Manufacturer of Controlled Substances; Notice of Application; AMRI Rensselaer, Inc., 47114 [2012-19174]
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47114
Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices
Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–19208 Filed 8–6–12; 8:45 am]
[FR Doc. 2012–19202 Filed 8–6–12; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on June 5, 2012, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rensselaer, New York 12144, 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:
Manufacturer of Controlled
Substances; Notice of Application;
Halo Pharmaceutical Inc.
By Notice dated April 17, 2012, and
published in the Federal Register on
April 26, 2012, 77 FR 24984, Catalent
Pharma Solutions, Inc., 10381 Decatur
Road, Philadelphia, Pennsylvania
19114, made application to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Noroxymorphone (9668), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance in finished
dosage form for 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.
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
Catalent Pharma Solutions, Inc. 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 Catalent Pharma
Solutions, 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.
Manufacturer of Controlled
Substances; Notice of Application;
AMRI Rensselaer, Inc.
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration;
Catalent Pharma Solutions, Inc.
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on July 6, 2012, Halo
Pharmaceutical Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981,
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
16:52 Aug 06, 2012
Jkt 226001
Drug
Drug
Schedule
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
I
II
Dihydromorphine is an intermediate
in the manufacture of Hydromorphone
and is not for commercial distribution.
The company plans to manufacture
Hydromorphone HCl for sale to other
manufacturers and to manufacture other
controlled substances 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 October 9, 2012.
Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–19184 Filed 8–6–12; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) ......
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Drug Schedule.
4–Anilino-N-phenethyl-4–Piperidine (8333) ...............................
Meperidine (9230) ........................
Fentanyl (9801) ............................
Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
BILLING CODE 4410–09–P
Fmt 4703
Sfmt 9990
II
II
II
The company plans to manufacture
bulk controlled substances for use in
product development and for
distribution to its customers.
In reference to drug code 7360
(Marihuana), the company plans to bulk
manufacture cannabidiol as a synthetic
intermediate, which will be further
synthesized to bulk manufacture a
synthetic THC (7370). No other activity
for this drug code is authorized for this
registration.
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 October 9, 2012.
[FR Doc. 2012–19174 Filed 8–6–12; 8:45 am]
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I
II
II
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]]>Agencies
[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Page 47114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19174]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
AMRI Rensselaer, Inc.
Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal
Regulations (CFR), this is notice that on June 5, 2012, AMRI
Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144, 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
------------------------------------------------------------------------
Marihuana (7360)............................................. I
Tetrahydrocannabinols (7370)................................. I
Amphetamine (1100)........................................... II
Lisdexamfetamine (1205)...................................... II
Methylphenidate (1724)....................................... II
Pentobarbital (2270)......................................... II
Drug Schedule................................................
4-Anilino-N-phenethyl-4-Piperidine (8333).................... II
Meperidine (9230)............................................ II
Fentanyl (9801).............................................. II
------------------------------------------------------------------------
The company plans to manufacture bulk controlled substances for use
in product development and for distribution to its customers.
In reference to drug code 7360 (Marihuana), the company plans to
bulk manufacture cannabidiol as a synthetic intermediate, which will be
further synthesized to bulk manufacture a synthetic THC (7370). No
other activity for this drug code is authorized for this registration.
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 October 9, 2012.
Dated: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-19174 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P
