Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.