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# Minor Drug Labeling Change Reporting Guide
- URL: https://www.fdaweb.com/minor-drug-labeling-change-reporting-guide/
- Published: 2024-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:25:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156527

FDA has published a draft guidance, *Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products*, with recommendations for applicants for NDAs and ANDAs for nonprescription drug products on documenting minor labeling changes in the next annual report. The [document](https://www.fda.gov/media/176915/download?ref=fdaweb.com) also gives examples of such minor labeling changes.

The guidance does not address labeling changes for prescription drugs and also does not address major and moderate labeling changes to approved NDAs and ANDAs for nonprescription drugs. Nor, FDA says, does it address chemistry, manufacturing, and controls postapproval manufacturing changes.