21 U.S.C. § 811 : US Code - Section 811: Authority and criteria for classification of substances

Search 21 U.S.C. § 811 : US Code - Section 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.
(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 drug which contains a controlled substance from the
application of this subchapter and subchapter II of this chapter if
such drug 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.
(C) Upon the recommendation of the Secretary 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 delivery
system, 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.