Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc., 38466-38467 [2015-16456]
Download as PDF
<![CDATA[
38466
Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
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 August 5, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before August 5,
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 March
3, 2015, United States Pharmacopeial
Convention, 12601 Twinbrook Parkway,
Rockville, Maryland 20852 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Lhorne on DSK7TPTVN1PROD with NOTICES
DATES:
Controlled substance
Schedule
Cathinone (1235) ..........................
Methaqualone (2565) ...................
Lysergic acid diethylamide (7315)
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
VerDate Sep<11>2014
14:37 Jul 02, 2015
I
I
I
I
I
Jkt 235001
4-Methyl-2,5dimethoxyamphetamine (7395).
3,4-Methylenedioxyamphetamine
(7400).
Codeine-N-oxide (9053) ...............
Difenoxin (9168) ...........................
Heroin (9200) ...............................
Morphine-N-oxide (9307) .............
Norlevorphanol (9634) ..................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Phenmetrazine (1631) ..................
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Glutethimide (2550) ......................
Phencyclidine (7471) ....................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Alphaprodine (9010) .....................
Anileridine (9020) .........................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
Schedule
DEPARTMENT OF JUSTICE
I
Drug Enforcement Administration
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
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 in bulk
powder form from foreign sources for
the manufacture of analytical reference
standards for sale to their customers.
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16445 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Halo
Pharmaceutical, Inc.
ACTION:
Notice of registration.
Halo Pharmaceutical, Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Halo Pharmaceutical, Inc.
registration as a manufacturer of those
controlled substances.
SUMMARY:
By notice
dated January 9, 2015, and published in
the Federal Register on January 26,
2015, 80 FR 3979, Halo Pharmaceutical,
Inc., 30 North Jefferson Road,
Whippany, New Jersey 07981 applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. No comments or objections
were submitted to this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Halo Pharmaceutical,
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:
SUPPLEMENTARY INFORMATION:
Controlled substance
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
Schedule
I
II
The company plans to manufacture
Hydromorphone HCL for sale to other
manufacturers and to manufacture other
controlled substances for distribution to
its customers. Dihydromorphine is an
intermediate in the manufacture of
Hydromorphone and is not for
commercial distribution.
E:\FR\FM\06JYN1.SGM
06JYN1
38467
Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
form (FDF) from foreign sources for
analytical testing and clinical trials in
which the foreign FDF will be compared
to the company’s own domesticallymanufactured FDF. This analysis is
required to allow the company to export
domestically-manufactured FDF to
foreign markets.
[FR Doc. 2015–16456 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–392]
[FR Doc. 2015–16444 Filed 7–2–15; 8:45 am]
Importer of Controlled Substances
Application: Kremers Urban
Pharmaceuticals, Inc.
ACTION:
DEPARTMENT OF JUSTICE
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
August 5, 2015. Such persons may also
file a written request for a hearing on
the application pursuant to 21 CFR
1301.43 on or before August 5, 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
12, 2015, Kremers Urban
Pharmaceuticals, Inc., 1101 C Avenue
West, Seymour, Indiana 47274 applied
to be registered as an importer of
methylphenidate (1724), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
listed substances in finished dosage
DATES:
Lhorne on DSK7TPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
VerDate Sep<11>2014
14:37 Jul 02, 2015
Jkt 235001
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals LLC
ACTION:
Controlled substance
Methylphenidate (1724) ................
Thebaine (9333) ...........................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
Schedule
II
II
II
II
The company is a contract
manufacturer. In reference to Poppy
Straw Concentrate the company will
manufacture thebaine intermediates for
sale to its customers for further
manufacture. No other activity for this
drug code is authorized for this
registration.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16443 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
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 September 4, 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
1301.33(a), this is notice that on March
20, 2015, AMPAC Fine Chemicals LLC,
Highway 50 and Hazel Avenue,
Building 05001, Rancho Cordova,
DATES:
PO 00000
California 95670 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
Frm 00041
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Rhodes
Technologies
ACTION:
Notice of registration.
Rhodes Technologies applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Rhodes
Technologies registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated January 21, 2015, and published
in the Federal Register on January 28,
2015, 80 FR 4593, Rhodes Technologies,
498 Washington Street, Coventry, Rhode
Island 02816 applied to be registered as
a manufacturer of certain basic classes
of controlled substances. One objection
was received on March 27, 2015.
However, after a thorough review of this
matter, the Drug Enforcement
Administration has concluded that the
issues raised in the objection do not
warrant the denial of this application.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Rhodes Technologies
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
SUMMARY:
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Pages 38466-38467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16456]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Halo
Pharmaceutical, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Halo Pharmaceutical, Inc. applied to be registered as a
manufacturer of certain basic classes of controlled substances. The
Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc.
registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and
published in the Federal Register on January 26, 2015, 80 FR 3979, Halo
Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey
07981 applied to be registered as a manufacturer of certain basic
classes of controlled substances. No comments or objections were
submitted to this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Halo Pharmaceutical, 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
------------------------------------------------------------------------
Dihydromorphine (9145)..................... I
Hydromorphone (9150)....................... II
------------------------------------------------------------------------
The company plans to manufacture Hydromorphone HCL for sale to
other manufacturers and to manufacture other controlled substances for
distribution to its customers. Dihydromorphine is an intermediate in
the manufacture of Hydromorphone and is not for commercial
distribution.
[[Page 38467]]
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16456 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P
