The Sterile Compounding Answer Book

A Guide to Contemporary Best Practices

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Page Count: 184

The Sterile Compounding Answer Book: A Guide to Contemporary Best Practices 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 Q&A approach provides a comprehensive overview and explanation of the requirements of USP Chapter<797> and specific guidance for sterile compounding. 

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    • The Sterile Compounding Answer Book (EPUB 1.06 MB)

The Sterile Compounding Answer Book: A Guide to Contemporary Best Practices 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 Q&A approach provides a comprehensive overview and explanation of the requirements of USP Chapter<797> and specific guidance for sterile compounding. Key discussion areas of the book include:

  • 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

The goals of The Sterile Compounding Answer Book are to clarify common questions, address special situations, streamline the nature of the information included in the USP chapter, and provide wording clarity. The book provides expert guidance and practical advice to pharmacists, technicians, and other health professionals involved in the sterile compounding of drugs.
 

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP

Patricia C. Kienle is Director, Accreditation and Medication Safety Cardinal Health. She is a known authority on sterile compounding, medication management and safety, accreditation, and regulatory issues. A graduate of the University of the Sciences in Philadelphia and Marywood University in Scranton, PA, Kienle also completed an executive fellowship in patient safety at Virginia Commonwealth University, and serves as Adjunct Associate Professor at Wilkes University. 

Ms. Kienle is a member of the USP Compounding Expert Committee, 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 and 2018 ASHP John W. Webb Lecture Award.