Hospital, Health System Drug Compounding Guidance

FDA has published a draft guidance, Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, describing how the agency will apply certain provisions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA) to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital or health system. The revised draft first addresses the requirement that compounding be based on the receipt of a valid prescription for an identified individual patient. It then addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product.

The guidance does not apply to human drug products compounded by outsourcing facilities under Section 503B of the FFDCA, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals.