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 in-
vestigational 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 Sub-
stances 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; 
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(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 sec-
tion 305 of the Controlled Substances 
Act.’’; and 
(2) in subsection (c)(1)— 
(A) by inserting, in subparagraph 
(A), after ‘‘subparagraph (B)’’ the fol-
lowing: ‘‘, (C), or (D)’’; and 
(B) by inserting after subpara-
graph (B) the following: 
‘‘(C) In the case of a violation of para-
graph (16) of subsection (a) of this section by 
an importer, exporter, manufacturer, or dis-
tributor (other than as provided in subpara-
graph (D)), up to $500,000 per violation. For 
purposes of this subparagraph, a violation is 
defined as each instance of importation, ex-
portation, manufacturing, distribution, or 
possession with intent to manufacture or dis-
tribute, in violation of paragraph (16) of sub-
section (a). 
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‘‘(D) In the case of a distribution, dis-
pensing, or possession with intent to dis-
tribute or dispense in violation of paragraph 
(16) of subsection (a) of this section at the re-
tail level, up to $1000 per violation. For pur-
poses 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 dis-
tributed, 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 dis-
cretion, collect data and analyze products to 
determine whether they contain anabolic 
steroids and are properly labeled in accord-
ance with this section. The Attorney General 
may publish in the Federal Register or on the 
website of the Drug Enforcement Administra-
tion a list of products that he has determined, 
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based on substantial evidence, contain an an-
abolic steroid and are not labeled in accord-
ance with this section. 
(b) The absence of a product from the list 
referred to in subsection (a) shall not con-
stitute evidence that the product does not 
contain an anabolic steroid. 
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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 
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