Montana Becomes First U.S. State to Allow Sale of Experimental Drugs Outside FDA Approval

Montana has finalized regulations making it the first U.S. state where companies can legally sell certain experimental drugs directly to consumers — without FDA approval. Any biotech company whose drug has passed Phase 1 safety testing can now apply to a state review board for $12,500 and, if approved, sell the treatment through licensed experimental treatment clinics. The first clinics are expected to open by end of 2026.

For research use only. Not for human consumption.