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The AHA today submitted comments on the Food and Drug Administration’s revised draft guidance on hospital and health system compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. 
 
“We are pleased that the FDA has responded to concerns voiced by the AHA and its members regarding the one-mile radius policy and has determined that it no longer will take into consideration whether compounded drug products are distributed only to health care facilities that are located within a one-mile radius of the compounding pharmacy.” AHA wrote. 
  
While the association also voiced support for FDA’s intention to use its enforcement discretion under certain circumstances, it expressed “serious concerns about a component of this risk-based compliance policy that would require compounded drug products to be used or discarded within 24 hours of transfer out of the pharmacy,” adding “While we agree that that compounded products should be subject to reasonable limitations to ensure quality and safety, requiring compounded drug products to be administered or discarded within 24 hours of their transfer out of the pharmacy is inconsistent with the science-based standards of the United States Pharmacopeia (USP); furthermore, such a policy is wasteful and will exacerbate drug shortages.” The association instead recommends that FDA allow hospitals and health systems to use the established beyond-use date timeframes that comply with the USP Chapters 797 and 795. 

If FDA declines to replace the 24-hour limitation with the BUD timeframes, “At the very least, to avoid the possible delays in access to critical compounded products … we urge the FDA to consider [automated dispensing cabinets] and Pyxis machines to be part of the compounding pharmacy and therefore not subject to the 24-hour limitation,” AHA said.