Notice2025-17583
Importer of Controlled Substances Application: Fresenius Kabi USA, 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
September 12, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Fresenius Kabi USA, LLC 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 90 Issue 175 (Friday, September 12, 2025)</title>
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[Federal Register Volume 90, Number 175 (Friday, September 12, 2025)]
[Notices]
[Page 44239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17583]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1594]
Importer of Controlled Substances Application: Fresenius Kabi
USA, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Fresenius Kabi USA, LLC 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
October 14, 2025. Such persons may also file a written request for a
hearing on the application on or before October 14, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on August 5, 2025, Fresenius Kabi USA, LLC, 3159 Staley
Road, Grand Island, New York 14072-2028, 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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Remifentanil............................ 9739 II
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The company plans to import the listed controlled substance(s) as
bulk active pharmaceutical ingredient to manufacture Food and Drug
Administration (FDA)-approved dosage forms. 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 FDA-approved or non-approved finished dosage forms for commercial
sale.
Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-17583 Filed 9-11-25; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on September 12, 2025.
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