USP 797

6 Common Pitfalls in USP <797> Data Trending—And How to Fix Them 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? […]

We are commonly asked by veterinary professionals (not to mention concerned friends and family members) whether the United States Pharmacopeia (USP) standards apply to pharmacies and veterinary practices that prepare compounded medications for pets.   The short answer is: Yes! The same USP standards that govern compounding pharmacies serving humans also apply to those providing medications for our beloved non-human family members.  In this blog post, we break down

As a standard of minimums, USP <797> lays a solid foundation for preserving patient safety and the efficacy of compounded sterile preparations. The expectation is that pharmacies will conduct further risk assessments to establish more detailed SOPs that address specific areas of their business. Not content to leave it up to their members, some state

If You Didn’t Document It, Did It Really Happen?  The 2022 revisions to USP <797> place an increased emphasis on the documentation of standard operating procedures (SOPs), including personnel training, sampling protocols, environmental maintenance, and more. In the event of an audit or adverse event, accurate and thorough record-keeping serves as evidence that processes and

USP <797> is often talked about as though compliance is a “pass/fail” test. Either CFU counts are exceeded or they are not. However, the USP <797> mentions data trending several times throughout the standard. In this post, we will look at what data trending is, how it’s used to promote patient safety, and how and

At its essence, USP <797> is a quality control (QC) standard used to protect patients from contamination that can occur when pharmacies produce compounded sterile preparations (CSPs). Media-fill, gloved fingertip, surface sampling, and other tests are used to confirm personnel competency and ensure bioburden control of compounding areas and personnel. For these results to be valid,

In our USP <797> Q&A Series, we’ve mentioned cleanrooms a few times but haven’t gone too deeply into the topic. As in other areas, the revised USP <797> standard includes a few changes. Some tighten up the requirements, while others leave things open to interpretation. Here are answers to some of the more frequent questions

In this series of Q&A posts, we’re answering questions from customers about USP <797> compliance. Some of these are common questions. Others, not so much. All are important.   Today, I’d like to respond to a few questions about pass-through sampling that we received during and after our webinar on Personnel Competency and Environmental Monitoring. This webinar

If you have questions about how to comply with the latest revisions to USP <797>, you’re not alone. Even though the standard has been in effect since November of 2023, we’re still getting a lot of foundational questions about specific requirements.   If you have a question, you can count on us to follow up with