As a result of the Coronavirus (COVID-19) pandemic, the US FDA has released a temporary guidance to relax certain restrictions on the manufacture of hand sanitizers in order to expedite its release to market.
As a result of the Coronavirus (COVID-19) pandemic, the US FDA has released a temporary guidance to relax certain restrictions on the manufacture of hand sanitizers in order to expedite its release to market. This policy was released without public comment to respond to market shortages but remains subject to comment in accordance with FDA good guidance practices.
This guideline establishes that, due to the public health emergency, FDA will not enforce action against firms preparing alcohol-based hand sanitizers for both consumer and public health use until such a time that the emergency is lifted by the Secretary of Health and Human Services provided certain criteria are met1. In a separate guidance, FDA specifies it does not intend to take action against compounders, including pharmacists in state-licensed pharmacies or Federal facilities, for the duration of the emergency2.
To comply with the guidance, a compounder must use ingredients of United States Pharmacopoeia (USP) grade and utilize the formulation consistent with the World Health Organization recommendations. The compounder is not permitted to add any other active or inactive ingredients, as they 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
Particular attention should be paid to ensure the ethanol or isopropyl alcohol is used in the correct quantities and prepared under conditions routinely used to compound similar nonsterile drugs. Simple records should be kept documenting the manufacturing process and assure each batch matches the formulation. The firm should also use the most accurate method for analysis for verification of alcohol content before each lot is released for distribution. This guidance also includes examples of proper package labeling for these products in accordance with the FDA requirements.
Firms should also register their facility and list products in the FDA Drug Registration and Listing System (DRLS). An automatic confirmation will be sent and firms may proceed to manufacture and distribute products without further communication from FDA.
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
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