This podcast will provide members an overview of where FDA draft guidance for hospital and health system compounding stands. We’ll provide a refresher on the guidance, as well as a discussion on how the revised USP chapters might impact practice compliance and what comes next with FDA advocacy.
SPEAKERS
Michael Ganio is Senior Director of Pharmacy Practice and Quality at ASHP. Dr. Ganio joined the staff at ASHP in January, 2018, after nearly two decades in hospital and health-system pharmacy practice. His responsibilities at ASHP span the practice of pharmacy and include drug shortages, pharmaceutical quality, sterile and non-sterile compounding, hazardous drug safety, and other practice-related topics.
Jillanne Schulte Wall is the Senior Director of Health & Regulatory Policy for the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD. She serves as ASHP’s primary liaison to federal regulatory agencies and, in conjunction with other members of the Government Relations team, develops and communicates of ASHP’s positions on federal and state laws, regulations, and guidance related to the profession of pharmacy. Additionally, Jillanne works closely with stakeholders in pharmacy, medicine, manufacturing, and patient advocacy on legislative and regulatory issues of importance to ASHP members.