Skip to Content

Notice

Manufacturer of Controlled Substances; Notice of Application

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

Pursuant to § 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:

DrugSchedule
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 § 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.

Start Signature

Dated: October 6, 2010.

Joseph T. Rannazzisi,

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

End Signature End Preamble

[FR Doc. 2010-25849 Filed 10-13-10; 8:45 am]

BILLING CODE 4410-09-P