Notice2021-22138
Importer of Controlled Substances Application: United States Pharmaceopeial Convention
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 12, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 194 (Tuesday, October 12, 2021)</title>
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[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56720-56721]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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