[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Notices]
[Pages 45786-45787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17958]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated February 12, 2008 and published in the Federal 
Register on February 21, 2008, (73 FR 9593), Roche Diagnostics 
Operations, Inc., Attn: Regulatory Compliance, 9115 Hague Road, 
Indianapolis, Indiana 46250, 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
------------------------------------------------------------------------
Lysergic acid diethylamide (7315)...........  I
Tetrahydrocannabinols (THC) (7370)..........  I
Alphamethadol (9605)........................  I
Hydromorphone (9150)........................  II
Benzoylecgonine (9180)......................  II
Methadone (9250)............................  II
Morphine (9300).............................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances for use in diagnostic products.
    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 
Roche Diagnostics Operations, Inc. to manufacture the listed basic 
classes of controlled substances is consistent with the public interest 
at this time. DEA has investigated Roche Diagnostics Operations, Inc. 
to ensure that the company's registration is consistent with the public 
interest. The investigation has included inspection

[[Page 45787]]

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: July 29, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E8-17958 Filed 8-5-08; 8:45 am]
BILLING CODE 4410-09-P