Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc., 46371-46372 [2013-18331]

Download as PDF Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices Drug Schedule mstockstill on DSK4VPTVN1PROD with NOTICES Meperidine (9230) ........................ Meperidine intermediate-A (9232) Meperidine intermediate-B (9233) Meperidine intermediate-C (9234) Metazocine (9240) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Methamphetamine (1105) ............ Methylphenidate (1724) ................ Metopon (9260) ............................ Moramide intermediate (9802) ..... Morphine (9300) ........................... Nabilone (7379) ............................ Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium poppy/Poppy Straw (9650) Oripavine (9330) ........................... Poppy Straw Concentrate (9670) Opium, granulated (9640) ............ Oxycodone (9143) ........................ Oxymorphone (9652) ................... Pentobarbital (2270) ..................... Phenazocine (9715) ..................... Phencyclidine (7471) .................... Phenmetrazine (1631) .................. Phenylacetone (8501) .................. Piminodine (9730) ........................ Powdered opium (9639) ............... Racemethorphan (9732) .............. Racemorphan (9733) ................... Remifentanil (9739) ...................... Secobarbital (2315) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Thebaine (9333) ........................... 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 II II II II II II II II II II Dated: July 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–18330 Filed 7–30–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc. The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse (NIDA) for research activities. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR § 1301.43 and in such form as prescribed by 21 CFR § 1316.47. 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 August 30, 2013. VerDate Mar<15>2010 16:14 Jul 30, 2013 Jkt 229001 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 substances 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. By Notice dated February 8, 2013, and published in the Federal Register on February 21, 2013, 78 FR 12101, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance as a finished drug product in dosage form 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 952(a), and determined that the registration of Meda Pharmaceuticals Inc., 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 Meda 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) PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 46371 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: July 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–18332 Filed 7–30–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc. By Notice dated April 10, 2013, and published in the Federal Register on April 19, 2013, 78 FR 23594, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, 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 Oxycodone (9143) ......................... Hydromorphone (9150) ................. Tapentadol (9780) ......................... Fentanyl (9801) ............................. Schedule II II II II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. 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 forms for commercial distribution in the United States. 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 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. DEA has investigated Almac Clinical Services, Inc., (ACSI) 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 E:\FR\FM\31JYN1.SGM 31JYN1 46372 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices 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: July 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Ampac Fine Chemicals, LLC. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 6, 2013, AMPAC Fine Chemicals, LLC., Highway 50 and Hazel Avenue, Building 05001, Rancho Cordova, California 95670, 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: Schedule mstockstill on DSK4VPTVN1PROD with NOTICES II II II Tapentadol (9780) ........................ II The company is a contract manufacturer. In reference to Poppy Straw Concentrate the company will manufacture Thebaine intermediates to sale to its customers for further manufacture. No other activity for this drug code is authorized for this registration. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, 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 September 30, 2013. VerDate Mar<15>2010 16:14 Jul 30, 2013 Jkt 229001 BILLING CODE 4410–09–P Drug Enforcement Administration BILLING CODE 4410–09–P Methylphenidate (1724) ................ Thebaine (9333) ........................... Poppy Straw Concentrate (9670) [FR Doc. 2013–18337 Filed 7–30–13; 8:45 am] DEPARTMENT OF JUSTICE [FR Doc. 2013–18331 Filed 7–30–13; 8:45 am] Drug Dated: July 23, 2013. Joseph T. Rannazzisi Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 14, 2013, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011, 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 Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II The company plans to manufacture small quantities of the listed controlled substances to make reference standards for distribution to their customers. 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 September 30, 2013. Dated: July 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–18339 Filed 7–30–13; 8:45 am] BILLING CODE 4410–09–P PO 00000 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Research Triangle Institute By Notice dated April 16, 2013, and published in the Federal Register on April 23, 2013, 78 FR 23958, Research Triangle Institute, Poonam G. Pande, Ph.D., RPH, RAC, Hermann Building, East Institute Drive, P.O. Box 12194, Research Triangle Park, North Carolina 27709, 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 Marihuana (7360) ......................... Cocaine (9041) ............................. Schedule I II The Institute will manufacture marihuana, and cocaine derivatives for use by their customers in analytical kits, reagents, and reference standards as directed by the National Institute on Drug Abuse. 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 Research Triangle Institute to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Research Triangle Institute 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. 823, 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: July 23, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–18336 Filed 7–30–13; 8:45 am] BILLING CODE 4410–09–P Frm 00061 Fmt 4703 Sfmt 9990 E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46371-46372]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18331]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Almac 
Clinical Services, Inc.

    By Notice dated April 10, 2013, and published in the Federal 
Register on April 19, 2013, 78 FR 23594, Almac Clinical Services, Inc., 
(ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, 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
------------------------------------------------------------------------
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import small quantities of the listed 
controlled substances in dosage form to conduct clinical trials.
    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 forms for commercial distribution 
in the United States.
    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 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. DEA has 
investigated Almac Clinical Services, Inc., (ACSI) 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

[[Page 46372]]

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: July 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-18331 Filed 7-30-13; 8:45 am]
BILLING CODE 4410-09-P