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

(a) Rules and regulations of Attorney General; hearing. The Attorney General must apply this subchapter to controlled substances listed in the schedules established by section 812 and to any other drug^* or substance added to those schedules under this subchapter. Except as provided in (d) and (e), the Attorney General may by rule: (1) add a drug or other substance to a schedule or transfer it between schedules if the Attorney General finds that it has a potential for abuse and makes the findings required by section 812(b) for the schedule where it will be placed; or (2) remove a drug or other substance from the schedules if the Attorney General finds that it does not meet the requirements for inclusion in any schedule. Rules under this subsection must be made on the record after an opportunity for a hearing under subchapter II of chapter 5 of title 5. The Attorney General may begin proceedings to issue, amend, or repeal such rules on the Attorney General’s own motion, at the Secretary’s request, or on the petition of any interested party. (b) Evaluation of drugs and other substances. Before beginning proceedings under (a) to control^* a drug or other substance or to remove it entirely from the schedules, and after gathering the necessary data, the Attorney General must request from the Secretary a scientific and medical evaluation and recommendations about whether the drug or substance should be controlled or removed. The Secretary must consider the factors in (c)(2), (3), (6), (7), and (8), and any scientific or medical considerations involved in (c)(1), (4), and (5). The recommendations must include the appropriate schedule, if any. The evaluation and recommendations must be in writing and submitted to the Attorney General within a reasonable time. The Secretary’s recommendations bind the Attorney General on scientific and medical matters. If the Secretary recommends that a drug or substance not be controlled, the Attorney General may not control it. If the Attorney General decides that these facts and all other relevant data are substantial evidence of potential for abuse warranting control, or substantial evidence that the drug or substance should be removed entirely from the schedules, the Attorney General must begin proceedings for control or removal under (a). (c) Factors determinative of control or removal from schedules. For each drug or other substance proposed to be controlled or removed, the Attorney General must consider these factors when making a finding under (a) or section 812(b): (1) Its actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The current state^* of scientific knowledge about it. (4) Its history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) Any risk to public health. (7) Its potential for psychological or physical dependence. (8) Whether it is an immediate precursor^* of a substance already controlled under this subchapter. This section does not define “immediate precursor.” (d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances^*. (1) If United States obligations under an international treaty, convention, or protocol in effect on October 27, 1970 require control, the Attorney General must issue an order controlling the drug under the schedule the Attorney General considers most appropriate to carry out those obligations. The Attorney General need not make the findings required by (a) or section 812(b), and need not follow the procedures in (a) and (b). (2)(A) When the Secretary of State receives notice from the Secretary-General of the United Nations that information has been sent by or to the World Health Organization under article 2 of the Convention on Psychotropic Substances, and the information may justify adding a drug or other substance to a Convention schedule, transferring it between schedules, or deleting it from the schedules, the Secretary of State must immediately send the notice to the Secretary of Health and Human Services. That Secretary must publish it in the Federal Register and give interested people an opportunity to submit comments about the scientific and medical evaluations the Secretary must prepare. The Secretary must prepare appropriate medical and scientific evaluations for transmission through the Secretary of State to the World Health Organization. (B) When the Secretary of State receives information that the United Nations Commission on Narcotic Drugs proposes to decide whether to add a drug or other substance to a Convention schedule, transfer it between schedules, or delete it, the Secretary of State must timely send notice to the Secretary of Health and Human Services. That Secretary must publish a summary in the Federal Register and give interested people an opportunity to submit comments about the recommendation the Secretary must provide under this subparagraph. The Secretary must evaluate the proposal and give a recommendation to the Secretary of State. That recommendation binds the United States representative in discussions and negotiations about the proposal. (3) When the United States receives notice under article 2 of the Convention that a drug or other substance has been added or transferred to a specified schedule, or receives a “schedule notice” that existing controls under this subchapter and the Federal Food, Drug, and Cosmetic Act do not meet the requirements of the Convention schedule where the drug or substance was placed, the Secretary of Health and Human Services, after consulting the Attorney General, must first decide whether those existing controls meet the requirements of the specified schedule or notice. The Secretary must then act as follows: (A) If the requirements are met but the Secretary still believes stricter controls should apply, recommend that the Attorney General begin proceedings under (a) and (b) to apply those controls. (B) If the requirements are not met and the Secretary agrees with the scheduling decision or notice, recommend proceedings under (a) and (b) under the appropriate schedule. (C) If the requirements are not met and the Secretary does not agree, the Secretary must: (i) if additional controls are needed to protect public health and safety, recommend proceedings under (a) and (b) to apply them; (ii) ask the Secretary of State to send a notice of qualified acceptance within the Convention period under article 2, paragraph 7, to the Secretary-General of the United Nations; (iii) ask the Secretary of State to send that notice and ask for review by the United Nations Economic and Social Council under article 2, paragraph 8; or (iv) for a schedule notice, ask the Secretary of State to take appropriate Convention action to begin proceedings to remove the drug or substance from the Convention schedules or transfer it to a different schedule. (4)(A) If the Attorney General decides, after consulting the Secretary of Health and Human Services, that proceedings recommended under (3)(B) or (3)(C)(i) will not finish within the period required by article 2, paragraph 7, the Attorney General, after consulting the Secretary and allowing interested people to comment on the temporary order’s requirements, must issue a temporary order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations. As part of the order, after consulting the Secretary, the Attorney General must except the drug or substance from any part C provision that is not needed to carry out those obligations. For proceedings under (3)(B), the Attorney General must at the same time ask the Secretary of State to send a notice of qualified acceptance. The temporary order ends when the controls resulting from the proceedings take effect. (B) After a notice of qualified acceptance is sent under (3)(C)(ii) or (iii), or after a request is made under (3)(C)(iv) about a schedule notice, the Attorney General, after consulting the Secretary and allowing comments, must issue an order controlling the drug or substance under schedule IV or V. For a drug covered by qualified acceptance, the Attorney General must choose the schedule most appropriate to carry out the minimum United States obligations; for a drug described in a schedule notice, the Attorney General must choose the schedule the Attorney General considers appropriate. The Attorney General must except any part C provision that is not needed to carry out those obligations. An order for a drug covered by qualified acceptance ends when Convention review reverses the decision and schedule IV or V control is no longer required, upon receipt of the review decision. An order for a drug described in a schedule notice ends when Convention action means schedule IV or V control is no longer required, upon receipt of notice of that action. (C) An order under (A) or (B) may be issued without the findings required by (a) or section 812(b), and without the procedures in (a) or (b). (5) Nothing in the 1978 amendments made by the Psychotropic Substances Act, or in regulations or orders under them, prevents the Secretary of Health and Human Services or the Attorney General from asking through the Secretary of State for Convention review of a scheduling decision based on new or additional information. (e) Immediate precursors. Without the findings required by (a) or section 812(b), and without the procedures in (a) and (b), the Attorney General may place an immediate precursor in the same schedule as the controlled substance^* of which it is an immediate precursor, or in another 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 may not be placed in a schedule solely because they are its precursors. (f) Abuse potential. If, when a new-drug application is submitted to the Secretary for a drug with a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that the drug has abuse potential, the Secretary must send that information to the Attorney General. This section does not define “new-drug application” or “abuse potential.” (g) Exclusion of non-narcotic substances sold over the counter without a prescription; dextromethorphan; exemption of substances lacking abuse potential. (1) The Attorney General must by regulation exclude from this subchapter and subchapter II of this chapter any non-narcotic drug^* containing a controlled substance if it may lawfully be sold without a prescription under the Federal Food, Drug, and Cosmetic Act. (2) Dextromethorphan is not considered included in a schedule merely because this subchapter was enacted, unless it is controlled after October 27, 1970 under the provisions above. (3) The Attorney General may by regulation exempt a compound, mixture, or preparation containing a controlled substance from all or part of this subchapter if the Attorney General finds that it fits one of these categories: (A) A mixture or preparation containing a nonnarcotic controlled substance that is approved for prescription use and also contains one or more active ingredients not listed in any schedule, in combinations, quantities, proportions, or concentrations that eliminate the potential for abuse. (B) A compound, mixture, or preparation containing any controlled substance that is not for administration to a human being or animal and is packaged in a form or concentration, or with adulterants or denaturants, so that as packaged it has no significant potential for abuse. (C) On the Secretary of Health and Human Services’ recommendation, a compound, mixture, or preparation containing an anabolic steroid^* intended for administration to a human being or animal that, because of its concentration, preparation, formulation, or delivery^* system, has no significant potential for abuse. (h) Temporary scheduling to avoid imminent hazards to public safety. (1) If the Attorney General finds that temporarily placing a substance in schedule I is necessary to avoid an imminent hazard to public safety, the Attorney General may issue an order placing it in schedule I temporarily, without the subsection (b) requirement concerning the Secretary. This may be done if either condition applies: (A) the substance is not listed in any other schedule in section 812; or (B) no exemption or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act. The order may not be issued until 30 days after both the date the Attorney General publishes in the Federal Register a notice of intent and grounds, and the date the Attorney General sends the notice required by paragraph (4). (2) Scheduling under this subsection ends 2 years after the order is issued. During proceedings under (a)(1), the Attorney General may extend it for up to 1 year. (3) For the imminent-hazard finding, the Attorney General must consider only (c)(4), (5), and (6), including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture^*, or distribution. (4) The Attorney General must send notice of a proposed order to the Secretary of Health and Human Services and, when issuing it, consider the Secretary’s comments. (5) The order is vacated when a later rulemaking proceeding under (a) about the substance ends. (6) The order is not subject to judicial review. (i) Temporary and permanent scheduling of recently emerged anabolic steroids. (1) The Attorney General may temporarily add a drug or other substance to the definition of “anabolic steroids” if it meets section 802(41)’s criteria but is not listed there or made an anabolic steroid by the Attorney General’s regulation, and if adding it will help prevent abuse or misuse. This section does not define “anabolic steroid.” (2) The order takes effect 30 days after notice in the Federal Register of the intent and grounds. It ends no later than 24 months after taking effect, but may be extended up to 6 months while proceedings under (6) are pending. (3) The Attorney General must send notice of the proposed order to the Secretary of Health and Human Services and consider the Secretary’s comments. (4) The temporary order is vacated when a permanent order under (6) is issued. (5) The order is not subject to judicial review. (6) The Attorney General may by rule permanently add the drug or substance to the definition of “anabolic steroids” if it meets section 802(41)’s criteria. The rulemaking may begin when the temporary order is issued. (j) Interim final rule; date of issuance; procedure for final rule. (1) For a drug referred to in (f), if the Secretary recommends schedule II, III, IV, or V control under (a) and (b), the Attorney General must issue an interim final rule controlling it under those subsections and section 812(b), using paragraph (3), no later than 90 days after the date in (2). (2) The date is the later of: (A) the date the Attorney General receives the Secretary’s scientific and medical evaluation and scheduling recommendation under (b); or (B) the date the Attorney General receives notice that the Secretary approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act, section 262(a) of title 42, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act, for the drug. (3) The rule becomes immediately effective as an interim final rule without a good-cause showing. It must allow interested people to comment and request a hearing. After those proceedings, the Attorney General must issue a final rule using the criteria in (b), (c), and (d) and section 812(b).