Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

Published date18 October 2023
Record Number2023-22955
CourtDrug Enforcement Administration,Justice Department
SectionNotices
Federal Register, Volume 88 Issue 200 (Wednesday, October 18, 2023)
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
                [Notices]
                [Page 71885]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2023-22955]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                [Docket No. DEA-1283]
                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
                November 17, 2023. Such persons may also file a written request for a
                hearing on the application on or before November 17, 2023.
                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 https://www.regulations.gov 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 https://www.regulations.gov. 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 2, 2023, 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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                 Controlled substance Drug code Schedule
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                Remifentanil......................... 9739 II.
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                 The company plans to import the listed controlled substance(s) as
                the bulk active pharmaceutical ingredient in order to manufacture Food
                and Drug Administration-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.
                Claude Redd,
                Acting Deputy Assistant Administrator.
                [FR Doc. 2023-22955 Filed 10-17-23; 8:45 am]
                BILLING CODE P
                

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