[113th Congress Public Law 260]
[From the U.S. Government Printing Office]



[[Page 128 STAT. 2929]]

Public Law 113-260
113th Congress

                                 An Act


 
  To amend the Controlled Substances Act to more effectively regulate 
       anabolic steroids. <<NOTE: Dec. 18, 2014 -  [H.R. 4771]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Designer 
Anabolic Steroid Control Act of 2014.>> 
SECTION 1. <<NOTE: 21 USC 801 note.>>  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 128 STAT. 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) <<NOTE: Regulations.>>  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) <<NOTE: Effective date. Federal Register, 
        publication.>>  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. <<NOTE: Expiration date.>> 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 128 STAT. 2931]]

             <<NOTE: Notification.>> ``(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 128 STAT. 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) <<NOTE: Definitions.>> 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. <<NOTE: 21 USC 825 note.>>  IDENTIFICATION AND PUBLICATION 
                    OF LIST OF PRODUCTS CONTAINING ANABOLIC 
                    STEROIDS.

    (a) In General.-- <<NOTE: Determination. Labeling. Federal Register, 
publication. Web posting.>> 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 128 STAT. 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.

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