FDA Issues New Guidance On Pharmaceutical Alcohol

To help protect consumers from methanol poisoning, the FDA has issued a new guidance,“Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs.  
 
This guidance is intended to alert pharmaceutical manufacturers and pharmacists in state- licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. 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 such products. 
 
FDA said it also 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. For example, certain inhalation products, mouthwashes, cough and cold products, and many topical drug products include pharmaceutical alcohol. As the COVID-19 pandemic has increased the demand for hand sanitizer products, the demand for pharmaceutical alcohol as the active ingredient of those products has also increased. In the past, increased stress on supply chains has made ingredients more vulnerable to economically motivated adulteration. 
 
For these reasons, FDA says the policy outlined in the guidance applies to pharmaceutical alcohol used as an active or inactive ingredient in a drug regardless of whether the drug product is a hand sanitizer. This policy will help pharmaceutical manufacturers and pharmacists who engage in drug compounding avoid using pharmaceutical alcohol contaminated with or substituted with methanol in drug products, said FDA. 
 
Further details on the guidance can be found here.

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