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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