[Title 21 CFR 1300.01]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1300 - DEFINITIONS]
[Sec. 1300.01 - Definitions relating to controlled substances.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1300.01Sec. 1300.01FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEDEFINITIONS
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

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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

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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

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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.
    (42) The term freight forwarding facility means a separate facility 
operated by a distributing registrant through which sealed, packaged 
controlled substances in unmarked shipping containers (i.e., the 
containers do not indicate that the contents include controlled 
substances) are, in the course of delivery to, or return from, 
customers, transferred in less than 24 hours. A distributing registrant 
who operates a freight forwarding facility may use the facility to 
transfer controlled substances from any location the distributing 
registrant operates that is registered with the Administration to 
manufacture, distribute, or import controlled substances, or, with 
respect to returns, registered to dispense controlled substances, 
provided that the notice required by Sec. 1301.12(b)(4) of Part 1301 of 
this chapter has been submitted and approved. For purposes of this 
definition, a distributing registrant is a person who is registered with 
the Administration as a manufacturer, distributor, and/or importer.

[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000]