In response to the shortage of alcohol-based hand sanitizer due to the COVID-19 pandemic, distillers and other entities that manufacture alcohol have stepped in to assist in the production of alcohol-based hand sanitizer. On March 24, 2020, the U.S. Food and Drug Administration (“FDA”) issued Guidance directed to these new alcohol-based hand sanitizer manufacturers.
The Guidance explains that the FDA “does not intend to take action against alcohol production firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the [COVID-19] public health emergency” so long as certain requirements are met. These requirements specify that:
- The alcohol manufactured as an API is not less than 94.9% ethanol by volume;
- Any water used to adjust the finished ethanol content must be sterilized and used quickly after sterilization;
- The alcohol (ethanol) must be denatured, either by the alcohol producer or at the point of production of the finished hand sanitizer product;
- The alcohol (ethanol) is prepared under sanitary conditions and the equipment used is well maintained and fit for this purpose;
- The alcohol manufacturer 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;
- The alcohol API is properly labeled prior to distribution; and
- The alcohol manufacturer must register their facility and list these hand sanitizer products in the FDA Drug Registration and Listing System (DRLS).
A significant purpose of the Guidance is to avoid the “adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in children” that has been reported to the FDA. Indeed, this is the primary purpose of the requirement that the alcohol be denatured. In addition, no ingredients other than alcohol, water, and denaturants may be included in the API.
The Guidance provides additional useful information for proper techniques and formulas that should be adhered to in the production of the API. Thus, distillers and other alcohol manufacturers looking to produce API for alcohol-based hand sanitizer should review the Guidance in its entirety.
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