[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59189-59190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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