Advocacy Alert: Official Date Postponed for USP Standards

The United States Pharmacopeia (USP) has issued an update regarding their <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as a new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. 
 
USP received appeals on these chapters that require, according to USP Bylaws, USP to postpose the official dates of the revised <795> and <797>, and the new general chapter <825> until further notice. The current official chapters of <795> (last revised in 2014) and <797> (last revised in 2008), including the section "Radiopharmaceuticals as CSPs," will remain official. The decisions on the appeals to <795>, <797> and <825> do not foreclose the possibility of future revisions to these chapters. 
 
With the postponement of the official date for USP <797> Pharmaceutical Compounding – Sterile Preparations, USP's new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official, but only informational, and it will not be applicable until the appeals process is complete. At this time, the earliest possible USP effective date for updated standards <795> and <797>, and new standards <800> and <825> is the second quarter of 2020. 

For more information contact AHE sister organization, ASHE @ 312-422-3800, ashe@aha.org.