From: https://beta.congress.gov/bill/113th-congress/house-bill/4771/text
IN THE HOUSE OF REPRESENTATIVES
May 29, 2014
Mr. Pitts (for himself and Mr. Pallone) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
September 15, 2014
Additional sponsors: Mr. Chaffetz, Mr. Ben Ray Lujan of New Mexico, Ms.
Shea-Porter, Mr. Amodei, and Ms. Duckworth
September 15, 2014
Reported from the Committee on Energy and Commerce with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
September 15, 2014
Reported from the Committee on the Judiciary with an amendment;
committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in boldface roman]
[For text of introduced bill, see copy of bill as introduced on May 29,
2014]
_______________________________________________________________________
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 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).''.
(c) Labeling Requirements.--
(1) In general.--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, that does not bear 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) 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) 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.''.
(2) Table of contents.--The table of contents for the
Comprehensive Drug Abuse Prevention and Control Act of 1970 is
amended by inserting after the item relating to section 305 the
following:
``Sec. 305A. Offenses involving false labeling of anabolic steroids.''.
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 305 of the
Controlled Substances Act.''; 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 paragraph (16) of subsection (a) shall be considered a
separate violation.''.
SEC. 4. IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS CONTAINING
ANABOLIC STEROIDS.
(a) 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.
(b) 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.
Union Calendar No. 434
113th CONGRESS
2d Session
H. R. 4771
[Report No. 113-587, Parts I and II]
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to more effectively regulate
anabolic steroids.
_______________________________________________________________________
September 15, 2014
Reported from the Committee on Energy and Commerce with an amendment
September 15, 2014
Reported from the Committee on the Judiciary with an amendment;
committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
