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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |