Section 503A of the U.S. Federal Food, Drug, and Cosmetic Act governs traditional compounding pharmacies that dispense patient-specific prescriptions of compounded drugs.
A 503A pharmacy holds a state pharmacy license. It compounds drugs for identified individual patients pursuant to valid prescriptions from licensed practitioners. The framework imposes specific obligations: patient-specific prescription, identifiable patient, USP <797> or <795> compliance for the compounding process, and state board recordkeeping for sourcing and dispensing.
APIs purchased by a 503A pharmacy are incorporated into compounded preparations under a prescription; they are not dispensed in their original form. The finished compounded drug is the regulated product. The API is one of its starting materials.
The second of two buyer categories at US Peptide Clinic. We supply active pharmaceutical ingredients to licensed 503A pharmacies. We do not compound, dispense, or assume any responsibility for the finished compounded preparation. The pharmacy retains every obligation under USP and state law.