Manufacturer of Controlled Substances; Notice of Application; Penick Corporation, 33441-33442 [2013-13221]
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33441
Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Technologies, Inc.
Importer of Controlled Substances;
Notice of Registration; Caraco
Pharmaceutical Laboratories, LTD
Manufacturer of Controlled
Substances; Notice of Application;
Agilent Technologies
By Notice dated January 15, 2013, and
published in the Federal Register on
January 29, 2013, 78 FR 6131, Mylan
Technologies, Inc., 110 Lake Street,
Saint Albans, Vermont 05478, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to afford the
company the opportunity to export
domestically-manufactured FDF to
foreign markets.
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
Mylan Pharmaceuticals, 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. DEA has investigated
Mylan 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) 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.
By Notice dated February 8, 2013, and
published in the Federal Register on
February 21, 2013, 78 FR 12101, 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 finished FDA
approved or non-approved dosage form
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
Caraco Pharmaceutical Laboratories,
Ltd., 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 Caraco Pharmaceutical
Laboratories, Ltd., 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) 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: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–13181 Filed 6–3–13; 8:45 am]
[FR Doc. 2013–13183 Filed 6–3–13; 8:45 am]
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Drug
Schedule
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Methylphenidate (1724) ................
Fentanyl (9801) ............................
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Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 27, 2013,
Agilent Technologies, 25200
Commercentre Drive, Lake Forest,
California 92630–8810, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances listed in schedule II:
Drug
1-Piperidinocyclohexanecarbonitrile (8603).
Benzoylecgonine (9180) ...............
Schedule
II
II
The company plans to manufacture
small quantities of the listed controlled
substances for use in diagnostic
products.
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 August 5, 2013.
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–13219 Filed 6–3–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Penick Corporation
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on April 23, 2013,
Penick Corporation, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
made application to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
Opium Tincture (9630), a basic class of
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Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices
controlled substance listed in schedule
II.
The company plans to manufacture
the listed controlled substance, as bulk
intermediates for distribution to its
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 August 5, 2013.
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
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 May 7, 2013, Sigma
Aldrich Research Biochemicals, Inc.,
1–3 Strathmore Road, Natick,
Massachusetts 01760–2447, made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Schedule
tkelley on DSK3SPTVN1PROD with NOTICES
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The company plans to manufacture
reference standards.
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).
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[FR Doc. 2013–13217 Filed 6–3–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
By Notice dated January 14, 2013, and
published in the Federal Register on
January 25, 2013, 78 FR 5499, Cerilliant
Corporation, 811 Paloma Drive, Suite A,
Round Rock, Texas 78665–2402, made
application to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
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Mephedrone
(4-Methyl-Nmethylcathinone) (1248).
MDPV
(3,4Methylenedioxypyrovalerone)
(7535).
Methylone (3,4-Methylenedioxy-Nmethylcathinone) (7540).
Sufentanil (9740) ..........................
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Manufacturer of Controlled
Substances; Notice of Registration;
Cerilliant Corporation
[FR Doc. 2013–13221 Filed 6–3–13; 8:45 am]
Drug
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 5, 2013.
Drug
Schedule
JWH–250 (6250) ..........................
SR–18 also known as RCS–8
(7008).
JWH–019 (7019) ..........................
JWH–081 (7081) ..........................
SR–19 also known as RCS–4
(7104).
JWH–122 (7122) ..........................
AM–2201 (7201) ...........................
JWH–203 (7203) ..........................
2C–T–2 (7385) .............................
JWH–398 (7398) ..........................
N-Ethyl-1-phenylcyclohexylamine
(7455).
2C–D (7508) .................................
2C–E (7509) .................................
2C–H (7517) .................................
2C–I (7518) ..................................
2C–C (7519) .................................
2C–N (7521) .................................
2C–P (7524) .................................
2C–T–4 (7532) .............................
AM–694 (7694) .............................
Metazocine (9240) ........................
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The company plans to manufacture
the listed controlled substances for
distribution to their research and
forensic customers conducting drug
testing and analysis.
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
Cerilliant Corporation to manufacture
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the listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated Cerilliant Corporation 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(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.
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–13225 Filed 6–3–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration; GE
Healthcare
By Notice dated February 8, 2013 and
published in the Federal Register on
February 21, 2013, 78 FR 12103, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Cocaine (9041), a basic
class of controlled substance listed in
schedule II.
The company plans to manufacture a
radioactive product to diagnose
Parkinson’s disease; and to manufacture
a bulk investigational new drug (IND)
for clinical trials.
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 GE
Healthcare to manufacture the listed
basic class of controlled substance is
consistent with the public interest at
this time. DEA has investigated GE
Healthcare 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(a), and in accordance with 21 CFR
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Agencies
[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Pages 33441-33442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13221]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
Penick Corporation
Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal
Regulations (CFR), this is notice that on April 23, 2013, Penick
Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070,
made application to the Drug Enforcement Administration (DEA) to be
registered as a bulk manufacturer of Opium Tincture (9630), a basic
class of
[[Page 33442]]
controlled substance listed in schedule II.
The company plans to manufacture the listed controlled substance,
as bulk intermediates for distribution to its 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 Sec. 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 August 5, 2013.
Dated: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-13221 Filed 6-3-13; 8:45 am]
BILLING CODE 4410-09-P