Policy for Testing of Alcohol

 

The U.S. FDA has issued new guidance in relation to the testing of ethanol and isopropyl alcohol for methanol.

 

This guidance is of particular importance during the coronavirus pandemic. The 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. This guidance was developed by the FDA’s Center for Drug Evaluation and Research (CDER), in cooperation with the Center for Biologics Evaluation and Research (CBER)and the Center for Veterinary Medicine (CVM).

 

For the purposes of this guidance, references to “manufacturers” include registered outsourcing facilities because outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. 

 

FDA 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.

 

See: https://www.fda.gov/media/145262/download 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)