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Notice

Manufacturer of Controlled Substances; Notice of Registration

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Information about this document as published in the Federal Register.

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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:

DrugSchedule
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Drug code 1726 (methylphenidate) has been withdrawn from the application for registration as all manufacturing activity for methylphenidate can be conducted under drug code 1724 for the same substance.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.

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Dated: January 14, 2009.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

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[FR Doc. E9-1196 Filed 1-21-09; 8:45 am]

BILLING CODE 4410-09-P