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Today, FDA issued a guidance to notify drug manufacturers, including repackers, relabelers, alcohol suppliers and compounders, of FDA’s policy on testing of alcohol (ethanol) or isopropyl alcohol for methanol prior to using the ingredient in drugs. This policy applies to any drug with alcohol as an ingredient, including hand sanitizer products, certain inhalation products, mouthwashes, cough and cold products, and many topical drug products.
Consistent with FDA’s temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of alcohol for methanol, if the firms use alcohol they have produced themselves (e.g., distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
FDA is aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizers that were manufactured with methanol or methanol-contaminated ethanol. FDA has also received numerous reports of dermal toxicity associated with these hand sanitizer products. FDA is concerned that other drugs containing ethanol or isopropyl alcohol, which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. Therefore, the policy outlined in this guidance applies to all alcohol or isopropyl alcohol used as an active or inactive ingredient in a drug.
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). Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP monograph for alcohol. Any ethanol found to contain more than 200 ppm methanol may be considered adulterated. Ethanol used to manufacture hand sanitizer products under 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. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol, and may consider any isopropyl alcohol with more than 200 ppm methanol to be adulterated.
The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-containing drugs should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers.
Contact FDA at COVID-19-Hand-Sanitizers@fda.hhs.gov with questions regarding ethanol or isopropyl alcohol hand sanitizer products.
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