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Standards Affected by Postponements of <795> Pharmaceutical Compounding — Nonsterile Preparations, <797> Pharmaceutical Compounding — Sterile Preparations, and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging

Type of Posting: General Announcement
Posting Date: 03-Feb-2020

On June 1, 2019, USP published revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations, as well as a new chapter, <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>. While the appeals process is pending, USP postponed the official date of the revised and new standards.

USP has identified several other standards that reference revised sections of <795>, <797>, and new chapter <825>. In each of these cases, the revised or new text referenced in the affected standards has been affected by the postponements of revisions to <795> and <797>, as well as the postponement of <825>. A list of the standards impacted, including the currently official text and revised (postponed) text can be found here

Standards that contain references to <795> and <797> were updated to align with the revisions to the chapters or to the existence of a new chapter, including:

  • updating section numbering, 
  • adding new concepts on assigning beyond-use dates (BUDs) for compounded sterile preparations (CSPs) (e.g., risk levels and Categories), or 
  • referencing the new standalone radiopharmaceutical compounding standards in <825>. 

Compendial users therefore should be aware of the potential postponement-related discrepancies in these cross-references. Refer to the list of standards impacted. If applying the currently official <795> and <797>, refer to the text under the column for “Currently Official Text.” For users early adopting the revised standards (see USP General Notices 3.10), refer to the cross-references under the column for “Revised Text."

Should you have any questions, please contact Jeanne Sun, Senior Manager, Healthcare Quality and Safety (