FDA revises action on compounded ibuprofen, citing oral version shortage

Paul Schloesser

Associate Editor

The FDA put out guidance Thursday expanding supply of a specific form of ibuprofen, one of the major active ingredients in over-the-counter pain relief medicine such as Advil.

In its newest revised guidance, the federal regulatory agency is now giving the green light to outsourcing facilities to provide compounded, orally suspended forms of ibuprofen to state-licensed pharmacies that can be given to patients at home, provided that a patient has a valid and patient-specific prescription.

Previous guidance came out back in January, initially allowing outsourcing facilities to compound orally suspended ibuprofen that would be used in hospitals and health systems amid “record high demand,” FDA said at the time.

FDA cited reports of hospitals and pharmacies having difficulty securing oral suspension forms of ibuprofen for kids and adults unable to swallow solid forms of the pain relief drug. The agency added that the increase in demand is tied to a surge in cases from three viruses: Covid-19, RSV and influenza — all of which can spark fevers in children.

“We recognize that hospitals, health systems, State-licensed pharmacies, and applicable Federal facilities have concerns about assuring access to these drug products to use for fever and pain treatment of pediatric patients, and adults who are unable to swallow solid oral dosage form products, during the winter months when respiratory illnesses are likely to be elevated. Therefore, FDA is issuing this policy to provide temporary flexibility,” the regulatory agency wrote.

Compounding matters is when a physician, pharmacist, or in this case an outsourcing facility, combines or alters ingredients of approved drugs to one more tailored to specific needs of a patient — which may not be FDA approved.

FDA said in its guidance that outsourcing facilities should meet certain standards when it comes to manufacturing the compounded version of ibuprofen, such as meeting monograph standards, complying with the FD&C Act, testing for diethylene glycol and ethylene glycol contamination on any component deemed higher-risk for contamination, and more.