Temporary Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol During the Public Health Emergency
CDER
2023-11-22
FDA-2020-D-2016-0007
05:00:00
https://api.regulations.gov/v4/comments/FDA-2020-D-2016-0007
Anonymous
Anonymous
Referring to Policy of Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, CDER Guidance for Industry, Dated October-2023, Section-III [Policy of Testing Methanol] A, Drug Products, to perform the specific identity test that includes a limit test for methanol, on each container within each shipment of each lot of pharmaceutical alcohol before the component is used in the manufacture or preparation of drug products.As stated under citation # 27  28 in the guideline, based on the knowledge of shipping controls, we the drug product manufacturer interpret, representative sample from each lot shall be used for Methanol testing to confirm its identity. 