[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06536]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Cambrex 
Charles City

ACTION: Notice of registration.

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SUMMARY: Cambrex Charles City applied to be registered as a 
manufacturer of certain basic classes of controlled substances. The 
Drug Enforcement Administration (DEA) grants Cambrex Charles City 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and 
published in the Federal Register on October 21, 2015, 80 FR 63835, 
Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 
applied to be registered as a manufacturer of certain basic classes of 
controlled substances. No other comments or objections were submitted 
for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Cambrex Charles City to manufacture 
the basic classes of controlled substances is consistent with the 
public interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing the company's background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the following basic classes of controlled substances:

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            Controlled substance                       Schedule
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Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium extracts (9610)......................  II
Opium fluid extract (9620).................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  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.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06536 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P