FDA Inspection Trends for 503B Compounders

Friday, January 28 | 1:00-1:20PM ET

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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.


Lou Diorio, RPh, FAPhA

Lou Diorio, RPh, FAPhA, is a principal of LDT Health Solutions, Inc, an international medication safety and quality management consulting company celebrating its 16th year of operation. Lou is a graduate of Long Island University’s Schwartz College of Pharmacy, where he is also an adjunct professor of pharmacy practice, a member of the college’s Alumni Board, and preceptor of pharmacy students. He serves as a member of the NY State Council of Health-System Pharmacists’ Research and Education Committee and also is a member of the New Jersey Society of Health-System Pharmacists’ Industry Relations Committee.

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