meto
Pharmacy & Regulation

503A Pharmacy

A US compounding pharmacy that prepares medications for individual patients based on a specific prescription.

Definition

A 503A pharmacy is a traditional state-licensed pharmacy regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act. It compounds medications for individual named patients in response to a valid prescription. Each 503A pharmacy must be licensed by its state board of pharmacy and is inspected by the FDA for compliance with USP 795 and USP 797 standards. Meto exclusively works with 503A pharmacies — every Rx is patient-specific, prescription-driven, and dispensed by a state-licensed compounder.

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