Ohana Bio Wants to Mass-Grow Marihuana for Med Science
Published Date: 3/27/2025
Notice
Summary
Ohana Bio Pharma, LLC wants to grow and make large amounts of marijuana for medical and scientific research. The DEA is reviewing their application and invites other registered manufacturers or applicants to share their thoughts by May 27, 2025. If approved, Ohana Bio Pharma will help supply researchers with important marijuana ingredients, boosting medical studies without extra costs to the public.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Deadline to Comment: May 27, 2025
If you are a registered bulk manufacturer or an applicant, you may submit electronic comments or objections about Ohana Bio Pharma's application through https://www.regulations.gov on or before May 27, 2025. After you submit a comment you will receive a Comment Tracking Number.
Application to Supply Researchers with Marijuana APIs
Ohana Bio Pharma, LLC applied on December 6, 2024 to be a DEA-registered bulk manufacturer located at 22 Frontage Road, Westerly, Rhode Island. The application seeks authorization to manufacture in bulk Marihuana (code 7360, Schedule I), Marihuana Extract (code 7350, Schedule I), and Tetrahydrocannabinol (code 7370, Schedule I) for production of active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers.
Registration Limits and Diversion Safeguards
If registered, the entity would be authorized only to conduct the bulk-manufacturing activities and coincident activities specifically allowed under DEA regulations, and DEA will evaluate the application under 21 U.S.C. 823(a) and 21 CFR part 1318 to ensure adequate safeguards against diversion are in place.
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