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

Manufacturers Notice of Registration - 2011

[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23627-23628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10144]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled Substances; Notice of Registration

By Notice dated October 6, 2010, and published in the Federal Register on October 14, 2010, 75 FR 63203, PCAS-Nanosyn, LLC, 3331-B Industrial Drive, Santa Rosa, California 95403, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:

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.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of PCAS-Nanosyn, LLC to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated PCAS-Nanosyn, LLC 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

[[Page 23628]]

the basic classes of controlled substances listed.

Dated: April 15, 2011.

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

[FR Doc. 2011-10144 Filed 4-26-11; 8:45 am]

BILLING CODE 4410-09-P

 

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