USP 797 Compounding Standards Compliance Guide

This guide outlines essential steps for ensuring compliance with the revised USP 797 compounding standards. It emphasizes the importance of discarding outdated standards and understanding the FDA's Insanitary Conditions at Compounding Facilities guidance. Engaging expert commissioning firms for cleanroom design and construction is recommended to prevent compliance issues. The guide details the necessity of exceeding minimum air changes per hour (ACPH) for classified spaces and the complexities involved in air handling unit design. It also discusses the critical separation of areas within cleanrooms, particularly for hazardous drug compounding. The document advises on the selection of biosafety cabinets and the importance of developing Acceptable Surface Limits (ASL) for hazardous drugs. Regular reviews of hazardous drug lists and sampling protocols are emphasized to maintain compliance and ensure worker safety. Additionally, it advocates for qualitative risk assessments to evaluate employee exposure throughout the hazardous drug life cycle.