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Notices of Registration - 2001[Federal Register: April 4, 2001 (Volume 66,
Number 65)] DEPARTMENT OF JUSTICE DRUG ENFORCEMENT ADMINISTRATION Manufacturer of Controlled Substances; Notice of Registration By Notice dated September 28, 2000, and published in the Federal Register on October 13, 2000, (65 FR 60978), Irix Pharmaceuticals, Inc., 101 Technology Place, Florence, South Carolina 29501, 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 methylphenidate for demonstration purposes and for dosage form development and stability studies. 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 Irix Pharmaceuticals,
Inc. to manufacture methylphenidate is consistent with the public
interest at this time. DEA has investigated the firm 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 Dated: March 26, 2001. Laura M. Nagel, [FR Doc. 01-8180 Filed 4-3-01; 8:45 am]
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