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# FDA Position on Reporting Threshold in USP Monographs
- URL: https://www.fdaweb.com/fda-position-on-reporting-threshold-in-usp-monographs/
- Published: 2020-08-13T12:00:00.000Z
- Updated: 2026-09-14T16:24:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147425

FDA is asking the United States Pharmacopeia (USP) not to reach any conclusion on including disregard limits/drug thresholds in drug substance and drug product monographs as proposed by the USP 8/13/19\. A just-released FDA 7/31 comment [letter](https://www.fda.gov/media/141063/download?ref=fdaweb.com) gives the agency’s rationale and reasons for its recommendation to not include reporting thresholds or disregard limits in individual USP monographs.

“We welcome scientific discussion on the issue and respectfully request that USP not reach any conclusion on the matter and/or proceed with any monograph revisions including reported thresholds until our comments not below are fully addressed,” FDA writes. The letter contains the agency’s general and specific comments.