Notice2021-17765
Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 19, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 158 (Thursday, August 19, 2021)</title>
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[Federal Register Volume 86, Number 158 (Thursday, August 19, 2021)]
[Notices]
[Page 46716]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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</html>Indexed from Federal Register on August 19, 2021.
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