USP 797 Gap Analysis Tool Recommendation

I continue to get emails asking for a recommendation of a Gap Analysis Tool. ASHP offered one when USP 797 was new, and the only one that I’m aware of since the revisions has been put together by the same person as the original, Eric Kastango. This time it is being sold through his company, CriticalPoint, rather than ASHP. You can learn more about the updated Gap Analysis Tool from CriticalPoint here.

If you want a flavor of what it offers you can link to it from Pharmacy OneSource’s Simplifi 797 website by clicking on the “Measure Your Compliance” button and take a free “Stat Gap” before purchasing the full version.


USP 797 Tip: Automated Compounding Device records

Pharmacy Purchasing & Products magazine has an article on Choosing an Automated Compounding Device in the December 2009 issue. It reviews different manufacturers’ devices and provides a list of minimum requirements to look for. What caught my eye was a short paragraph about ACD’s impact on USP 797, summarized below:

Automated compounding devices can improve the accuracy compared to manual compounding methods, but you need to make sure that operators are properly trained and you keep current with the calibration, verification, and documentation. USP 797 states that “…compounding personnel shall keep a daily record of the accuracy assessments and review the results over time. This review shall occur at least at weekly intervals to avoid potentially clinically significant errors over time.”

As hard as I try to resist plugging the product that my company markets, I just can’t… check out if you are looking for a tool to help keep track of all of the tasks and documentation that USP 797 requires.