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