Synopsis
By now those of us who compound on a daily basis are aware that the USP has postponed the implementation of the compounding General Chapters 795 and 797 as a result of legal challenge filed. This appeal to consider amending certain provisions is consistent with USP bylaws and will be handled with a “sense of urgency,” but no changes in the official chapters can be made while the appeal is pending. This will delay but not derail the updates of these chapters. What this means for the average compounding pharmacist is that focus should be on first complying with the current chapter, which is the current US standard, and then being aware of the current state of the revision process as it moves along. Furthermore, it is most important to realize that USP General Chapter 800 is not part of this appeal process and will become official on December 1, 2019. However, since all three of these chapters (795, 797, and 800) are so closely tied together, the USP has recommended that during the appeals process USP 800 be considered “informational” and not “compendially applicable.” But at the same time, the USP encourages the utilization of USP 800 in the interest of advancing public health.
