Notice2026-01072
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
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
January 21, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Mylan Pharmaceuticals Inc. 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 91 Issue 13 (Wednesday, January 21, 2026)</title>
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[Federal Register Volume 91, Number 13 (Wednesday, January 21, 2026)]
[Notices]
[Page 2560]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01072]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1643]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration Justice.
ACTION: Notice of application.
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SUMMARY: Mylan Pharmaceuticals Inc. 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
February 20, 2026. Such person may also file a hearing on the
application on or before February 20, 2026.
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="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online
instructions at the 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="http://www.regulations.gov">http://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 December 4, 2025, Mylan Pharmaceuticals Inc., 2829
Manufacturers Road, Greensboro, North Carolina 27406-4600, 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 in
finished dosage form for commercial distribution to their customers. 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.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-01072 Filed 1-20-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on January 21, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.