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Ken is a NJ trial attorney who has published 130 articles in national and New Jersey publications on litigation topics. He has been selected to write the new ABA book: DUI and Drug Possession Defense".

Thursday, March 08, 2018

Sec. 201 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 20

Sec. 201 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 20 
(C) the practitioner, acting in the usual course of profes- sional practice, determines there is a legitimate medical pur- pose for the issuance of the new prescription. 
PART B—AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES AUTHORITY AND CRITERIA FOR CLASSIFICATION OF SUBSTANCES 
SEC. 201. ΓΈ21 U.S.C. 811¿ (a) The Attorney General shall apply the provisions of this title to the controlled substances listed in the schedules established by section 202 of this title and to any other drug or other substance added to such schedules under this title. Except as provided in subsections (d) and (e), the Attorney General may by rule— 
(1) add to such a schedule or transfer between such sched- ules any drug or other substance if he— 
(A) finds that such drug or other substance has a po- tential for abuse, and 
(B) makes with respect to such drug or other sub- stance the findings prescribed by subsection (b) of section 202 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 rule- making procedures prescribed by subchapter II of chapter 5 of title 5 of the United States Code. Proceedings for the issuance, amend- ment, or repeal of such rules may be initiated by the Attorney Gen- eral (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party. 
(b) The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to re- move 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 re- moved 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 sci- entific 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 rec- ommends that a drug or other substance not be controlled, the At- torney 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 
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21 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 201 
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) In making any finding under subsection (a) of this section or under subsection (b) of section 202, 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 title. 
(d)(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on the ef- fective date of this part, the Attorney General shall issue an order controlling such drug under the schedule he deems most appro- priate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 202(b) and with- out regard to the procedures prescribed by subsections (a) and (b) of this section. 
(2)18 (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, pur- suant 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 Sec- retary of State shall immediately transmit the notice to the Sec- retary of Health, Education, and Welfare 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 sub- stance. The Secretary of Health, Education, and Welfare shall pre- pare 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 pro- posed 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 
18 Paragraphs (2) through (5) take effect on the date the Convention on Psychotropic Sub- stances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States. See section 112 of Public Law 95–633. The Convention entered into force in re- spect to the United States on July 15, 1980. 
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Sec. 201 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 22 
of State shall transmit timely notice to the Secretary of Health, Education, and Welfare 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 re- specting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The Secretary of Health, Education, and Welfare 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)19 When the United States receives notification of a sched- uling decision pursuant to article 2 of the Convention on Psycho- tropic 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 title to a drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act do not meet the requirements of the schedule of the Convention in which such drug or substance has been placed, the Secretary of Health, Education, and Welfare, after consultation with the Attorney General, shall first determine whether existing legal controls under this title 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 notifica- tion or schedule notice and shall take the following action: 
(A) If such requirements are met by such existing controls but the Secretary of Health, Education, and Welfare nonethe- less 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 con- trols and the Secretary of Health, Education, and Welfare con- curs in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall recommend to the At- torney 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 con- trols and the Secretary of Health, Education, and Welfare 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 sched- uling 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 
19 See footnote for paragraph (2). 
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 201 
Convention, to the Secretary-General of the United Na- tions; 
(iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in clause (ii) and re- quest the Secretary of State to ask for a review by the Eco- nomic and Social Council of the United Nations, in accord- ance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or 
(iv) in the case of a schedule notice, request the Sec- retary of State to take appropriate action under the Con- vention to initiate proceedings to remove the drug or sub- stance 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)20 If the Attorney General determines, after consultation with the Secretary of Health, Education, and Welfare, that pro- ceedings initiated under recommendations made under para- graph21 (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Conven- tion, the Attorney General, after consultation with the Secretary and after providing interested persons opportunity to submit com- ments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order control- ling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obliga- tions 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 title which he finds is not re- quired 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 Sec- retary 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 pro- ceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drug or sub- stance of the controls resulting from such proceedings. 
(B) After a notice of qualified acceptance of a scheduling deci- sion 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 Attorney General, after consultation with the Secretary of Health, Education, and Welfare and after providing interested persons opportunity to submit com- ments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drug or substance 
20 See footnote for paragraph (2).
21 So in law. Probably should be ‘‘subparagraph’’. 
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Sec. 201 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 24 
under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of arti- cle 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 Sec- retary, except such drug or substance from the application of any provision of part C of this title which he finds is not required to carry out the United States obligations under paragraph 7 of arti- cle 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 re- spect 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 re- quired to be controlled under schedule IV or V to carry out the minimum United States obligations under paragraph 7 of arti- cle 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 para- graph (3)(C), the drug or substance with respect to which such ac- tion 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 sub- stance 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 202(b) and without regard to the proce- dures prescribed by subsection (a) or (b) of this section. 
(5) Nothing in the amendments made by the Psychotropic Sub- stances Act of 1978 or the regulations or orders promulgated there- under shall be construed to preclude requests by the Secretary of Health, Education, and Welfare or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable pro- visions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information. 
(e) The Attorney General may, without regard to the findings required by subsection (a) of this section or section 202(b) and with- out 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 pre- cursor 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 precur- sors. 
(f) If, at the time a new-drug application is submitted to the Secretary for any drug having a stimulant, depressant, or hallu- cinogenic effect on the central nervous system, it appears that such 
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25 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 201 
drug has an abuse potential, such information shall be forwarded by the Secretary to the Attorney General. 
(g)(1) The Attorney General shall by regulation exclude any nonnarcotic drug which contains a controlled substance from the application of titles II and III of the Comprehensive Drug Abuse Prevention and Control Act (21 U.S.C. 802 et seq.)22 if such drug may, under the Federal Food, Drug, and Cosmetic Act, 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 title unless controlled after the date of such enactment pursuant to the foregoing provi- sions of this section. 
(3) The Attorney General may, by regulation, exempt any com- pound, mixture, or preparation containing a controlled substance from the application of all or any part of this title 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 ac- tive ingredients which are not listed in any schedule and which are included there 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. 
(C) Upon the recommendation of the Secretary of Health and Human Services, a compound, mixture, or preparation which contains any anabolic steroid, which is intended for ad- ministration to a human being or an animal, and which, be- cause of its concentration, preparation, formulation or delivery system, does not present any significant potential for abuse. (h)(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) 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 202 or if no exemption or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cos- metic Act. 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 
22 So in law. See section 2(b)(1) of Public Law 108–358 (118 Stat. 1663). Probably should be ‘‘this title and title III of this Act’’. Section 201 above is part of title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 201 et seq.). That Act contains a title III, which relates to imports and exports of controlled substances. (Title II of the Act has a separate short title, the ‘‘Controlled Substances Act’’. Title III of the Act also has a separate short title, the ‘‘Controlled Substances Import and Export Act’’.) 
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Sec. 201 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 26 
order and the grounds upon which such order is to be issued, and 
(B) the date the Attorney General has transmitted the no- tice 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 scheduling such substance, except that the Attorney General may, during the pendency of proceedings 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 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), including ac- tual abuse, diversion from legitimate channels, and clandestine im- portation, manufacture, or distribution. 
(4) The Attorney General shall transmit notice of an order pro- posed 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 sub- mitted by the Secretary in response to a notice transmitted pursu- ant to this paragraph. 
(5) An order issued under paragraph (1) with respect to a sub- stance shall be vacated upon the conclusion of a subsequent rule- making proceeding initiated under subsection (a) with respect to such substance. 
(6) An order issued under paragraph (1) is not subject to judi- cial review. 
(i) TEMPORARY AND PERMANENT SCHEDULING OF RECENTLY EMERGED ANABOLIC STEROIDS.— 
(1) The Attorney General may issue a temporary order adding a drug or other substance to the definition of anabolic steroids if the Attorney General finds that— 
(A) the drug or other substance satisfies the criteria for being considered an anabolic steroid under section 102(41) 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 defini- tion 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 ef- 
fect until 30 days after the date of the publication by the Attor- ney 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 para- graph (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 paragraph (1) to the Secretary of Health and Human Services. In issuing an order under para- graph (1), the Attorney General shall take into consideration 
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 202 
any comments submitted by the Secretary in response to a no- tice transmitted pursuant to this paragraph. 
(4) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent sched- uling order under paragraph (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 substance to the definition of ana- bolic steroids if such drug or other substance satisfies the cri- teria for being considered an anabolic steroid under section 102(41). Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under para- graph (1).
(j)(1) With respect to a drug referred to in subsection (f), if the 
Secretary of Health and Human Services recommends that the At- torney General control the drug in schedule II, III, IV, or V pursu- ant to subsections (a) and (b), the Attorney General shall, not later than 90 days after the date described in paragraph (2), issue an in- terim final rule controlling the drug in accordance with such sub- sections and section 202(b) using the procedures described in para- graph (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 rec- ommendation from the Secretary of Health and Human Serv- 
ices in accordance with subsection (b); or
(B) the date on which the Attorney General receives notifi- 
cation 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 or section 351(a) of the Public Health Service Act, or in- dexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act, with respect 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 requiring 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 accord- ance with the scheduling criteria of subsections (b), (c), and (d) of this section and section 202(b). 
SCHEDULES OF CONTROLLED SUBSTANCES 
SEC. 202. ΓΈ21 U.S.C. 812¿ (a) There are established five sched- ules 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 the date of enactment of this title and shall be updated and republished on an annual basis thereafter. 
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Sec. 202 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 28 
(b) Except where control is required by United States obliga- tions under an international treaty, convention, or protocol, in ef- fect on the effective date of this part, 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 se- vere psychological or physical dependence.
(3) S
CHEDULE 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 mod- 
erate or low physical dependence or high psychological depend- ence.
(4) S
CHEDULE 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 lim- 
ited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
(5) S
CHEDULE 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 lim- 
ited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.
(c)
23 Schedules I, II, III, IV, and V shall, unless and until 
amended pursuant to section 201, consist of the following drugs or 
23 For current placement of substances in the schedules, see part 1308 of title 21, Code of Fed- eral Regulations. Note that the schedules as they appear in section 202 may not show all con- trolled substances, and in some cases a substance may actually be on a different schedule than shown in section 202. This is because the Attorney General has rulemaking authority under sec- tion 201(a) to add substances to the schedules, to transfer substances from one schedule to an- other, and to remove substances from the schedules. 
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