FDA regulation for hand sanitizers. How are consumer hand sanitizers regulated in the USA ?

FDA regulation for hand sanitizers

FDA regulation for hand sanitizers finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for review under the FDA’s OTC Drug monograph system. 


FDA regulation for hand sanitizers reaffirms the requirement of additional safety and efficacy data on three other active ingredients (benzalkonium chloride, ethyl alcohol, and isopropyl alcohol )  to ensure the safety and efficacy of these ingredients.


At this time, the  FDA does not intend to take enforcement action to remove hand sanitizers containing benzalkonium chloride, ethyl alcohol, and isopropyl alcohol ingredients from the market”.  


FDA has still not published the final monograph for consumer hand sanitizers.


FDA has also published a temporary Policy for Alcohol-Based Hand sanitizer products during the Public Health Emergency (COVID-19), which allows non-drug manufacturing companies to produce alcohol-based hand sanitizers during the COVID 19 emergency. 


Upon completing registration and listing, firms receive an automatic confirmation from the FDA. They do not need to wait for further communication from the FDA before they begin to manufacture and distribute these products.

If you are planning to market hand sanitizers in the USA we can help you to comply with applicable  FDA regulations.   Please contact us for more information.


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