FDA guidance calls for testing all alcohol-based products for methanol

The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol. The final version expands the testing to all products that use pharmaceutical alcohols (PAs), not just hand sanitizers.

The guidance, which was issued on 17 October 2023, went into effect immediately.

The guidance has been revised to shift the focus from the COVID-19 pandemic. Its scope has also been expanded to include other products besides hand sanitizers. The agency is “concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination.”

The agency announced that “as the COVID-19 pandemic increased the demand for hand sanitizer products, the demand for pharmaceutical alcohol as the active ingredient of those products also increased. In the past, increased stress on supply chains has made ingredients more vulnerable to economically motivated adulteration.”

The draft guidance was issued in January 2021 in response to reports of methanol poisoning of consumers who ingested alcohol-based hand sanitizers (RELATED: FDA puts all Mexican hand sanitizers on import alert, Regulatory Focus 17 January 2021).

Although the COVID–19 Public Health Emergency ended on 11 May 2023, FDA determined that that the recommendations in the 2021 guidance were applicable outside the context of the COVID-19 response. The agency continues to issue warning letters to companies for manufacturing products that contain unacceptably high levels of methanol (RELATED: FDA warns API manufacturer, OTC maker for sloppy GMP oversight, Regulatory Focus 21 July 2023).

Under the final guidance, manufacturers and compounders should adhere to methanol limits set in the USP monographs for alcohol (ethyl alcohol or ethanol) and isopropyl alcohol. The limit is 200 parts per million (ppm) and products exceeding this threshold will be considered adulterated.
The guidance also species that drug manufacturers have a responsibility to know the entities involved in producing all the ingredients in the supply chain, including pharmaceutical alcohol. Additionally, all personnel in pharmaceutical manufacturing facilities should be aware of the importance of testing, and the hazards if testing is not completed.

The methanol contamination problem was first uncovered in the spring of 2020, when “numerous hand sanitizer products that were labeled to contain ethanol but tested positive for methanol contamination, and the drinking of some of these hand sanitizer products resulted in methanol poisoning,” FDA wrote.

In some cases, manufacturers labeled their products as containing methanol, even though methanol “is not an acceptable ingredient in any drug product,” FDA wrote.

FDA final guidance

FDA guidance calls for testing all alcohol-based products for methanol

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