With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this drug to treat fever in children or in patients that cannot swallow solid oral dosage forms (i.e., patient with an NG tube or with significant dysphagia).
The FDA has issued an immediately effective guidance (here) that outlines certain requirements for compounding for 503B outsourcing facilities, and notes that 503A compounders can also engage in limited compounding activities for this product; however, for 503A compounders, the requirement for individual patient prescriptions must still be met, and the FDA notes that “certain amounts are permissible under the law as long as the compounding is not done ‘regularly or in inordinate amounts.’” The guidance also explains that this enforcement strategy does not extend to acetaminophen suspension (although shortages of this medication have also been reported) due to what the Agency terms “other considerations,” which is likely potential for the serious side effect of liver toxicity if an error in compounding or dosing occurs.
Concurrent with the release of the guidance, the Agency issued a Q&A document (here) that answers certain questions about the compounding of ibuprofen suspension and provides a labeling format that should be used by compounders. The FDA also reminds the public that household teaspoons will vary the quantity of drug administered and cautions that a properly calibrated delivery device should be used for administration of the appropriate dose.
The guidance further notes, in regard to enforcement, that “as a temporary measure, until the FDA withdraws or revises this guidance, the FDA intends to prioritize its regulatory or enforcement action for compounding by outsourcing facilities of an ibuprofen oral suspension product (100 mg/5 mL) that is essentially a copy of an FDA‑approved drug product; or that uses a bulk drug substance that does not comply with section 503B(a)(2)(A) of the FD&C Act; or that does not meet specific CGMP requirements with regard to the establishment of an initial expiration date through product stability testing, to focus on the potential for harm to the public health.”
The document also contains information, in two separate appendices, on the requirements for establishing a By Use Date (BUD) and/or an expirations date. The conditions under this guidance shall remain in effect until such time as the shortage continues and/or until the FDA withdraws the guidance.
