Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance''). This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State- licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This draft guidance revises the draft guidance issued in 2016 entitled, ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time.