[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60918-60919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16588]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1391]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Galephar Pharmaceutical Research Inc has applied to be 
registered as an importer of basic class(es) of controlled 
substance(s). Refer to Supplementary Information listed below for 
further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants, therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
August 28, 2024. Such persons may also file a written request for a 
hearing on the application on or before August 28, 2024.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically

[[Page 60919]]

through the Federal eRulemaking Portal, which provides the ability to 
type short comments directly into the comment field on the web page or 
attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for 
submitting comments. Upon submission of your comment, you will receive 
a Comment Tracking Number. Please be aware that submitted comments are 
not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, 
your comment has been successfully submitted and there is no need to 
resubmit the same comment. All requests for a hearing must be sent to: 
(1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests 
for a hearing should also be sent to: Drug Enforcement Administration, 
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 
22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on June 12, 2024, Galephar Pharmaceutical Research Inc, 
#100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777-3873 applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Hydromorphone..........................     9150  II
Morphine...............................     9300  II
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    The company plans to import the listed controlled substances for 
analytical purposes only. No other activities for these drug codes are 
authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-16588 Filed 7-26-24; 8:45 am]
BILLING CODE 4410-09-P