Importer of Controlled Substances; Notice of Registration; S & B Pharma, Inc., 23374-23375 [2014-09578]
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Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
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The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of finished
FDA approved or non-approved dosage
forms for commercial distribution in the
United States.
Any bulk manufacturer who is
presently, or is applying to be,
registered with the 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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 28, 2014.
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 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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09567 Filed 4–25–14; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Meridian Medical
Technologies
Pursuant to 21 CFR 1301.34(a), this is
notice that on January 3, 2014, Meridian
Medical Technologies, 2555 Hermelin
Drive, St. Louis, Missouri 63144, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration 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.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, 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 for
use as reference standards.
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
Any bulk manufacturer who is
presently, or is applying to be,
registered with the 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.
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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 28, 2014.
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
PO 00000
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Fmt 4703
Sfmt 4703
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09571 Filed 4–25–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; S & B Pharma,
Inc.
By Notice dated January 15, 2014, and
published in the Federal Register on
February 4, 2014, 79 FR 6630, S & B
Pharma, Inc., DBA Norac Pharma, 405 S.
Motor Avenue, Azusa, California
91702–3232, made application to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
4-Anilino-N-phenethyl-4-piperidine
(8333).
Tapentadol (9780) ........................
Schedule
II
II
The company plans to import the
listed controlled substances for internal
use, and to manufacture bulk
intermediates for sale to its customers.
On February 10, 2014, S & B Pharma,
Inc., withdrew its request for the
addition of Fentanyl (9801) to this
registration.
No comments or objections have been
received. The DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
S & B Pharma, Inc. to import the basic
classes of controlled substances is
consistent with the public interest and
in accordance with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA has investigated
S & B Pharma, 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.
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Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09573 Filed 4–25–14; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2014–09578 Filed 4–25–14; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Importer of Controlled Substances,
Notice of Registration, Myoderm
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Noramco, Inc.
By Notice dated January 14, 2014, and
published in the Federal Register on
January 22, 2014, 79 FR 3627, Noramco,
Inc., 1440 Olympic Drive, Athens,
Georgia 30601, 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
tkelley on DSK3SPTVN1PROD with NOTICES
Phenylacetone (8501) ..................
Thebaine (9333) ...........................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture other controlled substances
for distribution to its customers.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
No comments or objections have been
received. The DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Noramco, Inc. to import the basic
classes of controlled substances is
consistent with the public interest and
in accordance with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA has investigated
Noramco, 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
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By Notice dated December 23, 2013,
and published in the Federal Register
on January 10, 2014, 79 FR 1887,
Myoderm, 48 East Main Street,
Norristown, Pennsylvania 19401, 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) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Nabilone (7379) ............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form for clinical trials, and
research.
The import of the above listed basic
classes of controlled substances will 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.
No comments or objections have been
received. The DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Myoderm to import the basic class of
controlled substance is consistent with
the public interest and in accordance
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
PO 00000
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Fmt 4703
Sfmt 4703
DEA has investigated Myoderm 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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09551 Filed 4–25–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated November 12, 2013,
and published in the Federal Register
on November 19, 2013, 78 FR 69447,
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
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
Schedule
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
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]]>Agencies
[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23374-23375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09578]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; S & B
Pharma, Inc.
By Notice dated January 15, 2014, and published in the Federal
Register on February 4, 2014, 79 FR 6630, S & B Pharma, Inc., DBA Norac
Pharma, 405 S. Motor Avenue, Azusa, California 91702-3232, made
application to the Drug Enforcement Administration (DEA) to be
registered as an importer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine (8333).. II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
internal use, and to manufacture bulk intermediates for sale to its
customers.
On February 10, 2014, S & B Pharma, Inc., withdrew its request for
the addition of Fentanyl (9801) to this registration.
No comments or objections have been received. The DEA has
considered the factors in 21 U.S.C. 823(a) and 952(a), and determined
that the registration of S & B Pharma, Inc. to import the basic classes
of controlled substances is consistent with the public interest and in
accordance with United States obligations under international treaties,
conventions, or protocols in effect on May 1, 1971. The DEA has
investigated S & B Pharma, 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.
[[Page 23375]]
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-09578 Filed 4-25-14; 8:45 am]
BILLING CODE 4410-09-P
