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 “The AHA is concerned that the one-mile radius limitation [included in draft guidance last year] is not workable for many hospitals and health systems that have centralized their sterile compounding activities in a single location and distribute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.”

Related News Articles

Headline
Microsoft July 22 released an update on the ongoing cyberattacks to SharePoint servers used within organizations, attributing the incidents to China-based…
Headline
The FBI, Cybersecurity and Infrastructure Security Agency, Department of Health and Human Services, and Multi-State Information Sharing and Analysis Center…
Headline
Microsoft July 19 issued an alert about active attacks from vulnerabilities targeting SharePoint servers used within organizations. The incidents have not…
Headline
Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., July 19 visited AtlantiCare health system in New Jersey, making stops at its…
Headline
In his latest AHA Cyber and Risk Intel blog, Scott Gee, AHA deputy national advisor for cybersecurity and risk, explains how hospitals can prepare for and…
AHA Cyber Intel
In today’s heightened threat environment, driven by domestic and geopolitical issues, it is more critical than ever for hospitals to prepare for and mitigate…