[House Report 113-587]
[From the U.S. Government Publishing Office]


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:

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).''.

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
                  (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. Sec. 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. 
Sec. 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 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. Sec. 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. Sec. 842. The CSA 
currently prohibits the unlawful importation, exportation, 
manufacture, distribution, or dispensation of a schedule III 
controlled substance. See 21 U.S.C. Sec. 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.

                            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 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.
    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 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. Sec. 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. 
Sec. 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 Federal 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. Sec. 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. Sec. 842) as described below.
    This section adds a new paragraph (16) to section 402(a) of 
the CSA (21 U.S.C. Sec. 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 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. Sec. 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



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TITLE II--CONTROL AND ENFORCEMENT

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Part A--Short Title; Findings and Declaration; Definitions

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                              definitions

    Sec. 102. As used in this title:
    (1) * * *

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    (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) * * *

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            (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;
            (lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
            (lxix) 17a-Methyl-5a-androstan-17b-ol;
            (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.

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    (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.

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         Part B--Authority To Control; Standards and Schedules

        authority and criteria for classification of substances

    Sec. 201. (a) * * *

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    (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).

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Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

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                  labeling and packaging requirements

    Sec. 305. (a) * * *

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    (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.

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Part D--Offenses and Penalties

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                      prohibited acts b--penalties

    Sec. 402. (a) It shall be unlawful for any person--
            (1) * * *

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            (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; [or]
            (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)[.]; or
            (16) to violate subsection (e) of section 305 of 
        the Controlled Substances Act.
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).

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    (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.

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    (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



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   TITLE III--IMPORTATION AND EXPORTATION; AMENDMENTS AND REPEALS OF 
REVENUE LAWS

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Part A--Importation and Exportation

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                      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,

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shall be punished as provided in subsection (b).

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