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

Issue Date: December 29, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Compounding
Status: Final

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

This guidance sets forth the 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 (FD&C Act or Act).

Download the Guidance Document