The 2019 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
2019 USP <797>&<800> Compliance Study


a National Study of Hazardous Drug Compounding Practices


The 2019 CriticalPoint USP Chapter 797 & 800 Gap Tool is updated and now reflects the 2019 version of USP 797 and 800 that will be enforceable effective December 1, 2019.

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 2019 USP 797 & 800 Compliance Study.

Study Directors