[Federal Register Volume 68, Number 177 (Friday, September 12, 2003)]
[Rules and Regulations]
[Page 53677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23287]



[[Page 53677]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-236F]


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

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

ACTION: Final rule; reinstatement of exemptions.

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SUMMARY: The DEA is withdrawing the suspension of the interim rule 
published on June 13, 2003 and reinstating the order published on 
January 15, 2003 designating two pharmaceutical preparations as exempt 
anabolic steroid products under the Controlled Substances Act (CSA). 
The current action is being taken after reconsidering the application 
for exemption in light of the comments and objections filed and other 
relevant information. This action is part of the ongoing implementation 
of the Anabolic Steroids Control Act (ASCA) of 1990.

EFFECTIVE DATE: September 12, 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 Public Law 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, Inc. to exempt two of their anabolic steroid products, 
Syntest H.S. and Syntest D.S. This application was forwarded to the 
Assistant Secretary for Health, Department of Health and Human Services 
(HHS) for her 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.
    DEA received two comments from interested persons that raised 
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 immediately suspended the effectiveness of this 
order until she reconsidered the application in light of the comments 
and objections filed.

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

    A preparation containing an anabolic steroid may be exempted from 
the requirements of the CSA if it has no significant potential for 
abuse. Accordingly, the DEA is responding only to those aspects of the 
comments received that raise the issue of abuse potential of Syntest 
H.S. and Syntest D.S. One commenter made reference to the abuse of 
anabolic steroids, in general. Although the abuse of anabolic steroids 
is of great concern to the DEA, no information was presented to alter 
the initial findings that the products do not possess a significant 
potential for abuse. The second commenter alleged that Syntho 
Pharmaceutical, Inc. distributed the products as exempt preparations 
prior to the exemptions being granted; however, there is no evidence of 
any abuse or significant potential for abuse of the products as a 
result of this activity by the company. Thus, after a thorough review 
and investigation of the two comments DEA received, and all other 
relevant information, the DEA found no indication that there is a 
significant potential for abuse of either Syntest H.S. or Syntest D.S. 
Therefore, in compliance with 21 CFR 1308.33(d), the Deputy Assistant 
Administrator reinstates her original order to add the products to the 
list of exempt anabolic steroids.

    Dated: September 8, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-23287 Filed 9-11-03; 8:45 am]
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