What Is a Section 503A Compounding Pharmacy?
Medical information: This website provides general educational information, not medical advice. Prescription decisions belong to a licensed healthcare professional. Compounded drugs are not FDA-approved.
Section 503A of the Federal Food, Drug, and Cosmetic Act describes conditions under which qualifying drug compounding by a licensed pharmacist or physician can receive exemptions from certain federal requirements. A pharmacy being state-licensed or operating under Section 503A does not make its compounded drugs FDA-approved.
Keep the product identity clear
Do not assume instructions for one brand, compounded formulation, concentration or delivery device apply to another. When in doubt, contact the prescribing clinician or dispensing pharmacy.