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