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Noramco Inc
FR Doc E9-1196[Federal Register: January 22, 2009 (Volume 74, Number 13)]
[Notices] [Page 4054] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja09-73]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated October 9, 2008 and published in the Federal Register on
October 17, 2008 (73 FR 61909), Noramco Inc., Division of Ortho McNeil, Inc.,
500 Swedes Landing Road, Wilmington, Delaware 19801-4417, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk
manufacturer of the basic classes of controlled substances listed in schedules I
and II:
|
Drug
|
Schedule
|
|
Codeine-N-oxide (9053)
|
I
|
|
Dihydromorphine (9145)
|
I
|
|
Morphine-N-oxide (9307)
|
I
|
|
Methylphenidate (1724)
|
II
|
|
Codeine (9050)
|
II
|
|
Dihydrocodeine (9120)
|
II
|
|
Oxycodone (9143)
|
II
|
|
Hydromorphone (9150)
|
II
|
|
Hydrocodone (9193)
|
II
|
|
Morphine (9300)
|
II
|
|
Thebaine (9333)
|
II
|
|
Opium extracts (9610)
|
II
|
|
Opium fluid extract (9620)
|
II
|
|
Opium tincture (9630)
|
II
|
|
Opium, powdered (9639)
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II
|
|
Opium, granulated (9640)
|
II
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Oxymorphone (9652)
|
II
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The company plans to bulk manufacture the above listed controlled substances
for sale and distribution to manufacturers for product development and
formulation.
Drug code 1726 (methylphenidate) has been withdrawn from the application for
registration as all manufacturing activity for methylphenidate can be conducted
under drug code 1724 for the same substance.
No comments or objections have been received. DEA has considered the factors
in 21 U.S.C. 823(a) and determined that the registration of Noramco Inc. to
manufacture the listed basic classes of controlled substances is consistent with
the public interest at this time. DEA has investigated Noramco Inc. to ensure
that the company's registration is consistent with the public interest. The
investigation has included inspection and testing of the company's physical
security systems, verification of the company's compliance with state and local
laws, and a review of the company's background and history. Therefore, pursuant
to 21 U.S.C. 823, and in accordance with 21 CFR
1301.33, the above named company
is granted registration as a bulk manufacturer of the basic classes of
controlled substances listed.
Dated: January 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration.
[FR Doc. E9-1196 Filed 1-21-09; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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