USP published a Notice of Intent To Revise (NITR) to postpone the official date for revised <795> Pharmaceutical Compounding – Nonsterile Preparations, <797> Pharmaceutical Compounding – Sterile Preparations and new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, which were published on June 1, 2019.
In the interim, the currently 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.
General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings is not subject to any pending appeals and will become official on December 1, 2019. 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.
USP's Bylaws provide that the date by which conformance with a standard is required shall be postponed while an appeal is pending. They further provide that if a standard is upheld, the date by which conformance is required shall be reestablished so that the period allowed for implementation is not less than that provided for upon original publication of the standard.
In practice, the above provisions mean the following with respect to the compounding chapters currently under appeal:
- Revised General Chapters <795>, <797> and the new General Chapter <825> will be postponed until further notice. None of these chapters will become official on the originally anticipated date of December 1, 2019.
- Regardless of the outcome of the appeals process, USP would not reestablish an official date for chapters <795>, <797>, or <825> without granting another six-month implementation period, at a minimum.
- USP cannot predict or project a future official date for any of these chapters at this time, as the appeals process remains actively in progress.
USP remains committed to advancing public health and to promoting the quality of compounded medicines and the safe handling of hazardous drugs. USP is committed to transparency and will continue to communicate updates on the compounding chapters.
Contact the Healthcare Quality & Safety Team at CompoundingSL@usp.org.