Pending · due 20 Sep 2026

The FDA approves a psilocybin, LSD or MDMA drug product whose approved labeling or REMS permits a retail pharmacy to dispense it to the patient for use outside a healthcare setting.

Resolved on Drugs@FDA (approval letters and approved labeling) read with the FDA REMS database (REMS@FDA). For each drug product whose active ingredient is psilocybin, LSD (lysergide, any salt) or MDMA (midomafetamine, any salt) that the FDA approves between the statement date and the deadline, check the approved labeling and any REMS in force on the approval date. TRUE on the approval date of the first such product whose labeling or REMS permits a retail or community pharmacy to dispense it to the patient or caregiver for use outside a healthcare setting. FALSE at the deadline if at least one such product has been approved and every such approval restricts dispensing to certified healthcare settings or requires administration under healthcare-provider supervision in a healthcare setting. If no such product is approved in the window, the condition is unmet and the item is void.

Resolution source: Drugs@FDA (approval letters and labeling) with the FDA REMS database (REMS@FDA)

Readings: 'Go through a retail pharmacy' reads as the FDA-approved labeling or REMS permitting a retail or community pharmacy to dispense the product to the patient for use outside a healthcare setting.; A product restricted to certified healthcare settings, or whose label requires administration under healthcare-provider supervision in a healthcare setting (the Spravato model the author uses as the reference), does not go through a retail pharmacy.; 'Them' and 'these drugs' = drug products whose active ingredient is psilocybin, LSD (lysergide) or MDMA (midomafetamine), in any salt or formulation the sponsor names as such. 'None of them' denies the disjunction, so one event covers all three ('A or B' is one event).; Denial: the forecaster asserts that the proposition is false. The claim presupposes at least one approval; if none occurs in the window, the condition is unmet and the item is void rather than scored as a correct denial.