The United States Pharmacopeia announced that, due to appeals underway, the previously announced implementation date of December 1, 2019 for Chapter 797 on Pharmaceutical Compounding of Sterile Preparations is officially postponed. Read more here. We do not know at this time what the new implementation deadline will be.
However, there is no reason to believe that any changes will be made to the updated standards for physician in-office compounding of allergen extract. For those of you have initiated changes to meet the updated standards for the compounding area, cleaning, staff training, and documentation, we encourage you to continue those efforts. For those of you who have not started, we strongly encourage you to proceed.
We will keep you updated as soon as more information is available.
For more on USP General Chapter <797> on Compounding of Sterile Preparations click here.
To review full USP General Chapter <797>, go to the USP.