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21 USC Sec. 802 01/02/01
Extract of the United States Code, Title 21.
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part A - Introductory Provisions
Sec. 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 systems; 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.
administrative details
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REFERENCES IN TEXT
This subchapter, referred to in introductory provisions and in par. (39)(A)(iii),
(v), was in the original ''this title'', meaning title II of Pub. L. 91-513,
Oct. 27, 1970, 84 Stat. 1242, as amended, and is popularly known as the
''Controlled Substances Act''. For complete classification of title II to the
Code, see second paragraph of Short Title note set out under section 801 of this
title and Tables.
Schedules I, II, III, IV, and V, referred to in pars. (6), (14), and (32)(A), are set out in section 812(c) of this title.
Subchapter II of this chapter, referred to in par. (39)(A)(iii), (v), was in the original ''title III'', meaning title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in par. (39)(A)(iv), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (Sec. 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
Section 401(d) of the Comprehensive Methamphetamine Control Act of 1996, referred to in par. (39)(A)(iv)(I)(aa), is section 401(d) of Pub. L. 104-237, which is set out below.
misc administrative
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REGULATION OF RETAIL SALES OF CERTAIN PRECURSOR CHEMICALS; EFFECT ON THRESHOLDS;
COMBINATION EPHEDRINE PRODUCTS
Section 401(d)-(f) of Pub. L. 104-237 provided that:
''(d) Regulation of Retail Sales. -
''(1) Pseudoephedrine. -
''(A) Limit. -
''(i) In general. - Not sooner than the effective date of this section (see Effective Date of 1996 Amendments note above) and subject to the requirements of clause (ii), the Attorney General may establish by regulation a single-transaction limit of 24 grams of pseudoephedrine base for retail distributors. Notwithstanding any other provision of law, the single-transaction threshold quantity for pseudoephedrine-containing compounds may not be lowered beyond that established in this paragraph.
''(ii) Conditions. - In order to establish a single-transaction limit of 24 grams of pseudoephedrine base, the Attorney General shall establish, following notice, comment, and an informal hearing that since the date of enactment of this Act (Oct. 3, 1996) there are a significant number of instances where ordinary over-the-counter pseudoephedrine products as established in paragraph (45) of section 102 of the Controlled Substances Act (21 U.S.C. 802(45)), as added by this Act, sold by retail distributors as established in paragraph (46) in section 102 of the Controlled Substances Act (21 U.S.C. 802(46)), are being widely used as a significant source of precursor chemicals for illegal manufacture of a controlled substance for distribution or sale.''(B) Violation. - Any individual or business that violates the thresholds established in this paragraph shall, with respect to the first such violation, receive a warning letter from the Attorney General and, if a business, the business shall be required to conduct mandatory education of the sales employees of the firm with regard to the legal sales of pseudoephedrine. For a second violation occurring within 2 years of the first violation, the business or individual shall be subject to a civil penalty of not more than $5,000. For any subsequent violation occurring within 2 years of the previous violation, the business or individual shall be subject to a civil penalty not to exceed the amount of the previous civil penalty plus $5,000.
''(2) Phenylpropanolamine. -
''(A) Limit. -
''(i) In general. - Not sooner than the effective date of this section and subject to the requirements of clause (ii), the Attorney General may establish by regulation a single-transaction limit of 24 grams of phenylpropanolamine base for retail distributors. Notwithstanding any other provision of law, the single-transaction threshold quantity for phenylpropanolamine-containing compounds may not be lowered beyond that established in this paragraph.
''(ii) Conditions. - In order to establish a single-transaction limit of 24 grams of phenylpropanolamine base, the Attorney General shall establish, following notice, comment, and an informal hearing, that since the date of enactment of this Act there are a significant number of instances where ordinary over-the-counter phenylpropanolamine products as established in paragraph (45) of section 102 of the Controlled Substances Act (21 U.S.C. 802(45)), as added by this Act, sold by retail distributors as established in paragraph (46) in section 102 of the Controlled Substances Act (21 U.S.C. 802(46)), are being used as a significant source of precursor chemicals for illegal manufacture of a controlled substance in bulk.''(B) Violation. - Any individual or business that violates the thresholds established in this paragraph shall, with respect to the first such violation, receive a warning letter from the Attorney General and, if a business, the business shall be required to conduct mandatory education of the sales employees of the firm with regard to the legal sales of pseudoephedrine. For a second violation occurring within 2 years of the first violation, the business or individual shall be subject to a civil penalty of not more than $5,000. For any subsequent violation occurring within 2 years of the previous violation, the business or individual shall be subject to a civil penalty not to exceed the amount of the previous civil penalty plus $5,000.
''(3) Significant number of instances. -
''(A) In general. - For purposes of this subsection, isolated or infrequent use, or use in insubstantial quantities, of ordinary over-the-counter pseudoephedrine or phenylpropanolamine, as defined in section 102(45) of the Controlled Substances Act, as added by section 401(b) of this Act, and sold at the retail level for the illicit manufacture of methamphetamine or amphetamine may not be used by the Attorney General as the basis for establishing the conditions under paragraph (1)(A)(ii) of this subsection, with respect to pseudoephedrine, and paragraph (2)(A)(ii) of this subsection, with respect to phenylpropanolamine.
''(B) Considerations and report. - The Attorney General shall -''(i) in establishing a finding under paragraph (1)(A)(ii) or (2)(A)(ii) of this subsection, consult with the Secretary of Health and Human Services in order to consider the effects on public health that would occur from the establishment of new single transaction limits as provided in such paragraph; and
''(ii) upon establishing a finding, transmit a report to the Committees on the Judiciary in both, respectively, the House of Representatives and the Senate in which the Attorney General will provide the factual basis for establishing the new single transaction limits.''(4) Definition of business. - For purposes of this subsection, the term 'business' means the entity that makes the direct sale and does not include the parent company of a business not involved in a direct sale regulated by this subsection.
''(5) Judicial review. - Any regulation promulgated by the Attorney General under this section shall be subject to judicial review pursuant to section 507 of the Controlled Substances Act (21 U.S.C. 877).
''(e) Effect on Thresholds. - Nothing in the amendments made by subsection (b) (amending this section) or the provisions of subsection (d) shall affect the authority of the Attorney General to modify thresholds (including cumulative thresholds) for retail distributors for products other than ordinary over-the-counter pseudoephedrine or phenylpropanolamine products (as defined in section 102(45) of the Controlled Substances Act (21 U.S.C. 802(45)), as added by this section) or for non-retail distributors, importers, or exporters.
''(f) Combination Ephedrine Products. -
''(1) In general. - For the purposes of this section, combination ephedrine products shall be treated the same as pseudoephedrine products, except that -
''(A) a single transaction limit of 24 grams shall be effective as of the date of enactment of this Act (Oct. 3, 1996) and shall apply to sales of all combination ephedrine products, notwithstanding the form in which those products are packaged, made by retail distributors or distributors required to submit a report under section 310(b)(3) of the Controlled Substances Act (21 U.S.C. 830(b)(3)) (as added by section 402 of this Act);
''(B) for regulated transactions for combination ephedrine products other than sales described in subparagraph (A), the transaction limit shall be -''(i) 1 kilogram of ephedrine base, effective on the date of enactment of this Act; or
''(ii) a threshold other than the threshold described in clause (i), if established by the Attorney General not earlier than 1 year after the date of enactment of this Act; and''(C) the penalties provided in subsection (d)(1)(B) of this section shall take effect on the date of enactment of this Act for any individual or business that violates the single transaction limit of 24 grams for combination ephedrine products.
''(2) Definition. - For the purposes of this section, the term 'combination ephedrine product' means a drug product containing ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically significant quantities of another active medicinal ingredient.''
EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41)
Section 1903 of Pub. L. 101-647 provided that:
''(a) Abuse Potential. - The Attorney General, upon the recommendation of the Secretary of Health and Human Services, may, by regulation, exempt any compound, mixture, or preparation containing a substance in paragraph (41) of section 102 of the Controlled Substances Act (21 U.S.C. 802(41)) (as added by section 2 (1902) of this Act) from the application of all or any part of the Controlled Substances Act (21 U.S.C. 801 et seq.) if, because of its concentration, preparation, mixture or delivery system, it has no significant potential for abuse.
''(b) Drugs for Treatment of Rare Diseases. - If the Attorney General finds that a drug listed in paragraph (41) of section 102 of the Controlled Substances Act (as added by section 2 (1902) of this Act) is -
''(1) approved by the Food and Drug Administration as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
''(2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes.
''(c) Date of Issuance of Regulations. - The
Attorney General shall issue regulations implementing this section not later
than 45 days after the date of enactment of this Act (Nov. 29, 1990), except
that the regulations required under section 3(a) (1903(a)) shall be issued not
later than 180 days after the date of enactment of this Act.''
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 814, 822, 823, 830, 862a, 889, 951, 956,
957, 958, 967, 1115, 1701, 1907 of this title;
title 7 sections 2015, 2021;
title 8 sections 1101, 1182, 1227;
title 10 section 986;
title 16 section 559b;
title 18 sections 342, 521, 842, 922, 924, 1791, 1952, 1961, 2118, 3142, 3563,
3592;
title 19 sections 1401, 1584, 1607;
title 20 section 1091;
title 22 sections 2291, 2708, 2714;
title 23 section 410;
title 25 section 4103;
title 29 sections 1111, 1854, 2892;
title 42 sections 201, 1437a, 1437d, 1437f, 1786, 2000e-2, 2473c, 3411, 3602,
3607, 5667, 5667a, 9919, 11851, 11905, 11924, 12602;
title 46 section 2101;
title 46 App. section 1903;
title 48 sections 1902, 1903;
title 49 sections 5331, 20140, 30301, 31102, 31301, 31306, 44106, 44111, 44703,
44710, 44713, 45101, 46306, 80302;
title 50 section 404i.
21 USC Sec. 853 Has Changes 01/02/01
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
Sec. 853. Criminal forfeitures
(a) Property subject to criminal forfeiture
Any person convicted of a violation of this subchapter or subchapter II of this
chapter punishable by imprisonment for more than one year shall forfeit to the
United States, irrespective of any provision of State law -
(1) any property constituting, or derived from, any proceeds the person obtained, directly or indirectly, as the result of such violation;
(2) any of the person's property used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, such violation; and
(3) in the case of a person convicted of engaging in a continuing criminal enterprise in violation of section 848 of this title, the person shall forfeit, in addition to any property described in paragraph (1) or (2), any of his interest in, claims against, and property or contractual rights affording a source of control over, the continuing criminal enterprise.
The court, in imposing sentence on such person, shall order, in addition to any other sentence imposed pursuant to this subchapter or subchapter II of this chapter, that the person forfeit to the United States all property described in this subsection. In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.
(b) Meaning of term ''property''
Property subject to criminal forfeiture under this section includes -
(1) real property, including things growing on, affixed to, and found in land; and
(2) tangible and intangible personal property, including rights, privileges, interests, claims, and securities.
(c) Third party transfers
All right, title, and interest in property described in subsection (a) of this
section vests in the United States upon the commission of the act giving rise to
forfeiture under this section. Any such property that is subsequently
transferred to a person other than the defendant may be the subject of a special
verdict of forfeiture and thereafter shall be ordered forfeited to the United
States, unless the transferee establishes in a hearing pursuant to subsection
(n) of this section that he is a bona fide purchaser for value of such property
who at the time of purchase was reasonably without cause to believe that the
property was subject to forfeiture under this section.
(d) Rebuttable presumption
There is a rebuttable presumption at trial that any property of a person
convicted of a felony under this subchapter or subchapter II of this chapter is
subject to forfeiture under this section if the United States establishes by a
preponderance of the evidence that -
(1) such property was acquired by such person during the period of the violation of this subchapter or subchapter II of this chapter or within a reasonable time after such period; and
(2) there was no likely source for such property other than the violation of this subchapter or subchapter II of this chapter.
(e) Protective orders
(1) Upon application of the United States, the court may enter a restraining order or injunction, require the execution of a satisfactory performance bond, or take any other action to preserve the availability of property described in subsection (a) of this section for forfeiture under this section -
(A) upon the filing of an indictment or information charging a violation of this subchapter or subchapter II of this chapter for which criminal forfeiture may be ordered under this section and alleging that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section; or
(B) prior to the filing of such an indictment or information, if, after notice to persons appearing to have an interest in the property and opportunity for a hearing, the court determines that -(i) there is a substantial probability that the United States will prevail on the issue of forfeiture and that failure to enter the order will result in the property being destroyed, removed from the jurisdiction of the court, or otherwise made unavailable for forfeiture; and
(ii) the need to preserve the availability of the property through the entry of the requested order outweighs the hardship on any party against whom the order is to be entered:
Provided, however, That an order entered pursuant to subparagraph (B) shall be effective for not more than ninety days, unless extended by the court for good cause shown or unless an indictment or information described in subparagraph (A) has been filed.(2) A temporary restraining order under this subsection may be entered upon application of the United States without notice or opportunity for a hearing when an information or indictment has not yet been filed with respect to the property, if the United States demonstrates that there is probable cause to believe that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section and that provision of notice will jeopardize the availability of the property for forfeiture. Such a temporary order shall expire not more than ten days after the date on which it is entered, unless extended for good cause shown or unless the party against whom it is entered consents to an extension for a longer period. A hearing requested concerning an order entered under this paragraph shall be held at the earliest possible time and prior to the expiration of the temporary order.
(3) The court may receive and consider, at a hearing held pursuant to this subsection, evidence and information that would be inadmissible under the Federal Rules of Evidence.
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(4) ORDER TO REPATRIATE AND DEPOSIT-(A) IN GENERAL- Pursuant to its authority to enter a pretrial restraining order under this section, the court may order a defendant to repatriate any property that may be seized and forfeited, and to deposit that property pending trial in the registry of the court, or with the United States Marshals Service or the Secretary of the Treasury, in an interest-bearing account, if appropriate.
(B) FAILURE TO COMPLY- Failure to comply with an order under this subsection, or an order to repatriate property under subsection (p), shall be punishable as a civil or criminal contempt of court, and may also result in an enhancement of the sentence of the defendant under the obstruction of justice provision of the Federal Sentencing Guidelines
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(f) Warrant of seizure
The Government may request the issuance of a warrant authorizing the seizure of
property subject to forfeiture under this section in the same manner as provided
for a search warrant. If the court determines that there is probable cause to
believe that the property to be seized would, in the event of conviction, be
subject to forfeiture and that an order under subsection (e) of this section may
not be sufficient to assure the availability of the property for forfeiture, the
court shall issue a warrant authorizing the seizure of such property.
(g) Execution
Upon entry of an order of forfeiture under this section, the court shall
authorize the Attorney General to seize all property ordered forfeited upon such
terms and conditions as the court shall deem proper. Following entry of an order
declaring the property forfeited, the court may, upon application of the United
States, enter such appropriate restraining orders or injunctions, require the
execution of satisfactory performance bonds, appoint receivers, conservators,
appraisers, accountants, or trustees, or take any other action to protect the
interest of the United States in the property ordered forfeited. Any income
accruing to or derived from property ordered forfeited under this section may be
used to offset ordinary and necessary expenses to the property which are
required by law, or which are necessary to protect the interests of the United
States or third parties.
(h) Disposition of property
Following the seizure of property ordered forfeited under this section, the
Attorney General shall direct the disposition of the property by sale or any
other commercially feasible means, making due provision for the rights of any
innocent persons. Any property right or interest not exercisable by, or
transferable for value to, the United States shall expire and shall not revert
to the defendant, nor shall the defendant or any person acting in concert with
him or on his behalf be eligible to purchase forfeited property at any sale held
by the United States. Upon application of a person, other than the defendant or
a person acting in concert with him or on his behalf, the court may restrain or
stay the sale or disposition of the property pending the conclusion of any
appeal of the criminal case giving rise to the forfeiture, if the applicant
demonstrates that proceeding with the sale or disposition of the property will
result in irreparable injury, harm, or loss to him.
(i) Authority of the Attorney General
With respect to property ordered forfeited under this section, the Attorney
General is authorized to -
(1) grant petitions for mitigation or remission of forfeiture, restore forfeited property to victims of a violation of this subchapter, or take any other action to protect the rights of innocent persons which is in the interest of justice and which is not inconsistent with the provisions of this section;
(2) compromise claims arising under this section;
(3) award compensation to persons providing information resulting in a forfeiture under this section;
(4) direct the disposition by the United States, in accordance with the provisions of section 881(e) of this title, of all property ordered forfeited under this section by public sale or any other commercially feasible means, making due provision for the rights of innocent persons; and
(5) take appropriate measures necessary to safeguard and maintain property ordered forfeited under this section pending its disposition.
(j) Applicability of civil forfeiture provisions
Except to the extent that they are inconsistent with the provisions of this
section, the provisions of section 881(d) of this title shall apply to a
criminal forfeiture under this section.
(k) Bar on intervention
Except as provided in subsection (n) of this section, no party claiming an
interest in property subject to forfeiture under this section may -
(1) intervene in a trial or appeal of a criminal case involving the forfeiture of such property under this section; or
(2) commence an action at law or equity against the United States concerning the validity of his alleged interest in the property subsequent to the filing of an indictment or information alleging that the property is subject to forfeiture under this section.
(l) Jurisdiction to enter orders
The district courts of the United States shall have jurisdiction to enter orders
as provided in this section without regard to the location of any property which
may be subject to forfeiture under this section or which has been ordered
forfeited under this section.
(m) Depositions
In order to facilitate the identification and location of property declared
forfeited and to facilitate the disposition of petitions for remission or
mitigation of forfeiture, after the entry of an order declaring property
forfeited to the United States, the court may, upon application of the United
States, order that the testimony of any witness relating to the property
forfeited be taken by deposition and that any designated book, paper, document,
record, recording, or other material not privileged be produced at the same time
and place, in the same manner as provided for the taking of depositions under
Rule 15 of the Federal Rules of Criminal Procedure.
(n) Third party interests
(1) Following the entry of an order of forfeiture under this section, the United States shall publish notice of the order and of its intent to dispose of the property in such manner as the Attorney General may direct. The Government may also, to the extent practicable, provide direct written notice to any person known to have alleged an interest in the property that is the subject of the order of forfeiture as a substitute for published notice as to those persons so notified.
(2) Any person, other than the defendant, asserting a legal interest in property which has been ordered forfeited to the United States pursuant to this section may, within thirty days of the final publication of notice or his receipt of notice under paragraph (1), whichever is earlier, petition the court for a hearing to adjudicate the validity of his alleged interest in the property. The hearing shall be held before the court alone, without a jury.
(3) The petition shall be signed by the petitioner under penalty of perjury and shall set forth the nature and extent of the petitioner's right, title, or interest in the property, the time and circumstances of the petitioner's acquisition of the right, title, or interest in the property, any additional facts supporting the petitioner's claim, and the relief sought.
(4) The hearing on the petition shall, to the extent practicable and consistent with the interests of justice, be held within thirty days of the filing of the petition. The court may consolidate the hearing on the petition with a hearing on any other petition filed by a person other than the defendant under this subsection.
(5) At the hearing, the petitioner may testify and present evidence and witnesses on his own behalf, and cross-examine witnesses who appear at the hearing. The United States may present evidence and witnesses in rebuttal and in defense of its claim to the property and cross-examine witnesses who appear at the hearing. In addition to testimony and evidence presented at the hearing, the court shall consider the relevant portions of the record of the criminal case which resulted in the order of forfeiture.
(6) If, after the hearing, the court determines that the petitioner has established by a preponderance of the evidence that -(A) the petitioner has a legal right, title, or interest in the property, and such right, title, or interest renders the order of forfeiture invalid in whole or in part because the right, title, or interest was vested in the petitioner rather than the defendant or was superior to any right, title, or interest of the defendant at the time of the commission of the acts which gave rise to the forfeiture of the property under this section; or
(B) the petitioner is a bona fide purchaser for value of the right, title, or interest in the property and was at the time of purchase reasonably without cause to believe that the property was subject to forfeiture under this section;
the court shall amend the order of forfeiture in accordance with its determination.(7) Following the court's disposition of all petitions filed under this subsection, or if no such petitions are filed following the expiration of the period provided in paragraph (2) for the filing of such petitions, the United States shall have clear title to property that is the subject of the order of forfeiture and may warrant good title to any subsequent purchaser or transferee.
(o) Construction
The provisions of this section shall be liberally construed to effectuate its
remedial purposes.
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(p) Forfeiture of substitute property
If any of the property described in subsection (a) of this section, as a result
of any act or omission of the defendant -
(1) cannot be located upon the exercise of due diligence;.
(2) has been transferred or sold to, or deposited with, a third party;
(3) has been placed beyond the jurisdiction of the court;
(4) has been substantially diminished in value; or
(5) has been commingled with other property which cannot be divided without difficulty;
the court shall order the forfeiture of any other property of the defendant up to the value of any property described in paragraphs (1) through (5)
(p) FORFEITURE OF SUBSTITUTE PROPERTY-
(1) IN GENERAL- Paragraph (2) of this subsection shall apply, if any property described in subsection (a), as a result of any act or omission of the defendant--
(A) cannot be located upon the exercise of due diligence;
(B) has been transferred or sold to, or deposited with, a third party;
(C) has been placed beyond the jurisdiction of the court;
(D) has been substantially diminished in value; or
(E) has been commingled with other property which cannot be divided without difficulty.(2) SUBSTITUTE PROPERTY- In any case described in any of subparagraphs (A) through (E) of paragraph (1), the court shall order the forfeiture of any other property of the defendant, up to the value of any property described in subparagraphs (A) through (E) of paragraph (1), as applicable.
(3) RETURN OF PROPERTY TO JURISDICTION- In the case of property described in paragraph (1)(C), the court may, in addition to any other action authorized by this subsection, order the defendant to return the property to the jurisdiction of the court so that the property may be seized and forfeited.
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(q) Restitution for cleanup of clandestine laboratory sites The court, when sentencing a defendant convicted of an offense under this subchapter or subchapter II of this chapter involving the manufacture of amphetamine or methamphetamine, shall -
(1) order restitution as provided in sections 3612 and 3664 of title 18;
(2) order the defendant to reimburse the United States, the State or local government concerned, or both the United States and the State or local government concerned for the costs incurred by the United States or the State or local government concerned, as the case may be, for the cleanup associated with the manufacture of amphetamine or methamphetamine by the defendant; and
(3) order restitution to any person injured as a result of the offense as provided in section 3663A of title 18.
administrative details omitted
REFERENCES IN TEXT
The Federal Rules of Evidence, referred to in subsec. (e)(3), are set out in the
Appendix to Title 28, Judiciary and Judicial Procedure.
The Federal Rules of Criminal Procedure, referred to in subsec. (m), are set out
in the Appendix to Title 18, Crimes and Criminal Procedure.
amendment details omitted
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 333, 848, 970 of this title;
title 18 sections 38, 229B, 793, 794, 798, 982, 986, 1028, 1029, 1834, 3554;
title 28 section 2461;
title 33 section 1415;
title 42 section 1786;
title 50 section 783.