By Notice dated September 1, 2000, and published in the Federal Register on September 25, 2000, (65 FR 57621), Glaxo Wellcome Inc., Attn: Jeffrey A. Weiss, 1011 North Avendell Avenue, P.O. Box 1217, Zebulon, North Carolina 27597-2309, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in Schedule II.
The remifentanil is being imported for the production of Ultiva dosage forms and for research and new product development.
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 Glaxo Wellcome Inc. to import remifentanil is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Glaxo Wellcome 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 section 1008(a) of the Controlled Substances Import and Export Act and in accordance with title 21, Code of Federal Regulations, section 1301.34, the above firm is granted registration as an importer of the basic class of controlled substance listed above.Start Signature
Dated: November 7, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 00-30291 Filed 11-27-00; 8:45 am]
BILLING CODE 4410-09-M