The Chapter 797 Answer Book

The Chapter <797> Answer Book, Second Edition provides expert guidance and a balance of both formal requirements of USP Chapter <797> and practical advice to ensure best practices. The book follows a sterile product from receipt to preparation in a healthcare facility, addressing core elements of the USP chapter. Key discussion areas of the book include: Overview of major changes between 2008 version of USP <797> and 2023 revision Quality-of-practice standards for sterile compounding issued by USP Guidelines, procedures, and compliance requirements for compounding sterile preparations Work practices to meet requirements and best practices Personnel training and core competencies, including suggested approaches for documenting competency Requirements for a sterile compounding suite, segregated compounding areas, and areas used for compounding radiopharmaceuticals and allergen extracts Approach to assigning beyond-use dates