USP chapter 797 is an enforceable regulation from the United States Pharmacopeia that addresses safety concerns regarding Compounded Sterile Preparations (or CSP for short). USP 797 came about due to several incidents of contamination that were introduced during the compounding process. This contamination caused several fatalities prompting the need for an enforceable regulation to govern the compounding of sterile preparations. While it is not federally regulated, nearly all states do have laws that refer to USP 797 either directly or indirectly, and even in the few states where there is no regulation a hospital or pharmacy may still want to follow USP 797 as a best practice to maximize patient safety and minimize liability.
You can download a free application note from Kanomax that explains how you can use our particle counters and other products to help your business comply with the regulation.