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[Federal Register Volume 74, Number 13 (Thursday, January 22, 2009)]
[Notices]
[Page 4054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1196]

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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).....................  II
Opium, granulated (9640)...................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------

    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    Drug code 1726 (methylphenidate) has been withdrawn from the 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
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