mdi Consultants
Since the beginning of the pandemic, the FDA has been in observation of reports of serious adverse events related to ingestion of alcohol-based hand sanitizers. The FDA has also received numerous reports of dermal toxicity associated with these products.
In the Spring 2020, FDA discovered a few hand sanitizer products that were labeled to contain ethanol but tested positive for methanol contamination. This resulted in serious adverse events consistent with methanol poisoning. Furthermore, some manufacturers even labeled their hand sanitizers as containing methanol even though it is not an approved ingredient for this type of drug products. Around the same time, methanol was detected in imported hand sanitizer drug products from multiple manufacturers through the screening and sampling of products at the point of import.
On September 1, 2020, the revised United States Pharmacopeia (USP) monograph for Alcohol (ethyl alcohol) became official and established a limit for methanol in alcohol of 200 parts per million (ppm). All manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for ethanol. Any ethanol found to contain more than the established limit may be considered adulterated. Ethanol used to manufacture hand sanitizer products under the FDA’s temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol.
Today, the FDA issued a guidance titled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19). The document is a notification for drug manufacturers, including repackers, relabelers, alcohol suppliers and compounders of the FDA’s policy on testing of alcohol (ethanol) or isopropyl alcohol for methanol prior to using the ingredient in drugs. This includes, but is not limited to hand sanitizer products, inhalation products, mouthwashes, cough and cold products, and other topical drug products.
mdi is working with several new manufacturers of ethyl alcohol hand sanitizers in setting up their quality systems in compliance with FDA requirements. You can be sure that once the pandemic eases up, the FDA investigators will be inspecting the manufacturers of these products. A lack of compliance can result in a warning letter, recalls and more serious legal actions.
If you have any questions about the guidance on testing of alcohol based drug products or the FDA cGMP’s for drug manufacturers, please email mdi Consultants at info@mdiconsultants.com RE: Alcohol.