Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc., 23375-23376 [2014-09574]

Download as PDF 23375 Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices 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 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. is granted registration as an importer of the basic classes of controlled substances listed. Dated: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09573 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2014–09578 Filed 4–25–14; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration DEPARTMENT OF JUSTICE Importer of Controlled Substances, Notice of Registration, Myoderm Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Noramco, Inc. By Notice dated January 14, 2014, and published in the Federal Register on January 22, 2014, 79 FR 3627, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601, 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 tkelley on DSK3SPTVN1PROD with NOTICES Phenylacetone (8501) .................. Thebaine (9333) ........................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ II II II II The company plans to import the listed controlled substances to manufacture other controlled substances for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). No comments or objections have been received. The 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 classes of controlled substances is consistent with the public interest and in accordance with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The 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 VerDate Mar<15>2010 17:06 Apr 25, 2014 Jkt 232001 By Notice dated December 23, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1887, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401, 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) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Nabilone (7379) ............................ Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II II II The company plans to import the listed controlled substances in finished dosage form for clinical trials, and research. 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. The DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Myoderm to import the basic class of controlled substance is consistent with the public interest and in accordance with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 DEA has investigated Myoderm 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 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09551 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc. By Notice dated November 12, 2013, and published in the Federal Register on November 19, 2013, 78 FR 69447, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, 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 Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Methadone (9250) ........................ Morphine (9300) ........................... Fentanyl (9801) ............................ Schedule II II II 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 E:\FR\FM\28APN1.SGM 28APN1 23376 Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices interest, and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. 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. Dated: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09574 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Organix, Inc. Notice of application with opportunity for comment. ACTION: Registered bulk manufacturers of the affected basic classes and applicants therefore may file written comments or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before June 27, 2014. ADDRESSES: Written comments should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled DATES: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ............................................... Lysergic acid diethylamide (7315) .................................................. Heroin (9200) .................................................................................. Morphine (9300) .............................................................................. I .............. I .............. I .............. II ............. The company plans to manufacture reference standards for distribution to its research and forensics customers. Dated: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–09553 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration tkelley on DSK3SPTVN1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Registration; American Radiolabeled Chemicals, Inc. By Notice dated December 16, 2013, and published in the Federal Register on January 2, 2014, 79 FR 151, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. Louis, Missouri 63146, made application by written correspondence to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Methadone (9250), a basic class of controlled substance listed in schedule II. The company plans to manufacture small quantities of the listed controlled VerDate Mar<15>2010 17:06 Apr 25, 2014 Jkt 232001 Narcotic/Nonnarcotic nonnarcotic nonnarcotic narcotic narcotic substance as radiolabeled compounds for biochemical research. No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of American Radiolabeled Chemicals, Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. The DEA has investigated American Radiolabeled Chemicals, 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(a) 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. PO 00000 Frm 00060 Fmt 4703 Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, and dispensers of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been re-delegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to sec. 7(g) of 28 CFR part 0, subpart R, App. In accordance with 21 CFR 1301.33(a), this is notice that on February 3, 2014, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, made application by written correspondence to the DEA to be registered as a bulk manufacturer of the following basic classes of narcotic and nonnarcotic controlled substances: Sfmt 4703 Dated: April 21, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2014–09552 Filed 4–25–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–390] Controlled Substances: 2014 Established Aggregate Production Quotas for Four Temporarily Controlled Synthetic Cannabinoids Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice. AGENCY: This notice establishes the initial 2014 aggregate production quotas for four temporarily controlled synthetic cannabinoids: N-(1-amino-3,3-dimethyl1-oxobutan-2-yl)-1-pentyl-1H-indazole3-carboxamide (ADB–PINACA); N-(1amino-3-methyl-1-oxobutan-2-yl)-1-(4fluorobenzyl)-1H-indazole-3carboxamide (AB–FUBINACA); SUMMARY: E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23375-23376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09574]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Mylan 
Pharmaceuticals, Inc.

    By Notice dated November 12, 2013, and published in the Federal 
Register on November 19, 2013, 78 FR 69447, Mylan Pharmaceuticals, 
Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, 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
Methadone (9250)...........................  II
Morphine (9300)............................  II
Fentanyl (9801)............................  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 domestically-manufactured 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

[[Page 23376]]

interest, and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. 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.

    Dated: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2014-09574 Filed 4-25-14; 8:45 am]
BILLING CODE 4410-09-P

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