Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc., 19016 [2013-07143]
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Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Notices
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: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
CFR § 1301.34, the above named
company is granted registration as an
importer of the basic classes of
controlled substances listed.
Dated: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–07150 Filed 3–27–13; 8:45 am]
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[FR Doc. 2013–07152 Filed 3–27–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals, Inc.
Importer of Controlled Substances;
Notice of Registration; Johnson
Matthey, Inc.
By Notice dated November 19, 2012,
and published in the Federal Register
on November 27, 2012, 77 FR 70824,
Johnson Matthey, Inc., Pharmaceutical
Materials, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742, 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
mstockstill on DSK4VPTVN1PROD with NOTICES
Coca Leaves (9040) .....................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
II
II
II
II
II
The company plans to import the
listed controlled substances as raw
materials, to be used in the manufacture
of bulk controlled substances, 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
Johnson Matthey, 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, at
this time. DEA has investigated Johnson
Matthey, 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
VerDate Mar<15>2010
20:20 Mar 27, 2013
Jkt 229001
By Notice dated November 27, 2012,
and published in the Federal Register
on December 5, 2012, 77 FR 72409,
Mylan Pharmaceuticals, Inc., 781
Chestnut Ridge Road, Morgantown,
West Virginia 26505, 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
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
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 allow the
company to export domesticallymanufactured 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
PO 00000
Frm 00063
Fmt 4703
Sfmt 9990
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: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–07143 Filed 3–27–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Patheon Pharmaceuticals, Inc.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on February 22, 2013,
Patheon Pharmaceuticals, Inc., 2110 E.
Galbraith Road, Cincinnati, Ohio 45237,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Gamma Hydroxybutyric
Acid (2010), a basic class of controlled
substance listed in schedule I.
The company plans to manufacture
the listed controlled substance for
distribution to its customers.
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 May 28, 2013.
Dated: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–07138 Filed 3–27–13; 8:45 am]
BILLING CODE 4410–09–P
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28MRN1
Agencies
[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Page 19016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07143]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated November 27, 2012, and published in the Federal
Register on December 5, 2012, 77 FR 72409, Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Road, Morgantown, West Virginia 26505, 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
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Methylphenidate (1724)..................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
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 allow the company 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.
Dated: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-07143 Filed 3-27-13; 8:45 am]
BILLING CODE 4410-09-P