The US is experiencing a surge in three viruses: COVID-19, respiratory syncytial virus (RSV) and influenza, any of which can cause fevers in young children. FDA is aware of increased demand for pediatric fever-reducing medications and that hospitals and health systems report challenges accessing these medications to use in the treatment of pediatric patients with fevers and adults who are unable to swallow solid oral dosage forms (e.g., persons with feeding tubes).

To help address these concerns, in January 2023, FDA issued a guidance that addresses outsourcing facilities’ compounding of certain ibuprofen oral suspension products for administration in hospitals and health systems.

We are continuing to closely monitor the ibuprofen and acetaminophen oral suspension supplies which have experienced increased demand since the fall of 2022. Companies continue to report inventory and are manufacturing at maximum output to fill the supply pipeline and ensure supplies are evenly distributed. We will continue our monitoring of the market and the companies’ ability to meet demand and will work with companies, within our authorities, on anything that will further increase supply. If the needs and circumstances related to this temporary policy on compounding ibuprofen for hospitals and healthcare systems evolve, FDA intends to update, modify, or withdrawn this policy as appropriate.

What fever-reducing medication is addressed in the FDA immediately-in-effect guidance released in January 2023?

FDA’s guidance addresses the compounding of ibuprofen oral suspension products (100 mg/5 mL) in outsourcing facilities, for administration of the suspension products in hospitals and health systems.

Why is FDA not issuing guidance for acetaminophen products, since consumers are also having trouble finding oral suspension formulations?

FDA has received reports related to hospitals and health systems also experiencing challenges with obtaining acetaminophen oral suspension products, which also reduce fever. FDA is not addressing acetaminophen oral suspensions at this time due to additional considerations.

What does the immediately-in-effect guidance say about quality control when preparing ibuprofen oral suspensions?

The guidance identifies steps that should be taken to reduce the risks associated with the compounded products and indicates that FDA intends to prioritize its regulatory and enforcement actions if these steps are not all followed. See the immediately-in-effect guidance for detailed information and references.

Can 503A compounders make ibuprofen and acetaminophen oral suspensions if a shortage has not been declared?

FDA recognizes significant interest among pharmacy compounding stakeholders in helping address demand and supply issues for pain and fever oral suspension medication. Compounded drugs containing acetaminophen or ibuprofen would need to meet all applicable requirements in section 503A of the FD&C Act. Although section 503A restricts compounded drugs that are essentially copies of commercially available drugs, including those that are not in shortage, certain amounts are permissible under the law as long as the compounding is not done "regularly or in inordinate amounts." All other conditions of section 503A would have to be met, including compounding pursuant to a valid prescription for an identified individual patient.

What information is available on dosing and risks for ibuprofen oral suspension?

An example of FDA-approved nonprescription labeling for a children’s ibuprofen oral suspension 100mg/5 mL is available below. This labeling information is based on FDA’s premarket review of FDA-approved nonprescription products. The labeling example includes certain content of a typical nonprescription label for a children’s ibuprofen oral suspension, but the example is not formatted per the nonprescription labeling formatting requirements, which can be found in the Code of Federal Regulations (21 CFR 201.66 and other sections). Compounded products do not undergo premarket review and are not FDA-approved.

Household spoons vary widely in volume and should NOT be used for administering medications. A dosing device (e.g., oral dosing syringe or dosing cup) that is marked in milliliters (mL) provides an accurate measurement.

Example of FDA-approved nonprescription labeling for a children's ibuprofen oral suspension (100mg/5mL)