FDA Draft Guidance Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

Published: 10/08/2021

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is revising their draft guidance, Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry, to, among other things, remove the one-mile radius provision. The agency is now proposing a two-part compliance policy. The policy describes circumstances under which the agency generally does not intend to take action against a hospital or health system pharmacy, that is not an outsourcing facil

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