The 90-day period for outsourcing facilities compounding semaglutide under section 503B expired, one month after the equivalent deadline for state-licensed pharmacies. With both periods closed, the shortage-based justification for compounding semaglutide no longer applied to either category of compounder. The FDA noted throughout that it could still act on other grounds, including findings that a product was of substandard quality or otherwise unsafe.
Sources: FDA — FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
