[Federal Register Volume 65, Number 28 (Thursday, February 10, 2000)]
[Notices]
[Pages 6634-6635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3145]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated October 1, 1999, and published in the Federal 
Register on October 13, 1999, (64 FR 55490), 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.
    DEA has considered the factors in Title 21, United States Code, 
Section

[[Page 6635]]

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 system, 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: February 4, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 00-3145 Filed 2-9-00; 8:45 am]
BILLING CODE 4410-09-M