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.