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Controlled Substances Act
PART B - AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES

§ 811. Authority and criteria for classification of substances.

• (a) Rules and regulations of Attorney General; hearing

The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by section 812 of this title and to any other drug or other substance added to such schedules under this subchapter. Except as provided in subsections (d) and (e) of this section, the Attorney General may by rule -

• (1) add to such a schedule or transfer between such schedules any drug or other substance if he -
  • (A) finds that such drug or other substance has a potential for abuse, and
  • (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed; or
• (2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.

Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.

• (b) Evaluation of drugs and other substances

The Attorney General shall, before initiating proceedings under subsection (a) of this section to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this section and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a) of this section.

• (c) Factors determinative of control or removal from schedules

In making any finding under subsection (a) of this section or under subsection (b) of section 812 of this title, the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:

• (1) Its actual or relative potential for abuse.
• (2) Scientific evidence of its pharmacological effect, if known.
• (3) The state of current scientific knowledge regarding the drug or other substance.
• (4) Its history and current pattern of abuse.
• (5) The scope, duration, and significance of abuse.
• (6) What, if any, risk there is to the public health.
• (7) Its psychic or physiological dependence liability.
• (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

• (d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances
  • (1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.
  • (2)
    • (A) Whenever the Secretary of State receives notification from the Secretary-General of the United Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the Convention on Psychotropic Substances, which may justify adding a drug or other substance to one of the schedules of the Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State shall immediately transmit the notice to the Secretary of Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such drug or substance. The Secretary of Health and Human Services shall prepare for transmission through the Secretary of State to the World Health Organization such medical and scientific evaluations as may be appropriate regarding the possible action that could be proposed by the World Health Organization respecting the drug or substance with respect to which a notice was transmitted under this subparagraph.
    • (B) Whenever the Secretary of State receives information that the Commission on Narcotic Drugs of the United Nations proposes to decide whether to add a drug or other substance to one of the schedules of the Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the Secretary of Health and Human Services of such information who shall publish a summary of such information in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The Secretary of Health and Human Services shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal.
  • (3) When the United States receives notification of a scheduling decision pursuant to article 2 of the Convention on Psychotropic Substances that a drug or other substance has been added or transferred to a schedule specified in the notification or receives notification (referred to in this subsection as a ''schedule notice'') that existing legal controls applicable under this subchapter to a drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) do not meet the requirements of the schedule of the Convention in which such drug or substance has been placed, the Secretary of Health and Human Services after consultation with the Attorney General, shall first determine whether existing legal controls under this subchapter applicable to the drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act, meet the requirements of the schedule specified in the notification or schedule notice and shall take the following action:
    • (A) If such requirements are met by such existing controls but the Secretary of Health and Human Services nonetheless believes that more stringent controls should be applied to the drug or substance, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance, pursuant to subsections (a) and (b) of this section, to apply to such controls.
    • (B) If such requirements are not met by such existing controls and the Secretary of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance under the appropriate schedule pursuant to subsections (a) and (b) of this section.
    • (C) If such requirements are not met by such existing controls and the Secretary of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall -
      • (i) if he deems that additional controls are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance pursuant to subsections (a) and (b) of this section, to apply such additional controls;
      • (ii) request the Secretary of State to transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to the Secretary-General of the United Nations;
      • (iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in clause (ii) and request the Secretary of State to ask for a review by the Economic and Social Council of the United Nations, in accordance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or
      • (iv) in the case of a schedule notice, request the Secretary of State to take appropriate action under the Convention to initiate proceedings to remove the drug or substance from the schedules under the Convention or to transfer the drug or substance to a schedule under the Convention different from the one specified in the schedule notice.
  • (4)
    • (A) If the Attorney General determines, after consultation with the Secretary of Health and Human Services, that proceedings initiated under recommendations made under paragraph (FOOTNOTE 1)
    • (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the Secretary and after providing interested persons opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. In the case of proceedings initiated under subparagraph (B) of paragraph (3), the Attorney General, concurrently with the issuance of such order, shall request the Secretary of State to transmit a notice of qualified acceptance to the Secretary-General of the United Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a drug or other substance subject to proceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drug or substance of the controls resulting from such proceedings. (FOOTNOTE 1) So in original. Probably should be ''subparagraph''.
    • (B) After a notice of qualified acceptance of a scheduling decision with respect to a drug or other substance is transmitted to the Secretary-General of the United Nations in accordance with clause (ii) or (iii) of paragraph (3)(C) or after a request has been made under clause (iv) of such paragraph with respect to a drug or substance described in a schedule notice, the Attorney General, after consultation with the Secretary of Health and Human Services and after providing interested persons opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention in the case of a drug or substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a drug or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. If, as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause (ii) or (iii) of paragraph (3)(C) -
    • (i) the decision is reversed, and
    • (ii) the drug or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention,
      
      
    the order issued under this subparagraph with respect to such drug or substance shall expire upon receipt by the United States of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under clause (iv) of paragraph (3)(C), the drug or substance with respect to which such action was taken is not required to be controlled under schedule IV or V, the order issued under this paragraph with respect to such drug or substance shall expire upon receipt by the United States of a notice of the action taken with respect to such drug or substance under the Convention.
    
    
    • (C) An order issued under subparagraph (A) or (B) may be issued without regard to the findings required by subsection (a) of this section or by section 812(b) of this title and without regard to the procedures prescribed by subsection (a) or (b) of this section.
    
    
    (5) Nothing in the amendments made by the Psychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder shall be construed to preclude requests by the Secretary of Health and Human Services or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information.

• (e) Immediate precursors

The Attorney General may, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section, place an immediate precursor in the same schedule in which the controlled substance of which it is an immediate precursor is placed or in any other schedule with a higher numerical designation. If the Attorney General designates a substance as an immediate precursor and places it in a schedule, other substances shall not be placed in a schedule solely because they are its precursors.

• (f) Abuse potential

If, at the time a new-drug application is submitted to the Secretary for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such drug has an abuse potential, such information shall be forwarded by the Secretary to the Attorney General.

• (g) Exclusion of non-narcotic substances sold over the counter without a prescription; dextromethorphan; exemption of substances lacking abuse potential
  • (1) The Attorney General shall by regulation exclude any non-narcotic substance from a schedule if such substance may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over the counter without a prescription.
  • (2) Dextromethorphan shall not be deemed to be included in any schedule by reason of enactment of this subchapter unless controlled after October 27, 1970 pursuant to the foregoing provisions of this section.
  • (3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing a controlled substance from the application of all or any part of this subchapter if he finds such compound, mixture, or preparation meets the requirements of one of the following categories:
    • (A) A mixture, or preparation containing a nonnarcotic controlled substance, which mixture or preparation is approved for prescription use, and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.
    • (B) A compound, mixture, or preparation which contains any controlled substance, which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse.

• (h) Temporary scheduling to avoid imminent hazards to public safety
  • (1) If the Attorney General finds that the scheduling of a substance in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of subsection (b) of this section relating to the Secretary of Health and Human Services, schedule such substance in schedule I if the substance is not listed in any other schedule in section 812 of this title or if no exemption or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). Such an order may not be issued before the expiration of thirty days from -
    • (A) the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and
    • (B) the date the Attorney General has transmitted the notice required by paragraph (4).
• (2) The scheduling of a substance under this subsection shall expire at the end of one year from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings under subsection (a)(1) of this section with respect to the substance, extend the temporary scheduling for up to six months.
• (3) When issuing an order under paragraph (1), the Attorney General shall be required to consider, with respect to the finding of an imminent hazard to the public safety, only those factors set forth in paragraphs (4), (5), and (6) of subsection (c) of this section, including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.
• (4) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.
• (5) An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) of this section with respect to such substance.
• (6) An order issued under paragraph (1) is not subject to judicial review.

§ 812. Schedules of controlled substances.

• (a) Establishment

There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and shall be updated and republished on an annual basis thereafter.

• (b) Placement on schedules; findings required

Except where control is required by United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:

• (1) Schedule I. -
  • (A) The drug or other substance has a high potential for abuse.
  • (B) The drug or other substance has no currently accepted medical use in treatment in the United States.
  • (C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
• (2) Schedule II. -
  • (A) The drug or other substance has a high potential for abuse.
  • (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
  • (C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
• (3) Schedule III. -
  • (A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
  • (B) The drug or other substance has a currently accepted medical use in treatment in the United States.
  • (C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
• (4) Schedule IV. -
  • (A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
  • (B) The drug or other substance has a currently accepted medical use in treatment in the United States.
  • (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
• (5) Schedule V. -
  • (A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
  • (B) The drug or other substance has a currently accepted medical use in treatment in the United States.
  • (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

• (c) Initial schedules of controlled substances

Schedules I, II, III, IV, and V shall, unless and until amended (FOOTNOTE 1) pursuant to section 811 of this title, consist of the following drugs or other substances, by whatever official name, common or usual name, chemical name, or brand name designated: (FOOTNOTE 1) Revised schedules are published in the Code of Federal Regulations, Part 1308 of Title 21, Food and Drugs.

• (a) Opiates

Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

• (1) Acetylmethadol.
• (2) Allylprodine.
• (3) Alphacetylmathadol. (FOOTNOTE 2) (FOOTNOTE 2) So in original. Probably should be ''Alphacetylmethadol.''
• (4) Alphameprodine.
• (5) Alphamethadol.
• (6) Benzethidine.
• (7) Betacetylmethadol.
• (8) Betameprodine.
• (9) Betamethadol.
• (10) Betaprodine.
• (11) Clonitazene.
• (12) Dextromoramide.
• (13) Dextrorphan.
• (14) Diampromide.
• (15) Diethylthiambutene.
• (16) Dimenoxadol.
• (17) Dimepheptanol.
• (18) Dimethylthiambutene.
• (19) Dioxaphetyl butyrate.
• (20) Dipipanone.
• (21) Ethylmethylthiambutene.
• (22) Etonitazene.
• (23) Etoxeridine.
• (24) Furethidine.
• (25) Hydroxypethidine.
• (26) Ketobemidone.
• (27) Levomoramide.
• (28) Levophenacylmorphan.
• (29) Morpheridine.
• (30) Noracymethadol.
• (31) Norlevorphanol.
• (32) Normethadone.
• (33) Norpipanone.
• (34) Phenadoxone.
• (35) Phenampromide.
• (36) Phenomorphan.
• (37) Phenoperidine.
• (38) Piritramide.
• (39) Propheptazine.
• (40) Properidine.
• (41) Racemoramide.
• (42) Trimeperidine.

• (b) Opium Derivatives

Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, isomers, and salt of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

• (1) Acetorphine.
• (2) Acetyldihydrocodeine.
• (3) Benzylmorphine.
• (4) Codeine methylbromide.
• (5) Codeine-N-Oxide.
• (6) Cyprenorphine.
• (7) Desomorphine.
• (8) Dihydromorphine.
• (9) Etorphine.
• (10) Heroin.
• (11) Hydromorphinol.
• (12) Methyldesorphine.
• (13) Methylhydromorphine.
• (14) Morphine methylbromide.
• (15) Morphine methylsulfonate.
• (16) Morphine-N-Oxide.
• (17) Myrophine.
• (18) Nicocodeine.
• (19) Nicomorphine.
• (20) Normorphine.
• (21) Pholcodine.
• (22) Thebacon.

• (c) Hallucinogenic Substances

Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

• (1) 3,4-methylenedioxy amphetamine.
• (2) 5-methoxy-3,4-methylenedioxy amphetamine.
• (3) 3,4,5-trimethoxy amphetamine.
• (4) Bufotenine.
• (5) Diethyltryptamine.
• (6) Dimethyltryptamine.
• (7) 4-methyl-2,5-diamethoxyamphetamine.
• (8) Ibogaine.
• (9) Lysergic acid diethylamide.
• (10) Marihuana.
• (11) Mescaline.
• (12) Peyote.
• (13) N-ethyl-3-piperidyl benzilate.
• (14) N-methyl-3-piperidyl benzilate.
• (15) Psilocybin.
• (16) Psilocyn.
• (17) Tetrahydrocannabinols.

• (a)

Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

• (1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.
• (2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium.
• (3) Opium poppy and poppy straw.
• (4) coca (FOOTNOTE 3) leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; cocaine, its salts, optical and geometric isomers, and salts of isomers; ecgonine, its derivatives, their salts, isomers, and salts of isomers; or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph. (FOOTNOTE 3) So in original. Probably should be capitalized.

• (b) Opiates

Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

• (1) Alphaprodine.
• (2) Anileridine.
• (3) Bezitramide.
• (4) Dihydrocodeine.
• (5) Diphenoxylate.
• (6) Fentanyl.
• (7) Isomethadone.
• (8) Levomethorphan.
• (9) Levorphanol.
• (10) Metazocine.
• (11) Methadone.
• (12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane.
• (13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid.
• (14) Pethidine.
• (15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.
• (16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.
• (17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid.
• (18) Phenazocine.
• (19) Piminodine.
• (20) Racemethorphan.
• (21) Racemorphan.

• (c) Methamphetamine

Unless specifically excepted or unless listed in another schedule, any injectable liquid which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.

• (a) Stimulants

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

• (1) Amphetamine, its salts, optical isomers, and salts of its optical isomers.
• (2) Phenmetrazine and its salts.
• (3) Any substance (except an injectable liquid) which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers.
• (4) Methylphenidate.

• (b) Depressants

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

• (1) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid.
• (2) Chorhexadol.
• (3) Glutehimide.
• (4) Lysergic acid.
• (5) Lysergic acid amide.
• (6) Methyprylon.
• (7) Phencyclidine.
• (8) Sulfondiethylmethane.
• (9) Sulfonethylmethane.
• (10) Sulfonmethane.

• (c) Nalorphine.

• (d) Narcotic Drug

Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof:

• (1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
• (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts.
• (3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
• (4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
• (5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
• (6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
• (7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
• (8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

• (e) Anabolic steroids.

• (1) Barbital.
• (2) Chloral betaine.
• (3) Chloral hydrate.
• (4) Ethchlorvynol.
• (5) Ethinamate.
• (6) Methohexital.
• (7) Meprobamate.
• (8) Methylphenobarbital.
• (9) Paraldehyde.
• (10) Petrichloral.
• (11) Phenobarbital.

Any compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

• (1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
• (2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
• (3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
• (4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
• (5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

§ 813. Treatment of controlled substance analogues.

A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I.

§ 814. Removal of exemption of certain drugs.

• (a) Removal of exemption

The Attorney General shall by regulation remove from exemption under section 802(39)(A)(iv) of this title a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance.

• (b) Factors to be considered

In removing a drug or group of drugs from exemption under subsection (a) of this section, the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption -

• (1) the scope, duration, and significance of the diversion;
• (2) whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and
• (3) whether the listed chemical can be readily recovered from the drug or group of drugs.

• (c) Specificity of designation

The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) of this section to the most particularly identifiable type of drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.

• (d) Reinstatement of exemption with respect to particular drug products
  • (1) Reinstatement On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a) of this section, the Attorney General shall by regulation reinstate the exemption with respect to that particular drug product if the Attorney General determines that the particular drug product is manufactured and distributed in a manner that prevents diversion.
  • (2) Factors to be considered In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider -
    • (A) the package sizes and manner of packaging of the drug product;
    • (B) the manner of distribution and advertising of the drug product;
    • (C) evidence of diversion of the drug product;
    • (D) any actions taken by the manufacturer to prevent diversion of the drug product; and
    • (E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) of this section as applied to the drug product.
  • (3) Status pending application for reinstatement A transaction involving a particular drug product that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) of this section shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless -
    • (A) the Attorney General has evidence that, applying the factors described in subsection (b) of this section to the drug product, the drug product is being diverted; and
    • (B) the Attorney General so notifies the applicant.
  • (4) Amendment and modification A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that -
    • (A) applying the factors described in subsection (b) of this section to the drug product, the drug product is being diverted; or
    • (B) there is a significant change in the data that led to the issuance of the regulation.

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