[Federal Register Volume 86, Number 158 (Thursday, August 19, 2021)]
[Notices]
[Page 46716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17765]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-887]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Galephar 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 file written comments on or objections to 
the issuance of the proposed registration on or before September 20, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 20, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on July 23, 2021, 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
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    The company plans to import the listed controlled substance in 
finished dosage form for analytical purpose only. No other activity for 
this drug code is 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.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17765 Filed 8-18-21; 8:45 am]
BILLING CODE 4410-09-P