Manufacturers Notice of Registration - 2001
[Federal Register: July 3, 2001 (Volume 66, Number 128)] [Notices] [Page 35268-35269] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr03jy01-73]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated December 4, 2000, and published in the Federal Register on January 10, 2001, (66 FR 2004), Medeva Pharmaceuticals CA, Inc., 3501 West Garry Avenue, Santa Ana,
California 92704, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of methylphenidate (1724), a basic class of controlled substance listed in schedule II.
The firm plans to manufacture the listed controlled substance to make finished dosage forms for distribution to its customers.
No comments or objections have been received. DEA has considered the factors in Title 21, United States Code, section 823(a) and determined that the registration of Medeva Pharmaceuticals CA, Inc. to manufacture the listed controlled substance is consistent with the public interest at this time. DEA has investigated Medeva Pharmaceuticals CA, Inc. on a regular basis to ensure that the company's continued registration is consistent with the public interest. These investigations have included inspection and testing of the company's physical security systems, audits of the company's records, 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 and 28 CFR 0.100 and 0.104, the Deputy Assistant Administrator, Office of Diversion Control, hereby orders that the application submitted by the above firm for registration as a bulk manufacturer of the basic class of controlled substance listed above is granted.
Dated: June 19, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 01-16680 Filed 7-2-01; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).