Importer of Controlled Substances Application: Benuvia Operations, LLC

Primary source

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Published

November 26, 2025

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 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Notices]
[Pages 54378-54379]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21173]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1619]


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 
December 26, 2025. Such persons may also file a written request for a 
hearing on the application on or before December 26, 2025.

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

[[Page 54379]]

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 October 2, 2025, 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):

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            Controlled substance              Drug code      Schedule
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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
5-Methoxy-N,N-diisopropyltryptamine........         7439  I
Dronabinol in an oral solution in a drug            7365  II
 product approved for marketing by the U.S.
 Food and Drug Administration.
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    The company plans to import bulk Active Pharmaceutical Ingredients, 
dosage forms, samples, as needed, for product development and support 
for future customer business. 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.

Justin Wood,
Acting Deputy Assistant Administrator.
[FR Doc. 2025-21173 Filed 11-25-25; 8:45 am]
BILLING CODE P


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