Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers 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 Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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