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COVID-19: How FDA-regulated food and beverage companies can make hand sanitizer

Kim Bousquet Melissa Gold March 25, 2020

Food and beverage companies are under enormous pressures to continue delivering safe and healthy products during this public health emergency. Many companies may also be interested in retrofitting their production facilities to help provide medical supplies and/or cleaning supplies. Here is some information on the regulations the FDA has begun to issue for these types of changes.

The FDA has published a newly issued Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).

The FDA’s March 2020 Temporary Policy notes the FDA does not intend to take enforcement action against companies “that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared,” when the following conditions are met.

Required ingredients (FDA March 2020 Temporary Policy)

  • The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.

    • Glycerol (1.45% v/v).

    • Hydrogen peroxide (0.125% v/v).

    • Sterile distilled water or boiled cold water.

  • The company does not add other active or inactive ingredients.

  • The company pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used.

Recordkeeping and safety (FDA March 2020 Temporary Policy)

In retrofitting their production facilities to help provide medical supplies and/or cleaning products, companies should:

  • Keep a simple record to document key steps and controls to assure each batch matches the formula developed for the drug product.

  • Ensure that the hand sanitizer is prepared under sanitary conditions, and equipment utilized is well maintained and fit for this purpose.

  • Use the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution.

  • Label the hand sanitizer consistent with the sample labels shown in the FDA March 2020 Temporary Policy guidance.

Registration (FDA March 2020 Temporary Policy)

  • Companies making this transition must register with the FDA Drug Registration and Listing System.

  • Importantly, once registered, companies can immediately begin producing and distributing product and need not wait for further communication from the FDA.

Note: Companies producing distilled spirts and industrial alcohol should also follow this guidance from the Alcohol and Tobacco Tax and Trade Bureau (TTB).

Feel free to contact us if you have additional questions.

Kim Bousquet is a partner in the Firm’s business litigation practice area. Melissa Gold is a business litigation associate.

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