Notice2021-23285
Importer of Controlled Substances Application: Globyz Pharma, LLC
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
October 26, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Globyz Pharma, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 86 Issue 204 (Tuesday, October 26, 2021)</title>
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[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59189-59190]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23285]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-917]
Importer of Controlled Substances Application: Globyz Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Globyz Pharma, LLC has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to Supplemental
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 November 26,
2021. Such persons may also file a written request for a hearing on the
application on or before November 26, 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 August 18, 2021, Globyz Pharma, LLC, 2101 Market
Street, Suite 5, Upper Chichester, Pennsylvania 19061-4001, 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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Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Oxycodone............................... 9143 II
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The company plans to import finished dosage unit products of the
above controlled substances solely for its customers to perform
analytical testing to meet Canadian requirements. The analysis is
required to allow its customers to export domestically
[[Page 59190]]
manufactured finished dosage forms to foreign markets. 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. 2021-23285 Filed 10-25-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on October 26, 2021.
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