Bulk Manufacturer of Controlled Substances Application: IRIX Manufacturing, Inc., 3981-3982 [2015-01314]
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3981
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices
[Docket No. DEA–392]
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers.
Importer of Controlled Substances
Registration: Cody Laboratories, Inc.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
[FR Doc. 2015–01317 Filed 1–23–15; 8:45 am]
Notice of registration.
BILLING CODE P
Cody Laboratories, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The DEA grants Cody
Laboratories, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated August 27, 2014, and published in
the Federal Register on September 4,
2014, 79 FR 52762, Cody Laboratories,
Inc., 601 Yellowstone Avenue, Cody,
Wyoming 82414–9321, applied to be
registered as an importer of certain basic
classes of controlled substances. No
comments or objections were submitted
to this notice. Comments and requests
for hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417 (January 25,
2007).
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, verifying the
company’s compliance with state and
local laws, and reviewing 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:
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent CTS, LLC
ACTION:
Notice of registration.
Catalent CTS, LLC applied to
be registered as an importer of certain
basic classes of controlled substances.
The DEA grants Catalent CTS, LLC
registration as an importer of those
controlled substances.
SUPPLEMENTARY INFORMATION:
By notice dated June 10, 2014, and
published in the Federal Register on
June 17, 2014, 79 FR 34551, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, applied to
be registered as an importer of certain
basic classes of controlled substances.
One comment of objection was received
on this registration and a request for a
hearing was received on September 3,
2014. The objection was resolved.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
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 Catalent CTS, 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. The DEA investigated the
Controlled substance
Schedule
company’s maintenance of effective
Phenylacetone (8501) ..........
II controls against diversion by inspecting
and testing the company’s physical
Poppy Straw Concentrate
(9670) ................................
II security systems, verifying the
Tapentadol (9780) ................
II company’s compliance with state and
local laws, and reviewing the company’s
The company plans to import narcotic background and history.
raw materials for manufacturing and
Therefore, pursuant to 21 U.S.C.
further distribution to its customers.
952(a) and 958(a), and in accordance
The company is registered with the DEA with 21 CFR 1301.34, the above-named
as a manufacturer of several controlled
company is granted registration as an
substances that are manufactured from
importer of the basic classes of
poppy straw concentrate.
controlled substances listed:
VerDate Sep<11>2014
18:48 Jan 23, 2015
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SUMMARY:
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Fmt 4703
Sfmt 4703
Controlled substance
Schedule
Marihuana (7360) .................
Poppy Straw Concentrate
(9670) ................................
I
II
The company plans to import a
finished pharmaceutical product
containing cannabis extracts in dosage
form for a clinical trial study.
This compound is listed under drug
code 7360. No other activity for this
drug code is authorized for this
registration.
In addition, the company plans to
import an ointment for the treatment of
wounds which contain trace amounts of
the controlled substances normally
found in poppy straw concentrate for
packaging and labeling to be used in
clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–01316 Filed 1–23–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: IRIX
Manufacturing, Inc.
ACTION:
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 1301.33(a) on
or before March 27, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
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
DATES:
E:\FR\FM\26JAN1.SGM
26JAN1
3982
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices
(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 section 7 of 28 CFR pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on August
14, 2014, IRIX Manufacturing, Inc., 309
Delaware Street, Building 1106,
Greenville, South Carolina 29605,
applied 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 API
for clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
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 section 7 of 28 CFR pt. 0,
subpart. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 19, 2014, Siemens Healthcare
Diagnostics, Inc., Attn: RA, 100 GBC
Drive, Mailstop 514, Newark, Delaware
19702, applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Tetrahydrocannabinols (7370) ......
Ecgonine (9180) ...........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
I
II
II
II
[Docket No. DEA–392]
The company plans to produce the
listed controlled substances in bulk to
be used in the manufacture of reagents
and drug calibrator controls which are
DEA exempt products.
In reference to drug code 7370 the
company plans to bulk manufacture a
synthetic tetrahydrocannabinol. No
other activity for this drug code is
authorized for this registration.
Bulk Manufacturer of Controlled
Substances Application: Siemens
Healthcare Diagnostics, Inc.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–01314 Filed 1–23–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
BILLING CODE P
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 1301.33(a) on
or before March 27, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
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
emcdonald on DSK67QTVN1PROD with NOTICES
18:48 Jan 23, 2015
Jkt 235001
[FR Doc. 2015–01298 Filed 1–23–15; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–392]
DATES:
VerDate Sep<11>2014
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2015–01315 Filed 1–23–15; 8:45 am]
Notice of application.
the factors in 21 U.S.C. 823(a) and
determined that the registration of
Pharmacore, Inc. to manufacture this
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. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration 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 an
active pharmaceutical ingredient (API)
for clinical trials.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances Registration: Lin Zhi
International, Inc.
[Docket No. DEA–392]
ACTION:
Manufacturer of Controlled
Substances Registration: Pharmacore,
Inc.
SUMMARY:
ACTION:
Notice of registration.
Pharmacore, Inc. applied to
be registered as a manufacturer of a
basic class of controlled substance. The
DEA grants Pharmacore, Inc. registration
as a manufacturer of this controlled
substance.
SUPPLEMENTARY INFORMATION: By notice
dated May 28, 2014, and published in
the Federal Register on June 3, 2014, 79
FR 31987, Pharmacore, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265, applied to be
registered as a manufacturer of a certain
basic class of controlled substance. No
comments or objections were submitted
to this notice.
The Drug Enforcement
Administration (DEA) has considered
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Notice of registration.
Lin Zhi International, Inc.,
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The DEA grants
Lin Zhi International, Inc. registration as
a manufacturer of those controlled
substances.
By notice
dated May 28, 2014, and published in
the Federal Register on June 4, 2014, 79
FR 32321, Lin Zhi International, Inc.,
670 Almanor Avenue, Sunnyvale,
California 94085, applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted to this notice.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823(a) and
determined that the registration of Lin
Zhi International, Inc. to manufacture
the basic classes of controlled
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 3981-3982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01314]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: IRIX
Manufacturing, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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
1301.33(a) on or before March 27, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled 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
[[Page 3982]]
(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 section 7 of 28 CFR
pt. 0, subpt. R, App.
In accordance with 21 CFR 1301.33(a), this is notice that on August
14, 2014, IRIX Manufacturing, Inc., 309 Delaware Street, Building 1106,
Greenville, South Carolina 29605, applied 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
API for clinical trials.
Dated: January 9, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-01314 Filed 1-23-15; 8:45 am]
BILLING CODE 4410-09-P
