[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14299-14300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05495]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Cambrex Charles City, Inc.

    By Notice dated September 27, 2013, and published in the Federal 
Register on October 25, 2013, 78 FR 64017, Cambrex Charles City, Inc., 
1205 11th Street, Charles City, Iowa 50616, made application by renewal 
to the Drug Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium, raw (9600)..........................  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

[[Page 14300]]

 
Noroxymorphone (9668)......................  II
Poppy Straw Concentrate (9670).............  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.
    No comments or objections have been received. The DEA has 
considered the factors in 21 U.S.C. 823(a) and determined that the 
registration of Cambrex Charles City, Inc., to manufacture the listed 
basic classes of controlled substances is consistent with the public 
interest at this time. The DEA has investigated Cambrex Charles City, 
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: February 19, 2014.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-05495 Filed 3-12-14; 8:45 am]
BILLING CODE 4410-09-P