Regulatory Differences Between 503A and 503B Facilities

This document is a Q&A guide addressing the regulatory differences between 503B outsourcing facilities and 503A hospital pharmacies, particularly in the context of the Drug Quality and Security Act (DQSA) enacted in 2013. It outlines the stringent regulations that 503B facilities must adhere to, including compliance with current Good Manufacturing Practices (cGMP) and registration with the FDA. The guide details the requirements for compounding sterile products as per USP <797> and USP <800>, highlighting the challenges faced by hospital pharmacies in meeting these standards. It also discusses the types of medications commonly outsourced to 503B facilities, the implications of drug shortages, and the advantages of collaborating with outsourcing facilities, such as extended beyond-use dating (BUD) and reduced compounding errors. The document emphasizes the importance of selecting reliable 503B providers to ensure quality and compliance in medication supply for health systems.