Setra Blog

Ensure USP <797> and <800> Compliance

With Setra's trusted room monitors, compounding pharmacies can significantly enhance safety measures and meet the stringent requirements outlined by USP <800> and USP <797> standards. Compliance not only safeguards the well-being of pharmacy personnel but also prevents contamination of medications. Setra's reputation for reliability is exemplified by being trusted in 13 of the 20 top-rated hospitals in the US*. By leveraging Setra's proven monitoring solutions, compounding pharmacies can effectively mitigate risk, prioritize safety, and ensure compliance with regulatory standards.

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.