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.
Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
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....[FDA]