Manufacturer of Controlled Substances; Notice of Registration, 19595-19596 [E9-9795]

Download as PDF Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9782 Filed 4–28–09; 8:45 am] 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975 (40 FR 43745–46), all applicants for registration to import the basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a)(2), authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with Title 21 Code of Federal Regulations § 1301.34(a), this is notice that on March 10, 2009, Almac Clinical Services Inc. (ACSI), 2661 Audubon Road, Audubon, Pennsylvania 19403, has made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: Drug pwalker on PROD1PC71 with NOTICES Oxycodone (9143) ........................ Fentanyl (9801) ............................ 17:48 Apr 28, 2009 BILLING CODE 4410–09–P Jkt 217001 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9789 Filed 4–28–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated January 30, 2009, and published in the Federal Register on February 6, 2009 (74 FR 6309), Mallinckrodt Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic Schedule classes of controlled substances listed in II schedule II: II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43, and in such form as prescribed by 21 CFR 1316.47. Any such comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than May 29, 2009. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR VerDate Nov<24>2008 Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9780 Filed 4–28–09; 8:45 am] 19595 Drug Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw (9650) ..................... Poppy Straw Concentrate (9670) II II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Mallinckrodt Inc. to import the basic classes of controlled substances 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 Mallinckrodt 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 PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 By Notice dated December 22, 2008, and published in the Federal Register on December 31, 2008 (73 FR 80431), Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702–3232, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Tetrahydrocannabinols (7370), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance in bulk for formulation into the pharmaceutical controlled substance Marinol® for sale to its customers. No comments or objections have been received. 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 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. E:\FR\FM\29APN1.SGM 29APN1 19596 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9795 Filed 4–28–09; 8:45 am] Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9791 Filed 4–28–09; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration Importer of Controlled Substances; Notice of Registration By Notice dated December 22, 2008, and published in the Federal Register on December 31, 2008 (73 FR 80431), Johnson Matthey Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, has made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II: By Notice dated January 9, 2009, and published in the Federal Register on January 21, 2009 (74 FR 3642), Noramco Inc., 1440 Olympic Drive, Athens, Georgia 30601, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Thebaine (9333), a basic class of controlled substance listed in schedule II. The company plans to import analytical reference standards for distribution to its customers for research purposes. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Noramco Inc. to import the basic class of controlled substance 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 Noramco 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic class of controlled substance listed. By Notice dated February 5, 2009, and published in the Federal Register on February 11, 2009 (74 FR 6920), Roche Diagnostics Operations Inc., Attn: Regulatory Compliance, 9115 Hague Road, Indianapolis, Indiana 46250, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule pwalker on PROD1PC71 with NOTICES Thebaine (9333) ........................... Noroxymorphone (9668) ............... II II The company plans to import analytical reference standards for distribution to its customers for research purposes. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Johnson Matthey Inc. to import the basic classes of controlled substances 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 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9788 Filed 4–28–09; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration Drug Lysergic acid diethylamide (7315) Tetrahydrocannabinols (7370) ..... Alphamethadol (9605) .................. Cocaine (9041) ............................. Ecgonine (9180) ........................... Methadone (9250) ........................ Morphine (9300) ........................... 17:48 Apr 28, 2009 Jkt 217001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 I I I II II II II The company plans to import the listed controlled substances for the manufacture of diagnostic products for distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Roche Diagnostics Operations Inc. to import the basic classes of controlled substances 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 Roche Diagnostics Operations 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: April 17, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E9–9784 Filed 4–28–09; 8:45 am] BILLING CODE 4410–09–P VerDate Nov<24>2008 Schedule E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19595-19596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9795]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated December 22, 2008, and published in the Federal 
Register on December 31, 2008 (73 FR 80431), Norac Inc., 405 S. Motor 
Avenue, P.O. Box 577, Azusa, California 91702-3232, made application by 
renewal to the Drug Enforcement Administration (DEA) to be registered 
as a bulk manufacturer of Tetrahydrocannabinols (7370), a basic class 
of controlled substance listed in schedule I.
    The company plans to manufacture the listed controlled substance in 
bulk for formulation into the pharmaceutical controlled substance 
Marinol[supreg] for sale to its customers.
    No comments or objections have been received. 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 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.


[[Page 19596]]


    Dated: April 17, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-9795 Filed 4-28-09; 8:45 am]
BILLING CODE 4410-09-P
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