83 FR 37525 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 148 (August 1, 2018)

Page Range37525-37525
FR Document2018-16466

Federal Register, Volume 83 Issue 148 (Wednesday, August 1, 2018)
[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Notices]
[Page 37525]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16466]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research 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 on or before August 31, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before August 31, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 
request 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/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 delegated 
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 1301.34(a), this is notice that on July 
3, 2018, Galephar Pharmaceutical Research Inc., #100 Carr 198 
Industrial Park, Juncos, Puerto Rico 00777 applied to be registered as 
an importer of the following basic class of controlled substance:

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                                          Drug
          Controlled substance            code           Schedule
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Hydromorphone..........................    9150  II
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    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.

    Dated: July 23, 2018.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2018-16466 Filed 7-31-18; 8:45 am]
 BILLING CODE 4410-09-P


Current View
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 application.
DatesRegistered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 31, 2018. Such persons may also file a written request for a hearing on the application on or before August 31, 2018.
FR Citation83 FR 37525 

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