Notice of Registration - 2012
[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70189-70190]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28499]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration;
Cambrex Charles City, Inc.
By Notice dated July 17, 2012 and published in the Federal Register
on July 26, 2012, 77 FR 43863, 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 (ANPP) (8333) |
II |
| Phenylacetone (8501) |
II |
| Cocaine (9041) |
II |
| Codeine (9050) |
II |
| Oxycodone (9143) |
II |
| Hydromorphone (9150) |
II |
| Hydrocodone (9193) |
II |
| Methadone (9250) |
II |
| Dextropropoxyphene, bulk (non-dosage forms) (9273) |
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 |
| 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. DEA has considered
the factors in 21 U.S.C. 823(a), and
[[Page 70190]]
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. 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(a), 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: November 14, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-28499 Filed 11-21-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
