IIB 

113TH CONGRESS 

2D SESSION H. R. 4771 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 16, 2014 

Received; read twice and referred to the Committee on the Judiciary 

AN ACT 

To amend the Controlled Substances Act to more effectively 

regulate anabolic steroids. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Designer Anabolic 

3 Steroid Control Act of 2014’’. 

4 SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES 

5 ACT. 

6 (a) DEFINITIONS.—Section 102(41) of the Controlled 

7 Substances Act (21 U.S.C. 802(41)) is amended— 

8 (1) in subparagraph (A)— 

9 (A) in clause (xlix), by striking ‘‘and’’ at 

10 the end; 

11 (B) by redesignating clause (xlx) as clause 

12 (lxxv); and 

13 (C) by inserting after clause (xlix) the fol14 lowing: 

15 ‘‘(l) 5α-Androstan-3,6,17-trione; 

16 ‘‘(li) 6-bromo-androstan-3,17-dione; 

17 ‘‘(lii) 6-bromo-androsta-1,4-diene-3,17-dione; 

18 ‘‘(liii) 4-chloro-17α-methyl-androsta-1,4-diene19 3,17β-diol; 

20 ‘‘(liv) 4-chloro-17α-methyl-androst-4-ene21 3β,17β-diol; 

22 ‘‘(lv) 4-chloro-17α-methyl-17β-hydroxy-androst23 4-en-3-one; 

24 ‘‘(lvi) 4-chloro-17α-methyl-17β-hydroxy25 androst-4-ene-3,11-dione; 


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1 ‘‘(lvii) 4-chloro-17α-methyl-androsta-1,4-diene2 3,17β-diol; 

3 ‘‘(lviii) 2α,17α-dimethyl-17β-hydroxy-5α4 androstan-3-one; 

5 ‘‘(lix) 2α,17α-dimethyl-17β-hydroxy-5β6 androstan-3-one; 

7 ‘‘(lx) 2α,3α-epithio-17α-methyl-5α-androstan8 17β-ol; 

9 ‘‘(lxi) [3,2-c]-furazan-5α-androstan-17β-ol; 

10 ‘‘(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; 

11 ‘‘(lxiii) 17α-methyl-androst-2-ene-3,17β-diol; 

12 ‘‘(lxiv) 17α-methyl-androsta-1,4-diene-3,17β13 diol; 

14 ‘‘(lxv) Estra-4,9,11-triene-3,17-dione; 

15 ‘‘(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien16 17-one; 

17 ‘‘(lxvii) 6α-Methyl-androst-4-ene-3,17-dione; 

18 ‘‘(lxviii) 17α-Methyl-androstan-3-hydroxyimine19 17β-ol; 

20 ‘‘(lxix) 17α-Methyl-5α-androstan-17β-ol; 

21 ‘‘(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; 

22 ‘‘(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole; 

23 ‘‘(lxxii) 4-Hydroxy-androst-4-ene-3,17- 

24 dione[3,2-c]pyrazole-5α-androstan-17β-ol; 

25 ‘‘(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; 


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1 ‘‘(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; 

2 and’’; and 

3 (2) by adding at the end the following: 

4 ‘‘(C)(i) Subject to clause (ii), a drug or hormonal sub5 stance (other than estrogens, progestins, corticosteroids, 

6 and dehydroepiandrosterone) that is not listed in subpara7 graph (A) and is derived from, or has a chemical structure 

8 substantially similar to, 1 or more anabolic steroids listed 

9 in subparagraph (A) shall be considered to be an anabolic 

10 steroid for purposes of this Act if— 

11 ‘‘(I) the drug or substance has been created or 

12 manufactured with the intent of producing a drug or 

13 other substance that either— 

14 ‘‘(aa) promotes muscle growth; or 

15 ‘‘(bb) otherwise causes a pharmacological 

16 effect similar to that of testosterone; or 

17 ‘‘(II) the drug or substance has been, or is in18 tended to be, marketed or otherwise promoted in any 

19 manner suggesting that consuming it will promote 

20 muscle growth or any other pharmacological effect 

21 similar to that of testosterone. 

22 ‘‘(ii) A substance shall not be considered to be a drug 

23 or hormonal substance for purposes of this subparagraph 

24 if it— 

25 ‘‘(I) is— 


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1 ‘‘(aa) an herb or other botanical; 

2 ‘‘(bb) a concentrate, metabolite, or extract 

3 of, or a constituent isolated directly from, an 

4 herb or other botanical; or 

5 ‘‘(cc) a combination of 2 or more sub6 stances described in item (aa) or (bb); 

7 ‘‘(II) is a dietary ingredient for purposes of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 301 et seq.); and 

10 ‘‘(III) is not anabolic or androgenic. 

11 ‘‘(iii) In accordance with section 515(a), any person 

12 claiming the benefit of an exemption or exception under 

13 clause (ii) shall bear the burden of going forward with the 

14 evidence with respect to such exemption or exception.’’. 

15 (b) CLASSIFICATION AUTHORITY.—Section 201 of 

16 the Controlled Substances Act (21 U.S.C. 811) is amend17 ed by adding at the end the following: 

18 ‘‘(i) TEMPORARY AND PERMANENT SCHEDULING OF

19 RECENTLY EMERGED ANABOLIC STEROIDS.— 

20 ‘‘(1) The Attorney General may issue a tem21 porary order adding a drug or other substance to 

22 the definition of anabolic steroids if the Attorney 

23 General finds that— 

24 ‘‘(A) the drug or other substance satisfies 

25 the criteria for being considered an anabolic 


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1 steroid under section 102(41) but is not listed 

2 in that section or by regulation of the Attorney 

3 General as being an anabolic steroid; and 

4 ‘‘(B) adding such drug or other substance 

5 to the definition of anabolic steroids will assist 

6 in preventing abuse or misuse of the drug or 

7 other substance. 

8 ‘‘(2) An order issued under paragraph (1) shall 

9 not take effect until 30 days after the date of the 

10 publication by the Attorney General of a notice in 

11 the Federal Register of the intention to issue such 

12 order and the grounds upon which such order is to 

13 be issued. The order shall expire not later than 24 

14 months after the date it becomes effective, except 

15 that the Attorney General may, during the pendency 

16 of proceedings under paragraph (6), extend the tem17 porary scheduling order for up to 6 months. 

18 ‘‘(3) The Attorney General shall transmit notice 

19 of an order proposed to be issued under paragraph 

20 (1) to the Secretary of Health and Human Services. 

21 In issuing an order under paragraph (1), the Attor22 ney General shall take into consideration any com23 ments submitted by the Secretary in response to a 

24 notice transmitted pursuant to this paragraph. 


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1 ‘‘(4) A temporary scheduling order issued under 

2 paragraph (1) shall be vacated upon the issuance of 

3 a permanent scheduling order under paragraph (6). 

4 ‘‘(5) An order issued under paragraph (1) is 

5 not subject to judicial review. 

6 ‘‘(6) The Attorney General may, by rule, issue 

7 a permanent order adding a drug or other substance 

8 to the definition of anabolic steroids if such drug or 

9 other substance satisfies the criteria for being con10 sidered an anabolic steroid under section 102(41). 

11 Such rulemaking may be commenced simultaneously 

12 with the issuance of the temporary order issued 

13 under paragraph (1).’’. 

14 SEC. 3. LABELING REQUIREMENTS. 

15 (a) IN GENERAL.—Section 305 of the Controlled 

16 Substances Act (21 U.S.C. 825) is amended by adding at 

17 the end the following: 

18 ‘‘(e) FALSE LABELING OF ANABOLIC STEROIDS.— 

19 ‘‘(1) It shall be unlawful to import, export, 

20 manufacture, distribute, dispense, or possess with 

21 intent to manufacture, distribute, or dispense, an 

22 anabolic steroid or product containing an anabolic 

23 steroid, unless the steroid or product bears a label 

24 clearly identifying an anabolic steroid or product 

25 containing an anabolic steroid by the nomenclature 


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1 used by the International Union of Pure and Applied 

2 Chemistry (IUPAC). 

3 ‘‘(2)(A) A product described in subparagraph 

4 (B) is exempt from the International Union of Pure 

5 and Applied Chemistry nomenclature requirement of 

6 this subsection if such product is labeled in the man7 ner required under the Federal Food, Drug, and 

8 Cosmetic Act. 

9 ‘‘(B) A product is described in this subpara10 graph if the product— 

11 ‘‘(i) is the subject of an approved applica12 tion as described in section 505(b) or (j) of the 

13 Federal Food, Drug, and Cosmetic Act; or 

14 ‘‘(ii) is exempt from the provisions of sec15 tion 505 of such Act relating to new drugs be16 cause— 

17 ‘‘(I) it is intended solely for investiga18 tional use as described in section 505(i) of 

19 such Act; and 

20 ‘‘(II) such product is being used ex21 clusively for purposes of a clinical trial 

22 that is the subject of an effective investiga23 tional new drug application.’’. 

24 (b) CLARIFICATION TO IMPORT AND EXPORT STAT25 UTE.—Section 1010 of the Controlled Substances Import 


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1 and Export Act (21 U.S.C. 960) is amended, in subsection 

2 (a)(1), by inserting ‘‘305,’’ before ‘‘1002’’. 

3 (c) CIVIL PENALTIES.—Section 402 of the Controlled 

4 Substances Act (21 U.S.C. 842) is amended— 

5 (1) in subsection (a)— 

6 (A) in paragraph (14), by striking ‘‘or’’ at 

7 the end; 

8 (B) in paragraph (15), by striking the pe9 riod at the end and inserting ‘‘; or’’; and 

10 (C) by inserting, after paragraph (15), the 

11 following: 

12 ‘‘(16) to violate subsection (e) of section 825 of 

13 this title.’’; and 

14 (2) in subsection (c)(1)— 

15 (A) by inserting, in subparagraph (A), 

16 after ‘‘subparagraph (B)’’ the following: ‘‘, (C), 

17 or (D)’’; and 

18 (B) by inserting after subparagraph (B) 

19 the following: 

20 ‘‘(C) In the case of a violation of paragraph (16) of 

21 subsection (a) of this section by an importer, exporter, 

22 manufacturer, or distributor (other than as provided in 

23 subparagraph (D)), up to $500,000 per violation. For pur24 poses of this subparagraph, a violation is defined as each 

25 instance of importation, exportation, manufacturing, disVerDate Sep 11 2014 01:42 Sep 17, 2014 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4771.RFS H4771

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1 tribution, or possession with intent to manufacture or dis2 tribute, in violation of paragraph (16) of subsection (a). 

3 ‘‘(D) In the case of a distribution, dispensing, or pos4 session with intent to distribute or dispense in violation 

5 of paragraph (16) of subsection (a) of this section at the 

6 retail level, up to $1000 per violation. For purposes of 

7 this paragraph, the term ‘at the retail level’ refers to prod8 ucts sold, or held for sale, directly to the consumer for 

9 personal use. Each package, container or other separate 

10 unit containing an anabolic steroid that is distributed, dis11 pensed, or possessed with intent to distribute or dispense 

12 at the retail level in violation of such paragraph (16) of 

13 subsection (a) shall be considered a separate violation.’’. 

14 SEC. 4. IDENTIFICATION AND PUBLICATION OF LIST OF 

15 PRODUCTS CONTAINING ANABOLIC 

16 STEROIDS. 

17 (a) IN GENERAL.—The Attorney General may, in the 

18 Attorney General’s discretion, collect data and analyze 

19 products to determine whether they contain anabolic 

20 steroids and are properly labeled in accordance with this 

21 Act and the amendments made by this Act. The Attorney 

22 General may publish in the Federal Register or on the 

23 website of the Drug Enforcement Administration a list of 

24 products which the Attorney General has determined, 

25 based on substantial evidence, contain an anabolic steroid 


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1 and are not labeled in accordance with this Act and the 

2 amendments made by this Act. 

3 (b) ABSENCE FROM LIST.—The absence of a product 

4 from the list referred to in subsection (a) shall not con5 stitute evidence that the product does not contain an ana6 bolic steroid. 

Passed the House of Representatives September 15, 

2014. 

Attest: KAREN L. HAAS, 

Clerk. 


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