[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Pages 51996-51998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14516]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-289I]
RIN 1117-AB04


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

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

ACTION: Interim rule and request for comments.

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SUMMARY: The Drug Enforcement Administration (DEA) is designating six 
pharmaceutical preparations as exempt anabolic steroid products under 
the Controlled Substances Act. This action is part of the ongoing 
implementation of the Anabolic Steroids Control Act of 1990.

DATES: This rule is effective September 1, 2006. Written comments must 
be postmarked, and electronic comments must be sent, on or before 
October 31, 2006.

ADDRESSES: To ensure proper handling of comments, please reference 
Docket No. DEA-289 on all written and electronic correspondence. 
Written comments sent via regular mail should be sent to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/ODL. Written comments sent via express mail should be 
sent to DEA Headquarters, Attention: DEA Federal Register 
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. 
Comments may be sent electronically to [email protected]. 
Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided at that 
site. DEA will accept attachments to electronic comments in Microsoft 
Word, Word Perfect, Adobe PDF, or Excel file formats only. DEA will not 
accept any file formats other than those specifically listed here.

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: 

Background

    The Anabolic Steroids Control Act (ASCA) of 1990 (Title XIX of Pub. 
L. 101-647) placed anabolic steroids into Schedule III of the 
Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). Section 1903 
of the ASCA provides that the Attorney General may exempt products 
which contain anabolic steroids from all or any part of the Controlled 
Substances Act if the products have no significant potential for abuse. 
The authority to exempt these products was delegated from the Attorney 
General to the Administrator of the Drug Enforcement Administration (28 
CFR 0.100(b)), who in turn, redelegated this authority to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration (28 CFR Part 0, Appendix to Subpart R, section 7(g)). 
The procedure for implementing this section of the ASCA is found in 
Sec.  1308.33 of Title 21 of the Code of Federal Regulations. Three 
applications which were in conformance with 21 CFR 1308.33 were 
received and forwarded to the Secretary of Health and Human Services 
for evaluation. The purpose of this rule is to identify six products 
which the Deputy Assistant Administrator, Office of Diversion Control, 
finds meet the exempt anabolic steroid product criteria.

Anabolic Steroid Products Being Added to the List of Products Exempted 
From Application of the CSA

    DEA received three letters dated June 8, 2005, July 1, 2005 and 
August 22, 2005, written to the DEA on behalf of Interpharm Inc., 
Lannett Company Inc., and ANDAPharm, LLC, respectively. Each of these 
three letters contained an application to exempt from control under the 
CSA two products, each containing esterified estrogens and 
methyltestosterone. In two letters dated November 14, 2005, DEA 
provided a copy of the Lannett and ANDAPharm applications to the 
Department of Health and Human Services (DHHS) along with a request for 
evaluation and a recommendation. In a letter dated November 15, 2005, 
DEA provided a copy of the Interpharm application to DHHS along with a 
request for evaluation and recommendation. In three separate letters 
dated March 30, 2006, the Assistant Secretary of Health for DHHS 
recommended that all six products, two products of esterified estrogen 
and methyltestosterone from each of the three applications, be exempted 
from control under the CSA based on their similarity to the products 
Estratest[reg], Estratest[reg] H.S., 
EssianTM and EssianTM H.S., which have been 
exempted from control under the CSA.
    DEA agrees with DHHS regarding the similarity of these products to 
products which have already been exempted from the regulatory controls 
of the Controlled Substances Act. Further, after reviewing several law 
enforcement databases, DEA has not found evidence of significant abuse 
or trafficking of these types of products.
    The Deputy Assistant Administrator, having reviewed the 
applications, recommendations of the Secretary, and other relevant 
information, finds that the following six products have no significant 
potential for abuse: Esterified Estrogens and Methyltestosterone, USP 
(1.25 mg/2.5 mg); Esterified Estrogens and Methyltestosterone, USP 
(0.625 mg/ 1.25 mg); Methyltestosterone and Esterified Estrogens (2.5 
mg/1.25 mg); Methyltestosterone and Esterified

[[Page 51997]]

Estrogens (1.25 mg/0.625 mg); Esterified Estrogens/Methyltestosterone 
(1.25 mg/2.5 mg) Tablet; and Esterified Estrogens/Methyltestosterone 
(0.625 mg/1.25 mg) Tablet H.S. Information on these products is given 
below.

                                                            Exempt Anabolic Steroid Products
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           Trade name                          Company                      Form                    Ingredients                        Quantity
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Esterified Estrogens and         Interpharm, Inc....................  Tablets.........  Esterfied Estrogens................  1.25 mg/Tablet.
 Methyltestosterone, USP (1.25                                                          Methyltestosterone.................  2.5 mg/Tablet.
 mg/2.5 mg).
Esterified Estrogens and         Interpharm, Inc....................  Tablets.........  Esterfied Estrogens................  0.625 mg/Tablet.
 Methyltestosterone, USP (0.625                                                         Methyltestosterone.................  1.25 mg/Tablet.
 mg/1.25 mg).
Methyltestosterone and           Lannett Company, Inc...............  Tablets.........  Esterfied Estrogens................  1.25 mg/Tablet.
 Esterified Estrogens (2.5 mg/                                                          Methyltestosterone.................  2.5 mg/Tablet.
 1.25 mg).
Methyltestosterone and           Lannett Company, Inc...............  Tablets.........  Esterfied Estrogens................  0.625 mg/Tablet.
 Esterified Estrogens (Half                                                             Methyltestosterone.................  1.25 mg/Tablet.
 Strength) (1.25 mg/0.625 mg).
Esterified Estrogens/            ANDAPharm, LLC.....................  Tablets.........  Esterfied Estrogens................  1.25 mg/Tablet.
 Methyltestosterone, (1.25 mg/                                                          Methyltestosterone.................  2.5 mg/Tablet.
 2.5 mg) Tablet.
Esterified Estrogens/            ANDAPharm, LLC.....................  Tablets.........  Esterfied Estrogens................  0.625 mg/Tablet.
 Methyltestosterone, (0.625 mg/                                                         Methyltestosterone.................  1.25 mg/Tablet.
 1.25 mg) Tablet.
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    Therefore, the Deputy Assistant Administrator hereby orders that 
the above anabolic steroid products be added to the list of products 
excluded from application of certain controls of the CSA and referenced 
in 21 CFR 1308.34.
    Interested persons are invited to submit their comments to this 
interim rule. If any comments or objections raise significant issues 
regarding any finding of fact or conclusion of law upon which this 
order is based, the Deputy Assistant Administrator shall immediately 
suspend the effectiveness of this order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Deputy Assistant Administrator shall reinstate, revoke, or amend 
his original order as he determines appropriate.

Regulatory Certifications

Regulatory Flexibility Act

    The granting of exemption status relieves persons who handle the 
exempted products in the course of legitimate business from the 
registration, recordkeeping, security, and other requirements imposed 
by the CSA. Accordingly, the Deputy Assistant Administrator certifies 
that this action will not have a significant economic impact upon a 
substantial number of small entities whose interests must be considered 
under the Regulatory Flexibility Act (5 U.S.C. 605(b)).

Executive Order 12866

    The Deputy Assistant Administrator has determined that this is not 
a ``significant rule,'' as that term is used in Executive Order 12866. 
This rule exempts the identified steroid products from the regulatory 
controls that apply to controlled substances. Therefore, this rule has 
not been reviewed by the Office of Management and Budget.

Executive Order 12988

    This interim rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This interim rule 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 law. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This interim rule will not result in the expenditure by State, 
local or tribal governments, in the aggregate, or by the private 
sector, of $117,000,000 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.

Small Business Regulatory Enforcement Fairness Act of 1996

    This interim rule is not a major rule as defined by section 804 of 
the Small Business Regulatory Enforcement Fairness Act of 1996. This 
rule will not result in an annual effect on the economy of $100,000,000 
or more, a major increase in costs or prices, or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (5 U.S.C. 553), 
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(b)(3)(B). Further, the 
Administrative Procedure Act permits an agency to make this rule 
effective upon the date of publication if the rule is ``a substantive 
rule which grants or recognizes an exemption or relieves a 
restriction'' (5 U.S.C. 553(d)(1)). As the rule adds six anabolic 
steroid products to the list of products exempted from regulatory 
control under the Controlled Substances Act and provides a benefit to 
the affected public, DEA finds that this rule meets the criteria set 
forth in 5 U.S.C. 553(b)(3)(B) and 5 U.S.C. 553(d)(1) for an exception 
to the usual notice and comment process.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    Pursuant to the authority vested in the Attorney General by section 
1903 of the Anabolic Steroids Control Act of 1990, delegated to the 
Administrator of the Drug Enforcement Administration pursuant to 21 
U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy Assistant 
Administrator of the DEA Office of Diversion Control pursuant to 28 CFR 
part 0, Appendix to Subpart R, section 7(g), the Deputy Assistant 
Administrator hereby orders that the following compounds, mixtures, or 
preparations containing anabolic steroids be exempted from application 
of sections 302 through 309 and sections 1002 through 1004 of the 
Controlled Substances Act (21 U.S.C. 822-829 and 21 U.S.C. 952-954) and 
21 CFR 1301.13, 1301.22, 1301.71 through 1301.76 for administrative 
purposes only and be

[[Page 51998]]

included in the list of products described in 21 CFR 1308.34.

                                                          New Exempt Anabolic Steroid Products
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            Trade name                        Company                    Form                      Ingredients                        Quantity
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Esterified Estrogens and           Interpharm, Inc..............  Tablets...........  Esterfied Estrogens.................  1.25 mg/Tablet.
 Methyltestosterone, USP (1.25 mg/                                                    Methyltestosterone..................  2.5 mg/Tablet.
 2.5 mg).
Esterified Estrogens and           Interpharm, Inc..............  Tablets...........  Esterfied Estrogens.................  0.625 mg/Tablet.
 Methyltestosterone, USP (0.625                                                       Methyltestosterone..................  1.25 mg/Tablet.
 mg/1.25 mg).
Methyltestosterone and Esterified  Lannett Company, Inc.........  Tablets...........  Esterfied Estrogens.................  1.25 mg/Tablet.
 Estrogens (2.5 mg/1.25 mg).                                                          Methyltestosterone..................  2.5 mg/Tablet.
Methyltestosterone and Esterified  Lannett Company, Inc.........  Tablets...........  Esterfied Estrogens.................  0.625 mg/Tablet.
 Estrogens (Half Strength) (1.25                                                      Methyltestosterone..................  1.25 mg/Tablet.
 mg/0.625 mg).
Esterified Estrogens/              ANDAPharm, LLC...............  Tablets...........  Esterfied Estrogens.................  1.25 mg/Tablet.
 Methyltestosterone, (1.25 mg/2.5                                                     Methyltestosterone..................  2.5 mg/Tablet.
 mg) Tablet.
Esterified Estrogens/              ANDAPharm, LLC...............  Tablets...........  Esterfied Estrogens.................  0.625 mg/Tablet.
 Methyltestosterone, (0.625 mg/                                                       Methyltestosterone..................  1.25 mg/Tablet.
 1.25 mg) Tablet.
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    Dated: August 24, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E6-14516 Filed 8-31-06; 8:45 am]
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