Final rule on safety and effectiveness of consumer hand sanitizers was issued by the FDA

The CDC advises that washing hands with soap and water is the best way to eliminate the spread of bacteria. When soap and water are unavailable, they recommend the use of alcohol-based hand rubs containing more than 60% alcohol. The FDA issued its final rule on over-the-counter (OTC) such hand sanitizers since millions of consumers use such rubs daily. It ruled that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. More data is needed on three other active ingredients (benzalkonium chloride, ethyl alcohol, and isopropyl alcohol). Ethyl alcohol is the most common ingredient in such rubs. These ingredient statuses will be addressed either after completion and analysis of the studies. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market. FDA anticipates the impact of this ruling to be minimal since <3% of the marketplace will be affected by the rule. Most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient. Products containing any ineligible active ingredients will require approval under a new drug application or abbreviated new drug application prior to marketing. @
FDA issues final rule on safety and effectiveness of consumer hand sanitizers

FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.

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