Recorded August 30, 2022 | On-Demand Webinar
Join FDLI in exploring recent regulatory developments in drug compounding. Last year, the DC District Court ruled in favor of drug compounders in Wellness Pharmacy, Inc. et al. v. Azar et al., finding that FDA’s memorandum of understanding limiting interstate distribution of compounded drugs was developed improperly and failed to assess the potential economic impact of the limitation on pharmacies. Most recently, FDA released long-awaited draft guidance on “Animal Drug Compounding from Bulk Drug Substances”. This webinar will address these updates and other important topics within drug compounding, including outsourcing facility compliance, limitations on FDA’s bulk list for compounding drug substances, and recent concerns about the safety and effectiveness of a commonly used compounded hormone therapy for women.