‘‘(lxxiv) 
[3,2-c]pyrazole-5α-androstan-17β-ol; 
and’’; and 
(2) by adding at the end the following: 
‘‘(C)(i) Subject to clause (ii), a drug or hormonal sub-
stance (other than estrogens, progestins, corticosteroids, 
and dehydroepiandrosterone) that is not listed in subpara-
graph (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 in-
tended 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 sub-
stances 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 amend-
ed by adding at the end the following: 
‘‘(i) TEMPORARY AND PERMANENT SCHEDULING OF 
RECENTLY EMERGED ANABOLIC STEROIDS.— 
‘‘(1) The Attorney General may issue a tem-
porary 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 tem-
porary 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 Attor-
ney General shall take into consideration any com-
ments 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 con-
sidered 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 man-
ner required under the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(B) A product is described in this subpara-
graph if the product— 
‘‘(i) is the subject of an approved applica-
tion as described in section 505(b) or (j) of the 
Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) is exempt from the provisions of sec-
tion 505 of such Act relating to new drugs be-
cause— 
‘‘(I) it is intended solely for investiga-
tional use as described in section 505(i) of 
such Act; and 
‘‘(II) such product is being used ex-
clusively for purposes of a clinical trial 
that is the subject of an effective investiga-
tional new drug application.’’. 
(b) CLARIFICATION TO IMPORT AND EXPORT STAT-
UTE.—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 pe-
riod 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 pur-
poses of this subparagraph, a violation is defined as each 
instance of importation, exportation, manufacturing, dis-
tribution, or possession with intent to manufacture or dis-
tribute, in violation of paragraph (16) of subsection (a). 
‘‘(D) In the case of a distribution, dispensing, or pos-
session 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 prod-
ucts 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, dis-
pensed, 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
113TH CONGRESS 
2D SESSION 
H. R. 4771 
AN ACT 
To amend the Controlled Substances Act to more 
effectively regulate anabolic steroids.