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# Draft Guide on Drug Composition Statements
- URL: https://www.fdaweb.com/draft-guide-on-drug-composition-statements/
- Published: 2024-04-26T12:00:00.000Z
- Updated: 2026-09-14T14:29:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156859

FDA is making available a draft guidance entitled “[Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvcmVndWxhdG9yeS1pbmZvcm1hdGlvbi9zZWFyY2gtZmRhLWd1aWRhbmNlLWRvY3VtZW50cy9jb250ZW50LWFuZC1mb3JtYXQtY29tcG9zaXRpb24tc3RhdGVtZW50LWFuZC1jb3JyZXNwb25kaW5nLXN0YXRlbWVudC1pbmdyZWRpZW50cy1sYWJlbGluZy1uZGFzLWFuZD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwNDI2LjkzOTI4OTIxIn0.UiUwp-V--UsIGiHS-NEmP5-kruUDKsxQreDODdtiwPE/s/1255931999/br/241440845803-l?ref=fdaweb.com).” The document describes best practices for writing composition statements and corresponding statements of ingredients in drug labeling submissions. It includes examples of common, recurring problems identified during the agency’s preliminary and substantive assessment of NDAs and ANDAs regarding the content and format of the composition statement and the corresponding statement of ingredients in labeling. Additionally, the guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are clear.