USP Postpones Effective Dates of Compounding Standards

Sep 25, 2019

The United States Pharmacopeia(USP) today notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards. Those standards include: general chapters 795 (Pharmaceutical Compounding – Nonsterile Preparations); 797 (Pharmaceutical Compounding – Sterile Preparations); and, 825 (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging).

In addition, due to the pending appeals, the USP new general chapter 800 (Hazardous Drugs Handling in Healthcare Settings) will remain official, but only informational and will not be applicable until the appeals process is complete.

Click here for existing FDA December 2016 Compounding Guidance.