II 

115TH CONGRESS 

2D SESSION S. 2742 

To amend the Controlled Substances Act to more effectively regulate selective 

androgen receptor modulators, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 24, 2018 

Mr. HATCH (for himself and Mr. WHITEHOUSE) 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 selective androgen receptor modulators, and for 

other purposes. 

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 ‘‘Selective Androgen Re5 ceptor Modulators Control Act of 2018’’ or the ‘‘SARMs 

6 Control Act of 2018’’. 


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1 SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES 

2 ACT. 

3 (a) DEFINITION.—Section 102 of the Controlled Sub4 stances Act (21 U.S.C. 802) is amended by adding at the 

5 end the following: 

6 ‘‘(57)(A) The term ‘SARM’— 

7 ‘‘(i) means any drug or other substance that is 

8 a selective androgen receptor agonist chemically un9 related to testosterone, estrogens, progestins, 

10 corticosteroids, and dehydroepiandrosterone; and 

11 ‘‘(ii) includes— 

12 ‘‘(I) (S)-N-(4-cyano-3- 

13 (trifluoromethyl)phenyl)-3-(4-cyanophenoxy)-2- 

14 hydroxy-2-methylpropanamide (commonly 

15 known as ‘ostarine’ or ‘enobosarm’); 

16 ‘‘(II) 4-((R)-2-((R)-2,2,2-trifluoro-1-hy17 droxyethyl)pyrrolidin-1-yl)-2- 

18 (trifluoromethyl)benzonitrile (commonly known 

19 as ‘LGD-4033’ or ‘ligandrol’); 

20 ‘‘(III) 9-chloro-2-ethyl-1-methyl-3-(2,2,2- 

21 trifluoroethyl)-3,6-dihydro-7H-pyrrolo[3,2- 

22 f]quinolin-7-one (commonly known as ‘LGD23 3303’); 

24 ‘‘(IV) isopropyl (S)-(7-cyano-4-(pyridin-2- 

25 ylmethyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-2 


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1 -yl)carbamate (commonly known as 

2 ‘LY2452473’ or ‘TT701’); 

3 ‘‘(V) 2-chloro-4-(((1R,2S)-1-(5-(4- 

4 cyanophenyl)-1,3,4-oxadiazol-2-yl)-2- 

5 hydroxypropyl)amino)-3-methylbenzonitrile 

6 (commonly known as ‘RAD-140’); 

7 ‘‘(VI) (S)-3-(4-acetamidophenoxy)-2-hy8 droxy-2-methyl-N-(4-nitro-3- 

9 (trifluoromethyl)phenyl)propanamide (com10 monly known as ‘andarine’); 

11 ‘‘(VII) 2-chloro-4-((7R,7aS)-7-hydroxy-1,3- 

12 dioxotetrahydro-1H-pyrrolo[1,2-c]imidazol13 2(3H)-yl)-3-methylbenzonitrile (commonly 

14 known as ‘BMS-564929’); 

15 ‘‘(VIII) 6-ethyl-4-(trifluoromethyl)-6,7,8,9- 

16 tetrahydropyrido[3,2-g]quinolin-2(1H)-one 

17 (commonly known as ‘LG-121071’); 

18 ‘‘(IX) (S)-3-(4-chloro-3-fluorophenoxy)-N19 (4-cyano-3-(trifluoromethyl)phenyl)-2-hydroxy20 2-methylpropanamide (commonly known as ‘S21 23’); and 

22 ‘‘(X) any salt, ester, ether, or substituted 

23 analogue of a drug or other substance described 

24 in subclauses (I) through (IX). 


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1 ‘‘(B) A substance excluded under subparagraph 

2 (A)(i) may at any time be scheduled by the Attorney Gen3 eral in accordance with the authority and requirements 

4 under subsections (a) through (c) of section 201 (21 

5 U.S.C. 811). 

6 ‘‘(C)(i) A drug or other substance (other than estro7 gens, progestins, corticosteroids, and 

8 dehydroepiandrosterone, unless scheduled under subpara9 graph (B)) that is not listed in subparagraph (A)(ii) and 

10 is derived from, or has a chemical structure substantially 

11 similar to, 1 or more SARMs listed in subparagraph 

12 (A)(ii) shall be considered to be a SARM for purposes of 

13 this title if the drug or other substance— 

14 ‘‘(I) has been created or manufactured with the 

15 intent of producing a drug or other substance that— 

16 ‘‘(aa) promotes muscle growth; or 

17 ‘‘(bb) otherwise causes a pharmacological 

18 effect similar to that of testosterone; or 

19 ‘‘(II) has been, or is intended to be, marketed 

20 or otherwise promoted in any manner suggesting 

21 that consuming the drug or other substance will pro22 mote muscle growth or any other pharmacological 

23 effect similar to that of testosterone. 


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1 ‘‘(ii) A drug or other substance shall not be consid2 ered to be a SARM for purposes of this subparagraph if 

3 the drug or other substance— 

4 ‘‘(I) is— 

5 ‘‘(aa) an herb or other botanical; 

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

7 of, or a constituent isolated directly from, an 

8 herb or other botanical; or 

9 ‘‘(cc) a combination of 2 or more sub10 stances described in item (aa) or (bb); 

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

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

13 301 et seq.); and 

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

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

16 claiming the benefit of an exemption or exception under 

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

18 evidence with respect to that exemption or exception.’’. 

19 (b) AMENDMENT TO SCHEDULE III.—Schedule III in 

20 section 202(c) of the Controlled Substances Act (21 

21 U.S.C. 812(c)) is amended by adding at the end the fol22 lowing: 

23 ‘‘(f) SARMs.’’. 

24 (c) TEMPORARY AND PERMANENT SCHEDULING OF

25 RECENTLY EMERGED SARMS.—Section 201 of the ConVerDate Sep 11 2014 20:57 Apr 25, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2742.IS S2742

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1 trolled Substances Act (21 U.S.C. 811) is amended by 

2 adding at the end the following: 

3 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

4 RECENTLY EMERGED SARMS.— 

5 ‘‘(1) TEMPORARY ORDERS.— 

6 ‘‘(A) IN GENERAL.—The Attorney General 

7 may issue a temporary order adding a drug or 

8 other substance to the definition of the term 

9 ‘SARM’ under section 102(57) if the Attorney 

10 General finds that— 

11 ‘‘(i) the drug or other substance satis12 fies the criteria for being considered a 

13 SARM but is not listed in that section or 

14 by regulation of the Attorney General as 

15 being a SARM; and 

16 ‘‘(ii) adding the drug or other sub17 stance to the definition of the term SARM 

18 will assist in preventing abuse or misuse of 

19 the drug or other substance. 

20 ‘‘(B) EFFECTIVE DATE; DURATION.—A 

21 temporary order issued under subparagraph 

22 (A)— 

23 ‘‘(i) shall take effect not earlier than 

24 30 days after the date of publication by 


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1 the Attorney General of a notice in the 

2 Federal Register of— 

3 ‘‘(I) the intention of the Attorney 

4 General to issue the temporary order; 

5 and 

6 ‘‘(II) the grounds on which the 

7 temporary order is to be issued; and 

8 ‘‘(ii) shall expire not later than 2 

9 years after the date on which the tem10 porary order becomes effective, except that 

11 the Attorney General may, during the 

12 pendency of proceedings under paragraph 

13 (2), extend the temporary order for not 

14 more than 6 months. 

15 ‘‘(C) NOTICE TO SECRETARY OF HEALTH

16 AND HUMAN SERVICES.— 

17 ‘‘(i) IN GENERAL.—The Attorney 

18 General shall transmit notice of a tem19 porary order proposed to be issued under 

20 subparagraph (A) to the Secretary of 

21 Health and Human Services. 

22 ‘‘(ii) CONSIDERATION.—In issuing a 

23 temporary order under subparagraph (A), 

24 the Attorney General shall take into con25 sideration any comments submitted by the 


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1 Secretary of Health and Human Services 

2 in response to a notice transmitted under 

3 this subparagraph. 

4 ‘‘(D) EFFECT OF PERMANENT SCHED5 ULING.—A temporary order issued under sub6 paragraph (A) shall be vacated upon the 

7 issuance of a permanent order issued under 

8 paragraph (2). 

9 ‘‘(E) JUDICIAL REVIEW.—A temporary 

10 order issued under subparagraph (A) shall not 

11 be subject to judicial review. 

12 ‘‘(2) PERMANENT ORDERS.— 

13 ‘‘(A) IN GENERAL.—The Attorney General 

14 may by rule issue a permanent order adding a 

15 drug or other substance to the definition of the 

16 term ‘SARM’ under section 102(57) if the drug 

17 or other substance satisfies the criteria for 

18 being considered a SARM under that section. 

19 ‘‘(B) TIMING.—The Attorney General may 

20 commence a rulemaking under subparagraph 

21 (A) simultaneously with the issuance of a tem22 porary order under paragraph (1).’’. 

23 (d) LABELING REQUIREMENTS.— 


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1 (1) IN GENERAL.—Section 305 of the Con2 trolled Substances Act (21 U.S.C. 825) is amended 

3 by adding at the end the following: 

4 ‘‘(f) FALSE LABELING OF SARMS.— 

5 ‘‘(1) PROHIBITION.—It shall be unlawful to im6 port, export, manufacture, distribute, dispense, or 

7 possess with intent to manufacture, distribute, or 

8 dispense, a SARM or product containing a SARM, 

9 unless the SARM or product containing the SARM 

10 bears a label clearly identifying the SARM or prod11 uct containing the SARM by the nomenclature used 

12 by the International Union of Pure and Applied 

13 Chemistry. 

14 ‘‘(2) EXEMPTION.— 

15 ‘‘(A) IN GENERAL.—A SARM or product 

16 containing a SARM described in subparagraph 

17 (B) shall be exempt from the International 

18 Union of Pure and Applied Chemistry nomen19 clature requirement under paragraph (1) if the 

20 SARM or product containing a SARM is la21 beled in the manner required under the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 301 

23 et seq.). 

24 ‘‘(B) EXEMPT PRODUCTS.—A SARM or 

25 product containing a SARM is described in this 


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1 subparagraph if the SARM or product con2 taining a SARM— 

3 ‘‘(i) is the subject of an approved ap4 plication as described in subsection (b) or 

5 (j) of section 505 of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 355); 

7 or 

8 ‘‘(ii) is exempt from the provisions of 

9 section 505 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355) relating 

11 to new drugs because— 

12 ‘‘(I) the SARM or product con13 taining a SARM is intended solely for 

14 investigational use as described in 

15 subsection (i) of that section; and 

16 ‘‘(II) the SARM or product con17 taining a SARM is being used exclu18 sively for purposes of a clinical trial 

19 that is the subject of an effective in20 vestigational new drug application.’’. 

21 (2) CLARIFICATION REGARDING FELONY DRUG

22 OFFENSES.—Section 102(44) of the Controlled Sub23 stances Act (21 U.S.C. 802(44)) is amended by in24 serting ‘‘SARMs,’’ after ‘‘anabolic steroids,’’. 


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1 (3) CIVIL PENALTIES.—Section 402 of the Con2 trolled Substances Act (21 U.S.C. 842) is amend3 ed— 

4 (A) in subsection (a)(16)— 

5 (i) by inserting ‘‘or (f)’’ after ‘‘sub6 section (e)’’; and 

7 (ii) by striking ‘‘825’’ and inserting 

8 ‘‘305’’; and 

9 (B) in subsection (c)(1)(D), by inserting 

10 ‘‘or a SARM’’ after ‘‘an anabolic steroid’’. 

11 SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

12 COSMETIC ACT. 

13 Section 413(c) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 350b(c)) is amended— 

15 (1) in paragraph (1), by striking ‘‘an anabolic 

16 steroid or an analogue of an anabolic steroid’’ and 

17 inserting ‘‘an anabolic steroid, a SARM, an analogue 

18 of an anabolic steroid, or an analogue of a SARM’’; 

19 and 

20 (2) in paragraph (2)— 

21 (A) in subparagraph (A), by striking 

22 ‘‘and’’ at the end; 

23 (B) in subparagraph (B), by striking the 

24 period at the end and inserting a semicolon; 

25 and 


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1 (C) by adding at the end the following: 

2 ‘‘(C) the term ‘analogue of a SARM’ 

3 means a substance that has a chemical struc4 ture that is substantially similar to the chemical 

5 structure of a SARM; and 

6 ‘‘(D) the term ‘SARM’ has the meaning 

7 given the term in section 102(57) of the Con8 trolled Substances Act (21 U.S.C. 802(57)).’’. 

Æ 


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