The Chapter <797> Answer Book provides expert guidance and a balance of both formal requirements of the USP chapter and practical advice in complying with the chapter. The Chapter <797> Answer Book will follow a sterile product from receipt to preparation in a healthcare facility, addressing core elements of the USP chapter. The Q&A approach provides a comprehensive overview and explanation of the requirements of USP Chapter <797> and specific guidance for nonsterile compounding.

Highlights of The Chapter <797> Answer Book include:

Outlines quality-of-practice standards for sterile compounding issued by USP
Describes the guidelines, procedures and compliance requirements for compounding sterile preparations
Discusses work practices to meet requirements and best practices
Defines personnel training and core competencies, including suggested approaches for documenting competency
Includes requirements for a sterile compounding suite, segregated compounding areas, and areas used for compounding radiopharmaceuticals and allergen extracts
Describes the approach to assigning beyond-use dates

The Answer Book addresses the seven major areas proposed for revision, with the goals of clarifying common questions, addressing special situations, streamlining the nature of the information included in the chapter, and improving wording clarity . The book will provide expert guidance and practical advice to pharmacists, technicians and other health professionals involved in the sterile compounding of drugs. Author Patricia Kienle is a known authority on sterile compounding. She currently serves as a member of the USP Compounding Expert Committee and was Chair of the subcommittee and Expert Panel that developed USP <800> as a guide for practical advice and explanation to help ensure compliance with the requirements of USP <800>.