TAGS: Toiletries
FDA has issued a guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.
Methanol: Unacceptable Ingredient for Any Drug
Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDA’s temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic.
However, 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 pharmaceutical 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.
USP Alcohol Monograph Limits Methanol
The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on 1 September 2020 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 Alcohol monograph. 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.
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, but not limited to, 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-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers.
Source: FDA