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) 5α-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-17α-methyl-androsta-1,4-diene-3,17β-diol; 

‘‘(liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol; 

‘‘(lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one; 

‘‘(lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11- 

dione; 

‘‘(lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol; 

‘‘(lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one; 

‘‘(lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one; 

‘‘(lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol; 

‘‘(lxi) [3,2-c]-furazan-5α-androstan-17β-ol; 

‘‘(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; 

‘‘(lxiii) 17α-methyl-androst-2-ene-3,17β-diol; 

‘‘(lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol; 

‘‘(lxv) Estra-4,9,11-triene-3,17-dione; 

‘‘(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one; 

‘‘(lxvii) 6α-Methyl-androst-4-ene-3,17-dione; 

‘‘(lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol; 

‘‘(lxix) 17α-Methyl-5α-androstan-17β-ol; 

‘‘(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; 

‘‘(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole; 

‘‘(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole5α-androstan-17β-ol; 

‘‘(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; 

‘‘(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and’’; and 

(2) by adding at the end the following: 
H. R. 4771—2 

‘‘(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. 
H. R. 4771—3 

‘‘(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 
H. R. 4771—4 

(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. 
H. R. 4771—5 

(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.