[Federal Register Volume 73, Number 52 (Monday, March 17, 2008)]
[Rules and Regulations]
[Pages 14178-14179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5173]



[[Page 14178]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

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


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

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

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing an 
Interim Rule 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: Effective Date: This final rule is effective April 16, 2008.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, 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). Section 1903 of the ASCA provides that 
the Attorney General may exempt products which contain anabolic 
steroids from all or any part of the CSA (21 U.S.C. 801 et seq.) 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 (DEA) (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 21 
CFR 1308.33. 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 finalize 
an interim rule regarding 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 (HHS) 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 HHS along with a 
request for evaluation and recommendation. In three separate letters 
dated March 30, 2006, the Assistant Secretary of Health for HHS 
recommended that all six products, two products of esterified estrogen 
and methyltestosterone from each of three applications, be exempted 
from control under the CSA based on their similarity to the products, 
Estratest[reg], Estratest[reg] H.S., Essian\TM\ and Essian\TM\ H.S., 
which have been exempted from control under the CSA (71 FR 10835, March 
3, 2006 and 71 FR 61876, October 20, 2006).
    DEA agreed with HHS regarding the similarity of these products to 
products which have already been exempted from the regulatory controls 
of the CSA. Further, after reviewing several law enforcement databases, 
DEA did not find evidence of significant abuse or trafficking of these 
types of products. Therefore, DEA published an Interim rule with 
request for comments (71 FR 51996, September 1, 2006) exempting these 
products from regulatory control under the CSA.

Comments Received

    DEA received one comment in opposition to the Interim Rule. As a 
basis for this objection, the commenter cited generally to Article I, 
Section 1 of the U.S. Constitution: ``All legislative powers herein 
granted shall be vested in a Congress of the United States, which shall 
consist of a Senate and House of Representatives.'' DEA has considered 
the comment and determined that the objection is without legal basis.
    Thus, the rule is being finalized without change. Accordingly, the 
Deputy Assistant Administrator, Office of Diversion Control, hereby 
affirms his order that the following anabolic steroid products be added 
to the list of products excluded from application of certain controls 
of the Controlled Substances Act and referenced in 21 CFR 1308.34.
    Exempt Anabolic Steroid Products:

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          Trade name                 Company              Form           Ingredients             Quantity
----------------------------------------------------------------------------------------------------------------
Esterified Estrogens and        Interpharm, Inc..  Tablets..........  Esterified         1.25 mg/Tablet.
 Methyltestosterone, USP (1.25                                         Estrogens.        2.5 mg/Tablet.
 mg/2.5 mg).                                                          Methyltestosteron
                                                                       e.
Esterified Estrogens and        Interpharm, Inc..  Tablets..........  Esterified         0.625 mg/Tablet.
 Methyltestosterone, USP                                               Estrogens.        1.25 mg/Tablet.
 (0.625 mg/1.25 mg).                                                  Methyltestosteron
                                                                       e.
Methyltestosterone and          Lannett Company,   Tablets..........  Esterified         1.25 mg/Tablet.
 Esterified Estrogens (2.5 mg/   Inc.                                  Estrogens.        2.5 mg/Tablet.
 1.25 mg).                                                            Methyltestosteron
                                                                       e.
Methyltestosterone and          Lannett Company,   Tablets..........  Esterified         0.625 mg/Tablet.
 Esterified Estrogens (Half      Inc.                                  Estrogens.        1.25 mg/Tablet.
 Strength) (1.25 mg/0.625 mg).                                        Methyltestosteron
                                                                       e.
Esterified Estrogens/           ANDAPharm, LLC...  Tablets..........  Esterified         1.25 mg/Tablet.
 Methyltestosterone, (1.25 mg/                                         Estrogens.        2.5 mg/Tablet.
 2.5 mg) Tablet.                                                      Methyltestosteron
                                                                       e.
Esterified Estrogens/           ANDAPharm, LLC...  Tablets..........  Esterified         0.625 mg/Tablet.
 Methyltestosterone, (0.625 mg/                                        Estrogens.        1.25 mg/Tablet.
 1.25 mg) Tablet.                                                     Methyltestosteron
                                                                       e.
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[[Page 14179]]

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. 601-612).

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866. It has been determined that this is not a 
significant regulatory action. Therefore, this action has not been 
reviewed by the Office of Management and Budget. This final rule 
exempts the identified steroid products from the regulatory controls 
that apply to controlled substances.

Executive Order 12988

    This 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 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 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 or 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) 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.

Congressional Review Act

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Congressional 
Review Act). This rule will not result in an annual effect on the 
economy of $100 million 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.

21 CFR Part 1308--Schedules of Controlled Substances

    The Interim Rule with Request for Comment amending the list of 
exempt anabolic steroid products described in 21 CFR 1308.34 published 
at 71 FR 51996, September 1, 2006 is hereby adopted as a final rule 
without change.

    Dated: March 8, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E8-5173 Filed 3-14-08; 8:45 am]
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