Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc., 29337 [2015-12327]

Download as PDF 29337 Federal Register / Vol. 80, No. 98 / Thursday, May 21, 2015 / Notices 2015, 80 FR 7633, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Myoderm 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 controlled substances: Controlled substance Schedule tkelley on DSK3SPTVN1PROD with NOTICES 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 sale. Dated: May 15, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–12329 Filed 5–20–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 20:28 May 20, 2015 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc. ACTION: Dated: May 15, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–12327 Filed 5–20–15; 8:45 am] BILLING CODE P Notice of registration. Mylan Pharmaceuticals, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and published in the Federal Register on January 26, 2015, 80 FR 3980, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: SUMMARY: Controlled substance 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 PO 00000 analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Frm 00039 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Noramco, Inc. ACTION: Notice of registration. Noramco, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as an importer of those controlled substances. SUMMARY: By notice dated January 9, 2015, and published in the Federal Register on January 26, 2015, 80 FR 3980, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801–4417 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Noramco, 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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: SUPPLEMENTARY INFORMATION: Controlled substance Phenylacetone (8501) .................. E:\FR\FM\21MYN1.SGM 21MYN1 Schedule II

Agencies

[Federal Register Volume 80, Number 98 (Thursday, May 21, 2015)]
[Notices]
[Page 29337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12327]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Mylan 
Pharmaceuticals, Inc.

ACTION: Notice of registration.

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

SUMMARY: Mylan Pharmaceuticals, Inc. applied to be registered as an 
importer of certain basic classes of controlled substances. The Drug 
Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. 
registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and 
published in the Federal Register on January 26, 2015, 80 FR 3980, 
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West 
Virginia 26505 applied to be registered as an importer of certain basic 
classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(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. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing 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:

------------------------------------------------------------------------
            Controlled substance                       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.

    Dated: May 15, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-12327 Filed 5-20-15; 8:45 am]
BILLING CODE P

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