AHA recommends changes to FDA draft hospital and health system compounding guidance

The AHA today urged the Food and Drug Administration to revise its draft compounding guidance to allow hospital and health system pharmacies to continue to distribute compounded drug products to other health care facilities in the same system. The AHA “strongly recommends that the FDA remove the arbitrary one-mile radius limitation and replace it with an alternative approach that would support the existing hospital and health system care delivery model and also put into place widely-vetted, evidence-based limits on anticipatory compounding in hospitals and health systems to ensure safe, high-quality patient care,” wrote Ashley Thompson, AHA senior vice president for public policy analysis and development. Specifically, AHA recommends limiting the distribution of non-patient-specific sterile compounded drugs in hospitals and health systems based on the beyond-use date timeframes contained in USP Chapters 797 and 800. “This approach would limit the amount of a compounded drug that could be created and distributed without a prescription and would ensure its timely use,” AHA said. The association also supports FDA’s proposals to limit the distribution of sterile drugs compounded in a hospital pharmacy prior to receipt of a patient-specific order to health care facilities owned and controlled by the same entity as the hospital pharmacy, and limit their administration to patients in those facilities pursuant to a specific prescription or order.