administrator may, upon the production 
by the importer of satisfactory proof, by affidavit or otherwise, issue 
a duplicate permit. Nothing in this part shall affect the right, hereby 
reserved by the Administrator, to cancel a permit at any time for proper 
cause.
    (b) An import permit shall not be valid after the date specified 
therein, and in no event shall the date be subsequent to 6 months after 
the date the permit is issued. Any unused import permit shall be 
returned for cancellation by the registrant to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.17  Special report from importers.

    Whenever requested by the Administrator, importers shall render to 
him not later than 30 days after receipt of the request therefor a 
statement under oath of the stocks of controlled substances on hand as 
of the date specified by the Administrator in his request, and, if 
desired by the Administrator, an estimate of the probable requirements 
for legitimate uses of the importer for any subsequent period that may 
be designated by the Administrator. In lieu of any special statement 
that may be considered necessary, the Administrator may accept the 
figures given upon the reports subsequent by said importer under part 
1304 of this chapter.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13969, Mar. 24, 1997]

Sec. 1312.18  Contents of import declaration.

    (a) Any non-narcotic controlled substance listed in Schedule III, 
IV, or V, not subject to the requirement of an import permit pursuant to 
Sec. 1312.13 (b) or (c) of this chapter, may be imported if that 
substance is needed for medical, scientific or other legitimate uses in 
the United States, and will be imported pursuant to a controlled 
substances import declaration.
    (b) Any person registered or authorized to import and desiring to 
import any non-narcotic controlled substance in Schedules III, IV, or V 
which is not subject to the requirement of an import permit as described 
in paragraph (a) of this section, must furnish a controlled substances 
import declaration on DEA Form 236 to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537, not later 
than 15 calendar days prior to the proposed date of importation and 
distribute four copies of same as hereinafter directed in Sec. 1312.19.
    (c) DEA Form 236 must be executed in quintuplicate and will include 
the following information:
    (1) The name, address, and registration number of the importer; and 
the name and address and registration number of the import broker, if 
any; and
    (2) A complete description of the controlled substances to be 
imported, including drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in any finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed import date, the foreign port of exportation to the 
United States, the port of entry, and the name, address, and 
registration number of the recipient in the United States; and
    (4) The name and address of the consignor in the foreign country of 
exportation, and any registration or license numbers if the consignor is 
required to have such numbers either by the country of exportation or 
under U.S. law.
    (d) Notwithstanding the time limitations included in paragraph (a) 
of this section, an applicant may obtain a special waiver of these time 
limitations in

[[Page 123]]

emergency or unusual instances, provided that a specific confirmation is 
received from the Administrator or his delegate advising the registrant 
to proceed pursuant to the special waiver.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997]

Sec. 1312.19  Distribution of import declaration.

    The required five copies of the controlled substances import 
declaration will be distributed as follows:
    (a) Copy 1, Copy 2, and Copy 3 shall be transmitted to the foreign 
shipper. The foreign shipper will submit Copy 1 to the proper 
governmental authority in the foreign country, if required as a 
prerequisite to export authorization. Copy 1 will then accompany the 
shipment to its destination, and shall be retained on file by the 
importer. Copy 2 shall be detached and retained by the appropriate 
customs official of the foreign country. Copy 3 shall be removed by the 
District Director of the U.S. Customs Service at the port of entry, who 
shall sign and date the certification of customs on Copy 3, noting any 
changes from the entries made by the importer, and shall then forward 
that copy to the Drug Operations Section of the Administration.
    (b) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.18, directly to the Drug Enforcement Administration, Drug 
Operations Section, Washington, DC 20537.
    (c) Copy 5 shall be retained by the importer on file as his record 
of authority for the importation.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971; 37 
FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
further amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 
1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

                  Exportation of Controlled Substances

Sec. 1312.21  Requirement of authorization to export.

    (a) No person shall in any manner export or cause to be exported 
from the United States any controlled substance listed in Schedule I or 
II, or any narcotic substance listed in Schedule III or IV, or any non-
narcotic substance in Schedule III which the Administrator has 
specifically designated by regulation in Sec. 1312.30 of this part or 
any non-narcotic substance in Schedule IV or V which is also listed in 
Schedule I or II of the Convention on Psychotropic Substances unless and 
until such person is properly registered under the Act (or exempted from 
registration) and the Administrator has issued a permit pursuant to 
Sec. 1312.23 of this part.
    (b) No person shall in any manner export or cause to be exported 
from the United States any non-narcotic controlled substance listed in 
Schedule III, IV, or V, excluding those described in paragraph (a) of 
this section, or any narcotic controlled substance listed in Schedule V, 
unless and until such person is properly registered under the Act (or 
exempted from registration) and has furnished a special controlled 
substance export invoice as provided by section 1003 of the Act (21 
U.S.C. 953(e)) to the Administrator pursuant to Sec. 1312.28 of this 
part.
    (c) A separate authorization repuest is obtained for each 
consignment of such controlled substances to be exported.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987]

Sec. 1312.22  Application for export permit.

    (a) An application for a permit to export controlled substances 
shall be made on DEA Form 161 which may be obtained from, and shall be 
filed with, the Drug Enforcement Administration, Drug Operations 
Section, Washington, DC 20537. Each application shall show the 
exporter's name, address, and registration number; a detailed 
description of each controlled substance desired to be exported 
including the drug name, dosage form, National Drug Code (NDC) number, 
the Administration Controlled Substance Code Number as set forth in part 
1308 of this chapter, the number and size of packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the

[[Page 124]]

quantity of any controlled substance (expressed in anhydrous acid, base, 
or alkaloid) given in kilograms or parts thereof. The application shall 
include the name, address, and business of the consignee, foreign port 
of entry, the port of exportation, the approximate date of exportation, 
the name of the exporting carrier or vessel (if known, or if unknown it 
should be stated whether shipment will be made by express, freight, or 
otherwise, exports of controlled substances by mail being prohibited), 
the date and number, if any, of the supporting foreign import license or 
permit accompanying the application, and the authority by whom such 
foreign license or permit was issued. The application shall also contain 
an affidavit that the packages are labeled in conformance with 
obligations of the United States under international treaties, 
conventions, or protocols in effect on May 1, 1971, and that, to the 
best of affiant's knowledge and belief, the controlled substances 
therein are to be applied exclusively to medical or scientific uses 
within the country to which exported, will not be reexported therefrom 
and that there is an actual need for the controlled substance for 
medical or scientific uses within such country. In the case of 
exportation of crude cocaine, the affidavit may state that to the best 
of knowledge and belief, the controlled substances will be processed 
within the country to which exported, either for medical or scientific 
use within that country or for reexportation in accordance with the laws 
of that country to another for medical or scientific use within that 
country. The application shall be signed and dated by the exporter and 
shall contain the address from which the substances will be shipped for 
exportation.
    (b) There shall also be submitted with the application any import 
license or permit (and a translation thereof if in a foreign language) 
or a certified copy of any such license or permit issued by competent 
authorities in the country of destination, or other documentary evidence 
deemed adequate by the Administrator, showing that the merchandise is 
consigned to an authorized permittee, that it is to be applied 
exclusively to medical or scientific use within the country of 
destination, that it will not be reexported from such country, and that 
there is an actual need for the controlled substance for medical or 
scientific use within such country. (In the case of exportation of bulk 
coca leaf alkaloid, the submitted evidence need only show the material 
outlined in paragraph (a) of this section for such exportations.)
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.23  Issuance of export permit.

    (a) The Administrator may authorize exportation of any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III or IV if he finds that such exportation 
is permitted by subsections 1003(a), (b), (c), or (d) of the Act (21 
U.S.C. 953 (a), (b), (c), or (d).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as shall be designated by regulation in 
Sec. 1312.30 of this part be exported only pursuant to the issuance of 
an export permit. The Administrator may authorize the exportation of 
such substances if he finds that such exportation is permitted by 
section 1003(e) of the Act (21 U.S.C. 953(e)).
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
it shall be exported only pursuant to the issuance of an export permit. 
The Administrator may authorize the exportation of such substances if he 
finds that such exportation is permitted by section 1003(e) of the Act 
(21 U.S.C. 953(e)).
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.

[[Page 125]]

    (e) Each export permit shall be issued in septuplet and serially 
numbered, with all seven copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. Each export permit shall be predicated upon an import 
certificate or other documentary evidence. Export permits are not 
transferable.
    (f) No export permit shall be issued for the exportation of any 
narcotic drug to any country when the Administrator has information to 
show that the estimates submitted with respect to that country for the 
current period, under the Narcotic Limitation Convention of 1931, or the 
Single Convention on Narcotic Drugs of 1961, have been, or, considering 
the quantity proposed to be imported, will be exceeded. If it shall 
appear through subsequent advice received from the International 
Narcotic Control Board of the United Nations that the estimates of the 
country of destination have been adjusted to permit further importation 
of the narcotic drug, an export permit may then be issued if otherwise 
permissible.
[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987]

Sec. 1312.24  Distribution of copies of export permit.

    Copies of the export permit shall be distributed and serve purposes 
as follows:
    (a) The original, duplicate, and triplicate copies (Copy 1, Copy 2, 
and Copy 3) shall be transmitted by the Administration to the exporter 
who will retain the triplicate copy (Copy 3) as his record of authority 
for the exportation. The exporter shall present to the District Director 
of the U.S. Customs Service at the port of export and at the time of 
shipment, the original and duplicate copies (Copy 1 and Copy 2). After 
endorsing the port of export on the reverse side of the original and 
duplicate copies (Copy 1 and Copy 2) the District Director shall forward 
the endorsed original copy (Copy 1) with the shipment, and return the 
endorsed duplicate copy (Copy 2) to the Drug Enforcement Administration, 
Drug Operations Section, Washington, DC 20537.
    (b) The quadruplet copy (Copy 4) shall be forwarded by the 
Administrator to the District Director of the U.S. Customs Service at 
the port of export for comparison with the original copy (Copy 1) and 
for retention for the customs record.
    (c) The quintuplet copy (Copy 5) shall be forwarded by the 
Administration to the officer in the country of destination who issued 
the import certificate, or other documentary evidence upon which the 
export permit is founded.
    (d) The sextuplet and septuplet copies (Copy 6 and Copy 7) shall be 
retained by the Administration.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 
FR 13969, Mar. 24, 1997]

Sec. 1312.25  Expiration date.

    An export permit shall not be valid after the date specified 
therein, which date shall conform to the expiration date specified in 
the supporting import certificate or other documentary evidence upon 
which the export permit is founded, but in no event shall the date be 
subsequent to 6 months after the date the permit is issued. Any unused 
export permit shall be returned by the permittee to the Drug Operations 
Section for cancellation.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.26  Records required of exporter.

    The exporter shall keep a record of any serial numbers that might 
appear on packages of narcotic drugs in quantities of one ounce or more 
in such a manner as will identify the foreign consignee, along with Copy 
3 of the export permit.

Sec. 1312.27  Contents of special controlled substances invoice.

    (a) A person registered or authorized to export any non-narcotic 
controlled substance listed in Schedule III, IV, or V, which is not 
subject to the requirement of an export permit pursuant to

[[Page 126]]

Sec. 1312.23 (b) or (c), or any person registered or authorized to 
export any controlled substance in Schedule V, must furnish a special 
controlled substances export invoice on DEA Form 236 to the Drug 
Enforcement Administration, Drug Operations Section, Washington, DC 
20537, not less than 15 calendar days prior to the proposed date of 
exportation, and distribute four copies of same as hereinafter directed 
in Sec. 1312.28 of this part.
    (b) This invoice must be executed by the exporter in quintuplicate 
and include the following information.
    (1) The name, address, and registration number, if any, of the 
exporter; and the name, address and registration number of the exporter 
broker, if any; and
    (2) A complete description of the controlled substances to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed export date, the port of exportation, the foreign 
port of entry, the carriers and shippers involved, method of shipment, 
the name of the vessel if applicable, and the name, address, and 
reghstration number, if any, of any forwarding agent utilized; and
    (4) The name and address of the consignee in the country of 
destination, and any registration or license number if the consignee is 
required to have such numbers either by the country of destination or 
under United States law. In addition, documentation must be provided to 
show that:
    (i) The consignee is authorized under the laws and regulations of 
the country of destination to receive the controlled substances, and 
that
    (ii) The substance is being imported for consumption within the 
importing country to satisfy medical, scientific or other legitimate 
purposes, and that
    (5) The reexport of non-narcotic controlled substances in Schedules 
III and IV, and controlled substances in Schedule V is not permitted 
under the authority of 21 U.S.C. 953(e), except as provided below:
    (i) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e, the material must undergo further 
manufacturing process. This further manufactured material may only be 
reexported to a country of ultimate consumption.
    (ii) Finished dosage units, if reexported, will be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination.
    (iii) Any reexportation be made known to DEA at the time the initial 
DEA Form 236, Controlled Substances Import/Export Declaration is 
completed, by checking the box marked ``other'' on the certification. 
The following information will be furnished in the remarks section:
    (A) Indicate ``for reexport''.
    (B) Indicate if reexport is bulk or finished dosage units.
    (C) Indicate product name, dosage strength, commercial package size, 
and quantity.
    (D) Indicate name of consignee, complete address, and expected 
shipment date, as well as, the name and address of the ultimate 
consignee in the country to where the substances will be reexported.
    (E) A statement that the consignee in the country of ultimate 
destination is authorized under the laws and regulations of the country 
of ultimate destination to receive the controlled substances.
    (iv) Shipments which have been exported from the United States and 
are refused by the consignee in the country of destination, or are 
otherwise unacceptable or undeliverable, may be returned to the 
registered exporter in the United States upon authorization of the Drug 
Enforcement Administration. In this circumstance, the exporter in the 
United States shall file a written request for reexport, along with a 
completed DEA Form 236, Import Declaration with the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537. A brief 
summary

[[Page 127]]

of the facts that warrant the return of the substance to the United 
States along with an authorization from the country of export will be 
included with the request. DEA will evaluate the request after 
considering all the facts as well as the exporter's registration status 
with DEA. The substance may be returned to the United States only after 
affirmative authorization is issued in writing by DEA.
    (c) Notwithstanding the time limitations included in paragraph (a) 
of this section, a registrant may obtain a special waiver of these time 
limitations in emergency or unusual instances; provided that a specific 
confirmation is received from the Administrator or his delegate advising 
the registrant to proceed pursuant to the special waiver.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997]

Sec. 1312.28  Distribution of special controlled substances invoice.

    The required five copies of the special controlled substances export 
invoice, DEA (or BND) Form 236, will be distributed as follows:
    (a) Copy 1 shall accompany the shipment and remain with the shipment 
to its destination.
    (b) Copy 2 shall accompany the shipment and will be detached and 
retained by appropriate customs officials at the foreign country of 
destination.
    (c) Copy 3 shall accompany the shipment and will be detached by the 
District Director of the U.S. Customs Service at the port of 
exportation, who shall sign and date the certification of customs on 
such Copy 3, noting any changes from the entries made by the exporter, 
and shall then promptly forward Copy 3 to the Drug Control Section of 
the Administration.
    (d) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.27 of this part, directly to the Drug Enforcement 
Administration, Drug Operations Section, Washington, DC 20537. The 
documentation required by Sec. 1312.27(b)(4) of this part must be 
attached to this copy.
    (e) Copy 5 shall be retained by the exporter on file as his record 
of authority for the exportation.
[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17291, May 7, 1987; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.29  Domestic release prohibited.

    An exporter or a forwarding agent acting for an exporter must either 
deliver the controlled substances to the port or border, or deliver the 
controlled substances to a bonded carrier approved by the consignor for 
delivery to the port or border, and may not, under any other 
circumstances, release a shipment of controlled substances to anyone, 
including the foreign consignee or his agent, within the United States.

Sec. 1312.30  Schedule III, IV, and V non-narcotic controlled substances 
          requiring an import and export permit.

    The following Schedule III, IV, and V non-narcotic controlled 
substances have been specifically designated by the Administrator of the 
Drug Enforcement Administration as requiring import and export permits 
pursuant to sections 1002(b)(2) and 1003(e)(3) of the Act (21 U.S.C. 
952(b)(2) and 953(e)(3)):
    (a) [Reserved]
[52 FR 17291, May 7, 1987]

     Transshipment and In-Transit Shipment of Controlled Substances

Sec. 1312.31  Schedule I: Application for prior written approval.

    (a) A controlled substance listed in schedule I may be imported into 
the United States for transshipment, or may be transferred or 
transshipped within the United States for immediate exportation, 
provided that:
    (1) The controlled substance is necessary for scientific, medical, 
or other legitimate purposes in the country of destination, and
    (2) A transshipment permit has been issued by the Administrator.
    (b) An application for a transshipment permit must be submitted to 
the Drug Enforcement Administration,

[[Page 128]]

Drug Operations Section, Washington, DC 20537, at least 30 days, or in 
the case of an emergency as soon as practicable, prior to the expected 
date of importation, transfer or transshipment. Each application shall 
contain the following:
    (1) The date of execution;
    (2) The identification and description of the controlled substance;
    (3) The net quantity thereof;
    (4) The number and size of the controlled substance containers;
    (5) The name, address, and business of the foreign exporter;
    (6) The foreign port of exportation;
    (7) The approximate date of exportation;
    (8) The identification of the exporting carrier;
    (9) The name, address and business of the importer, transferor, or 
transshipper;
    (10) The registration number, if any, of the importer, transferor or 
transshipper;
    (11) The U.S. port of entry;
    (12) The approximate date of entry;
    (13) The name, address and business of the consignee at the foreign 
port of entry;
    (14) The shipping route from the U.S. port of exportation to the 
foreign port of entry;
    (15) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (16) The signature of the importer, transferor or transshipper, or 
his agent accompanied by the agent's title.
    (c) An application shall be accompanied by an export license, 
permit, or a certified copy of the export license, permit, or other 
authorization, issued by a competent authority of the country of origin 
(or other documentary evidence deemed adequate by the Administrator).
    (d) An application shall be accompanied by an import license or 
permit or a certified copy of such license or permit issued by a 
competent authority of the country of destination (or other documentary 
evidence deemed adequate by the Administrator), indicating that the 
controlled substance:
    (1) Is to be applied exclusively to scientific, medical or other 
legitimate uses within the country of destination;
    (2) Will not be exported from such country; and
    (3) Is needed therein because there is an actual shortage thereof 
and a demand therefor for scientific, medical or other legitimate uses 
within such country.
    (e) Verification by an American consular officer of the signatures 
on a foreign import license or permit shall be required, if such license 
or permit does not bear the seal of the authority signing them.
    (f) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (g) The Administrator shall, within 21 days from the date of receipt 
of the application, either grant or deny the application. The applicant 
shall be accorded an opportunity to amend the application, with the 
Administrator either granting or denying the amended application within 
7 days of its receipt. If the Administrator does not grant or deny the 
application within 21 days of its receipt, or in the case of an amended 
application, within 7 days of its receipt, the application shall be 
deemed approved and the applicant may proceed.
[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]

Sec. 1312.32  Schedules II, III, IV: Advance notice.

    (a) A controlled substance listed in Schedules II, III, or IV may be 
imported into the United States for transshipment, or may be transferred 
or transshipped within the United States for immediate exportation, 
provided that written notice is submitted to the Drug Enforcement 
Administration,

[[Page 129]]

Drug Operations Section, Washington, DC 20537, at least 15 days prior to 
the expected date of importation, transfer or transshipment.
    (b) Each advance notice shall contain those items required by 
Sec. 1312.31 (b) and (c).
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997]

                                Hearings

Sec. 1312.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the denial of an application for an import, export or 
transshipment permit, the procedures for such hearing shall be governed 
generally by the adjudication procedures set forth in the Administrative 
Procedure Act (5 U.S.C. 551-559) and specifically by sections 1002 and 
1003 of the Act (21 U.S.C. 952 and 953), by Secs. 1312.42-1312.47, and 
by the procedures for administrative hearings under the Act set forth in 
Secs. 1316.41- 1316.67 of this chapter.
    (b) [Reserved]
[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1312.42  Purpose of hearing.

    (a) If requested by a person applying for an import, export, or 
transshipment permit, the Administrator shall hold a hearing for the 
purpose of receiving factual evidence regarding the issues involved in 
the issuance or denial of such permit to such person.
    (b) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.
[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1312.43  Waiver or modification of rules.

    The Administrator of the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.
[36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973]

Sec. 1312.44  Request for hearing or appearance; waiver.

    (a) Any applicant entitled to a hearing pursuant to Sec. 1312.42 and 
who desires a hearing on the denial of his application for an import, 
export, or transshipment permit shall, within 30 days after the date of 
receipt of the denial of his application, file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any applicant entitled to a hearing pursuant to Sec. 1312.42 
may, within the period permitted for filing a request for a hearing, 
file with the Administrator a waiver of an opportunity for a hearing, 
together with a written statement regarding his position on the matters 
of fact and law involved in such hearing. Such statement, if admissible, 
shall be made a part of the record and shall be considered in light of 
the lack of opportunity for cross-examination in determining the weight 
to be attached to matters of fact asserted therein.
    (c) If any applicant entitled to a hearing pursuant to Sec. 1312.42 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing unless he shows good cause for such failure.
    (d) If the applicant waives or is deemed to have waived this 
opportunity for the hearing, the Administrator may cancel the hearing, 
if scheduled, and issue his final order pursuant to Sec. 1312.47 without 
a hearing.
[37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1312.45  Burden of proof.

    At any hearing on the denial of an application for an import, 
export, or transshipment permit, the Administrator shall have the burden 
of proving that the requirements for such permit pursuant to sections 
1002, 1003, and 1004

[[Page 130]]

of the Act (21 U.S.C. 952, 953, and 954) are not satisfied.
[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1312.46  Time and place of hearing.

    (a) If any applicant for an import, export, or transshipment permit 
requests a hearing on the issuance or denial of his application, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant of the time and place at least 30 days prior to 
the hearing, unless the applicant waives such notice and requests the 
hearing be held at an earlier time, in which case the Administrator 
shall fix a date for such hearing as early as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.
[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1312.47  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the issuance or denial of the application for and import, export, or 
transshipment permit. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The Administrator 
shall serve one copy of his order upon the applicant.
[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]









[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: 21CFR1313]

[Page 130-137]
 
                         TITLE 21-FOOD AND DRUGS
 
 CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1313--IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS--Table of Contents


Sec.
1313.01  Scope.
1313.02  Definitions.

                     Importation of Listed Chemicals

1313.12  Requirement of authorization to import.
1313.13  Contents of import declaration.
1313.14  Distribution of import declaration.
1313.15  Waiver of 15-day advance notice for regular importers.

                     Exportation of Listed Chemicals

1313.21  Requirement of authorization to export.
1313.22  Contents of export declaration.
1313.23  Distribution of export declaration.
1313.24  Waiver of 15-day advance notice for chemical exporters.
1313.25  Foreign import restrictions.

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals

1313.31  Advance notice of importation for transshipment or transfer.
1313.32  Requirement of authorization for international transactions.
1313.33  Contents of an international transaction declaration.
1313.34  Distribution of the international transaction declaration.
1313.41  Suspension of shipments.

                                Hearings

1313.51  Hearings generally.
1313.52  Purpose of hearing.
1313.53  Waiver of modification of rules.
1313.54  Request for hearing.
1313.55  Burden of proof.
1313.56  Time and place of hearing.
1313.57  Final order.

    Authority:  21 U.S.C. 802, 830, 871(b), 971.

    Source:  54 FR 31665, Aug. 1, 1989, unless otherwise noted.

Sec. 1313.01  Scope.

    Procedures governing the importation, exportation, transshipment and 
in-transit shipment of listed chemicals pursuant to section 1018 of the 
Act (21 U.S.C. 971) are governed generally by that section and 
specifically by the sections of this part.
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]

Sec. 1313.02  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 13969, Mar. 24, 1997]

[[Page 131]]

                     Importation of Listed Chemicals

Sec. 1313.12  Requirement of authorization to import.

    (a) Each regulated person who imports a listed chemical that meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, shall notify the 
Administrator of the importation not later than 15 days before the 
transaction is to take place.
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the importation:

Drug Enforcement Administration, P.O. Box 28346, Washington, DC 20038.

    A copy of the completed DEA Form 486 may be transmitted directly to 
the Drug Enforcement Administration, Drug Control Section, through 
electronic facsimile media not later than 15 days prior to the 
importation.
    (c) The 15-day advance notification requirement for listed chemical 
imports may be waived for:
    (1) Any regulated person who has satisfied the requirements for 
reporting to the Administration as a regular importer of such listed 
chemicals; or
    (2) A specific listed chemical, as set forth in paragraph (f) of 
this section, for which the Administrator determines that advance 
notification is not necessary for effective chemical diversion control.
    (d) For imports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Chemical Operations Section, on or 
before the date of importation through use of the mailing address listed 
in Sec. 1313.12(b) or through use of electronic facsimile media.
    (e) For importations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA Form 486 is required, 
however, the regulated person shall submit quarterly reports to the Drug 
Enforcement Administration, Chemical Operations Section, P.O. Box 28346, 
Washington, DC 20038, by no later than the 15th day of the month 
following the end of each quarter. The report shall contain the 
following information regarding each individual importation:
    (1) The name of the listed chemical;
    (2) The quantity and date imported;
    (3) The name and full business address of the supplier;
    (4) The foreign port of embarkation; and
    (5) The port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) has been waived for imports of the following listed 
chemicals:
    (1) [Reserved]
[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995]

Sec. 1313.13  Contents of import declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter may be imported if that chemical is necessary for medical, 
commercial, scientific, or other legitimate uses within the United 
States. Chemical importations into the United States for immediate 
transfer/transshipment outside the United States must comply with the 
procedures set forth in Sec. 1313.31.
    (b) Any regulated person who desires to import a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures set forth in Sec. 1313.12 and distribute three copies 
of DEA Form 486 as directed in Sec. 1313.14.
    (c) The DEA Form 486 must be executed in triplicate and must include 
the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical importer; the name, 
address, telephone, telex, and where available, the facsmile number of 
the broker or forwarding agent (if any); and
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each chemical as it is designated 
in 1310.02 of this chapter, the size or weight of container, the number 
of containers, the net weight of each listed chemical given in kilograms 
or parts thereof; and the gross weight of the shipment given in 
kilograms or parts thereof; and

[[Page 132]]

    (3) The proposed import date, the foreign port of exportation and 
the first U.S. Customs Port of Entry; and
    (4) The name, address, telephone number, telex number, and, where 
available, the facsmile number of the consignor in the foreign country 
of exportation.
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]

Sec. 1313.14  Distribution of import declaration.

    The required three copies of the listed chemical import declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the regulated person as the 
official record of import. Import declaration forms involving a List I 
chemical must be retained for four years; declaration forms for List II 
chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.12.
    (c) Copy 3 shall be presented to the U.S. Customs Sevice along with 
the customs entry. If the import is a regulated transaction for which 
the 15-day advance notice requirement has been waived, the regulated 
person shall declare this information to the U.S. Customs Service 
Official by checking the block on the DEA Form 486 designated for this 
purpose.
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]

Sec. 1313.15  Waiver of 15-day advance notice for regular importers.

    (a) Each regulated person seeking designation as a ``regular 
importer'' shall provide, by certified mail return receipt requested, to 
the Administration such information as is required under 
Sec. 1300.02(b)(13), documenting their status as a regular importer.
    (b) Each regulated person making application under paragraph (a) of 
this section shall be considered a ``regular importer'' for purposes of 
waiving the 15-day advance notice, 30 days after receipt of the 
application by the Administration, as indicated on the return receipt, 
unless the regulated person is otherwise notified in writing by the 
Administration.
    (c) The Administrator, may, at any time, disqualify a regulated 
person's status as a regular importer on the grounds that the chemical 
being imported may be diverted to the clandestine manufacture of a 
controlled substance.
    (d) Unless the Administration notifies the chemical importer to the 
contrary, the qualification of a regular importer of any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
importer as a regular importer of all three of these chemicals.
    (e) All chemical importers shall be required to file a DEA Form 486 
as required by Section 1313.12.
[60 FR 32464, June 22, 1995, as amended at 62 FR 13969, Mar. 24, 1997]

                     Exportation of Listed Chemicals

Sec. 1313.21  Requirement of authorization to export.

    (a) No person shall export or cause to be exported from the United 
States any chemical listed in Sec. 1310.02 of this chapter, which meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, until such time as the 
Administrator has been notified. Notification must be made not later 
than 15 days before the transaction is to take place. In order to 
facilitate the export of listed chemicals and implement the purpose of 
the Act, regulated persons may wish to provide notification to the 
Administration as far in advance of the 15 days as possible.
    (b) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the exportation:

    Drug Enforcement Administration, P.O. Box 28346, Washington, DC 
20038.

    A copy of the completed DEA Form 486 may be transmitted directly to 
the Drug Enforcement Administration, Drug Control Section, through 
electronic facsimile media not later than 15 days prior to the 
exportation.

[[Page 133]]

    (c) The 15-day advance notification requirement for listed chemical 
exports may be waived for:
    (1) Any regulated person who has satisfied the requirements of 
Section 1313.24 for reporting to the Administration an established 
business relationship with a foreign customer as defined in 
Sec. 1300.02(b)(12).
    (2) A specific listed chemical to a specified country, as set forth 
in paragraph (f) of this section, for which the Administrator determines 
that advance notification is not necessary for effective chemical 
diversion control.
    (d) For exports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Chemical Operations Section, on or 
before the date of exportation through use of the mailing address listed 
in Section 1313.12(b) or through use of electronic facsimile media.
    (e) For exportations where advance notification is waived pursuant 
to paragraph (c)(2) of this section, the regulated person shall file 
quarterly reports to the Drug Enforcement Administration, Chemical 
Operations Section, P.O. Box 28346, Washington, DC 20038, by no later 
than the 15th day of the month following the end of each quarter. The 
report shall contain the following information regarding each individual 
importation:
    (1) The name of the listed chemical;
    (2) The quantity and date exported;
    (3) The name and full business address of the foreign customer;
    (4) The port of embarkation; and
    (5) The foreign port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) of this section has been waived for exports of the 
following listed chemicals to the following countries:

                                                                        
------------------------------------------------------------------------
             Name of Chemical                          Country          
------------------------------------------------------------------------
[Reserved]................................  ............................
------------------------------------------------------------------------

    (g) No person shall export or cause to be exported any listed 
chemical, knowing or having reasonable cause to believe the export is in 
violation of the laws of the country to which the chemical is exported 
or the chemical will be used to manufacture a controlled substance in 
violation of the Act or the laws of the country to which the chemical is 
exported. The Administration will publish a notice of foreign import 
restrictions for listed chemicals of which DEA has knowledge as provided 
in Sec. 1313.25.
[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995; 62 FR 13969, Mar. 24, 1997]

Sec. 1313.22  Contents of export declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter which meets or exceeds the quantitative threshold criteria 
established in Sec. 1310.04(f) of this chapter may be exported if that 
chemical is needed for medical, commercial, scientific, or other 
legitimate uses.
    (b) Any regulated person who desires to export a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures outlined in Sec. 1313.21 and distribute three copies 
of DEA Form 486 as directed in Sec. 1313.23.
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical exporter; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the export broker, if any;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Sec. 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (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 chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).

[[Page 134]]

    (d) Notwithstanding the time limitations included in paragraph (b) 
of this section, a regulated person may receive a waiver of the 15-day 
advance notification requirement following the procedures outlined in 
Sec. 1313.24.
    (e) Declared exports of listed chemicals which are refused, 
rejected, or otherwise deemed undeliverable may be returned to the U.S. 
chemical exporter of record. A brief written notification (this does not 
require a DEA Form 486) 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.
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]

Sec. 1313.23  Distribution of export declaration.

    The required three copies of the listed chemical export declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the chemical exporters as 
the official record of export. Export declaration forms involving a List 
I chemical must be retained for four years; declaration forms for list 
II chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.21
    (c) Copy 3 shall be presented to the U.S. Customs Service at the 
port of exit for each export of a listed chemical or chemicals on or 
before the day of exportation, and when possible, along with the 
Shippers Export Declaration.
[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 61 
FR 51004, Sept. 30, 1996]

Sec. 1313.24  Waiver of 15-day advance notice for chemical exporters.

    (a) Each regulated person shall provide to the Administration the 
identity and information listed in Sec. 1300.02(b)(12) for an 
established business relationship with a foreign customer not later than 
August 31, 1989.
    (b) Not later than October 31, 1989, each regular customer so 
identified in notifications made under Sec. 1313.24(a) shall be a 
regular customer for purposes of waiving the 15-day advance notice 
requirement, unless the regulated person is otherwise notified in 
writing by the Administration.
    (c) Each foreign customer identified on an initial DEA Form 486 
submitted after the effective date of the implementation of part 1313 
shall, after the expiration of the 15-day period, qualify as a regular 
customer, unless the Administration otherwise notifies the regulated 
person in writing.
    (d) Unless the Administration notifies the chemical exporter to the 
contrary, the qualification of a regular customer for any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
customer as a regular customer for all three of these chemicals.
    (e) The Administrator may notify any chemical exporter that a 
regular customer has been disqualified or that a new customer for whom a 
notification has been submitted is not to be accorded the status of a 
regular customer. In the event of a disqualification of an established 
regular customer, the chemical exporter will be notified in writing of 
the reasons for such action.

Public reporting (one-time) burden for this collection of information is 
estimated to average four hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing and 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,

[[Page 135]]

Washington, DC 20537; and to the Office of Management and Budget, 
Paperwork Reduction Project No. 1117-0025, Washington, DC 20503.
[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 
FR 13969, Mar. 24, 1997]

Sec. 1313.25  Foreign import restrictions.

    Any export from the United States in violation of the law of the 
country to which the chemical is exported is subject to the penalties of 
Title 21 United States Code 960(d).

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals

Sec. 1313.31  Advance notice of importation for transshipment or 
          transfer.

    (a) A quantity of a chemical listed in Sec. 1310.02 of this chapter 
that meets or exceeds the threshold reporting requirements found in 
Sec. 1310.04(f) of this chapter may be imported into the United States 
for transshipment, or may be transferred or transshipped within the 
United States for immediate exportation, provided that advance notice is 
given to the Administration.
    (b) Advance notification must be provided to the Drug Enforcement 
Administration, P.O. Box 28346, Washington, DC 20038, not later than 15 
days prior to the proposed date the listed chemical will transship or 
transfer through the United States. The written notification (not a DEA 
Form 486) shall contain the following information:
    (1) The date the notice was executed;
    (2) The complete name and description of the listed chemical as it 
appears on the label or container.
    (3) The name of the listed chemical as designated by Sec. 1310.02 of 
this chapter.
    (4) The number of containers and the size or weight of the container 
for each listed item;
    (5) The new weight of each listed chemical given in kilograms or 
parts thereof;
    (6) The gross weight of the shipment given in kilograms or parts 
thereof;
    (7) The name, address, telephone number, telex number, business of 
the foreign exporter and, where available, the facsimile number;
    (8) The foreign port of exportation;
    (9) The approxhmate date of exportation;
    (10) The complete identification of the exporting carrier;
    (11) The name, address, business, telephone number, telex number, 
and, where available, the facsimile number of the importer, transferor, 
or transshipper;
    (12) The U.S. port of entry;
    (13) The approximate date of entry;
    (14) The name, address, telephone number, telex number, business of 
the consignee and, where available, facsimile number of the consignee at 
the foreign port of entry;
    (15) The shipping route from the U.S. port of exportation to the 
foreign port of entry at final destination;
    (16) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (17) The signature of the importer, transferor or transshipper, or 
his agent, accompanied by the agent's title.
    (c) Unless notified to the contrary prior to the expected date of 
delivery, the importation for transshipment or transfer is considered 
approved.
    (d) No waiver of the 15-day advance notice will be given for imports 
of listed chemicals in quantities meeting or exceeding threshold 
quantities for transshipment or transfer outside the United States.

Sec. 1313.32  Requirement of authorization for international 
          transactions.

    (a) A broker or trader shall notify the Administrator prior to an 
international transaction involving a listed chemical which meets or 
exceeds the threshold amount identified in Section 1310.04 of this 
chapter, in which the broker or trader participates. Notification must 
be made no later than 15 days before the transaction is to take place. 
In order to facilitate an international transaction involving listed 
chemicals and implement the purpose of the Act, regulated persons may 
wish to provide advance notification to the Administration as far in 
advance of the 15 days as possible.

[[Page 136]]

    (b)(1) A completed DEA Form 486 must be received at the following 
address not later than 15 days prior to the international transaction:

    Drug Enforcement Administration, P.O. Box 28346, Washington, D.C. 
20038

    (2) A copy of the DEA Form 486 may be transmitted directly to the 
Drug Enforcement Administration, Chemical Operations Section, through 
electronic facsimile media not later than 15 days prior to the 
exportation.
    (c) No person shall serve as a broker or trader for an international 
transaction involving a listed chemical knowing or having reasonable 
cause to believe that the transaction is in violation of the laws of the 
country to which the chemical is exported or the chemical will be used 
to manufacture a controlled substance in violation of the laws of the 
country to which the chemical is exported. The Administration will 
publish a notice of foreign import restrictions for listed chemicals of 
which DEA has knowledge as provided in Section 1313.25.
[60 FR 32465, June 22, 1995; 61 FR 17566, Apr. 22, 1996]

Sec. 1313.33  Contents of an international transaction declaration.

    (a) An international transaction involving a chemical listed in 
Sec. 1310.02 of this chapter which meets the threshold criteria 
established in Sec. 1310.04 of this chapter may be arranged by a broker 
or trader if the chemical is needed for medical, commercial, scientific, 
or other legitimate uses.
    (b) Any broker or trader who desires to arrange an international 
transaction involving a listed chemical which meets the criteria set 
forth in Section 1310.04 shall notify the Administration through the 
procedures outlined in Section 1313.32(b).
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical exporter; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the chemical importer;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Section 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The proposed export date, the port of exportation, and the port 
of importation; and
    (4) The name, address, telephone, telex, and where available, the 
facsimile number, of the consignee in the country where the chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).
[60 FR 32465, June 22, 1995]

Sec. 1313.34  Distribution of the international transaction declaration.

    The required three copies of the DEA Form 486 will be distributed as 
follows:
    (a) Copies 1 and 3 shall be retained on file by the broker or trader 
as the official record of the international transaction. Declaration 
forms involving List I chemicals shall be retained for List II chemicals 
shall be retained for four years; declaration forms for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 1313.32.
[60 FR 32465, June 22, 1995; 60 FR 35264, July 6, 1995]

Sec. 1313.41  Suspension of shipments.

    (a) The Administrator may suspend any importation or exportation of 
a chemical listed in Sec. 1310.02 of this chapter based on evidence that 
the chemical proposed to be imported or exported may be diverted to the 
clandestine manufacture of a controlled substance. If the Administrator 
so suspends, he shall provide written notice of such suspension to the 
regulated person. Such notice shall contain a statement of the legal and 
factual basis for the order.
    (b) Upon service of the order of suspension, the regulated person to 
whom the order applies under paragraph (a) of

[[Page 137]]

this section must, if he desires a hearing, file a written request for a 
hearing pursuant to Secs. 1313.51-1313.57.

                                Hearings

Sec. 1313.51  Hearings generally.

    In any case where a regulated person requests a hearing regarding 
the suspension of a shipment of a listed chemical, the procedures for 
such hearing shall be governed generally by the procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 6053 of the Chemical Diversion and Trafficking Act (Pub. L. 100-
690), by 21 CFR 1313.52-1313.57, and by the procedures for 
administrative hearings under the Controlled Substances Act set forth in 
Secs. 1316.41-1316.67 of this chapter.

Sec. 1313.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall cause a hearing to be held for the purpose of receiving factual 
evidence regarding the issues involved in the suspension of shipments 
within 45 days of the date of the request, unless the requesting party 
requests an extension of time.

Sec. 1313.53  Waiver of modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

Sec. 1313.54  Request for hearing.

    (a) Any person entitled to a hearing pursuant to Sec. 1313.52 and 
desiring a hearing shall, within 30 days after receipt of the notice to 
suspend the shipment, file with the Administrator a written request for 
a hearing in the form prescribed in Sec. 1316.47 of this chapter.
    (b) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1313.41 fails to file a request for a hearing 
or a notice of appearance, or if he so files and fails to appear at the 
hearing, he shall be deemed to have waived his opportunity for the 
hearing or to participate in the hearing, unless he shows good cause for 
such failure.
    (c) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to 
Sec. 1313.57.

Sec. 1313.55  Burden of proof.

    At any hearing regarding the suspension of shipments, the Agency 
shall have the burden of proving that the requirements of this part for 
such suspension are satisfied.

Sec. 1313.56  Time and place of hearing.

    (a) If any regulated person requests a hearing on the suspension of 
shipments, a hearing will be scheduled no later than 45 days after the 
request is made, unless the regulated person requests an extension to 
this date.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.

Sec. 1313.57  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order 
regarding the suspension of shipment. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The Administrator shall serve one copy of his order upon each party in 
the hearing.









[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: 21CFR1316]

[Page 137-159]
 
                         TITLE 21-FOOD AND DRUGS
 
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

                  Subpart A--Administrative Inspections

Sec.
1316.01  Scope of subpart A.
1316.02  Definitions.

[[Page 138]]

1316.03  Authority to make inspections.
1316.04  Exclusion from inspection.
1316.05  Entry.
1316.06  Notice of inspection.
1316.07  Requirement for administrative inspection warrant; exceptions.
1316.08  Consent to inspection.
1316.09  Application for administrative inspection warrant.
1316.10  Administrative probable cause.
1316.11  Execution of warrants.
1316.12  Refusal to allow inspection with an administrative warrant.
1316.13  Frequency of administrative inspections.

       Subpart B--Protection of Researchers and Research Subjects

1316.21  Definitions.
1316.22  Exemption.
1316.23  Confidentiality of identity of research subjects.
1316.24  Exemption from prosecution for researchers.

                   Subpart C--Enforcement Proceedings

1316.31  Authority for enforcement proceeding.
1316.32  Notice of proceeding; time and place.
1316.33  Conduct of proceeding.
1316.34  Records of proceeding.

                   Subpart D--Administrative Hearings

1316.41  Scope of subpart D.
1316.42  Definitions.
1316.43  Information; special instructions.
1316.44  Waiver or modification of rules.
1316.45  Filings; address; hours.
1316.46  Inspection of record.
1316.47  Request for hearing.
1316.48  Notice of appearance.
1316.49  Waiver of hearing.
1316.50  Appearance; representation; authorization.
1316.51  Conduct of hearing and parties; ex parte communications.
1316.52  Presiding officer.
1316.53  Time and place of hearing.
1316.54  Prehearing conference.
1316.55  Prehearing ruling.
1316.56  Burden of proof.
1316.57  Submission of documentary evidence and affidavits and 
          identification of witnesses subsequent to prehearing 
          conference.
1316.58  Summary of testimony; affidavits.
1316.59  Submission and receipt of evidence.
1316.60  Objections; offer of proof.
1316.61  Exceptions to rulings.
1316.62  Appeal from ruling of presiding officer.
1316.63  Official transcript; index; corrections.
1316.64  Proposed findings of fact and conclusions of law.
1316.65  Report and record.
1316.66  Exceptions.
1316.67  Final order.
1316.68  Copies of petitions for judicial review.

       Subpart E--Seizure, Forfeiture, and Disposition of Property

1316.71  Definitions.
1316.72  Officers who will make seizures.
1316.73  Custody and other duties.
1316.74  Appraisement.
1316.75  Advertisement.
1316.76  Requirements as to claim and bond.
1316.77  Administrative forfeiture.
1316.78  Judicial forfeiture.
1316.79  Petitions for remission or mitigation of forfeiture.
1316.80  Time for filing petitions.
1316.81  Handling of petitions.

    Subpart F--Expedited Forfeiture Proceedings for Certain Property

1316.90  Purpose and scope.
1316.91  Definitions.
1316.92  Petition for expedited release in an administrative forfeiture 
          action.
1316.93  Ruling on petition for expedited release in an administrative 
          forfeiture action.
1316.94  Posting of substitute res in an administrative forfeiture 
          action.
1316.95  Petition for expedited release of a conveyance in a judicial 
          forfeiture action.
1316.96  Ruling on a petition for expedited release of a conveyance in a 
          judicial forfeiture action.
1316.97  Initiating judicial forfeiture proceeding against a conveyance 
          within 60 days of the filing of a claim and cost bond.
1316.98  Substitute res bond in a judicial forfeiture action against a 
          conveyance.
1316.99  Notice provisions.

    Source:  36 FR 7820, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                  Subpart A--Administrative Inspections

    Authority:  21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.

Sec. 1316.01  Scope of subpart A.

    Procedures regarding administrative inspections and warrants 
pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 
U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those

[[Page 139]]

sections and specifically by the sections of this subpart.

Sec. 1316.02  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administration means the Drug Enforcement 
Administration.
    (c) The term controlled premises means--
    (1) Places where original or other records or documents required 
under the Act are kept or required to be kept, and
    (2) Places, including factories, warehouses, or other establishments 
and conveyances, where persons registered under the Act or exempted from 
registration under the Act, or regulated persons may lawfully hold, 
manufacture, or distribute, dispense, administer, or otherwise dispose 
of controlled substances or listed chemicals or where records relating 
to those activities are maintained.
    (d) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (e) The term inspector means an officer or employee of the 
Administration authorized by the Administrator to make inspections under 
the Act.
    (f) The term register and registration refer to registration 
required and permitted by sections 303 and 1008 of the Act (21 U.S.C. 
823 and 958).
    (g) Any term not defined 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.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 
FR 13969, Mar. 24, 1997]

Sec. 1316.03  Authority to make inspections.

    In carrying out his functions under the Act, the Administrator, 
through his inspectors, is authorized in accordance with sections 510 
and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises 
and conduct administrative inspections thereof, for the purpose of:
    (a) Inspecting, copying, and verifying the correctness of records, 
reports, or other documents reqtired to be kept or made under the Act 
and regulations promulgated under the Act, including, but not limited 
to, inventory and other records required to be kept pursuant to part 
1304 of this chapter, order form records required to be kept pursuant to 
part 1305 of this chapter, prescription and distribution records 
required to be kept pursuant to part 1306 of this chapter, records of 
listed chemicals, tableting machines, and encapsulating machines 
required to be kept pursuant to part 1310 of this chapter, import/export 
records of listed chemicals required to be kept pursuant to part 1313 of 
this chapter, shipping records identifying the name of each carrier used 
and the date and quantity of each shipment, and storage records 
identifying the name of each warehouse used and the date and quantity of 
each storage.
    (b) Inspecting within reasonable limits and to a reasonable manner 
all pertinent equipment, finished and unfinished controlled substances, 
listed chemicals, and other substances or materials, containers, and 
labeling found at the controlled premises relating to this Act;
    (c) Making a physical inventory of all controlled substances and 
listed chemicals on-hand at the premises;
    (d) Collecting samples of controlled substances or listed chemicals 
(in the event any samples are collected during an inspection, the 
inspector shall issue a receipt for such samples on DEA Form 84 to the 
owner, operator, or agent in charge of the premises);
    (e) Checking of records and information on distribution of 
controlled substances or listed chemicals by the registrant or regulated 
person (i.e., has the distribution of controlled substances or listed 
chemicals increased markedly within the past year, and if so why);
    (f) Except as provided in Sec. 1316.04, all other things therein 
(including records, files, papers, processes, controls and facilities) 
appropriate for verification of

[[Page 140]]

the records, reports, documents referred to above or otherwise bearing 
on the provisions of the Act and the regulations thereunder.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 
FR 32465, June 22, 1995]

Sec. 1316.04  Exclusion from inspection.

    (a) Unless the owner, operator or agent in charge of the controlled 
premises so consents in writing, no inspection authorized by these 
regulations shall extend to:
    (1) Financial data:
    (2) Sales data other than shipping data; or
    (3) Pricing data.
    (b) [Reserved]

Sec. 1316.05  Entry.

    An inspection shall be carried out by an inspector. Any such 
inspector, upon (a) stating his purpose and (b) presenting to the owner, 
operator or agent in charge of the premises to be inspected (1) 
appropriate credentials, and (2) written notice of his inspection 
authority under Sec. 1316.06 of this chapter, and (c) receiving informed 
consent under Sec. 1316.08 or through the use of administrative warrant 
issued under Secs. 1316.09-1316.13, shall have the right to enter such 
premises and conduct inspections at reasonable times and in a reasonable 
manner.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, l973; 62 FR 13970, Mar. 24, 1997]

Sec. 1316.06  Notice of inspection.

    The notice of inspection (DEA (or DNB) Form 82) shall contain:
    (a) The name and title of the owner, operator, or agent in charge of 
the controlled premises;
    (b) The controlled premises name;
    (c) The address of the controlled premises to be inspected;
    (d) The date and time of the inspection;
    (e) A statement that a notice of inspection is given pursuant to 
section 510 of the Act (21 U.S.C. 880);
    (f) A reproduction of the pertinent parts of section 510 of the Act; 
and
    (g) The signature of the inspector.

Sec. 1316.07  Requirement for administrative inspection warrant; 
          exceptions.

    In all cases where an inspection is contemplated, an administrative 
inspection warrant is required pursuant to section 510 of the Act (21 
U.S.C. 880), except that such warrant shall not be required for 
establishments applying for initial registration under the Act, for the 
inspection of books and records pursuant to an administrative subpoena 
issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for 
entries in administrative inspections (including seizures of property):
    (a) With the consent of the owner, operator, or agent in charge of 
the controlled premises as set forth in Sec. 1316.08;
    (b) In situations presenting imminent danger to health or safety;
    (c) In situations involving inspection of conveyances where there is 
reasonable cause to obtain a warrant;
    (d) In any other exceptional or emergency circumstance or time or 
opportunity to apply for a warrant is lacking; or
    (e) In any other situations where a warrant is not constitutionally 
required.

Sec. 1316.08  Consent to inspection.

    (a) An administrative inspection warrant shall not be required if 
informed consent is obtained from the owner, operator, or agent in 
charge of the controlled premises to be inspected.
    (b) Wherever possible, informed consent shall consist of a written 
statement signed by the owner, operator, or agent in charge of the 
premises to be inspected and witnessed by two persons. The written 
consent shall contain the following information:
    (1) That he (the owner, operator, or agent in charge of the 
premises) has been informed of his constitutional right not to have an 
administrative inspection made without an administrative inspection 
warrant;
    (2) That he has right to refuse to consent to such an inspection;
    (3) That anything of an incriminating nature which may be found may 
be seized and used against him in a criminal prosecution;
    (4) That he has been presented with a notice of inspection as set 
forth in Sec. 1316.06;

[[Page 141]]

    (5) That the consent is given by him is voluntary and without 
threats of any kind; and
    (6) That he may withdraw his consent at any time during the course 
of inspection.
    (c) The written consent shall be produced in duplicate and be 
distributed as follows:
    (1) The original will be retained by the inspector; and
    (2) The duplicate will be given to the person inspected.
[36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1316.09  Application for administrative inspection warrant.

    (a) An administrative inspection warrant application shall be 
submitted to any judge of the United States or of a State court of 
record, or any United States magistrate and shall contain the following 
information:
    (1) The name and address of the controlled premises to be inspected;
    (2) A statement of statutory authority for the administrative 
inspection warrant, and that the fact that the particular inspection in 
question is designed to insure compliance with the Act and the 
regulations promulgated thereunder;
    (3) A statement relating to the nature and extent of the 
administrative inspection, including, where necessary, a request to 
seize specified items and/or to collect samples of finished or 
unfinished controlled substances or listed chemicals;
    (4) A statement that the establishment either:
    (i) Has not been previously inspected, or
    (ii) Was last inspected on a particular date.
    (b) The application shall be submitted under oath to an appropriate 
judge or magistrate.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995]

Sec. 1316.10  Administrative probable cause.

    If the judge or magistrate is satisfied that ``administrative 
probable cause,'' as defined in section 510(d)(1) of the Act (21 U.S.C. 
880(d)(1)) exists, he shall issue an administrative warrant. 
Administrative probable cause shall not mean criminal probable cause as 
defined by Federal statute or case law.

Sec. 1316.11  Execution of warrants.

    An administrative inspection warrant shall be executed and returned 
as required by, and any inventory or seizure made shall comply with the 
requirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The 
inspection shall begin as soon as is practicable after the issuance of 
the administrative inspection warrant and shall be completed with 
reasonable promptness. The inspection shall be conducted during regular 
business hours and shall be completed in a reasonable manner.

Sec. 1316.12  Refusal to allow inspection with an administrative 
          warrant.

    If a registrant or any person subject to the Act refuses to permit 
execution of an administrative warrant or impedes the inspector in the 
execution of that warrant, he shall be advised that such refusal or 
action constitutes a violation of section 402(a)(6) of the Act (21 
U.S.C. 842(a)(6)). If he persists and the circumstances warrant, he 
shall be arrested and the inspection shall commence or continue.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]

Sec. 1316.13  Frequency of administrative inspections.

    Except where circumstances otherwise dictate, it is the intent of 
the Administration to inspect all manufacturers of controlled substances 
listed in Schedules I and II and distributors of controlled substances 
listed in Schedule I once each year. Distributors of controlled 
substances listed in Schedules II through V and manufacturers of 
controlled substances listed in Schedules III through V shall be 
inspected as circumstances may require, based in part on the 
registrant's history of compliance with the requirements of this chapter 
and maintenance of effective controls and procedures to guard

[[Page 142]]

against the diversion of controlled substances.
[62 FR 13969, Mar. 24, 1997]

       Subpart B--Protection of Researchers and Research Subjects

    Authority:  21 U.S.C. 830, 871(b).

Sec. 1316.21  Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) The term investigative personnel includes managers, Diversion 
Investigators, attorneys, analysts and support personnel employed by the 
Drug Enforcement Administration who are involved in the processing, 
reviewing and analyzing of declarations and other relevant documents or 
data relative to regulated transactions or are involved in conducting 
investigations initiated pursuant to the receipt of such declarations, 
documents or data.
    (b) The term law enforcement personnel means Special Agents employed 
by the Drug Enforcement Administration who, in the course of their 
official duties, gain knowledge of information which is confidential 
under such section.
[54 FR 31670, Aug. 1, 1989]

Sec. 1316.22  Exemption.

    (a) Any person who is aggrieved by a disclosure of information in 
violation of subsection (c)(1) of Section 310 of the Controlled 
Substances Act (21 U.S.C. 830) may bring a civil action against the 
violator for appropriate relief.
    (b) Notwithstanding the provision of paragraph (a), a civil action 
may not be brought under such paragraph against investigative or law 
enforcement personnel of the Drug Enforcement Administration.
[54 FR 31670, Aug. 1, 1989]

Sec. 1316.23  Confidentiality of identity of research subjects.

    (a) Any person conducting a bona fide research project directly 
related to the enforcement of the laws under the jurisdiction of the 
Attorney General concerning drugs or other substances which are or may 
be subject to control under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the 
identity of those persons who are the subjects of such research may 
petition the Administrator of the Drug Enforcement Administration for a 
grant of confidentiality: Providing, That:
    (1) The Attorney General is authorized to carry out such research 
under the provisions of Section 502(a) (2-6) of the Controlled 
Substances Act of 1970 (21 U.S.C. 872(a) (2-6)); and the research is 
being conducted with funds provided in whole or part by the Department 
of Justice; or
    (2) The research is of a nature that the Attorney General would be 
authorized to carry out under the provisions of Section 502(a) (2-6) of 
the Controlled Substances Act (21 U.S.C. 872(a) (2-6), and is being 
conducted with funds provided from sources outside the Department of 
Justice.
    (b) All petitions for Grants of Confidentiality shall be addressed 
to the Administrator, Drug Enforcement Administration, Washington, DC 
20537, and shall contain the following:
    (1) A statement as to whether the research protocol requires the 
manufacture, production, import, export, distribution, dispensing, 
administration, or possession of controlled substances, and if so the 
researcher's registration number or a statement that an application for 
such registration has been submitted to DEA;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;

[[Page 143]]

    (8) A specific request to withhold the names and/or any other 
identifying characteristics of the research subjects; and
    (9) Statements establishing that a grant of confidentiality is 
necessary to the successful completion of the research project.
    (c) The grant of confidentiality of identity of research subjects 
shall consist of a letter issued by the Administrator, which shall 
include:
    (1) The researcher's name and address.
    (2) The researcher's registration number, if applicable.
    (3) The title and purpose of the research.
    (4) The location of the research project.
    (5) An authorization for all persons engaged in the research to 
withhold the names and identifying characteristics of persons who are 
the subjects of such research, stating that persons who obtain this 
authorization may not be compelled in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceeding to 
identify the subjects of such research for which this authorization was 
obtained.
    (6) The limits of this authorization, if any.
    (7) A statement to the effect that the grant of confidentiality of 
identity of research subjects shall be perpetual but shall pertain only 
to the subjects of the research described in the research protocol, the 
description of the research submitted to DEA, or as otherwise 
established by DEA.
    (d) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (c) of this section and stating the starting and 
finishing dates of the research for which the confidentiality of 
identity of research subjects was granted; upon receipt of this letter, 
the research shall return the original letter of exemption.
[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997]

Sec. 1316.24  Exemption from prosecution for researchers.

    (a) Upon registration of an individual to engage in research in 
controlled substances under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801), the Administrator of the Drug Enforcement 
Administration, on his own motion or upon request in writing from the 
Secretary or from the researcher or researching practitioner, may exempt 
the registrant when acting within the scope of his registration, from 
prosecution under Federal, State, or local laws for offenses relating to 
possession, distribution or dispensing of those controlled substances 
within the scope of his exemption. However, this exemption does not 
diminish any requirement of compliance with the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 301).
    (b) All petitions for Grants of Exemption from Prosecution for the 
Researcher shall be addressed to the Administrator, Drug Enforcement 
Administration, 1405 I Street NW., Washington, DC 20537 and shall 
contain the following:
    (1) The researcher's registration number if any, for the project;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request for exemption from prosecution by Federal, 
State, or local authorities for offenses related to the possession, 
distribution, and dispensing of controlled substances in accord with the 
procedures described in the research protocol;
    (9) A statement establishing that a grant of exemption from 
prosecution is

[[Page 144]]

necessary to the successful completinn of the research project.
    (c) Any researcher or practitioner proposing to engage in research 
requesting both exemption from prosecution and confidentiality of 
identity of research subjects may submit a single petition incorporating 
the information required in Sec. Sec. 1316.23(b) and 1316.24(b).
    (d) The exemption shall consist of a letter issued by the 
Administrator, which shall include:
    (1) The researcher's name and address;
    (2) The researcher's registration number for the research project;
    (3) The location of the research project;
    (4) A concise statement of the scope of the researcher's 
registration;
    (5) Any limits of the exemption; and
    (6) A statement that the exemption shall apply to all acts done in 
the scope of the exemption while the exemption is in effect. The 
exemption shall remain in effect until completion of the research 
project or until the registration of the researcher is either revoked or 
suspended or his renewal of registration is denied. However, the 
protection afforded by the grant of exemption from prosecution during 
the research period shall be perpetual.
    (e) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (d) of this section and stating the date of which 
the period of exemption concluded; upon receipt of this letter the 
researcher shall return the original letter of exemption.
[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997]

                   Subpart C--Enforcement Proceedings

    Authority:  21 U.S.C. 871(b), 883.

Sec. 1316.31  Authority for enforcement proceeding.

    A hearing may be ordered or granted by any Special Agent in Charge 
of the Drug Enforcement Administration, at his discretion, to permit any 
person against whom criminal and/or civil action is contemplated under 
the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) or the 
Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 
951) an opportunity to present his views and his proposals for bringing 
his alleged violations into compliance with the law. Such hearing will 
also permit him to show cause why prosecution should not be instituted, 
or to present his views on the contemplated proceeding.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]

Sec. 1316.32  Notice of proceeding; time and place.

    Appropriate notice designating the time and place for the hearing 
shall be given to the person. Upon request, timely and properly made, by 
the person to whom notice has been given, the time or place of the 
hearing, or both, may be changed if the request states reasonable 
grounds for such change. Such request shall be addressed to the Special 
Agent in Charge who issued the notice.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]

Sec. 1316.33  Conduct of proceeding.

    Presentation of views at a hearing under this subpart shall be 
private and informal. The views presented shall be confined to matters 
relevant to bringing violations into compliance with the Act or to other 
contemplated proceedings under the Act. These views may be presented 
orally or in writing by the person to whom the notice was given, or by 
his authorized representative.

Sec. 1316.34  Records of proceeding.

    A formal record, either verbatim or summarized, of the hearing may 
be made at the discretion of the Special Agent in Charge. If a verbatim 
record is to be made, the person attending the hearing will be so 
advised prior to the start of the hearing.
[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]

[[Page 145]]

                   Subpart D--Administrative Hearings

    Authority:  21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.

Sec. 1316.41  Scope of subpart D.

    Procedures in any administrative hearing held under the Act are 
governed generally by the rule making and/or adjudication procedures set 
forth in the Administrative Procedure Act (5 U.S.C. 551-559) and 
specifically by the procedures set forth in this subpart, except where 
more specific regulations (set forth in Secs. 1301.51-1301.57, 
Secs. 1303.31-1303.37, Secs. 1308.41-1308.51, Secs. 1311.51-1311.53, 
Secs. 1312.41-1312.47, or Secs. 1313.51-1313.57) apply.
[36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, 
Mar. 24, 1997]

Sec. 1316.42  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (c) The term hearing means any hearing held pursuant to the Act.
    (d) The term Hearing Clerk means the hearing clerk of the 
Administration.
    (e) The term person includes an individual, corporation, government 
or governmental subdivision or agency, business trust, partnership, 
association or other legal entitx.
    (f) The term presiding officer means an administrative law judge 
qualified and appointed as provided in the Administrative Procedure Act 
(5 U.S.C. 556).
    (g) The term proceeding means all actions involving a hearing, 
colmencing with the publication by the Administrator of the notice of 
proposed rule making or the issuance of an order to show cause.
    (h) Any term not defined 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.
[36 FR 7820, Apr. 24, 1971, as amended at 38 FR 757, Jan. 4, 1973. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13969, 
Mar. 24, 1997]

Sec. 1316.43  Information; special instructions.

    Information regarding procedure under these rules and instructions 
supplementing these rules in special instances will be furnished by the 
Hearing Clerk upon request.

Sec. 1316.44  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this subpart by 
notice in advance of the hearing, if he determines that no party in the 
hearing will be unduly prejudiced and the ends of justice will thereby 
be served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

Sec. 1316.45  Filings; address; hours.

    Documents required or permitted to be filed in, and correspondence 
relating to, hearings governed by the regulations in this chapter shall 
be filed with the Hearing Clerk, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537. This office is open Monday 
through Friday from 8:30 a.m. to 5 p.m. eastern standard or daylight 
saving time, whichever is effective in the District of Columbia at the 
time, except on national legal holidays. Documents shall be dated and 
deemed filed upon receipt by the Hearing Clerk.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 55 FR 27464, July 3, 1990]

Sec. 1316.46  Inspection of record.

    (a) The record bearing on any proceeding, except for material 
described in subsection (b) of this section, shall be available for 
inspection and copying by any person entitled to participate in such 
proceeding, during office hours in the office of the Hearing Clerk, Drug

[[Page 146]]

Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) The following material shall not be available for inspection as 
part of the record:
    (1) A research protocol filed with an application for registration 
to conduct research with controlled substances listed in Schedule I, 
pursuant to Sec. 1301.32 (a)(6) of this chapter, if the applicant 
requests that the protocol be kept confidential;
    (2) An outline of a production or manufacturing process filed with 
an application for registration to manufacture a new narcotic controlled 
substance, pursuant to Sec. 1301.33 of this chapter, if the applicant 
requests that the outline be kept confidential;
    (3) Any confidential or trade secret information disclosed in 
conjunction with an application for registration, or in reports filed 
while registered, or acquired in the course of an investigation, 
entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C. 
842(a) (8)) or any other law restricting public disclosure of 
information; and
    (4) Any material contained in any investigatory report, memorandum, 
or file, or case report compiled by the Administration.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]

Sec. 1316.47  Request for hearing.

    (a) Any person entitled to a hearing and desiring a hearing shall, 
within the period permitted for filing, file a request for a hearing in 
the following form:

------------ (Date)

Administrator, Drug Enforcement Administration, United States Department 
of Justice, Washington, DC 20537, Attention: DEA Federal Register 
Representative.

    Dear Sir: The undersigned -------------------- (Name of person) 
hereby requests a hearing in the matter of: ------------------------ 
(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to the proceeding should be 
addressed to:
 _______________________________________________________________________

                                 (Name)

 _______________________________________________________________________

                            (Street address)

 _______________________________________________________________________

                            (City and State)

    Respectfully yours,
 _______________________________________________________________________

                          (Signature of person)

    (b) The Administrative Law Judge, upon request and showing of good 
cause, may grant a reasonable extension of the time allowed for response 
to an Order to Show Cause.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting 
Sec. 1316.47, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

Sec. 1316.48  Notice of appearance.

    Any person entitled to a hearing and desiring to appear in any 
hearing, shall, if he has not filed a request for hearing, file within 
the time specified in the notice of proposed rule making, a written 
notice of appearance in the following form:

------------ (Date)

Administrator, Drug Enforcement Administration, United States Department 
of Justice, Washington, DC 20537, Attention: DEA Federal Register 
Representative.

    Dear Sir: Please take notice that -------------------- (Name of 
person) will appear in the matter of: ------------------------ 
(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to this appearance should be 
addressed to:

 _______________________________________________________________________

                                 (Name)

 _______________________________________________________________________

[[Page 147]]

                            (Street address)

 _______________________________________________________________________

                            (City and State)

    Respectfully yours,

 _______________________________________________________________________

                          (Signature of person)

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 40 FR 57210, 
Dec. 8, 1975]

Sec. 1316.49  Waiver of hearing.

    Any person entitled to a hearing may, within the period permitted 
for filing a request for hearing or notice of appearance, waiver of an 
opportunity for a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such statement, if admissible, shall be made a part of the record and 
shall be considered in light of the lack of opportunity for crors-
examination in determining the weight to be attached to matters of fact 
asserted therein.

Sec. 1316.50  Appearance; representation; authorization.

    Any person entitled to appear in a hearing may appear in person or 
by a representative in any proceeding or hearing and may be heard with 
respect to matters relevant to the issues under consideration. A 
representative must either be an employee of the person or an attorney 
at law who is a member of the bar, in good standing, of any State, 
territory, or the District of Columbia, and admitted to practice before 
the highest court of that jurisdiction. Any representative may be 
required by the Administrator or the presiding officer to present a 
notarized power of attorney showing his authority to act in such 
representative capacity and/or an affidavit or certificate of admission 
to practice.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1316.51  Conduct of hearing and parties; ex parte communications.

    (a) Hearings shall be conducted in an informal but orderly manner in 
accordance with law and the directions of the presiding officer.
    (b) Participants in any hearing and their representatives, whether 
or not members of the bar, shall conduct themselves in accordance with 
judicial standards of practice and ethics and the directions of the 
presiding officer. Refusal to comply with this section shall constitute 
grounds for immediate exclusion from any hearing.
    (c) If any official of the Administration is contacted by any 
individual in private or public life concerning any substantive matter 
which is the subject of any hearing, at any time after the date on which 
the proceedings commence, the official who is contacted shall prepare a 
memorandum setting forth the substance of the conversation and shall 
file this memorandum in the appropriate public docket file. The 
presiding officer and employees of the Administration shall comply with 
the requirements of 5 U.S.C. 554(d) regarding ex parte communications 
and participation in any hearing.

Sec. 1316.52  Presiding officer.

    A presiding officer, designated by the Administrator, shall preside 
over all hearings. The functions of the presiding officer shall commence 
upon his designation and terminate upon the certification of the record 
to the Administrator. The presiding officer shall have the duty to 
conduct a fair hearing, to take all necessary action to avoid delay, and 
to maintain order. He shall have all powers necessary to these ends, 
including (but not limited to) the power to:
    (a) Arrange and change the date, time, and place of hearings (other 
than the time and place prescribed in Sec. 1301.56) and prehearing 
conferences and issue notice thereof.
    (b) Hold conferences to settle, simplify, or determine the issues in 
a hearing, or to consider other matters that may aid in the expeditious 
disposition of the hearing.
    (c) Require parties to state their position in writing with respect 
to the various issues in the hearing and to exchange such statements 
with all other parties.
    (d) Sign and issue subpoenas to compel the attendance of witnesses 
and the

[[Page 148]]

production of documents and materials to the extent necessary to conduct 
administrative hearings pending before him.
    (e) Examine witnesses and direct witnesses to testify.
    (f) Receive, rule on, exclude, or limit evidence.
    (g) Rule on procedural items pending before him.
    (h) Take any action permitted to the presiding officer as authorized 
by this part or by the provisions of the Administrative Procedure Act (5 
U.S.C. 551-559).
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 42 FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, 1997]

Sec. 1316.53  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
notice of hearing published in the Federal Register but thereafter it 
may be moved to a different place and may be continued from day to day 
or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.

Sec. 1316.54  Prehearing conference.

    The presiding officer on his own motion, or on the motion of any 
party for good cause shown, may direct all parties to appear at a 
specified time and place for a conference for:
    (a) The simplification of the issues.
    (b) The possibility of obtaining stipulations, admission of facts, 
and documents.
    (c) The possibility of limiting the number of expert witnesses.
    (d) The identification and, if practicable, the scheduling of all 
witnesses to be called.
    (e) The advance submission at the prehearing conference of all 
documentary evidence and affidavits to be marked for identification.
    (f) Such other matters as may aid in the expeditious disposition of 
the hearing.

Sec. 1316.55  Prehearing ruling.

    The presiding officer may have the prehearing conference reported 
verbatim and shall make a ruling reciting the action taken at the 
conference, the agreements made by the partier, the schedule of 
witnesses, and a statement of the issues for hearing. Such ruling shall 
control the subsequent course of the hearing unless modified by a 
subsequent ruling.

Sec. 1316.56  Burden of proof.

    At any hearing, the proponent for the issuance, amendment, or repeal 
of any rule shall have the burden of proof.

Sec. 1316.57  Submission of documentary evidence and affidavits and 
          identification of witnesses subsequent to prehearing 
          conference.

    All documentary evidence and affidavits not submitted and all 
witnesses not identified at the prehearing conference shall be submitted 
or identified to the presiding officer as soon as possible, with a 
showing that the offering party had good cause for failing to so submit 
or identify at the prehearing conference. If the presiding officer 
determines that good cause does exist, the documents or affidavits shall 
be submitted or witnesses identified to all parties sufficiently in 
advance of the offer of such documents or affidavits or witnesses at the 
hearing to avoid prejudice or surprise to the other parties. If the 
presiding officer determines that good cause does not exist, he may 
refuse to admit as evidence such documents or affidavits or the 
testimony of such witnesses.

Sec. 1316.58  Summary of testimony; affidavits.

    (a) The presiding officer may direct that summaries of the direct 
testimony of witnesses be prepared in writing and served on all parties 
in advance of the hearing. Witnesses will not be permitted to read 
summaries of their testimony into the record and all witnesses shall be 
available for cross-examination. Each witness shall, before proceeding 
to testify, be sworn or make affirmation.
    (b) Affidavits submitted at the prehearing conference or pursuant to 
Sec. 1316.57 with good cause may be examined by all parties and opposing 
affidavits may be submitted to the presiding officer within a perhod of 
time fixed by him. Affidavits admitted into evidence shall be considered 
in light of the lack

[[Page 149]]

of opportunity for cross-examination in determining the weight to be 
attached to statements made therein.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1316.59  Submission and receipt of evidence.

    (a) The presiding officer shall admit only evidence that is 
competent, relevant, material and not unduly repetitious.
    (b) Opinion testimony shall be admitted when the presiding officer 
is satisfied that the witness is properly qualified.
    (c) The authenticity of all documents submitted in advance shall be 
deemed admitted unless written objection thereto is filed with the 
presiding officer, except that a party will be permitted to challenge 
such authenticity at a later time upon a showing of good cause for 
failure to have filed such written objection.
    (d) Samples, if otherwise admissible into evidence, may be displayed 
at the hearing and may be described for purposes of the record, or may 
be admitted in evidence as exhibits.
    (e) Where official notice is taken or is to be taken of a material 
fact not appearing in the evidence of record, any party, on timely 
request, shall be afforded opportunity to controvert such fact.
    (f) The presiding officer shall file as exhibits copies of the 
folloving documents:
    (1) The order to show cause or notice of hearing;
    (2) Any notice of waiver or modification of rules made pursuant to 
Sec. 1316.44 or otherwise;
    (3) Any waiver of hearing (together with any statement filed 
therewith) filed pursuant to Sec. 1316.49 or otherwise;
    (4) The prehearing ruling, if any, made pursuant to Sec. 1316.55;
    (5) Any other document necessary to show the basis for the hearing.

Sec. 1316.60  Objections; offer of proof.

    If any party in the hearing objects to the admission or rejection of 
any evidence or to other limitation of the scope of any examination or 
cross-examination, he shall state briefly the grounds for such objection 
without extended argument or debate thereon except as permitted by the 
presiding officer. A ruling of the presiding officer on any such 
objection shall be a part of the transcript together with such offer of 
proof as has been made if a proper foundation has been laid for its 
admission. An offer of proof made in connection with an objection taken 
to any ruling of the presiding officer rejecting or excluding proffered 
oral testimony shall consist of a statement of the substance of the 
evidence which the party contends would be adduced by such testimony; 
and, if the excluded evidence consists of evidence in documentary or 
written form a copy of such evidence shall be marked for identification 
and shall accompany the records as the offer of proof.

Sec. 1316.61  Exceptions to rulings.

    Exceptions to rulings of the presiding officer are unnecessary. It 
is sufficient that a party, at the time the ruling of the presiding 
officer is sought, makes known the action that he desires the presiding 
officer to take, or his objection to an action taken, and his grounds 
therefor.

Sec. 1316.62  Appeal from ruling of presiding officer.

    Rulings of the presiding officer may not be appealed to the 
Administrator prior to his consideration of the entire hearing, except 
with the consent of the presiding officer and where he certifies on the 
record or in writing that the allowance of an interlocutory appeal is 
clearly necessary to prevent exceptional delay, expense, or prejudice to 
any party or substantial detriment to the public interest. If an appeal 
is allowed, any party in the hearing may file a brief in quintuplicate 
with the Administrator within such period that the presiding officer 
directs. No oral argument will be heard unless the Administrator directs 
otherwise.

Sec. 1316.63  Official transcript; index; corrections.

    (a) Testimony given at a hearing shall be reported verbatim. The 
Administration will make provision for a stenographic record of the 
testimony and for such copies of the transcript

[[Page 150]]

thereof as it requires for its own purpose.
    (b) At the close of the hearing, the presiding officer shall afford 
the parties and witnesses time (not longer than 30 days, except in 
unusual cases) in which to submit written proposed corrections of the 
transcript, pointing out errors that may have been made in transcribing 
the testimony. The presiding officer shall promptly thereafter order 
such corrections made as in his judgment are required to make the 
transcript conform to the testimony.
[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 2046, 
Jan. 15, 1985]

Sec. 1316.64  Proposed findings of fact and conclusions of law.

    Any party in the hearing may file in quintuplicate proposed findings 
of fact and conclusions of law within the time fixed by the presiding 
officer. Any party so filing shall also serve one copy of his proposed 
findings and conclusion upon each other party in the hearing. The party 
shall include a statement of supporting reasons for the proposed 
findings and conclusions, together with evidence of record (including 
specific and complete citations of the pages of the transcript and 
exhibits) and citations of authorities relied upon.

Sec. 1316.65  Report and record.

    (a) As soon as practicable after the time for the parties to file 
proposed findings of fact and conclusions of law has expired, the 
presiding officer shall prepare a report containing the following:
    (1) His recommended rulings on the proposed findings of fact and 
conclusions of law;
    (2) His recommended findings of fact and conclusions of law, with 
the reasons therefore; and
    (3) His recommended decision.
    (b) The presiding officer shall serve a copy of his report upon each 
party in the hearing. The report shall be considered to have been served 
when it is mailed to such party or its attorney of record.
    (c) Not less than twenty-five days after the date on which he caused 
copies of his report to be served upon the parties, the presiding 
officer shall certify to the Administrator the record, which shall 
contain the transcript of testimony, exhibits, the findings of fact and 
conclusions of law proposed by the parties, the presiding officer's 
report, and any exceptions thereto which may have been filed by the 
parties.
[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 55332, Sept. 26, 1979]

Sec. 1316.66  Exceptions.

    (a) Within twenty days after the date upon which a party is served a 
copy of the report of the presiding officer, such party may file with 
the Hearing Clerk, Office of the Administrative Law Judge, exceptions to 
the recommended decision, findings of fact and conclusions of law 
contained in the report. The party shall include a statement of 
supporting reasons for such exceptions, together with evidence of record 
(including specific and complete citations of the pages of the 
transcript and exhibits) and citations of the authorities relied upon.
    (b) The Hearing Clerk shall cause such filings to become part of the 
record of the proceeding.
    (c) The Administrative Law Judge may, upon the request of any party 
to a proceeding, grant time beyond the twenty days provided in paragraph 
(a) of this section for the filing of a response to the exceptions filed 
by another party if he determines that no party in the hearing will be 
unduly prejudiced and that the ends of justice will be served thereby. 
Provided however, that each party shall be entitled to only one filing 
under this section; that is, either a set of exceptions or a response 
thereto.
[44 FR 55332, Sept. 26, 1979]

Sec. 1316.67  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his final order in the proceeding, 
which shall set forth the final rule and the findings of fact and 
conclusions of law upon which the rule is based. This order shall 
specify the date on which it shall take effect,

[[Page 151]]

which date shall not be less than 30 days from the date of publication 
in the Federal Register unless the Administrator finds that the public 
interest in the matter necessitates an earlier effective date, in which 
event the Administrator shall specify in the order his findings as to 
the conditions which led him to conclude that an earlier effective date 
was required.
[44 FR 42179, July 19, 1979, as amended at 44 FR 55332, Sept. 26, 1979]

Sec. 1316.68  Copies of petitions for judicial review.

    Copies of petitions for judicial review, filed pursuant to section 
507 of the Act (21 U.S.C. 877) shall be delivered to and served upon the 
Administrator in quintuplicate. The Administrator shall certify the 
record of the hearing and shall file the certified record in the 
appropriate U.S. Court of Appeals.
[36 FR 7820, Apr. 24, 1971. Redesignated at 44 FR 42179, July 19, 1979]

       Subpart E--Seizure, Forfeiture, and Disposition of Property

    Authority:  21 U.S.C 871(b), 881, 965, 19 U.S.C. 1606, 1607, 1608, 
1610, 1613, 1618, 28 U.S.C. 509, 510.

Sec. 1316.71  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term custodian means the officer required under Sec. 1316.72 
to take custody of particular property which has been seized pursuant to 
the Act.
    (c) The term property means a controlled substance, raw material, 
product, container, equipment, money or other asset, vessel, vehicle, or 
aircraft within the scope of the Act.
    (d) The terms seizing officer, officer seizing, etc., mean any 
officer, authorized and designated by Sec. 1316.72 to carry out the 
provisions of the Act, who initially seizes property or adopts a seizure 
initially made by any other officer or by a private person.
    (e) The term Special Agents-in-Charge means Drug Enforcement 
Administration Special Agents-in-Charge or Resident Agents in Charge and 
Federal Bureau of Investigation Special Agents-in-Charge.
    (f) Any term not defined in this section shall have the definition 
set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 20096, Mar. 27, 1980; 47 FR 43370, Oct. 1, 1982; 49 
FR 28701, July 16, 1984; 62 FR 13969, Mar. 24, 1997]

Sec. 1316.72  Officers who will make seizures.

    For the purpose of carrying out the provisions of the Act, all 
special agents of the Drug Enforcement Administration and the Federal 
Bureau of Investigation are authorized and designated to seize such 
property as may be subject to seizure.
[47 FR 43370, Oct. 1, 1982]

Sec. 1316.73  Custody and other duties.

    An officer seizing property under the Act shall store the property 
in a location designated by the custodian, generally in the judicial 
district of seizure. The Special Agents-in-Charge are designated as 
custodians to receive and maintain in storage all property seized 
pursuant to the Act, are authorized to dispose of any property pursuant 
to the Act and any other applicable statutes or regulations relative to 
disposal, and to perform such other duties regarding such seized 
property as are appropriate, including the impound release of property 
pursuant to 28 CFR 0.101(c).
[47 FR 43370, Oct. 1, 1982]

Sec. 1316.74  Appraisement.

    The custodian shall appraise the property to determine the domestic 
value at the time and place of seizure. The domestic value shall be 
considered the price at which such or similar property is freely offered 
for sale. If there is no market for the property at the place of 
seizure, the domestic value shall be considered the value in the 
principal market nearest the place of seizure.


[[Page 152]]


(Sec. 606, 46 Stat. 754 (19 U.S.C. 1606))
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 52 FR 41418, Oct. 28, 1987]

Sec. 1316.75  Advertisement.

    (a) If the appraised value does not exceed the monetary amount set 
forth in title 19, United States Code, Section 1607; the seized 
merchandise is any monetary instrument within the meaning of section 
5312(a)(3) of title 31 of the United States Code; or if a conveyance 
used to import, export or otherwise transport or store any controlled 
substance is involved, the custodian or DEA Asset Forfeiture Section 
shall cause a notice of the seizure and of the intention to forfeit and 
sell or otherwise dispose of the property to be published once a week 
for at least 3 successive weeks in a newspaper of general circulation in 
the judicial district in which the processing for forfeiture is brought.
    (b) The notice shall: (1) Describe the property seized and show the 
motor and serial numbers, if any; (2) state the time, cause, and place 
of seizure; and (3) state that any person desiring to claim the property 
may, within 20 days from the date of first publication of the notice, 
file with the custodian or DEA Asset Forfeiture Section a claim to the 
property and a bond with satisfactory sureties in the sum of $5,000 or 
ten percent of the value of the claimed property whichever is lower, but 
not less than $250.

(Sec. 607, 46 Stat. 754, as amended (19 U.S.C. 1607); Pub. L. 98-473, 
Pub. L. 98-573)
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 52 FR 24446, July 1, 1987; 56 FR 8686, Mar. 1, 
1991]

Sec. 1316.76  Requirements as to claim and bond.

    (a) The bond shall be rendered to the United States, with sureties 
to be approved by the custodian or DEA Asset Forfeiture Section, 
conditioned that in the case of condemnation of the property the obligor 
shall pay all costs and expenses of the proceedings to obtain such 
condemnation. When the claim and bond are received by the custodian or 
DEA Asset Forfeiture Section, he shall, after finding the documents in 
proper form and the sureties satisfactory, transmit the documents, 
together with a description of the property and a complete statement of 
the facts and circumstances surrounding the seizure, to the United 
States Attorney for the judicial district in which the proceeding for 
forfeiture is brought. If the documents are not in satisfactory 
condition when first received, a reasonable time for correction may be 
alloved. If correction is not made within a reasonable time the 
documents may be treated as nugatory, and the case shall proceed as 
though they had not been tendered.
    (b) The filing of the claim and the posting of the bond does not 
entitle the claimant to possession of the property, however, it does 
stop the administrative forfeiture proceedings. The bond posted to cover 
corts may be in cash, certified check, or satisfactory sureties. The 
costs and expenses secured by the bond are such as are incurred after 
the filing of the bond including storage cost, safeguarding, court fees, 
marshal's costs, etc.

(Sec. 608, 46 Stat. 755 (19 U.S.C. 1608); Pub. L. 98-473, Pub. L. 98-
573)
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 49 FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 
FR 8686, Mar. 1, 1991]

Sec. 1316.77  Administrative forfeiture.

    (a) For property seized by officers of the Drug Enforcement 
Administration, if the appraised value does not exceed the 
jurisdictional limits in Sec. 1316.75(a), and a claim and bond are not 
filed within the 20 days hereinbefore mentioned, the DEA Special Agent-
in-Charge or DEA Asset Forfeiture Section shall declare the property 
forfeited. The DEA Special Agent-in-Charge or DEA Asset Forfeiture 
Section shall prepare the Declaration of Forfeiture and forward it to 
the Administrator of the Administration as notification of the action he 
has taken. Thereafter, the property shall be retained in the district of 
the DEA Special Agent-in-Charge or DEA Asset Forfeiture Section or 
delivered elsewhere for official use, or otherwise disposed of, in 
accordance with official instructions received by the DEA Special

[[Page 153]]

Agent-in-Charge or DEA Asset Forfeiture Section.
    (b) For property seized by officers of the Federal Bureau of 
Investigation, if the appraised value does not exceed the jurisdictional 
limits in Sec. 1316.75(a), and a claim and bond are not filed within the 
20 days hereinbefore mentioned, the FBI Property Management Officer 
shall declare the property forfeited. The FBI Property Management 
Officer shall prepare the Declaration of Forfeiture. Thereafter, the 
property shall be retained in the field office or delivered elsewhere 
for official use, or otherwise disposed of, in accordance with the 
official instructions of the FBI Property Management Officer.

(28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98-473, Pub. 
L. 98-573)
[48 FR 35087, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 
1997]

Sec. 1316.78  Judicial forfeiture.

    If the appraised value is greater than the jurisdictional limits in 
Sec. 1316.75(a) or a claim and satisfactory bond have been received for 
property the jurisdictional limits in Sec. 1316.76, the custodian or DEA 
Asset Forfeiture Section shall transmit a description of the property 
and a complete statement of the facts and circumstances surrounding the 
seizure to the U.S. Attorney for the judicial district in which the 
proceeding for forfeiture is sought for the purpose of instituting 
condemnation proceedings. The U.S. Attorney shall also be furnished the 
newspaper advertisements required by Sec. 1316.75. The Forfeiture 
Counsel of DEA shall make applications to the U.S. District Courts to 
place property in official DEA use.

(Sec. 610, 46 Stat. 755 (19 U.S.C. 1610); Pub. L. 98-473, Pub. L. 98-
573)
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 
FR 32174, Aug. 13, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 
1991]

Sec. 1316.79  Petitions for remission or mitigation of forfeiture.

    (a) Any person interested in any property which has been seized, or 
forfeited either administratively or by court proceedings, may file a 
petition for remission or mitigation of the forfeiture. Such petition 
shall be filed in triplicate with the DEA Asset Forfeiture Section or 
Special Agent-in-Charge of the DEA or FBI, depending upon which agency 
seized the property, for the judicial district in which the proceeding 
for forfeiture is brought. It shall be addressed to the Director of the 
FBI or the Administrator of the DEA, depending upon which agency seized 
the property, if the property is subject to administrative forfeiture 
pursuant to Sec. 1316.77, and addressed to the Attorney General if the 
property is subject to judicial forfeiture pursuant to Sec. 1316.78. The 
petition must be executed and sworn to by the person alleging interest 
in the property.
    (b) The petition shall include the following: (1) A complete 
description of the property, including motor and serial numbers, if any, 
and the date and place of seizure; (2) the petitioner's interest in the 
property, which shall be supported by bills of sale, contracts, 
mortgages, or other satisfactory documentary evidence; and, (3) the 
facts and circumstances, to be established by satisfactory proof, relied 
upon by the petitioner to justify remission or mitigation.
    (c) Where the petition is for restoration of the proceeds of sale, 
or for value of the property placed in official use, it must be 
supported by satisfactory proof that the petitioner did not know of the 
seizure prior to the declaration of condemnation of forfeiture and was 
in such circumstances as prevented him from knowing of the same.

(Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 1613, 1618; 28 
U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d)); Pub. L. 98-473, Pub. L. 
98-573)
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 48 FR 35088, Aug. 3, 1983; 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991]

Sec. 1316.80  Time for filing petitions.

    (a) In order to be considered as seasonably filed, a petition for 
remission or mitigation of forfeiture should be filed within 30 days of 
the receipt of the notice of seizure. If a petition for remission or 
mitigation of forfeiture has not been received within 30 days of

[[Page 154]]

the notice of seizure, the property will either be placed in official 
service or sold as soon as it is forfeited. Once property is placed in 
official use, or is sold, a petition for remission or mitigation of 
forfeiture can no longer be accepted.
    (b) A petition for restoration of proceeds of sale, or for the value 
of property placed in official use, must be filed within 90 days of the 
sale of the property, or within 90 days of the date the property is 
placed in official use.

(Secs. 613, 618, 46 Stat. 756, 757, as amended (19 U.S.C. 1613, 1618); 
Pub. L. 98-473, Pub. L. 98-573)
[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 49 FR 50643, Dec. 31, 1984]

Sec. 1316.81  Handling of petitions.

    Upon receipt of a petition, the custodian or DEA Asset Forfeiture 
System shall request an appropriate investigation. The petition and the 
report of investigation shall be forwarded to the Director of the FBI or 
to the Administrator of the DEA, depending upon which agency seized the 
property. If the petition involves a case which has been referred to the 
U.S. Attorney for the institution of court proceedings, the custodian or 
DEA Asset Forfeiture System shall transmit the petition to the U.S. 
Attorney for the judicial district in which the proceeding for 
forfeiture is brought. He shall notify the petitioner of this action.

(28 U.S.C. 509 and 510; 21 U.S.C. 871 and 881(d); Pub. L. 98-473, Pub. 
L. 98-573)
[48 FR 35088, Aug. 3, 1983, as amended at 49 FR 1178, Jan. 10, 1984; 49 
FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, Mar. 24, 
1997]

    Subpart F--Expedited Forfeiture Proceedings for Certain Property

    Authority:  21 U.S.C. 822, 871, 872, 880, 881, 881-1, 883, 958, 965; 
19 U.S.C. 1606, 1607, 1608, 1610, 1613, 1618; 28 U.S.C. 509, 510; Pub. 
L. No. 100-690, sec. 6079, 6080.

    Source:  54 FR 37610, Sept. 11, 1989, unless otherwise noted.

Sec. 1316.90  Purpose and scope.

    (a) The following definitions, regulations, and criteria are 
designed to establish and implement procedures required by sections 6079 
and 6080 of the Anti-Drug Abuse Act of 1988, Public Law No. 100-690 (102 
Stat. 4181). They are intended to supplement existing law and procedures 
relative to the forfeiture of property under the identified statutory 
authority. The provisions of these regulations do not affect the 
existing legal and equitable rights and remedies of those with an 
interest in property seized for forfeiture, nor do these provisions 
relieve interested parties from their existing obligations and 
responsibilities in pursuing their interests through such courses of 
action. These regulations are intended to reflect the intent of Congress 
to minimize the adverse impact on those entitled to legal or equitable 
relief occasioned by the prolonged detention of property subject to 
forfeiture due to violations of law involving personal use quantities of 
controlled substances, and conveyances seized for drug-related offenses. 
The definition of personal use quantities of a controlled substance as 
contained herein is intended to distinguish between those quantities 
small in amount which are generally considered to be possessed for 
personal consumption and not for further distribution, and those larger 
quantities generally considered to be subject to further distribution.
    (b) In this regard, for violations involving the porsession of 
personal use quantities of a controlled substance, section 6079(b)(2) 
requires either that administrative forfditure be completed within 21 
days of the seizure of the property, or alternatively, that procedures 
are established that provide a means by which an individual entitled to 
relief may initiate an expedited administrative review of the legal and 
factual basis of the seizure for forfeiture. Should an individual 
request relief pursuant to these regulations and be entitled to the 
return of the seized property, such property shall be returned 
immediately following that determination, and the administrative 
forfeiture process shall cease. Should the individual not be entitled to 
the return of the seized property, however, the administrative 
forfeiture of that property shall proceed. The owner may, in any event, 
obtain release of property

[[Page 155]]

pending the administrative forfeiture by submitting to the agency making 
the determination, property sufficient to preserve the government's 
vested interest for purposes of the administrative forfeiture.
    (c) Section 6080 requires a similar expedited review by the Attorney 
General or his representative in those instances where a conveyance is 
being forfeited in a civil judicial proceeding following its seizure for 
a drug-related offense.

Sec. 1316.91  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Appraised Value means the estimated domestic price at 
the time of seizure at which such or similar property is freely offered 
for sale.
    (b) The term Commercial Fishing Industry Vessel means a vessel that:
    (1) Commercially engages in the catching, taking, or harvesting of 
fish or an activity that can reasonably be expected to result in the 
catching, taking, or harvesting of fish;
    (2) Commercially prepares fish or fish products other than by 
gutting, decapitating, gilling, skinning, shucking, icing, freezing, or 
brine chilling; or
    (3) Commercially supplies, stores, refrigerates, or transports fish, 
fish products, or materials directly related to fishing or the 
preparation of fish to or from a fishing, fish processing, or fish 
tender vessel or fish processing facility.
    (c) The term Controlled Substance has the meaning given in section 
802 of title 21, United States Code (U.S.C.).
    (d) The term Drug-Related Offense means any proscribed offense which 
involves the possession, distribution, manufacture, cultivation, sale, 
transfer, or the attempt or conspiracy to possess, distribute, 
manufacture, cultivate, sell or transfer any substance the possession of 
which is prohibited by Title 21, U.S.C.
    (e) The term Immediately means within 20 days of the filing of a 
petition for expedited release by an owner.
    (f) The term Interested Party means one who was in legal possession 
of the property at the time of seizure and is entitled to legal 
possdssion at the time of the granting of the petition for expedited 
release. This includes a lienholder (to the extent of his interest in 
the property) whose claim is in writing (except for a maritime lien 
which need not be in writing), unless the collateral is in the 
porsession of the secured party. The agreement securing such lien must 
create or provide for a security interest in the collateral, describe 
the collateral, and be signed by the debtor.
    (g) The term Legal and Factual Basis of the Seizure means a 
statement of the applicable law under which the property is seized, and 
a statement of the circumstances of the seizure sufficiently precise to 
enable an owner or other interested party to identify the date, place, 
and use or acquisition which makes the property subject to forfeiture.
    (h) The term Normal and Customary Manner means that inquiry 
suggested by particular facts and circumstances which would customarily 
be undertaken by a reasonably prudent individual in a like or similar 
situation. Actual knowledge of such facts and circumstances is 
unnecessary, and implied, imputed, or constructive knowledge is 
sufficient. An established norm, standard, or custom is persuasive but 
not conclusive or controlling in determining whether an owner acted in a 
normal and customary manner to ascertain how property would be used by 
another legally in possession of the property. The failure to act in a 
normal and customary manner as defined herein will result in the denial 
of a petition for expedited release of the property and is intended to 
have the desirable effect of inducing owners of the property to exercise 
greater care in transferring possession of their property.
    (i) The term Owner means one having a legal and possessory interest 
in the property seized for forfeiture. Even though one may hold primary 
and direct title to the property seized, such person may not have 
sufficient actual beneficial interest in the property to support a 
petition as owner if the facts indicate that another person had dominion 
and control over the property.
    (j) The term Personal Use Quantities means possession of controlled 
substances in circumstances where there

[[Page 156]]

is no other evidence of an intent to distribute, of to facilitate the 
manufacturing, compounding, processing, delivering, importing or 
exporting of any controlled substance. Evidence of personal use 
quantities shall not include sweepings or other evidence of possession 
of quantities of a controlled substance for other than personal use.
    (1) Such other evidence shall include:
    (i) Evidence, such as drug scales, drug distribution paraphernalia, 
drug records, drug packaging material, method of drug packaging, drug 
``cutting'' agents and other equipment, that indicates an intent to 
process, package or distribute a controlled substance;
    (ii) Information from reliable sources indicating possession of a 
controlled substance with intent to distribute;
    (iii) The arrest and/or conviction record of the person or persons 
in actual or constructive possession of the controlled substance for 
offenses under Federal, State or local law that indicates an intent to 
distribute a controlled substance;
    (iv) The controlled substance is related to large amounts of cash or 
any amount of prerecorded government funds;
    (v) The controlled substance is possessed under circumstances that 
indicate such a controlled substance is a sample intended for 
distribution in anticipation of a transaction involving large 
quantities, or is part of a larger delivery; or
    (vi) Statements by the possessor, or otherwise attributable to the 
possessor, including statements of conspirators, that indicate 
possession with intent to distribute.
    (2) Possession of a controlled substance shall be presumed to be for 
personal use when there are no indicia of illicit drug trafficking or 
distribution such as, but not limited to, the factors listed above and 
the amounts do not exceed the following quantities:
    (i) One gram of a mixture of substance containing a detectable 
amount of heroin;
    (ii) One gram of a mixture or substance containing a detectable 
amount of--
    (A) Coca leaves, except coba leaves and extracts of coca leaves frol 
which cocaine, ecgonine, and derivations of ecgonine or their salts have 
been removed;
    (B) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers;
    (C) Ecgonine, its derivatives, their salts, isomers, and salts of 
isomers; or
    (D) Any compound, mixture or preparation which contains any quantity 
of any of the substances referred to in paragraphs (j)(2)(ii)(A) through 
(j)(2)(ii)(C) of this section;
    (iii) \1/10\th gram of a mixture or substance described in paragraph 
(j)(2)(ii) of this section which contains cocaine base;
    (iv) \1/10\th gram of a mixture or substance containing a detectable 
amount of phencyclidine (PCP);
    (v) 500 micrograms of a mixture or substance containing a detectable 
amount of lysergic acid diethylamide (LSD);
    (vi) One ounce of a mixture of substance containing a detectable 
amount of marihuana;
    (vii) One gram of methamphetamine, its salts, isomers, and salts of 
its isomers, or one gram of a mixture or substance containing a 
detectable amount of methamphetamine, its salts, isomers, or salts of 
its isomers.
    (3) The possession of a narcotic, a depressant, a stimulant, a 
hallucinogen or cannabis-controlled substance will be considered in 
excess of personal use quantities if the dosage unit amount possessed 
provides the same or greater equivalent efficacy as described in 
paragraph (j)(2) of this section.
    (k) The term Property means property subject to forfeiture under 
title 21, U.S.C., sections 881(a) (4), (6), and (7); title 19, U.S.C., 
section 1595a, and; title 49, U.S.C. App., section 782.
    (l) The term Seizing Agency means the Federal agency which has 
seized the property or adopted the seizure of another agency, and has 
the responsibility for administratively forfeiting the property;
    (m) The term Statutory Rights or Defenses to the Forfeiture means 
all legal and equitable rights and remedies available to a claimant of 
property seized for forfeiture.
    (n) The term Sworn to as used in Secs. 1316.92(e) and 1316.95(c) 
refers to the

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oath as provided by Title 28, U.S.C., section 1746.

Sec. 1316.92  Petition for expedited release in an administrative 
          forfeiture action.

    (a) Where property is seized for administrative forfeiture involving 
controlled substances in personal use quantities the owner may petition 
the seizing agency for expedited release of the property.
    (b) Where property described in paragraph (a) of this section is a 
commercial fishing industry vessel proceeding to or from a fishing area 
or intermediate port of call or actually engaged in fishing operations, 
which would be subject to seizure for administrative forfeiture for a 
violation of law involving controlled substances in personal use 
quantities, a summons to appear shall be isrued in lieu of a physical 
seizure. The vessel shall report to the port designated in the summons. 
The seizing agency shall be authorized to effect administrative 
forfeiture as if the vessel had been physically seized. Upon answering 
the summons to appear on or prior to the last reporting date specified 
in the summons, the owner of the vessel may file a petition for 
expedited release pursuant to paragraph (a) of this section and the 
provisions of paragraph (a) of this section and other provishons in this 
subpart pertaining to a petition for expedited release shall apply as if 
the vessel had been physically seized.
    (c) The owner filing the petition for expedited release shall 
establish the following:
    (1) The owner has a valid, good faith interest in the seized 
property as owner or otherwise;
    (2) The owner reasonably attempted to ascertain the use of the 
property in a normal and customary manner; and
    (3) The owner did not know or consent to the illegal use of the 
property, or in the event that the owner knew or should have known of 
the illegal use, the owner did what reasonably could be expected to 
prevent the violation.
    (d) In addition to those factors listed in paragraph (c) of this 
section, if an owner can demonstrate that the owner has other statutnry 
rights or defenses that would cause the owner to prevail on the issue of 
forfeiture, such factors shall also be considered in ruling on the 
petition for expedited release.
    (e) A petition for expedited release must be filed in a timely 
manner to be considered by the seizing agency. In order to be filed in a 
timely manner, the petition must be received by the appropriate seizing 
agency within 20 days from the date of the first publication of the 
notice of seizure. The petition must be executed and sworn to by the 
owner and both the envelope and the request must be clearly marked 
``PETITION FOR EXPEDITED RELEASE.'' Such petition shall be filed in 
triplicate with the Special Agent in Charge of the Drug Enforcement 
Administration (DEA) or Federal Bureau of Investigation (FBI) field 
office in the judicial district in which the property was seized, 
depending upon which agency seized the property. The petition shall be 
addressed to the Director of the FBI or to the Administrator of the DEA, 
depending upon which agency seized the property.
    (f) The petition shall include the following:
    (1) A complete description of the property, including identification 
numbers, if any, and the date and place of seizure;
    (2) The petitioner's interest in the property, which shall be 
supported by title documentation, bills of sale, contracts, mortgages, 
or other satisfactory documentary evidence; and
    (3) A statement of the facts and circumstances, to be established by 
satisfactory proof, relied upon by the petitioner to justify expedited 
release of the seized property.

Sec. 1316.93  Ruling on petition for expedited release in an 
          administrative forfeiture action.

    (a) Upon receipt of a petition for expedited release filed pursuant 
to Sec. 1316.92(a), the seizing agency shall determine first whether a 
final administrative determination of the case, without regard to the 
provisions of this subpart, can be made within 21 days of the seizure. 
If such a final administrative determination is made within 21 days, no 
further action need be taken under this subpart.

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    (b) If no such final administrative determination is made within 21 
days of the seizure, the following procedure shall apply. The seizing 
agency shall, within 20 days after the receipt of the petition for 
expedited release, determine whether the petition filed by the owner has 
established the factors listed in Sec. 1316.92(c) and:
    (1) If the seizing agency determines that those factors have been 
established, it shall terminate the administrative proceedings and 
return the property to the owner (or in the case of a commercial fishing 
industry vessel for which a summons has been issued shall dismiss the 
summons), except where it is evidence of a violation of law; or
    (2) If the seizing agency determines that those factors have not 
been established, the agency shall proceed with the administrative 
forfeiture.

Sec. 1316.94  Posting of substitute res in an administrative forfeiture 
          action.

    (a) Where property is seized for administrative forfeiture involving 
controlled substances in personal use quantities, the owner may obtain 
release of the property by posting a substitute res with the seizing 
agency. The property will be released to the owner upon the payment of 
an amount equal to the appraised value of the property if it is not 
evidence of a violation of law or has design or other characteristics 
that particularly suit it for use in illegal activities. This payment 
must be in the form of a traveler's check, a money order, a cashier's 
check or an irrevocable letter of credit made payable to the seizing 
agency. A bond in the form of a cashier's check will be considered as 
paid once the check has been accepted for payment by the financial 
institution which issued the check.
    (b) If a substitute res is posted and the property is 
administratively forfeited, the seizing agency will forfeit the 
substitute res in lieu of the property.

Sec. 1316.95  Petition for expedited release of a conveyance in a 
          judicial forfeiture action.

    (a) Where a conveyance has been seized and is being forfeited in a 
judicial proceeding for a drug-related offense, the owner may petition 
the United States Attorney for an expedited release of the conveyance.
    (b) The owner filing the petition for expedited release shall 
establish the following:
    (1) The owner has a valid, good faith interest in the seized 
conveyance as owner or otherwise;
    (2) The owner has statutory rights or defenses that would show to a 
substantial probability that the owner would prevail on the issue of 
forfeiture;
    (3) The owner reasonably attempted to ascertain the use of the 
conveyance in a normal and customary manner; and
    (4) The owner did not know or consent to the illegal use of the 
conveyance; or in the event that the owner knew or should have known of 
the illegal use, the owner did what reasonably could be expected to 
prevent the violation.
    (c) A petition for expedited release must be filed in a timely 
manner in order to be considered by the United States Attorney. To be 
considered as filed in a timely manner, the petition must be received by 
the appropriate United States Attorney within 20 days from the date of 
the first publication of the notice of the action and arrest of the 
property, or within 30 days after filing of the claim, whichever occurs 
later. The petition must be executed and sworn to by the owner, and both 
the envelope and the request must be clearly marked ``PETITION FOR 
EXPEDITED RELEASE.'' Such petition shall be filed in triplicate and 
addressed to and filed with the United States Attorney prosecuting the 
conveyance for forfeiture with a copy to the seizing agency.
    (d) The petition shall include the following:
    (1) A complete description of the conveyance, including the 
identification number, and the date and place of seizure;
    (2) The petitioner's interest in the conveyance, which shall be 
supported by bills of sale, contracts, mortgages, or other satisfactory 
documentary evidence; and,
    (3) The facts and circumstances, to be established by satisfactory 
proof, relied

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upon by the petitioner to justify expedited release of the seized 
conveyance.

Sec. 1316.96  Ruling on a petition for expedited release of a conveyance 
          in a judicial forfeiture action.

    (a) Upon receipt of a petition for expedited release filed pursuant 
to Sec. 1316.95, the United States Attorney shall rule on the petition 
within 20 days of receipt. A petition shall be deemed filed on the date 
it is received by the United States Attorney.
    (b) If the United States Attorney does not rule on the petition for 
expedited release within 20 days after the date on which it is filed, 
the conveyance shall be returned to the owner or interested party 
pending further forfeiture proceedings, except where it is evidence of a 
violation of law. Release of conveyance under provisions of this 
paragraph shall not affect the forfeiture action with respect to that 
conveyance.
    (c) Upon a favorable ruling on the petition for expedited release, 
the United States Attorney shall, where necessary, move to terminate the 
judicial proceedings against the conveyance and immediately direct the 
return of the conveyance except where it is evidence of a violation of 
law.
    (d) If, within 20 days, the United States Attorney denies the 
petition for expedited release, the government shall retain possession 
of the conveyance until the owner provides a substitute res bond 
pursuant to Sec. 1316.98 or the forfeiture is finalized.

Sec. 1316.97  Initiating judicial forfeiture proceeding against a 
          conveyance within 60 days of the filing of a claim and cost 
          bond.

    (a) The United States Attorney shall file a complaint for forfeiture 
of the conveyance within 60 days of the filing of the claim and cost 
bond.
    (b) Upon the failure of the United States Attorney to file a 
complaint for forfeiture of a conveyance within 60 days unless the court 
extends the 60-day period following a showing of good cause, or unless 
the owner and the United States Attorney agree to such an extension, the 
court shall order the return of the conveyance and the return of any 
bond.

Sec. 1316.98  Substitute res bond in a judicial forfeiture action 
          against a conveyance.

    (a) Where a conveyance is being forfeited in a judicial proceeding 
for a drug-related offense, the owner may obtain release of the property 
by filing a substitute res bond with the seizing agency. The conveyance 
will be released to the owner upon the payment of a bond in the amount 
of the appraised value of the conveyance if it is not evidence of a 
violation of law or has design or other characteristics that 
particularly suit it for use in illegal activities. This bond must be in 
the form of a traveler's check, a money order, a cashier's check or an 
irrevocable letter of credit made payable to the Department of Justice 
or to the United States Customs Service depending on which agency seized 
the conveyance. A bond in the form of a cashier's check will be 
considered as paid once the check has been accepted for payment by the 
financial institution which issued the check.
    (b) If a substitute res bond is filed and the conveyance is 
judicially forfeited, the court will forfeit the bond in lieu of the 
property.

Sec. 1316.99  Notice provisions.

    (a) Special notice provision. At the time of seizure of property 
defined in Sec. 1316.91 for violations involving the possession of 
personal use quantities of a controlled substance and conveyances seized 
pursuant to Sec. 1316.95, written notice must be provided to the 
possessor of the property regarding applicable statutes and Federal 
regulations including the procedures established for the filing of a 
petition for expedited release and for the posting of a substitute res 
bond as set forth in sections 6079 and 6080 of the Anti-Drug Abuse Act 
of 1988 and implementing regulations.
    (b) Standard notice provision. The standard notice to the owner as 
required by title 19, U.S.C., section 1607 and applicable regulations, 
shall be made at the earliest practicable opportunity after determining 
ownership of the seized property or conveyance and shall include the 
legal and factual basis of the seizure.

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