FDA updates guidance to increase supplies of ibuprofen for children

The FDA has issued immediately in-effect guidance to increase supplies of pediatric ibuprofen, which, as a result of infections stemming from COVID-19, influenza, and RSV, has been in high demand this winter.

The report notes, "the United States is currently experiencing a significant number of infections involving 3 viruses: COVID-19, RSV, and influenza. Each of these viruses may produce fever in young children ... the FDA is issuing this policy to provide temporary flexibility to help ensure that treatment options are available when hospitals, health systems, state-licensed pharmacies, and applicable federal facilities are unable to obtain ibuprofen oral suspension drug products to use for fever and pain treatment of pediatric patients and adults who are unable to swallow solid oral dosage form products."

The FDA continues to monitor the global pharmaceutical supply chain and is working with manufacturers to bolster supply, but notes that some temporary flexibility is needed to insure ibuprofen is available during this period of increased demand. The guidance includes steps that outsourcing facilities should take to reduce the risks associated with compounded products, including, but not limited to:

-ibuprofen oral suspension products have a concentration of 100 mg/5mL

-each shipment be tested for identity and evaluted for conformity with appropriate specifications before use in compounding

-the outsourcing facility perform a limit test for diethylene glycol (DEG) and ethylene glycol (EG) on all containers of all lots at a higher risk of DEG and EG contamination.

-the ibuprofen oral suspension formulation is compounded using sterile water that complies with USP sterile water monograph

You can read the full report here.