Achieving Your Personnel Best: Training Personnel in USP Chapter 797 and Opportunities for Quality Assessment Plans
ACPE Number:0204-0000-25-400-H07-P/T Content Release Date: May 13, 2025 Expiration Date: May 27, 2026 Activity Type: Application-based CE Credits: 1.5 contact hours (0.15 CEUs) Activity Fee: Free
Activity Overview
United States Pharmacopeia General Chapter 797 (USP <797>) sets the minimum standards for sterile compounding to ensure quality and safety of compounded sterile products 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.
*Please note, this activity was presented live on April 8, 2025. You can only claim credit once for this activity; live or home study.
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.
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.
Patricia C. Kienle 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 Manager of Compounding St. Jude Children's Research Hospital Memphis, Tennessee
Cindy Brasher 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 Director of Inpatient Pharmacy Operations Nationwide Children's Hospital Columbus, Ohio
Ashley Duty 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.
Jeffery S. Vender, MD, MCCM, MBA is the Emeritus, Harris Family Foundation Chairman of the Department of Anesthesiology at NorthShore University Health System in Evanston, Illinois and a Clinical Professor at the University of Chicago Pritzker School Of Medicine in Chicago, Illinois. He is a past member of the NorthShore University Health System Faculty Practice Associates Board of Directors, Past Chair of the Medical Executive Committee for the Professional Staff at NorthShore and previously served on Northshore’s Board of Directors. Dr. Vender served as Chair of Anesthesia from 1990-2015 and received an appointment of adjunct Professor of Biomedical Engineering at Northwestern University. He served as the Director of the Critical Care Services at Evanston Hospital from 1987-2000 and the Interim Chairman at Northwestern University Department of Anesthesiology from July 1999 until October 2000. Dr. Vender has participated and Chaired numerous state and national committees of various medical organizations, edited several medical texts, has published over 135 articles and book chapters and has been an invited lecturer at over 250 national and international meetings on topics of anesthesiology, critical care, organizational change, and leadership. In addition, Dr. Vender serves as an editor and/or reviewer for many medical journals.
In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.
An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience.
No one in control of the content of this activity has a relevant financial (RFR) with an ineligible company.
As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CE activity.
Per ACPE requirements, CPE credit must be claimed within 60 days of being earned – no exceptions! To verify that you have completed the required steps and to ensure your credits have been reported to CPE Monitor, we encourage you to check your NABP eProfile account to validate your credits were transferred successfully before the ACPE 60-day deadline. After the 60 day deadline, ASHP will no longer be able to award credit for this activity.
Provided by ASHP
Supported by an educational grant from Pfizer Inc.
