89–761 

113TH CONGRESS REPT. 113–587 " ! HOUSE OF REPRESENTATIVES 2d Session Part 2 

DESIGNER ANABOLIC STEROID CONTROL ACT OF 2014 

SEPTEMBER 15, 2014.—Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 

Mr. GOODLATTE, from the Committee on the Judiciary, 

submitted the following 

R E P O R T 

[To accompany H.R. 4771] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on the Judiciary, to whom was referred the bill 

(H.R. 4771) to amend the Controlled Substances Act to more effectively regulate anabolic steroids, having considered the same, reports favorably thereon with an amendment and recommends that 

the bill as amended do pass. 

CONTENTS 

Page 

The Amendment ...................................................................................................... 1 

Purpose and Summary ............................................................................................ 4 

Background and Need for the Legislation ............................................................. 4 

Hearings ................................................................................................................... 5 

Committee Consideration ........................................................................................ 5 

Committee Votes ...................................................................................................... 6 

Committee Oversight Findings ............................................................................... 6 

New Budget Authority and Tax Expenditures ...................................................... 6 

Congressional Budget Office Cost Estimate .......................................................... 6 

Duplication of Federal Programs ............................................................................ 8 

Disclosure of Directed Rule Makings ..................................................................... 8 

Performance Goals and Objectives ......................................................................... 8 

Advisory on Earmarks ............................................................................................. 8 

Section-by-Section Analysis .................................................................................... 8 

Changes in Existing Law Made by the Bill, as Reported ..................................... 10 

The Amendment 

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 


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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-3,17+-diol; 

‘‘(liv) 4-chloro-17a-methyl-androst-4-ene-3+,17+-diol; 

‘‘(lv) 4-chloro-17a-methyl-17+-hydroxy-androst-4-en-3-one; 

‘‘(lvi) 4-chloro-17a-methyl-17+-hydroxy-androst-4-ene-3,11-dione; 

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

‘‘(lviii) 2a,17a-dimethyl-17+-hydroxy-5a-androstan-3-one; 

‘‘(lix) 2a,17a-dimethyl-17+-hydroxy-5+-androstan-3-one; 

‘‘(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17+-ol; 

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

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

‘‘(lxiii) 17a-methyl-androst-2-ene-3,17+-diol; 

‘‘(lxiv) 17a-methyl-androsta-1,4-diene-3,17+-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-17+-ol; 

‘‘(lxix) 17a-Methyl-5a-androstan-17+-ol; 

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

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

‘‘(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5a-androstan-17+-ol; 

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

‘‘(lxxiv) [3,2-c]pyrazole-5a-androstan-17+-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.— 


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‘‘(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 


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(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. 

Purpose and Summary 

H.R. 4771 is intended to more effectively regulate anabolic 

steroids. It does this by adding 25 new ‘‘designer’’ chemicals, all of 

which have been marketed as anabolic steroids, to the list of substances that meet the Controlled Substances Act (‘‘CSA’’) definition 

of anabolic steroid. 

H.R. 4771 amends the CSA’s scheduling authority to allow the 

Attorney General to issue a temporary order adding a drug or other 

substance to the list of anabolic steroids if he determines: (1) that 

the drug or other substance is an anabolic steroid, and (2) adding 

the drug or other substance to the list of anabolic steroids will assist in preventing the unlawful importation, manufacture, distribution or dispensing of the drug or other substance. 

H.R. 4771 also establishes a new subsection (e) in section 305 of 

the CSA (21 U.S.C. § 825) criminalizing the false labeling of anabolic steroids or substances containing anabolic steroids, and establishes new civil penalties for violations. 

Finally, the legislation gives the Attorney General the authority 

to publish, in the Federal Register, a list of products that contain 

anabolic steroids and are improperly labeled. 

Background and Need for the Legislation 

Anabolic steroids are synthetically-produced variants of the naturally occurring male hormone testosterone (‘‘anabolic’’ means that 

the substance affects the body in a similar fashion as testosterone). 

They are currently listed as controlled substances under Schedule 

III of the CSA (21 U.S.C. § 802(41)). Only a small number of anabolic steroids are approved for either human or veterinary use. 

They may be prescribed by a physician for the treatment of a variety of therapeutic uses, including testosterone deficiency, delayed 

puberty, low red blood cell count, breast cancer, and tissue wasting 

resulting from AIDS. However, anabolic steroids are also used illicitly as performance-enhancing drugs. Long-term or high-dosage use 


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of these substances can have severe adverse health effects, including dramatic mood swings, increased feelings of hostility, increased 

levels of aggression, and stunted level of growth in children, as well 

as heart and liver damage. 

Unlike most other controlled substances, anabolic steroids are 

often disguised as legal products such as dietary supplements. This 

poses a substantial risk to consumers. Although anabolic steroids 

are listed as controlled substances in Schedule III of the CSA, 

chemists are able to create ‘‘designer’’ anabolic steroids that are 

chemically distinct from the listed steroids but have the same pharmacological effect. The Drug Enforcement Administration (DEA), 

which enforces the CSA on behalf of the Attorney General, cannot 

take enforcement action against those who manufacture, market, 

or distribute unscheduled anabolic steroids. This poses a significant 

risk to consumers, especially if the ‘‘designer’’ anabolic steroids are 

being falsely marketed as dietary supplements. 

During full Committee consideration of H.R. 4771, the Judiciary 

Committee adopted by voice vote an amendment in the nature of 

a substitute. The amendment preserves several provisions in the 

bill as reported by the Committee on Energy and Commerce, including the addition of 25 new chemicals to the definition of anabolic steroids in the CSA; the amendment to DEA’s temporary and 

permanent scheduling authority; and the provision giving the Attorney General the authority to publish a list of improperly labeled 

substances. 

The substitute amendment substantially revises the criminal and 

civil penalties contained in the bill as reported by the Committee 

on Energy and Commerce, which created a new section of the CSA 

criminalizing the false labeling of anabolic steroids and assigning 

criminal and civil penalties. The Committee on the Judiciary concluded that creation of a new section of the CSA to prohibit the 

false labeling of anabolic steroids is redundant and unnecessary. 

Rather, the substitute amendment achieves this prohibition by 

amending existing section 305 of the CSA (21 U.S.C. § 825) (relating to labeling and packaging). In doing so, the amendment builds 

upon the existing statutory framework for imposing civil penalties 

for this type of conduct. See 21 U.S.C. § 842. The CSA currently 

prohibits the unlawful importation, exportation, manufacture, distribution, or dispensation of a schedule III controlled substance. 

See 21 U.S.C. § 841(b)(1)(E)). Therefore, the Committee concluded 

that it was unnecessary to create a new criminal offense for the 

false labeling of anabolic steroids where the elements of such offense are largely consistent with existing law. 

Hearings 

The Committee on the Judiciary held no hearings on H.R. 4771. 

Committee Consideration 

On September 10, 2014, the Committee met in open session and 

ordered the bill H.R. 4771 reported, with an amendment, by voice 

vote, a quorum being present. 


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Committee Votes 

In compliance with clause 3(b) of rule XIII of the Rules of the 

House of Representatives, the Committee advises that there were 

no recorded votes during the Committee’s consideration of H.R. 

4771. 

Committee Oversight Findings 

In compliance with clause 3(c)(1) of rule XIII of the Rules of the 

House of Representatives, the Committee advises that the findings 

and recommendations of the Committee, based on oversight activities under clause 2(b)(1) of rule X of the Rules of the House of Representatives, are incorporated in the descriptive portions of this report. 

New Budget Authority and Tax Expenditures 

Clause 3(c)(2) of rule XIII of the Rules of the House of Representatives is inapplicable because this legislation does not provide new 

budgetary authority or increased tax expenditures. 

Congressional Budget Office Cost Estimate 

In compliance with clause 3(c)(3) of rule XIII of the Rules of the 

House of Representatives, the Committee sets forth, with respect to 

the bill, H.R.4771, the following estimate and comparison prepared 

by the Director of the Congressional Budget Office under section 

402 of the Congressional Budget Act of 1974: 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, September 15, 2014. 

Hon. BOB GOODLATTE, CHAIRMAN, Committee on the Judiciary, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 4771, the ‘‘Designer Anabolic Steroid Control Act of 2014.’’ 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Mark Grabowicz, who 

can be reached at 226–2860. 

Sincerely, 

DOUGLAS W. ELMENDORF, 

DIRECTOR. 

Enclosure 

cc: Honorable John Conyers, Jr. 

Ranking Member 

H.R. 4771—Designer Anabolic Steroid Control Act of 2014. 

As ordered reported by the House Committee on the Judiciary 

on September 15, 2014. 

CBO estimates that implementing H.R. 4771 would have no significant costs to the Federal Government. Enacting the bill could 


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affect direct spending and revenues; therefore, pay-as-you-go procedures apply. However, CBO estimates that any effects would be insignificant for each year. 

H.R. 4771 would expand the list of anabolic steroids regulated by 

the Drug Enforcement Administration (DEA) to include about twodozen new substances and would establish new crimes relating to 

false labeling of steroids. As a result, the government might be able 

to pursue cases involving drug use that it otherwise would not be 

able to prosecute. CBO expects that H.R. 4771 would apply to a relatively small number of additional offenders, however, so any increase in costs for law enforcement, court proceedings, or prison operations would not be significant. Any such costs would be subject 

to the availability of appropriated funds. 

Because those prosecuted and convicted under H.R. 4771 could 

be subject to civil and criminal fines, the Federal Government 

might collect additional fines if the legislation is enacted. Civil 

fines are recorded as revenues. Criminal fines are recorded as revenues, deposited in the Crime Victims Fund, and later spent. CBO 

expects that any additional revenues and direct spending would not 

be significant because of the small number of additional cases likely to be affected. 

H.R. 4771 contains no intergovernmental mandates as defined in 

the Unfunded Mandates Reform Act (UMRA) and would impose no 

costs on state, local, or tribal governments. 

The bill would impose private-sector mandates by adding 25 new 

compounds, and any compounds found to be structurally similar, to 

the list of anabolic steroids regulated under the Controlled Substances Act. Consumers would need a prescription from a licensed 

practitioner to purchase products containing the newly listed compounds. Sellers, manufacturers, and importers of such products 

would be required to obtain an authorization from state and Federal authorities in order to make or possess the compounds. 

However, based on information from the Food and Drug Administration (FDA), DEA, and industry professionals, CBO expects that 

the majority of the affected entities would either replace the regulated compounds with new ones or discontinue the distribution of 

the affected products. Therefore, the cost of the mandate would be 

the forgone income from lost sales. 

Because of the nature of the market being regulated, the scope 

of sales affected is difficult to determine. As products are found to 

contain compounds that are structurally similar to the compounds 

listed, industry sales could decline significantly. Some industry experts estimate that the revenues generated by the sale of products 

containing such compounds amount to between $2 billion and $5 

billion annually. (Those figures include sales of some products that 

already are not in compliance or not being sold in compliance with 

FDA or DEA regulations.) Although identifying which items would 

be affected by the legislation would be difficult, given the estimated 

magnitude of industry profits, even a 10 percent decrease in income 

as a result of the bill would exceed the annual threshold for private-sector mandates ($152 million in 2014, adjusted annually for 

inflation). 

The bill also would impose a private-sector mandate on importers, exporters, manufacturers, and distributors by requiring that 

any anabolic steroid or product containing an anabolic steroid be 


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labeled as such, using the nomenclature of the International Union 

of Pure and Applied Chemistry. The cost of the mandate would 

probably be small. 

On July 25, 2014, CBO transmitted a cost estimate for H.R. 4771 

as ordered reported by the House Committee on Energy and Commerce on July 15, 2014. The estimate of Federal costs is the same 

for the two versions of the bill. 

The CBO staff contacts for this estimate are Mark Grabowicz (for 

Federal costs) and Marin Burnett (for the private-sector impact). 

The estimate was approved by Theresa Gullo, Deputy Assistant Director for Budget Analysis. 

Duplication of Federal Programs 

No provision of H.R. 4771 establishes or reauthorizes a program 

of the Federal Government known to be duplicative of another Federal program, a program that was included in any report from the 

Government Accountability Office to Congress pursuant to section 

21 of Public Law No. 111–139, or a program related to a program 

identified in the most recent Catalog of Federal Domestic Assistance. 

Disclosure of Directed Rule Makings 

The Committee estimates that H.R. 4771 specifically directs to be 

completed no specific rule makings within the meaning of 5 U.S.C. 

§ 551. 

Performance Goals and Objectives 

The Committee states that pursuant to clause 3(c)(4) of rule XIII 

of the Rules of the House of Representatives, H.R. 4771 is intended 

to more effectively regulate anabolic steroids. 

Advisory on Earmarks 

In accordance with clause 9 of rule XXI of the Rules of the House 

of Representatives, H.R. 4771 does not contain any congressional 

earmarks, limited tax benefits, or limited tariff benefits as defined 

in clause 9(e), 9(f), or 9(g) of Rule XXI. 

Section-by-Section Analysis 

The following discussion describes the bill as reported by the 

Committee. 

Sec. 1. Short Title. This section cites the short title of the bill as 

the ‘‘Designer Anabolic Steroid Control Act of 2014.’’ 

Sec. 2. Amendments to the Controlled Substances Act. This section adds 25 new substances to the list of what constitutes an anabolic steroid under section 402 of the CSA (21 U.S.C. § 802). This 

section also amends the definition of anabolic steroid to include 

substances that promote muscle growth, otherwise cause a pharmacological effect similar to testosterone, or are marketed in a manner suggesting that the substances do either of those things. The 

definition excludes from the definition of anabolic steroid herbs or 

other botanicals, concentrates, metabolites, or extracts of, or constituents isolated directly from, an herb or other botanical, or any 

combination of the two; dietary ingredients for purposes of the FedVerDate Sep 11 2014 02:00 Sep 16, 2014 Jkt 089761 PO 00000 Frm 00008 Fmt 6659 Sfmt 6601 E:\HR\OC\HR587P2.XXX HR587P2

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eral Food, Drug, or Cosmetic Act; or substances that are not anabolic or androgenic. 

Section 2 also authorizes the Attorney General to issue a temporary order adding a drug or other substance to the definition of 

anabolic steroids if the Attorney General finds (1) that the drug or 

other substance satisfies the criteria for being considered an anabolic steroid but is not listed in the CSA or the relevant regulations 

as being an anabolic steroid; and (2) adding the drug or other substance to the definition of anabolic steroids will assist in preventing 

abuse or misuse of the drug or other substance. This section imposes a timeline upon the Attorney General for issuing such an 

order, and allows the Attorney General to extend the order once for 

up to six (6) months. This section also requires the Attorney General to transmit notice of a proposed order to the Secretary of 

Health and Human Services; provides that a temporary scheduling 

order shall be vacated upon the issuance of a permanent scheduling order; provides that a temporary scheduling order is not subject to judicial review; and provides that the Attorney General may 

initiate a rulemaking to control a drug or other substance simultaneously with the temporary scheduling order. 

Sec. 3. Labeling Requirements. This section adds a new subsection (e) to section 305 of the CSA (21 U.S.C. § 825) prohibiting 

the importation, exportation, manufacture, distribution, or dispensation—or possession with intent to manufacture, distribute, or 

dispense—an anabolic steroid unless the anabolic steroid is clearly 

labeled using the nomenclature of the International Union of Pure 

and Applied Chemistry (IUPAC). IUPAC has long been recognized 

as the world authority on chemical nomenclature. This section exempts drugs or other substances from the IUPAC nomenclature requirement if the product(s) are labeled in the manner required 

under the Federal Food, Drug, and Cosmetic Act. Violations of the 

new subsection (e) are subject to civil penalties contained in section 

402 of the CSA (21 U.S.C. § 842) as described below. 

This section adds a new paragraph (16) to section 402(a) of the 

CSA (21 U.S.C. § 842(a)), which provides that violations of section 

825(e) are subject to civil penalties under the CSA. Section 3 creates new civil penalties in subsection (c) of section 402 for violations of paragraph (16). False labeling violations by importers, exporters, manufacturers, or distributors, but not retailers, are punishable by a fine of up to $500,000 per violation. ‘‘Violation’’ is defined as ‘‘each instance’’ of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or 

distribute, in violation of paragraph (16). In the case, for example, 

of a shipping container that is wrapped and transported as one cohesive item but holds within it thousands of boxes containing tens 

of thousands of individual bottles or packages, this section would 

treat that shipping container as one ‘‘instance’’ (and hence one violation) punishable by a civil fine of up to $500,000. 

With regard to distribution, dispensing, or possession with intent 

to distribute or dispense at the retail level, Section 3 imposes a 

civil penalty of up to $1,000 per violation. ‘‘At the retail level’’ is 

defined as products sold, or held for sale, directly to the consumer 

for personal use. This would include not only products held for sale 

on the shelves of a retail establishment, but also the products held 

in stock. Each package, container or other separate unit containing 


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an anabolic steroid that is distributed, dispensed, or possessed with 

intent to distribute or dispense at the retail level is considered to 

be a separate violation. 

Section 3 also amends the Controlled Substances Import and Export Act (21 U.S.C. § 960 et seq.) to clarify that violations of subsection (e) involving the importation or exportation of falsely-labeled anabolic steroids may be punished in accordance with the 

provisions of the Import and Export Act. 

Sec. 4. Identification and Publication of List of Products Containing Anabolic Steroids. This section gives the Attorney General 

the authority to collect data and analyze products to determine 

whether they contain anabolic steroids and are properly labeled in 

accordance with this section, and to publish in the Federal Register, or on the DEA website, a list of products that he has determined contain an anabolic steroid and are not appropriately labeled. 

Changes in Existing Law Made by the Bill, as Reported 

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italics, 

existing law in which no change is proposed is shown in roman): 

CONTROLLED SUBSTANCES ACT 

* * * * * * * 

TITLE II—CONTROL AND ENFORCEMENT 

* * * * * * * 

PART A—SHORT TITLE; FINDINGS AND DECLARATION; DEFINITIONS

* * * * * * * 

DEFINITIONS

SEC. 102. As used in this title: 

(1) * * * 

* * * * * * * 

(41)(A) The term ‘‘anabolic steroid’’ means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and 

dehydroepiandrosterone), and includes— 

(i) * * * 

* * * * * * * 

(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one); 

øand¿ 

(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; 


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(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; 

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

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

(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 

ø(xlx)¿ (lxxv) any salt, ester, or ether of a drug or substance described in this paragraph. 

* * * * * * * 

(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 


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burden of going forward with the evidence with respect to such exemption or exception. 

* * * * * * * 

PART B—AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES

AUTHORITY AND CRITERIA FOR CLASSIFICATION OF SUBSTANCES

SEC. 201. (a) * * * 

* * * * * * * 

(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). 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND

DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * * 


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LABELING AND PACKAGING REQUIREMENTS

SEC. 305. (a) * * * 

* * * * * * * 

(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. 

* * * * * * * 

PART D—OFFENSES AND PENALTIES

* * * * * * * 

PROHIBITED ACTS B—PENALTIES

SEC. 402. (a) It shall be unlawful for any person— 

(1) * * * 

* * * * * * * 

(14) who is a regulated seller or an employee or agent of 

such seller to disclose, in violation of regulations under subparagraph (C) of section 310(e)(1), information in logbooks 

under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement 

authorities; øor¿ 

(15) to distribute a scheduled listed chemical product to a 

regulated seller, or to a regulated person referred to in section 

310(b)(3)(B), unless such regulated seller or regulated person 

is, at the time of such distribution, currently registered with 

the Drug Enforcement Administration, or on the list of persons 

referred to under section 310(e)(1)(B)(v)ø.¿; or 

(16) to violate subsection (e) of section 305 of the Controlled 

Substances Act. 


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As used in paragraph (11), the term ‘‘laboratory supply’’ means a 

listed chemical or any chemical, substance, or item on a special 

surveillance list published by the Attorney General, which contains 

chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. For purposes of 

paragraph (11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing 

that a laboratory supply sold by the firm, or any other person or 

firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 

weeks or more after the notification the notified firm distributes a 

laboratory supply to the customer. For purposes of paragraph (15), 

if the distributor is temporarily unable to access the list of persons 

referred to under section 310(e)(1)(B)(v), the distributor may rely 

on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the 

list referred to under section 310(e)(1)(B)(v). 

* * * * * * * 

(c)(1)(A) Except as provided in subparagraph (B), (C), or (D) of 

this paragraph and paragraph (2), any person who violates this section shall, with respect to any such violation, be subject to a civil 

penalty of not more than $25,000. The district courts of the United 

States (or, where there is no such court in the case of any territory 

or possession of the United States, then the court in such territory 

or possession having the jurisdiction of a district court of the 

United States in cases arising under the Constitution and laws of 

the United States) shall have jurisdiction in accordance with section 1355 of title 28 of the United States Code to enforce this paragraph. 

* * * * * * * 

(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. 

* * * * * * * 


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CONTROLLED SUBSTANCES IMPORT AND EXPORT ACT 

* * * * * * * 

TITLE III—IMPORTATION AND EXPORTATION; 

AMENDMENTS AND REPEALS OF REVENUE LAWS 

* * * * * * * 

PART A—IMPORTATION AND EXPORTATION

* * * * * * * 

PROHIBITED ACTS A—PENALTIES

SEC. 1010. (a) Any person who— 

(1) contrary to section 305, 1002, 1003, or 1007, knowingly 

or intentionally imports or exports a controlled substance, 

* * * * * * * 

shall be punished as provided in subsection (b). 

* * * * * * * 

Æ 


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