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USP 797

The Importance of Trending in USP <797> Compliance

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 when it’s required. 

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USP 797 FAQs: Positive and Negative Controls

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, the medium used in these tests must be uncontaminated and capable of supporting growth. This can be confirmed using positive and negative controls. 

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USP <797> Q&A: Cleanroom Requirements

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 we get on USP <797> cleanroom standards. 

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Demonstrating USP <797> Surface Sampling Competency

In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing ample evidence that these SOPs are followed and effective.

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USP 797 FAQs: Media Kits

Lately, the Pace® microbiology team has been fielding a lot of questions on how to interpret and implement different aspects of the revised USP <797> standard. Here are some of the most frequently asked questions regarding the use of sampling media kits.

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10 Tips for Proper Shipping of USP 797 Samples

The 2023 revisions to USP <797> increase compliance requirements for compounding pharmacies. Following proper handling and shipping procedures for lab media can help ensure all that extra effort doesn’t go to waste. Here are ten tips for ensuring your gloved fingertip and surface samples arrive safely.

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