Notice2025-02594
Importer of Controlled Substances Application: Mylan Inc.
Primary source
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Published
February 13, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Mylan 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 90 Issue 29 (Thursday, February 13, 2025)</title>
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[Federal Register Volume 90, Number 29 (Thursday, February 13, 2025)]
[Notices]
[Page 9556]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02594]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1486]
Importer of Controlled Substances Application: Mylan Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Mylan 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
March 17, 2025. Such persons may also file a written request for a
hearing on the application on or before March 17, 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 December 10, 2024, Mylan Inc., 3711 Collins Ferry
Road, Morgantown, West Virginia 26505-2362, 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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Amphetamine............................. 1100 II
Methylphenidate......................... 1724 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Methadone............................... 9250 II
Morphine................................ 9300 II
Fentanyl................................ 9801 II
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The company plans to import the listed controlled substances as
bulk active pharmaceutical ingredients for internal testing purposes
only and finished dosage forms for analytical testing and distribution
for clinical trials to support foreign market participation. No other
activities for these drug codes are 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-02594 Filed 2-12-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on February 13, 2025.
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