80 FR 63838 - Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 203 (October 21, 2015)

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63838-63839]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26675]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


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

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 
1301.33(a) on or before December 21, 2015.

[[Page 63839]]


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 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 
24, 2015, 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 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.

    Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-26675 Filed 10-20-15; 8:45 am]
BILLING CODE 4410-09-P