The Chapter 797 Answer Book

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.
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

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