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

Issuing agencies

Abstract

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).