E6-17522. Schedules of Controlled Substances: Exempt Anabolic Steroid Products

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Final rule.

SUMMARY:

The Drug Enforcement Administration (DEA) is finalizing an Interim Rule designating two 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 October 20, 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: [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). 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 0.100(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 § 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 evaluation. The purpose of this rule is to finalize an interim rule regarding 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 January 12, 2004, written to the DEA on behalf of Pharmaceutics International Inc. (PII), and an application to exempt from control under the CSA two products each containing esterified estrogens and methyltestosterone. In a letter dated April 1, 2004, DEA provided a copy of this application to the Department of Health and Human Services (DHHS) along with a request for evaluation and a recommendation. In a letter dated September 22, 2005, the Assistant Secretary of Health for DHHS recommended that both Essian^TM and Essian^TM H.S. be exempted from control under the CSA based on their similarity to the products, Estratest® and Estratest® H.S., respectively, both of which have been exempted from control under the CSA.

DEA agreed 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 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 10835, March 3, 2006).

Comments Received

The DEA received no comments in response to the Interim Rule. Thus, the rule is being finalized without change. Accordingly, the Deputy Assistant Administrator 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

Trade name	Company	Form	Ingredients	Quantity
EssianTM H.S	Pharmaceutics International Inc	Tablets	Esterfied Estrogens Methyltestosterone	0.625mg/Tablet. 1.25mg/Tablet.
EssianTM	Pharmaceutics International Inc	Tablets	Esterfied Estrogens Methyltestosterone	1.25mg/Tablet. 2.5mg/Tablet.

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 final 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 final 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 final 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 final rule will not result in the expenditure by State, local or 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.

Small Business Regulatory Enforcement Fairness Act of 1996

This final rule is not a major rule as defined by § 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.

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

Pursuant to the authority vested in the Attorney General by section 1903 of the Anabolic Steroid 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 adopts as a final rule, without change, the interim rule which was published at 71 FR 10835, on March 3, 2006 amending the list described in 21 CFR 1308.34.

Dated: October 10, 2006.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control.