Manufacturer of Controlled Substances; Notice of Application; Penick Corporaton, 23595-23596 [2013-09317]
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23595
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
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
forms 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 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 May 20, 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: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
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BILLING CODE 4410–09–P
Importer of Controlled Substances;
Notice of Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; GE Healthcare
By Notice dated January 31, 2013, and
published in the Federal Register on
February 6, 2013, 78 FR 8583, GE
Healthcare, 3350 North Ridge Avenue,
Jkt 229001
[FR Doc. 2013–09290 Filed 4–18–13; 8:45 am]
Drug Enforcement Administration
BILLING CODE 4410–09–P
17:11 Apr 18, 2013
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
[FR Doc. 2013–09302 Filed 4–18–13; 8:45 am]
VerDate Mar<15>2010
Arlington Heights, Illinois 60004–1412,
made application by renewal to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
Cocaine (9041), a basic class of
controlled substance listed in schedule
II.
The company plans to import small
quantities of ioflupane, in the form of
three separate analogues of Cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission.
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
GE Healthcare 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 GE Healthcare 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.
By Notice dated January 16, 2013, and
published in the Federal Register on
January 25, 2013, 78 FR 5497, Nebraska
State Penitentiary, 4201 South 14th
Street, Lincoln, Nebraska 68502, made
application to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Pentobarbital (2270), a
basic class of controlled substance listed
in schedule II.
The facility intends to import the
above listed controlled substance for
legitimate use. Supplies of this
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Sfmt 4703
particular controlled substance are
inadequate and are not available in the
form needed within the current
domestic supply of 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
Nebraska State Penitentiary 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 Nebraska State
Penitentiary to ensure that its
registration is consistent with the public
interest. The investigation has included
inspection and testing of the Nebraska
State Penitentiary facility’s physical
security systems, verification of its
compliance with state and local laws,
and a review of its 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
facility is granted registration as an
importer of the basic class of controlled
substance listed.
Dated: April 11, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–09299 Filed 4–18–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Penick Corporaton
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 1, 2013,
Penick Corporation, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
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
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
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Schedule
II
II
II
II
II
II
II
II
II
II
23596
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
Drug
Schedule
Oxymorphone (9652) ...................
II
The company plans to manufacture
the listed controlled substances as bulk
controlled substance intermediates for
distribution to its customers.
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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than June 18, 2013.
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Drug Enforcement Administration
Manufacturer of Controlled
Substances, Notice of Application,
Rhodes Technologies
Pursuant to § 1301.33(a) Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 6, 2013,
Rhodes Technologies, 498 Washington
Street, Coventry, Rhode Island 02816,
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:
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Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion and sale to dosage form
manufacturers.
17:11 Apr 18, 2013
Jkt 229001
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances, Notice of Application,
American Radiolabeled Chemicals, Inc.
DEPARTMENT OF JUSTICE
VerDate Mar<15>2010
[FR Doc. 2013–09283 Filed 4–18–13; 8:45 am]
Drug Enforcement Administration
BILLING CODE 4410–09–P
Tetrahydrocannabinols (7370) .....
Methylphenidate (1724) ................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Fentanyl (9801) ............................
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
[FR Doc. 2013–09317 Filed 4–18–13; 8:45 am]
Drug
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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than June 18, 2013.
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 11, 2013,
American Radiolabeled Chemicals, Inc.,
101 Arc Drive, St. Louis, Missouri
63146, 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
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Ibogaine (7260) ............................
Lysergic acid diethylamide (7315)
Tetrahydrocannabinols (7370) .....
Dimethyltryptamine (7435) ...........
1-[1-(2Thienyl)cyclohexyl]piperidine
(7470).
Dihydromorphine (9145) ...............
Heroin (9200) ...............................
Normorphine (9313) .....................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Amobarbital (2125) .......................
Phencyclidine (7471) ....................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Metazocine (9240) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
PO 00000
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I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Drug
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Phenazocine (9715) .....................
Carfentanil (9743) .........................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances as radiolabeled compounds
for biochemical research.
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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than June 18, 2013.
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–09315 Filed 4–18–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances, Notice of Application,
Navinta, LLC
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on February 13, 2013,
Navinta, LLC., 1499 Lower Ferry Road,
Ewing, New Jersey 08618–1414, made
application to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the basic classes
of controlled substances:
Drug
Pentobarbital (2270) .....................
Remifentanil (9739) ......................
Schedule
II
II
The company plans initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then to
produce commercial size batches for
distribution to dosage form
manufacturers upon FDA approval.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substance,
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]]>Agencies
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23595-23596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09317]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
Penick Corporaton
Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal
Regulations (CFR), this is notice that on March 1, 2013, Penick
Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070,
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 Schedule
------------------------------------------------------------------------
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Ecgonine (9180)............................ II
Hydrocodone (9193)......................... II
Morphine (9300)............................ II
Oripavine (9330)........................... II
Thebaine (9333)............................ II
[[Page 23596]]
Oxymorphone (9652)......................... II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
as bulk controlled substance intermediates for distribution to its
customers.
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 (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than June 18, 2013.
Dated: April 10, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-09317 Filed 4-18-13; 8:45 am]
BILLING CODE 4410-09-P
