Importer of Controlled Substances, Notice of Registration, Noramco, Inc., 17230-17231 [2013-06321]
Download as PDF
<![CDATA[
17230
Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, Noramco Inc.
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on July 22, 2011, 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 basic classes of controlled
substances listed in schedule II:
Drug
Schedule
srobinson on DSK4SPTVN1PROD with NOTICES
Phenylacetone (8501) ..................
Thebaine (9333) ...........................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
18:04 Mar 19, 2013
Jkt 229001
Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–06330 Filed 3–19–13; 8:45 am]
II
II
II
II
II
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
The company plans to import
Thebaine (9333) analytical reference
standards for distribution to its
customers. The company plans to
import an intermediate form of
Tapentadol (9780) to bulk manufacture
Tapentadol for distribution to its
customers. The company plans to
import Phenylacetone (8501) and Poppy
Straw Concentrate (9670) to
manufacture other controlled
substances.
Comments and request for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
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
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
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than April 19, 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,
VerDate Mar<14>2013
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.
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, United States
Pharmacopeial Convention
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on January 21, 2013, United States
Pharmacopeial Convention, 12601
Twinbrook Parkway, Rockville,
Maryland 20852, made application to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
Norlevorphanol (9634) ..................
Levomethorphan (9210) ...............
Difenoxin (9168) ...........................
I
II
II
The company plans to import the
listed controlled substances in bulk
powder form from foreign sources for
the manufacture of analytical reference
standards for sale to their customers.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedules I and 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than April 19, 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: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–06318 Filed 3–19–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Registration, Noramco, Inc.
By Notice dated October 9, 2012, and
published in the Federal Register on
October 18, 2012, 77 FR 64142,
Noramco, Inc., 500 Swedes Landing
Road, Wilmington, Delaware 19801–
4417, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
the basic classes of controlled
substances:
Drug
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
II
The company plans to import raw
Opium (9600) and Poppy Straw
concentrate (9670) to manufacture other
controlled substances. The company
plans to import Tapentadol (9780) in
intermediate form for the bulk
manufacture of Tapentadol (9780) for
distribution to its customers. The
company plans to import Phenylacetone
(8501) in bulk for the manufacture of a
controlled substance.
Comments and requests for hearings
on applications to import narcotic raw
E:\FR\FM\20MRN1.SGM
20MRN1
17231
Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Notices
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
Noramco Inc., 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, at
this time. 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
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–06321 Filed 3–19–13; 8:45 am]
BILLING CODE 4410–09–P
FDA approved or non-approved dosage
form for commercial distribution in the
United States.
One comment objecting to the
granting of registration as an importer of
the basic class of controlled substance
listed to this applicant and a request for
a hearing were received on December
31, 2012. The objection and request for
a hearing were withdrawn.
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
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: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Registration, Watson
Pharma, Inc.
[FR Doc. 2013–06328 Filed 3–19–13; 8:45 am]
By Notice dated November 5, 2012,
and published in the Federal Register
on November 13, 2012, 77 FR 67675,
Watson Pharma, Inc., 2455 Wardlow
Road, Corona, California 92880–2882,
made application to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
DEPARTMENT OF JUSTICE
Drug
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application:
Morton Grove Pharmaceuticals
Schedule
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
srobinson on DSK4SPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
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
VerDate Mar<14>2013
18:04 Mar 19, 2013
Jkt 229001
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on December 14, 2012,
Morton Grove Pharmaceuticals, 6451
Main Street, Morton Grove, Illinois
60053–2633, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of Gamma
Hydroxybutyric Acid (2010), a basic
class of controlled substance listed in
schedule I.
The company plans to manufacture
the listed controlled substance for
distribution to its customers.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substance,
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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 May 20, 2013.
Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–06332 Filed 3–19–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration:
Noramco, Inc.
By Notice dated November 1, 2012,
and published in the Federal Register
on November 9, 2012, 77 FR 67397,
Noramco, Inc., 1440 Olympic Drive,
Athens, Georgia 30601, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances:
Drug
Gamma
Hydroxybutyric
Acid
(2010).
Codeine-N-Oxide (9053) ..............
Dihydromorphine (9145) ...............
Morphine-N-oxide (9307) .............
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
Carfentanil (9743) .........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
I
I
I
I
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 distribution to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Noramco, Inc., to manufacture the listed
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17230-17231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06321]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances, Notice of Registration,
Noramco, Inc.
By Notice dated October 9, 2012, and published in the Federal
Register on October 18, 2012, 77 FR 64142, Noramco, Inc., 500 Swedes
Landing Road, Wilmington, Delaware 19801-4417, made application by
renewal to the Drug Enforcement Administration (DEA) to be registered
as an importer of the basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................... II
Opium, raw (9600).......................... II
Poppy Straw Concentrate (9670)............. II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to import raw Opium (9600) and Poppy Straw
concentrate (9670) to manufacture other controlled substances. The
company plans to import Tapentadol (9780) in intermediate form for the
bulk manufacture of Tapentadol (9780) for distribution to its
customers. The company plans to import Phenylacetone (8501) in bulk for
the manufacture of a controlled substance.
Comments and requests for hearings on applications to import
narcotic raw
[[Page 17231]]
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 Noramco Inc., 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, at this
time. 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 is granted registration as an importer
of the basic classes of controlled substances listed.
Dated: March 12, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-06321 Filed 3-19-13; 8:45 am]
BILLING CODE 4410-09-P
