The Outsourcing Facilities Association and compounding pharmacy FarmaKeio Superior Custom Compounding filed a lawsuit following the FDA’s initial announcement, arguing that the shortages were ongoing and that the decision would limit access to essential medicines.
After reevaluating the situation, the agency said it does not plan to take action against compounding pharmacies that violate the law requiring a drug’s inclusion on the FDA shortage list for compounding.
Tirzepatide, the main ingredient of both medicines, fell into short supply because of high demand. Similar GLP-1 medications — semaglutide (Ozempic, Rybelsus, Wegovy), liraglutide (Saxenda, Victoza) and dulaglutide (Trulicity) — remain on the FDA’s drug shortage list.
