[Congressional Bills 113th Congress]
[From the U.S. Government Printing Office]
[H.R. 4771 Enrolled Bill (ENR)]
H.R.4771
One Hundred Thirteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Friday,
the third day of January, two thousand and fourteen
An Act
To amend the Controlled Substances Act to more effectively regulate
anabolic steroids.
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 ``Designer Anabolic Steroid Control
Act of 2014''.
SEC. 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) 5a-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-17a-methyl-androsta-1,4-diene-3,17b-diol;
``(liv) 4-chloro-17a-methyl-androst-4-ene-3b,17b-diol;
``(lv) 4-chloro-17a-methyl-17b-hydroxy-androst-4-en-3-one;
``(lvi) 4-chloro-17a-methyl-17b-hydroxy-androst-4-ene-3,11-
dione;
``(lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-diol;
``(lviii) 2a,17a-dimethyl-17b-hydroxy-5a-androstan-3-one;
``(lix) 2a,17a-dimethyl-17b-hydroxy-5b-androstan-3-one;
``(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17b-ol;
``(lxi) [3,2-c]-furazan-5a-androstan-17b-ol;
``(lxii) 3b-hydroxy-estra-4,9,11-trien-17-one;
``(lxiii) 17a-methyl-androst-2-ene-3,17b-diol;
``(lxiv) 17a-methyl-androsta-1,4-diene-3,17b-diol;
``(lxv) Estra-4,9,11-triene-3,17-dione;
``(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
``(lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
``(lxviii) 17a-Methyl-androstan-3-hydroxyimine-17b-ol;
``(lxix) 17a-Methyl-5a-androstan-17b-ol;
``(lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
``(lxxi) 17b-Hydroxy-androstano[3,2-c]isoxazole;
``(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5a-
androstan-17b-ol;
``(lxxiii) [3,2-c]pyrazole-androst-4-en-17b-ol;
``(lxxiv) [3,2-c]pyrazole-5a-androstan-17b-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).''.
SEC. 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 825 of this
title.''; 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 such paragraph (16) of subsection (a) shall be considered
a separate violation.''.
SEC. 4. IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS CONTAINING
ANABOLIC STEROIDS.
(a) In General.--The Attorney General may, in the Attorney
General's discretion, collect data and analyze products to determine
whether they contain anabolic steroids and are properly labeled in
accordance with this Act and the amendments made by this Act. The
Attorney General may publish in the Federal Register or on the website
of the Drug Enforcement Administration a list of products which the
Attorney General has determined, based on substantial evidence, contain
an anabolic steroid and are not labeled in accordance with this Act and
the amendments made by this Act.
(b) Absence From List.--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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.
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