CHA has submitted comments to the Food and Drug Administration (FDA) on its revised draft guidance on hospital and health system compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act.
In the letter, CHA applauds the agency for revising its earlier 2016 draft guidance to eliminate the previously proposed policy that would have established a one-mile radius requirement as criteria for medication distribution by a hospital or health system. CHA previously advocated for the removal of this policy.
CHA raises concerns about the proposed policy that would require compounded drug products to be administered or discarded within 24 hours of transfer out of the pharmacy, which does not align with the beyond use dates for sterile compounded drug products established by the United States Pharmacopeia.
Additionally, CHA prepared a grid with specific recommendations for revisions to the language included in the FDA’s draft guidance.
CHA thanks members for their input, which helped inform comments.