Methanol Found in Pharmaceutical Supply Chain

According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol. Methanol is a toxic form of alcohol that is not an acceptable ingredient in drug products. As a result, the FDA recently issued a new guidance: “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, During the Public Health Emergency (COVID-19).” This policy notifies drug manufacturers and compounders of FDA’s policy on certain testing procedures that should be performed on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs.

The guidance urges compounders on the importance of testing to confirm that alcohol used in the compounding and manufacturing of products are free from methanol contamination. The document also suggests the importance of vendor qualification, and that testing for methanol be conducted in a laboratory that has been previously inspected by FDA and found in compliance with CGMP.

The Excerpt below from page 9 of the guidance addresses compounding:

“Compounded drug products containing ethanol with more than 200 ppm methanol may be considered adulterated under section 501(b) of the FD&C Act and would not qualify for the relevant exemptions in section 503A(a) or 503B(a) because they do not comply with the standards in the applicable USP monograph. Pharmacists in State-licensed pharmacies, Federal facilities, or outsourcing facilities that compound products using ethanol must test the ethanol for methanol content using the test method that appears in the Identification section of the USP Alcohol Monograph or, in the case of State-licensed pharmacies and Federal facilities, ensure that such testing was properly done by a reliable supplier.”