Advanced Environmental Monitoring to Align with Updated USP <797> and <800> Standards
With the updated USP <797> and <800> regulations having come into effect on November 1st, 2023, pharmaceutical compounding faces new challenges in environmental control. These standards, vital to ensuring the safety and efficacy of compounded sterile preparations (CSPs), emphasize a risk-based approach to beyond-use dates and the criticality of precise environmental controls. For facilities looking to meet these new benchmarks, understanding and preparing for compliance is paramount.