FDA Releases Final Guidance on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Summary

The Food and Drug Administration (FDA) has released a guidance document outlining its approach to regulating pharmacies that compound human drugs, following amendments to the Federal Food, Drug, and Cosmetic Act by the Drug Quality and Security Act. The guidance aims to clarify the FDA's stance on enforcing the FD&C Act for these entities.