Importer of Controlled Substances Registration: Almac Clinical Services Inc. (ACSI), 46335-46336 [2015-19109]

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 46336 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices Controlled substance Fentanyl (9801) ............................ II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19109 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Meridian Medical Technologies ACTION: The company plans to manufacture the listed controlled substance as an active pharmaceutical ingredient (API) for clinical trials. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19164 Filed 8–3–15; 8:45 am] Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22553, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144 applied to be registered as an importer of a certain basic class of controlled substance. 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 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. 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 morphine (9300), a basic class controlled substance listed in schedule II. VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 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: Controlled substance Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Schedule II II [FR Doc. 2015–19099 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P Notice of registration. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, 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 for use as reference standards. This is the sole purpose for which the company will be authorized by the DEA to import morphine. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Schedule DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Pharmacore, Inc. Manufacturer of Controlled Substances Registration: Cambrex Charles City ACTION: ACTION: Notice of registration. Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer 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, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 applied to be registered as a manufacturer 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(a) and determined that the registration of Pharmacore, 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 SUMMARY: PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 Notice of registration. Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances. SUMMARY: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22555, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a manufacturer 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(a) and determined that the registration of Cambrex Charles City 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46335-46336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19109]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Almac Clinical 
Services Inc. (ACSI)

ACTION: Notice of registration.

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SUMMARY: 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:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Tapentadol (9780)..........................  II

[[Page 46336]]

 
Fentanyl (9801)............................  II
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    The company plans to import small quantities of the listed 
controlled substances in dosage form to conduct clinical trials.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19109 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P