How to Transition from 503A to 503B: A Road-Map to Compliance

Inside this White Paper

This white paper presents a detailed roadmap for compounding pharmacies aiming to transition from a 503A patient-specific model to a 503B outsourcing facility. It explores the strategic planning, facility design, regulatory compliance, and quality system development required to meet FDA expectations and successfully operate at scale. Beginning with a comprehensive assessment of business viability and risk, the paper guides readers through the necessary upgrades in infrastructure, cleanroom classifications, and environmental controls. It then delves into the creation of robust quality systems, including SOPs, documentation protocols, and testing procedures, all aligned with current good manufacturing practices (cGMP). The paper also outlines the FDA registration process, inspection preparedness, and ongoing regulatory engagement. Finally, it addresses market entry strategies, internal audit practices, and client engagement to ensure longterm compliance and commercial success. This document serves as a practical and strategic guide for pharmacy leaders, quality professionals, and facility planners navigating the complex transition to 503B operations.

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