Importer of Controlled Substances Registration: CODY LABORATORIES, INC., 34552 [2014-14151]
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Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices
dispensers of controlled substances
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to sec. 7(g) of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on May 8,
2014, Alkermes Gainesville LLC, 1300
Gould Drive, Gainesville, Georgia
30504, applied 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
above listed controlled substance for
analytical research and testing.
The import of the above listed basic
class of controlled substance would be
granted only for analytical testing and
clinical testing. This authorization does
not extend to the import of a finished
Food and Drug Administration
approved or non-approved dosage form
for commercial distribution in the
United States.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, and
dispensers of controlled substances
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to sec. 7(g) of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.34(a), this is notice that on
December 9, 2013, Meda
Pharmaceuticals, Inc., 705 Eldorado
Street, Decatur, Illinois 62523, applied
to be registered as an importer of
Nabilone (7379), a basic class of nonnarcotic controlled substance listed in
schedule II.
The company plans to import the
FDA approved listed controlled
substance as a finished drug product in
dosage form for distribution to its
customers.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
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[FR Doc. 2014–14150 Filed 6–16–14; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Application: MEDA
PHARMACEUTICALS, INC.
[Docket No. DEA–392]
ACTION:
Importer of Controlled Substances
Registration: CODY LABORATORIES,
INC.
Notice of Application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before July 17, 2014. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before July 17,
2014.
DATES:
Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESS:
The
Attorney General has delegated his
authority under the Controlled
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:43 Jun 16, 2014
Jkt 232001
ACTION:
Notice of Registration.
Cody Laboratories, Inc.
applied to be registered as an importer
of certain basic classes of narcotic or
non-narcotic controlled substances. The
DEA grants Cody Laboratories, Inc.
registration as an importer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated December 31, 2013, and
published in the Federal Register on
January 10, 2014, 79 FR 1888, Cody
Laboratories, Inc., 601 Yellowstone
Avenue, Cody, Wyoming 82414–9321,
applied to be registered as an importer
of certain basic classes of narcotic or
non-narcotic controlled substances.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
958(a) and determined that the
registration of Cody Laboratories, 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. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verified the company’s
compliance with state and local laws,
and reviewed 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 narcotic
or non-narcotic controlled substances
listed:
Controlled substance
Phenylacetone (8501) ..................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
The company plans to import narcotic
raw materials for manufacturing and
further distribution to its customers.
The company is registered with the DEA
as a manufacturer of several controlled
substances that are manufactured from
poppy straw concentrate.
The company plans to import an
intermediate form of tapentadol (9780),
to bulk manufacture tapentadol for
distribution to its customers.
Comments and request for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(2007).
In reference to the non-narcotic raw
material, no comments or objections
have been received.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–14151 Filed 6–16–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: STEPAN COMPANY
ACTION:
Notice of registration.
Stepan Company applied to
be registered as an importer of a basic
class of a narcotic controlled substance.
The DEA grants Stepan Company
SUMMARY:
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Page 34552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14151]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: CODY
LABORATORIES, INC.
ACTION: Notice of Registration.
-----------------------------------------------------------------------
SUMMARY: Cody Laboratories, Inc. applied to be registered as an
importer of certain basic classes of narcotic or non-narcotic
controlled substances. The DEA grants Cody Laboratories, Inc.
registration as an importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and
published in the Federal Register on January 10, 2014, 79 FR 1888, Cody
Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414-9321,
applied to be registered as an importer of certain basic classes of
narcotic or non-narcotic controlled substances.
The Drug Enforcement Administration (DEA) has considered the
factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the
registration of Cody Laboratories, 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. The DEA investigated the company's
maintenance of effective controls against diversion by inspecting and
testing the company's physical security systems, verified the company's
compliance with state and local laws, and reviewed 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 narcotic or non-
narcotic controlled substances listed:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................... II
Poppy Straw Concentrate (9670)............. II
Tapentadol (9780).......................... II
------------------------------------------------------------------------
The company plans to import narcotic raw materials for
manufacturing and further distribution to its customers. The company is
registered with the DEA as a manufacturer of several controlled
substances that are manufactured from poppy straw concentrate.
The company plans to import an intermediate form of tapentadol
(9780), to bulk manufacture tapentadol for distribution to its
customers.
Comments and request for hearings on applications to import
narcotic raw material are not appropriate. 72 FR 3417 (2007).
In reference to the non-narcotic raw material, no comments or
objections have been received.
Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14151 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P
