USA FDA releases policy for the temporary preparation of certain alcohol-based hand sanitizer products in response to COVID-19 outbreak

The US FDA has announced a revised policy for the temporary preparation of certain alcohol-based hand sanitizers. The temporary policy is being issued due to a decrease in availability of antiseptic rubs for health care providers and in the consumer market.

In the guidance, the FDA provides specific formulation details and labeling guidance for alcohol-based hand sanitizers, which can be viewed here. Hand sanitizers created can be used for consumers as well as health care professionals. Drug establishment registration and product listing requirements are still in effect, but FDA has cleared other regulatory barriers.

In light of the current situation, comments can be submitted to FDA, but the policy is for immediate implementation.

How TSG can help

TSG’s consultants can help coordinate the registration and listing of your antiseptic rub with the FDA. Our consultants also have an understanding of the proper concentration levels of active ingredients required to be compliant, as well as developing and reviewing label claims.