In an effort to increase the supply of ibuprofen oral suspension products in hospitals and health systems, the Food and Drug Administration (FDA) has issued guidance on the preparation of compounded versions of the analgesic/antipyretic medication.

Compounded products are not approved by the FDA as they have not undergone review for safety, effectiveness, or quality. Increased demand for ibuprofen oral suspension products due to a surge in 3 circulating viruses (COVID-19, respiratory syncytial virus, and influenza) has prompted the Agency to issue recommendations for the compounding of ibuprofen oral suspension 100mg/5mL by outsourcing facilities.

For facilities that intend to compound, testing of all components is required, in addition to antimicrobial effectiveness testing and stability testing. The compounded product will only be provided directly to a hospital or health system for in-patient use. Outsourcing facilities are also expected to report adverse events associated with the compounded products to the FDA.

In addition to ibuprofen oral suspension, the FDA has also received reports that hospitals and health systems are experiencing challenges obtaining acetaminophen oral suspension products. In a press statement, the Agency noted that they will not be addressing this issue with updated guidance at this time as it requires additional considerations.

Adverse events or quality problems from compounded products should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

Reference

US Food and Drug Administration. Compounding certain ibuprofen oral suspension products under Section 503B of the Federal Food, Drug, and Cosmetic Act. Accessed January 23, 2023. https://www.fda.gov/media/164693/download.