Clinical Firm Applies to Import Controlled Marijuana Extracts into U.S.
Published Date: 3/17/2025
Notice
Summary
Fisher Clinical Services, Inc. wants to become an official importer of some controlled substances, including marijuana extracts and other drugs. People and companies involved with these substances can share their thoughts or ask for a hearing by April 16, 2025. This move could impact how these drugs are imported and regulated, so keep an eye on the deadline to have your say!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Comment and Hearing Deadline—April 16, 2025
If you are a registered bulk manufacturer or an applicant, you may submit electronic comments or objections about Fisher Clinical Services, Inc.'s importer application on or before April 16, 2025, via https://www.regulations.gov. You may also file a written request for a hearing by April 16, 2025, using the addresses listed in the notice.
Import Authorization Limited to Clinical Trials Only
Fisher Clinical Services, Inc. applied (on September 13, 2024) to import these controlled substances: Marihuana Extract (code 7350, Schedule I), Marihuana (7360, I), Dimethyltryptamine (7435, I), Psilocybin (7437, I), Methylphenidate (1724, II), Levorphanol (9220, II), Noroxymorphone (9668, II), and Tapentadol (9780, II). If registered, the company may import those listed substances only for clinical trials; the registration does not authorize import of FDA-approved or non-approved finished dosage forms for commercial sale.
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