Implementation of the Anabolic Steroid Control Act of 2004, 74653-74658 [05-23907]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Rules and Regulations]
[Pages 74653-74658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23907]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300 and 1308

[Docket No. DEA-264]
RIN 1117-AA95


Implementation of the Anabolic Steroid Control Act of 2004

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: The purpose of this rulemaking is to conform the Drug 
Enforcement Administration's (DEA) regulations to the provisions of the 
Anabolic Steroid Control Act of 2004. Effective January 20, 2005, the 
Act amended the Controlled Substances Act (CSA) and replaced the 
existing definition of ``anabolic steroid'' with a new definition. This 
new definition altered the basis for all future administrative 
scheduling actions relating to the control of anabolic steroids as 
Schedule III controlled substances by eliminating the requirement to 
prove muscle growth. Additionally, the Act lists 59 specific substances 
as being anabolic steroids. As such, these substances and their salts, 
esters and ethers are Schedule III controlled substances. This 
rulemaking amends 21 CFR Parts 1300 and 1308 to reflect these changes.
    The Act also amends the CSA by revising the language requiring 
exclusion of certain over the counter products from regulation as 
controlled substances. The Act clarifies that the exclusionary language 
in 21 U.S.C. 811(g)(1) pertains only to non-narcotic ``drugs'' that 
may, under the Federal Food, Drug, and Cosmetic Act (FDCA),

[[Page 74654]]

be lawfully sold over the counter without a prescription.
    The statute is self-implementing with the changes that became 
effective on January 20, 2005. DEA has no authority to revise the 
changes and is simply modifying its regulations to conform to the 
statute. Consequently, public comments are not being solicited since 
they could not alter this rule.

DATES: The rule is effective January 17, 2006.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537. Telephone (202) 307-
7183.

SUPPLEMENTARY INFORMATION:

DEA's Legal Authority

    DEA is the primary agency responsible for implementing the 
provisions of the federal Controlled Substances Act and the Controlled 
Substances Import and Export Act (21 U.S.C. 801-971) (CSA). DEA 
publishes the implementing regulations for the CSA in Title 21 of the 
Code of Federal Regulations (CFR), Sec. Sec.  1300.01 to 1316.99. The 
statutory scheme is designed to ensure that there is a sufficient 
supply of controlled substances for legitimate medical purposes and 
deter the diversion of controlled substances for illegal purposes. The 
CSA mandates that DEA establish a closed system of control for 
manufacturing, distributing, and dispensing controlled substances. Any 
person who manufactures, distributes, dispenses, imports, exports, or 
conducts research or chemical analysis with controlled substances must 
register with DEA (unless exempt) and comply with the applicable CSA 
requirements for the activity.
    Drugs controlled under the CSA include opiates, hallucinogens and 
central nervous system stimulants and depressants. In addition, as a 
result of the passage of the Anabolic Steroid Control Act of 1990, 
anabolic steroids, as a class of drugs, were placed under the CSA 
effective February 27, 1991.
    On October 22, 2004, the President signed into law the Anabolic 
Steroid Control Act of 2004, Public Law 108-358 (118 Stat. 1661). 
Section 2(a) amended the Controlled Substances Act (21 U.S.C. 802) by 
replacing the existing definition of ``anabolic steroid'' with a new 
definition for use in the future to administratively classify new 
steroids as Schedule III anabolic steroids. In addition, the Act listed 
59 specific substances as being Schedule III anabolic steroids. Ethers 
of these listed steroids were also, for the first time, controlled in 
Schedule III, while the isomers of these steroids were removed from 
Schedule III controls. Additionally, section 2(b) amended the 
Controlled Substances Act (21 U.S.C. 811(g)) by revising the language 
excluding certain over the counter products from regulation as 
controlled substances. The statute is self-implementing with changes 
that became effective January 20, 2005.
    DEA is promulgating this rule as a final rule rather than a 
proposed rule because the changes are being made to correspond to 
statutory revisions. DEA has no authority to revise the changes and is 
simply amending its regulations to conform to the statute. Since DEA 
could not revise the rule based on public comments, DEA finds that 
notice and opportunity for public comment are unnecessary under the 
Administrative Procedure Act, 5 U.S.C. 553(b)(B).

Congressional Action

    Congress enacted the Anabolic Steroid Control Act of 2004, Public 
Law 108-358 (118 Stat. 1661), which the President signed on October 22, 
2004. The House Report (108-461) stated that the purpose of the Act is 
``to prevent the abuse of steroids by professional athletes. It will 
also address the widespread use of steroids and steroid precursors by 
college, high school, and even middle school students.'' The House 
Report also noted that steroid precursors ``are as dangerous to the 
body as those banned under the original Act.''
    The Act does two things of relevance to this rulemaking. It 
replaces the existing definition of ``anabolic steroid'' in 21 U.S.C. 
802 and revises the language exempting certain over the counter 
products from regulation as controlled substances. The changes to the 
definition include the following:
     Elimination of the need to prove that a steroid promotes 
muscle growth in order to administratively place the steroid into 
Schedule III of the CSA.
     Correction of the listing of steroid names resulting from 
the passage of the Anabolic Steroid Control Act of 1990.
     Replacement of the list of 23 steroids with a list of 59 
steroids, including both intrinsically active steroids as well as 
steroid metabolic precursors.
     Automatic scheduling of the salts, esters and ethers of 
Schedule III anabolic steroids without the need to prove that these 
salts, esters or ethers promote muscle growth.
     Removal of the automatic scheduling of isomers of steroids 
listed as Schedule III anabolic steroids.
     Addition of dehydroepiandrosterone (DHEA) to the list of 
excluded substances.

Changes to Exclusionary Language of 21 U.S.C. 811(g)

    In addition to revising the definition of anabolic steroid, the Act 
also amends the CSA by revising the language requiring exclusion of 
certain over the counter products from regulation as controlled 
substances. The Act clarifies that the exclusionary language in 21 
U.S.C. 811 (g)(1) pertains only to nonnarcotic ``drugs'' that may, 
under the Federal Food, Drug, and Cosmetic Act (FDCA), be lawfully sold 
over the counter without a prescription.
    Congress modified 21 U.S.C. 811(g) by changing the language in 
paragraphs (1) and (3). Paragraph (g)(1) previously read:

    The Attorney General shall by regulation exclude any nonnarcotic 
substance from a schedule if such substance may, under the Federal 
Food, Drug, and Cosmetic Act [21 U.S.C.A. Sec.  301 et seq.], be 
lawfully sold over the counter without a prescription.

    The revised paragraph reads:

    The Attorney General shall by regulation exclude any non-
narcotic drug which contains a controlled substance from the 
application of titles II and III of the Comprehensive Drug Abuse 
Prevention and Control Act (21 U.S.C. 802 et seq.) if such drug may, 
under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. Sec.  
301 et seq.], be lawfully sold over the counter without a 
prescription.

    The change from ``substance'' to ``drug'' clarifies that only those 
over the counter (OTC) non-narcotic products containing controlled 
substances that are regulated as drugs under the Federal Food, Drug, 
and Cosmetic Act (FDCA) will be excluded from CSA regulatory 
requirements. Many of these steroids have previously been marketed as 
dietary supplements. Such dietary supplements (which are subject to 
requirements implemented pursuant to the Dietary Supplement Health and 
Education Act of 1994) are subject to different regulatory requirements 
than OTC non-prescription drugs under FDCA provisions.
    This statutory change serves to clarify this distinction. The 
exclusion provided under 21 U.S.C. 811(g)(1) pertains only to 
nonnarcotic ``drugs'' that may, under the FDCA, be lawfully sold over 
the counter without a prescription.
    The second revision to paragraph (g) specifies that the Attorney 
General may exclude by regulation, any compound, mixture, or 
preparation containing an

[[Page 74655]]

anabolic steroid and which is intended for administration to a human 
being or animal, if the Secretary of Health and Human Services 
recommends the exemption because its concentration, preparation, 
formulation, or delivery system means it does not present any 
significant potential for abuse. DEA has already incorporated this 
provision in its regulations (21 CFR 1308.33). In contrast, DEA can, 
without seeking a recommendation from the Secretary of Health and Human 
Services, exempt any chemical preparation or mixture containing a 
controlled substance which is not intended for human or veterinary use 
and which is determined not to have a significant abuse potential 
because of its concentration, preparation or formulation. This latter 
provision is incorporated into 21 CFR 1308.23.

Impact of the Changes

    The impact of the revisions is to make all of the listed steroids 
and any of their salts, esters, or ethers, Schedule III controlled 
substances and subject to CSA requirements. Any person who 
manufactures, distributes, dispenses, imports or exports a substance 
defined as an anabolic steroid or who engages in research or conducts 
instructional activities with respect to substances defined as anabolic 
steroids must obtain a Schedule III registration in accordance with the 
CSA and its implementing regulations. Manufacturers and importers of 
the listed steroids must register with DEA and are permitted to 
distribute the steroids only to other DEA registrants. Only persons 
registered as dispensers are allowed to dispense the steroids to end 
users. Registered dispensers, however, are limited to practitioners, 
who are defined in the CSA as physicians, dentists, veterinarians, 
scientific investigators, pharmacies, hospitals, or other persons 
licensed, registered, or otherwise permitted by the U.S. or the 
jurisdiction in which they practice or conduct research, to distribute, 
dispense, conduct research with respect to, administer, or use in 
teaching or chemical analysis, a controlled substance in the course of 
professional practice or research, 21 U.S.C. 802(21).
    As of January 20, 2005, manufacture, import, export, distribution, 
or sale of the listed steroids except by DEA registrants has been a 
violation of the CSA that may result in imprisonment and fines (21 
U.S.C. 841, 960). Possession of the steroids unless legally obtained is 
also subject to criminal penalties (21 U.S.C. 844).
    In addition, under the CSA, a nonnarcotic Schedule III substance 
may be imported only if it is imported for medical, scientific, or 
other legitimate uses (21 U.S.C. 952(b)) under an import declaration 
filed with DEA (21 CFR 1312.18). Importation of these Schedule III 
steroids will be illegal unless the person importing the steroids is 
registered with DEA as an importer or researcher and files the required 
declaration for each shipment. An individual who purchases these 
substances directly from foreign companies and has them shipped to the 
U.S. is considered to be importing even if the steroids are intended 
for personal use. Illegal importation of a Schedule III anabolic 
steroid is a violation of the CSA that may result in imprisonment and 
fines(21 U.S.C. 960).

Requirements for Handling Substances Defined as Anabolic Steroids

    Effective January 20, 2005, those substances defined as anabolic 
steroids became subject to CSA regulatory controls and administrative, 
civil and criminal sanctions applicable to the manufacture, 
distribution, dispensing, importing and exporting of a Schedule III 
controlled substance, including the following:
    Registration. Any person who manufactures, distributes, dispenses, 
imports or exports a substance defined as an anabolic steroid or who 
engages in research or conducts instructional activities with respect 
to substances defined as anabolic steroids or who proposes to engage in 
such activities must be registered to conduct such activities with 
Schedule III controlled substances in accordance with 21 CFR part 1301.
    Security. Substances defined as anabolic steroids are subject to 
Schedule III-V security requirements and must be manufactured, 
distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), 
(c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76 and 
1301.77.
    Labeling and Packaging. All labels and labeling for commercial 
containers of substances defined as anabolic steroids which are 
distributed on or after January 17, 2006, shall comply with 
requirements of 21 CFR 1302.03-1302.07.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of any substance defined as an anabolic steroid 
is required to keep an inventory of all stocks of the substances on 
hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11. Every registrant 
who desires registration in Schedule III for any substance defined as 
an anabolic steroid shall conduct an inventory of all stocks of the 
substances on hand at time of registration.
    Records. All registrants are required to keep records pursuant to 
21 CFR 1304.03, 1304.04, 1304.05, 1304.21, 1304.22, 1304.23 and 
1304.26.
    Prescriptions. All prescriptions for these Schedule III compounds 
or for products containing these Schedule III compounds would be 
required to be issued pursuant to 21 CFR 1306.03-1306.06 and 1306.21-
1306.27. All prescriptions for these Schedule III compounds or for 
products containing these Schedule III compounds, if authorized for 
refilling, would be limited to five refills.
    Importation and Exportation. All importation and exportation of any 
substance defined as an anabolic steroid must be in compliance with 21 
CFR part 1312.
    Criminal Liability. Any activity with any substance defined as an 
anabolic steroid not authorized by, or in violation of, the Controlled 
Substances Act or the Controlled Substances Import and Export Act 
occurring on or after January 20, 2005, is unlawful.

Disposal of Anabolic Steroids

    Persons who possess substances defined as anabolic steroids and who 
wish to dispose of them rather than becoming registered to handle them 
should contact their local DEA Diversion field office for assistance in 
disposing of these substances legally. The DEA Diversion field office 
will provide the person with instructions regarding the disposal. A 
list of local DEA Diversion field offices may be found at https://www.deadiversion.usdoj.gov.

Required Certifications

Executive Order 12866

    The Deputy Administrator certifies that this rulemaking has been 
drafted in accordance with the principles in Executive Order 12866 
section 1(b). DEA has determined that this is a significant regulatory 
action. Therefore, this action has been reviewed by the Office of 
Management and Budget. DEA does not have any discretion in the 
implementation of the Anabolic Steroid Control Act of 2004, and this 
rule merely codifies those statutory changes.
    DEA did, however, analyze the economic impacts of the changes in 
recognition of the market that exists for these products. DEA was not 
able to determine the size of the market for these substances with any 
degree of certainty. The National Nutritional Foods Association 
indicates that the nutritional supplement market in 2003 had sales of 
$19.8 billion. The sports nutrition part of the market had sales of

[[Page 74656]]

$2 billion. Steroid precursors make up some fraction of the sports 
nutrition market. DEA believes that most steroids sold in dietary 
supplements in the U.S. are imported in bulk, primarily from China. 
According to U.S. International Trade Commission data, in the first 
nine months of 2004, China was the source of 3,900 kilograms of the 
4,145 kg of the anabolic agents and androgens imported. The import 
value of the Chinese product is about $0.27 per gram. The price per 
gram for pure steroid products, as listed on Internet sites, ranges 
from $1.39 to $73 (omitting Methyl D, which sells for $150 to more than 
$500/gram). Most pure products sell for between $2.50 per gram and 
$32.00/gram. Extrapolating the Chinese imports to a full year and 
applying the per gram markup, DEA estimates the steroid retail market 
to range from $13 million to $166 million. Because most steroids have 
per gram prices of less than $8, DEA estimates that the market is 
probably in the middle of the range.
    DEA also looked at the firms that market steroid containing 
supplement products. Based on Internet searches, DEA identified 64 
firms that sell these products under their brand name. Besides the 
marketers' websites, the products were available from more than 150 
Internet sites that cater to the body building and nutritional 
supplement market. These products may also be available from some 
retail store outlets and gyms.
    The 64 firms identified as marketing the products under their brand 
name represent a variety of sectors. DEA was able to locate some 
industrial sector and financial information for 45 of the firms. Of 
those whose business category was available, five categorize themselves 
as food processors who manufacture dry condensed and evaporated dairy 
products (NAICS 311514) (whey products are widely sold as high protein 
supplements). Five classified themselves as manufacturers of 
pharmaceuticals (NAICS 325412) or botanicals (NAICS 325411). Seventeen 
listed themselves as drug (NAICS 424210) or food wholesalers (NAICS 
424490). Twelve listed themselves as store retailers (NAICS 446191, 
445299), and two as mail order houses (NAICS 454113). The others for 
which information was available categorized themselves as a book 
publisher, a research lab, a radio station, and a doctor's office. 
There were 19 firms for whom DEA could find no information in U.S. 
business databases; one of these is British. Of the 18 remaining, DEA 
was unable to locate any information (web site, address, phone number) 
on four firms whose products are being sold. Two others had web sites, 
but no location information, and three had web sites and telephone 
numbers, but no addresses.
    All of the firms identified are small entities under the Small 
Business Administration standards. Only two of the firms reported 
revenues above $20 million; one of these filed for Chapter 11 
protection in 2003 and has since sold all of its assets. Only three 
firms had revenues between $10 million and $20 million; all of these 
listed themselves as drug wholesalers. The 16 firms with revenues 
between $1 million and $10 million were also mainly wholesalers or 
manufacturers. Eighteen firms reported revenues of $100,000 to $1 
million. Four reported revenues of less than $100,000. Of the firms for 
which data were found, the majority had fewer than ten employees. It is 
likely that the firms for which data were not available are very small. 
Given the size of the firms, it is also likely that these firms are, at 
most, repackaging or relabeling products manufactured elsewhere.
    DEA was not able to identify any firm that appeared to market only 
the steroid precursors although they may be the main product line for a 
few firms. Removing these products from the market will undoubtedly 
have a negative effect on many of the firms. Similarly, the 160 
Internet sites identified as selling these products offer a variety of 
other nutritional products; some also sell sporting equipment, 
clothing, books, and videos. Because there is no legal substitute that 
produces the effects claimed for these products, it is likely that both 
the producers and the Internet sites will experience a loss of revenue. 
Without information on the percentage of revenues derived from the 
product lines, DEA is not able to determine whether the removal of 
these products alone will result in the closure of any of the firms.

Regulatory Flexibility Act/Small Business Regulatory Enforcement 
Fairness Act of 1996

    The Regulatory Flexibility Act (5 U.S.C. 605(b)), as amended by the 
Small Business Regulatory Enforcement Fairness Act of 1996, applies 
only to regulations subject to notice and comment. Because DEA is 
simply promulgating a final rule to conform to statutory provisions, 
the Regulatory Flexibility Act does not apply to this action.

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act, including notice of 
proposed rulemaking and the opportunity for public comment, if it is 
determined to be unnecessary, impracticable, or contrary to the public 
interest (5 U.S.C. 553). The provisions of the Anabolic Steroid Control 
Act of 2004, Public Law 108-358, are self-implementing. DEA has no 
discretion in this matter. The changes in this rulemaking provide 
conforming amendments to make the language of the regulations 
consistent with that of the law. Hence, DEA finds it unnecessary to 
publish for public notice and comment.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local and 
tribal governments, in the aggregate, or by the private sector, of 
$115,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

List of Subjects

21 CFR Part 1300

    Chemicals; Drug traffic control.

21 CFR Part 1308

    Administrative practice and procedure; Drug traffic control; 
Reporting and recordkeeping requirements.


0
For the reasons set forth above, 21 CFR parts 1300 and 1308 are amended 
as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f).


0
2. In Sec.  1300.01(b), paragraph (4) is revised to read as follows:


Sec.  1300.01  Definitions relating to controlled substances.

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    (b) * * *
    (4) 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) 3[beta],17-dihydroxy-5a-androstane
(ii) 3[alpha],17[beta]-dihydroxy-5a-androstane
(iii) 5[alpha]-androstan-3,17-dione
(iv) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(v) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(vi) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(vii) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(viii) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(ix) 4-androstenedione (androst-4-en-3,17-dione)
(x) 5-androstenedione (androst-5-en-3,17-dione)
(xi) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xii) boldenone (17[beta]-hydroxyandrost-1,4,-diene-3-one)
(xiii) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xiv) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(xv) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(xvi) [Delta]1-dihydrotestosterone (a.k.a. `1-testosterone') (17[beta]-
hydroxy-5[alpha]-androst-1-en-3-one)
(xvii) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(xviii) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-
androstan-3-one)
(xix) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(xx) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(xxi) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(xxii) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-c]-
furazan)
(xxiii) 13[beta]-ethyl-17[alpha]-hydroxygon-4-en-3-one
(xxiv) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-one)
(xxv) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-3-
one)
(xxvi) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3-
one)
(xxvii) mesterolone (1[alpha]methyl-17[beta]-hydroxy-[5[alpha]]-
androstan-3-one)
(xxviii) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-
dien-3-one)
(xxix) methandriol (17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-
5-ene)
(xxx) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-3-
one)
(xxxi) 17[alpha]-methyl-3[beta], 17[beta]-dihydroxy-5a-androstane
(xxxii) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(xxxiii) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(xxxiv) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-
hydroxy-17[beta]-hydroxyestr-4-en-3-one)
(xxxv) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9(10)-
dien-3-one)
(xxxvi) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9-
11-trien-3-one)
(xxxvii) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-
4-en-3-one)
(xxxviii) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-
4-en-3-one)
(xxxix) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17b[beta]-
hydroxy-17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. `17-
[alpha]-methyl-1-testosterone')
(xl) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(xli) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-ene)
(xlii) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-ene)
(xliii) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-ene)
(xliv) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-5-ene)
(xlv) 19-nor-4-androstenedione (estr-4-en-3,17-dione)
(xlvi) 19-nor-5-androstenedione (estr-5-en-3,17-dione
(xlvii) norbolethone (13[beta], 17[alpha]-diethyl-17[beta]-hydroxygon-
4-en-3-one)
(xlviii) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(xlix) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-
one)
(l) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-one)
(li) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-[5[alpha]]-
androstan-3-one)
(lii) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-en-
3-one)
(liii) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-
hydroxy-[5[alpha]]-androstan-3-one)
(liv) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androst-
2-eno[3,2-c]-pyrazole)
(lv) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-3-
one)
(lvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic 
acid lactone)
(lvii) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(lviii) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(lix) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one)
(lx) Any salt, ester, or ether of a drug or substance described in this 
paragraph. Except such term does not include an anabolic steroid that 
is expressly intended for administration through implants to cattle or 
other nonhuman species and that has been approved by the Secretary of 
Health and Human Services for such administration. If any person 
prescribes, dispenses, or distributes such steroid for human use, the 
person shall be considered to have prescribed, dispensed, or 
distributed an anabolic steroid within the meaning of this paragraph.
* * * * *

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
3. The authority citation for part 1308 continues to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.


0
4. In Sec.  1308.13, paragraph (f) is revised to read as follows:


Sec.  1308.13  Schedule III.

* * * * *
    (f) Anabolic Steroids. Unless specifically excepted or unless 
listed in another schedule, any material, compound, mixture or 
preparation containing any quantity of the following substances, 
including its salts, esters and ethers:
    (1) Anabolic steroids (see Sec.  1300.01 of this chapter)--4000
    (2) [Reserved]
* * * * *

0
5. In Sec.  1308.21, paragraph (a) is revised to read as follows:


Sec.  1308.21  Application for exclusion of a non-narcotic drug.

    (a) Any person seeking to have any nonnarcotic drug that may, under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully 
sold over the counter without a prescription, excluded from any 
schedule, pursuant to section 201(g)(1) of the Act (21 U.S.C. 
811(g)(1)), may apply to the Administrator, Drug Enforcement 
Administration, Department of Justice, Washington, DC 20537.
* * * * *

0
6. In Sec.  1308.33, paragraph (a) is revised to read as follows:


Sec.  1308.33  Exemption of certain anabolic steroid products; 
application.

    (a) The Administrator, upon the recommendation of Secretary of 
Health and Human Services, may, by regulation, exempt from the 
application of all or any part of the Act any compound, mixture, or 
preparation containing an anabolic steroid as defined in part 1300 of 
this chapter, which is intended for administration to

[[Page 74658]]

a human being or animal, if, because of its concentration, preparation, 
formulation, or delivery system, it has no significant potential for 
abuse.
* * * * *

    Dated: November 23, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-23907 Filed 12-15-05; 8:45 am]
BILLING CODE 4410-09-P