Importer of Controlled Substances; Notice of Registration; Watson Pharma, Inc., 64016-64017 [2013-25094]

Download as PDF 64016 Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices August 14, 2013, 78 FR 49546, Siegfried USA, LLC., 33 Industrial Park Road, Pennsville, New Jersey 08070, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Schedule Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II The company plans to import the listed controlled substances to bulk manufacture APIs for distribution to its customer. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Siegfried USA, LLC., 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. DEA has investigated Siegfried USA, LLC., 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. [FR Doc. 2013–25090 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE emcdonald on DSK67QTVN1PROD with NOTICES Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration, Boehringer Ingelheim Chemicals By Notice dated June 18, 2013, and published in the Federal Register on July 1, 2013, 78 FR 39337, Boehringer Ingelheim Chemicals, 2820 N. Normandy Drive, Petersburg, Virginia 23805, made application by renewal to the Drug Enforcement Administration 17:55 Oct 24, 2013 Jkt 232001 Dated: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25086 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE May 1, 1971. DEA has investigated Akorn, 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: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25081 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Watson Pharma, Inc. By Notice dated May 24, 2013, and published in the Federal Register on June 4, 2013, 78 FR 33440, Watson Pharma, Inc., 2455 Wardlow Road, Corona, California 92880–2882, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug Enforcement Administration Drug Importer of Controlled Substances, Notice of Registration, Akorn, Inc. Dated: October 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. VerDate Mar<15>2010 (DEA) to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to bulk manufacture amphetamine. 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 Boehringer Ingelheim Chemicals 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 Boehringer Ingelheim Chemicals 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. Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ By Notice dated June 18, 2013, and published in the Federal Register on July 1, 2013, 78 FR 39337, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil in bulk for use in dosage form manufacturing. 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 Akorn, Inc., consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Schedule II II II II The company plans to import the listed controlled substances for analytical testing and clinical trials. The import of the above listed basic classes of controlled substances will 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 Watson Pharma, Inc., to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under E:\FR\FM\25OCN1.SGM 25OCN1 Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices international treaties, conventions, or protocols in effect on May 1, 1971. DEA has investigated Watson Pharma, 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: October 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cedarburg Pharmaceuticals, Inc. Schedule emcdonald on DSK67QTVN1PROD with NOTICES II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Regarding the drug code (8333), the company plans manufacture this controlled substance for commercial sale. 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 17:55 Oct 24, 2013 Jkt 232001 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cambrex Charles City, Inc. Drug Pursuant to § 1301.33(a), of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 8, 2013, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, 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 [FR Doc. 2013–25102 Filed 10–24–13; 8:45 am] 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 December 24, 2013. Dated: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25091 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P 4-Anilino-N-phenethyl-4-piperidine (8333). Remifentanil (9739) ...................... Fentanyl (9801) ............................ Dated: October 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 25, 2013, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, 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: [FR Doc. 2013–25094 Filed 10–24–13; 8:45 am] Drug (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 24, 2013. 64017 Schedule Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ I II II II II II II II 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 sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Pharmacore, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 16, 2013, PharmaCore, Inc., 4180 Mendenhall Oaks Parkway, High Point, NC 27265, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as active pharmaceutical ingredients (API) for clinical trials. 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 24, 2013. Dated: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25088 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 64016-64017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25094]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Watson 
Pharma, Inc.

    By Notice dated May 24, 2013, and published in the Federal Register 
on June 4, 2013, 78 FR 33440, Watson Pharma, Inc., 2455 Wardlow Road, 
Corona, California 92880-2882, made application by renewal to the Drug 
Enforcement Administration (DEA) to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical testing and clinical trials.
    The import of the above listed basic classes of controlled 
substances will 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 Watson Pharma, Inc., to import the basic classes of 
controlled substances is consistent with the public interest and with 
United States obligations under

[[Page 64017]]

international treaties, conventions, or protocols in effect on May 1, 
1971. DEA has investigated Watson Pharma, 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: October 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-25094 Filed 10-24-13; 8:45 am]
BILLING CODE 4410-09-P