Applications, hearings, determinations, etc.: Novartis Pharmaceuticals Corp.,

[Federal Register: February 4, 1999 (Volume 64, Number 23)]

[Notices]

[Page 5678-5679]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04fe99-90]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled Substances; Notice of Registration

By Notice dated July 13, 1998, and published in the Federal Register on July 29, 1998, (63 FR 40543), Novartis Pharmaceuticals Corp., Regulatory Compliance, 556 Morris Avenue, Summit, New Jersey 07901, 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 finished product for distribution to its customers.

[[Page 5679]]

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 Novartis Pharmaceuticals Corp. to manufacture methylphenidate is consistent with the public interest at this time. DEA has investigated Novartis Pharmaceuticals Corp. 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. Sec. 823 and 28 CFR Secs. 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: January 22, 1999. John H. King, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 99-2679Filed2-3-99; 8:45 am]

BILLING CODE 4410-09-M