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Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.
The US Pharmacopeia (USP) published revised general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, on Nov. 1, 2022. USP’s Compounding Expert Committee has made these changes as a result of the evolving practice of compounded medicine and current scientific evidence, according to the organization. The revised chapters clarify misunderstood topics and include input from more than 1400 comments received during the public comment period. The changes become official on Nov. 1, 2023.
“The revisions to <795> and <797> will significantly advance compounding quality, accounting for the realities of pharmacy practice and the needs of patients. Some specific updates to chapter <795> include recommendations and requirements for facilities and equipment, minimum frequencies for cleaning, and more information about the protective garb that personnel wear. Among the changes to chapter <797>, there are updates to labeling requirements and the frequency of surface contamination testing based on the products being compounded,” the organization said in an interview with Pharmaceutical Technology.
A robust scientific and risk-based approach to the assignment of beyond-use dates (BUD) for compounded medicines is also included in the revised chapters. BUD is the date after which a compounded medicine cannot be used, according to USP. “This approach allows for longer beyond-use dates under certain circumstances, while still aiming to protect patients from the potentially dangerous consequences when ingredients breakdown or harmful microbials emerge over time,” USP said in the interview.