FDA Guidance

Many companies are considering converting, or have converted, their manufacturing operations to begin producing hand sanitizers to address the nationwide shortage.  Chemical manufacturers, beer and liquor distilleries, and others have the capability to produce quantities of hand sanitizer.  While this is a laudable effort, companies should be cognizant of the federal requirements that govern such products.

On Friday, March 20th, the United States Food and Drug Administration (“FDA”) issued guidance allowing entities that are not currently licensed or registered drug manufacturers to prepare alcohol-based hand sanitizer products during the COVID-19 public health emergency, either for public distribution or for their own internal use.¹ The FDA’s action is based on the difficulty of both consumers and healthcare professionals to procure alcohol-based hand sanitizers that are effective against SARS-CoV-2, the virus that causes the disease known as COVID-19, as well as the reports of consumers producing their own hand sanitizers.  In an effort to alleviate the shortage of effective hand sanitizers, the FDA will not pursue violations of FDA regulations – i.e., the FDA is exercising their enforcement discretion -- for the duration of the public health emergency against those companies that prepare alcohol-based hand sanitizers provided that certain conditions are met.  

First, the hand sanitizer must be manufactured using only United States Pharmacopoeia (“USP”) or Food Chemical Codex (“FCC”) grade ingredients in the preparation of the product and only in percentages consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (80%, volume/volume) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, volume/volume) in an aqueous solution.
2. Glycerol (1.45%, volume/volume). 
3. Hydrogen peroxide (0.125%, volume/volume). 
4. Sterile distilled water or boiled cold water. 

Importantly, the manufacturer must not add “other active or inactive ingredients,” as any such ingredients could “impact the quality and potency of the product.”  This language was presumably included to curb the use of aloe or scented essential oils that have no specific benefits with respect to SARS-CoV-2 and could dilute the product below the recommended potency. Note that other agency review or approvals -- EPA or state agencies -- may also be triggered by the addition of aloes or scents, even if all-natural (e.g., lavender), so strict adherence to the FDA formula is recommended.  

Entities choosing to manufacture alcohol-based sanitizers must also keep simple records to “document key steps and controls” in the manufacture of the product to ensure all batches are meeting the formula detailed above, with a focus on ensuring the active ingredient is correct.  Entities must also use the most “accurate method of analysis available at the site for verification of alcohol content,” including, but not limited to, gas chromatography, alcoholmeters, hydrometers, or other chemical analyses.  Sampling should be performed on materials prior to filling into final containers.  The final hand sanitizer product must also be labeled consistent with labeling found in the appendices to the FDA’s guidance document.  Finally, manufacturers need to prepare the sanitizer under sanitary conditions with equipment “well maintained and fit” to manufacture this product.

Manufacturers intending to shift operation to producing hand sanitizer are also required to register their facility and list the products it intends to produce in the FDA’s Drug Registration and Listing System.  No further approvals or communication with the FDA is necessary prior to manufacture and distribution of these products.   

If you have any questions, or for further information please contact Doug Cohen, or Franca DeRosa.

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The views expressed herein are solely the views of the authors and do not represent the views of Brown Rudnick LLP, those parties represented by the authors, or those parties represented by Brown Rudnick LLP. Specific legal advice depends on the facts of each situation and may vary from situation to situation. Information contained in this article is not intended to constitute legal advice by the authors or the lawyers at Brown Rudnick LLP, and it does not establish a lawyer-client relationship.

¹ “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) - Guidance for Industry,” March 2020, U.S. Department of Health and Human Services, Food and Drug Administration, and the Center for Drug Evaluation and Research (CDER).