The 2020 USP <797> & <800> Compliance Study


a National Study of Sterile Compounding Practices

Study Directors: Kate Douglass, MS, RN, QP503A qualified Abby Roth, CMQ/OE, QP503A qualified


Study Advisor:


Eric S Kastango, RPh, MBA, FASHP







Welcome to
2020 USP <797>&<800>

Compliance Study


a National Study of Sterile Compounding Practices


The 2020 CriticalPoint USP Chapter 797 & 800 Gap Tool is updated and now reflects the 2019 version of USP 797 and 800 that were scheduled to become official December 1, 2019 but as of 9/23/19 have been officially postponed until the USP Appointed Panel decides on whether to deny or remand the existing appeals. Though USP Chapter 800 will remain official as of December 1, 2019, it is not compendially applicable since the 2019 versions of USP 795 and 797 have been postponed and USP 795 (2014) and USP 797 (2008) do not mention USP 800. For more information on the USP announcement and CriticalPoint’s response please click here.

When the USP Appointed Panel makes its decision (anticipated in December 2019), CriticalPoint will evaluate whether it will reactivate the Gap Tool developed to USP 797 (2008).

To use the Tool, 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 start answering questions. You also have the opportunity to review an abbreviated sample report.

In addition to assisting pharmacies understand the requirements of the 2019 USP 797 and 800 chapters, the CriticalPoint Gap Tool provides a detailed and individualized Action Plan for compliance. CriticalPoint also uses these data to understand sterile compounding practices.


We will be using the blinded data collected from July 18, 2019 through June 30, 2020 to write our annual CriticalPoint Compliance Study results articles. If you’d like to view the articles from the 2018 Compliance Study, they can be found here.


Thank you for using the CriticalPoint Gap Tool whether if it’s your first time or you have completed the tool in previous years. Thank you too to our sponsors and supporters for helping to make this study possible.

If you have questions or need any assistance, please contact the Study Team at 973-256-6500 or via email at

Log In
To begin, click the Register link below.


Thank you again for your participation in the 2020 USP  797 & 800 Compliance Study.

Study Directors