Manufacturer of Controlled Substances; Notice of Application; Agilent Technologies, 33441 [2013-13219]
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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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BILLING CODE 4410–09–P
Drug
Schedule
tkelley on DSK3SPTVN1PROD with NOTICES
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]
BILLING CODE 4410–09–P
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
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13219]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
Agilent Technologies
Pursuant to Sec. 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 Schedule
------------------------------------------------------------------------
1-Piperidinocyclohexane-
carbonitrile (8603). II
Benzoylecgonine (9180)..................... 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 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. 2013-13219 Filed 6-3-13; 8:45 am]
BILLING CODE 4410-09-P
