---
kind: "section"
citation: "21 U.S.C. § 811"
title: "21"
title_heading: "Food and Drugs"
number: "811"
heading: "Authority and criteria for classification of substances"
release: "119-102"
url: "https://uscodex.org/usc/21/811"
units:
  - "Chapter 13 — Drug Abuse Prevention and Control"
  - "Subchapter I — Control and Enforcement"
  - "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](/usc/21/802.md?p=6) listed in the schedules established by [section 812 of this title](/usc/21/812.md) and to any other [drug](/usc/21/321.md?p=g-1) or other substance added to such schedules under this subchapter. Except as provided in subsections [(d)](#d) and [(e)](#e), the Attorney General may by rule—
  - (1) add to such a schedule or transfer between such schedules any [drug](/usc/21/321.md?p=g-1) or other substance if he—
    - (A) finds that such [drug](/usc/21/321.md?p=g-1) or other substance has a potential for abuse, and
    - (B) makes with respect to such [drug](/usc/21/321.md?p=g-1) or other substance the findings prescribed by subsection (b) of [section 812 of this title](/usc/21/812.md) for the schedule in which such [drug](/usc/21/321.md?p=g-1) is to be placed; or
  - (2) remove any [drug](/usc/21/321.md?p=g-1) or other substance from the schedules if he finds that the [drug](/usc/21/321.md?p=g-1) 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](/usc/5/chptI-ch5.md) 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](/usc/21/802.md?p=24), 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)](#a) to [control](/usc/21/802.md?p=5) a [drug](/usc/21/321.md?p=g-1) or other substance or to remove a [drug](/usc/21/321.md?p=g-1) or other substance entirely from the schedules, and after gathering the necessary data, request from the [Secretary](/usc/21/802.md?p=24) a scientific and medical evaluation, and his recommendations, as to whether such [drug](/usc/21/321.md?p=g-1) or other substance should be so controlled or removed as a [controlled substance](/usc/21/802.md?p=6). In making such evaluation and recommendations, the [Secretary](/usc/21/802.md?p=24) shall consider the factors listed in paragraphs [(2)](#c-2), [(3)](#c-3), [(6)](#c-6), [(7)](#c-7), and [(8)](#c-8) of subsection (c) and any scientific or medical considerations involved in paragraphs [(1)](#c-1), [(4)](#c-4), and [(5)](#c-5) of such subsection. The recommendations of the [Secretary](/usc/21/802.md?p=24) shall include recommendations with respect to the appropriate schedule, if any, under which such [drug](/usc/21/321.md?p=g-1) or other substance should be listed. The evaluation and the recommendations of the [Secretary](/usc/21/802.md?p=24) shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the [Secretary](/usc/21/802.md?p=24) to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the [Secretary](/usc/21/802.md?p=24) recommends that a [drug](/usc/21/321.md?p=g-1) or other substance not be controlled, the Attorney General shall not [control](/usc/21/802.md?p=5) the [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=5) or substantial evidence that the [drug](/usc/21/321.md?p=g-1) or other substance should be removed entirely from the schedules, he shall initiate proceedings for [control](/usc/21/802.md?p=5) or removal, as the case may be, under [subsection (a)](#a).
- (c) **Factors determinative of control or removal from schedules—** In making any finding under [subsection (a)](#a) of this section or under subsection (b) of [section 812 of this title](/usc/21/812.md), the Attorney General shall consider the following factors with respect to each [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=26) of current scientific knowledge regarding the [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=23) 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](/usc/21/802.md?p=5) is required by [United States](/usc/21/802.md?p=28) obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such [drug](/usc/21/321.md?p=g-1) under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by [subsection (a)](#a) of this section or [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsections [(a)](#a) and [(b)](#b) of this section.
  - (2)
    - (A) Whenever the Secretary of State receives notification from the [Secretary](/usc/21/802.md?p=24)-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](/usc/21/802.md?p=31), which may justify adding a [drug](/usc/21/321.md?p=g-1) or other substance to one of the schedules of the Convention, transferring a [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=24) of Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested [persons](/usc/21/379j–21.md?p=k-10) to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such [drug](/usc/21/321.md?p=g-1) or substance. The [Secretary](/usc/21/802.md?p=24) 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](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=17) of the United Nations proposes to decide whether to add a [drug](/usc/21/321.md?p=g-1) or other substance to one of the schedules of the Convention, transfer a [drug](/usc/21/321.md?p=g-1) or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the [Secretary](/usc/21/802.md?p=24) 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](/usc/21/379j–21.md?p=k-10) to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The [Secretary](/usc/21/802.md?p=24) 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](/usc/21/802.md?p=28) in discussions and negotiations relating to the proposal.
  - (3) When the [United States](/usc/21/802.md?p=28) receives notification of a scheduling decision pursuant to article 2 of the [Convention on Psychotropic Substances](/usc/21/802.md?p=31) that a [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=5) applicable under this subchapter to a [drug](/usc/21/321.md?p=g-1) or substance and the [controls](/usc/21/802.md?p=5) required by the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] do not meet the requirements of the schedule of the Convention in which such [drug](/usc/21/321.md?p=g-1) or substance has been placed, the [Secretary](/usc/21/802.md?p=24) of Health and Human Services after consultation with the Attorney General, shall first determine whether existing legal [controls](/usc/21/802.md?p=5) under this subchapter applicable to the [drug](/usc/21/321.md?p=g-1) or substance and the [controls](/usc/21/802.md?p=5) required by the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), 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](/usc/21/802.md?p=5) but the [Secretary](/usc/21/802.md?p=24) of Health and Human Services nonetheless believes that more stringent [controls](/usc/21/802.md?p=5) should be applied to the [drug](/usc/21/321.md?p=g-1) or substance, the [Secretary](/usc/21/802.md?p=24) shall recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance, pursuant to subsections [(a)](#a) and [(b)](#b) of this section, to apply to such [controls](/usc/21/802.md?p=5).
    - (B) If such requirements are not met by such existing [controls](/usc/21/802.md?p=5) and the [Secretary](/usc/21/802.md?p=24) of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, the [Secretary](/usc/21/802.md?p=24) shall recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance under the appropriate schedule pursuant to subsections [(a)](#a) and [(b)](#b) of this section.
    - (C) If such requirements are not met by such existing [controls](/usc/21/802.md?p=5) and the [Secretary](/usc/21/802.md?p=24) of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, the [Secretary](/usc/21/802.md?p=24) shall—
      - (i) if he deems that additional [controls](/usc/21/802.md?p=5) are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance pursuant to subsections [(a)](#a) and [(b)](#b) of this section, to apply such additional [controls](/usc/21/802.md?p=5);
      - (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](/usc/21/802.md?p=24)-General of the United Nations;
      - (iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in [clause (ii)](#d-3-C-ii) and request the Secretary of State to ask for a review by the Economic and Social [Council](/usc/21/2011.md?p=1) 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](/usc/21/321.md?p=g-1) or substance from the schedules under the Convention or to transfer the [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=24) of Health and Human Services, that proceedings initiated under recommendations made under paragraph[^1] (B) or (C)(i) of [paragraph (3)](#d-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](/usc/21/802.md?p=24) and after providing interested [persons](/usc/21/379j–21.md?p=k-10) 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](/usc/21/321.md?p=g-1) or substance under schedule IV or V, whichever is most appropriate to carry out the minimum [United States](/usc/21/802.md?p=28) 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](/usc/21/802.md?p=24), except such [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention. In the case of proceedings initiated under [subparagraph (B)](#d-3-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](/usc/21/802.md?p=24)-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](/usc/21/321.md?p=g-1) or other substance subject to proceedings initiated under subsections [(a)](#a) and [(b)](#b) of this section shall expire upon the effective date of the application to the [drug](/usc/21/321.md?p=g-1) or substance of the [controls](/usc/21/802.md?p=5) resulting from such proceedings.
    - (B) After a notice of qualified acceptance of a scheduling decision with respect to a [drug](/usc/21/321.md?p=g-1) or other substance is transmitted to the [Secretary](/usc/21/802.md?p=24)-General of the United Nations in accordance with clause [(ii)](#d-3-C-ii) or [(iii)](#d-3-C-iii) of paragraph (3)(C) or after a request has been made under [clause (iv)](#d-3-C-iv) of such paragraph with respect to a [drug](/usc/21/321.md?p=g-1) or substance described in a schedule notice, the Attorney General, after consultation with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services and after providing interested [persons](/usc/21/379j–21.md?p=k-10) opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the [drug](/usc/21/321.md?p=g-1) or substance under schedule IV or V, whichever is most appropriate to carry out the minimum [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention in the case of a [drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=g-1) or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the [Secretary](/usc/21/802.md?p=24), except such [drug](/usc/21/321.md?p=g-1) 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](/usc/21/802.md?p=28) 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)](#d-3-C-ii) or [(iii)](#d-3-C-iii) of paragraph (3)(C)—
      - (i) the decision is reversed, and
      - (ii) the [drug](/usc/21/321.md?p=g-1) or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention,

      the order issued under this subparagraph with respect to such [drug](/usc/21/321.md?p=g-1) or substance shall expire upon receipt by the [United States](/usc/21/802.md?p=28) of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under [clause (iv)](#d-3-C-iv) of paragraph (3)(C), the [drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=g-1) or substance shall expire upon receipt by the [United States](/usc/21/802.md?p=28) of a notice of the action taken with respect to such [drug](/usc/21/321.md?p=g-1) or substance under the Convention.

    - (C) An order issued under subparagraph [(A)](#d-4-A) or [(B)](#d-4-B) may be issued without regard to the findings required by [subsection (a)](#a) of this section or by [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsection [(a)](#a) or [(b)](#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](/usc/21/802.md?p=24) 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)](#a) of this section or [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsections [(a)](#a) and [(b)](#b) of this section, place an [immediate precursor](/usc/21/802.md?p=23) in the same schedule in which the [controlled substance](/usc/21/802.md?p=6) of which it is an [immediate precursor](/usc/21/802.md?p=23) is placed or in any other schedule with a higher numerical designation. If the Attorney General designates a substance as an [immediate precursor](/usc/21/802.md?p=23) 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](/usc/21/321.md?p=g-1) application is submitted to the [Secretary](/usc/21/802.md?p=24) for any [drug](/usc/21/321.md?p=g-1) having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such [drug](/usc/21/321.md?p=g-1) has an abuse potential, such information shall be forwarded by the [Secretary](/usc/21/802.md?p=24) 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](/usc/21/802.md?p=17) which contains a [controlled substance](/usc/21/802.md?p=6) from the application of this subchapter and subchapter II of this chapter if such [drug](/usc/21/321.md?p=g-1) may, under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) 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](/usc/21/802.md?p=6) 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](/usc/21/802.md?p=6), 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](/usc/21/802.md?p=6), 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](/usc/21/802.md?p=24) of Health and Human Services, a compound, mixture, or preparation which contains any [anabolic steroid](/usc/21/802.md?p=41-A), which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or [delivery](/usc/21/802.md?p=8) 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 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)](#b) relating to the [Secretary](/usc/21/802.md?p=24) 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](/usc/21/812.md) or if no exemption or approval is in effect for the substance under section 505 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 355](/usc/21/355.md)]. 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)](#h-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)](#a-1) with respect to the substance, extend the temporary scheduling for up to 1 year.
  - (3) When issuing an order under [paragraph (1)](#h-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)](#c-4), [(5)](#c-5), and [(6)](#c-6) of subsection (c), including actual abuse, diversion from legitimate channels, and clandestine importation, [manufacture](/usc/21/802.md?p=15), or [distribution](/usc/21/360eee.md?p=5).
  - (4) The Attorney General shall transmit notice of an order proposed to be issued under [paragraph (1)](#h-1) to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. In issuing an order under [paragraph (1)](#h-1), the Attorney General shall take into consideration any comments submitted by the [Secretary](/usc/21/802.md?p=24) in response to a notice transmitted pursuant to this paragraph.
  - (5) An order issued under [paragraph (1)](#h-1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under [subsection (a)](#a) with respect to such substance.
  - (6) An order issued under [paragraph (1)](#h-1) is not subject to judicial review.
- (i) **Temporary and permanent scheduling of recently emerged anabolic steroids—**
  - (1) The Attorney General may issue a temporary order adding a [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) if the Attorney General finds that—
    - (A) the [drug](/usc/21/321.md?p=g-1) or other substance satisfies the criteria for being considered an [anabolic steroid](/usc/21/802.md?p=41-A) under [section 802(41) of this title](/usc/21/802.md?p=41) but is not listed in that section or by regulation of the Attorney General as being an [anabolic steroid](/usc/21/802.md?p=41-A); and
    - (B) adding such [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) will assist in preventing abuse or misuse of the [drug](/usc/21/321.md?p=g-1) or other substance.
  - (2) An order issued under [paragraph (1)](#i-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)](#i-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)](#i-1) to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. In issuing an order under [paragraph (1)](#i-1), the Attorney General shall take into consideration any comments submitted by the [Secretary](/usc/21/802.md?p=24) in response to a notice transmitted pursuant to this paragraph.
  - (4) A temporary scheduling order issued under [paragraph (1)](#i-1) shall be vacated upon the issuance of a permanent scheduling order under [paragraph (6)](#i-6).
  - (5) An order issued under [paragraph (1)](#i-1) is not subject to judicial review.
  - (6) The Attorney General may, by rule, issue a permanent order adding a [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) if such [drug](/usc/21/321.md?p=g-1) or other substance satisfies the criteria for being considered an [anabolic steroid](/usc/21/802.md?p=41-A) under [section 802(41) of this title](/usc/21/802.md?p=41). Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under [paragraph (1)](#i-1).
- (j) **Interim final rule; date of issuance; procedure for final rule—**
  - (1) With respect to a [drug](/usc/21/321.md?p=g-1) referred to in [subsection (f)](#f), if the [Secretary](/usc/21/802.md?p=24) of Health and Human Services recommends that the Attorney General [control](/usc/21/802.md?p=5) the [drug](/usc/21/321.md?p=g-1) in schedule II, III, IV, or V pursuant to subsections [(a)](#a) and [(b)](#b), the Attorney General shall, not later than 90 days after the date described in [paragraph (2)](#j-2), issue an interim final rule controlling the [drug](/usc/21/321.md?p=g-1) in accordance with such subsections and [section 812(b) of this title](/usc/21/812.md?p=b) using the procedures described in [paragraph (3)](#j-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](/usc/21/802.md?p=24) of Health and Human Services in accordance with [subsection (b)](#b); or
    - (B) the date on which the Attorney General receives notification from the [Secretary](/usc/21/802.md?p=24) of Health and Human Services that the [Secretary](/usc/21/802.md?p=24) has approved an application under section 505(c), 512, or 571 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 355(c)](/usc/21/355.md?p=c), 360b, 360ccc] or [section 262(a) of title 42](/usc/42/262.md?p=a), or indexed a [drug](/usc/21/321.md?p=g-1) under section 572 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 360ccc–1](/usc/21/360ccc–1.md)], with respect to the [drug](/usc/21/321.md?p=g-1) described in [paragraph (1)](#j-1).
  - (3) A rule issued by the Attorney General under [paragraph (1)](#j-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](/usc/21/379j–21.md?p=k-10) 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 scheduling criteria of subsections [(b)](#b), [(c)](#c), and [(d)](#d) of this section and [section 812(b) of this title](/usc/21/812.md?p=b).

## Footnotes

[^1]: So in original. Probably should be “subparagraph”.

## Source credit

(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.)

## Notes

### 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 “Controlled Substances Act”. For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

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 chapter 9 (§ 301 et seq.) of this title. For complete classification 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. 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, repealed 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 classification 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, referred 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 titles II and III of the Comprehensive Drug Abuse Prevention 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 subchapter 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), substituted “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 subpar. (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” substituted for “Secretary of Health, Education, and Welfare” in subsec. (d)(2), (3), (4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96–88 which is classified to section 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.