The FDA has removed semaglutide from its drug shortage list after confirming that the current supply of the medication can meet present and future demand. Novo Nordisk, the manufacturer, stated it continues to ship all doses of semaglutide regularly to wholesalers following investments to increase its manufacturing capacity.
In February 2022, semaglutide was added to the FDA shortage list due to limited commercial availability in the US. This allowed compounding pharmacies to manufacture and distribute the drug. However, during the shortage, the FDA issued warnings about using off-brand semaglutide and counterfeit forms circulating through the US drug supply chain.
As part of this update, the FDA has also removed tirzepatide (Mounjaro/Zepbound) from its shortage list about two months ago. The agency continues to allow compounded forms of both drugs to be manufactured or distributed by state-licensed pharmacies and outsourcing facilities within specific deadlines.
The removal of semaglutide from the drug shortage list comes as public officials raise concerns about counterfeit and illegal forms of diabetes and obesity medications entering the US. Attorneys general from 38 states and US territories have urged the FDA to take action against counterfeit GLP-1 drugs, citing reports of active ingredients being sold illegally and compounding pharmacies participating in the market illicitly.
Source: https://www.healio.com/news/endocrinology/20250221/fda-removes-semaglutide-from-drug-shortage-list