FDA releases guidance for outsourcing facilities compounding certain ibuprofen oral suspension products; guidance intended to help hospitals, health systems meet demand for fever-reducing products during respiratory illness surge

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January 25, 2023 (press release) –

To help hospitals and health systems meet demand during the current surge in respiratory illnesses for fever-reducing products to treat pediatric patients and adults unable to swallow solid oral dosage forms, the Food and Drug Administration Friday released guidance for outsourcing facilities compounding certain ibuprofen oral suspension products.

“Although FDA is monitoring the global pharmaceutical supply chain and working, within its authorities, with manufacturers of approved ibuprofen oral suspension products, to bolster supply, temporary flexibility is needed to help ensure that treatment options are available to hospitals and health systems during this period of increased demand,” the guidance states. 

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