S. 3346 — Freedom to Heal Act of 2025

This section establishes a special registration process under the Controlled Substances Act for physicians to directly administer schedule I eligible investigational drugs (as defined in the Right to Try law, 21 U.S.C. 360bbb-0a) to eligible patients (i.e., those with life-threatening diseases or conditions who have exhausted approved treatments and cannot participate in clinical trials). (As background, Right to Try enables manufacturer shipment of such drugs directly to physicians without standard FDA expanded access approval.) The process requires physicians to apply to the Attorney General with (1) evidence of existing registration to dispense or administer schedules II-V controlled substances; (2) Right to Try compliance documentation, including manufacturer/sponsor verification, supply agreement with administration guidance, and physician affirmation of consistent use; (3) specified drug quantity; (4) state law authorization; (5) relevant training/credentials; (6) treatment site description; and (7) anti-diversion information. The Attorney General must approve or issue a show-cause order within 45 days and accept electronic applications. Additional provisions include (1) possession limits to application or supplemental notification quantities (deemed approved after 30 days unless show cause issued); (2) single registration for related sites in the same city/county under common control, with site notifications; and (3) rulemaking, with an interim final rule within 240 days of enactment (bypassing standard notice-and-comment) and a final rule within two years (using standard procedures), addressing delivery, storage/security, records, registration renewal/suspension/revocation, and anti-diversion controls. (Thus, this enables controlled access to schedule I investigational drugs, such as certain experimental psychedelics or opioids, for Right to Try patients while imposing DEA safeguards.)