United States Pharmacopeia General Chapter 797 (USP <797>) sets the minimum standards for sterile compounding to ensure quality and safety of compounded sterile preparations and is enforceable by the FDA, CMS, state agencies, and accreditation bodies. In November 2023, updates to USP <797> became official. This interactive web-based activity will address frequently asked questions regarding facility environmental monitoring. Expert faculty will help build strategies to address current challenges with viable air and surface monitoring.
Speakers
Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is Director of Accreditation and Medication Safety for Cardinal Health. She received her pharmacy degree from Philadelphia College of Pharmacy and Science and a Master in Public Administration degree from Marywood University in Scranton, Pennsylvania. She is author of The Chapter <795> Answer Book, The Chapter <797> Answer Book, and The Chapter <800> Answer Book and co-author of Meeting Accreditation Standards: A Pharmacy Preparation Guide. With over 600 invited presentations and 100 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues.
Abby Roth, CMQ/OE, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
Target Audience
The target audience for the education is pharmacists, pharmacy technicians and medication safety officers practicing in hospitals and health systems, including all settings responsible for preparing, labeling, packaging, storing and distributing compounded sterile preparations. This also may be of interest to infection control practitioners and risk management practicing in hospitals and health systems.
Learning Objective
Develop strategies to address current challenges in the viable air and surface monitoring of sterile compounding facilities.
Schedule of Activities
- Introduction and Announcements
- Presentation
- Assessment with a passing score of 70% or higher
- Evaluation
Accredited for CPE
ACPE #: 0204-0000-25-402-H07-P/T
Content Release Date: March 26, 2025
Expiration Date: May 27, 2026
Activity Type: Application-based
CE Credit: 0.5 contact hours (0.05 CEUs)
Activity Fee: No charge
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.
Provided by ASHP. Supported by an educational grant from Pfizer Inc.
