Source: http://www.thefederalregister.com/d.p/2001-04-04-01-8180
Timestamp: 2013-05-20 11:47:12
Document Index: 617398754

Matched Legal Cases: ['art 7114', 'art 3944', 'art 6726', 'art 140', 'art 5250', 'art 1739', 'art 30206', 'art 514', 'art 9740', 'art 180']

Irix Pharmaceuticals, Inc., Daily Rules, Proposed Rules, and Notices of the Federal Government
14 CFR Part 7114 CFR Part 3944 CFR Part 6726 CFR Part 140 CFR Part 5250 CFR Part 1739 CFR Part 30206 CFR Part 514 CFR Part 9740 CFR Part 180	Federal Register: April 4, 2001 (Volume 66, Number 65)
DOCID: FR Doc 01-8180
SUBJECT CATEGORY: Manufacturer of Controlled Substances; Notice of Registration DOCUMENT SUMMARY: 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 bulk manufacturer of the basic class of controlled substance listed above is granted. Dated: March 26, 2001. Laura M. Nagel,
[FR Doc. 018180 Filed 4301; 8:45 am]
BILLING CODE 441009M
SUMMARY: Irix Pharmaceuticals, Inc., DOCUMENT BODY 2: 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.