The Food and Drug Administration (FDA) published a final rule to ensure that over-the-counter (OTC) hand sanitizers are safe and effective for consumers.
In the June 2016 proposed rule on OTC hand sanitizers (“topical consumer antiseptic rub products”), the FDA requested more clinical evidence to support the safety and efficacy of active ingredients used in OTC hand sanitizers.
The final rule states that certain active ingredients are not allowed to be used in OTC hand sanitizers, which are meant for use without water and soap. Specifically, the Agency determined that 28 active ingredients — such as triclosan and benzethonium chloride — are not eligible for final evaluation under the OTC Drug Review for use in consumer antiseptic rubs.
“We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data,” stated Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
The status of the 3 active ingredients — benzalkonium chloride, ethyl alcohol, and isopropyl alcohol — will be determined after an analysis of the studies. The Agency does not plan to remove hand sanitizers containing these 3 ingredients from the market.
For more information visit federalregister.gov.