FDA issues temporary policy for the preparation of alcohol based hand sanitizer

FDA issues temporary policy for the preparation of alcohol based hand sanitizer

THE WHAT? As more and more businesses turn their hand to the production of hand sanitizer, the US Food and Drug Administration has issued a temporary policy on the preparation of the popular product.

THE DETAILS The policy applies to firms that register as OTC drug manufacturers to prepare alcohol-based hand sanitizers for the duration of the public health emergency.

The FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care professional hand rubs for the duration of the emergency as long as the hand sanitizer is manufactured using only US Pharmacopoeia-grade ingredients consistent with WHO recommendations; the correct amount of active ingredient is used; it is prepared under sanitary conditions; and the finished product is subject to analysis for verification of its alcohol content; labeled consistently with the relevant regulations; and the facility is registered.  

THE WHY? With hand hygiene an important part of the US response to COVID-19, alcohol-based hand sanitizer has become a sought-after commodity and subject to shortages caused by panic buying and stockpiling. The FDAs guidance will enable and incentivise further production.

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