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[House Report 113-587]
[From the U.S. Government Printing Office]


113th Congress                                            Rept. 113-587
                        HOUSE OF REPRESENTATIVES
 2d Session                                                      Part 1

======================================================================



 
             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. Upton, from the Committee on Energy and Commerce, 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 Energy and Commerce, 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, report favorably thereon with an amendment and 
recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     4
Hearings.........................................................     4
Committee Consideration..........................................     5
Committee Votes..................................................     5
Committee Oversight Findings.....................................     5
Statement of General Performance Goals and Objectives............     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     5
Committee Cost Estimate..........................................     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     7
Duplication of Federal Programs..................................     7
Disclosure of Directed Rule Makings..............................     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     8
Section-by-Section Analysis of the Legislation...................     8
Changes in Existing Law Made by the Bill, as Reported............     8

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.--
          ``(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.''.

                          Purpose and Summary

    The bill would amend the Controlled Substances Act (CSA) to 
expand the definition of ``anabolic steroids,'' authorize the 
Attorney General to issue a temporary order adding a drug or 
substance to the definition of anabolic steroids and to collect 
data and analyze products to determine whether they contain 
anabolic steroids and are properly labeled, and impose 
additional criminal and civil penalties for possessing or 
trafficking any anabolic steroid that does not bear a label 
clearly identified the anabolic steroid by the nomenclature 
used by the International Union of Pure and Applied Chemistry 
or is not labeled in a manner that is not labeled in the manner 
required under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

                  Background and Need for Legislation

    Misbranded products that contain designer anabolic steroids 
present serious health risks to consumers. Consumers oftentimes 
unknowingly purchase products labeled as dietary supplements 
that contain such ingredients. Anabolic steroids are synthetic 
forms of testosterone that can be extremely dangerous and are 
Class III controlled substances under the Controlled Substances 
Act. To skirt the law, however, certain entities alter the 
chemical structure of such substances and promote these 
designer products for their anabolic effects. H.R. 4771 
provides the Drug Enforcement Administration (DEA) with the 
tools and authority to protect consumers from these dangerous 
products.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on H.R. 4771.

                        Committee Consideration

    On June 19, 2014, the Subcommittee on Health met in open 
markup session and approved H.R. 4771 for full Committee 
consideration by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 4771 reported. A motion by Mr. Upton to order H.R. 4771 
reported to the House, with amendment, was agreed to by voice 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held hearings 
on this legislation.

         Statement of General Performance Goals and Objectives

    The objective of this legislation is to ensure that the DEA 
has adequate authority to protect consumers from designer 
anabolic steroids.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
4771 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 4771 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 25, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
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.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 4771--Designer Anabolic Steroid Control Act of 2014

    CBO estimates that implementing H.R. 4771 would have no 
significant costs to the federal government. Enacting the bill 
could 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 two dozen 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.
    H.R. 4771 would impose private-sector mandates, as defined 
in UMRA, on manufacturers, sellers, importers, exporters, 
distributors, and consumers of products that contain certain 
chemical compounds that would be defined as anabolic steroids. 
CBO estimates that the cost of complying with those mandates 
would probably exceed the annual threshold established in UMRA 
for private-sector mandates ($152 million in 2014, adjusted 
annually for inflation).
    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 in order 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), the 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.
    The bill also would impose a mandate on importers, 
exporters, manufacturers, and distributors by requiring that 
any anabolic steroid or product containing an anabolic steroid 
be labeled as such, using the nomenclature of the International 
Union of Pure and Applied Chemistry. The cost of the mandate 
would probably be small.
    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.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    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 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 enacting H.R. 4771 
specifically directs to be completed zero specific rule makings 
within the meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1: Short title

    Section 1 provides the short title of the ``Designer 
Anabolic Steroid Control Act of 2014.''

Section 2: Amendments to the Controlled Substances Act

    Subsection (a) amends section 102(41) of the CSA by adding 
25 substances to the definition of ``anabolic steroid.''
    In addition, it provides that a drug or hormonal substance 
that is not listed under section 102(41), but is derived from, 
or has a chemical structure substantially similar to, one or 
more of the listed anabolic steroids, such drug or hormonal 
substance shall be considered an anabolic steroid for purposes 
of the CSA if it has been created or manufactured with the 
intent of producing a drug or other substance that either 
promotes muscle growth or causes a pharmacological effect 
similar to that of testosterone, or has been, or is intended to 
be, marketed or otherwise promoted as such.
    Further, it clarifies that a substance shall not be 
considered a drug or hormonal substance for such purposes if 
any person claiming such exemption provides evidence that it 
(A) is an herb or other botanical, or a concentrate, 
metabolite, or extract thereof; (B) is a dietary supplement 
under the FFDCA; and (C) is not anabolic or androgenic.
    Subsection (b) authorizes the Attorney General to issue a 
temporary order adding a drug or substance to section 102(41) 
if it meets the criteria under such section and doing so will 
assist in preventing abuse or misuse of the drug or other 
substance. In doing so, the Attorney General must transmit 
notice of such order to the Secretary of Health and Human 
Services and take into consideration any comments submitted by 
the Secretary in response. The Attorney General may commence a 
rulemaking to issue a permanent order adding such drug or 
substance to section 102(41) simultaneously with the issuance 
of such temporary order.
    Finally, section 2 imposes enhanced criminal and civil 
penalties for possessing or trafficking in any anabolic steroid 
or product containing an anabolic steroid that does not bear a 
label clearly identifying the anabolic steroid by the 
nomenclature used by the International Union of Pure and 
Applied Chemistry or is not labeled in a manner that is not 
labeled in the manner required under the FFDCA.

         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 italic, existing law in which no change is 
proposed is shown in roman):

      COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970


                            TABLE OF CONTENTS

                    TITLE II--CONTROL AND ENFORCEMENT

     * * * * * * *

 Part C--Registration of Manufacturers, Distributors, and Dispensers of 
               Controlled Substances; Piperidine Reporting

     * * * * * * *
Sec. 305A. Offenses involving false labeling of anabolic steroids.

           *       *       *       *       *       *       *


                   TITLE II--CONTROL AND ENFORCEMENT


       Part A--Short Title; Findings and Declaration; Definitions


                              short title

  Sec. 100. This title may be cited as the ``Controlled 
Substances Act''.

           *       *       *       *       *       *       *


                              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 (17b-hydroxyestr-4,9,11-trien-3-
        one); [and]
          (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
          [(xlx)] (lxxv) any salt, ester, or ether of a drug or 
        substance described in this paragraph.
The substances excluded under this subparagraph may at any time 
be scheduled by the Attorney General in accordance with the 
authority and requirements of subsections (a) through (c) of 
section 201.

           *       *       *       *       *       *       *

          (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.

           *       *       *       *       *       *       *


         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

           *       *       *       *       *       *       *



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.

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