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FDA‌ ‌Ethanol‌ ‌Guidance‌ ‌for‌ ‌Hand‌ ‌Sanitizer‌ ‌Manufacturing‌


 

In the wake of the coronavirus (COVID-19 disease) pandemic, the Alcohol and Tobacco Tax and Trade Bureau (TTB) as well as the Food and Drug Administration (FDA) has recently released temporary policies regarding taxation, preparation, and distribution of certain alcohol-based hand sanitizers and antiseptic products. To meet the growing demand, these guidance’s allow entities that are not currently licensed, not registered drug manufacturers1, and not regulated by the FDA, to prepare alcohol-based hand sanitizers for public distribution or individual use. The TTB has backed this guidance by providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers2

When it comes to the use of ethanol in hand sanitizer products, there are several FDA recommendations that manufacturers should be aware of to avoid negative action and assure public safety;

  1. Hand sanitizer should be manufactured using only the following ingredients3:
  2. (1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR (2) United States                        Pharmacopeia (USP grade) Isopropyl Alcohol.
  3. Glycerin (glycerol) USP or Food Chemical Codex (FCC) (also known as “food grade”).
  4. Hydrogen peroxide.
  5. Sterile water (e.g., by boiling, distillation, or other processes that result in water that meets the specifications for Purified Water USP).
  6. Alcohol (ethanol) used for hand sanitizer should be derived from distillation or fermentation processes that are typically used for consumable goods. Alcohol derived from synthetic processes, such as isopropyl alcohol, can be used only if it meets USP or FCC grade. No other chemicals may be present and the manufacturer must take measures to avoid cross-contamination. 
  7. The alcohol (ethanol) is denatured either by the alcohol producer or at the site producing the finished hand sanitizer product. Denatured ethanol is essentially alcohol that has been processed to be undrinkable4. This process is critical to prevent human consumption that could lead to adverse reactions from the product. The FDA has a separate guidance providing formulas for denaturing. The TTB notes that whether or not alcohol is denatured, it may be delivered tax-free to state and local governments for non-beverage purposes5.
  8. General rules that manufacturers should be consistently abiding by are also revisited by the FDA. Firstly, ensuring any hand sanitizer produced is made in a clean and sterile environment. Secondly, documenting the active ingredient along with the amount used. Thirdly, they must guarantee the use of accurate analysis and testing before finalizing the product along with providing correlating drug fact labels for each product. Then they must assure packaging and distribution is appropriate for liquid drug products. Finally, register their facility and list of products generated in the FDA Drug Registration and Listing System. Any additional active ingredients, not included under this recommendation would nullify any protection for the manufacturer. 

The TTB and FDA has made it clear that these recommendations are temporary and should only be taken into consideration during unforeseen circumstances. Such as the current global health crisis. However, it is reassuring both agencies have acted quickly in allowing manufacturers using ethanol for other reasons, to shift focus on keeping one another healthy.

For more detailed information on recommended hand sanitizer formulas, denaturing formulas, and drug facts, you can visit https://www.fda.gov/media/136289/download. For TTB’s public guidance you can visit https://www.ttb.gov/public-guidance/ttb-pg-2020-1a.