
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC802]

 
                        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.

(Pub. L. 91-513, title II, Sec. 102, Oct. 27, 1970, 84 Stat. 1242; Pub. 
L. 93-281, Sec. 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633, title I, 
Sec. 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88, title V, 
Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132, Sec. 16(a), 
Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98-473, title II, Sec. 507(a), 
(b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98-509, title III, 
Sec. 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99-514, Sec. 2, Oct. 
22, 1986, 100 Stat. 2095; Pub. L. 99-570, title I, Secs. 1003(b), 1203, 
1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-13, 3207-56; Pub. L. 99-646, 
Sec. 83, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 100-690, title VI, 
Sec. 6054, Nov. 18, 1988, 102 Stat. 4316; Pub. L. 101-647, title XIX, 
Sec. 1902(b), title XXIII, Sec. 2301, title XXXV, Sec. 3599I, Nov. 29, 
1990, 104 Stat. 4852, 4858, 4932; Pub. L. 103-200, Secs. 2(a), 7-9(a), 
Dec. 17, 1993, 107 Stat. 2333, 2340; Pub. L. 103-322, title IX, 
Sec. 90105(d), title XXXIII, Sec. 330024(a), (b), (d)(1), Sept. 13, 
1994, 108 Stat. 1988, 2150; Pub. L. 104-237, title II, Secs. 204(a), 
209, title IV, Sec. 401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 
3106, 3107; Pub. L. 104-294, title VI, Secs. 604(b)(4), 607(j), Oct. 11, 
1996, 110 Stat. 3506, 3512; Pub. L. 105-115, title I, Sec. 126(c)(3), 
Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106-172, Secs. 3(c), 5(a), Feb. 
18, 2000, 114 Stat. 9, 10; Pub. L. 106-310, div. B, title XXXVI, 
Sec. 3622(a), Oct. 17, 2000, 114 Stat. 1231.)

                       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.


                               Amendments

    2000--Par. (32)(A). Pub. L. 106-172, Sec. 5(a)(1), substituted 
``subparagraph (C)'' for ``subparagraph (B)'' in introductory 
provisions.
    Par. (32)(B), (C). Pub. L. 106-172, Sec. 5(a)(2), (3), added subpar. 
(B) and redesignated former subpar. (B) as (C).
    Par. (34)(X), (Y). Pub. L. 106-172, Sec. 3(c), added subpar. (X) and 
redesignated former subpar. (X) as (Y).
    Par. (39)(A)(iv)(II). Pub. L. 106-310 substituted ``9 grams'' for 
``24 grams'' in two places and inserted before semicolon at end ``and 
sold in package sizes of not more than 3 grams of pseudoephedrine base 
or 3 grams of phenylpropanolamine base''.
    1997--Par. (9)(A). Pub. L. 105-115 redesignated cl. (i) as subpar. 
(A) and struck out cl. (ii) which read as follows: ``any derivative of 
barbituric acid which has been designated by the Secretary as habit 
forming under section 352(d) of this title; or''.
    1996--Par. (26). Pub. L. 104-294, Sec. 607(j)(1), amended par. (26) 
generally. Prior to amendment, par. (26) read as follows: ``The term 
`State' means any State, territory, or possession of the United States, 
the District of Columbia, the Commonwealth of Puerto Rico, the Trust 
Territory of the Pacific Islands, and the Canal Zone.''
    Par. (34)(P), (S), (U). Pub. L. 104-237, Sec. 209(1), substituted 
``Isosafrole'' for ``Insosafrole'' in subpar. (P), ``N-Methylephedrine'' 
for ``N-Methylepherdrine'' in subpar. (S), and ``Hydriodic acid'' for 
``Hydriotic acid'' in subpar. (U).
    Par. (35)(G). Pub. L. 104-237, Sec. 209(2), amended subpar. (G) 
generally, inserting ``(or Methyl Ethyl Ketone)'' before period at end.
    Par. (35)(I), (J). Pub. L. 104-237, Sec. 204(a), added subpars. (I) 
and (J).
    Par. (39)(A)(iv)(I)(aa). Pub. L. 104-237, Sec. 401(a)(1), (b)(1), 
substituted ``, 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);'' for 
``as the only active medicinal ingredient or contains ephedrine or its 
salts, optical isomers, or salts of optical isomers and therapeutically 
insignificant quantities of another active medicinal ingredient;''.
    Par. (39)(A)(iv)(II). Pub. L. 104-237, Sec. 401(a)(2), (b)(2), 
inserted ``, pseudoephedrine, phenylpropanolamine,'' after ``ephedrine'' 
and inserted before semicolon ``, 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 24 grams of pseudoephedrine or 
24 grams of phenylpropanolamine in a single transaction''.
    Pars. (43), (44). Pub. L. 104-237, Sec. 401(b)(3), and Pub. L. 104-
294, Secs. 604(b)(4), 607(j)(2), amended section identically, 
redesignating par. (43), relating to felony drug offense, as (44).
    Pars. (45), (46). Pub. L. 104-237, Sec. 401(b)(4), added pars. (45) 
and (46).
    1994--Par. (34)(V), (W). Pub. L. 103-322, Sec. 330024(b), realigned 
margins and capitalized first letter.
    Par. (35). Pub. L. 103-322, Sec. 330024(d)(1), made technical 
correction to directory language of Pub. L. 103-200, Sec. 2(a)(4)(B). 
See 1993 Amendment note below.
    Par. (39)(A)(iv)(II). Pub. L. 103-322, Sec. 330024(a), substituted 
``; or'' for period at end.
    Par. (43). Pub. L. 103-322, Sec. 90105(d), added par. (43) defining 
``felony drug offense''.
    1993--Par. (33). Pub. L. 103-200, Sec. 2(a)(1), substituted ``any 
list I chemical or any list II chemical'' for ``any listed precursor 
chemical or listed essential chemical''.
    Par. (34). Pub. L. 103-200, Sec. 2(a)(2), substituted ``list I 
chemical'' for ``listed precursor chemical'' and ``important to the 
manufacture'' for ``critical to the creation'' in introductory 
provisions.
    Par. (34)(A), (F), (H). Pub. L. 103-200, Sec. 2(a)(3), inserted ``, 
its esters,'' before ``and''.
    Par. (34)(O). Pub. L. 103-200, Sec. 8(1), (2), redesignated subpar. 
(P) as (O) and struck out former subpar. (O) which read as follows: ``D-
lysergic acid.''
    Par. (34)(P) to (S). Pub. L. 103-200, Sec. 8(2), redesignated 
subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) 
redesignated (O).
    Par. (34)(T). Pub. L. 103-200, Sec. 8(2), redesignated subpar. (V) 
as (T). Former subpar. (T) redesignated (S).
    Par. (34)(U). Pub. L. 103-200, Sec. 8(1), (2), redesignated subpar. 
(X) as (U) and struck out former subpar. (U) which read as follows: ``N-
ethylephedrine.''
    Par. (34)(V). Pub. L. 103-200, Sec. 8(2), (4), added subpar. (V) and 
redesignated former subpar. (V) as (T).
    Par. (34)(W). Pub. L. 103-200, Sec. 8(1), (4), added subpar. (W) and 
struck out former subpar. (W) which read as follows: ``N-
ethylpseudoephedrine.''
    Par. (34)(X). Pub. L. 103-200, Sec. 8(2), (3), redesignated subpar. 
(Y) as (X) and substituted ``through (U)'' for ``through (X)''.
    Par. (34)(Y). Pub. L. 103-200, Sec. 8(2), redesignated subpar. (Y) 
as (X).
    Par. (35). Pub. L. 103-200, Sec. 2(a)(4)(A), (C), substituted ``list 
II chemical'' for ``listed essential chemical'' and struck out ``as a 
solvent, reagent, or catalyst'' before ``in manufacturing''.
    Pub. L. 103-200, Sec. 2(a)(4)(B), as amended by Pub. L. 103-322, 
Sec. 330024(d)(1), inserted ``(other than a list I chemical)'' before 
``specified'' the first time appearing.
    Par. (37). Pub. L. 103-200, Sec. 9(a), amended par. (37) generally. 
Prior to amendment, par. (37) read as follows: ``The term `regular 
supplier' means, with respect to a regulated person, a supplier with 
whom the regulated person has an established business relationship that 
is reported to the Attorney General.''
    Par. (38). Pub. L. 103-200, Sec. 2(a)(5), inserted before period at 
end ``or who acts as a broker or trader for an international transaction 
involving a listed chemical, a tableting machine, or an encapsulating 
machine''.
    Par. (39)(A). Pub. L. 103-200, Secs. 2(a)(6)(A), 7, in introductory 
provisions, substituted ``importation, or exportation of, or an 
international transaction involving shipment of,'' for ``importation or 
exportation of'' and inserted ``a listed chemical, or if the Attorney 
General establishes a threshold amount for a specific listed chemical,'' 
before ``a threshold amount,''.
    Par. (39)(A)(iii). Pub. L. 103-200, Sec. 2(a)(6)(B), inserted ``or 
any category of transaction for a specific listed chemical or 
chemicals'' after ``transaction''.
    Par. (39)(A)(iv). Pub. L. 103-200, Sec. 2(a)(6)(C), amended cl. (iv) 
generally. Prior to amendment, cl. (iv) read as follows: ``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; or''.
    Par. (39)(A)(v). Pub. L. 103-200, Sec. 2(a)(6)(D), inserted before 
semicolon at end ``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''.
    Par. (40). Pub. L. 103-200, Sec. 2(a)(7), substituted ``list I 
chemical or a list II chemical'' for ``listed precursor chemical or a 
listed essential chemical'' in two places.
    Pars. (42), (43). Pub. L. 103-200, Sec. 2(a)(8), added pars. (42) 
and (43).
    1990--Par. (32)(A). Pub. L. 101-647, Sec. 3599I, substituted ``the 
stimulant'' for ``the stimulent'' in cl. (ii) and ``a stimulant'' for 
``a stimulent'' in cl. (iii).
    Par. (34)(M) to (Y). Pub. L. 101-647, Sec. 2301(a), added subpars. 
(M) to (Y).
    Par. (35)(E). Pub. L. 101-647, Sec. 2301(b), struck out subpar. (E) 
``Hydriodic acid.''
    Par. (41). Pub. L. 101-647, Sec. 1902(b), added par. (41).
    1988--Par. (8). Pub. L. 100-690, Sec. 6054(1), inserted ``or a 
listed chemical'' after ``a controlled substance''.
    Par. (11). Pub. L. 100-690, Sec. 6054(2), inserted ``or a listed 
chemical'' after ``a controlled substance'' in two places.
    Pars. (33) to (40). Pub. L. 100-690, Sec. 6054(3), added pars. (33) 
to (40).
    1986--Par. (6). Pub. L. 99-514 substituted ``Internal Revenue Code 
of 1986'' for ``Internal Revenue Code of 1954''.
    Par. (14). Pub. L. 99-570, Sec. 1870, and Pub. L. 99-646 amended 
par. (14) identically, substituting ``any optical'' for ``the optical'' 
in second and third sentences.
    Par. (25). Pub. L. 99-570, Sec. 1003(b)(1), added par. (25). Former 
par. (25) redesignated (26).
    Pars. (26) to (31). Pub. L. 99-570, Sec. 1003(b)(2), redesignated 
pars. (25) to (30) as (26) to (31), respectively.
    Par. (32). Pub. L. 99-570, Sec. 1203, added par. (32).
    1984--Pars. (14) to (16). Pub. L. 98-473, Sec. 507(a), added par. 
(14) and redesignated former pars. (14) to (16) as (15) to (17), 
respectively.
    Par. (17). Pub. L. 98-473, Sec. 507, redesignated former par. (16) 
as (17), and expanded and revised definition of ``narcotic drug'', 
including within term poppy straw, cocaine, and ecgonine. Former par. 
(17) redesignated (18).
    Pars. (18) to (28). Pub. L. 98-473, Sec. 507(a), redesignated former 
pars. (17) to (27) as (18) to (28), respectively.
    Par. (29). Pub. L. 98-509 which directed the substitution of ``one 
hundred and eighty'' for ``twenty-one'' in par. (28), was executed to 
par. (29) in view of the redesignation of par. (28) as par. (29) by Pub. 
L. 98-473.
    Pub. L. 98-473, Sec. 507(a), redesignated former par. (28) as (29). 
Former par. (29) redesignated (30).
    Par. (30). Pub. L. 98-473, Sec. 507(a), redesignated former par. 
(29) as (30).
    1979--Par. (4). Pub. L. 96-132 substituted provisions defining 
``Drug Enforcement Administration'' for provisions defining ``Bureau of 
Narcotics and Dangerous Drugs''.
    1978--Par. (29). Pub. L. 95-633 added par. (29).
    1974--Pars. (27), (28). Pub. L. 93-281 added pars. (27) and (28).

                         Change of Name

    ``Secretary of Health and Human Services'' substituted for 
``Secretary of Health, Education, and Welfare'' in par. (24) pursuant to 
section 509(b) of Pub. L. 96-88, which is classified to section 3508(b) 
of Title 20, Education.


                    Effective Date of 2000 Amendment

    Pub. L. 106-310, div. B, title XXXVI, Sec. 3622(b), Oct. 17, 2000, 
114 Stat. 1231, provided that: ``The amendments made by subsection (a) 
[amending this section] shall take effect 1 year after the date of the 
enactment of this Act [Oct. 17, 2000].''


                    Effective Date of 1997 Amendment

    Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, 
except as otherwise provided, see section 501 of Pub. L. 105-115, set 
out as a note under section 321 of this title.


                    Effective Date of 1996 Amendments

    Amendment by section 604(b)(4) of Pub. L. 104-294 effective Sept. 
13, 1994, see section 604(d) of Pub. L. 104-294, set out as a note under 
section 13 of Title 18, Crimes and Criminal Procedure.
    Section 401(g) of Pub. L. 104-237 provided that: ``Notwithstanding 
any other provision of this Act [see section 1(a) of Pub. L. 104-237, 
set out as a Short Title of 1996 Amendments note under section 801 of 
this title], this section [amending this section and section 814 of this 
title and enacting provisions set out as a note below] shall not apply 
to the sale of any pseudoephedrine or phenylpropanolamine product prior 
to 12 months after the date of enactment of this Act [Oct. 3, 1996], 
except that, on application of a manufacturer of a particular 
pseudoephedrine or phenylpropanolamine drug product, the Attorney 
General may, in her sole discretion, extend such effective date up to an 
additional six months. Notwithstanding any other provision of law, the 
decision of the Attorney General on such an application shall not be 
subject to judicial review.''


                    Effective Date of 1994 Amendment

    Section 330024(f) of Pub. L. 103-322 provided that: ``The amendments 
made by this section [amending this section and sections 824, 960, and 
971 of this title] shall take effect as of the date that is 120 days 
after the date of enactment of the Domestic Chemical Diversion Control 
Act of 1993 [Dec. 17, 1993].''


                    Effective Date of 1993 Amendment

    Section 11 of Pub. L. 103-200 provided that: ``This Act [enacting 
section 814 of this title, amending this section and sections 821 to 
824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting 
provisions set out as a note under section 801 of this title] and the 
amendments made by this Act shall take effect on the date that is 120 
days after the date of enactment of this Act [Dec. 17, 1993].''


                    Effective Date of 1990 Amendment

    Section 1902(d) of Pub. L. 101-647 provided that: ``This section 
[amending this section and section 812 of this title and enacting 
provisions set out as a note under section 829 of this title] and the 
amendment made by this section shall take effect 90 days after the date 
of enactment of this Act [Nov. 29, 1990].''


                    Effective Date of 1988 Amendment

    Section 6061 of title VI of Pub. L. 100-690 provided that: ``Except 
as otherwise provided in this subtitle, this subtitle [subtitle A 
(Secs. 6051-6061) of title VI of Pub. L. 100-690, enacting section 971 
of this title, amending this section and sections 830, 841 to 843, 872, 
876, 881, 960, and 961 of this title, and enacting provisions set out as 
notes under this section and section 971 of this title] shall take 
effect 120 days after the enactment of this Act [Nov. 18, 1988].''


                    Effective Date of 1978 Amendment

    Amendment by Pub. L. 95-633 effective on date the Convention on 
Psychotropic Substances enters into force in the United States [July 15, 
1980], see section 112 of Pub. L. 95-633, set out as an Effective Date 
note under section 801a of this title.


                               Regulations

    Section 301(b) of Pub. L. 98-509 provided that: ``The Secretary of 
Health and Human Services shall, within ninety days of the date of the 
enactment of this Act [Oct. 19, 1984], promulgate regulations for the 
administration of section 102(28) of the Controlled Substances Act [21 
U.S.C. 802(29)] as amended by subsection (a) and shall include in the 
first report submitted under section 505(b) [now 503(b)] of the Public 
Health Service Act [42 U.S.C. 290aa-2(b)] after the expiration of such 
ninety days the findings of the Secretary with respect to the effect of 
the amendment made by subsection (a).''


 Report on Diversion of Ordinary, Over-the-Counter Pseudoephedrine and 
                      Phenylpropanolamine Products

    Pub. L. 106-310, div. B, title XXXVI, Sec. 3642, Oct. 17, 2000, 114 
Stat. 1237, provided that:
    ``(a) Study.--The Attorney General shall conduct a study of the use 
of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine 
products in the clandestine production of illicit drugs. Sources of data 
for the study shall include the following:
        ``(1) Information from Federal, State, and local clandestine 
    laboratory seizures and related investigations identifying the 
    source, type, or brand of drug products being utilized and how they 
    were obtained for the illicit production of methamphetamine and 
    amphetamine.
        ``(2) Information submitted voluntarily from the pharmaceutical 
    and retail industries involved in the manufacture, distribution, and 
    sale of drug products containing ephedrine, pseudoephedrine, and 
    phenylpropanolamine, including information on changes in the 
    pattern, volume, or both, of sales of ordinary, over-the-counter 
    pseudoephedrine and phenylpropanolamine products.
    ``(b) Report.--
        ``(1) Requirement.--Not later than 1 year after the date of the 
    enactment of this Act [Oct. 17, 2000], the Attorney General shall 
    submit to Congress a report on the study conducted under subsection 
    (a).
        ``(2) Elements.--The report shall include--
            ``(A) the findings of the Attorney General as a result of 
        the study; and
            ``(B) such recommendations on the need to establish 
        additional measures to prevent diversion of ordinary, over-the-
        counter pseudoephedrine and phenylpropanolamine (such as a 
        threshold on ordinary, over-the-counter pseudoephedrine and 
        phenylpropanolamine products) as the Attorney General considers 
        appropriate.
        ``(3) Matters considered.--In preparing the report, the Attorney 
    General shall consider the comments and recommendations including 
    the comments on the Attorney General's proposed findings and 
    recommendations, of State and local law enforcement and regulatory 
    officials and of representatives of the industry described in 
    subsection (a)(2).
    ``(c) Regulation of Retail Sales.--
        ``(1) In general.--Notwithstanding section 401(d) of the 
    Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104-237] 
    (21 U.S.C. 802 note) and subject to paragraph (2), the Attorney 
    General shall establish by regulation a single-transaction limit of 
    not less than 24 grams of ordinary, over-the-counter pseudoephedrine 
    or phenylpropanolamine (as the case may be) for retail distributors, 
    if the Attorney General finds, in the report under subsection (b), 
    that--
            ``(A) there is a significant number of instances (as set 
        forth in paragraph (3)(A) of such section 401(d) for purposes of 
        such section) where ordinary, over-the-counter pseudoephedrine 
        products, phenylpropanolamine products, or both such products 
        that were purchased from retail distributors were widely used in 
        the clandestine production of illicit drugs; and
            ``(B) the best practical method of preventing such use is 
        the establishment of single-transaction limits for retail 
        distributors of either or both of such products.
        ``(2) Due process.--The Attorney General shall establish the 
    single-transaction limit under paragraph (1) only after notice, 
    comment, and an informal hearing.''


  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.
