ASHP's Chapter Answer Book Prepares Pharmacies for New Safety Requirements


ASHP recently released a new reference to provide expert guidance and practical advice to pharmacists, technicians, and other health professionals involved in the compounding and handling of hazardous drugs. The Chapter <800> Answer Book by Patricia C. Kienle, RPh, MPA, FASHP, is the first publication to clarify the differences between current practice and the new standards that pharmacies will be required to follow when the US Pharmacopeia (USP) General Chapter <800> becomes enforceable on July 1, 2018.

The Chapter <800> Answer Book addresses key areas of compliance, including facility design, use of personal protective equipment, decontamination and cleaning of compounding and administration areas, training personnel, and environmental monitoring. The easy-to-use guide provides an overview of the requirements and key issues of each of the 19 areas covered by Chapter <800>, followed by questions and answers covering the specifics of compliance.

The publication features a glossary of key terms, acronyms, and abbreviations, as well as extensive reference to the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. “The Competency Assessment for Compounding Hazardous Drugs,” an updated excerpt from ASHP’s best-selling publication, Competence Assessment Tools for Health-System Pharmacies, Fifth Edition, is also included as an appendix.

“The new requirements imposed by Chapter <800> will require pharmacies, oncology infusion centers, and other health care settings to significantly adjust their processes for handling hazardous drugs,” said Kienle, author of the book. “The Chapter <800> Answer Book will serve as a practical resource to ensure that these settings are well-equipped to protect the safety of healthcare workers and patients who are exposed to these powerful medications.”

Kienle is Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. Kienle is also the author of companion guide to Compounding Sterile Preparations: ASHP’s Visual Guide to Chapter <797> and is co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide.

For more information or to place an order (978-1-58528-573-0), visit, email, or call 866-279-0681 (U.S. & Canada) or 001-301-664-8700 (international). For bulk sales inquiries and desk copy requests, contact ASHP sales representative Chris Jezowski at

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