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Monographs Affected by Revision to <797> Pharmaceutical Compounding—Sterile Preparations

Type of Posting: Notice of Intent to Revise
Posting Date: 01–Nov–2022
Targeted Official Date: 01–Nov–2023
Expert Committee: Various

In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to a revision of General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.

General Chapter <795> was proposed for comment in PF 47(6) and will be official on November 1, 2023. USP has identified other documentary standards referencing General Chapter <797> impacted by the revisions in PF 47(6). It is anticipated that these references will be updated on November 1, 2022 and will become official November 1, 2023. A list of the monographs that USP intends to revise  can be found here.

Interested stakeholders are encouraged to alert USP staff to any impact they may recognize related to the anticipated update of those monographs.

Should you have any questions or comments, please contact or the affected monograph’s liaisons.