This PDF is the current document as it appeared on Public Inspection on 07/25/2012 at 08:45 am.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 4, 2012, 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:
|Gamma Hydroxybutyric Acid (2010)||I|
|Dextropropoxyphene, bulk (non-dosage forms) (9273)||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|
|Poppy Straw Concentrate (9670)||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.
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 September 24, 2012.
Dated: July 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2012-18212 Filed 7-25-12; 8:45 am]
BILLING CODE 4410-09-P