21 U.S.C. § 811 — Authority and criteria for classification of

Page 794 TITLE 21—FOOD AND DRUGS § 803 listed chemicals (as defined in section 102(45) of such Act [21 U.S.C. 802(45)]).’’ REPORT ON DIVERSION OF ORDINARY, OVER-THE- COUNTER PSEUDOEPHEDRINE AND PHENYLPROPANOLA- MINE PRODUCTS Pub. L. 106–310, div. B, title XXXVI, § 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 investiga- tions 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 phenyl- propanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenyl- propanolamine 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 re- sult of the study; and ‘‘(B) such recommendations on the need to estab- lish additional measures to prevent diversion of or- dinary, over-the-counter pseudoephedrine and phen- ylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenyl- propanolamine 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 rec- ommendations, 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 Gen- eral 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, phenyl- propanolamine 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 lim- its for retail distributors of either or both of such products. ‘‘(2) DUE PROCESS.—The Attorney General shall es- tablish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hear- ing.’’ REGULATION OF RETAIL SALES OF CERTAIN PRECURSOR CHEMICALS; EFFECT ON THRESHOLDS; COMBINATION EPHEDRINE PRODUCTS Pub. L. 104–237, title IV, § 401(d)–(f), Oct. 3, 1996, 110 Stat. 3108, which authorized the Attorney General to establish a single-transaction limit of 24 grams for pseudoephedrine, phenylpropanolamine, and combina- tion ephedrine products for retail distributors, was re- pealed by Pub. L. 109–177, title VII, § 712(b), Mar. 9, 2006, 120 Stat. 264. EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41) Pub. L. 101–647, title XIX, § 1903, Nov. 29, 1990, 104 Stat. 4853, as amended by Pub. L. 108–358, § 2(c), Oct. 22, 2004, 118 Stat. 1663, provided that: ‘‘(a) DRUGS FOR TREATMENT OF RARE DISEASES.—If the Attorney General finds that a drug listed in para- graph (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 condi- tion, 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. ‘‘(b) DATE OF ISSUANCE OF REGULATIONS.—The Attor- ney General shall issue regulations implementing this section not later than 45 days after the date of enact- ment of this Act [Nov. 29, 1990], except that the regula- tions required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of en- actment of this Act.’’ § 803. Repealed. Pub. L. 95–137, § 1(b), Oct. 18, 1977, 91 Stat. 1169 Section, Pub. L. 91–513, title II, § 103, Oct. 27, 1970, 84 Stat. 1245, authorized Bureau of Narcotics and Dan- gerous Drugs to add, during fiscal year 1971, 300 agents, together with necessary supporting personnel, and pro- vided for appropriations of $6,000,000 to carry out such addition. 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 provi- sions of this subchapter to the controlled sub- stances 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 sub- sections (d) and (e), the Attorney General may by rule— (1) add to such a schedule or transfer be- tween such schedules any drug or other sub- stance 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 sub- section shall be made on the record after oppor- tunity for a hearing pursuant to the rulemaking Page 795 TITLE 21—FOOD AND DRUGS § 811 procedures prescribed by subchapter II of chap- ter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initi- ated by the Attorney General (1) on his own mo- tion, (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) 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 evalua- tion, and his recommendations, as to whether such drug or other substance should be so con- trolled 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) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Sec- retary shall include recommendations with re- spect 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 rea- sonable time. The recommendations of the Sec- retary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary rec- ommends that a drug or other substance not be controlled, the Attorney General shall not con- trol the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evi- dence 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). (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 con- sider the following factors with respect to each drug or other substance proposed to be con- trolled 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 pro- tocols requiring control; procedures respect- ing changes in drug schedules of Convention on Psychotropic Substances (1) If control is required by United States obli- gations under international treaties, conven- tions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order con- trolling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by sub- section (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 sec- tion. (2)(A) Whenever the Secretary of State re- ceives notification from the Secretary-General of the United Nations that information has been transmitted by or to the World Health Organiza- tion, 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 sci- entific 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 ap- propriate regarding the possible action that could be proposed by the World Health Organiza- tion respecting the drug or substance with re- spect 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 Sec- retary of Health and Human Services of such in- formation 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 subpara- graph, 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 discus- sions and negotiations relating to the proposal. (3) When the United States receives notifica- tion 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 notifi- cation or receives notification (referred to in this subsection as a ‘‘schedule notice’’) that ex- isting legal controls applicable under this sub- chapter to a drug or substance and the controls required by the Federal Food, Drug, and Cos- Page 796 TITLE 21—FOOD AND DRUGS § 811 1 So in original. Probably should be ‘‘subparagraph’’. metic 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 con- trols 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 ex- isting 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 rec- ommend to the Attorney General that he ini- tiate 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 pro- ceedings 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 trans- mitted 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 sub- sections (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 Conven- tion, 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 Sec- retary 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, re- quest the Secretary of State to take appro- priate action under the Convention to ini- tiate proceedings to remove the drug or sub- stance from the schedules under the Conven- tion or to transfer the drug or substance to a schedule under the Convention different from the one specified in the schedule no- tice. (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 1 (B) or (C)(i) of paragraph (3) will not be com- pleted within the time period required by para- graph 7 of article 2 of the Convention, the Attor- ney General, after consultation with the Sec- retary and after providing interested persons op- portunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a tem- porary order controlling the drug or substance under schedule IV or V, whichever is most ap- propriate 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 subpara- graph (B) of paragraph (3), the Attorney Gen- eral, 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 pursu- ant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subpara- graph controlling a drug or other substance sub- ject 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. (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 sub- stance described in a schedule notice, the Attor- ney General, after consultation with the Sec- retary of Health and Human Services and after providing interested persons opportunity to sub- mit 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 ap- propriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention in the case of a drug or sub- stance for which a notice of qualified acceptance was transmitted or whichever the Attorney Gen- eral 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, ex- cept such drug or substance from the applica- tion 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 Con- vention 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 de- cision is not required to be controlled under schedule IV or V to carry out the minimum Page 797 TITLE 21—FOOD AND DRUGS § 811 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 sub- stance shall expire upon receipt by the United States of a notice of the action taken with re- spect to such drug or substance under the Con- vention. (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 regu- lations or orders promulgated thereunder shall be construed to preclude requests by the Sec- retary of Health and Human Services or the At- torney General through the Secretary of State, pursuant to article 2 or other applicable provi- sions 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 sub- sections (a) and (b) of this section, place an im- mediate precursor in the same schedule in which the controlled substance of which it is an imme- diate precursor is placed or in any other sched- ule 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 sched- ule solely because they are its precursors. (f) Abuse potential If, at the time a new-drug application is sub- mitted 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 informa- tion 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 drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug may, under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], be law- fully sold over the counter without a prescrip- tion. (2) Dextromethorphan shall not be deemed to be included in any schedule by reason of enact- ment of this subchapter unless controlled after October 27, 1970 pursuant to the foregoing provi- sions of this section. (3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing a controlled substance from the ap- plication 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 mix- ture or preparation is approved for prescrip- tion use, and which contains one or more other active ingredients which are not listed in any schedule and which are included there- in 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 pack- aged it does not present any significant poten- tial for abuse. (C) Upon the recommendation of the Sec- retary of Health and Human Services, a com- pound, mixture, or preparation which contains any anabolic steroid, which is intended for ad- ministration to a human being or an animal, and which, because of its concentration, prep- aration, formulation or delivery system, 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 tem- porary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of sub- section (b) 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 sub- stance 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 Attor- ney General of a notice in the Federal Reg- ister 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 trans- mitted the notice required by paragraph (4). (2) The scheduling of a substance under this subsection shall expire at the end of 2 years from the date of the issuance of the order sched- uling such substance, except that the Attorney General may, during the pendency of pro- ceedings under subsection (a)(1) with respect to the substance, extend the temporary scheduling for up to 1 year. (3) When issuing an order under paragraph (1), the Attorney General shall be required to con- sider, with respect to the finding of an imminent hazard to the public safety, only those factors Page 798 TITLE 21—FOOD AND DRUGS § 811 set forth in paragraphs (4), (5), and (6) of sub- section (c), including actual abuse, diversion from legitimate channels, and clandestine im- portation, manufacture, or distribution. (4) The Attorney General shall transmit notice of an order proposed to be issued under para- graph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consid- eration any comments submitted by the Sec- retary in response to a notice transmitted pur- suant 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 pro- ceeding initiated under subsection (a) with re- spect to such substance. (6) An order issued under paragraph (1) is not subject to judicial review. (i) Temporary and permanent scheduling of re- cently emerged anabolic steroids (1) The Attorney General may issue a tem- porary order adding a drug or other substance to the definition of anabolic steroids if the Attor- ney General finds that— (A) the drug or other substance satisfies the criteria for being considered an anabolic ster- oid under section 802(41) of this title but is not listed in that section or by regulation of the Attorney General as being an anabolic steroid; and (B) adding such drug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of the drug or other substance. (2) An order issued under paragraph (1) shall not take effect until 30 days after 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. The order shall expire not later than 24 months after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (6), extend the temporary scheduling order for up to 6 months. (3) The Attorney General shall transmit notice of an order proposed to be issued under para- graph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consid- eration any comments submitted by the Sec- retary in response to a notice transmitted pur- suant to this paragraph. (4) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent scheduling order under para- graph (6). (5) An order issued under paragraph (1) is not subject to judicial review. (6) The Attorney General may, by rule, issue a permanent order adding a drug or other sub- stance to the definition of anabolic steroids if such drug or other substance satisfies the cri- teria for being considered an anabolic steroid under section 802(41) of this title. Such rule- making may be commenced simultaneously with the issuance of the temporary order issued under paragraph (1). (j) Interim final rule; date of issuance; procedure for final rule (1) With respect to a drug referred to in sub- section (f), if the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule II, III, IV, or V pursuant to subsections (a) and (b), the At- torney General shall, not later than 90 days after the date described in paragraph (2), issue an interim final rule controlling the drug in ac- cordance with such subsections and section 812(b) of this title using the procedures described in paragraph (3). (2) The date described in this paragraph shall be the later of— (A) the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the Secretary of Health and Human Services in ac- cordance with subsection (b); or (B) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c), 360b, 360ccc] or section 262(a) of title 42, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc–1], with re- spect to the drug described in paragraph (1). (3) A rule issued by the Attorney General under paragraph (1) shall become immediately effective as an interim final rule without requir- ing the Attorney General to demonstrate good cause therefor. The interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with the sched- uling criteria of subsections (b), (c), and (d) of this section and section 812(b) of this title. (Pub. L. 91–513, title II, § 201, Oct. 27, 1970, 84 Stat. 1245; Pub. L. 95–633, title I, § 102(a), Nov. 10, 1978, 92 Stat. 3769; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 98–473, title II, §§ 508, 509(a), Oct. 12, 1984, 98 Stat. 2071, 2072; Pub. L. 108–358, § 2(b), Oct. 22, 2004, 118 Stat. 1663; Pub. L. 112–144, title XI, § 1153, July 9, 2012, 126 Stat. 1132; Pub. L. 113–260, § 2(b), Dec. 18, 2014, 128 Stat. 2930; Pub. L. 114–89, § 2(b), Nov. 25, 2015, 129 Stat. 700.) Editorial Notes REFERENCES IN TEXT This subchapter, referred to in subsecs. (a), (c)(8), (d)(3), (4)(A), (B), and (g)(2), (3), was in the original ‘‘this title’’, meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the ‘‘Con- trolled 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. The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (d)(3) and (g)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chap- ter 9 (§ 301 et seq.) of this title. For complete classifica- tion of this Act to the Code, see section 301 of this title and Tables. Schedules I, II, III, IV, and V, referred to in subsecs. (d)(4)(A), (B), (h)(1), and (j)(1), are set out in section 812(c) of this title. The Psychotropic Substances Act of 1978, referred to in subsec. (d)(5), is Pub. L. 95–633, Nov. 10, 1978, 92 Stat. Page 799 TITLE 21—FOOD AND DRUGS § 812 1 See Amendment of Schedules of Controlled Substances note below. 3768, which enacted sections 801a, 830, and 852 of this title, amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, re- pealed section 830 of this title effective Jan. 1, 1981, and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of this title. For complete classifica- tion of this Act to the Code, see Short Title of 1978 Amendment note set out under section 801 of this title and Tables. This subchapter and subchapter II of this chapter, re- ferred to in subsec. (g)(1), was in the original ‘‘titles II and III of the Comprehensive Drug Abuse Prevention and Control Act’’, which was translated as meaning ti- tles II and III of the Comprehensive Drug Abuse Pre- vention and Control Act of 1970, Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 1285, to reflect the probable intent of Congress. Title II is classified principally to this sub- chapter and part A of title III comprises subchapter II of this chapter. For complete classification of this Act to the Code, see Short Title notes set out under section 801 of this title and Tables. AMENDMENTS 2015—Subsec. (j). Pub. L. 114–89 added subsec. (j). 2014—Subsec. (i). Pub. L. 113–260 added subsec. (i). 2012—Subsec. (h)(2). Pub. L. 112–144 substituted ‘‘2 years’’ for ‘‘one year’’ and ‘‘1 year’’ for ‘‘six months’’. 2004—Subsec. (g)(1). Pub. L. 108–358, § 2(b)(1), sub- stituted ‘‘drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug’’ for ‘‘substance from a schedule if such substance’’. Subsec. (g)(3)(C). Pub. L. 108–358, § 2(b)(2), added sub- par. (C). 1984—Subsec. (g)(3). Pub. L. 98–473, § 509(a), added par. (3). Subsec. (h). Pub. L. 98–473, § 508, added subsec. (h). 1978—Subsec. (d). Pub. L. 95–633 designated existing provisions as par. (1) and added pars. (2) to (5). Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in subsec. (d)(2), (3), (4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96–88 which is classified to sec- tion 3508(b) of Title 20, Education. EFFECTIVE DATE OF 2004 AMENDMENT Amendment by Pub. L. 108–358 effective 90 days after Oct. 22, 2004, see section 2(d) of Pub. L. 108–358, set out as a note under section 802 of this title. 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. § 812. Schedules of controlled substances (a) Establishment There are established five schedules of con- trolled 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.1 (b) Placement on schedules; findings required Except where control is required by United States obligations under an international trea- ty, 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 re- quired for such schedule are made with respect to such drug or other substance. The findings re- quired 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 cur- rently 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 cur- rently 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 poten- tial for abuse less than the drugs or other sub- stances in schedules I and II. (B) The drug or other substance has a cur- rently accepted medical use in treatment in the United States. (C) Abuse of the drug or other substance may lead to moderate or low physical depend- ence 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 cur- rently 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 cur- rently 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 pursuant to section 811 of this title, consist of the following drugs or other sub- stances,1 by whatever official name, common or usual name, chemical name, or brand name des- ignated: