The United States Pharmacopeia (USP) announced recently that it is postponing the official dates of pending revisions to the following three standards until further notice as a result of pending appeals to provisions on these standards:

Revisions to:

• USP <795> Pharmaceutical Compounding – Nonsterile Preparations
• USP <797> Pharmaceutical Compounding – Sterile Preparations

New chapter:

• USP <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging

All three documents were originally intended to take effect on December 1, 2019, to align with new General Chapter:

• USP <800> Hazardous Drugs—Handling in Healthcare Settings<800>

USP <800> will still become official on December 1, 2019, according to USP.  In its announcement, USP further stated “During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health.”

The Joint Commission issued an October 2, 2019, statement on this matter stating in part that it “will continue to survey compliance with sterile compounding against the principles within the USP Chapters that are currently in effect.”

David Stymiest may be contacted at DStymiest@ssr-inc.com.