Compassionate use

Compassionate use, formally known in U.S. regulation as "expanded access," is a mechanism codified at 21 CFR 312.300–320 that permits patients with serious or immediately life-threatening conditions to receive investigational drugs outside a clinical trial when no comparable FDA-approved therapy exists. FDA distinguishes three pathways: individual-patient, intermediate-size, and treatment IND/protocol. In cannabis medicine, the most notable historical program is the federal Compassionate Investigational New Drug program, created in 1978 after Randall v. U.S. to supply University of Mississippi-grown cannabis cigarettes to a small cohort of seriously ill patients. The George H.W. Bush administration closed it to new entrants in 1991–1992 during the AIDS crisis; as of the mid-2020s a handful of original patients (widely reported as approximately two to four, depending on year) continued to receive federal cannabis. Expanded access also played a prominent role in the pre-approval distribution of GW Pharmaceuticals' cannabidiol oral solution to children with refractory epilepsy, including the widely publicized case of Charlotte Figi, before Epidiolex's 2018 approval. → See also: Epidiolex, Medical marijuana.