FDA Temporarily Relaxes Requirements For Alcohol Used in Hand Sanitizers

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Hand sanitizers are regulated by the FDA as over-the-counter (OTC) drugs. Among other things, this means that the active and inactive ingredients in hand sanitizers are tightly regulated by the FDA. Apparently, FDA has been receiving requests for guidance “on the preparation and distribution of alcohol for incorporation into hand sanitizer products for the public’s use” from “entities that are not currently regulated by the FDA as drug manufacturers.” In response, the FDA issued the new immediately-in-effect guidance, “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).”

The policy outlines the conditions under which FDA does not intend to take action against “alcohol production firms”—entities that manufacture “alcohol” intended for use as the active ingredient in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs. For the purposes of this guidance, the term “alcohol” refers only to ethanol and ethyl alcohol; the policy does not apply to isopropyl alcohol or any other active ingredient used in alcohol-based hand sanitizers.

For the duration of the current public health emergency, FDA will not take action against alcohol production firms provided that all the following conditions are met:

• The only ingredients used in the production of the alcohol active ingredient are alcohol, water, and if denatured at the point of production, denaturants. [FDA notes that using “different or additional ingredients in [an alcohol active ingredient] may impact the quality and potency of the finished hand sanitizer product.”]
• The alcohol active ingredient meets, at a minimum, the United States Pharmacopoeia or Food Chemical Codex grade requirements for purity (i.e., not less than 94.9% ethanol by volume).
• The alcohol is prepared “under sanitary conditions and equipment used is well maintained and fit for this purpose.”
• Any water used to adjust the finished ethanol content in the alcohol active ingredient is sterile (e.g., boiling the water, distillation, or reverse osmosis).
• The alcohol production firm uses “the most accurate method of analysis available at the site for verification of ethanol content in a sample before each batch is released for distribution or for use in producing the hand sanitizer,” such as gas chromatography, specific gravity (e.g., alcoholmeter, hydrometer, pycnometer, or gravity density meter), or “another test that is at least as accurate.”
• The alcohol is denatured according to the US Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau regulations, using Formula No. 40-B (27 C.F.R. § 21.76) or Formula No. 40-A (27 C.F.R. § 21.75). The alcohol may be denatured either at the point of production of the alcohol active ingredient (by the alcohol production firm) or the point of production of the finished hand sanitizer (by a compounder or manufacturer). [FDA explains that this denaturing “is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children.”]
• The alcohol production firm complies with FDA’s drug registration and listing requirements (i.e., their facilities are registered with FDA as drug manufacturing establishments and the alcohol active ingredient listed with FDA).
• If the alcohol active ingredient is distributed to another producer (i.e., the alcohol production firm manufactures the alcohol active ingredient, but not the finished hand sanitizer), its labeling complies with the requirements set forth in the guidance. Among other things, the labels must specify the ethanol content and identify the alcohol as denatured or undenatured.