Notice2022-01817
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 31, 2022
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 87 Issue 20 (Monday, January 31, 2022)</title>
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[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4943-4944]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01817]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-946]
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 file written comments on or objections to
the issuance of the proposed registration on or before March 2, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 2, 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,
[[Page 4944]]
Virginia 22152. All request 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 December 7, 2021, Mylan Pharmaceuticals Inc., 2898
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 above controlled substance as a
Federal Drug Administration-approved drug product in finished dosage
form for commercial distribution to its customers.
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).
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01817 Filed 1-28-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on January 31, 2022.
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