Importer of Controlled Substances; Notice of Registration, 14689 [2011-6165]
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Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, VA 22152; and must be
filed no later than April 15, 2011.
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 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.
Dated: March 8, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
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
Meridian Medical Technologies 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
Meridian Medical Technologies 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: March 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–6166 Filed 3–16–11; 8:45 am]
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[FR Doc. 2011–6165 Filed 3–16–11; 8:45 am]
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DEPARTMENT OF JUSTICE
14689
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
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 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–6164 Filed 3–16–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Importer of Controlled Substances;
Notice of Registration
srobinson on DSKHWCL6B1PROD with NOTICES
Drug Enforcement Administration
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Importer of Controlled Substances;
Notice of Registration
Drug Enforcement Administration
By Notice dated November 29, 2010,
and published in the Federal Register
on December 9, 2010 (75 FR 76755),
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:
Manufacturer of Controlled
Substances; Notice of Application
By Notice dated November 19, 2010,
and published in the Federal Register
on December 3, 2010, 75 FR 75496,
Meridian Medical Technologies, 2555
Hermelin Drive, St. Louis, Missouri
63144, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
Morphine (9300), a basic class of
controlled substance listed in schedule
II.
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world,
including in Europe. The company has
been asked to ensure that its product
sold to European customers meets
standards established by the European
Pharmacopeia, which is administered
by the Directorate for the Quality of
Medicines (EDQM). In order to ensure
that its product will meet European
specifications, the company seeks to
import morphine supplied by EDQM to
use as reference standards. This is the
sole purpose for which the company
will be authorized by DEA to import
morphine.
VerDate Mar<15>2010
15:48 Mar 16, 2011
Jkt 223001
Drug
Schedule
Methylphenidate (1724) .................
Oxycodone (9143) .........................
Hydromorphone (9150) ..................
Fentanyl (9801) ..............................
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
PO 00000
Frm 00043
Fmt 4703
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 9, 2010,
Mallinckrodt, Inc., 3600 North Second
Street, St. Louis, Missouri 63147, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Sfmt 4703
Drug
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) .............................
Codeine (9050) ..............................
Diprenorphine (9058) .....................
Etorphine HCl (9059) .....................
E:\FR\FM\17MRN1.SGM
17MRN1
Schedule
I
I
I
I
I
I
I
II
II
II
II
II
II
II
Agencies
[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Page 14689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6165]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated November 19, 2010, and published in the Federal
Register on December 3, 2010, 75 FR 75496, Meridian Medical
Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered as an importer of Morphine (9300), a basic class of
controlled substance listed in schedule II.
The company manufactures a product containing morphine in the
United States. The company exports this product to customers around the
world, including in Europe. The company has been asked to ensure that
its product sold to European customers meets standards established by
the European Pharmacopeia, which is administered by the Directorate for
the Quality of Medicines (EDQM). In order to ensure that its product
will meet European specifications, the company seeks to import morphine
supplied by EDQM to use as reference standards. This is the sole
purpose for which the company will be authorized by DEA to import
morphine.
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 Meridian Medical Technologies 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 Meridian
Medical Technologies 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: March 9, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-6165 Filed 3-16-11; 8:45 am]
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