a National Study of Sterile Compounding Practices
The 2021 Compliance Site update.
At this location, you may register for and access the CriticalPoint USP 797 and 800 electronic Gap Tools. Data from these tools were published annually from 2011 through 2018. If you’d like to view the articles from the 2018 USP 797 and 800 Compliance Study, you can access it here.
The USP 797 Gap Tool has been updated to reflect the version of USP General Chapter 797 that was published on June 1, 2019. The USP received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of the chapter back to the expert committee. Users should understand that the CriticalPoint 797 Gap Tool measures compliance to the 2019 version that is not enforceable. It may be used to “work ahead” in areas other than the beyond-use dating since we believe the 2019 chapter reflects more current thinking about sterile compounding practice. The Action Plans received by the user for areas of noncompliance also closely reflect current CriticalPoint thinking.
The USP 800 Gap Tool continues to measure compliance with the original version of the chapter published in 2016 and is an accurate measure of compliance. Users should understand, however, that the Action Plans generated in areas of noncompliance are correct but do not reflect CriticalPoint’s most current best practices. Currently, USP 800 is not compendially applicable.
The Gap Tools will not be updated further until there is final clarity on new USP standards.
To use the Tools, you can click on “Register” below and use the Survey Code L797Z. Once you establish your account, please read “How to Use the CriticalPoint USP 797 and 800 Gap Tool” before you begin to answer questions. You will also have the opportunity to review an abbreviated sample report.
CriticalPoint does not have plans for the use of the blinded data collected from the completion of these tools in 2019 or 2020. They are offered as a free resource to sterile compounders.
Thank you for using the CriticalPoint Gap Tools whether it’s your first time or you are a returning participant. If you have questions or need any assistance, please contact the Study Team at 973-256-6500 or via email at firstname.lastname@example.org.