Manufacturer of Controlled Substances Registration: Pharmacore, Inc., 46336 [2015-19099]
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46336
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
Controlled substance
Fentanyl (9801) ............................
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19109 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Meridian Medical
Technologies
ACTION:
The company plans to manufacture
the listed controlled substance as an
active pharmaceutical ingredient (API)
for clinical trials.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19164 Filed 8–3–15; 8:45 am]
Meridian Medical
Technologies applied to be registered as
an importer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
grants Meridian Medical Technologies
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22553, Meridian Medical
Technologies, 2555 Hermelin Drive, St.
Louis, Missouri 63144 applied to be
registered as an importer of a certain
basic class of controlled substance. No
comments or objections were submitted
for this notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Meridian Medical Technologies 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. 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 morphine (9300), a basic
class controlled substance listed in
schedule II.
VerDate Sep<11>2014
18:45 Aug 03, 2015
Jkt 235001
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 the basic classes of
controlled substances:
Controlled substance
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Schedule
II
II
[FR Doc. 2015–19099 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
Notice of registration.
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the Quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards.
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Schedule
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Pharmacore,
Inc.
Manufacturer of Controlled
Substances Registration: Cambrex
Charles City
ACTION:
ACTION:
Notice of registration.
Pharmacore, Inc. applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants
Pharmacore, Inc. registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22554, Pharmacore, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Pharmacore, Inc. to
manufacture 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
SUMMARY:
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
Notice of registration.
Cambrex Charles City applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Cambrex
Charles City registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22555, Cambrex Charles City,
1205 11th Street, Charles City, Iowa
50616 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Cambrex Charles City
to manufacture 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Page 46336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19099]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Pharmacore,
Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Pharmacore, Inc. applied to be registered as a manufacturer of
certain basic classes of controlled substances. The Drug Enforcement
Administration (DEA) grants Pharmacore, Inc. registration as a
manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and
published in the Federal Register on April 22, 2015, 80 FR 22554,
Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North
Carolina 27265 applied to be registered as a manufacturer of certain
basic classes of controlled substances. No comments or objections were
submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Pharmacore, Inc. to manufacture 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. 823(a), and in accordance with 21
CFR 1301.33, the above-named company is granted registration as a bulk
manufacturer of the basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substance as
an active pharmaceutical ingredient (API) for clinical trials.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19099 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P
