82 FR 43571 - Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 179 (September 18, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 179 (September 18, 2017)
| Page Range | 43571-43571 | |
| FR Document | 2017-19834 |
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)] [Notices] [Page 43571] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19834] ----------------------------------------------------------------------- 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 November 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 Assistant Administrator of the DEA Diversion Control Division (``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 11, 2017, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code 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 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-19834 Filed 9-15-17; 8:45 am] BILLING CODE P
![Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 43571
The company plans to manufacture Administrator’’) pursuant to section 7 of Register Representative/DRW, 8701
bulk active pharmaceutical ingredients 28 CFR part 0, appendix to subpart R. Morrissette Drive, Springfield, Virginia
(APIs) for distribution to its customers. In accordance with 21 CFR 22152.
Dated: September 13, 2017 1301.34(a), this is notice that on August SUPPLEMENTARY INFORMATION: The
9, 2017, Specgx LLC, 3600 North Attorney General has delegated his
Demetra Ashley,
Second Street, Saint Louis, Missouri authority under the Controlled
Acting Assistant Administrator.
63147 applied to be registered as an Substances Act to the Administrator of
[FR Doc. 2017–19786 Filed 9–15–17; 8:45 am] importer of the following basic classes
BILLING CODE 4410–09–P
the Drug Enforcement Administration
of controlled substances: (DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
Drug
DEPARTMENT OF JUSTICE Controlled substance code Schedule respect to the promulgation and
implementation of 21 CFR part 1301,
Drug Enforcement Administration Marihuana ....................... 7360 I incident to the registration of
Phenylacetone ................ 8501 II manufacturers, distributors, dispensers,
[Docket No. DEA–392] Coca Leaves .................. 9040 II importers, and exporters of controlled
Opium, raw ..................... 9600 II substances (other than final orders in
Importer of Controlled Substances Poppy Straw Con- 9670 II connection with suspension, denial, or
Application: Specgx LLC centrate. revocation of registration) has been
redelegated to the Assistant
ACTION: Notice of application. The company plans to import the Administrator of the DEA Diversion
listed controlled substances to bulk Control Division (‘‘Assistant
DATES: Registered bulk manufacturers of manufacture into Active Pharmaceutical Administrator’’) pursuant to section 7 of
the affected basic classes, and Ingredients for distribution to its 28 CFR part 0, appendix to subpart R.
applicants therefore, may file written customers. In reference to drug code In accordance with 21 CFR
comments on or objections to the 7360 (marihuana) the company plans to 1301.33(a), this is notice that on July 11,
issuance of the proposed registration in import a synthetic cannabidiol. No other 2017, Halo Pharmaceutical, Inc., 30
accordance with 21 CFR 1301.34(a) on activity for this drug code is authorized North Jefferson Road, Whippany, New
or before October 18, 2017. Such for this registration. Placement of these Jersey 07981 applied to be registered as
persons may also file a written request drug codes onto the company’s a bulk manufacturer the following basic
for a hearing on the application registration does not translate into classes of controlled substances:
pursuant to 21 CFR 1301.43 on or before automatic approval of subsequent
October 18, 2017. permit applications to import controlled Drug
Controlled substance Schedule
ADDRESSES: Written comments should substances. Approval of permit code
be sent to: Drug Enforcement applications will occur only when the
registrant’s business activity is Dihydromorphine .......... 9145 I
Administration, Attention: DEA Federal Hydromorphone ............ 9150 II
Register Representative/DRW, 8701 consistent with what is authorized
Morrissette Drive, Springfield, Virginia under 21 U.S.C. 952(a)(2). Authorization The company plans to manufacture
22152. All requests for hearing must be will not extend to the import of FDA Hydromorphone (9150) for distribution
sent to: Drug Enforcement approved or non-approved finished to its customers. Dihydromorphine
Administration, Attn: Administrator, dosage forms for commercial sale. (9145) is an intermediate in the
8701 Morrissette Drive, Springfield, Dated: September 11, 2017. manufacture of Hydromorphone and is
Virginia 22152. All request for hearing Demetra Ashley, not for commercial distribution.
should also be sent to: (1) Drug Acting Assistant Administrator. Dated: September 11, 2017.
Enforcement Administration, Attn: [FR Doc. 2017–19784 Filed 9–15–17; 8:45 am] Demetra Ashley,
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
BILLING CODE 4410–09–P Acting Assistant Administrator.
(2) Drug Enforcement Administration, [FR Doc. 2017–19834 Filed 9–15–17; 8:45 am]
Attn: DEA Federal Register DEPARTMENT OF JUSTICE
BILLING CODE P
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152. Drug Enforcement Administration
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: The [Docket No. DEA–392]
Attorney General has delegated his Drug Enforcement Administration
authority under the Controlled Bulk Manufacturer of Controlled
Substances Act to the Administrator of [Docket No. DEA–392]
Substances Application: Halo
the Drug Enforcement Administration Pharmaceutical, Inc. Importer of Controlled Substances
(DEA), 28 CFR 0.100(b). Authority to Application: Unither Manufacturing
exercise all necessary functions with ACTION: Notice of application.
LLC
respect to the promulgation and
implementation of 21 CFR part 1301, DATES: Registered bulk manufacturers of ACTION: Notice of application.
incident to the registration of the affected basic classes, and
manufacturers, distributors, dispensers, applicants therefore, may file written DATES: Registered bulk manufacturers of
sradovich on DSKBBY8HB2PROD with NOTICES
importers, and exporters of controlled comments on or objections to the the affected basic classes, and
substances (other than final orders in issuance of the proposed registration in applicants therefore, may file written
connection with suspension, denial, or accordance with 21 CFR 1301.33(a) on comments on or objections to the
revocation of registration) has been or before November 17, 2017. issuance of the proposed registration in
redelegated to the Assistant ADDRESSES: Written comments should accordance with 21 CFR 1301.34(a) on
Administrator of the DEA Diversion be sent to: Drug Enforcement or before October 18, 2017. Such
Control Division (‘‘Assistant Administration, Attention: DEA Federal persons may also file a written request
VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1](https://thefederalregister.org/doc/82_FR_43750/page/1.svg)
Document Created: 2017-09-16 00:53:02
Document Modified: 2017-09-16 00:53:02
| 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 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 November 17, 2017. | |
| FR Citation | 82 FR 43571 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR