Importer of Controlled Substances; Notice of Registration; Watson Pharma, Inc., 64016-64017 [2013-25094]
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64016
Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
August 14, 2013, 78 FR 49546, Siegfried
USA, LLC., 33 Industrial Park Road,
Pennsville, New Jersey 08070, made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
Schedule
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
The company plans to import the
listed controlled substances to bulk
manufacture APIs for distribution to its
customer.
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a), and
determined that the registration of
Siegfried USA, LLC., 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 Siegfried USA, LLC., 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.
[FR Doc. 2013–25090 Filed 10–24–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
emcdonald on DSK67QTVN1PROD with NOTICES
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Registration, Boehringer
Ingelheim Chemicals
By Notice dated June 18, 2013, and
published in the Federal Register on
July 1, 2013, 78 FR 39337, Boehringer
Ingelheim Chemicals, 2820 N.
Normandy Drive, Petersburg, Virginia
23805, made application by renewal to
the Drug Enforcement Administration
17:55 Oct 24, 2013
Jkt 232001
Dated: September 27, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–25086 Filed 10–24–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
May 1, 1971. DEA has investigated
Akorn, 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 class of controlled substance
listed.
Dated: September 27, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–25081 Filed 10–24–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Watson
Pharma, Inc.
By Notice dated May 24, 2013, and
published in the Federal Register on
June 4, 2013, 78 FR 33440, Watson
Pharma, Inc., 2455 Wardlow Road,
Corona, California 92880–2882, 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 Enforcement Administration
Drug
Importer of Controlled Substances,
Notice of Registration, Akorn, Inc.
Dated: October 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
VerDate Mar<15>2010
(DEA) to be registered as an importer of
Phenylacetone (8501), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance to bulk
manufacture amphetamine.
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
Boehringer Ingelheim Chemicals 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 Boehringer Ingelheim
Chemicals 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.
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
By Notice dated June 18, 2013, and
published in the Federal Register on
July 1, 2013, 78 FR 39337, Akorn, Inc.,
1222 W. Grand Avenue, Decatur, Illinois
62522, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
Remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import
Remifentanil in bulk for use in dosage
form manufacturing.
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
Akorn, Inc., consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Schedule
II
II
II
II
The company plans to import the
listed controlled substances for
analytical testing and 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 a 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
Watson Pharma, Inc., to import the basic
classes of controlled substances is
consistent with the public interest and
with United States obligations under
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
international treaties, conventions, or
protocols in effect on May 1, 1971. DEA
has investigated Watson 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.
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: October 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cedarburg Pharmaceuticals, Inc.
Schedule
emcdonald on DSK67QTVN1PROD with NOTICES
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Regarding the drug code (8333), the
company plans manufacture this
controlled substance for commercial
sale.
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
17:55 Oct 24, 2013
Jkt 232001
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cambrex Charles City, Inc.
Drug
Pursuant to § 1301.33(a), of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on May 8, 2013,
Cedarburg Pharmaceuticals, Inc., 870
Badger Circle, Grafton, Wisconsin
53024, 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:
VerDate Mar<15>2010
[FR Doc. 2013–25102 Filed 10–24–13; 8:45 am]
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 December 24, 2013.
Dated: September 27, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–25091 Filed 10–24–13; 8:45 am]
BILLING CODE 4410–09–P
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4-Anilino-N-phenethyl-4-piperidine
(8333).
Remifentanil (9739) ......................
Fentanyl (9801) ............................
Dated: October 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 25, 2013,
Cambrex Charles City, Inc., 1205 11th
Street, Charles City, Iowa 50616, 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:
[FR Doc. 2013–25094 Filed 10–24–13; 8:45 am]
Drug
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than December 24, 2013.
64017
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Methadone (9250) ........................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers, for dosage form
development, for clinical trials, and for
use in stability qualification studies.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
PO 00000
Frm 00059
Fmt 4703
Sfmt 9990
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Pharmacore, Inc.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on May 16, 2013,
PharmaCore, Inc., 4180 Mendenhall
Oaks Parkway, High Point, NC 27265,
made application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
Noroxymorphone (9668), a basic class of
controlled substance listed in schedule
II.
The company plans to manufacture
the listed controlled substance as active
pharmaceutical ingredients (API) for
clinical trials.
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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than December 24, 2013.
Dated: September 27, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–25088 Filed 10–24–13; 8:45 am]
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Agencies
[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 64016-64017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25094]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Watson
Pharma, Inc.
By Notice dated May 24, 2013, and published in the Federal Register
on June 4, 2013, 78 FR 33440, Watson Pharma, Inc., 2455 Wardlow Road,
Corona, California 92880-2882, 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
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
analytical testing and 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 a 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 Watson Pharma, Inc., to import the basic classes of
controlled substances is consistent with the public interest and with
United States obligations under
[[Page 64017]]
international treaties, conventions, or protocols in effect on May 1,
1971. DEA has investigated Watson 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.
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: October 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-25094 Filed 10-24-13; 8:45 am]
BILLING CODE 4410-09-P