By Vicki G. Norton, Ph.D. and Brandon A. Chan, Ph.D.
Montana Senate Bill 535 established a framework for licensed experimental treatment centers to offer patients access to experimental treatments that have completed Phase I clinical trials but have not yet received full approval from the United States Food and Drug Administration. On April 10, 2026, the Montana Department of Public Health and Human Services published a notice of proposed rulemaking proposing the adoption of 25 new rules to implement SB 535’s licensing and operational requirements for experimental treatment centers.