With the challenges of increasing costs to hospital pharmacies to upgrade and validate facilities, qualify sterile compounding personnel, and manage daily work load, a 503b outsourcing facility can be used to fill the gap between traditional pharmacy compounding and the ability to produce larger scale batch size of commonly used medication for health system organizations.
This module (0.5 CE), along with the other three MCPHS sterile compounding CE modules, ‘Parenteral Nutrition CSPs-2020 Update' (2.0 CE), ‘History and Basics - Aseptic Technique USP 797, 2019/20' (1.5 CE), and 'What's the Hazard? USP 800 Review' (1.0 CE), total to 5.0 credits of sterile compounding.
Learning Objectives
Upon completion of this activity, the participant should be able to:
-Compare the key differences between 503a vs 503b
-Define cGMP
-Explain the pharmacist’s role in 503a vs 503b.
-Identify who has regulatory oversight of 503a vs 503b.
-Determine how to choose a 503b facility.
