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


a National Study of Sterile Compounding Practices

Study Directors : Eric S Kastango, RPh, MBA, FASHP Kate Douglass, MS, RN, QP503A qualified





Welcome to
2019 USP <797>&<800> Compliance Study


a National Study of Hazardous Drug Compounding Practices


The 2019 CriticalPoint USP <797> & <800> Compliance Study Results report have been published. To read the full reports click here for both the <797> & <800> reports

The USP Chapter <797> & <800> Gap Tool is still available for use. Please note that the 797 items reflect the current version of USP Chapter 797 (2008 version).


CriticalPoint is hard at work developing an updated gap tool that will reflect the final USP Chapter 797 that was published by USP on June 1, 2019. Our goal is to have the revised tool ready for use as of July 15, 2019 so that locations can use it to gauge the work they need to do before the chapter becomes enforceable December 1, 2019. We will provide a new survey code to use between 7/15/19 through 11/30/2019 when the site is updated.


Thank you to everyone participating whether if it’s your first time or you have completed the Gap Tool previously. These data are important to understanding sterile compounding practices.

Thank you too to our sponsors and supporters for helping to make this study possible.

To use the Gap Tool (based on the current standards) you can click on the Register button below and use the Survey Code (TBD)  

If you have an active account you can continue to access your survey by logging into the site below with your username and password and make updates to your survey until we post the revised tool in July 2019.

Before you begin your study, we encourage to read the How To Use the Gap Tool, view a Sample Report or access to your prior Gap Analysis (if applicable) once you login to your account.

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