FDA Inspection Trends for 503B Compounders

Identifying and interpreting enforcement trends inside the regulatory actions for 503B outsourced compounders can assist health care facilities in choosing appropriate 503B partners. Furthermore, an understanding of the FDA’s current focus can help hospital and health system pharmacies monitor their outsourcing partners while improving their own compounding programs. Utilizing the largest independent database of FDA compounding activities and documents outside of the FDA itself, Lou Diorio, RPh, FAPhA, of LDT Health Solutions will analyze the long-term trends and current developments in FDA inspections of 503B compounders.