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In comments on the Food and Drug Administration (FDA)’s draft guidance on hospital and health system compounding, Premier supports permanently abandoning the arbitrary geographical limitation known as the “one-mile radius”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Premier remains concerned about provisions of the draft guidance that conflict with United States Pharmacopeia (USP) provisions and may lead to increased waste, shortages, and costs, including: