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FDA Regulatory Focus on Compounding Children's Ibuprofen in Response to Increased Demand

February 10 2023

The guidance issued by the Food and Drug Administration (FDA) was released due to an increase in demand for pediatric fever-reducing medications, including ibuprofen oral suspension, as three viruses including COVID-19, Respiratory Syncytial Virus (RSV), and Influenza are currently increasing and causing fever in young children.

This guidance supersedes the previous guidance issued on January 20, 2023 and that the FDA is closely monitoring the needs and circumstances related to this temporary policy, and intends to update, modify, or withdraw it as necessary.

There are several key points regarding this FDA guidance.

1. Ensuring that all bulk drug substances used in compounding are FDA-approved or are otherwise eligible for use in compounded drugs under the FD&C Act.

2. Properly following Current Good Manufacturing Practice (CGMP) requirements for the compounding of drugs, including requirements for testing the identity, strength, quality, and purity of the finished drug product.

3. Establishing an appropriate initial expiration date for the compounded ibuprofen oral suspension product based on stability testing.

4. Properly labeling the compounded product with all necessary information, including the name and address of the outsourcing facility, the name of the licensed pharmacist responsible for compounding the product, the name and strength of the drug product, and the expiration date.

5. Properly storing and handling the compounded ibuprofen oral suspension product to maintain its quality and reduce the potential for harm to patients.

It is important to note that this guidance is temporary and subject to change as FDA continues to assess the current circumstances related to the supply and demand of ibuprofen oral suspension products. Outsourcing facilities should stay up-to-date on any updates or changes to this guidance and be prepared to adjust their compounding practices accordingly.

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