[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4771 Enrolled Bill (ENR)]

        H.R.4771

                     One Hundred Thirteenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Friday,
           the third day of January, two thousand and fourteen


                                 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:
    ``(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.
        ``(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
            (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.
    (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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.