Importer of Controlled Substances Application: United States Pharmacopeial Convention, 38466 [2015-16445]
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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
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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
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Drug Enforcement Administration
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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
]]>Agencies
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Page 38466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16445]
[[Page 38466]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
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
1301.34(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:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Cathinone (1235)........................... I
Methaqualone (2565)........................ I
Lysergic acid diethylamide (7315).......... I
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
4-Methyl-2,5-dimethoxyamphetamine (7395)... I
3,4-Methylenedioxyamphetamine (7400)....... I
Codeine-N-oxide (9053)..................... I
Difenoxin (9168)........................... I
Heroin (9200).............................. I
Morphine-N-oxide (9307).................... I
Norlevorphanol (9634)...................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Phenmetrazine (1631)....................... II
Methylphenidate (1724)..................... II
Amobarbital (2125)......................... II
Pentobarbital (2270)....................... II
Secobarbital (2315)........................ II
Glutethimide (2550)........................ II
Phencyclidine (7471)....................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Phenylacetone (8501)....................... II
Alphaprodine (9010)........................ II
Anileridine (9020)......................... II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Hydrocodone (9193)......................... II
Levomethorphan (9210)...................... II
Levorphanol (9220)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................ II
Thebaine (9333)............................ II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Sufentanil (9740).......................... 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 non-approved 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
