Importer of Controlled Substances Application: Myonex 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

March 23, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Myonex 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

<html>
<head>
<title>Federal Register, Volume 88 Issue 56 (Thursday, March 23, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17627-17628]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05913]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1145]


Importer of Controlled Substances Application: Myonex Inc.

AGENCY: Drug Enforcement Administration, Justice.

[[Page 17628]]


ACTION: Notice of application.

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

SUMMARY: Myonex 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
April 24, 2023. Such persons may also file a written request for a 
hearing on the application on or before April 24, 2023.

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 December 21, 2022, Myonex Inc.. 100 Progress Drive, 
Horsham, Pennsylvania 19044, applied to be registered as an importer of 
the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine.............................    1100  II
Lisdexamfetamine........................    1205  II
Methylphenidate.........................    1724  II
Nabilone................................    7379  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Hydrocodone.............................    9193  II
Morphine................................    9300  II
Oxymorphone.............................    9652  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
dosage form for clinical trials, research, and analytical purposes. 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. 2023-05913 Filed 3-22-23; 8:45 am]
BILLING CODE P


</pre></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on March 23, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.