Importer of Controlled Substances; Notice of Registration, 14689 [2011-6164]

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

Agencies

[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Page 14689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6164]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration

    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:

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

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