[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2742 Introduced in Senate (IS)]
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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.
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 ``Selective Androgen Receptor
Modulators Control Act of 2018'' or the ``SARMs Control Act of 2018''.
SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT.
(a) Definition.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by adding at the end the following:
``(57)(A) The term `SARM'--
``(i) means any drug or other substance that is a selective
androgen receptor agonist chemically unrelated to testosterone,
estrogens, progestins, corticosteroids, and
dehydroepiandrosterone; and
``(ii) includes--
``(I) (S)-N-(4-cyano-3-(trifluoromethyl)phenyl)-3-
(4-cyanophenoxy)-2-hydroxy-2-methylpropanamide
(commonly known as `ostarine' or `enobosarm');
``(II) 4-((R)-2-((R)-2,2,2-trifluoro-1-
hydroxyethyl)pyrrolidin-1-yl)-2-
(trifluoromethyl)benzonitrile (commonly known as `LGD-
4033' or `ligandrol');
``(III) 9-chloro-2-ethyl-1-methyl-3-(2,2,2-
trifluoroethyl)-3,6-dihydro-7H-pyrrolo[3,2-f]quinolin-
7-one (commonly known as `LGD-3303');
``(IV) isopropyl (S)-(7-cyano-4-(pyridin-2-
ylmethyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-2 -
yl)carbamate (commonly known as `LY2452473' or
`TT701');
``(V) 2-chloro-4-(((1R,2S)-1-(5-(4-cyanophenyl)-
1,3,4-oxadiazol-2-yl)-2- hydroxypropyl)amino)-3-
methylbenzonitrile (commonly known as `RAD-140');
``(VI) (S)-3-(4-acetamidophenoxy)-2-hydroxy-2-
methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)propanamide
(commonly known as `andarine');
``(VII) 2-chloro-4-((7R,7aS)-7-hydroxy-1,3-
dioxotetrahydro-1H-pyrrolo[1,2-c]imidazol- 2(3H)-yl)-3-
methylbenzonitrile (commonly known as `BMS-564929');
``(VIII) 6-ethyl-4-(trifluoromethyl)-6,7,8,9-
tetrahydropyrido[3,2-g]quinolin-2(1H)-one (commonly
known as `LG-121071');
``(IX) (S)-3-(4-chloro-3-fluorophenoxy)-N-(4-cyano-
3-(trifluoromethyl)phenyl)-2-hydroxy- 2-
methylpropanamide (commonly known as `S-23'); and
``(X) any salt, ester, ether, or substituted
analogue of a drug or other substance described in
subclauses (I) through (IX).
``(B) A substance excluded under subparagraph (A)(i) may at any
time be scheduled by the Attorney General in accordance with the
authority and requirements under subsections (a) through (c) of section
201 (21 U.S.C. 811).
``(C)(i) A drug or other substance (other than estrogens,
progestins, corticosteroids, and dehydroepiandrosterone, unless
scheduled under subparagraph (B)) that is not listed in subparagraph
(A)(ii) and is derived from, or has a chemical structure substantially
similar to, 1 or more SARMs listed in subparagraph (A)(ii) shall be
considered to be a SARM for purposes of this title if the drug or other
substance--
``(I) has been created or manufactured with the intent of
producing a drug or other substance that--
``(aa) promotes muscle growth; or
``(bb) otherwise causes a pharmacological effect
similar to that of testosterone; or
``(II) has been, or is intended to be, marketed or
otherwise promoted in any manner suggesting that consuming the
drug or other substance will promote muscle growth or any other
pharmacological effect similar to that of testosterone.
``(ii) A drug or other substance shall not be considered to be a
SARM for purposes of this subparagraph if the drug or other substance--
``(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 that
exemption or exception.''.
(b) Amendment to Schedule III.--Schedule III in section 202(c) of
the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding
at the end the following:
``(f) SARMs.''.
(c) Temporary and Permanent Scheduling of Recently Emerged SARMs.--
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended
by adding at the end the following:
``(k) Temporary and Permanent Scheduling of Recently Emerged
SARMs.--
``(1) Temporary orders.--
``(A) In general.--The Attorney General may issue a
temporary order adding a drug or other substance to the
definition of the term `SARM' under section 102(57) if
the Attorney General finds that--
``(i) the drug or other substance satisfies
the criteria for being considered a SARM but is
not listed in that section or by regulation of
the Attorney General as being a SARM; and
``(ii) adding the drug or other substance
to the definition of the term SARM will assist
in preventing abuse or misuse of the drug or
other substance.
``(B) Effective date; duration.--A temporary order
issued under subparagraph (A)--
``(i) shall take effect not earlier than 30
days after the date of publication by the
Attorney General of a notice in the Federal
Register of--
``(I) the intention of the Attorney
General to issue the temporary order;
and
``(II) the grounds on which the
temporary order is to be issued; and
``(ii) shall expire not later than 2 years
after the date on which the temporary order
becomes effective, except that the Attorney
General may, during the pendency of proceedings
under paragraph (2), extend the temporary order
for not more than 6 months.
``(C) Notice to secretary of health and human
services.--
``(i) In general.--The Attorney General
shall transmit notice of a temporary order
proposed to be issued under subparagraph (A) to
the Secretary of Health and Human Services.
``(ii) Consideration.--In issuing a
temporary order under subparagraph (A), the
Attorney General shall take into consideration
any comments submitted by the Secretary of
Health and Human Services in response to a
notice transmitted under this subparagraph.
``(D) Effect of permanent scheduling.--A temporary
order issued under subparagraph (A) shall be vacated
upon the issuance of a permanent order issued under
paragraph (2).
``(E) Judicial review.--A temporary order issued
under subparagraph (A) shall not be subject to judicial
review.
``(2) Permanent orders.--
``(A) In general.--The Attorney General may by rule
issue a permanent order adding a drug or other
substance to the definition of the term `SARM' under
section 102(57) if the drug or other substance
satisfies the criteria for being considered a SARM
under that section.
``(B) Timing.--The Attorney General may commence a
rulemaking under subparagraph (A) simultaneously with
the issuance of a temporary order under paragraph
(1).''.
(d) Labeling Requirements.--
(1) In general.--Section 305 of the Controlled Substances
Act (21 U.S.C. 825) is amended by adding at the end the
following:
``(f) False Labeling of SARMs.--
``(1) Prohibition.--It shall be unlawful to import, export,
manufacture, distribute, dispense, or possess with intent to
manufacture, distribute, or dispense, a SARM or product
containing a SARM, unless the SARM or product containing the
SARM bears a label clearly identifying the SARM or product
containing the SARM by the nomenclature used by the
International Union of Pure and Applied Chemistry.
``(2) Exemption.--
``(A) In general.--A SARM or product containing a
SARM described in subparagraph (B) shall be exempt from
the International Union of Pure and Applied Chemistry
nomenclature requirement under paragraph (1) if the
SARM or product containing a SARM is labeled in the
manner required under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
``(B) Exempt products.--A SARM or product
containing a SARM is described in this subparagraph if
the SARM or product containing a SARM--
``(i) is the subject of an approved
application as described in subsection (b) or
(j) of section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355); or
``(ii) is exempt from the provisions of
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) relating to new
drugs because--
``(I) the SARM or product
containing a SARM is intended solely
for investigational use as described in
subsection (i) of that section; and
``(II) the SARM or product
containing a SARM is being used
exclusively for purposes of a clinical
trial that is the subject of an
effective investigational new drug
application.''.
(2) Clarification regarding felony drug offenses.--Section
102(44) of the Controlled Substances Act (21 U.S.C. 802(44)) is
amended by inserting ``SARMs,'' after ``anabolic steroids,''.
(3) Civil penalties.--Section 402 of the Controlled
Substances Act (21 U.S.C. 842) is amended--
(A) in subsection (a)(16)--
(i) by inserting ``or (f)'' after
``subsection (e)''; and
(ii) by striking ``825'' and inserting
``305''; and
(B) in subsection (c)(1)(D), by inserting ``or a
SARM'' after ``an anabolic steroid''.
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
Section 413(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350b(c)) is amended--
(1) in paragraph (1), by striking ``an anabolic steroid or
an analogue of an anabolic steroid'' and inserting ``an
anabolic steroid, a SARM, an analogue of an anabolic steroid,
or an analogue of a SARM''; and
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking the period at
the end and inserting a semicolon; and
(C) by adding at the end the following:
``(C) the term `analogue of a SARM' means a
substance that has a chemical structure that is
substantially similar to the chemical structure of a
SARM; and
``(D) the term `SARM' has the meaning given the
term in section 102(57) of the Controlled Substances
Act (21 U.S.C. 802(57)).''.
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