03-14901. Schedules of Controlled Substances: Exempt Anabolic Steroid Products

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Suspension of interim rule.

SUMMARY:

The DEA is suspending the order published January 15, 2003 designating two pharmaceutical preparations as exempt anabolic steroid products under the Controlled Substances Act (CSA). This suspension was brought about by the receipt of two comments that raised significant issues regarding the order. This action is part of the ongoing implementation of the Anabolic Steroid Control Act (ASCA) of 1990.

EFFECTIVE DATE:

June 13, 2003.

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 ASCA of 1990 (Title XIX of Pub. L. 101-647) placed anabolic steroids into Schedule III of the CSA (21 U.S.C. 812). 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 (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.

In conformance with § 1308.33 of Title 21 of the Code of Federal Regulations, an application was received from Syntho Pharmaceuticals to exempt two of their anabolic steroid products, Syntest H.S. and Syntest D.S. This application was forwarded to the Secretary of Health and Human Services (HHS) for his evaluation. Upon the recommendation of HHS and other relevant information, the DEA published an interim rule and request for comments (68 FR 1964, January 15, 2003) in which the Deputy Assistant Administrator ordered the products to be added to the list of exempt anabolic steroids.

Suspension of Order To Add Anabolic Steroid Products to the List of Products Exempted From Application of the CSA

DEA received two comments from interested persons that raised significant issues regarding findings of fact or conclusions of law upon which this order was based. As set forth in 21 CFR 1308.33(d), the Deputy Assistant Administrator hereby immediately suspends the effectiveness of this order until she may reconsider the application in light of the comments and objections filed. Thereafter, the Deputy Assistant Administrator will reinstate, revoke, or amend her original order as she determines appropriate.

Dated: June 4, 2003.

Laura M. Nagel,

Deputy Assistant Administrator, Office of Diversion Control.