IB Union Calendar No. 434 113th CONGRESS 2d Session H. R. 4771 [Report No. 113–587, Parts I and II] 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 Luján 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.

1. Short title This Act may be cited as the Designer Anabolic Steroid Control Act of 2014 . 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) 5α-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-17α-methyl-androsta-1,4-diene-3,17β-diol; (liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol; (lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one; (lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione; (lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol; (lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one; (lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one; (lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol; (lxi) [3,2-c]-furazan-5α-androstan-17β-ol; (lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; (lxiii) 17α-methyl-androst-2-ene-3,17β-diol; (lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol; (lxv) Estra-4,9,11-triene-3,17-dione; (lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one; (lxvii) 6α-Methyl-androst-4-ene-3,17-dione; (lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol; (lxix) 17α-Methyl-5α-androstan-17β-ol; (lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; (lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole; (lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol; (lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; (lxxiv) [3,2-c]pyrazole-5α-androstan-17β-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: 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. .

1. Short title This Act may be cited as the Designer Anabolic Steroid Control Act of 2014 . 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) 5α-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-17α-methyl-androsta-1,4-diene-3,17β-diol; (liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol; (lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one; (lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione; (lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol; (lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one; (lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one; (lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol; (lxi) [3,2-c]-furazan-5α-androstan-17β-ol; (lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; (lxiii) 17α-methyl-androst-2-ene-3,17β-diol; (lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol; (lxv) Estra-4,9,11-triene-3,17-dione; (lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one; (lxvii) 6α-Methyl-androst-4-ene-3,17-dione; (lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol; (lxix) 17α-Methyl-5α-androstan-17β-ol; (lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; (lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole; (lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol; (lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; (lxxiv) [3,2-c]pyrazole-5α-androstan-17β-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). . 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. . 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.

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