The Food and Drug Administration issued Wednesday a proposed rule requesting further data to support the safety and efficacy of specific active ingredients used in topical consumer antiseptic rubs, including hand sanitizers.
The data request does not mean the FDA believes these products are unsafe or ineffective. Instead, the agency seeks to ensure that regular use of these products do not cause unknown safety and efficacy concerns.
The FDA is requesting manufacturers to provide additional data for three active ingredients in the products — ethanol or ethyl alcohol, isopropyl alcohol and benzalkonium chloride.
The proposed rule does not currently request any hand sanitizer products to be taken off the market. However, manufacturers who wish to continue marketing these products under the Over the Counter Drug Review process must provide the FDA with additional information on the active ingredients' safety and effectiveness.
The proposal is available for public comment for 180 days. Companies have one year to submit new data and information. The FDA will evaluate the data and comments regarding the proposal before issuing a final rule on the matter.
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