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Your comments on USP’s proposed public standards play a key role in USP’s standards-setting process by helping to shape the content of new and revised standards. The more comments USP’s proposed standards receive from stakeholders — industry, academia, regulatory authorities, healthcare professionals, associations, patients — the stronger and more useful they become.
If USP develops a new or revised standard for your product where you hold a FDA marketing authorization, please comment if you support, request modification or if there could potentially be a compliance issue.
The assigned Expert Committee reviews all comments, and decides whether the suggested changes should be incorporated, partially incorporated, or not incorporated into the proposed standard.
Depending on the nature of your comment, please provide justification and supporting information that will help with its evaluation. USP posts the lists of Revisions, Deferrals, Cancellations, and Commentary for each issue of USP–NF. If the proposed standard advances to official status and is published, a summary of the comments and the Expert Committee's responses will be released to the public. The proposal status and commentary are posted on the USP–NF Standards Updates page under the Proposal Status/Commentary section.
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Compendial requests
In certain cases, FDA comments on a PF proposal and asks USP to reach out to contributors. USP then engages contributors through a Compendial Request. We ask contributors to please respond promptly to USP’s request(s) to address these comments and accelerate the standards setting process.