Temporary Relaxation of FDA Guidance for Alcohol Based Hand Sanitizers

The US Federal Drug Administration (FDA) has
temporarily relaxed guidance associated with the manufacture of alcohol-based hand
sanitizers in order to expediate their release into the marketplace.

Entitled “Temporary Policy for Preparation of Certain
Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
(COVID-19),” the FDA announcement comes in the wake of the Coronavirus
(COVID-19) pandemic. It was released without public comment to respond to
shortages on the market, although comments will still be accepted in accordance
with FDA good guidance practices.

This temporary policy establishes that, while there is a public health
emergency, the FDA will not enforce actions against firms preparing
alcohol-based hand sanitizers for consumer and public health use. This
temporary measure will cease when the Secretary of Health and Human Services
lifts the emergency status.

The FDA has also issued, “Policy for Temporary
Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency,” which specifies that the FDA does not intend to take action
against compounders, including pharmacists in state-licensed pharmacies or
Federal facilities, for the duration of the emergency.

The guidance states that the compounder must use ingredients that are of United
States Pharmacopoeia (USP) grade and they must also follow a formulation that
is consistent with World Health Organization (WHO) recommendations. They
are not allowed to add other active or inactive ingredients, as these may
affect the quality and efficacy of the product.

Compounders may utilize the following formula:

  • Alcohol (ethanol) (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

Compounders need to ensure the ethanol or isopropyl
alcohol is used in the correct quantities and must be prepared under the same conditions
routinely used when compounding similar nonsterile drugs.

Compounders should keep simple records to document the
manufacturing process and assure each batch matches the formulation. They should
also accurately verify that each batch has the correct alcohol content before it
is distributed.

The new guidance also contains examples of acceptable
package labeling for these products in accordance with the FDA requirements.

Stakeholders should remember that all firms must list their facility and
products in the FDA Drug
Registration and Listing System
(DRLS). An
automatic confirmation will be sent and then firms can begin manufacturing and
distributing hand sanitizer products without further communication from FDA.

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