Manufacturer of Controlled Substances; Notice of Registration, 31314 [E9-15447]

Download as PDF 31314 Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Notices CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: June 23, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–15443 Filed 6–29–09; 8:45 am] Springfield, Virginia 22152; and must be filed no later than August 31, 2009. Dated: June 22, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–15442 Filed 6–29–09; 8:45 am] BILLING CODE 4410–09–P Dated: June 23, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–15447 Filed 6–29–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 8, 2009, Chattem Chemicals Inc., 3801 St. Elmo Avenue, Building 18, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule sroberts on PROD1PC70 with NOTICES6 4–Methoxyamphetamine (7411) ... Dihydromorphine (9145) ............... Amphetamine (1100) .................... Methamphetamine (1105) ............. Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................. Hydrocodone (9193) ..................... Meperidine (9230) ......................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) .................... Noroxymorphone (9668) ............... Alfentanil (9737) ............................ Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................. I I II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, VerDate Nov<24>2008 19:55 Jun 29, 2009 Jkt 217001 By Notice dated September 22, 2008, and published in the Federal Register on September 29, 2008, (73 FR 56612), Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to produce sodium oxybate for sale to customers. One objection was received; however, the objector is not registered with DEA as a bulk manufacturer of Gamma Hydroxybutyric Acid (GHB). DEA has determined that the objection received is without merit and does not warrant denial of the application. DEA has also determined that the Food and Drug Administration does not preclude the sale of GHB to other manufacturers for the development of generic GHB products. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Johnson Matthey Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Johnson Matthey Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, 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 in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Manufacturer of Controlled Substances; Notice of Registration By Notice dated June 19, 2008, and published in the Federal Register on June 27, 2008, (73 FR 36573), Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702–3232, made application by letter to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance in bulk for sale to its customers. One objection was received; however, the objector is not registered with DEA as a bulk manufacturer of Gamma Hydroxybutyric Acid (GHB). DEA has determined that the objection received is without merit and does not warrant denial of the application. DEA has also determined that the Food & Drug Administration does not preclude the sale of GHB to other manufacturers for the development of generic GHB products. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Norac Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Norac Inc. to ensure that the company’s registration is consistent with the public interest. The investigation included the inspection and testing of the company’s physical security systems, 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 in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed. E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 74, Number 124 (Tuesday, June 30, 2009)]
[Notices]
[Page 31314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15447]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated September 22, 2008, and published in the Federal 
Register on September 29, 2008, (73 FR 56612), Johnson Matthey Inc., 
Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New 
Jersey 08066-1742, made application by letter to the Drug Enforcement 
Administration (DEA) to be registered as a bulk manufacturer of Gamma 
Hydroxybutyric Acid (2010), a basic class of controlled substance 
listed in schedule I.
    The company plans to produce sodium oxybate for sale to customers.
    One objection was received; however, the objector is not registered 
with DEA as a bulk manufacturer of Gamma Hydroxybutyric Acid (GHB). DEA 
has determined that the objection received is without merit and does 
not warrant denial of the application. DEA has also determined that the 
Food and Drug Administration does not preclude the sale of GHB to other 
manufacturers for the development of generic GHB products.
    DEA has considered the factors in 21 U.S.C. 823(a) and determined 
that the registration of Johnson Matthey Inc. to manufacture the listed 
basic class of controlled substance is consistent with the public 
interest at this time. DEA has investigated Johnson Matthey Inc. to 
ensure that the company's registration is consistent with the public 
interest. The investigation has included inspection and testing of the 
company's physical security systems, 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 in 
accordance with 21 CFR 1301.33, the above named company is granted 
registration as a bulk manufacturer of the basic class of controlled 
substance listed.

    Dated: June 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-15447 Filed 6-29-09; 8:45 am]
BILLING CODE 4410-09-P
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