IV Been There Too: Safely and Effectively Incorporating Technology and a Designated Person in USP <797> Compliance
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.
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.
Kevin N. Hansen, PharmD, MS, BCSCP 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 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 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.
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:
- Evaluate opportunities to safely and effectively incorporate technology into sterile compounding aligning with USP <797> standards.
- Apply best practices for overcoming challenges with the use of designated persons.
Accredited for CPE
ACPE #: 0204-0000-25-401-H07-P/T
Content Release Date: May 27, 2025
Expiration Date: May 27, 2026
Activity Type: Application-based
CE Credit: 1.0 contact hours (0.10 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.
