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21 U.S. Code § 811 - Authority and criteria for classification of substances

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(a) Rules and regulations of Attorney General; hearingThe Attorney General shall apply the provisions of this subchapter to thecontrolled substances listed in the schedules established bysection 812 of this title and to any other drugor other substance added to such schedules under this subchapter. Except as provided in subsections (d) and (e), the Attorney General may by rule—
(1) add to such a schedule or transfer between such schedules anydrug or other substance if he—
(A)
finds that suchdrug or other substance has a potential for abuse, and
(B)
makes with respect to suchdrug or other substance the findings prescribed by subsection (b) ofsection 812 of this title for the schedule in which such drugis to be placed; or
(2)
remove anydrug or other substance from the schedules if he finds that thedrug or other substance does not meet the requirements for inclusion in any schedule.
Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of theSecretary, 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) tocontrol a drugor other substance or to remove a drugor other substance entirely from the schedules, and after gathering the necessary data, request from theSecretary a scientific and medical evaluation, and his recommendations, as to whether such drugor other substance should be so controlled or removed as acontrolled substance. In making such evaluation and recommendations, the Secretaryshall 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 Secretaryshall include recommendations with respect to the appropriate schedule, if any, under which such drugor other substance should be listed. The evaluation and the recommendations of the Secretaryshall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretaryto the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretaryrecommends that a drugor other substance not be controlled, the Attorney General shall not controlthe drugor 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 controlor substantial evidence that the drugor other substance should be removed entirely from the schedules, he shall initiate proceedings for controlor removal, as the case may be, under subsection (a).

(c) Factors determinative of control or removal from schedulesIn making any finding under subsection (a) of this section or under subsection (b) ofsection 812 of this title, the Attorney General shall consider the following factors with respect to each drugor 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)
Thestate of current scientific knowledge regarding the drugor 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 animmediate precursor of a substance already controlled under this subchapter.
(d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances
(1)
Ifcontrol is required byUnited States obligations under international treaties, conventions, or protocols in effect onOctober 27, 1970, the Attorney General shall issue an order controlling such drugunder the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section orsection 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.
(2)
(A)
Whenever theSecretary of Statereceives notification from theSecretary-General of theUnited Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the Convention on Psychotropic Substances, which may justify adding a drugor other substance to one of the schedules of the Convention, transferring a drugor substance from one schedule to another, or deleting it from the schedules, the Secretaryof Stateshall immediately transmit the notice to the Secretaryof Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such drugor substance. The Secretaryof Health and Human Services shall prepare for transmission through the Secretaryof Stateto 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 drugor substance with respect to which a notice was transmitted under this subparagraph.
(B)
Whenever theSecretary of Statereceives information that the Commission onNarcotic Drugs of theUnited Nations proposes to decide whether to add a drugor other substance to one of the schedules of the Convention, transfer a drugor substance from one schedule to another, or delete it from the schedules, the Secretaryof Stateshall transmit timely notice to the Secretaryof Health and Human Services of such information who shall publish a summary of such information in the Federal Register and provide opportunity to interested persons to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The Secretaryof Health and Human Services shall evaluate the proposal and furnish a recommendation to the Secretaryof Statewhich shall be binding on the representative of the United Statesin discussions and negotiations relating to the proposal.
(3) When theUnited States receives notification of a scheduling decision pursuant to article 2 of theConvention on Psychotropic Substances that a drugor 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 controlsapplicable under this subchapter to a drugor substance and the controlsrequired by theFederal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] do not meet the requirements of the schedule of the Convention in which such drugor substance has been placed, the Secretaryof Health and Human Services after consultation with the Attorney General, shall first determine whether existing legal controlsunder this subchapter applicable to the drugor substance and the controlsrequired by theFederal 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 existingcontrols but theSecretary of Health and Human Services nonetheless believes that more stringent controlsshould be applied to the drugor substance, theSecretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drugor substance, pursuant to subsections (a) and (b) of this section, to apply to such controls.
(B)
If such requirements are not met by such existingcontrols and theSecretary of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, theSecretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drugor substance under the appropriate schedule pursuant to subsections (a) and (b) of this section.
(C) If such requirements are not met by such existingcontrols and theSecretary of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, theSecretary shall—
(i)
if he deems that additionalcontrols are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the drugor substance pursuant to subsections (a) and (b) of this section, to apply such additionalcontrols;
(ii)
request theSecretary of Stateto transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to theSecretary-General of theUnited Nations;
(iii)
request theSecretary of Stateto transmit a notice of qualified acceptance as prescribed in clause (ii) and request theSecretary of Stateto ask for a review by the Economic and Social Council of theUnited 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 theSecretary of Stateto take appropriate action under the Convention to initiate proceedings to remove the drugor substance from the schedules under the Convention or to transfer the drugor 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 theSecretary of Health and Human Services, that proceedings initiated under recommendations made under paragraph [1] (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the Secretaryand after providing interested persons opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the drugor substance under schedule IV or V, whichever is most appropriate to carry out the minimum United Statesobligations 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 drugor substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United Statesobligations 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 Secretaryof Stateto transmit a notice of qualified acceptance to the Secretary-General of theUnited Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a drugor other substance subject to proceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drugor substance of the controlsresulting from such proceedings.
(B) After a notice of qualified acceptance of a scheduling decision with respect to adrug or other substance is transmitted to theSecretary-General of theUnited 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 drugor substance described in a schedule notice, the Attorney General, after consultation with the Secretaryof Health and Human Services and after providing interested persons opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drugor substance under schedule IV or V, whichever is most appropriate to carry out the minimum United Statesobligations under paragraph 7 of article 2 of the Convention in the case of a drugor substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a drugor substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drugor substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the United Statesobligations under paragraph 7 of article 2 of the Convention. If, as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause (ii) or (iii) of paragraph (3)(C)—
(i)
the decision is reversed, and
(ii)
thedrug or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimumUnited States obligations under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to suchdrug or substance shall expire upon receipt by theUnited 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 drugor 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 drugor substance shall expire upon receipt by theUnited States of a notice of the action taken with respect to such drugor substance under the Convention.
(C)
An order issued under subparagraph (A) or (B) may be issued without regard to the findings required by subsection (a) of this section or bysection 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 thePsychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder shall be construed to preclude requests by the Secretaryof Health and Human Services or the Attorney General through the Secretaryof State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information.
(e) Immediate precursors

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

(f) Abuse potential

If, at the time a new-drug application is submitted to theSecretary for any drughaving a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such drughas an abuse potential, such information shall be forwarded by theSecretary 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 acontrolled substance from the application of this subchapter and subchapter II of this chapter if such drugmay, under theFederal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], be lawfully sold over the counter without a prescription.
(2)
Dextromethorphan shall not be deemed to be included in any schedule by reason of enactment of this subchapter unless controlled afterOctober 27, 1970 pursuant to the foregoing provisions of this section.
(3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing acontrolled substance from the application of all or any part of this subchapter if he finds such compound, mixture, or preparation meets the requirements of one of the following categories:
(A)
A mixture, or preparation containing a nonnarcoticcontrolled substance, which mixture or preparation is approved for prescription use, and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.
(B)
A compound, mixture, or preparation which contains anycontrolled 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 theSecretary of Health and Human Services, a compound, mixture, or preparation which contains any anabolic steroid, which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or deliverysystem, 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) relating to theSecretary of Health and Human Services, schedule such substance in schedule I if the substance is not listed in any other schedule insection 812 of this title or if no exemption or approval is in effect for the substance under section 505 of theFederal Food, Drug, and Cosmetic Act [21 U.S.C. 355]. Such an order may not be issued before the expiration of thirty days from—
(A)
the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and
(B)
the date the Attorney General has transmitted the notice required by paragraph (4).
(2)
The scheduling of a substance under this subsection shall expire at the end of 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 actual abuse, diversion from legitimate channels, and clandestine importation,manufacture, or distribution.
(4)
The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to theSecretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by theSecretary in response to a notice transmitted pursuant to this paragraph.
(5)
An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to such substance.
(6)
An order issued under paragraph (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 adrug or other substance to the definition of anabolic steroids if the Attorney General finds that—
(A)
thedrug or other substance satisfies the criteria for being considered an anabolic steroid undersection 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 suchdrug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of thedrug 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 paragraph (1) to theSecretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by theSecretary in response to a notice transmitted pursuant to this paragraph.
(4)
A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent scheduling 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 adrug or other substance to the definition of anabolic steroids if suchdrug or other substance satisfies the criteria for being considered an anabolic steroid undersection 802(41) of this title. Such rulemaking 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 adrug referred to in subsection (f), if theSecretary of Health and Human Services recommends that the Attorney General controlthe drugin schedule II, III, IV, or V pursuant to subsections (a) and (b), the Attorney General shall, not later than 90 days after the date described in paragraph (2), issue an interim final rule controlling the drugin accordance with such subsections andsection 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 theSecretary of Health and Human Services in accordance with subsection (b); or
(B)
the date on which the Attorney General receives notification from theSecretary of Health and Human Services that theSecretary has approved an application under section 505(c), 512, or 571 of theFederal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c), 360b, 360ccc] orsection 262(a) of title 42, or indexed a drugunder section 572 of theFederal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc–1], with respect to the drugdescribed 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 accordance with the scheduling criteria of subsections (b), (c), and (d) of this section andsection 812(b) of this title.

[1] So in original. Probably should be “subparagraph”.
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 ofPub. 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 undersection 801 of this title and Tables.

TheFederal 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, seesection 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 insection 812(c) of this title.

ThePsychotropic Substances Act of 1978, referred to in subsec. (d)(5), isPub. 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 andsection 242a of Title 42, The Public Health and Welfare, repealedsection 830 of this title effectiveJan. 1, 1981, and enacted provisions set out as notes under sections801,801a,812, and830 of this title. For complete classification of this Act to the Code, see Short Title of 1978 Amendment note set out undersection 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 ComprehensiveDrug Abuse Prevention andControl Act”, which was translated as meaning titles II and III of theComprehensive Drug Abuse Prevention and Control Act of 1970,Pub. L. 91–513,Oct. 27, 1970,84 Stat. 1242, 1285, to reflect the probable intent ofCongress. 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 undersection 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“drugwhich contains a controlled substancefrom 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 tosection 509(b) of Pub. L. 96–88 which is classified tosection 3508(b) of Title 20, Education.

Effective Date of 2004 Amendment

Amendment byPub. L. 108–358 effective 90 days afterOct. 22, 2004, seesection 2(d) of Pub. L. 108–358, set out as a note undersection 802 of this title.

Effective Date of 1978 Amendment

Amendment byPub. L. 95–633 effective on date the Convention on Psychotropic Substancesenters into force in the United States[July 15, 1980], seesection 112 of Pub. L. 95–633, set out as an Effective Date note undersection 801a of this title.

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21 1308, 1316

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