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Importer of Controlled Substances Application: Benuvia Operations, LLC

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 dr...

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Department of Justice

Drug Enforcement Administration

[Docket No. DEA-1619]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

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 https://www.regulations.gov 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 https://www.regulations.gov. 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 ( printed 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):

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
5-Methoxy-N,N-diisopropyltryptamine	7439	I
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration	7365	II

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

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

90 FR 54378

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Importer of Controlled Substances Application: Benuvia Operations, LLC,” thefederalregister.org (November 26, 2025), https://thefederalregister.org/documents/2025-21173/importer-of-controlled-substances-application-benuvia-operations-llc.