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# Draft Guide on Harmonizing Drug Compendial Standards
- URL: https://www.fdaweb.com/draft-guide-on-harmonizing-drug-compendial-standards/
- Published: 2019-07-11T12:00:00.000Z
- Updated: 2026-09-15T01:37:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144507

*Federal Register* notice: FDA has made available a draft guidance entitled “Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.” The document is intended to assist applicants in revising an existing monograph or developing a new monograph under the United States Pharmacopeial Convention Pending Monograph Process during FDA’s evaluation of a drug substance master file or drug product application. It describes the process that allows for revising compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-14781.pdf?ref=fdaweb.com).