[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Rules and Regulations]
[Pages 35293-35294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14901]



Drug Enforcement Administration

21 CFR Part 1308

[DEA-236S]


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

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

ACTION: Suspension of interim rule.

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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

[[Page 35294]]

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: (202) 307-
7183.

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 Sec.  1308.33 of Title 21 of the Code of Federal Regulations.
    In conformance with Sec.  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.
[FR Doc. 03-14901 Filed 6-12-03; 8:45 am]
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