FDA Update: FDA provides testing method to assess quality of hand sanitizer products for impurities

As we have learned during these “EUA” times and lack of FDA oversight on new companies manufacturing and selling various products during this pandemic, there are some very serious situations of adulterated products. The FDA is trying hard to monitor this situation and address critical issues as they pop up.

The FDA’s investigation of contaminated hand sanitizers continues. The newest addition is a laboratory testing method, provided by the agency, to assess the quality of finished hand sanitizer products. This test is to help assure that hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. The method can be used for hand sanitizers labeled to contain alcohol (ethanol) or isopropyl alcohol (isopropanol/2-propanol) as the active ingredient and can screen for potentially harmful impurities.

As the investigation into contaminated hand sanitizers continues, the FDA updates consumers through their website. The FDA has also released temporary guidances for industry that temporarily produce hand sanitizers.

For any other questions on FDA regulation and compliance with producing hand sanitizers, please email mdi Consultants at [email protected] RE: Hand Sanitizer.