Importer of Controlled Substances Application: Mylan Inc.

Primary source

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Published

February 17, 2023

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 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10382-10383]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03395]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1140]


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 20, 2023. 
Such persons may also file a written request for a hearing on the 
application on or before March 20, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal,

[[Page 10383]]

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, 8701 Morrissette 
Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 2, 2022, 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
------------------------------------------------------------------------

    The company plans to import bulk active pharmaceutical ingredients 
for internal testing purposes only and 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 Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-03395 Filed 2-16-23; 8:45 am]
BILLING CODE P


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