FDA Revises Guidance on Compounding Ibuprofen

FDA has revised its emergency guidance on compounding certain ibuprofen oral suspension products to address ongoing product shortages. Last month, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products, which 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 increase in demand has been attributed to recent surges in Covid-19, respiratory syncytial virus and influenza, any of which can cause fever in young children.

The revision “addresses outsourcing facilities providing certain ibuprofen oral suspension products to state-licensed pharmacies (including those within hospitals and health systems) and applicable federal facilities to dispense to patients for home use, following receipt of a valid, patient-specific prescription from a health care provider,” the agency says.