UNITED STATES – FDA is issuing an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to improve the supply of ibuprofen oral suspension products amid record high demand.
The guidance describes FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for use in hospitals and health systems.
The U.S. is currently experiencing a surge in three viruses: COVID-19, respiratory syncytial virus (RSV) and influenza, any of which can cause fever in young children. FDA has received reports of increased demand for pediatric fever-reducing medications, including ibuprofen oral suspension products, and reports related to hospitals and health systems experiencing challenges with obtaining these medications to use in the treatment of pediatric patients with fever and adults who are unable to swallow solid oral dosage forms (e.g., people with feeding tubes). Read More
