03-772. Schedules of Controlled Substances: Exempt Anabolic Steroid Products

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Interim rule and request for comments.

SUMMARY:

The Drug Enforcement Administration (DEA) is designating two pharmaceutical preparations as exempt anabolic steriod products under the Controlled Substances Act. This action is part of the ongoing implementation of the Anabolic Steriod Control Act of 1990.

DATES:

Effective date: January 15, 2003.

Comment date: Comments must be received on or before March 17, 2003.

ADDRESSES:

Comments must be submitted to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537. Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone: [phone].

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 (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 (28 CFR 0.1009b)), who, in turn, redelegated this authority to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (28 CFR appendix to subpart R, section 7, paragraph (g)). The procedure for implementing this section of the ASCA is found in § 1308.33 of title 21 of the Code of Federal Regulations. An application which was in conformance with § 1308.33 of title 21 of the Code of Federal regulations was received and was forwarded to the Secretary of Health and Human Services for his evaluation. The purpose of this rule is to identify two 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 a letter dated June 18, 2002, written tot he DEA on behalf of Syntho Pharmaceuticals Inc., and two petitions to exempt from control under the CSA a two products each containing esterified estrogens and methyltestosterone. In a letter dated July 16, 2002, DEA provided a copy of these petitions to the Department of Health and Human Services (HHS) along with a request for evaluation and recommendation. In a letter dated September 14, 2002, the Assistant Secretary of Health for HHS recommended that both Syntest H.S. and Syntest D.S. be exempted from controls under the CSA based on their similarity to the products, Estratest H.S. and Estratest, respectively, both of which have been exempted from control under the CSA. A subsequent examination of DEA databases did not reveal any evidence of abuse or diversion of Estratest H.S. and Estratest.

The Deputy Assistant Administrator, having reviewed the application, recommendation of the Secretary, and other relevant information, finds that Syntest H.S. and Syntest D.S. have no significant potential for abuse. Information on these products is given below.

Exempt Anabolic Products

Trade name	Company	Form	Ingredients	Quantity
Syntest H.S	Syntho Pharmaceuticals, Farmingdale, NY	Tablets	Esterfied Estrogrens	0.62mg/Tablet.
			Methylestosterone	1.25mg/Tablet.
Syntest D.S	Syntho Pharmaceuticals, Farmingdale, NY	Tablets	Esterfied Estrogrens	1.25mg/Tablet.
			Methylestosterone	2.5mg/Tablet.

Therefore, the Deputy Assistant Administrator hereby orders that the above anabolic steroid products be added to the list of products excluded from application of the CSA and referenced in 21 CFR 1308.34

Interested persons are invited to submit their comments in writing with regard 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 she may reconsider the application in light of the comments and objections filed. Thereafter, the Deputy Assistant Administrator shall reinstate, revoke, or amend her original order as she 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, record keeping, 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 interest must be considered under the Regulatory Flexibility Act. (5 U.S.C. 605(b)).

Executive Order 12866

It has been determined that drug control matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of Executive Order 12866. Accordingly, this action is not subject to those provisions of Executive Order 12l778 which are contingent upon review by OMB. Nevertheless, the Deputy Assistant Administrator has determined that this is not a “major rule,” as that term is used in Executive Order 12866, and that it would otherwise meet the applicable standards of sections 2(a) and 2(b)(2) of Executive Order 12788.

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 $100,000,000 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.

Dated: January 6, 2003.

Laura M. Nagel,

Deputy Assistant Administrator, Office of Diversion Control.