-CITE-
21 USC Part B - Authority
To Control; Standards and Schedules 01/22/02
-EXPCITE-
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.
-HEAD-
Part B - Authority To Control;
Standards and Schedules
-SECREF-
PART REFERRED TO IN OTHER
SECTIONS
This part is referred to in
title 50 section 404i.
-CITE-
21 USC Sec. 811 01/22/02
-EXPCITE-
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
-HEAD-
Sec. 811. Authority and criteria
for classification of substances
-STATUTE-
(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 schedulesany
drug or other substance if he -
(A) finds that such drug
or other substance has a potentialfor 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 ecommendations 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 valuations 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 (FOOTNOTE 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.
(FOOTNOTE 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.
-SOURCE-
(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, Sec.
508, 509(a), Oct. 12, 1984, 98 Stat. 2071,
2072.)
-REFTEXT-
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 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.
-MISC2-
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-
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.
-MISC4-
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.
-SECREF-
SECTION
REFERRED TO IN OTHER SECTIONS
This section is referred
to in sections 812, 872,
1115 of this title.
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