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.”…
