DEA OKs Importing Trippy Ibogaine—Hallucinations for Pharma Now?
Published Date: 2/26/2025
Notice
Summary
Catalent Pharma Solutions, LLC wants to become an official importer of certain controlled substances, including the Schedule I drug Ibogaine. This affects companies and people involved in drug manufacturing who can comment or request a hearing by March 28, 2025. No fees or immediate changes happen now, but this is a key step in controlling drug imports.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Application to Import Schedule I Ibogaine
Catalent Pharma Solutions, LLC applied on November 19, 2024 to be registered as an importer of the Schedule I controlled substance ibogaine (drug code 7260). The company says it plans to import finished dosage unit products only for clinical trials, research, and analytical activities.
Import Not Allowed for Commercial Sale
The DEA notice says authorization will not extend to import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. The registration would only cover the specific research and clinical-trial import activities authorized under the drug code.
Opportunity to Comment or Request Hearing
Registered bulk manufacturers and other applicants may submit electronic comments or objections, or file a written request for a hearing, on Catalent's application on or before March 28, 2025. Comments must be submitted through https://www.regulations.gov and hearing requests must be filed with the DEA at the addresses listed in the notice.
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Key Dates
Department and Agencies
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