Manufacturer of Controlled Substances; Notice of Application, 14689-14690 [2011-6157]

Download as PDF Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, VA 22152; and must be filed no later than April 15, 2011. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: March 8, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 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 Meridian Medical Technologies 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 Meridian Medical Technologies 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: March 9, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–6166 Filed 3–16–11; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2011–6165 Filed 3–16–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 14689 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 9, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–6164 Filed 3–16–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Importer of Controlled Substances; Notice of Registration srobinson on DSKHWCL6B1PROD with NOTICES Drug Enforcement Administration Drug Enforcement Administration DEPARTMENT OF JUSTICE Importer of Controlled Substances; Notice of Registration Drug Enforcement Administration By Notice dated November 29, 2010, and published in the Federal Register on December 9, 2010 (75 FR 76755), 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: Manufacturer of Controlled Substances; Notice of Application By Notice dated November 19, 2010, and published in the Federal Register on December 3, 2010, 75 FR 75496, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world, including in Europe. The company has been asked to ensure that its product sold to European customers meets standards established by the European Pharmacopeia, which is administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM to use as reference standards. This is the sole purpose for which the company will be authorized by DEA to import morphine. VerDate Mar<15>2010 15:48 Mar 16, 2011 Jkt 223001 Drug Schedule Methylphenidate (1724) ................. Oxycodone (9143) ......................... Hydromorphone (9150) .................. Fentanyl (9801) .............................. 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 PO 00000 Frm 00043 Fmt 4703 Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 9, 2010, Mallinckrodt, Inc., 3600 North Second Street, St. Louis, Missouri 63147, 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: Sfmt 4703 Drug Tetrahydrocannabinols (7370) ....... Codeine-N-oxide (9053) ................ Dihydromorphine (9145) ................ Difenoxin (9168) ............................ Morphine-N-oxide (9307) ............... Normorphine (9313) ....................... Norlevorphanol (9634) ................... Amphetamine (1100) ..................... Methamphetamine (1105) .............. Methylphenidate (1724) ................. Nabilone (7379) ............................. Codeine (9050) .............................. Diprenorphine (9058) ..................... Etorphine HCl (9059) ..................... E:\FR\FM\17MRN1.SGM 17MRN1 Schedule I I I I I I I II II II II II II II 14690 Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices Drug Schedule Dihydrocodeine (9120) .................. Oxycodone (9143) ......................... Hydromorphone (9150) .................. Diphenoxylate (9170) ..................... Ecgonine (9180) ............................ Hydrocodone (9193) ...................... Levorphanol (9220) ........................ Meperidine (9230) .......................... Methadone (9250) ......................... Methadone intermediate (9254) .... Metopon (9260) ............................. Dextropropoxyphene, bulk (9273) Morphine (9300) ............................ Oripavine (9330) ............................ Thebaine (9333) ............................ Opium extracts (9610) ................... Opium fluid extract (9620) ............. Opium tincture (9630) .................... Opium, powdered (9639) ............... Opium, granulated (9640) .............. Levo-alphacetylmethadol (9648) ... Oxymorphone (9652) ..................... Noroxymorphone (9668) ................ Alfentanil (9737) ............................. Remifentanil (9739) ....................... Sufentanil (9740) ........................... Fentanyl (9801) .............................. 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 Dated: March 8, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–6156 Filed 3–16–11; 8:45 am] BILLING CODE 4410–09–P The firm plans to manufacture the listed controlled substances for internal use and for sale to other companies. 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 May 16, 2011. Dated: March 9, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration srobinson on DSKHWCL6B1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 10, 2010, 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 4-Anilino-N-Phenethyl-4-Piperidine Jkt 223001 Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated November 18, 2010, and published in the Federal Register on December 3, 2010, (75 FR 75498), Agilent Technologies, 25200 Commercentre Drive, Lake Forest, California 92630–8810, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Schedule Phencyclidine (7471) ..................... 1-piperidinocyclohexanecarbonitrile (8603). Benzoylecgonine (9180) ................ BILLING CODE 4410–09–P 15:48 Mar 16, 2011 DEPARTMENT OF JUSTICE Drug [FR Doc. 2011–6157 Filed 3–16–11; 8:45 am] VerDate Mar<15>2010 (ANPP) (8333), a basic class of controlled substance. The company plans to use this controlled substance in the manufacture of another controlled substance. 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 May 16, 2011. II II II The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products. 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 Agilent Technologies to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Agilent Technologies to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 classes of controlled substances listed. Dated: March 9, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–6163 Filed 3–16–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated November 1, 2010, and published in the Federal Register on November 12, 2010, 75 FR 69464, Noramco Inc., 1440 Olympic Drive, Athens, Georgia 30601, 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 Codeine-N-Oxide (9053) .............. Morphine-N-Oxide (9307) ............. Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Sufentanil (9740) .......................... Carfentanil (9743) ......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule I I 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 distribution to its customers. 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 Noramco Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated E:\FR\FM\17MRN1.SGM 17MRN1

Agencies

[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Pages 14689-14690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6157]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on November 9, 2010, 
Mallinckrodt, Inc., 3600 North Second Street, St. Louis, Missouri 
63147, 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
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)................  I
Codeine-N-oxide (9053)......................  I
Dihydromorphine (9145)......................  I
Difenoxin (9168)............................  I
Morphine-N-oxide (9307).....................  I
Normorphine (9313)..........................  I
Norlevorphanol (9634).......................  I
Amphetamine (1100)..........................  II
Methamphetamine (1105)......................  II
Methylphenidate (1724)......................  II
Nabilone (7379).............................  II
Codeine (9050)..............................  II
Diprenorphine (9058)........................  II
Etorphine HCl (9059)........................  II

[[Page 14690]]

 
Dihydrocodeine (9120).......................  II
Oxycodone (9143)............................  II
Hydromorphone (9150)........................  II
Diphenoxylate (9170)........................  II
Ecgonine (9180).............................  II
Hydrocodone (9193)..........................  II
Levorphanol (9220)..........................  II
Meperidine (9230)...........................  II
Methadone (9250)............................  II
Methadone intermediate (9254)...............  II
Metopon (9260)..............................  II
Dextropropoxyphene, bulk (9273).............  II
Morphine (9300).............................  II
Oripavine (9330)............................  II
Thebaine (9333).............................  II
Opium extracts (9610).......................  II
Opium fluid extract (9620)..................  II
Opium tincture (9630).......................  II
Opium, powdered (9639)......................  II
Opium, granulated (9640)....................  II
Levo-alphacetylmethadol (9648)..............  II
Oxymorphone (9652)..........................  II
Noroxymorphone (9668).......................  II
Alfentanil (9737)...........................  II
Remifentanil (9739).........................  II
Sufentanil (9740)...........................  II
Fentanyl (9801).............................  II
------------------------------------------------------------------------

    The firm plans to manufacture the listed controlled substances for 
internal use and for sale to other companies.
    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 May 16, 2011.

    Dated: March 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-6157 Filed 3-16-11; 8:45 am]
BILLING CODE 4410-09-P

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