Premier Recommends Compounding Reforms to Prevent Drug Shortages

In comments on the Food and Drug Administration (FDA)’s draft guidance on hospital and health system compounding, Premier supports permanently abandoning the arbitrary geographical limitation known as the “one-mile radius” provision for hospital compounding. This waiver allows hospitals to consolidate pharmacy services into a single hub to preserve personal protective equipment, maximize use of available pharmacy staff and avoid compounding at the patient bedside which can lead to increased rates of medication errors. Moving forward, Premier recommends that the FDA adopt a time-based standard rooted in scientific evidence for sterility and stability of the compounded product.

Premier remains concerned about provisions of the draft guidance that conflict with United States Pharmacopeia (USP) provisions and may lead to increased waste, shortages, and costs, including:

• The requirement that compounded drugs be used or discarded within 24 hours of transfer out of the pharmacy. In lieu of introducing a new arbitrary standard, Premier urges the FDA to defer to time-based standards, specifically USP or the FDA- approved manufacturer labeling, that are rooted in scientific evidence for sterility and stability of the compounded product.
• Local enforcement of federal policy that could lead to various interpretations of the guidance. To create consistency in enforcement of the guidance at the local level, Premier urges the FDA to issue enforcement guidance to state Boards of Pharmacy and other local governing bodies.
• The discrepancy in the definition of compounding utilized by FDA and USP. Premier urges the FDA to work with USP to ensure consistency in definitions, standards, and requirements for compounding to minimize confusion at the patient-care level.