Notice2021-25575
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
November 23, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Mylan Technologies, 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 86 Issue 223 (Tuesday, November 23, 2021)</title>
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[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Page 66589]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25575]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-924]
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. 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 file written comments on or objections to
the issuance of the proposed registration on or before December 23,
2021. Such persons may also file a written request for a hearing on the
application on or before December 23, 2021.
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 October 22, 2021, 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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Controlled substance Drug 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. This analysis is required
to allow the company to export domestically manufactured finished
dosage form to foreign markets. No other activity for these drug codes
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. 2021-25575 Filed 11-22-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on November 23, 2021.
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