USP <797> and Parenteral Nutrition: What’s New on the Menu
ACPE Number:0204-0000-25-403-H07-P/T Content Release Date: May 14, 2025 Expiration Date: May 27, 2026 Activity Type: Knowledge-based CE Credits: 0.5 contact hours (0.05 CEUs) Activity Fee: Free
Podcast 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 preparations and is enforceable by the FDA, 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.
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.
This activity was planned to meet the educational needs of 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.
Phil Ayers, PharmD, BCNSP, FMSHP, FASHP, FASPEN Chief Clinical Pharmacy Services Mississippi Baptist Medical Center Clinical Associate Professor University of Mississippi School of Pharmacy Jackson, Mississippi
Phil Ayers 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, Moderator Senior Director, Pharmacy Practice and Quality ASHP Bethesda, Maryland
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).
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:
Phil Ayers – Fresenius Kabi: Speakers bureau; Fresenius Kabi, Bbraun, American Regent: 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.