Draft Guide on OTC Drug Minor Changes

FDA has released a draft guidance entitled “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain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.