[1/20/2023] 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).
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. 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.
FDA has also received reports related to hospitals and health systems experiencing challenges with obtaining acetaminophen oral suspension products, which also reduce fever. FDA is not addressing acetaminophen oral suspensions at this time due to additional considerations.
In addition to drugs administered in hospitals, FDA understands families in the US are concerned about access to over-the-counter oral suspension medications for pain and fever. The agency continues to work closely, within its authorities, with the manufacturers on their efforts to further increase supply.
Questions and Answers: Compounded Oral Suspension Medications for Pain and Fever