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Monographs Affected by Revision to <126> Somatropin Bioidentity Tests

Type of Posting: Notice of Intent to Revise
Posting Date: 30–Sept–2022
Targeted Official Date: 01–May–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 <126> Somatropin Bioidentity Tests.

General Chapter <126> was proposed for comment in Pharmacopeial Forum 47(4) and will be official on May 1, 2023.  USP has identified other documentary standards referencing General Chapter <126> impacted by the revisions in PF 47(4). It is anticipated that these references will be updated on November 1, 2023 and will become official May 1, 2023. A list of the monographs that that USP intends to modify 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 Rebecca Potts, Senior Scientist II (, or the affected monograph’s liaisons.