November 06, 2020

Overview of USP Chapters on Compounding and Current Status of FDA’s Guidance and Enforcement Efforts Regarding Compounding

Developments in Pharmacy Law Seminar Presented by American Society of Pharmacy Law



Jonathan Keller and Steve Lokensgard provided a thorough overview of the most pertinent sections of United States Pharmacopeia (USP) Chapters 795, 797, 800 and 825 as it relates to pharmacy compounding requirements. They walked through the prior appeals of these chapters, the outcome and their current status. Further, they offered their thoughts as to what action USP may take in the future regarding these chapters. The presenters then delved into the current status of Food and Drug Administration (FDA) guidance and enforcement efforts relating to hospitals and health systems, the 5% rule, the guidance addressing “essentially copies,” office stock, the memorandum of understanding (MOU) with states, and the impact of the COVID-19 public health emergency on FDA guidance. They also reviewed state initiatives on the limits of traditional pharmacy compounding and their position on compounding within hospitals and health systems.

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