Operational Considerations for Sterile Compounding During Emergencies

This guide addresses operational considerations for pharmacy compounders not registered as outsourcing facilities during public health emergencies and natural disasters. It outlines the challenges that compounding operations may face due to increased demand and supply chain disruptions. The document emphasizes the importance of compliance with federal, state, and local laws while providing strategies to maintain the quality of compounded sterile preparations (CSPs). It details the standards set forth in USP General Chapter <797> for minimizing microbial contamination risks and suggests risk-mitigating strategies for compounding entities. Additionally, it discusses the appropriate use of compounded drugs when FDA-approved alternatives are unavailable and highlights the need for careful sourcing and adherence to interim guidance from regulators. The guide also provides recommendations for fluid conservation strategies and practices to avoid during compounding, ensuring that compounders can effectively manage resources while maintaining safety and compliance during emergencies.