503A and 503B side by side
| Question | 503A pharmacy | 503B outsourcing facility |
|---|---|---|
| Law | FD&C Act section 503A | FD&C Act section 503B, added by the Drug Quality and Security Act of 2013 |
| Prescription | Valid and patient-specific | Patient-specific prescription, or an order from a healthcare provider |
| CGMP | Exempt | Required |
| Main overseer | State board of pharmacy, with FDA surveillance and for-cause inspections | FDA, on a risk-based inspection schedule |
| Status | State-licensed pharmacy or physician | Voluntary category that reports adverse events and product information to FDA |
| FDA-approved product? | No | No |
| Typical customer | An individual patient | Hospitals, clinics and practices buying office stock |
Which is safer, 503A or 503B?
Neither label answers that on its own. A 503B facility works to CGMP and FDA describes it as subject to increased quality standards. A 503A pharmacy works to state pharmacy rules and USP compounding chapters. FDA verifies the safety, effectiveness and quality of neither product before marketing, so check the specific pharmacy: its licenses, inspection history and testing.
Can a 503A pharmacy supply office stock?
Generally no. FDA says a prescription for office use does not meet the patient-specific requirement in section 503A. Where state law allows them, outsourcing facilities can fill orders from a healthcare provider.
Which model fits direct-to-patient telehealth?
503A, in most cases. A telehealth order starts with one patient, one prescriber and one prescription, and that is the shape section 503A was written around. A 503B facility’s advantage, supply without a patient-specific prescription, gives a direct-to-patient brand little it can use.
Does SourceRX work with 503B?
SourceRX storefronts run on the 503A model: every compounded order resolves to a recorded, patient-specific prescription before it can be filled. There is no 503B storefront type, because a gate built around naming a patient would produce a record that looks like compliance for an order that does not need one. See how the controls work.
Sources
General information, not legal or medical advice. Rules vary by state and change over time, so have healthcare counsel review your plans.