Importer of Controlled Substances, Notice of Application, Mylan Pharmaceuticals, Inc., 72409 [2012-29410]
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72409
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that the
Order to Show Cause issued to Amy S.
Benjamin, N.P., be, and it hereby is,
dismissed.
Dated: November 16, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–29302 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, Mylan
Pharmaceuticals, Inc.
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on October 8, 2012, 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
mstockstill on DSK4VPTVN1PROD with
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
17:19 Dec 04, 2012
Jkt 229001
Dated: November 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–29410 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Fisher Clinical
Services, Inc.
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.
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
VerDate Mar<15>2010
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 January 4, 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
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.
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on October 16, 2012, Fisher Clinical
Services, Inc., 7554 Schantz Road,
Allentown, Pennsylvania 18106, made
application to the Drug Enforcement
Administration (DEA) for registration as
an importer of levorphanol (9220), a
basic class of controlled substance in
schedule II.
The company plans to import the
listed controlled substance for analytical
research and clinical trials.
The import of the above listed basic
class of controlled substance would be
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 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 schedules I or II, which fall
under the authority of section
1002(a)(2)(B) of the Act 21 U.S.C.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
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 January 4, 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: November 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–29404 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application:
Siemens Healthcare Diagnostics, Inc.
Pursuant to § 1301.33(a) Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 7, 2012,
Siemens Healthcare Diagnostics, Inc.,
Attn: RA, 100 GBC Drive, Mail Stop 514,
Newark, Delaware 19702, 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:
Drug
Tetrahydrocannabinols (7370) .....
Ecgonine (9180) ...........................
Morphine (9300) ...........................
E:\FR\FM\05DEN1.SGM
05DEN1
Schedule
I
II
II
]]>Agencies
[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Page 72409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29410]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Application, Mylan
Pharmaceuticals, Inc.
Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this
is notice that on October 8, 2012, 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.
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 January 4, 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 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: November 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-29410 Filed 12-4-12; 8:45 am]
BILLING CODE 4410-09-P
