FDA Guidance to Help Ease Ibuprofen Oral Suspension Supply Issues

Published: 01/24/2023

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued immediate-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 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 ibupro

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