The Chapter <800> Answer Book

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Page Count: 240

Kienle’s updated resource provides guidance and practical advice about requirements for implementation, receiving, handling and transport of hazardous drugs (HDs), ongoing medical surveillance of personnel handling HDs, and establishment of separate negative pressure containment areas for compounding of HDs.  

NOTE: The link below allows you to download the ePub file. If you want the PDF files, click on Table of Contents, browse the chapters by clicking on the drop-down symbol ^, select a chapter, and you will see the DOWNLOAD PDF orange button in the upper right. Most ePub files can be opened in eBook readers, like the B&N Nook and Kobo eReader. These files have to be converted to .Mobi format before they are usable on the Amazon Kindle device or app. For your computer, the easiest way to open an ePub file is to double-click on it and let your PC decide which default application should open the file. If no program opens it, then you probably do not have an application installed that can view ePub files. ePub files can also be opened on a computer with various free programs including Adobe Digital Editions. If you have access to this title you can download the ePub here:

    • The Chapter <800> Answer Book (EPUB 1.15 MB)
    • The Chapter <800> Answer Book (PDF 1.97 MB)

The book follows a HD as it transits through a healthcare facility, addressing core elements of the USP chapter, to answer major questions healthcare systems may have when implementing the standards. 

Key discussion areas include:  

  • Practical advice and explanations to help ensure compliance with the requirements of USP <800> 
  • Significantly updated Q&A throughout addressing the revised USP <795> and USP <797> Chapters related to HDs 
  • Work practices to meet regulatory requirements and best practices  
  • Personnel training and core competencies, including suggested approaches for documenting competency 

The Q&A approach of the chapter provides a comprehensive overview and explanation of the requirements of USP <800> as well as: 

  • Hazardous Drug Risk Assessment Form 
  • Sample Form: Employee Acknowledgement of Hazardous Drug Risk 
  • List of Policies Required and Recommended in USP <800> 
  • List of new and updated questions since the first edition 
  • Sample “Action Plan” for Compliance with USP <800> 

Patricia C. Kienle, RPh, MPA, 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.