Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

Food and Drug Administration, HHS.

The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000038) entitled “Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.” This proposed order, if finalized, will permit minor dosage form changes, i.e., from tablets or capsules to chewable tablets, orally disintegrating tablets, or films, of over-the-counter (OTC) monograph drugs that are in conformity with the requirements of the order, the Federal Food, Drug, and Cosmetic Act (FD&C Act), and other applicable requirements, without the issuance of a separate order amending an applicable OTC monograph to add the new dosage form or otherwise finding the new dosage form to be generally recognized as safe and effective (GRASE).

Submit electronic comments on the proposed administrative order by October 3, 2025.

The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 3, 2025. Please note that late, untimely filed comments will not be considered. Instructions for submitting comments are contained in the proposed order OTC000038, which can be viewed in the OTC Monographs@FDA portal at https://dps.fda.gov/​omuf. Comments must be submitted electronically.