Notice of Application - 2010
[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63203]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc10-98]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application
Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal
Regulations (CFR), this is notice that on January 28, 2010, PCAS-Nanosyn, LLC., 3331-B Industrial Drive, Santa Rosa, California 95403, made application to the Drug Enforcement Administration (DEA) as a bulk
manufacturer of the basic classes of controlled substances listed in
schedule II:
| Drug |
Schedule |
| Amphetamine (1100) |
II |
| Methamphetamine (1105) |
II |
| Methylphenidate (1724) |
II |
| Phencyclidine (7471) |
II |
| Codeine (9050) |
II |
| Diprenorphine (9058) |
II |
| Oxycodone (9143) |
II |
| Hydromorphone (9150) |
II |
| Hydrocodone (9193) |
II |
| Methadone (9250) |
II |
| Morphine (9300) |
II |
| Oxymorphone (9652) |
II |
| Fentanyl (9801) |
II |
The company is a contract manufacturer. At the request of the
company's customers, it manufactures derivatives of controlled
substances in bulk form only. The primary service provided by the
company to its customers is the development of the process of
manufacturing the derivative. As part of its service to its customers,
the company distributes the derivatives of the controlled substances it
manufactures to those customers. The company's customers use the newly-created processes and the manufactured derivatives in furtherance of
formulation processes and dosage form manufacturing; pre-clinical
studies, including toxicological studies; clinical studies supporting
investigational Drug Applications; and use in stability 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 Sec. 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 13, 2010.
Dated: October 6, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-25849 Filed 10-13-10; 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). |
