FDA OKs hospitals to compound ibuprofen amid drug shortage

As drugmakers report high demand and waning supply of pediatric fever-reducers, the FDA posted an immediately-in-effect guidance Jan. 20 to help boost access to ibuprofen oral suspension products. 

Fever-reducing drugs have been in shortage for weeks as waves of COVID-19, flu and respiratory syncytial virus infections hit children's hospitals. In response to reported difficulties getting pediatric ibuprofen oral suspension drug products, hospitals and health systems can compound certain forms of ibuprofen, according to the guidance. 

The FDA guidance clarifies that the change is only applicable to hospitals "because hospitals treat patients with more acute needs and have better controls to assure appropriate dosing and administration than generally would be found in the household setting."

Compounded drugs aren't FDA-approved because the altered products haven't gone through agency safety, efficacy and quality reviews, but because of the shortage, the temporary measure allows hospitals to compound ibuprofen oral suspension 100 mg/5 mL, which "is essentially a copy of an FDA-approved drug product," the FDA said. 

Walgreens and Rite Aid previously limited purchases to some pain medications because of the shortage as pharmaceutical companies build up supply. Acetaminophen is also in low supply, but the FDA said it's "not addressing acetaminophen oral suspensions at this time due to additional considerations."

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