81_FR_15620 81 FR 15564 - Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.

81 FR 15564 - Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

Page Range15564-15564
FR Document2016-06533

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.

Federal Register, Volume 81 Issue 56 (Wednesday, March 23, 2016)
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15564]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06533]


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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 October 13, 2015, and 
published in the Federal Register on October 21, 2015, 80 FR 63838, 
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 for 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 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: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06533 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                  15564                                 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices

                                                                                                                                       Controlled substance                                                                                                      Schedule

                                                  Pentobarbital (2270) ....................................................................................................................................................................................      II
                                                  Secobarbital (2315) .....................................................................................................................................................................................      II
                                                  Glutethimide (2550) .....................................................................................................................................................................................      II
                                                  Nabilone (7379) ...........................................................................................................................................................................................    II
                                                  1-Phenylcyclohexylamine (7460) .................................................................................................................................................................               II
                                                  Phencyclidine (7471) ...................................................................................................................................................................................       II
                                                  1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................                    II
                                                  Alphaprodine (9010) ....................................................................................................................................................................................       II
                                                  Cocaine (9041) ............................................................................................................................................................................................    II
                                                  Codeine (9050) ............................................................................................................................................................................................    II
                                                  Dihydrocodeine (9120) ................................................................................................................................................................................         II
                                                  Oxycodone (9143) .......................................................................................................................................................................................       II
                                                  Hydromorphone (9150) ...............................................................................................................................................................................           II
                                                  Diphenoxylate (9170) ..................................................................................................................................................................................        II
                                                  Ecgonine (9180) ..........................................................................................................................................................................................     II
                                                  Ethylmorphine (9190) ..................................................................................................................................................................................        II
                                                  Hydrocodone (9193) ....................................................................................................................................................................................        II
                                                  Levomethorphan (9210) ..............................................................................................................................................................................           II
                                                  Levorphanol (9220) .....................................................................................................................................................................................       II
                                                  Isomethadone (9226) ..................................................................................................................................................................................         II
                                                  Meperidine (9230) .......................................................................................................................................................................................      II
                                                  Meperidine intermediate-A (9232) ...............................................................................................................................................................               II
                                                  Meperidine intermediate-B (9233) ...............................................................................................................................................................               II
                                                  Meperidine intermediate-C (9234) ...............................................................................................................................................................               II
                                                  Metazocine (9240) .......................................................................................................................................................................................      II
                                                  Methadone (9250) .......................................................................................................................................................................................       II
                                                  Methadone intermediate (9254) ..................................................................................................................................................................               II
                                                  Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................                              II
                                                  Morphine (9300) ..........................................................................................................................................................................................     II
                                                  Thebaine (9333) ..........................................................................................................................................................................................     II
                                                  Levo-alphacetylmethadol (9648) .................................................................................................................................................................               II
                                                  Oxymorphone (9652) ...................................................................................................................................................................................         II
                                                  Noroxymorphone (9668) ..............................................................................................................................................................................           II
                                                  Racemethorphan (9732) ..............................................................................................................................................................................           II
                                                  Alfentanil (9737) ..........................................................................................................................................................................................   II
                                                  Remifentanil (9739) .....................................................................................................................................................................................      II
                                                  Sufentanil (9740) .........................................................................................................................................................................................    II
                                                  Carfentanil (9743) ........................................................................................................................................................................................    II
                                                  Tapentadol (9780) .......................................................................................................................................................................................      II
                                                  Fentanyl (9801) ...........................................................................................................................................................................................    II



                                                    The company plans to manufacture                                         grants Halo Pharmaceutical, Inc.                                            local laws, and reviewing the company’s
                                                  small quantities of the listed controlled                                  registration as a manufacturer of those                                     background and history.
                                                  substances to make reference standards                                     controlled substances.                                                        Therefore, pursuant to 21 U.S.C.
                                                  which will be distributed to their                                         SUPPLEMENTARY INFORMATION: By notice                                        823(a), and in accordance with 21 CFR
                                                  customers.                                                                 dated October 13, 2015, and published                                       1301.33, the above-named company is
                                                    Dated: March 14, 2016.                                                   in the Federal Register on October 21,                                      granted registration as a bulk
                                                  Louis J. Milione,                                                          2015, 80 FR 63838, Halo                                                     manufacturer of the following basic
                                                  Deputy Assistant Administrator.
                                                                                                                             Pharmaceutical, Inc., 30 North Jefferson                                    classes of controlled substances:
                                                                                                                             Road, Whippany, New Jersey 07981
                                                  [FR Doc. 2016–06535 Filed 3–22–16; 8:45 am]
                                                                                                                             applied to be registered as a                                                         Controlled substance                          Schedule
                                                  BILLING CODE 4410–09–P
                                                                                                                             manufacturer of certain basic classes of
                                                                                                                             controlled substances. No comments or                                       Dihydromorphine (9145) ...............                  I
                                                                                                                             objections were submitted for this                                          Hydromorphone (9150) ................                   II
                                                  DEPARTMENT OF JUSTICE
                                                                                                                             notice.
                                                  Drug Enforcement Administration                                               The DEA has considered the factors in                                       The company plans to manufacture
                                                                                                                             21 U.S.C. 823(a) and determined that                                        Hydromorphone HCl for sale to other
                                                  [Docket No. DEA–392]                                                       the registration of Halo Pharmaceutical,                                    manufacturers and to manufacture other
                                                                                                                             Inc. to manufacture the basic classes of                                    controlled substances for distribution to
                                                  Manufacturer of Controlled                                                 controlled substances is consistent with
                                                  Substances Registration: Halo                                                                                                                          its customers. Dihydromorphine is an
                                                                                                                             the public interest and with United                                         intermediate in the manufacture of
                                                  Pharmaceutical, Inc.                                                       States obligations under international
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                                                                                                                         Hydromorphone and is not for
                                                  ACTION:       Notice of registration.                                      treaties, conventions, or protocols in                                      commercial distribution.
                                                                                                                             effect on May 1, 1971. The DEA
                                                                                                                                                                                                           Dated: March 14, 2016.
                                                  SUMMARY:  Halo Pharmaceutical, Inc.                                        investigated the company’s maintenance
                                                  applied to be registered as a                                              of effective controls against diversion by                                  Louis J. Milione,
                                                  manufacturer of certain basic classes of                                   inspecting and testing the company’s                                        Deputy Assistant Administrator.
                                                  controlled substances. The Drug                                            physical security systems, verifying the                                    [FR Doc. 2016–06533 Filed 3–22–16; 8:45 am]
                                                  Enforcement Administration (DEA)                                           company’s compliance with state and                                         BILLING CODE 4410–09–P




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Document Created: 2016-03-23 00:04:01
Document Modified: 2016-03-23 00:04:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of registration.
FR Citation81 FR 15564 

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