Notice2024-24557
Importer of Controlled Substances Application: Mylan Technologies 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
October 23, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Mylan Technologies Inc 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 89 Issue 205 (Wednesday, October 23, 2024)</title>
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[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Page 84624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24557]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1441]
Importer of Controlled Substances Application: Mylan Technologies
Inc
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Mylan Technologies Inc 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 22, 2024. Such persons may also file a written request for a
hearing on the application on or before November 22, 2024.
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 October 8, 2024, Mylan Technologies Inc., 110 Lake
Street, Saint Albans, Vermont 05478-2266, 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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Methylphenidate........................ 1724 II
Fentanyl............................... 9801 II
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The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically manufactured FDF to foreign markets. 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. 2024-24557 Filed 10-22-24; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on October 23, 2024.
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