Food and Drug Administration
Although some distilleries have tried to pitch in to produce hand sanitizer in the wake of a national shortage caused by the coronavirus public health emergency, hand sanitizers are actually regulated by the Food and Drug Administration (FDA) as an over-the-counter pharmaceutical. In an effort to help ease the shortage, the FDA provided guidance on how a pharmacist can compound hand sanitizer.
The FDA announced on March 13, 2020, without prior public comment, its Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, which authorizes pharmacies to compound hand sanitizer during the current COVID-19 public health emergency.
Hand hygiene, especially washing hands with soap and water, is an important part of helping to minimize the spread of the COVID-19 disease. However, if soap and water are not readily available, the U.S. Centers for Disease Control and Prevention (CDC) recommends an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
To help alleviate the difficulties many consumers are having in accessing alcohol-based hand sanitizers, the FDA is permitting state-licensed pharmacies or federal facilities and registered outsourcing facilities (i.e., 503B facilities) to prepare alcohol-based hand sanitizers for consumer use provided the following criteria are met:
- Only the following United States Pharmacopoeia (USP) grade ingredients are to be used, in the following formulation:
- Alcohol (ethanol) (80%, volume/volume (v/v)) in a denatured aqueous solution 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.
- Particular attention is used to ensure either ethanol or isopropyl alcohol is used as the active ingredient and that the correct amount of the active ingredient is used.
- The hand sanitizer is prepared under conditions routinely used by the facility to compound similar nonsterile drugs.
- The hand sanitizer is labeled consistent with the “Drug Facts Label” provided in the FDA’s policy.
It should be noted that the policy does not apply to other types of hand sanitizers, including those:
- That use different active ingredients.
- Whose potency falls above or below the formulation described above.
- That are marketed with claims that do not conform to the Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products.
- Whose advertising or promotion is false or misleading.
The FDA’s policy stresses that no additional ingredients (active or inactive) may be added, as such additional ingredients may reduce the safety and effectiveness of the product.
The FDA’s guidance will remain in effect for the duration of the public health emergency, which was declared on January 27, 2020. The declaration of a public health emergency will last for the duration of the emergency or 90 days, but may be extended by the Secretary of Health and Human Services.
Alcohol Tobacco and Tax Trade Bureau (TTB)
With respect to the TTB, the Acting Administrator has temporarily waived provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees (DSP) who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency.
The following changes have been made that would allow any DSP to immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, without first having to obtain authorization. These changes are approved through at least June 30, 2020:
- TTB is exempting alcohol fuel plants (AFP) and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer.
- All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are composed of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.
However, there are a few points to note regarding the above exemptions:
- Hand sanitizer products are not subject to federal excise tax if made with denatured ethanol; however, if made with undenatured ethanol, federal excise tax applies.
- As stated above in (2), TTB-permitted DSPs may manufacture hand sanitizer products that are composed of denatured or undenatured ethanol. However, the FDA only permits hand sanitizer products composed of undenatured ethanol. Absent additional guidance by the FDA on production of hand sanitizer with denatured ethanol, DSPs producing hand sanitizer composed of denatured ethanol, although compliant with TTB regulations, risk not being in compliance with FDA standards.
A full summary of the TTB changes can be found here.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.