Manufacturer of Controlled Substances; Notice of Registration, 17968 [2011-7540]

Download as PDF 17968 Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices Drug Schedule Methylphenidate (1724) ................ Fentanyl (9801) ............................ 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. 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: March 21, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration wwoods2 on DSK1DXX6B1PROD with NOTICES BILLING CODE 4410–09–P Manufacturer of Controlled Substances; Notice of Registration DEPARTMENT OF JUSTICE By Notice dated November 1, 2010, and published in the Federal Register on November 12, 2010, 75 FR 69460, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Cocaine (9041), a basic class of controlled substance listed in schedule II. Jkt 223001 [FR Doc. 2011–7544 Filed 3–30–11; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P 11:23 Mar 31, 2011 Dated: March 21, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE [FR Doc. 2011–7545 Filed 3–30–11; 8:45 am] VerDate Mar<15>2010 The company plans to import small quantities of ioflupane, in the form of three separate analogues of Cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. 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 GE Healthcare 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 GE Healthcare 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. By Notice dated August 2, 2010, and published in the Federal Register on September 1, 2010, (75 FR 53720), Austin Pharma LLC., 811 Paloma Drive, Suite A, Round Rock, Texas 78665– 2402, 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 Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Alphamethadol (9605) .................. Nabilone (7379) ............................ Methadone (9250) ........................ Methadone Intermediate (9254) ... Levo-alphacetylmethadol (9648) .. Alfentanil (9737) ........................... PO 00000 Frm 00152 Fmt 4703 Sfmt 4703 I I I II II II II II Drug Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ Schedule II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic THC (7370). No other activity for this drug code is authorized for this registration. 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 Austin Pharma LLC. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Austin Pharma 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. 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: March 21, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–7540 Filed 3–30–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated August 13, 2010, and published in the Federal Register on September 1, 2010, 75 FR 53719, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (GHB) (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture Gamma Hydroxybutyric Acid (GHB) E:\FR\FM\31MR1.SGM 31MR1

Agencies

[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Notices]
[Page 17968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7540]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated August 2, 2010, and published in the Federal 
Register on September 1, 2010, (75 FR 53720), Austin Pharma LLC., 811 
Paloma Drive, Suite A, Round Rock, Texas 78665-2402, 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
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Alphamethadol (9605).......................   I
Nabilone (7379)............................  II
Methadone (9250)...........................  II
Methadone Intermediate (9254)..............  II
Levo-alphacetylmethadol (9648).............  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution to its customers.
    In reference to drug code 7360 (Marihuana), the company plans to 
bulk manufacture cannabidiol as a synthetic intermediate. This 
controlled substance will be further synthesized to bulk manufacture a 
synthetic THC (7370). No other activity for this drug code is 
authorized for this registration.
    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 
Austin Pharma LLC. to manufacture the listed basic classes of 
controlled substances is consistent with the public interest at this 
time. DEA has investigated Austin Pharma 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. 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: March 21, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-7540 Filed 3-30-11; 8:45 am]
BILLING CODE 4410-09-P

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