The FDA's list of dangerous hand sanitizers is now at 100+
On August 7, 2020, the FDA issued updated guidance to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This testing will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination.
The FDA updated their guidance to provide clarification that companies must test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. The FDA recommended using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by the FDA and is compliant with current good manufacturing practices (CGMP).
Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidance and as a result, may be considered evidence of substitution or contamination, or both. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste, and the manufacturer or compounder should contact the FDA regarding the test results and the alcohol’s source.
Pharmacy list also updated
The temporary guidance has also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities.
The agency also included an additional denaturant formula in the temporary guidance. Denaturing alcohol in hand sanitizers is critical to deterring children from unintentional ingestion. The FDA has said that consumer and health care professional safety is a top priority for FDA, and an important part of the FDA’s mission is to protect the public from harm, especially as they seek to help increase hand sanitizer supply.
For questions, email the FDA here: COVID-19-Hand-Sanitizers@fda.hhs.gov
The list of dangerous hand sanitizers
For the latest list of dangerous hand sanitizers as of August 10, 2020, and a list of products on their dangerous hand sanitizer list, go here (scroll down to see the list).