On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that has significant public health implications. The revised guidance further “addresses 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.”
As the shortage becomes more severe, the Agency is exercising even greater enforcement discretion regarding the compounding of an FDA-approved product to ease the impact on patients and healthcare staff at hospitals and health systems. The guidance will remain in effect until the shortage dissipates and the FDA publishes a Federal Register (FR) notice announcing its intention to stop enforcement discretion, but the FDA will likely give outsourcing facilities at least sixty-days’ notice before withdrawal of the guidance. We will keep an eye on developments and let you know when the FR notice is issued.