Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc., 63220 [2016-22074]

Download as PDF 63220 Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices Company FR Docket Sigma Aldrich Research Biochemicals, Inc ............................................................................. 81 FR 38217 .......................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted registration as a bulk manufacturer to the above listed persons. Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. 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 July 27, 2016, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance [FR Doc. 2016–22082 Filed 9–13–16; 8:45 am] BILLING CODE 4410–09–P Dihydromorphine (9145) ............... Hydromorphone (9150) ................ DEPARTMENT OF JUSTICE I II The company plans to manufacture Hydromorphone (9150) for distribution to its customers. Dihydromorphine (9145) is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc. ACTION: Schedule Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. Notice of application. [FR Doc. 2016–22074 Filed 9–13–16; 8:45 am] 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 November 14, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: The Attorney General has delegated her SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 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 DATES: Published June 13, 2016. 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 October 14, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 14, 2016. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated her 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 February 26, 2016, 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: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Cathinone (1235) ......................................................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. Lysergic acid diethylamide (7315) ............................................................................................................................................................... Marihuana (7360) ........................................................................................................................................................................................ VerDate Sep<11>2014 20:55 Sep 13, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1 I I I I

Agencies

[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22074]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Halo 
Pharmaceutical, Inc.

ACTION: Notice of application.

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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 
1301.33(a) on or before November 14, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 July 
27, 2016, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, 
New Jersey 07981 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Dihydromorphine (9145).....................  I
Hydromorphone (9150).......................  II
------------------------------------------------------------------------

    The company plans to manufacture Hydromorphone (9150) for 
distribution to its customers. Dihydromorphine (9145) is an 
intermediate in the manufacture of Hydromorphone and is not for 
commercial distribution.

    Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22074 Filed 9-13-16; 8:45 am]
 BILLING CODE 4410-09-P

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