Importer of Controlled Substances Application: Meridian Medical Technologies, 22553-22554 [2015-09343]
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
Controlled substance
Schedule
Nabilone (7379) ............................
Phencyclidine (7471) ....................
Cocaine (9041) .............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Ethylmorphine (9190) ...................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Thebaine (9333) ...........................
Opium, powdered (9639) .............
Levo-alphacetylmethadol (9648) ..
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis.
In reference to drug codes 7360 and
7370, the company plans to import a
synthetic cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for this drug code is authorized for this
registration.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09344 Filed 4–21–15; 8:45 am]
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333) ..........................
Remifentanil (9739) ......................
Fentanyl (9801) ............................
Importer of Controlled Substances
Application: PHARMACORE
Notice of application.
Drug Enforcement Administration
Registered bulk manufacturers of
the affected basic class, 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
May 22, 2015. Such persons may also
file a written request for a hearing on
the application pursuant to 21 CFR
1301.43 on or before May 22, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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. Comments
and requests for any hearings on
DATES:
Jkt 235001
II
II
II
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09332 Filed 4–21–15; 8:45 am]
[Docket No. DEA–392]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Schedule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
18:00 Apr 21, 2015
Controlled substance
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Regarding the drug code (8333), the
company plans to manufacture this
listed controlled substance for
commercial sale.
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
VerDate Sep<11>2014
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
Cedarburg Pharmaceuticals, 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 listed:
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
ACTION:
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
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, dispenser,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix of subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on August
29, 2014, Pharmacore, 4180 Mendenhall
Oaks Parkway, High Point, North
Carolina 27265 applied to be registered
as an importer of poppy straw
concentrate (9670), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed controlled substance to
manufacture bulk controlled substance
intermediates for sale to its customers.
22553
[FR Doc. 2015–09350 Filed 4–21–15; 8:45 am]
BILLING CODE P
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Cedarburg
Pharmaceuticals, Inc.
ACTION:
Notice of registration.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Cedarburg Pharmaceuticals,
Inc. applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The DEA grants
Cedarburg Pharmaceuticals, Inc.
registration as a manufacturer of the
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated June 10, 2014, and published in
the Federal Register on June 17, 2014,
79 FR 34553, Cedarburg
Pharmaceuticals, Inc., 870 Badger
Circle, Grafton, Wisconsin 53024
applied to be registered as a
SUMMARY:
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Meridian Medical
Technologies
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, 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
May 22, 2015. Such persons may also
file a written request for a hearing on
DATES:
E:\FR\FM\22APN1.SGM
22APN1
22554
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
the application pursuant to 21 CFR
1301.43 on or before May 22, 2015.
DEPARTMENT OF JUSTICE
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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.
ADDRESSES:
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, dispensers,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on January
8, 2015, Meridian Medical
Technologies, 2555 Hermelin Drive, St.
Louis, Missouri 63144 applied to be
registered as an importer of morphine
(9300), a basic class of controlled
substance listed in schedule II.
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09343 Filed 4–21–15; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
Drug Enforcement Administration
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–09334 Filed 4–21–15; 8:45 am]
[Docket No. DEA–392]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Pharmacore,
Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ACTION:
Notice of application.
[Docket No. DEA–392]
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 June 22, 2015.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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.
ADDRESSES:
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, dispensers,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
February 4, 2015, Pharmacore, Inc.,
4180 Mendenhall Oaks Parkway, High
Point, North Carolina 27265, applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Oxymorphine (9652) .....................
Noroxymorphone (9668) ..............
Schedule
II
II
The company plans to manufacture
the listed controlled substance as an
active pharmaceutical ingredient (API)
for clinical trials.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Importer of Controlled Substances
Application: Actavis Laboratories FL,
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 1301.34(a) on
or before May 22, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before May 22,
2015.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 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, dispensers,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
November 19, 2014, Actavis
Laboratories FL, Inc., 4955 Orange
Drive, Davie, Florida 33314 applied to
be registered as an importer of the
following basic classes of controlled
substances:
ADDRESSES:
E:\FR\FM\22APN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22553-22554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09343]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Meridian Medical
Technologies
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class, 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 May 22, 2015. Such persons may also file a
written request for a hearing on
[[Page 22554]]
the application pursuant to 21 CFR 1301.43 on or before May 22, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
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, dispensers, importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
January 8, 2015, Meridian Medical Technologies, 2555 Hermelin Drive,
St. Louis, Missouri 63144 applied to be registered as an importer of
morphine (9300), a basic class of controlled substance listed in
schedule II.
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: April 14, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-09343 Filed 4-21-15; 8:45 am]
BILLING CODE 4410-09-P
