IV Been There Too: Safely and Effectively Incorporating Technology and a Designated Person in USP <797> Compliance
ACPE Number:0204-0000-25-401-H07-P/T Content Release Date: May 27, 2025 Expiration Date: May 27, 2026 Activity Type: Application-based CE Credits: 1.0 contact hours (0.10 CEUs) Activity Fee: Free
Activity Overview
There is a potpourri of questions surrounding the new USP <797> updates and many pharmacists and pharmacy technicians are unclear on how to obtain answers. As more facilities use technology and incorporate a designated person, it is crucial for best practice use cases to be shared among pharmacists, pharmacy technicians, and medication safety officers, so these healthcare professionals may learn ways to overcome common challenges in different scenarios. This educational activity will describe opportunities to implement and validate technology for sterile compounding, achieve organizational buy-in, and describe a use case where technology was safely and effectively integrated and USP <797> compliant. This activity will also highlight an example of incorporating a designated person and their experiences, challenges, and future opportunities.
*Please note, this activity was presented live on April 22, 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.
Kevin N. Hansen, PharmD, MS, BCSCP Senior Director, Pharmacy Compounding Services Premier Inc. Charlotte, North Carolina
Kevin Hansen is Senior Director of the Pharmacy Compounding Services at Premier Inc., based in Charlotte, North Carolina. In this role, he supports members through providing evaluation and audits of 503B Outsourcing Facilities, and services related to insourced compounding. He earned his Doctor of Pharmacy degree from LECOM, completed a PGY1/PGY2/MS health-system pharmacy administration and leadership presidency program at the University of North Carolina Medical Center, and is a board-certified sterile compounding pharmacist.
George R. Smith, PharmD, BCPS, BCSCP System Sterile Compounding Services Specialist Prisma Health Sterile Compounding Clinical Instructor University of South Carolina College of Pharmacy; Kennedy Pharmacy Innovation Center Columbia, South Carolina
George Smith is a board-certified sterile compounding safety advocate currently holding the position as the System Sterile Compounding Services Specialist at Prisma Health, the largest health-system in South Carolina. Additionally, Dr. Smith is a Clinical Instructor of Sterile Compounding for the Kennedy Pharmacy Innovation Center through the University of South Carolina College of Pharmacy and the Principal of Echelon Compounding LLC, a consulting firm dedicated to advancing sterile compounding. Dr. Smith is also an active participant the Section Advisory Group on Compounding for the ASHP Section of Inpatient Practitioners.
Glen J. Gard, CPhT-Adv, CSPT, FNHIA National Director, Sterile Compounding & Pharmacy Compliance Option Care Health Chicago, Illinois
Glen Gard is National Director of Compounding & Pharmacy Compliance for Option Care Health in Chicago, Illinois and is a member of the State of Illinois Board of Pharmacy. Mr. Gard is an inaugural member of the PTCB’s CSPT exam development committee. He is an active member of ASHP having served as the chair of the Pharmacy Technician Forum Executive Committee and is a current member of the Education and Workforce Development Committee. Additionally, Mr. Gard has been an active member of NHIA and currently serves as Vice Chair of the Sterile Compounding Practice Committee.
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.
The following persons in control of this activity’s content have relevant financial relationships:
George R Smith: Intelliguard, ARxIUM – Consultant
All other persons in control of content do not have any relevant financial relationships 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.
