Has adherence to USP 797 started to feel like a checkbox exercise? Take samples, count CFUs, compare results to USP 797 action levels, file the environmental monitoring report—as long as the CFU counts stay under the limits, it’s all good…right?
Or is it? The USP 797 standard requires compounding pharmacies to build an effective monitoring program. Because the standard focuses on minimum requirements, it leaves many details open, which means each facility must assess its own risks and design a program that truly protects patients. As we discussed in a recent post, data trending is such an essential component of meaningful environmental monitoring the authors of the USP 797 standard made it a requirement. If you missed that post, you can catch up here: The Importance of Trending in USP <797> data compliance.
