Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical Laboratories, LTD., 12101-12102 [2013-03902]

Download as PDF Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices I order that the application of John V. Scalera, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This order is effective March 25, 2013. Dated: February 12, 2013. Michele M. Leonhart, Administrator. 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: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03879 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2013–03905 Filed 2–20–13; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration DEPARTMENT OF JUSTICE erowe on DSK2VPTVN1PROD with NOTICES Importer of Controlled Substances; Notice of Application; Meda Pharmaceuticals, Inc. Drug Enforcement Administration Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on December 4, 2012, 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. 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 II, which falls 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 March 25, 2013. 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 classes of any controlled substances in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 Importer of Controlled Substances; Notice of Application; Mallinckrodt, LLC. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on November 30, 2012, Mallinckrodt, LLC., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II Dated: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03898 Filed 2–20–13; 8:45 am] The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. No comments, objections, or requests for any hearings will be accepted on any application for registration or reregistration to import crude opium, poppy straw, concentrate of poppy straw or coca leaves. Comments and requests for hearings on applications to import narcotic raw material are not appropriate, in accordance with 72 FR 3417 (2007). In reference to Phenylacetone (8501), the company plans to import the controlled substance for the bulk manufacture of amphetamine products for sale to its customers. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedules 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 Frm 00071 Fmt 4703 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 March 25, 2013. 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, 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. Schedule Drug PO 00000 12101 Sfmt 4703 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical Laboratories, LTD. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on November 22, 2012, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey 08512, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials, and research. The import of the above listed basic class of controlled substance is 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 E:\FR\FM\21FEN1.SGM 21FEN1 12102 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices for commercial distribution in the United States. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance listed in schedule II, which falls 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 March 25, 2013. 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 schedules 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: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03902 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration erowe on DSK2VPTVN1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Application; Mallinckrodt, LLC Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 30, 2012, Mallinckrodt, LLC, 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 manufacturer of the following basic classes of controlled substances: Drug Schedule 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) ............................ 4-Anilino-N-phenethyl-4-piperidine (8333). Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Opium, powdered (9639) ............. Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ I I I I I I I 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 The firm plans to manufacture the listed controlled substances for internal use and for sale to other companies. 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 April 22, 2013. Dated: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03892 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Pharmagra Labs, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on December 3, 2012, Pharmagra Labs, Inc., 158 McLean Road, Brevard, North Carolina 28712, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of pentobarbital (2270), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed substance for analytical research and clinical trials. 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 April 22, 2013. Dated: February 8, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–03888 Filed 2–20–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Sigma Aldrich Research Biochemicals, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 21, 2012, Sigma Aldrich Research Biochemicals, Inc., 1–3 Strathmore Road, Natick, Massachusetts 01760– 2447, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following classes of controlled substances: Drug Cathinone (1235) .......................... Methcathinone (1237) .................. E:\FR\FM\21FEN1.SGM 21FEN1 Schedule I I

Agencies

[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12101-12102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03902]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; Caraco 
Pharmaceutical Laboratories, LTD.

    Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this 
is notice that on November 22, 2012, Caraco Pharmaceutical 
Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey 
08512, made application to the Drug Enforcement Administration (DEA) to 
be registered as an importer of Fentanyl (9801), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, and research.
    The import of the above listed basic class of controlled substance 
is 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

[[Page 12102]]

for commercial distribution in the United States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance listed in schedule II, which falls 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 March 25, 2013.
    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 
schedules 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: February 8, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-03902 Filed 2-20-13; 8:45 am]
BILLING CODE 4410-09-P