II 

112TH CONGRESS 

2D SESSION S. 3431 

To amend the Controlled Substances Act to more effectively regulate anabolic 

steroids. 

IN THE SENATE OF THE UNITED STATES 

JULY 25, 2012 

Mr. WHITEHOUSE (for himself and Mr. HATCH) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 Steroid Control Act of 2012’’. 

6 SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES 

7 ACT. 

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

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

10 (1) in subparagraph (A)— 


jbell on DSK7SPTVN1PROD with BILLS
2 

•S 3431 IS

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

2 the end; 

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

4 (lxxvii); and 

5 (C) by inserting after clause (xlix) the fol6 lowing: 

7 ‘‘(l) 5α-Androstan-3,6,17-trione; 

8 ‘‘(li) Androst-4-ene-3,6,17-trione; 

9 ‘‘(lii) Androsta-1,4,6-triene-3,17- 

10 dione; 

11 ‘‘(liii) 6-bromo-androstan-3,17-dione; 

12 ‘‘(liv) 6-bromo-androsta-1,4-diene13 3,17-dione; 

14 ‘‘(lv) 4-chloro-17α-methyl-androsta15 1,4-diene-3,17β-diol; 

16 ‘‘(lvi) 4-chloro-17α-methyl-androst-4- 

17 ene-3β,17β-diol; 

18 ‘‘(lvii) 4-chloro-17α-methyl-17β-hy19 droxy-androst-4-en-3-one; 

20 ‘‘(lviii) 4-chloro-17α-methyl-17β-hy21 droxy-androst-4-ene-3,11-dione; 

22 ‘‘(lix) 4-chloro-17α-methyl-androsta23 1,4-diene-3,17β-diol; 

24 ‘‘(lx) 2α,17α-dimethyl-17β-hydroxy25 5α-androstan-3-one; 


jbell on DSK7SPTVN1PROD with BILLS
3 

•S 3431 IS

1 ‘‘(lxi) 2α,17α-dimethyl-17β-hydroxy2 5β-androstan-3-one; 

3 ‘‘(lxii) 2α,3α-epithio-17α-methyl-5α4 androstan-17β-ol; 

5 ‘‘(lxiii) [3,2-c]-furazan-5α-androstan6 17β-ol; 

7 ‘‘(lxiv) 3β-hydroxy-estra-4,9,11-trien8 17-one; 

9 ‘‘(lxv) 17α-methyl-androst-2-ene10 3,17β-diol; 

11 ‘‘(lxvi) 17α-methyl-androsta-1,4-diene12 3,17β-diol; 

13 ‘‘(lxvii) Estra-4,9,11-triene-3,17-dione; 

14 ‘‘(lxviii) 18a-Homo-3-hydroxy-estra15 2,5(10)-dien-17-one; 

16 ‘‘(lxix) 6α-Methyl-androst-4-ene-3,17- 

17 dione; 

18 ‘‘(lxx) 17α-Methyl-androstan-3- 

19 hydroxyimine-17β-ol; 

20 ‘‘(lxxi) 17α-Methyl-5α-androstan-17β21 ol; 

22 ‘‘(lxxii) 17β-Hydroxy-androstano[2,3- 

23 d]isoxazole; 

24 ‘‘(lxxiii) 17β-Hydroxy-androstano[3,2- 

25 c]isoxazole; 


jbell on DSK7SPTVN1PROD with BILLS
4 

•S 3431 IS

1 ‘‘(lxxiv) 4-Hydroxy-androst-4-ene2 3,17-dione[3,2-c]pyrazole-5α-androstan3 17β-ol; 

4 ‘‘(lxxv) [3,2-c]pyrazole-androst-4-en5 17β-ol; 

6 ‘‘(lxxvi) [3,2-c]pyrazole-5α-androstan7 17β-ol; and’’; and 

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

9 ‘‘(C)(i) Subject to clause (ii) and the limi10 tations under section 201(i)(6), a drug or hor11 monal substance (other than estrogens, 

12 progestins, corticosteroids, and 

13 dehydroepiandrosterone) that is not listed in 

14 subparagraph (A) and is derived from, or has 

15 a chemical structure substantially similar to, 1 

16 or more anabolic steroids listed in subpara17 graph (A) shall be considered to be an anabolic 

18 steroid for purposes of this Act if— 

19 ‘‘(I) the drug or substance has been 

20 created or manufactured with the intent of 

21 producing a drug or other substance that 

22 either— 

23 ‘‘(aa) promotes muscle growth; or 


jbell on DSK7SPTVN1PROD with BILLS
5 

•S 3431 IS

1 ‘‘(bb) otherwise causes a pharma2 cological effect similar to that of tes3 tosterone; or 

4 ‘‘(II) the drug or substance has been, 

5 or is intended to be, marketed or otherwise 

6 promoted in any manner suggesting that 

7 consuming it will promote muscle growth 

8 or any other pharmacological effect similar 

9 to that of testosterone. 

10 ‘‘(ii) A substance shall not be considered to 

11 be a drug or hormonal substance for purposes 

12 of this subparagraph if it— 

13 ‘‘(I) is— 

14 ‘‘(aa) an herb or other botanical; 

15 ‘‘(bb) a concentrate, metabolite, 

16 or extract of, or a constituent isolated 

17 directly from, an herb or other botan18 ical; or 

19 ‘‘(cc) a combination of 2 or more 

20 substances described in item (aa) or 

21 (bb); and 

22 ‘‘(II) is a dietary ingredient for pur23 poses of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 301 et seq.). 


jbell on DSK7SPTVN1PROD with BILLS
6 

•S 3431 IS

1 ‘‘(iii) In accordance with section 515(a), 

2 any person claiming the benefit of an exemption 

3 or exception under clause (ii) shall bear the 

4 burden of going forward with the evidence with 

5 respect to such exemption or exception.’’. 

6 (b) CLASSIFICATION AUTHORITY.—Section 201 of 

7 the Controlled Substances Act (21 U.S.C. 811) is amend8 ed by adding at the end the following: 

9 ‘‘(i) TEMPORARY AND PERMANENT SCHEDULING OF

10 RECENTLY EMERGED ANABOLIC STEROIDS.— 

11 ‘‘(1) The Attorney General may issue a tem12 porary order adding a drug or other substance to 

13 the list of anabolic steroids if the Attorney General 

14 finds that— 

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

16 the criteria for being considered an anabolic 

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

18 in that section or by regulation of the Attorney 

19 General as being an anabolic steroid; and 

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

21 to the list of anabolic steroids will assist in pre22 venting the unlawful importation, manufacture, 

23 distribution, or dispensing of such drug or other 

24 substance. 


jbell on DSK7SPTVN1PROD with BILLS
7 

•S 3431 IS

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

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

3 publication by the Attorney General of a notice in 

4 the Federal Register of the intention to issue such 

5 order and the grounds upon which such order is to 

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

7 months after the date it becomes effective, except 

8 that the Attorney General may, during the pendency 

9 of proceedings under paragraph (5), extend the tem10 porary scheduling order for up to 6 months. 

11 ‘‘(3) A temporary scheduling order issued under 

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

13 a permanent scheduling order under paragraph (5). 

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

15 not subject to judicial review. 

16 ‘‘(5) The Attorney General may, by rule, issue 

17 a permanent order adding a drug or other substance 

18 to the list of anabolic steroids if such drug or other 

19 substance satisfies the criteria for being considered 

20 an anabolic steroid under section 102(41). Such 

21 rulemaking may be commenced simultaneously with 

22 the issuance of the temporary order issued under 

23 paragraph (1). 

24 ‘‘(6) If a drug or other substance has not been 

25 temporarily or permanently added to the list of anaVerDate Mar 15 2010 04:31 Jul 26, 2012 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3431.IS S3431

jbell on DSK7SPTVN1PROD with BILLS
8 

•S 3431 IS

1 bolic steroids pursuant to this subsection, the drug 

2 or other substance shall be considered an anabolic 

3 steroid if in any criminal, civil, or administrative 

4 proceeding arising under this Act it has been deter5 mined in such proceeding, based on evidence pre6 sented in the proceeding, that the substance satisfies 

7 the criteria for being considered an anabolic steroid 

8 under paragraph (41)(A), (41)(C)(i), or (41)(C)(ii) 

9 of section 102.’’. 

10 (c) LABELING REQUIREMENTS.—The Controlled 

11 Substances Act is amended by inserting after section 305 

12 (21 U.S.C. 825) the following: 

13 ‘‘§ 305A. Offenses involving false labeling of anabolic 

14 steroids 

15 ‘‘(a) UNLAWFUL ACTS.— 

16 ‘‘(1) It shall be unlawful— 

17 ‘‘(A) to import into the United States or to 

18 export from the United States; 

19 ‘‘(B) to manufacture, distribute, dispense, 

20 sell, or offer to sell; or 

21 ‘‘(C) to possess with intent to manufac22 ture, distribute, dispense, sell, or offer to sell; 

23 any anabolic steroid, or any product containing an 

24 anabolic steroid, unless it bears a label clearly identi25 fying any anabolic steroid contained in such steroid 


jbell on DSK7SPTVN1PROD with BILLS
9 

•S 3431 IS

1 or product by the nomenclature used by the Inter2 national Union of Pure and Applied Chemistry 

3 (IUPAC). 

4 ‘‘(2) A product that is the subject of an ap5 proved application as described in section 505(b), (i) 

6 or (j) of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 355(b), (i), or (j)) is exempt from the 

8 International Union of Pure and Applied Chemistry 

9 nomenclature requirement of this subsection if such 

10 product is labeled in the manner required by the 

11 Federal Food, Drug, and Cosmetic Act. 

12 ‘‘(b) CRIMINAL PENALTIES.—Any person who vio13 lates subsection (a) knowing, intending, or having reason14 able cause to believe, that the substance or product is an 

15 anabolic steroid, or contains an anabolic steroid, shall be 

16 sentenced to a term of imprisonment of not more than 

17 10 years, a fine not to exceed the greater of that author18 ized in accordance with the provisions of title 18, United 

19 States Code, or $500,000 if the defendant is an individual 

20 or $2,500,000 if the defendant is other than an individual, 

21 or both. 

22 ‘‘(c) CIVIL PENALTIES.— 

23 ‘‘(1) Any person who violates subsection (a) 

24 shall be subject to a civil penalty as follows: 


jbell on DSK7SPTVN1PROD with BILLS
10 

•S 3431 IS

1 ‘‘(A) In the case of an importer, exporter, 

2 manufacturer, or distributor (other than as pro3 vided in subparagraph (B)), up to $500,000 per 

4 violation. For purposes of this subparagraph, a 

5 violation is defined as each instance of importa6 tion, exportation, manufacturing, or distribu7 tion, and each anabolic steroid or product im8 ported, exported, manufactured, or distributed. 

9 ‘‘(B) In the case of a sale or offer to sell 

10 at retail, up to $25,000 per violation. For pur11 poses of this subparagraph, each sale and each 

12 product offered for sale shall be considered a 

13 separate violation. Continued offers to sell by a 

14 person 10 or more days after written notice (in15 cluding through electronic message) to the per16 son by the Attorney General or the Secretary 

17 shall be considered additional violations. 

18 ‘‘(2) In this subsection, the term ‘product’ 

19 means a discrete article, either in bulk or in finished 

20 form prepared for sale. A number of articles, if simi21 larly packaged and bearing identical labels, shall be 

22 considered as one product, but each package size, 

23 form, or differently labeled article shall be consid24 ered a separate product. 


jbell on DSK7SPTVN1PROD with BILLS
11 

•S 3431 IS

1 ‘‘(d) IDENTIFICATION AND PUBLICATION OF LIST OF

2 PRODUCTS CONTAINING ANABOLIC STEROIDS.— 

3 ‘‘(1) The Attorney General may, in his discre4 tion, collect data and analyze products to determine 

5 whether they contain anabolic steroids and are prop6 erly labeled in accordance with this section. The At7 torney General may publish in the Federal Register 

8 or on the website of the Drug Enforcement Adminis9 tration a list of products that he has determined, 

10 based on substantial evidence, contain an anabolic 

11 steroid and are not labeled in accordance with this 

12 section. 

13 ‘‘(2) The absence of a product from the list re14 ferred to in paragraph (1) shall not constitute evi15 dence that the product does not contain an anabolic 

16 steroid.’’. 

17 SEC. 3. SENTENCING COMMISSION GUIDELINES. 

18 The United States Sentencing Commission shall— 

19 (1) review and amend the Federal sentencing 

20 guidelines with respect to offenses involving anabolic 

21 steroids, including the offenses established in section 

22 2 (section 305A of the Controlled Substance Act); 

23 (2) amend the Federal sentencing guidelines, 

24 including notes to the drug quantity tables, to pro25 vide clearly that in a case involving an anabolic sterVerDate Mar 15 2010 04:31 Jul 26, 2012 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3431.IS S3431

jbell on DSK7SPTVN1PROD with BILLS
12 

•S 3431 IS

1 oid not in a tablet, capsule, liquid, or other form 

2 where dosage can be readily ascertained (such as a 

3 powder, topical cream, gel, or aerosol), the sentence 

4 shall be determined based on the entire weight of the 

5 mixture or substance; 

6 (3) amend the applicable guidelines by desig7 nating quantities of mixture or substance that cor8 respond to a unit so that offenses involving such 

9 forms of anabolic steroids are penalized at least as 

10 severely as offenses involving forms whose dosage 

11 can be readily ascertained; and 

12 (4) take such other action as the Commission 

13 considers necessary to carry out this Act and this 

14 section. 

15 SEC. 4. CONGRESSIONAL OVERSIGHT. 

16 The Administrator of the Drug Enforcement Admin17 istration shall report to Congress every 2 years— 

18 (1) what anabolic steroids have been scheduled 

19 on a temporary basis under the provisions of this 

20 Act; and 

21 (2) the findings and conclusions that led to 

22 such scheduling. 

Æ 


jbell on DSK7SPTVN1PROD with BILLS