Notice2021-26677
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
December 9, 2021
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 Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 86 Issue 234 (Thursday, December 9, 2021)</title>
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[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70147-70148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26677]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 937]
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
Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and
[[Page 70148]]
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before January 10, 2022.
Such persons may also file a written request for a hearing on the
application on or before January 10, 2022.
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 September 8, 2021, 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 of controlled
substance:
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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 substances for
bulk manufacture. 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. 2021-26677 Filed 12-8-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on December 9, 2021.
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