[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3431 Introduced in Senate (IS)]
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.
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 2012''.
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
(lxxvii); and
(C) by inserting after clause (xlix) the following:
``(l) 5a-Androstan-3,6,17-trione;
``(li) Androst-4-ene-3,6,17-trione;
``(lii) Androsta-1,4,6-triene-3,17-dione;
``(liii) 6-bromo-androstan-3,17-dione;
``(liv) 6-bromo-androsta-1,4-diene-3,17-
dione;
``(lv) 4-chloro-17a-methyl-androsta-1,4-
diene-3,17b-diol;
``(lvi) 4-chloro-17a-methyl-androst-4-ene-
3b,17b-diol;
``(lvii) 4-chloro-17a-methyl-17b-hydroxy-
androst-4-en-3-one;
``(lviii) 4-chloro-17a-methyl-17b-hydroxy-
androst-4-ene-3,11-dione;
``(lix) 4-chloro-17a-methyl-androsta-1,4-
diene-3,17b-diol;
``(lx) 2a,17a-dimethyl-17b-hydroxy-5a-
androstan-3-one;
``(lxi) 2a,17a-dimethyl-17b-hydroxy-5b-
androstan-3-one;
``(lxii) 2a,3a-epithio-17a-methyl-5a-
androstan-17b-ol;
``(lxiii) [3,2-c]-furazan-5a-androstan-17b-
ol;
``(lxiv) 3b-hydroxy-estra-4,9,11-trien-17-
one;
``(lxv) 17a-methyl-androst-2-ene-3,17b-
diol;
``(lxvi) 17a-methyl-androsta-1,4-diene-
3,17b-diol;
``(lxvii) Estra-4,9,11-triene-3,17-dione;
``(lxviii) 18a-Homo-3-hydroxy-estra-
2,5(10)-dien-17-one;
``(lxix) 6a-Methyl-androst-4-ene-3,17-
dione;
``(lxx) 17a-Methyl-androstan-3-
hydroxyimine-17b-ol;
``(lxxi) 17a-Methyl-5a-androstan-17b-ol;
``(lxxii) 17b-Hydroxy-androstano[2,3-
d]isoxazole;
``(lxxiii) 17b-Hydroxy-androstano[3,2-
c]isoxazole;
``(lxxiv) 4-Hydroxy-androst-4-ene-3,17-
dione[3,2-c]pyrazole-5a-androstan-17b-ol;
``(lxxv) [3,2-c]pyrazole-androst-4-en-17b-
ol;
``(lxxvi) [3,2-c]pyrazole-5a-androstan-17b-
ol; and''; and
(2) by adding at the end the following:
``(C)(i) Subject to clause (ii) and the limitations
under section 201(i)(6), 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); and
``(II) is a dietary ingredient for purposes
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
``(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 list 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
list of anabolic steroids will assist in preventing the
unlawful importation, manufacture, distribution, or
dispensing of such 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 (5), extend the temporary scheduling order for up to
6 months.
``(3) A temporary scheduling order issued under paragraph
(1) shall be vacated upon the issuance of a permanent
scheduling order under paragraph (5).
``(4) An order issued under paragraph (1) is not subject to
judicial review.
``(5) The Attorney General may, by rule, issue a permanent
order adding a drug or other substance to the list 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).
``(6) If a drug or other substance has not been temporarily
or permanently added to the list of anabolic steroids pursuant
to this subsection, the drug or other substance shall be
considered an anabolic steroid if in any criminal, civil, or
administrative proceeding arising under this Act it has been
determined in such proceeding, based on evidence presented in
the proceeding, that the substance satisfies the criteria for
being considered an anabolic steroid under paragraph (41)(A),
(41)(C)(i), or (41)(C)(ii) of section 102.''.
(c) Labeling Requirements.--The Controlled Substances Act is
amended by inserting after section 305 (21 U.S.C. 825) the following:
``Sec. 305A. Offenses involving false labeling of anabolic steroids
``(a) Unlawful Acts.--
``(1) It shall be unlawful--
``(A) to import into the United States or to export
from the United States;
``(B) to manufacture, distribute, dispense, sell,
or offer to sell; or
``(C) to possess with intent to manufacture,
distribute, dispense, sell, or offer to sell;
any anabolic steroid, or any product containing an anabolic
steroid, unless it bears a label clearly identifying any
anabolic steroid contained in such steroid or product by the
nomenclature used by the International Union of Pure and
Applied Chemistry (IUPAC).
``(2) A product that is the subject of an approved
application as described in section 505(b), (i) or (j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (i), or
(j)) 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 by the Federal Food,
Drug, and Cosmetic Act.
``(b) Criminal Penalties.--Any person who violates subsection (a)
knowing, intending, or having reasonable cause to believe, that the
substance or product is an anabolic steroid, or contains an anabolic
steroid, shall be sentenced to a term of imprisonment of not more than
10 years, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, United States Code, or
$500,000 if the defendant is an individual or $2,500,000 if the
defendant is other than an individual, or both.
``(c) Civil Penalties.--
``(1) Any person who violates subsection (a) shall be
subject to a civil penalty as follows:
``(A) In the case of an importer, exporter,
manufacturer, or distributor (other than as provided in
subparagraph (B)), up to $500,000 per violation. For
purposes of this subparagraph, a violation is defined
as each instance of importation, exportation,
manufacturing, or distribution, and each anabolic
steroid or product imported, exported, manufactured, or
distributed.
``(B) In the case of a sale or offer to sell at
retail, up to $25,000 per violation. For purposes of
this subparagraph, each sale and each product offered
for sale shall be considered a separate violation.
Continued offers to sell by a person 10 or more days
after written notice (including through electronic
message) to the person by the Attorney General or the
Secretary shall be considered additional violations.
``(2) In this subsection, the term `product' means a
discrete article, either in bulk or in finished form prepared
for sale. A number of articles, if similarly packaged and
bearing identical labels, shall be considered as one product,
but each package size, form, or differently labeled article
shall be considered a separate product.
``(d) Identification and Publication of List of Products Containing
Anabolic Steroids.--
``(1) The Attorney General may, in his discretion, collect
data and analyze products to determine whether they contain
anabolic steroids and are properly labeled in accordance with
this section. The Attorney General may publish in the Federal
Register or on the website of the Drug Enforcement
Administration a list of products that he has determined, based
on substantial evidence, contain an anabolic steroid and are
not labeled in accordance with this section.
``(2) The absence of a product from the list referred to in
paragraph (1) shall not constitute evidence that the product
does not contain an anabolic steroid.''.
SEC. 3. SENTENCING COMMISSION GUIDELINES.
The United States Sentencing Commission shall--
(1) review and amend the Federal sentencing guidelines with
respect to offenses involving anabolic steroids, including the
offenses established in section 2 (section 305A of the
Controlled Substance Act);
(2) amend the Federal sentencing guidelines, including
notes to the drug quantity tables, to provide clearly that in a
case involving an anabolic steroid not in a tablet, capsule,
liquid, or other form where dosage can be readily ascertained
(such as a powder, topical cream, gel, or aerosol), the
sentence shall be determined based on the entire weight of the
mixture or substance;
(3) amend the applicable guidelines by designating
quantities of mixture or substance that correspond to a unit so
that offenses involving such forms of anabolic steroids are
penalized at least as severely as offenses involving forms
whose dosage can be readily ascertained; and
(4) take such other action as the Commission considers
necessary to carry out this Act and this section.
SEC. 4. CONGRESSIONAL OVERSIGHT.
The Administrator of the Drug Enforcement Administration shall
report to Congress every 2 years--
(1) what anabolic steroids have been scheduled on a
temporary basis under the provisions of this Act; and
(2) the findings and conclusions that led to such
scheduling.
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