[Federal Register Volume 61, Number 24 (Monday, February 5, 1996)]
[Notices]
[Page 4289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2315]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated August 21, 1995, and published in the Federal
Register on August 30, 1995, (60 FR 45169), Celgene Corporation, 7
Powder Horn Drive, Warren, New Jersey 07059, made application to the
Drug Enforcement Administration (DEA) for registration as a bulk
manufacturer of the basic classes of controlled substances listed
below:
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Drug Schedule
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2, 5-Dimethoxyamphetamine (7396)........... I
Amphetamine (1100)......................... II
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A registered manufacturer filed an objection dated October 16,
1995, to the registration of Celgene Corporation as a bulk manufacturer
of amphetamine stating that they do not believe there is need for
another manufacturer. They also requested a hearing if DEA would not
deny the application. Under Title 21, Code of Federal Regulations,
Section 1301.43(b), DEA is not required to limit the number of
manufacturers solely because a smaller number is capable of producing
an adequate supply provided effective controls against diversion are
maintained. DEA has conducted an investigation of Celgene Corporation,
and determined that effective controls against diversion will be
maintained. The request for a hearing is not valid since it was
received after July 20, 1995, the date Title 21, Code of Federal
Regulations, Section 1304.43(a) was amended to eliminate the third-
party manufacturer hearing requirement for objections to certain bulk
manufacturers.
Therefore, pursuant to section 303 of the Comprehensive Drug Abuse
Prevention and Control Act of 1970 and Title 21, Code of Federal
Regulations, Section 1301.54(e), Deputy Assistant Administrator, Office
of Diversion Control, hereby orders that the application submitted by
the above firm for registration as a bulk manufacturer of the basic
classes of controlled substances listed above is granted.
Dated: December 15, 1995.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 96-2315 Filed 2-2-96; 8:45 am]
BILLING CODE 4410-09-M
