
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC811]

 
                        TITLE 21--FOOD AND DRUGS
 
              CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
 
                  SUBCHAPTER I--CONTROL AND ENFORCEMENT
 
          Part B--Authority To Control; Standards and Schedules
 
Sec. 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 listed in the schedules established by 
section 812 of this title and to any other drug or other substance added 
to such schedules under this subchapter. Except as provided in 
subsections (d) and (e) of this section, the Attorney General may by 
rule--
        (1) add to such a schedule or transfer between such schedules 
    any drug or other substance if he--
            (A) finds that such drug or other substance has a potential 
        for abuse, and
            (B) makes with respect to such drug or other substance the 
        findings prescribed by subsection (b) of section 812 of this 
        title for the schedule in which such drug is to be placed; or

        (2) remove any drug or other substance from the schedules if he 
    finds that the drug or other substance does not meet the 
    requirements for inclusion in any schedule.

Rules of the Attorney General under this 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 the Secretary, or (3) on the petition of any interested 
party.

(b) Evaluation of drugs and other substances

    The Attorney General shall, before initiating proceedings under 
subsection (a) of this section to control a drug or other substance or 
to remove a drug or other substance entirely from the schedules, and 
after gathering the necessary data, request from the Secretary a 
scientific and medical evaluation, and his recommendations, as to 
whether such drug or other substance should be so controlled or removed 
as a controlled substance. In making such evaluation and 
recommendations, the Secretary shall consider the factors listed in 
paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this section 
and any scientific 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 recommends that a drug or other substance 
not be controlled, the Attorney 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 substance should be removed entirely from the schedules, he 
shall initiate proceedings for control or removal, as the case may be, 
under subsection (a) of this section.

(c) Factors determinative of control or removal from schedules

    In making any finding under subsection (a) of this section or under 
subsection (b) of section 812 of this title, the Attorney General shall 
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 subchapter.

(d) International treaties, conventions, and protocols requiring 
        control; procedures respecting changes in drug schedules of 
        Convention on Psychotropic Substances

    (1) If control is required by United States obligations under 
international treaties, conventions, or protocols in effect on October 
27, 1970, the Attorney General shall issue an order controlling such 
drug under the schedule he deems most appropriate to carry out such 
obligations, without regard to the findings required by subsection (a) 
of this section or section 812(b) of this title and without regard to 
the procedures prescribed by subsections (a) and (b) of this section.
    (2)(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, pursuant to article 
2 of the Convention on Psychotropic Substances, which may justify adding 
a drug or other substance to one of the schedules of the Convention, 
transferring a drug or substance from one schedule to another, or 
deleting it from the schedules, the Secretary of State shall immediately 
transmit the notice to the Secretary of Health and Human Services who 
shall publish it in the Federal Register and provide opportunity to 
interested persons to submit to him comments respecting the scientific 
and medical evaluations which he is to prepare respecting such drug or 
substance. The Secretary of Health and Human Services shall prepare for 
transmission through the Secretary of State to the World Health 
Organization such medical and scientific evaluations as may be 
appropriate regarding the possible action that could be proposed 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 of State shall transmit 
timely notice to the Secretary 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 to submit 
to him comments respecting the recommendation which he is to furnish, 
pursuant to this subparagraph, respecting such proposal. The Secretary 
of Health and Human Services shall evaluate the proposal and furnish a 
recommendation to the Secretary of State which shall be binding on the 
representative of the United States in discussions and negotiations 
relating to the proposal.
    (3) When the United States receives notification of a scheduling 
decision pursuant to article 2 of the Convention on Psychotropic 
Substances that a drug or other substance has been added or transferred 
to a schedule specified in the notification or receives notification 
(referred to in this subsection as a ``schedule notice'') that existing 
legal controls applicable under this subchapter to a drug or substance 
and the controls required by the Federal 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 drug or substance has been placed, the 
Secretary of Health and Human Services after consultation with the 
Attorney General, shall first determine whether existing legal controls 
under this subchapter applicable to the drug or substance and the 
controls required by the Federal Food, Drug, and Cosmetic Act, meet the 
requirements of the schedule specified in the notification or schedule 
notice and shall take the following action:
        (A) If such requirements are met by such existing controls but 
    the Secretary of Health and Human Services nonetheless believes that 
    more stringent controls should be applied to the drug or substance, 
    the Secretary shall 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 controls 
    and the Secretary of Health and Human Services concurs in the 
    scheduling decision or schedule notice transmitted by the 
    notification, the Secretary shall recommend to the Attorney General 
    that he initiate 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 controls 
    and the Secretary of Health and Human Services does not concur in 
    the scheduling decision or schedule notice transmitted by the 
    notification, the Secretary shall--
            (i) if he deems that additional controls are necessary to 
        protect the public health and safety, recommend to the Attorney 
        General that he initiate proceedings for scheduling the drug or 
        substance pursuant to 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 
        Convention, to the Secretary-General of the United Nations;
            (iii) request the Secretary of State to transmit a notice of 
        qualified acceptance as prescribed in clause (ii) and request 
        the Secretary of State to ask for a review by the Economic and 
        Social Council of the United Nations, in accordance with 
        paragraph 8 of article 2 of the Convention, of the scheduling 
        decision; or
            (iv) in the case of a schedule notice, request the Secretary 
        of State to take appropriate action under the Convention to 
        initiate proceedings to remove the drug or substance 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) If the Attorney General determines, after consultation with 
the Secretary of Health and Human Services, that proceedings initiated 
under recommendations made under paragraph \1\ (B) or (C)(i) of 
paragraph (3) will not be completed within the time period required by 
paragraph 7 of article 2 of the Convention, the Attorney General, after 
consultation with the Secretary and 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 drug or substance under schedule IV or 
V, whichever is most appropriate to carry out the minimum United States 
obligations under paragraph 7 of article 2 of the Convention. As a part 
of such order, the Attorney General shall, after consultation with the 
Secretary, except such drug or substance from the application of any 
provision of part C of this subchapter which he finds is not required to 
carry out the United States obligations under paragraph 7 of article 2 
of the Convention. In the case of proceedings initiated under 
subparagraph (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-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 proceedings initiated under 
subsections (a) and (b) of this section shall expire upon the effective 
date of the application to the drug or substance of the controls 
resulting from such proceedings.
---------------------------------------------------------------------------
    \1\ So in original. Probably should be ``subparagraph''.
---------------------------------------------------------------------------
    (B) After a notice of qualified acceptance of a scheduling decision 
with respect to a drug or other substance is transmitted to the 
Secretary-General of the United Nations in accordance with clause (ii) 
or (iii) of paragraph (3)(C) or after a request has been made under 
clause (iv) of such paragraph with respect to a drug or substance 
described in a schedule notice, the Attorney General, after consultation 
with the Secretary of 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 drug or substance under schedule IV or V, 
whichever is most appropriate to carry out the minimum United States 
obligations under paragraph 7 of article 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 Secretary, except such drug or substance from the application of any 
provision of part C of this subchapter which he finds is not required to 
carry out the United States obligations under paragraph 7 of article 2 
of the Convention. 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) the drug or substance subject to such decision is not 
    required to be controlled under schedule IV or V to carry out the 
    minimum United States obligations under paragraph 7 of article 2 of 
    the Convention,

the order issued under this subparagraph with respect to such drug or 
substance shall expire upon receipt by the United States of the review 
decision. If, as a result of action taken pursuant to action initiated 
under a request transmitted under clause (iv) of paragraph (3)(C), the 
drug or substance with respect to which such action was taken is not 
required to be controlled under schedule IV or V, the order issued under 
this paragraph with respect to such drug or substance shall expire upon 
receipt by the United States of a notice of the action taken with 
respect to such drug or 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 by section 812(b) of this title and without regard to the 
procedures prescribed by subsection (a) or (b) of this section.
    (5) Nothing in the amendments made by the Psychotropic Substances 
Act of 1978 or the regulations or orders promulgated thereunder shall be 
construed to preclude requests by the Secretary 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) of this section or section 812(b) of this title and 
without 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 precursor 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 precursors.

(f) Abuse potential

    If, at the time a new-drug application is submitted to the Secretary 
for any drug having a stimulant, depressant, or hallucinogenic effect on 
the central nervous system, it appears that such drug has an abuse 
potential, such information shall be forwarded by the Secretary to the 
Attorney General.

(g) Exclusion of non-narcotic substances sold over the counter without a 
        prescription; dextromethorphan; exemption of substances lacking 
        abuse potential

    (1) The Attorney General shall by regulation exclude any non-
narcotic substance from a schedule if such substance may, under the 
Federal 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 
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 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, 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, 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.

(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) of this section relating to the Secretary 
of Health and Human Services, schedule such substance in schedule I if 
the substance is not listed in any other schedule in section 812 of this 
title or if no exemption or approval is in effect for the substance 
under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
355]. Such an order may not be issued before the expiration of thirty 
days from--
        (A) the date of the publication by the 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 one year 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) of this section with 
respect to the substance, extend the temporary scheduling for up to six 
months.
    (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) of this section, 
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 the Secretary of Health and Human 
Services. In issuing an order under paragraph (1), the Attorney General 
shall take into consideration any comments submitted by the Secretary 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) of this section with respect 
to such substance.
    (6) An order issued under paragraph (1) is not subject to judicial 
review.

(Pub. L. 91-513, title II, Sec. 201, Oct. 27, 1970, 84 Stat. 1245; Pub. 
L. 95-633, title I, Sec. 102(a), Nov. 10, 1978, 92 Stat. 3769; Pub. L. 
96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 98-
473, title II, Secs. 508, 509(a), Oct. 12, 1984, 98 Stat. 2071, 2072.)

                       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, as 
amended, 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, as 
amended, which is classified generally to chapter 9 (Sec. 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, IV, and V, referred to in subsecs. (d)(4)(A), (B), and 
(h)(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.


                               Amendments

    1984--Subsec. (g)(3). Pub. L. 98-473, Sec. 509(a), added par. (3).
    Subsec. (h). Pub. L. 98-473, Sec. 508, added subsec. (h).
    1978--Subsec. (d). Pub. L. 95-633 designated existing provisions as 
par. (1) and added pars. (2) to (5).

                         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 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.

                  Section Referred to in Other Sections

    This section is referred to in sections 812, 872, 1115 of this 
title.
