Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc., 46335 [2015-19162]

Download as PDF 46335 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as a manufacturer of those controlled substances. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] By notice dated February 11, 2015, and published in the Federal Register on February 19, 2015, 80 FR 8902, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Johnson Matthey, Inc. to manufacture 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. 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: SUPPLEMENTARY INFORMATION: Controlled substance Schedule tkelley on DSK3SPTVN1PROD with NOTICES Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Diphenoxylate (9170) ................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... I II II II II II II II II II II II [FR Doc. 2015–19100 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 ACTION: Notice of registration. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19162 Filed 8–3–15; 8:45 am] BILLING CODE P Actavis Laboratories FL, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Laboratories FL, Inc., registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22554, Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of a 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 Actavis Laboratories FL, 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 following basic classes of controlled substances: SUMMARY: Controlled substance The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. The thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc. finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Fentanyl (9801) ............................ Schedule II II II II II II The company plans to import the above-listed controlled substances for clinical trials, research and analytical purposes. The import of the above-listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Almac Clinical Services Inc. (ACSI) ACTION: Notice of registration. Almac Clinical Services Inc. (ACSI) applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Almac Clinical Services Inc. (ACSI) registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22556, Almac Clinical Services Inc. (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 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 Almac Clinical Services Inc. (ACSI) 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 following basic classes of controlled substances: SUMMARY: Controlled substance Oxycodone (9143) ........................ Hydromorphone (9150) ................ Tapentadol (9780) ........................ E:\FR\FM\04AUN1.SGM 04AUN1 Schedule II II II

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Page 46335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19162]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Actavis 
Laboratories FL, Inc.

ACTION: Notice of registration.

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

SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015, 80 FR 22554, 
Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 
applied to be registered as an importer of a 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 Actavis Laboratories FL, 
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 following basic classes of 
controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the above-listed controlled substances 
for clinical trials, research and analytical purposes.
    The import of the above-listed basic classes of controlled 
substances would be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
Food and Drug Administration approved or non-approved dosage form for 
commercial distribution in the United States.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19162 Filed 8-3-15; 8:45 am]
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