Drug Shortage
A situation where supply of an approved drug is insufficient to meet demand, which can trigger regulatory provisions allowing compounding. Sustained high demand for GLP-1 receptor agonists created shortages that led to extensive compounding of semaglutide and tirzepatide.
Technical Context
FDA Drug Shortage staff work to prevent and mitigate shortages through: early warning requirements (manufacturers must notify FDA 6 months before discontinuation), expediting manufacturing changes and facility approvals, allowing temporary importation of foreign-approved products, and exercising enforcement discretion for compounding. The semaglutide shortage (2022-2024) was driven by unprecedented demand growth (>300% year-over-year prescription increases) outpacing Novo Nordisk's manufacturing capacity expansion. During the shortage, FDA listed semaglutide on its shortage list, which legally permitted 503A and 503B pharmacies to compound semaglutide products. The subsequent resolution of the shortage and FDA's determination that semaglutide was no longer in shortage status triggered legal challenges from compounding pharmacies and advocacy groups seeking to continue compounding access.