```

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

                                                 Union Calendar No. 434
113th CONGRESS
  2d Session
                                H. R. 4771

                  [Report No. 113-587, Parts I and II]

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

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 29, 2014

Mr. Pitts (for himself and Mr. Pallone) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

                           September 15, 2014

Additional sponsors: Mr. Chaffetz, Mr. Ben Ray Lujan of New Mexico, Ms. 
               Shea-Porter, Mr. Amodei, and Ms. Duckworth

                           September 15, 2014

  Reported from the Committee on Energy and Commerce with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                           September 15, 2014

    Reported from the Committee on the Judiciary with an amendment; 
committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                           in boldface roman]
[For text of introduced bill, see copy of bill as introduced on May 29, 
                                 2014]

_______________________________________________________________________

                                 A BILL

 
  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).''.
    (c) Labeling Requirements.--
            (1) In general.--The Controlled Substances Act is amended 
        by inserting after section 305 (21 U.S.C. 825) the following:

``SEC. 305A. OFFENSES INVOLVING FALSE LABELING OF ANABOLIC STEROIDS.

    ``(a) Unlawful Acts.--
            ``(1) It shall be unlawful--
                    ``(A) to import into the United States or to export 
                from the United States;
                    ``(B) to manufacture, distribute, dispense, sell, 
                or offer to sell; or
                    ``(C) to possess with intent to manufacture, 
                distribute, dispense, sell, or offer to sell;
        any anabolic steroid, or any product containing an anabolic 
        steroid, that does not bear a label clearly identifying any 
        anabolic steroid contained in such steroid or product 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) Criminal Penalties.--Any person who violates subsection (a) 
knowing, intending, or having reasonable cause to believe, that the 
substance or product is an anabolic steroid, or contains an anabolic 
steroid, shall be sentenced to a term of imprisonment of not more than 
10 years, a fine not to exceed the greater of that authorized in 
accordance with the provisions of title 18, United States Code, or 
$500,000 if the defendant is an individual or $2,500,000 if the 
defendant is other than an individual, or both.
    ``(c) Civil Penalties.--
            ``(1) Any person who violates subsection (a) shall be 
        subject to a civil penalty as follows:
                    ``(A) In the case of an importer, exporter, 
                manufacturer, or distributor (other than as provided in 
                subparagraph (B)), up to $500,000 per violation. For 
                purposes of this subparagraph, a violation is defined 
                as each instance of importation, exportation, 
                manufacturing, or distribution, and each anabolic 
                steroid or product imported, exported, manufactured, or 
                distributed.
                    ``(B) In the case of a sale or offer to sell at 
                retail, up to $25,000 per violation. For purposes of 
                this subparagraph, each sale and each product offered 
                for sale shall be considered a separate violation. 
                Continued offers to sell by a person 10 or more days 
                after written notice (including through electronic 
                message) to the person by the Attorney General or the 
                Secretary shall be considered additional violations.
            ``(2) In this subsection, the term `product' means a 
        discrete article, either in bulk or in finished form prepared 
        for sale. A number of articles, if similarly packaged and 
        bearing identical labels, shall be considered as one product, 
        but each package size, form, or differently labeled article 
        shall be considered a separate product.
    ``(d) Identification and Publication of List of Products Containing 
Anabolic Steroids.--
            ``(1) The Attorney General may, in his discretion, collect 
        data and analyze products to determine whether they contain 
        anabolic steroids and are properly labeled in accordance with 
        this section. The Attorney General may publish in the Federal 
        Register or on the website of the Drug Enforcement 
        Administration a list of products that he has determined, based 
        on substantial evidence, contain an anabolic steroid and are 
        not labeled in accordance with this section.
            ``(2) The absence of a product from the list referred to in 
        paragraph (1) shall not constitute evidence that the product 
        does not contain an anabolic steroid.''.
            (2) Table of contents.--The table of contents for the 
        Comprehensive Drug Abuse Prevention and Control Act of 1970 is 
        amended by inserting after the item relating to section 305 the 
        following:

``Sec. 305A. Offenses involving false labeling of anabolic steroids.''.

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 305 of the 
        Controlled Substances Act.''; 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 paragraph (16) of subsection (a) shall be considered a 
separate violation.''.

SEC. 4. IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS CONTAINING 
              ANABOLIC STEROIDS.

    (a) The Attorney General may, in his discretion, collect data and 
analyze products to determine whether they contain anabolic steroids 
and are properly labeled in accordance with this section. The Attorney 
General may publish in the Federal Register or on the website of the 
Drug Enforcement Administration a list of products that he has 
determined, based on substantial evidence, contain an anabolic steroid 
and are not labeled in accordance with this section.
    (b) 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.
                                                 Union Calendar No. 434

113th CONGRESS

  2d Session

                               H. R. 4771

                  [Report No. 113-587, Parts I and II]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                           September 15, 2014

  Reported from the Committee on Energy and Commerce with an amendment

                           September 15, 2014

    Reported from the Committee on the Judiciary with an amendment; 
committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed
```