The FDA’s latest Report on the State of Pharmaceutical Quality raised a red flag every 503A pharmacy and 503B outsourcing facility should notice: API manufacturers serving the compounding market are drawing a disproportionate share of FDA actions. 

Over the past five years, FDA inspection data shows that 72% of actions (warning letters/import alerts/regulatory meetings) were taken against API manufacturers that exclusively supply compounding pharmacies, despite these sites accounting for only 18% of API manufacturers in the FDA’s Site Catalog. Read More >