AHA recommends FDA actions to ease regulation, improve device security

AHA again urged the Food and Drug Administration today to allow health system pharmacies to distribute compounded products to other system facilities located more than one mile away. “The AHA is concerned that the one-mile radius limitation [included in draft guidance last year] is not workable for many hospitals and health systems that have centralized their sterile compounding activities in a single location and distribute compounded products to their other system facilities located more than one mile away,” wrote Ashley Thompson, AHA senior vice president for public policy analysis and development, responding to the agency’s request for information on regulatory flexibilities and efficiencies. Instead of the one-mile limit, AHA recommends that the agency allow hospitals and health systems to use the beyond-use date timeframes contained in United States Pharmacopoeia Chapters 797 and 800. AHA also recommended greater FDA oversight of medical device cybersecurity. “We recommend that the FDA proactively set clear measurable expectations for manufacturers before incidents and play a more active role during cybersecurity attacks.”