Manufacturer of Controlled Substances: Notice of Application, 44285-44286 [2010-18474]

Download as PDF 44285 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices Drug Schedule Methylphenidate (1724) ................ Fentanyl (9801) ............................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Dated: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated April 20, 2010, and published in the Federal Register on April 26, 2010, (75 FR 21661), Almac Clinical Services Inc., (ACSI), 2661 Audubon Road, Audubon, Pennsylvania 19403, 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: The company plans to import the listed controlled substances to manufacture bulk controlled substance intermediates 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 952(a) and determined that the registration of Penick Corporation 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 Penick Corporation 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: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Dated: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–18475 Filed 7–27–10; 8:45 am] [FR Doc. 2010–18476 Filed 7–27–10; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P By Notice dated April 26, 2010 and published in the Federal Register on April 30, 2010, (75 FR 22844), Penick Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070, 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 Schedule Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw (9650) ..................... Concentrate of Poppy Straw (9670). PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Manufacturer of Controlled Substances: Notice of Application Importer of Controlled Substances: Notice of Registration DEPARTMENT OF JUSTICE sroberts on DSKD5P82C1PROD with NOTICES The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. 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 Almac Clinical Services Inc. (ACSI) 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 Almac Clinical Services Inc. (ACSI) 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. Drug Enforcement Administration BILLING CODE 4410–09–P Jkt 220001 II II II DEPARTMENT OF JUSTICE [FR Doc. 2010–18486 Filed 7–27–10; 8:45 am] 19:05 Jul 27, 2010 Schedule Oxycodone (9143) ........................ Hydromorphone (9150) ................ Fentanyl (9801) ............................ II II II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. 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 Mylan Pharmaceuticals 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 Mylan Pharmaceuticals 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. VerDate Mar<15>2010 Drug II II II II Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on January 27, 2009, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceuticals Service, 25 Patton Road, Devens, Massachusetts 01434, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Amphetamine (1100) .................... Methylphenidate (1724) ................ Nabilone (7379) ............................ Alfentanil (9737) ........................... Sufentanil (9740) .......................... Remifentanil (9739) ...................... Hydrocodone (9193) ..................... Schedule II II II II II II II The company plans to utilize this facility to manufacture small quantities E:\FR\FM\28JYN1.SGM 28JYN1 44286 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices of the listed controlled substances in bulk and to conduct analytical testing in support of the company’s primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to the company’s 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, Springfield, Virginia 22152; and must be filed no later than September 27, 2010. Dated: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated March 5, 2010, and published in the Federal Register on March 19, 2010, (75 FR 13304), Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule Dihydromorphine (9145) ............... Hydromorphone (9150) ................ sroberts on DSKD5P82C1PROD with NOTICES [FR Doc. 2010–18500 Filed 7–27–10; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P I II Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. The company plans to manufacture Hydromorphone HCL for sale to other manufacturers and for the manufacture of other controlled substance dosage units 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 determined that the registration of Halo Pharmaceutical Inc., to manufacture the listed basic classes of controlled substances is consistent with the public 19:05 Jul 27, 2010 Dated: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P [FR Doc. 2010–18474 Filed 7–27–10; 8:45 am] VerDate Mar<15>2010 interest at this time. DEA has investigated Halo Pharmaceutical 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 classes of controlled substances listed. Jkt 220001 By Notice dated March 16, 2010, and published in the Federal Register on March 24, 2010, (75 FR 14190), Sigma Aldrich Research Biochemicals, Inc., 1–3 Strathmore Road, Natick, Massachusetts 01760–2447, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: Drug Schedule Cathinone (1235) .......................... Methcathinone (1237) .................. Aminorex (1585) ........................... Alpha-ethyltryptamine (7249) ....... Lysergic acid diethylamide (7315) Tetrahydrocannabinols (7370) ..... 4-Bromo-2,5dimethoxyamphetamine (7391). 4-Bromo-2,5dimethoxyphenethylamine (7392). 2,5-Dimethoxyamphetamine (7396). 3,4-Methylenedioxyamphetamine (7400). N-Hydroxy-3,4methylenedioxyamphetamine (7402). 3,4-Methylenedioxy-Nethylamphetamine (7404). 3,4Methylenedioxymethamphetamine (MDMA) (7405). Psilocybin (7437) .......................... 5-Methoxy-N,Ndiisopropyltryptamine (7439). PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 I I I I I I I I I I I I I Drug 1-[1-(2Thienyl)cyclohexyl]piperidine (TCP) (7470). N-Benzylpiperazine (BZP) (7493) Heroin (9200) ............................... Normorphine (9313) ..................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Nabilone (7379) ............................ 1-Phenylcyclohexylamine (7460) Phencyclidine (7471) .................... Cocaine (9041) ............................. Codeine (9050) ............................. Diprenorphine (9058) ................... Ecgonine (9180) ........................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Meperidine (9230) ........................ Metazocine (9240) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Levo-alphacetylmethadol (9648) .. Remifentanil (9739) ...................... Carfentanil (9743) ......................... Fentanyl (9801) ............................ Schedule I I 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 reference standards. 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 Sigma Aldrich Research Biochemicals, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Sigma Aldrich Research Biochemicals, 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 classes of controlled substances listed. Dated: July 19, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–18495 Filed 7–27–10; 8:45 am] BILLING CODE 4410–09–P I I E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44285-44286]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18474]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances: Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on January 27, 2009, Johnson 
Matthey Pharmaceutical Materials, Inc., Pharmaceuticals Service, 25 
Patton Road, Devens, Massachusetts 01434, made application to the Drug 
Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the basic classes of controlled substances listed in 
schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Alfentanil (9737)..........................  II
Sufentanil (9740)..........................  II
Remifentanil (9739)........................  II
Hydrocodone (9193).........................  II
------------------------------------------------------------------------

    The company plans to utilize this facility to manufacture small 
quantities

[[Page 44286]]

of the listed controlled substances in bulk and to conduct analytical 
testing in support of the company's primary manufacturing facility in 
West Deptford, New Jersey. The controlled substances manufactured in 
bulk at this facility will be distributed to the company's 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, Springfield, Virginia 22152; and must be filed no 
later than September 27, 2010.

    Dated: July 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-18474 Filed 7-27-10; 8:45 am]
BILLING CODE 4410-09-P
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