The revised USP General Chapter <797> offers compounders pathways for extended beyond-use dates (BUDs) in sterile preparations, with increasing BUDs tied to stricter requirements. Compliance is emphasized as a continuous journey, according to Kevin Hansen, PharmD. The revised chapter categorizes sterile compounding into three groups, simplifying determination based on preparation environment. Category 1 allows flexibility, with BUDs of up to 24 hours if refrigerated. Category 2 involves greater processing rigor for longer-lasting medications, while Category 3 permits a maximum BUD of 180 days under frozen conditions, with strict controls corresponding to the level of risk. Considerations for each category provide guidance for compounding pharmacists. To learn more about the revised USP <797> click here!
#USP797 #SterileCompounding #PharmacyPractices
