Importer of Controlled Substances Application: Benuvia Operations, LLC

Primary source

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Published

September 15, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Benuvia Operations, LLC 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 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Page 63622]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19998]



[[Page 63622]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1266]


Importer of Controlled Substances Application: Benuvia 
Operations, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Benuvia Operations, LLC 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 
October 16, 2023. Such persons may also file a written request for a 
hearing on the application on or before October 16, 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 August 10, 2023, Benuvia Operations, LLC, 3950 North 
Mays Street, Round Rock, Texas 78665-2729, applied to be registered as 
an importer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Ibogaine...........................            7260  I
Tetrahydrocannabinols..............            7370  I
Mescaline..........................            7381  I
3,4-Methylenedioxyamphetamine......            7400  I
3,4-Methylenedioxymethamphetamine..            7405  I
5-Methoxy-N,N-dimethyltryptamine...            7431  I
Dimethyltryptamine.................            7435  I
Psilocybin.........................            7437  I
Psilocyn...........................            7438  I
5-Methoxy-N,N-diisopropyltryptamine            7439  I
Dronabinol in an oral solution in a            7365  II
 drug product approved for
 marketing by the U.S. Food and
 Drug Administration.
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
clinical trial manufacturing 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.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-19998 Filed 9-14-23; 8:45 am]
BILLING CODE P


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