Achieving Your Personnel Best: Training Personnel in USP Chapter <797> and Opportunities for Quality Assessment Plans
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 educational activity will address changes to USP <797> where implementation challenges have been reported such as training personnel including students, new practitioners, non-pharmacy staff entering the cleanroom, and healthcare professionals involved in sterile compounding outside of the pharmacy. Additionally, as more accreditation organizations are assessing quality assurance and control plans, best practices for implementing and improving a written quality plan will be discussed.
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.
Cindy Brasher, PharmD, MS, BCSCP is Manager of Compounding at St. Jude Children's Research Hospital in Columbus, Ohio. She received her PharmD from the University of Tennessee College of Pharmacy, completed the health systems pharmacy administration PGY1/PGY2 residency program at Mission Hospital in Asheville, North Carolina, and a master's in pharmacy administration through the University of North Carolina Chapel Hill. Currently, Cindy is serving on the ASHP Section Advisory Group on Compounding and the Tennessee Pharmacist Association Compounding Society.
Ashley M. Duty, PharmD, MS, BCSCP, FASHP is Director of Pharmacy Operations at Nationwide Children's Hospital in Columbus, Ohio. Prior to this, Ashley served as a pharmacy manager at Children's Mercy Kansas City. She earned her Doctor of Pharmacy from the Raabe College of Pharmacy at Ohio Northern University and a Master's of Science in Health-System Pharmacy Administration from Northeast Ohio Medical University. She completed a PGY1/2 Health-System Pharmacy Administration residency at the Cleveland Clinic. In 2019, Ashley became a Board Certified Sterile Compounding Pharmacist. Ashley's interests include sterile compounding operations, medication safety, and policy work.
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 Objectives
After participating in this CPE activity, learners should be able to:
- Design education and competency assessment for non-pharmacy personnel involved in sterile compounding or tasks associated with USP <797>.
- Develop quality assurance and control plans including procedures for improvement when challenges arise.
- Apply best practices for training and assessing pharmacy students and new practitioners.
Accredited for CPE
ACPE #: 0204-0000-25-400-H07-P/T
Content Release Date: May 13, 2025
Expiration Date: May 27, 2026
Activity Type: Application-based
CE Credit: 1.5 contact hours (0.15 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.
