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# Draft Guide on OTC Drug Minor Changes
- URL: https://www.fdaweb.com/draft-guide-on-otc-drug-minor-changes/
- Published: 2025-06-04T12:00:00.000Z
- Updated: 2026-09-14T15:13:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159299

FDA has released a [draft guidance](https://www.fda.gov/media/186760/download?ref=fdaweb.com) entitled “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter (OTC) Monograph Drugs.” The document provides recommendations for how requestors can comply with the requirements described in a proposed administrative order (OTC000038) under the same title. The recommendations are intended to assist requestors when making a minor change in an OTC product’s dosage form. Specifically, it provides advice on demonstrating that a minor change in a solid oral dosage form from a tablet or capsule to a chewable tablet, orally disintegrating tablet, or film will not affect the drug’s safety or effectiveness. It also describes how to demonstrate that such a change will not materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product.