Setra Blog


April 25, 2023

Meeting environmental requirements of USP <797> and <800>

 

Safety is Top Priority. Compliance is Essential. Will you be ready by November 2023?

Revised standards for USP General Chapter <797> for compounded sterile preparation (CSP) have been finalized and have an estimated effective date of Nov 1, 2023. These revisions will also affect USP <800> where hazardous drug (HD) compounding is applicable. Both standards include environmental monitoring and management requirements that were not previously enforced and must be met to achieve accreditation through local and national governing bodies come November 2023. Understanding the conditions and monitoring requirements is critical in ensuring compliance.

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March 03, 2022

Monitoring Compounding Pharmacies with Setra CEMS

The quality of compounded medications, and therefore patient safety, is a critical concern for compounding pharmacies. Pharmacies performing compounded sterile preparations (CSPs) must meet specific cleanroom standards like those outlined in USP 797 and USP 800 to ensure sterile conditions and the quality of CSPs are maintained. As such, it is crucial environmental parameters stay within specified limits.

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