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U.S. Code as of:
01/19/04
Section 802. Definitions
As used in this subchapter:
(1) The term "addict" means any individual who habitually uses
any narcotic drug so as to endanger the public morals, health,
safety, or welfare, or who is so far addicted to the use of
narcotic drugs as to have lost the power of self-control with
reference to his addiction.
(2) The term "administer" refers to the direct application of a
controlled substance to the body of a patient or research subject
by -
(A) a practitioner (or, in his presence, by his authorized
agent), or
(B) the patient or research subject at the direction and in the
presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or
any other means.
(3) The term "agent" means an authorized person who acts on
behalf of or at the direction of a manufacturer, distributor, or
dispenser; except that such term does not include a common or
contract carrier, public warehouseman, or employee of the carrier
or warehouseman, when acting in the usual and lawful course of the
carrier's or warehouseman's business.
(4) The term "Drug Enforcement Administration" means the Drug
Enforcement Administration in the Department of Justice.
(5) The term "control" means to add a drug or other substance, or
immediate precursor, to a schedule under part B of this subchapter,
whether by transfer from another schedule or otherwise.
(6) The term "controlled substance" means a drug or other
substance, or immediate precursor, included in schedule I, II, III,
IV, or V of part B of this subchapter. The term does not include
distilled spirits, wine, malt beverages, or tobacco, as those terms
are defined or used in subtitle E of the Internal Revenue Code of
1986.
(7) The term "counterfeit substance" means a controlled substance
which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other
identifying mark, imprint, number, or device, or any likeness
thereof, of a manufacturer, distributor, or dispenser other than
the person or persons who in fact manufactured, distributed, or
dispensed such substance and which thereby falsely purports or is
represented to be the product of, or to have been distributed by,
such other manufacturer, distributor, or dispenser.
(8) The terms "deliver" or "delivery" mean the actual,
constructive, or attempted transfer of a controlled substance or a
listed chemical, whether or not there exists an agency
relationship.
(9) The term "depressant or stimulant substance" means -
(A) a drug which contains any quantity of barbituric acid or
any of the salts of barbituric acid; or
(B) a drug which contains any quantity of (i) amphetamine or
any of its optical isomers; (ii) any salt of amphetamine or any
salt of an optical isomer of amphetamine; or (iii) any substance
which the Attorney General, after investigation, has found to be,
and by regulation designated as, habit forming because of its
stimulant effect on the central nervous system; or
(C) lysergic acid diethylamide; or
(D) any drug which contains any quantity of a substance which
the Attorney General, after investigation, has found to have, and
by regulation designated as having, a potential for abuse because
of its depressant or stimulant effect on the central nervous
system or its hallucinogenic effect.
(10) The term "dispense" means to deliver a controlled substance
to an ultimate user or research subject by, or pursuant to the
lawful order of, a practitioner, including the prescribing and
administering of a controlled substance and the packaging, labeling
or compounding necessary to prepare the substance for such
delivery. The term "dispenser" means a practitioner who so delivers
a controlled substance to an ultimate user or research subject.
(11) The term "distribute" means to deliver (other than by
administering or dispensing) a controlled substance or a listed
chemical. The term "distributor" means a person who so delivers a
controlled substance or a listed chemical.
(12) The term "drug" has the meaning given that term by section
321(g)(1) of this title.
(13) The term "felony" means any Federal or State offense
classified by applicable Federal or State law as a felony.
(14) The term "isomer" means the optical isomer, except as used
in schedule I(c) and schedule II(a)(4). As used in schedule I(c),
the term "isomer" means any optical, positional, or geometric
isomer. As used in schedule II(a)(4), the term "isomer" means any
optical or geometric isomer.
(15) The term "manufacture" means the production, preparation,
propagation, compounding, or processing of a drug or other
substance, either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical
synthesis or by a combination of extraction and chemical synthesis,
and includes any packaging or repackaging of such substance or
labeling or relabeling of its container; except that such term does
not include the preparation, compounding, packaging, or labeling of
a drug or other substance in conformity with applicable State or
local law by a practitioner as an incident to his administration or
dispensing of such drug or substance in the course of his
professional practice. The term "manufacturer" means a person who
manufactures a drug or other substance.
(16) The term "marihuana" means all parts of the plant Cannabis
sativa L., whether growing or not; the seeds thereof; the resin
extracted from any part of such plant; and every compound,
manufacture, salt, derivative, mixture, or preparation of such
plant, its seeds or resin. Such term does not include the mature
stalks of such plant, fiber produced from such stalks, oil or cake
made from the seeds of such plant, any other compound, manufacture,
salt, derivative, mixture, or preparation of such mature stalks
(except the resin extracted therefrom), fiber, oil, or cake, or the
sterilized seed of such plant which is incapable of germination.
(17) The term "narcotic drug" means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin, or independently by means of chemical synthesis,
or by a combination of extraction and chemical synthesis:
(A) Opium, opiates, derivatives of opium and opiates, including
their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers, whenever the existence of such isomers,
esters, ethers, and salts is possible within the specific
chemical designation. Such term does not include the isoquinoline
alkaloids of opium.
(B) Poppy straw and concentrate of poppy straw.
(C) Coca leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine, and derivatives of ecgonine or
their salts have been removed.
(D) Cocaine, its salts, optical and geometric isomers, and
salts of isomers.
(E) Ecgonine, its derivatives, their salts, isomers, and salts
of isomers.
(F) Any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subparagraphs
(A) through (E).
(18) The term "opiate" means any drug or other substance having
an addiction-forming or addiction-sustaining liability similar to
morphine or being capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability.
(19) The term "opium poppy" means the plant of the species
Papaver somniferum L., except the seed thereof.
(20) The term "poppy straw" means all parts, except the seeds, of
the opium poppy, after mowing.
(21) The term "practitioner" means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices or does research,
to distribute, dispense, conduct research with respect to,
administer, or use in teaching or chemical analysis, a controlled
substance in the course of professional practice or research.
(22) The term "production" includes the manufacture, planting,
cultivation, growing, or harvesting of a controlled substance.
(23) The term "immediate precursor" means a substance -
(A) which the Attorney General has found to be and by
regulation designated as being the principal compound used, or
produced primarily for use, in the manufacture of a controlled
substance;
(B) which is an immediate chemical intermediary used or likely
to be used in the manufacture of such controlled substance; and
(C) the control of which is necessary to prevent, curtail, or
limit the manufacture of such controlled substance.
(24) The term "Secretary", unless the context otherwise
indicates, means the Secretary of Health and Human Services.
(25) The term "serious bodily injury" means bodily injury which
involves -
(A) a substantial risk of death;
(B) protracted and obvious disfigurement; or
(C) protracted loss or impairment of the function of a bodily
member, organ, or mental faculty.
(26) The term "State" means a State of the United States, the
District of Columbia, and any commonwealth, territory, or
possession of the United States.
(27) The term "ultimate user" means a person who has lawfully
obtained, and who possesses, a controlled substance for his own use
or for the use of a member of his household or for an animal owned
by him or by a member of his household.
(28) The term "United States", when used in a geographic sense,
means all places and waters, continental or insular, subject to the
jurisdiction of the United States.
(29) The term "maintenance treatment" means the dispensing, for a
period in excess of twenty-one days, of a narcotic drug in the
treatment of an individual for dependence upon heroin or other
morphine-like drugs.
(30) The term "detoxification treatment" means the dispensing,
for a period not in excess of one hundred and eighty days, of a
narcotic drug in decreasing doses to an individual in order to
alleviate adverse physiological or psychological effects incident
to withdrawal from the continuous or sustained use of a narcotic
drug and as a method of bringing the individual to a narcotic
drug-free state within such period.
(31) The term "Convention on Psychotropic Substances" means the
Convention on Psychotropic Substances signed at Vienna, Austria, on
February 21, 1971; and the term "Single Convention on Narcotic
Drugs" means the Single Convention on Narcotic Drugs signed at New
York, New York, on March 30, 1961.
(32)(A) Except as provided in subparagraph (C), the term
"controlled substance analogue" means a substance -
(i) the chemical structure of which is substantially similar to
the chemical structure of a controlled substance in schedule I or
II;
(ii) which has a stimulant, depressant, or hallucinogenic
effect on the central nervous system that is substantially
similar to or greater than the stimulant, depressant, or
hallucinogenic effect on the central nervous system of a
controlled substance in schedule I or II; or
(iii) with respect to a particular person, which such person
represents or intends to have a stimulant, depressant, or
hallucinogenic effect on the central nervous system that is
substantially similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the central nervous
system of a controlled substance in schedule I or II.
(B) The designation of gamma butyrolactone or any other chemical
as a listed chemical pursuant to paragraph (34) or (35) does not
preclude a finding pursuant to subparagraph (A) of this paragraph
that the chemical is a controlled substance analogue.
(C) Such term does not include -
(i) a controlled substance;
(ii) any substance for which there is an approved new drug
application;
(iii) with respect to a particular person any substance, if an
exemption is in effect for investigational use, for that person,
under section 355 of this title to the extent conduct with
respect to such substance is pursuant to such exemption; or
(iv) any substance to the extent not intended for human
consumption before such an exemption takes effect with respect to
that substance.
(33) The term "listed chemical" means any list I chemical or any
list II chemical.
(34) The term "list I chemical" means a chemical specified by
regulation of the Attorney General as a chemical that is used in
manufacturing a controlled substance in violation of this
subchapter and is important to the manufacture of the controlled
substances, and such term includes (until otherwise specified by
regulation of the Attorney General, as considered appropriate by
the Attorney General or upon petition to the Attorney General by
any person) the following:
(A) Anthranilic acid, its esters, and its salts.
(B) Benzyl cyanide.
(C) Ephedrine, its salts, optical isomers, and salts of optical
isomers.
(D) Ergonovine and its salts.
(E) Ergotamine and its salts.
(F) N-Acetylanthranilic acid, its esters, and its salts.
(G) Norpseudoephedrine, its salts, optical isomers, and salts
of optical isomers.
(H) Phenylacetic acid, its esters, and its salts.
(I) Phenylpropanolamine, its salts, optical isomers, and salts
of optical isomers.
(J) Piperidine and its salts.
(K) Pseudoephedrine, its salts, optical isomers, and salts of
optical isomers.
(L) 3,4-Methylenedioxyphenyl-2-propanone.
(M) Methylamine.
(N) Ethylamine.
(O) Propionic anhydride.
(P) Isosafrole.
(Q) Safrole.
(R) Piperonal.
(S) N-Methylephedrine.
(T) N-methylpseudoephedrine.
(U) Hydriodic acid.
(V) Benzaldehyde.
(W) Nitroethane.
(X) Gamma butyrolactone.
(Y) Any salt, optical isomer, or salt of an optical isomer of
the chemicals listed in subparagraphs (M) through (U) of this
paragraph.
(35) The term "list II chemical" means a chemical (other than a
list I chemical) specified by regulation of the Attorney General as
a chemical that is used in manufacturing a controlled substance in
violation of this subchapter, and such term includes (until
otherwise specified by regulation of the Attorney General, as
considered appropriate by the Attorney General or upon petition to
the Attorney General by any person) the following chemicals:
(A) Acetic anhydride.
(B) Acetone.
(C) Benzyl chloride.
(D) Ethyl ether.
(E) Repealed. Pub. L. 101-647, title XXIII, Sec. 2301(b), Nov.
29, 1990, 104 Stat. 4858.
(F) Potassium permanganate.
(G) 2-Butanone (or Methyl Ethyl Ketone).
(H) Toluene.
(I) Iodine.
(J) Hydrochloric gas.
(36) The term "regular customer" means, with respect to a
regulated person, a customer with whom the regulated person has an
established business relationship that is reported to the Attorney
General.
(37) The term "regular importer" means, with respect to a listed
chemical, a person that has an established record as an importer of
that listed chemical that is reported to the Attorney General.
(38) The term "regulated person" means a person who manufactures,
distributes, imports, or exports a listed chemical, a tableting
machine, or an encapsulating machine or who acts as a broker or
trader for an international transaction involving a listed
chemical, a tableting machine, or an encapsulating machine.
(39) The term "regulated transaction" means -
(A) a distribution, receipt, sale, importation, or exportation
of, or an international transaction involving shipment of, a
listed chemical, or if the Attorney General establishes a
threshold amount for a specific listed chemical, a threshold
amount, including a cumulative threshold amount for multiple
transactions (as determined by the Attorney General, in
consultation with the chemical industry and taking into
consideration the quantities normally used for lawful purposes),
of a listed chemical, except that such term does not include -
(i) a domestic lawful distribution in the usual course of
business between agents or employees of a single regulated
person;
(ii) a delivery of a listed chemical to or by a common or
contract carrier for carriage in the lawful and usual course of
the business of the common or contract carrier, or to or by a
warehouseman for storage in the lawful and usual course of the
business of the warehouseman, except that if the carriage or
storage is in connection with the distribution, importation, or
exportation of a listed chemical to a third person, this clause
does not relieve a distributor, importer, or exporter from
compliance with section 830 of this title;
(iii) any category of transaction or any category of
transaction for a specific listed chemical or chemicals
specified by regulation of the Attorney General as excluded
from this definition as unnecessary for enforcement of this
subchapter or subchapter II of this chapter;
(iv) any transaction in a listed chemical that is contained
in a drug that may be marketed or distributed lawfully in the
United States under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) unless -
(I)(aa) the drug contains ephedrine or its salts, optical
isomers, or salts of optical isomers, pseudoephedrine or its
salts, optical isomers, or salts of optical isomers, or
phenylpropanolamine or its salts, optical isomers, or salts
of optical isomers unless otherwise provided by regulation of
the Attorney General issued pursuant to section 814(e) of
this title, except that any sale of ordinary over-the-counter
pseudoephedrine or phenylpropanolamine products by retail
distributors shall not be a regulated transaction (except as
provided in section 401(d) of the Comprehensive
Methamphetamine Control Act of 1996); or
(bb) the Attorney General has determined under section 814
of this title that the drug or group of drugs is being
diverted to obtain the listed chemical for use in the illicit
production of a controlled substance; and
(II) the quantity of ephedrine, pseudoephedrine,
phenylpropanolamine, or other listed chemical contained in
the drug included in the transaction or multiple transactions
equals or exceeds the threshold established for that chemical
by the Attorney General, except that the threshold for any
sale of products containing pseudoephedrine or
phenylpropanolamine products by retail distributors or by
distributors required to submit reports by section 830(b)(3)
of this title shall be 9 grams of pseudoephedrine or 9 grams
of phenylpropanolamine in a single transaction and sold in
package sizes of not more than 3 grams of pseudoephedrine
base or 3 grams of phenylpropanolamine base; or
(v) any transaction in a chemical mixture which the Attorney
General has by regulation designated as exempt from the
application of this subchapter and subchapter II of this
chapter based on a finding that the mixture is formulated in
such a way that it cannot be easily used in the illicit
production of a controlled substance and that the listed
chemical or chemicals contained in the mixture cannot be
readily recovered; and
(B) a distribution, importation, or exportation of a tableting
machine or encapsulating machine.
(40) The term "chemical mixture" means a combination of two or
more chemical substances, at least one of which is not a list I
chemical or a list II chemical, except that such term does not
include any combination of a list I chemical or a list II chemical
with another chemical that is present solely as an impurity.
(41)(A) The term "anabolic steroid" means any drug or hormonal
substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, and corticosteroids) that
promotes muscle growth, and includes -
(i) boldenone,
(ii) chlorotestosterone,
(iii) clostebol,
(iv) dehydrochlormethyltestosterone,
(v) dihydrotestosterone,
(vi) drostanolone,
(vii) ethylestrenol,
(viii) fluoxymesterone,
(ix) formebulone,
(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.
(B)(i) Except as provided in clause (ii), such term does not
include an anabolic steroid which is expressly intended for
administration through implants to cattle or other nonhuman species
and which has been approved by the Secretary of Health and Human
Services for such administration.
(ii) If any person prescribes, dispenses, or distributes such
steroid for human use, such person shall be considered to have
prescribed, dispensed, or distributed an anabolic steroid within
the meaning of subparagraph (A).
(42) The term "international transaction" means a transaction
involving the shipment of a listed chemical across an international
border (other than a United States border) in which a broker or
trader located in the United States participates.
(43) The terms "broker" and "trader" mean a person that assists
in arranging an international transaction in a listed chemical by -
(A) negotiating contracts;
(B) serving as an agent or intermediary; or
(C) bringing together a buyer and seller, a buyer and
transporter, or a seller and transporter.
(44) The term "felony drug offense" means an offense that is
punishable by imprisonment for more than one year under any law of
the United States or of a State or foreign country that prohibits
or restricts conduct relating to narcotic drugs, marihuana, or
depressant or stimulant substances.
(45) The term "ordinary over-the-counter pseudoephedrine or
phenylpropanolamine product" means any product containing
pseudoephedrine or phenylpropanolamine that is -
(A) regulated pursuant to this subchapter; and
(B)(i) except for liquids, sold in package sizes of not more
than 3.0 grams of pseudoephedrine base or 3.0 grams of
phenylpropanolamine base, and that is packaged in blister packs,
each blister containing not more than two dosage units, or where
the use of blister packs is technically infeasible, that is
packaged in unit dose packets or pouches; and
(ii) for liquids, sold in package sizes of not more than 3.0
grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine
base.
(46)(A) The term "retail distributor" means a grocery store,
general merchandise store, drug store, or other entity or person
whose activities as a distributor relating to pseudoephedrine or
phenylpropanolamine products are limited almost exclusively to
sales for personal use, both in number of sales and volume of
sales, either directly to walk-in customers or in face-to-face
transactions by direct sales.
(B) For purposes of this paragraph, sale for personal use means
the sale of below-threshold quantities in a single transaction to
an individual for legitimate medical use.
(C) For purposes of this paragraph, entities are defined by
reference to the Standard Industrial Classification (SIC) code, as
follows:
(i) A grocery store is an entity within SIC code 5411.
(ii) A general merchandise store is an entity within SIC codes
5300 through 5399 and 5499.
(iii) A drug store is an entity within SIC code 5912.
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