Guide on Testing Pharmaceutical Alcohols

FDA has posted a final guidance entitled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” The document is intended to alert pharmaceutical makers and state-licensed pharmacies 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 has also received numerous reports of dermal toxicity associated with such products,” the guidance says.

FDA’s guidance also highlights concerns with other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used ingredients in a variety of drug products, because they could similarly be susceptible to methanol contamination. “For example,” it says, “certain inhalation products, mouthwashes, cough and cold products, and many topical drug products include pharmaceutical alcohol.”