Guidance on Ibuprofen Compounding to Help Shortages: FDA

In a move to help curb product shortages, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products. The document describes regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for use in hospitals and health systems.

An FDA notice acknowledges that there has been increase in demand for ibuprofen suspension due to recent surges in Covid-19, respiratory syncytial virus and influenza, any of which can cause fever in young children. “The agency understands these concerns and is working closely, within its authorities, with manufacturers on their efforts to further increase supply in response to the increased demand,” it says. “FDA is continuously assessing the demand for and supply of ibuprofen oral suspension products and if the situation changes, the agency may update, modify or withdraw this policy as appropriate.”