As FDA oversight of pharmaceutical quality continues to intensify, compounding pharmacies are operating in a regulatory environment shaped by increased inspections, and enforcement activity across the entire supply chain.

In recent years, the FDA took significant action against API manufacturers that supply compounding pharmacies. In the past few months, we’ve now seen these actions extend to API distributors. Scrutiny is extending downstream to compounders as well.

Recent FDA actions make it clear that regulatory expectations are no longer limited to individual pharmacies. Oversight now spans API manufacturers, distributors, and compounders alike, reinforcing that quality and compliance are supply chain-wide responsibilities. Read More >