FDA Seeks to Establish New Safety and Efficacy Rules on Antiseptic Products

The FDA is considering tightening up its requirements for OTC topical antiseptic products with a proposal that calls for a slew of new effectiveness and safety data.

A proposed rule would require sponsors to consider the benefit-to-risk ratio for OTC antiseptic products that contain any of the following active ingredients: alcohol, isopropyl alcohol and benzalkonium chloride.

To establish that these ingredients are generally recognized as safe for use as topical antiseptics, the proposal calls for both clinical and nonclinical studies.