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

Federal Register, Volume 78 Issue 207 (Friday, October 25, 2013)

Federal Register Volume 78, Number 207 (Friday, October 25, 2013)

Notices

Page 64017

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2013-25091

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

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

Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 25, 2013, 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

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.

Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).

Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 24, 2013.

Dated: September 27, 2013.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

FR Doc. 2013-25091 Filed 10-24-13; 8:45 am

BILLING CODE 4410-09-P