Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever
The US is experiencing challenges related to 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 fever and pain-reducing oral suspension medications and that hospitals, health systems, and state-licensed pharmacies report challenges accessing these medications to use for fever and pain treatment of pediatric patients 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. FDA subsequently updated the guidance to address the provision of such products to state licensed pharmacies (including those within hospitals and health systems), and to applicable federal facilities, for dispensing to patients following receipt of a patient-specific prescription.
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. We will continue our monitoring of the market and the companies’ ability to meet demand and will work with companies, within our authorities, on opportunities that will further increase supply. As relevant needs and circumstances related to this temporary policy on compounding ibuprofen oral suspension products evolve, FDA intends to update, modify, or withdraw this policy as appropriate.
What fever-reducing medication is addressed in the FDA immediately-in-effect guidance released in January 2023 and revised in February 2023?
FDA’s guidance addresses the compounding of ibuprofen oral suspension products (100 mg/5 mL) in outsourcing facilities.
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, health systems, and pharmacies experiencing challenges with obtaining acetaminophen oral suspension products, which also reduce fever and pain. 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 compounded ibuprofen oral suspension 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. Compounded ibuprofen and acetaminophen oral suspensions would have to comply with all applicable statutory and regulatory requirements, including special packaging standards like child-resistant packaging that are generally required under the Poison Prevention Packaging Act (PPPA).
Accidental overdose of ibuprofen or acetaminophen may have serious health effects. For additional information on packaging and labeling of compounded ibuprofen oral suspension products for dispensing to patients for use at home after receiving a valid, patient-specific prescription, see the immediately-in-effect guidance. For additional information on acetaminophen drug products, including risks involving serious liver damage, see CDER’s acetaminophen page.
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 appropriately marked in milliliters (mL) provides an accurate measurement.
Example of FDA-approved nonprescription labeling for a children's ibuprofen oral suspension (100mg/5mL)
Active ingredients (in each 5 mL)
Ibuprofen 100 mg
Purpose (NSAID)* …… Fever reducer/Pain reliever
*nonsteroidal anti-inflammatory drug
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child:
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Do not use
Ask a doctor before use if
Drug Facts (continues)
Ask a doctor or pharmacist before use if the
When using this product
Stop use and ask a doctor if
- FDA’s Acetaminophen webpage
- CDER Statement: FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems
- FDA Guidance for Industry: Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act