Regulations
& Codified CSA > USC > Subchapter I, Part B, Section 811
Part B -- Authority to Control; Standards and
Schedules
Section 811. Authority and Criteria for Classification of Substances
Rules and regulations of Attorney General; hearing
(a) 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.
Evaluation of Drugs and Other Substances
(b) 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.
Factors Determinative of Control or Removal from Schedules
(c) 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.
International treaties, conventions, and protocols requiring control; procedures respecting
changes in drug schedules of Convention on Psychotropic Substances
(d)(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 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, recommended 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 (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.
(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.
Immediate Precursors
(e) 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.
Abuse Potential
(f) 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.
Non-narcotic substances sold over the counter without prescription; dextromethorphan
(g)(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, 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.
Temporary Scheduling to Avoid Imminent Hazards to Public Safety
(h)(1) If the Attorney General finds that the scheduling of a substance in schedule I on a
temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order
and without regard to the requirements of subsection (b) 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 355 of this title. 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, Section 201, Oct. 27, 1970, 84 Stat. 1245; Pub.L. 95-633, Title I,
Section 102(a), Nov. 10, 1978, 92 Stat. 3769; Pub.L. 96-88, Title V, Section 509, Oct. 17, 1979,
93 Stat. 695; Pub.L. 98-473, Title II, Sections 508, 509(a), Oct. 12, 1984, 98 Stat. 2071, 2072.)
EDITORIAL NOTES
References in Text. The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (d)(3)
and (g)(1), is Act June 25, 1938, c. 675, 52 Stat. 1040, as amended, which is classified generally
to chapter 9 (section 301 et seq.) of Title 21, U.S.C.A., Food and Drugs.
Schedules IV and V, referred to in subsec. (d)(4)(A), (B), 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.
11, 1978, 92 Stat. 3768, which enacted sections 801a, 830, and 852 of Title 21, U.S.C.A., Food
and Drugs, amended this section and sections 352, 802, 812, 823, 827, 841 to 843, 872, 881, 952,
953, and 965 of Title 21 and section 242a of Title 42, U.S.C.A., The Public Health and Welfare,
and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of Title 21.
Change of Name. "Secretary of Health and Human Services" was substituted for "Secretary of
Health, Education, and Welfare" on authority of Pub.L. 96-88, Title V, Section 509, Oct. 17,
1979, 93 Stat. 695, which is classified to section 3508 of Title 20, U.S.C.A., Education.
Code of Federal Regulations
Administrative policies, practices, and procedures, see 21 CFR 1316.01 et seq.
Schedules, see 21 CFR 1308.01 et seq. and Table.
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