In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has grown further following the FDA’s March 20 guidance regarding the manufacture of hand sanitizers by companies not previously registered to make over-the-counter (OTC) drugs. In response, FDA issued additional guidance on March 24 on its temporary policy for the manufacture of alcohol for incorporation into alcohol-based hand sanitizers during the public health emergency.
Read our LawFlash on the prior guidance.
Conditions for Manufacturing Alcohol for Hand Sanitizer Products
FDA agreed that it would allow companies to prepare and distribute alcohol (only ethanol or ethyl alcohol) for incorporation into alcohol-based hand sanitizer products for consumer use and for use as healthcare personnel hand rubs under the following conditions:
- The alcohol must be manufactured under sanitary conditions and meet, at a minimum, the United States Pharmacopoeia (USP) or Food Chemical Codex (FCC) grade requirements for purity, that is, not less than 94.9% ethanol by volume. The manufacturer should use the most accurate method of analysis available at the site for verification of ethanol content in a sample before each batch is released. Methods can include gas chromatography, specific gravity, or another test that is at least as accurate. A simple record should be used to document key steps and controls.
- Water used to adjust the finished ethanol content in the alcohol must be sterile (e.g., boiling the water, distillation, or reverse osmosis).
- The alcohol may be denatured at the point of production, or the point of manufacture or compounding of the hand sanitizer. Alcohol intended for incorporation into a finished hand sanitizer product must be labeled as “denatured” or “undenatured.”
- The alcohol may be denatured using one of two formulas:
1. 27 CFR 21.76 Formula No. 40-B (preferred formula): To every 100 gallons of alcohol add 1/16 avoirdupois ounce of denatonium benzoate, N.F., and 1⁄8 gallon of tert-butyl alcohol; or
2. 27 CFR 21.75 Formula No. 40-A (alternative formula): To every 100 gallons of alcohol, add one pound of sucrose octaacetate and 1⁄8 gallon of tert-butyl alcohol.
- Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol may not contain any other ingredients.
- The product, if distributed to other producers, must be labeled in accordance with the temporary policy, including use of directions for use, manufacturer address and FDA registration number, and identification of the alcohol content.
- The manufacturing facility must be registered in the FDA Drug Registration and Listing System. Upon completion of registration and listing, firms receive automatic confirmation from FDA and do not need to wait for further communication from FDA before they begin to manufacture and distribute these products.
Purchasing Alcohol Made Under the Temporary Policy
Companies purchasing alcohol produced under this guidance should do the following:
- Consider obtaining a guaranty from the supplier that the product is not adulterated or misbranded under the current FDA guidance and is manufactured consistent with the above policy
- Request certificates of analysis and certificates of conformance
- Request further test results or records for manufactured batches if there is any question about the facility or the effectiveness of a particular batch of product
- Request the manufacturer’s FDA registration number (DUNS)
Coronavirus COVID-19 Task Force
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Contacts
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Washington, DC
Kathleen Sanzo
Jacqueline Berman