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. Faculty experts highlight USP <797> and discuss opportunities to reduce medication errors, with respect to sterility, stability, and compatibility when compounding parenteral nutrition and assigning a beyond use date.
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.
Phil Ayers, PharmD, BCNSP, FMSHP, FASHP, FASPEN, is a clinical specialist in nutrition support at Baptist Medical Center in Jackson, Mississippi and serves the Department of Pharmacy as Chief of Clinical Pharmacy Services. Dr. Ayers also serves as Clinical Associate Professor with the School of Pharmacy at the University of Mississippi. He received his Bachelor of Science and Doctor of Pharmacy degree from the University of Mississippi. He currently serves the American Society for Parenteral and Enteral Nutrition (ASPEN) on the Board of Directors as Immediate Past President and is Past Chair of the ASPEN Parenteral Nutrition Safety Committee. Phil is a member of the USP Expert Compounding Committee and Past Chair of the Parenteral Nutrition Subcommittee. Dr. Ayers was awarded the ASPEN Excellence in Nutrition Support Education Award, 2011 and the ASPEN Stanley Serlick Award for Parenteral Nutrition Safety in 2016.
Michael Ganio, PharmD, MS, BCSCP, FASHP, joined the staff at ASHP as Director of Pharmacy Practice and Quality in January of 2018. As a member of the Center on Medication Safety and Quality team, his responsibilities span the practice of pharmacy and include drug shortages, pharmaceutical quality, sterile and non-sterile drug compounding practices, hazardous drug handling, and the ASHP Standardize 4 Safety initiative. Dr. Ganio earned his Pharm.D. from the Rutgers University Ernest Mario School of Pharmacy and his Master’s degree in Health-System Pharmacy Administration from The Ohio State University College of Pharmacy. He completed a PGY1 Pharmacy Practice residency at The Ohio State University Wexner Medical Center. Dr. Ganio is a Board Certified Pharmacotherapy Specialist (BCPS) and a Board Certified Sterile Compounding Pharmacist (BCSCP).
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
- Discuss best practices for compounding parenteral nutrition to address sterility, stability, compatibility, and beyond use date considerations.
Schedule of Activities
- Introduction and Announcements
- Audio Presentation
- Assessment with a passing score of 70% or higher
- Evaluation
Accredited for CPE
ACPE #: 0204-0000-25-403-H07-P/T
Content Release Date: May 14, 2025
Expiration Date: May 27, 2026
Activity Type: Knowledge-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.
