Available Until 5/21/2025

Frontline Conversations: Targeting Compliance Gaps with USP Chapter <797>

Content Release Date: July 1, 2024
Expiration Date: May 21, 2025
CE Credits: There is no CE credit with this activity
Activity Fee: Free

Activity Overview

Health systems have worked diligently to ensure that they are in compliance with the revised USP Chapter <797> requirements. This Frontline Conversations session will focus on questions related to USP Chapter <797> with expert faculty for any size facility. This session follows two live webinars that summarized key revisions to the revised USP Chapter <797>, assessing facility and personnel, best practices for training and monitoring personnel, safety features of technologies and standardization of IV compounding, and how facilities can perform a gap analysis of its facility, personnel, polices, and environmental monitoring.   

No formal presentation was planned for this session. Attendees submitted questions for the faculty experts. 

More in this Series:

This activity was planned to meet the educational needs of pharmacists, pharmacy technicians, and medication safety officers practicing in hospitals and health systems. 

At the conclusion of this activity, participants should be able to:

  • Perform a gap analysis that includes facility, personnel, policy and procedure development and review, environmental monitoring, and accreditation gaps.
  • Identify opportunities to implement technologies and standardization that improve safety of IV compounding in small, medium, and large institutions.

How It Works 

Questions pre-submitted during registration were addressed before live questions.

During the session, questions were submitted via the chat. 

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, Activity Chair 
Director, Accreditation and Medication Safety
Cardinal Health
Wilkes-Barre, Pennsylvania 

Patricia 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.


Glen J. Gard, CPhT-Adv, CSPT, FNHIA
National Director, Sterile Compounding & Pharmacy Compliance
Option Care Health
Chicago, Illinois  

Glen Gard, CPhT-Adv, CSPT, FNHIA is the national director of compounding & pharmacy compliance for Option Care Health 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. 


Abby Roth, CMQ/OE
Pure Microbiology
Allentown, Pennsylvania 

Abby Roth, CMQ/OE founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations. 


Michael Ganio, PharmD, MS, BCSCP, FASHP
Senior Director, Pharmacy Practice and Quality
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:

  • Patricia C. Kienle: BD – Speaker’s Bureau

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 activit

Provided by ASHP

Supported by an educational grant from Pfizer Inc.