Rule addresses the safety and effectiveness of OTC hand sanitizers.
The U.S. Food and Drug Administration finally issued its final rule regarding the safety and effectiveness of over-the-counter hand sanitizers (formally known as topical consumer antiseptic rub products). The rule prohibits the use of 28 active ingredients (including triclosan and benzethonium chloride) and seeks to ensure that the agency’s safety and effectiveness evaluations and determinations are consistent and up to date and appropriately reflect current scientific knowledge and increasing use patterns.
The FDA is seeking more data on three other active ingredients –– benzalkonium chloride, ethyl alcohol and isopropyl alcohol –– to determine if they are generally recognized as safe and effective for use in OTC consumer antiseptic rub products.
Since most OTC hand sanitizers do not contain any of the 28 ingredients banned by the rule, less than 3% of products on the market will be affected. Any that contain one of the listed ingredients will require approval under a new drug application or abbreviated new drug application before marketing.
Most products today are based on ethanol, so the future decision on this ingredient could have a significant impact.
