[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:
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Drug Schedule
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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
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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