[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56720-56721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22138]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-909]


Importer of Controlled Substances Application: United States 
Pharmaceopeial Convention

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: United States Pharmaceopeial Convention 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 12, 
2021. Such persons may also file a written request for a hearing on the 
application on or before November 12, 2021.

[[Page 56721]]


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 
request 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, 2019, United States Pharmaceopeial 
Convention, 7135 English Muffin Way, Frederick, Maryland 21704, 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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Lisdexamfetamine........................   1205  II
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    The company plans to import the bulk control substance for 
analytical testing purposes. No other activity for these drug codes 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 the Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-22138 Filed 10-8-21; 8:45 am]
BILLING CODE 4410-09-P