    [United States Statutes at Large, Volume 128, 113th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 113-260
    113th Congress

    An Act

    To amend the Controlled Substances Act to more effectively regulate
    anabolic steroids. <>

    Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled, <>
    SECTION 1. <>  SHORT TITLE.

    This Act may be cited as the ``Designer Anabolic Steroid Control Act
    of 2014''.
    SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT.

    (a) Definitions.--Section 102(41) of the Controlled Substances Act
    (21 U.S.C. 802(41)) is amended--
    (1) in subparagraph (A)--
    (A) in clause (xlix), by striking ``and'' at the
    end;
    (B) by redesignating clause (xlx) as clause (lxxv);
    and
    (C) by inserting after clause (xlix) the following:
    ``(l) 5a-Androstan-3,6,17-trione;
    ``(li) 6-bromo-androstan-3,17-dione;
    ``(lii) 6-bromo-androsta-1,4-diene-3,17-dione;
    ``(liii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-diol;
    ``(liv) 4-chloro-17a-methyl-androst-4-ene-3b,17b-diol;
    ``(lv) 4-chloro-17a-methyl-17b-hydroxy-androst-4-en-3-one;
    ``(lvi) 4-chloro-17a-methyl-17b-hydroxy-androst-4-ene-3,11-
    dione;
    ``(lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-diol;
    ``(lviii) 2a,17a-dimethyl-17b-hydroxy-5a-androstan-3-one;
    ``(lix) 2a,17a-dimethyl-17b-hydroxy-5b-androstan-3-one;
    ``(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17b-ol;
    ``(lxi) [3,2-c]-furazan-5a-androstan-17b-ol;
    ``(lxii) 3b-hydroxy-estra-4,9,11-trien-17-one;
    ``(lxiii) 17a-methyl-androst-2-ene-3,17b-diol;
    ``(lxiv) 17a-methyl-androsta-1,4-diene-3,17b-diol;
    ``(lxv) Estra-4,9,11-triene-3,17-dione;
    ``(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
    ``(lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
    ``(lxviii) 17a-Methyl-androstan-3-hydroxyimine-17b-ol;
    ``(lxix) 17a-Methyl-5a-androstan-17b-ol;
    ``(lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
    ``(lxxi) 17b-Hydroxy-androstano[3,2-c]isoxazole;
    ``(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-
    5a-androstan-17b-ol;
    ``(lxxiii) [3,2-c]pyrazole-androst-4-en-17b-ol;
    ``(lxxiv) [3,2-c]pyrazole-5a-androstan-17b-ol; and''; and
    (2) by adding at the end the following:

    [[Page 2930]]

    ``(C)(i) Subject to clause (ii), a drug or hormonal substance (other
    than estrogens, progestins, corticosteroids, and dehydroepiandrosterone)
    that is not listed in subparagraph (A) and is derived from, or has a
    chemical structure substantially similar to, 1 or more anabolic steroids
    listed in subparagraph (A) shall be considered to be an anabolic steroid
    for purposes of this Act if--
    ``(I) the drug or substance has been created or manufactured
    with the intent of producing a drug or other substance that
    either--
    ``(aa) promotes muscle growth; or
    ``(bb) otherwise causes a pharmacological effect
    similar to that of testosterone; or
    ``(II) the drug or substance has been, or is intended to be,
    marketed or otherwise promoted in any manner suggesting that
    consuming it will promote muscle growth or any other
    pharmacological effect similar to that of testosterone.

    ``(ii) A substance shall not be considered to be a drug or hormonal
    substance for purposes of this subparagraph if it--
    ``(I) is--
    ``(aa) an herb or other botanical;
    ``(bb) a concentrate, metabolite, or extract of, or
    a constituent isolated directly from, an herb or other
    botanical; or
    ``(cc) a combination of 2 or more substances
    described in item (aa) or (bb);
    ``(II) is a dietary ingredient for purposes of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
    ``(III) is not anabolic or androgenic.

    ``(iii) In accordance with section 515(a), any person claiming the
    benefit of an exemption or exception under clause (ii) shall bear the
    burden of going forward with the evidence with respect to such exemption
    or exception.''.
    (b) Classification Authority.--Section 201 of the Controlled
    Substances Act (21 U.S.C. 811) is amended by adding at the end the
    following:
    ``(i) <>  Temporary and Permanent Scheduling of
    Recently Emerged Anabolic Steroids.--
    ``(1) The Attorney General may issue a temporary order
    adding a drug or other substance to the definition of anabolic
    steroids if the Attorney General finds that--
    ``(A) the drug or other substance satisfies the
    criteria for being considered an anabolic steroid under
    section 102(41) but is not listed in that section or by
    regulation of the Attorney General as being an anabolic
    steroid; and
    ``(B) adding such drug or other substance to the
    definition of anabolic steroids will assist in
    preventing abuse or misuse of the drug or other
    substance.
    ``(2) <>  An order issued under paragraph (1) shall not
    take effect until 30 days after 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. <> The order
    shall expire not later than 24 months after the date it becomes
    effective, except that the Attorney General may, during the
    pendency of proceedings under paragraph (6), extend the
    temporary scheduling order for up to 6 months.

    [[Page 2931]]

    <> ``(3) 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.
    ``(4) A temporary scheduling order issued under paragraph
    (1) shall be vacated upon the issuance of a permanent scheduling
    order under paragraph (6).
    ``(5) An order issued under paragraph (1) is not subject to
    judicial review.
    ``(6) The Attorney General may, by rule, issue a permanent
    order adding a drug or other substance to the definition of
    anabolic steroids if such drug or other substance satisfies the
    criteria for being considered an anabolic steroid under section
    102(41). Such rulemaking may be commenced simultaneously with
    the issuance of the temporary order issued under paragraph
    (1).''.
    SEC. 3. LABELING REQUIREMENTS.

    (a) In General.--Section 305 of the Controlled Substances Act (21
    U.S.C. 825) is amended by adding at the end the following:
    ``(e) False Labeling of Anabolic Steroids.--
    ``(1) It shall be unlawful to import, export, manufacture,
    distribute, dispense, or possess with intent to manufacture,
    distribute, or dispense, an anabolic steroid or product
    containing an anabolic steroid, unless the steroid or product
    bears a label clearly identifying an anabolic steroid or product
    containing an anabolic steroid by the nomenclature used by the
    International Union of Pure and Applied Chemistry (IUPAC).
    ``(2)(A) A product described in subparagraph (B) is exempt
    from the International Union of Pure and Applied Chemistry
    nomenclature requirement of this subsection if such product is
    labeled in the manner required under the Federal Food, Drug, and
    Cosmetic Act.
    ``(B) A product is described in this subparagraph if the
    product--
    ``(i) is the subject of an approved application as
    described in section 505(b) or (j) of the Federal Food,
    Drug, and Cosmetic Act; or
    ``(ii) is exempt from the provisions of section 505
    of such Act relating to new drugs because--
    ``(I) it is intended solely for
    investigational use as described in section 505(i)
    of such Act; and
    ``(II) such product is being used exclusively
    for purposes of a clinical trial that is the
    subject of an effective investigational new drug
    application.''.

    (b) Clarification to Import and Export Statute.--Section 1010 of the
    Controlled Substances Import and Export Act (21 U.S.C. 960) is amended,
    in subsection (a)(1), by inserting ``305,'' before ``1002''.
    (c) Civil Penalties.--Section 402 of the Controlled Substances Act
    (21 U.S.C. 842) is amended--
    (1) in subsection (a)--
    (A) in paragraph (14), by striking ``or'' at the
    end;
    (B) in paragraph (15), by striking the period at the
    end and inserting ``; or''; and

    [[Page 2932]]

    (C) by inserting, after paragraph (15), the
    following:
    ``(16) to violate subsection (e) of section 825 of this
    title.''; and
    (2) in subsection (c)(1)--
    (A) by inserting, in subparagraph (A), after
    ``subparagraph (B)'' the following: ``, (C), or (D)'';
    and
    (B) <> by inserting after
    subparagraph (B) the following:

    ``(C) In the case of a violation of paragraph (16) of subsection (a)
    of this section by an importer, exporter, manufacturer, or distributor
    (other than as provided in subparagraph (D)), up to $500,000 per
    violation. For purposes of this subparagraph, a violation is defined as
    each instance of importation, exportation, manufacturing, distribution,
    or possession with intent to manufacture or distribute, in violation of
    paragraph (16) of subsection (a).
    ``(D) In the case of a distribution, dispensing, or possession with
    intent to distribute or dispense in violation of paragraph (16) of
    subsection (a) of this section at the retail level, up to $1000 per
    violation. For purposes of this paragraph, the term `at the retail
    level' refers to products sold, or held for sale, directly to the
    consumer for personal use. Each package, container or other separate
    unit containing an anabolic steroid that is distributed, dispensed, or
    possessed with intent to distribute or dispense at the retail level in
    violation of such paragraph (16) of subsection (a) shall be considered a
    separate violation.''.
    SEC. 4. <>  IDENTIFICATION AND PUBLICATION
    OF LIST OF PRODUCTS CONTAINING ANABOLIC
    STEROIDS.

    (a) In General.-- <> The Attorney General may, in the Attorney
    General's discretion, collect data and analyze products to determine
    whether they contain anabolic steroids and are properly labeled in
    accordance with this Act and the amendments made by this Act. The
    Attorney General may publish in the Federal Register or on the website
    of the Drug Enforcement Administration a list of products which the
    Attorney General has determined, based on substantial evidence, contain
    an anabolic steroid and are not labeled in accordance with this Act and
    the amendments made by this Act.

    [[Page 2933]]

    (b) Absence From List.--The absence of a product from the list
    referred to in subsection (a) shall not constitute evidence that the
    product does not contain an anabolic steroid.

    Approved December 18, 2014.

    LEGISLATIVE HISTORY--H.R. 4771:
    ---------------------------------------------------------------------------

    HOUSE REPORTS: No. 113-587, Pt. 1 (Comm. on Energy and Commerce) and
    Pt. 2 (Comm. on the Judiciary).
    CONGRESSIONAL RECORD, Vol. 160 (2014):
    Sept. 15, considered and passed House.
    Dec. 11, considered and passed Senate.