[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4771 Engrossed in House (EH)]

113th CONGRESS
  2d Session
                                H. R. 4771

_______________________________________________________________________

                                 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.

            Passed the House of Representatives September 15, 2014.

            Attest:

                                                                 Clerk.
113th CONGRESS

  2d Session

                               H. R. 4771

_______________________________________________________________________

                                 AN ACT

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