ACPE Activity Number: 0204-0000-22-574-H07 P/T
Release Date: 8/16/2022
Expiration Date: 08/02/2025
Activity Type: Knowledge-based
CE Credits: 1 contact hour
Activity Fee: Free of charge
This activity is a recording from a live webinar and those that claim credit for the live webinar should not claim credit for this activity.
Institutions are turning to 503B Outsourcing Facilities to manage workforce and drug shortages. Recent draft FDA guidance further supports outsourcing, particularly for products prepared in advance of a prescription or order. Several high-profile 503B recalls and facility closures may lead purchasers to question how to evaluate the quality of outsourced products. This one-hour live activity will review applicable standards and guidance and introduce the updated ASHP Outsourcing Vendor Assessment Tool. Two members of the ASHP Outsourcing Vendor Assessment Tool expert panel will share their perspectives: one expert panel member will review important outsourcing considerations from the health-system perspective, and the other will review important considerations from the 503B perspective.
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
This activity is intended for pharmacists and pharmacy purchasers who are interested in understanding how to evaluate outsourcing vendors for meeting institutional needs and for compliance with regulatory guidance and/or compounding standards.
At the conclusion of this activity, participants should be able to:
1. Explain FDA compounding guidance related to hospitals and health systems.
2. Describe the purpose for outsourcing compounded preparations within applicable USP standards and FDA guidance.
3. Discuss ways the ASHP Outsourcing Vendor Assessment Tool can help purchasers make decisions about outsourcing vendors.
Michael Ganio, PharmD, MS, FASHP
Senior Director, Pharmacy Practice and Quality
ASHP Center on Medication Safety and Quality
Ben Lopez, Pharm.D., MS, MHA, BCPS
Director of Pharmacy Operations
The Ohio State University Wexner Medical Center
Kenneth Jozefczyk, BSPharm, MS, RPh, BCSCP
Director of Centralized Pharmacy Services
BayCare Health System
No one in control of the content of this activity has a relevant financial relationship (RFR) 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 CPE activity.