Importer of Controlled Substances Application: Mylan Inc.

Primary source

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Published

February 24, 2022

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 Supplemental Information listed below for further drug information.

Full Text

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<title>Federal Register, Volume 87 Issue 37 (Thursday, February 24, 2022)</title>
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[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10387-10388]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03907]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-957]


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 Supplemental 
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 28, 2022. 
Such persons may also file a written request for a hearing on the 
application on or before March 28, 2022.

ADDRESSES: The DEA 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 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="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,

[[Page 10388]]

8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 15, 2021, 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):

------------------------------------------------------------------------
                                           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
------------------------------------------------------------------------

    The company plans to import finished dosage forms for analytical 
testing and distribution for clinical trials. 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 the Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03907 Filed 2-23-22; 8:45 am]
BILLING CODE P


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