80 FR 38466 - Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 128 (July 6, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 128 (July 6, 2015)
| Page Range | 38466-38467 | |
| FR Document | 2015-16456 |
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)] [Notices] [Pages 38466-38467] From the Federal Register Online [www.thefederalregister.org] [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
![38466 Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
DEPARTMENT OF JUSTICE Controlled substance Schedule DEPARTMENT OF JUSTICE
Drug Enforcement Administration 4-Methyl-2,5- I Drug Enforcement Administration
dimethoxyamphetamine (7395).
[Docket No. DEA–392] 3,4-Methylenedioxyamphetamine I
(7400). [Docket No. DEA–392]
Importer of Controlled Substances Codeine-N-oxide (9053) ............... I
Difenoxin (9168) ........................... I Manufacturer of Controlled
Application: United States Substances Registration: Halo
Heroin (9200) ............................... I
Pharmacopeial Convention Morphine-N-oxide (9307) ............. I Pharmaceutical, Inc.
Norlevorphanol (9634) .................. I
ACTION: Notice of application. Amphetamine (1100) .................... II ACTION: Notice of registration.
Methamphetamine (1105) ............ II
DATES: Registered bulk manufacturers of Phenmetrazine (1631) .................. II
the affected basic classes, and Methylphenidate (1724) ................ II SUMMARY: Halo Pharmaceutical, Inc.
applicants therefore, may file written Amobarbital (2125) ....................... II applied to be registered as a
comments on or objections to the Pentobarbital (2270) ..................... II manufacturer of certain basic classes of
issuance of the proposed registration in Secobarbital (2315) ...................... II controlled substances. The Drug
accordance with 21 CFR 1301.34(a) on Glutethimide (2550) ...................... II Enforcement Administration (DEA)
Phencyclidine (7471) .................... II
or before August 5, 2015. Such persons grants Halo Pharmaceutical, Inc.
4-Anilino-N-phenethyl-4-piperidine II
may also file a written request for a (ANPP) (8333). registration as a manufacturer of those
hearing on the application pursuant to Phenylacetone (8501) .................. II controlled substances.
21 CFR 1301.43 on or before August 5, Alphaprodine (9010) ..................... II SUPPLEMENTARY INFORMATION: By notice
2015. Anileridine (9020) ......................... II
Cocaine (9041) ............................. II dated January 9, 2015, and published in
ADDRESSES: Written comments should the Federal Register on January 26,
be sent to: Drug Enforcement Codeine (9050) ............................. II
Dihydrocodeine (9120) ................. II 2015, 80 FR 3979, Halo Pharmaceutical,
Administration, Attention: DEA Federal Oxycodone (9143) ........................ II Inc., 30 North Jefferson Road,
Register Representative/ODXL, 8701 Hydromorphone (9150) ................ II Whippany, New Jersey 07981 applied to
Morrissette Drive, Springfield, Virginia Diphenoxylate (9170) ................... II be registered as a manufacturer of
22152. Request for hearings should be Hydrocodone (9193) ..................... II certain basic classes of controlled
sent to: Drug Enforcement Levomethorphan (9210) ............... II
substances. No comments or objections
Administration, Attention: Hearing Levorphanol (9220) ...................... II
Meperidine (9230) ........................ II were submitted to this notice.
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152. Methadone (9250) ........................ II The DEA has considered the factors in
Dextropropoxyphene, bulk (non- II 21 U.S.C. 823(a) and determined that
SUPPLEMENTARY INFORMATION: The dosage forms) (9273).
Attorney General has delegated his the registration of Halo Pharmaceutical,
Morphine (9300) ........................... II Inc. to manufacture the basic classes of
authority under the Controlled Thebaine (9333) ........................... II
Substances Act to the Administrator of Oxymorphone (9652) ................... II controlled substances is consistent with
the Drug Enforcement Administration Noroxymorphone (9668) .............. II the public interest and with United
(DEA), 28 CFR 0.100(b). Authority to Alfentanil (9737) ........................... II States obligations under international
exercise all necessary functions with Sufentanil (9740) .......................... II treaties, conventions, or protocols in
respect to the promulgation and effect on May 1, 1971. The DEA
implementation of 21 CFR part 1301, The company plans to import the investigated the company’s maintenance
incident to the registration of listed controlled substances in bulk of effective controls against diversion by
manufacturers, distributors, dispensers, powder form from foreign sources for inspecting and testing the company’s
importers, and exporters of controlled the manufacture of analytical reference physical security systems, verifying the
substances (other than final orders in standards for sale to their customers. company’s compliance with state and
The company plans to import local laws, and reviewing the company’s
connection with suspension, denial, or
analytical reference standards for background and history.
revocation of registration) has been
distribution to its customers for research
redelegated to the Deputy Assistant Therefore, pursuant to 21 U.S.C.
and analytical purposes. Placement of
Administrator of the DEA Office of 823(a), and in accordance with 21 CFR
these drug codes onto the company’s
Diversion Control (‘‘Deputy Assistant 1301.33, the above-named company is
registration does not translate into
Administrator’’) pursuant to section 7 of granted registration as a bulk
automatic approval of subsequent
28 CFR part 0, appendix to subpart R. manufacturer of the basic classes of
permit applications to import controlled
In accordance with 21 CFR controlled substances:
substances. Approval of permit
1301.34(a), this is notice that on March
applications will occur only when the
3, 2015, United States Pharmacopeial Controlled substance Schedule
registrant’s business activity is
Convention, 12601 Twinbrook Parkway,
consistent with what is authorized Dihydromorphine (9145) ............... I
Rockville, Maryland 20852 applied to be
under to 21 U.S.C. 952(a)(2). Hydromorphone (9150) ................ II
registered as an importer of the
Authorization will not extend to the
following basic classes of controlled
import of FDA approved or non-
substances: The company plans to manufacture
approved finished dosage forms for
Lhorne on DSK7TPTVN1PROD with NOTICES
commercial sale. Hydromorphone HCL for sale to other
Controlled substance Schedule manufacturers and to manufacture other
Dated: June 25, 2015. controlled substances for distribution to
Cathinone (1235) .......................... I Joseph T. Rannazzisi,
Methaqualone (2565) ................... I its customers. Dihydromorphine is an
Deputy Assistant Administrator. intermediate in the manufacture of
Lysergic acid diethylamide (7315) I
Marihuana (7360) ......................... I [FR Doc. 2015–16445 Filed 7–2–15; 8:45 am] Hydromorphone and is not for
Tetrahydrocannabinols (7370) ..... I BILLING CODE 4410–09–P commercial distribution.
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![Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices 38467
Dated: June 25, 2015. form (FDF) from foreign sources for California 95670 applied to be registered
Joseph T. Rannazzisi, analytical testing and clinical trials in as a bulk manufacturer of the following
Deputy Assistant Administrator. which the foreign FDF will be compared basic classes of controlled substances:
[FR Doc. 2015–16456 Filed 7–2–15; 8:45 am] to the company’s own domestically-
BILLING CODE 4410–09–P manufactured FDF. This analysis is Controlled substance Schedule
required to allow the company to export
Methylphenidate (1724) ................ II
domestically-manufactured FDF to
Thebaine (9333) ........................... II
DEPARTMENT OF JUSTICE foreign markets. Poppy Straw Concentrate (9670) II
Dated: June 25, 2015. Tapentadol (9780) ........................ II
Drug Enforcement Administration
Joseph T. Rannazzisi,
[Docket No. DEA–392] Deputy Assistant Administrator. The company is a contract
manufacturer. In reference to Poppy
[FR Doc. 2015–16444 Filed 7–2–15; 8:45 am]
Importer of Controlled Substances Straw Concentrate the company will
BILLING CODE 4410–09–P
Application: Kremers Urban manufacture thebaine intermediates for
Pharmaceuticals, Inc. sale to its customers for further
DEPARTMENT OF JUSTICE manufacture. No other activity for this
ACTION: Notice of application. drug code is authorized for this
Drug Enforcement Administration registration.
DATES: Registered bulk manufacturers of
the affected basic class, and applicants [Docket No. DEA–392] Dated: June 25, 2015.
therefore, may file written comments on Joseph T. Rannazzisi,
or objections to the issuance of the Bulk Manufacturer of Controlled Deputy Assistant Administrator.
proposed registration in accordance Substances Application: AMPAC Fine [FR Doc. 2015–16443 Filed 7–2–15; 8:45 am]
with 21 CFR 1301.34(a) on or before Chemicals LLC BILLING CODE 4410–09–P
August 5, 2015. Such persons may also
file a written request for a hearing on ACTION: Notice of application.
the application pursuant to 21 CFR DEPARTMENT OF JUSTICE
DATES: Registered bulk manufacturers of
1301.43 on or before August 5, 2015.
the affected basic classes, and Drug Enforcement Administration
ADDRESSES: Written comments should
applicants therefore, may file written
be sent to: Drug Enforcement comments on or objections to the [Docket No. DEA–392]
Administration, Attention: DEA Federal issuance of the proposed registration in
Register Representative/ODXL/8701 Manufacturer of Controlled
accordance with 21 CFR 1301.33(a) on
Morrissette Drive, Springfield, Virginia Substances Registration: Rhodes
or before September 4, 2015.
22152. Request for hearings should be Technologies
ADDRESSES: Written comments should
sent to: Drug Enforcement
Administration, Attention: Hearing be sent to: Drug Enforcement ACTION: Notice of registration.
Clerk/LJ, 8701 Morrissette Drive, Administration, Attention: DEA Federal
Register Representative/ODXL, 8701 SUMMARY: Rhodes Technologies applied
Springfield, Virginia 22152. to be registered as a manufacturer of
Morrissette Drive, Springfield, Virginia
SUPPLEMENTARY INFORMATION: The certain basic classes of controlled
22152. Request for hearings should be
Attorney General has delegated his substances. The Drug Enforcement
sent to: Drug Enforcement
authority under the Controlled Administration (DEA) grants Rhodes
Administration, Attention: Hearing
Substances Act to the Administrator of Technologies registration as a
the Drug Enforcement Administration Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152. manufacturer of those controlled
(DEA), 28 CFR 0.100(b). Authority to substances.
exercise all necessary functions with SUPPLEMENTARY INFORMATION: The
respect to the promulgation and Attorney General has delegated his SUPPLEMENTARY INFORMATION: By notice
implementation of 21 CFR part 1301, authority under the Controlled dated January 21, 2015, and published
incident to the registration of Substances Act to the Administrator of in the Federal Register on January 28,
manufacturers, distributors, dispensers, the Drug Enforcement Administration 2015, 80 FR 4593, Rhodes Technologies,
importers, and exporters of controlled (DEA), 28 CFR 0.100(b). Authority to 498 Washington Street, Coventry, Rhode
substances (other than final orders in exercise all necessary functions with Island 02816 applied to be registered as
connection with suspension, denial, or respect to the promulgation and a manufacturer of certain basic classes
revocation of registration) has been implementation of 21 CFR part 1301, of controlled substances. One objection
redelegated to the Deputy Assistant incident to the registration of was received on March 27, 2015.
Administrator of the DEA Office of manufacturers, distributors, dispensers, However, after a thorough review of this
Diversion Control (‘‘Deputy Assistant importers, and exporters of controlled matter, the Drug Enforcement
Administrator’’) pursuant to section 7 of substances (other than final orders in Administration has concluded that the
28 CFR part 0, appendix to subpart R. connection with suspension, denial, or issues raised in the objection do not
In accordance with 21 CFR revocation of registration) has been warrant the denial of this application.
1301.34(a), this is notice that on January redelegated to the Deputy Assistant The DEA has considered the factors in
12, 2015, Kremers Urban Administrator of the DEA Office of 21 U.S.C. 823(a) and determined that
Pharmaceuticals, Inc., 1101 C Avenue Diversion Control (‘‘Deputy Assistant the registration of Rhodes Technologies
Lhorne on DSK7TPTVN1PROD with NOTICES
West, Seymour, Indiana 47274 applied Administrator’’) pursuant to section 7 of to manufacture the basic classes of
to be registered as an importer of 28 CFR part 0, appendix to subpart R. controlled substances is consistent with
methylphenidate (1724), a basic class of In accordance with 21 CFR the public interest and with United
controlled substance listed in schedule 1301.33(a), this is notice that on March States obligations under international
II. 20, 2015, AMPAC Fine Chemicals LLC, treaties, conventions, or protocols in
The company plans to import the Highway 50 and Hazel Avenue, effect on May 1, 1971. The DEA
listed substances in finished dosage Building 05001, Rancho Cordova, investigated the company’s maintenance
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Document Created: 2015-12-15 13:17:39
Document Modified: 2015-12-15 13:17:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 80 FR 38466 |
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