503A Traditional Pharmacy

Compounds medications based on individual prescriptions. Requires a valid patient-specific prescription from a licensed provider. State-regulated. Cannot produce drugs in bulk without prescriptions.

503B Outsourcing Facility

FDA-registered facilities that can produce compounded drugs in larger quantities without patient-specific prescriptions. Subject to FDA oversight including cGMP requirements and regular inspections. Can supply directly to healthcare facilities.

503A pharmacies require a provider to write a prescription specifically for a patient, while 503B facilities supply hospitals and clinics that can then administer the compounded drug. 503B facilities face stricter federal oversight, which is generally considered an additional quality safeguard.

State
Pharmacy Type
Specialty

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