The FDA announced that the nationwide shortage of semaglutide injection products has been resolved, following confirmation from the manufacturer that production capacity now meets current and projected demand. Semaglutide injection products have been in shortage since 2022 due to increased demand.
The agency simultaneously outlined a graduated timeline for compounding facilities to transition away from producing semaglutide copies. Compounded drugs are not FDA-approved and must meet specific conditions to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
The regulatory guidance establishes distinct compliance windows for different categories of compounding facilities. State-licensed pharmacies and physicians operating under section 503A of the Federal Food, Drug, and Cosmetic Act have until April 22, 2025—60 days from today's announcement—to cease compounding semaglutide products. Outsourcing facilities regulated under section 503B have been granted a 90-day window to May 22, 2025.
"FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe," the agency stated in its announcement.
While the shortage designation has been lifted, the FDA acknowledged that "patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies."
The announcement comes amid ongoing shortages of other GLP-1 medications. Dulaglutide injection remains in shortage status, though the manufacturer reports all presentations are available. Liraglutide injection similarly maintains its shortage designation. The manufacturer has indicated availability of two presentations while three others have limited availability.
The FDA emphasized that manufacturer-reported availability does not constitute an official FDA determination that a shortage has been resolved. The agency continues to actively monitor drug availability and assess whether demand or projected demand exceeds available supply for each product in shortage.