Manufacturer of Controlled Substances; Notice of Registration; Catalent Pharma Solutions, Inc., 47114 [2012-19202]

Download as PDF 47114 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–19208 Filed 8–6–12; 8:45 am] [FR Doc. 2012–19202 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 5, 2012, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc. By Notice dated April 17, 2012, and published in the Federal Register on April 26, 2012, 77 FR 24984, Catalent Pharma Solutions, Inc., 10381 Decatur Road, Philadelphia, Pennsylvania 19114, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials. The import of the above listed basic class of controlled substance would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. 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 Catalent Pharma Solutions, 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. DEA has investigated Catalent Pharma Solutions, 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. Manufacturer of Controlled Substances; Notice of Application; AMRI Rensselaer, Inc. Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Catalent Pharma Solutions, Inc. Drug Enforcement Administration DEPARTMENT OF JUSTICE Drug Enforcement Administration mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 6, 2012, 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 following basic classes of controlled substances: VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 Drug Drug Schedule Dihydromorphine (9145) ............... Hydromorphone (9150) ................ 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 to manufacture other controlled substances 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, Springfield, Virginia 22152; and must be filed no later than October 9, 2012. Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–19184 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P PO 00000 Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ...... Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Drug Schedule. 4–Anilino-N-phenethyl-4–Piperidine (8333) ............................... Meperidine (9230) ........................ Fentanyl (9801) ............................ Dated: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P Fmt 4703 Sfmt 9990 II II II The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol as a synthetic intermediate, which will be further synthesized to bulk manufacture a synthetic THC (7370). No other activity for this drug code is authorized for this registration. 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 October 9, 2012. [FR Doc. 2012–19174 Filed 8–6–12; 8:45 am] Frm 00087 I I II II II II E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Page 47114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19202]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Catalent Pharma Solutions, Inc.

    By Notice dated April 17, 2012, and published in the Federal 
Register on April 26, 2012, 77 FR 24984, Catalent Pharma Solutions, 
Inc., 10381 Decatur Road, Philadelphia, Pennsylvania 19114, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as an importer of Noroxymorphone (9668), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials.
    The import of the above listed basic class of controlled substance 
would be granted only for analytical testing and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial distribution in the United 
States.
    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 Catalent Pharma Solutions, 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.
    DEA has investigated Catalent Pharma Solutions, 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.

    Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-19202 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P

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