New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols

FDA recently published a guidance for manufacturers and suppliers of the glycols to spread awareness about the potential health risk. In early 2023 FDA received the reports on poisoning of liquid drug products those have glycerin and glycols as ingredients. These products were contaminated with diethylene glycol or ethylene glycol. The aim of this guidance is to aware the manufacturers to prevent the use of contaminated products.

This guidance provides the importance to good manufacturing procedure and highlights the key steps to ensure the detection of contaminated DEG and EG. Manufacturer and responsible for the compliance with the FDA guidance and conduct the required tests to detect the contamination in the products. FDA also suggests that manufacturers must not rely on the supplier certificate for the tests and should conduct the required tests. Each components added the drug products should be tested by the manufacturer.

It is important to know that this FDA guidance does not legally enforce the responsibility but it is the recommendation of the agency on its current thinking. It is crucial to comply with the guidance to prevent this type of poisoning in future. Guidance also provides the historical data of this type of incidents and also provides the international cases of liquid drug products contamination.

Overall this guidance provides the resources for the manufacturers and suppliers to outline the steps to minimize the risk associated to use of the glycols and their contamination in drug products.

Check full guidance on FDA's website