[Federal Register: June 13, 2003 (Volume 68, Number 114)]
[Rules and Regulations]
[Page 35293-35294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn03-16]
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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