The Chapter <797> Answer Book, 2nd Edition, offers a comprehensive overview and explanation of the requirements and recommendations of USP Chapter <797>, as well as practical advice and consideration in complying with the chapter. The Answer Book is written in plain language in a question-and-answer format by Patricia C. Kienle, RPh, MPA, BCSCP, FASHP.
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The Chapter <797> Answer Book (EPUB 1.59 MB)
The Chapter <797> Answer Book (PDF 2.55 MB)
The Chapter <797> Answer Book, 2nd Edition provides expert guidance and practical advice to pharmacists, technicians and other health professionals involved in sterile compounding. The book follows a sterile product from receipt to preparation in a healthcare facility, addressing core elements of the revised USP chapter, to answer major questions healthcare systems may have when implementing the new standards.
Key discussion areas of the book include:
Overview of the major changes between 2008 version of USP <797> and 2023 revision
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 cleanroom suite, segregated compounding areas, storage areas and areas used for compounding hazardous drugs
Approach to assigning beyond-use dates
Patricia C. Kienle, RPh, MPA, BCSCP, FASHP
Patricia C. Kienle is Director, Accreditation and Medication Safety, at Cardinal Health. She is a known authority on compounding, medication safety, accreditation, and regulatory issues. A graduate of the University of the Sciences in Philadelphia and Marywood University in Scranton, Pennsylvania, Kienle also completed an executive fellowship in patient safety at Virginia Commonwealth University and serves as adjunct clinical faculty at Wilkes University.
Kienle has served on the board of directors of ASHP and as president of the Pennsylvania Society of Hospital Pharmacists. She has also earned numerous state and national awards acknowledging her expertise in and dedication to hospital pharmacy, including the 2014 ASHP Award for Distinguished Leadership, 2018 ASHP John W. Webb Lecture Award, and 2022 Harvey A.K. Whitney Lecture Award.