[Federal Register: September 12, 2003 (Volume 68, Number 177)]
[Rules and Regulations]
[Page 53677]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se03-9]
[[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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