Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc., 39340 [2013-15604]

Download as PDF 39340 Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices Drug Schedule Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Morphine (9300) ........................... Thebaine (9333) ........................... Opium, powdered (9639) ............. Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II II II II Boehringer Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805–9372, 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: Amphetamine (1100) II Drug Schedule Methylphenidate (1724) ................ Methadone (9250) ........................ Methadone Intermediate (9254) ... Tapentadol (9780) ........................ The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. 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 SA INTL GMBH C/O., Sigma Aldrich Co. 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, at this time. DEA has investigated SA INTL GMBH C/O., Sigma Aldrich Co. 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. II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to Methadone Intermediate (9254) the company plans to produce Methadone HCL active pharmaceutical ingredients (APIs) for sale 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 August 30, 2013. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15604 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration [FR Doc. 2013–15576 Filed 6–28–13; 8:45 am] Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 21, 2013, Chemtos, LLC., 14101 W. Highway 290, Building 2000B, Austin, Texas 78737– 9331, 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; Chemtos, LLC. BILLING CODE 4410–09–P mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 31, 2013, VerDate Mar<15>2010 22:39 Jun 28, 2013 Jkt 229001 Drug Schedule Amphetamine (1100) .................... PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 II Drug Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Etorphine HCL (9059) .................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Isomethadone (9226) ................... Meperidine (9230) ........................ Meperidine-intermediate-A (9232) Meperidine-intermediate-B (9233) Meperidine-intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Dihydroetorphine (9334) ............... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Racemethorphan (9732) .............. Racemorphan (9733) ................... Schedule 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 II II II The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers for use as reference standards. 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 August 30, 2013. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15572 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Patheon Pharmaceuticals, Inc. By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19016, Patheon E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Page 39340]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15604]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Boehringer Ingelheim Chemicals, Inc.

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on May 31, 2013, Boehringer 
Ingelheim Chemicals, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 
23805-9372, 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:

------------------------------------------------------------------------
               Drug Schedule                    Amphetamine (1100) II
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Methadone (9250)...........................  II
Methadone Intermediate (9254)..............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers for formulation into finished 
pharmaceuticals. In reference to Methadone Intermediate (9254) the 
company plans to produce Methadone HCL active pharmaceutical 
ingredients (APIs) for sale 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 Sec.  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 August 30, 2013.

     Dated: June 18, 2013.
Joseph T. Rannazzisi,
 Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-15604 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P