Importer of Controlled Substances Application: Benuvia Operations, LLC
Published Date: 11/26/2025
Notice
Summary
Benuvia Operations, LLC wants to become an official importer of some powerful controlled substances like Ibogaine and Tetrahydrocannabinols. People and companies involved with these drugs can share their thoughts or ask for a hearing by December 26, 2025. This move could shake up the import scene and means Benuvia might soon handle these substances legally, with all eyes on the deadline!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Benuvia applied to import listed controlled drugs
Benuvia Operations, LLC applied on October 2, 2025 to be registered as an importer of several controlled substances, including Schedule I drugs (for example, Ibogaine, MDMA, DMT, mescaline, and tetrahydrocannabinols) and a Schedule II dronabinol oral solution. If registered, the company would be authorized to import those listed substances as specified in the application.
Import authorization excludes finished commercial dosage forms
The notice states authorization will be limited to importing bulk active pharmaceutical ingredients, dosage forms, and samples for product development and customer support, and will not extend to importing FDA-approved or non‑approved finished dosage forms for commercial sale. Applicants whose commercial business depends on importing finished dosage forms would not receive that authority under this registration.
Stakeholders can comment or request hearing
Registered bulk manufacturers of the affected drug classes and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before December 26, 2025. Comments must be submitted through Regulations.gov and hearing requests must be sent to the DEA addresses listed in the notice.
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Key Dates
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