LicensureType
How FDA licensed a biological product, from the Purple Book. Only products licensed under a BLA carry one.
- Values
- 3
- Schemas
- v3
- Referenced by
- POST /v3/{environment}/healthcare/hcp/{aggkHcpId}/prescriptions
- STANDALONELicensed on its own data under section 351(a). Reference products are standalone.
- BIOSIMILARLicensed under section 351(k) as highly similar to a reference product.
- INTERCHANGEABLEA biosimilar FDA has also found interchangeable, so a pharmacist may substitute it for the reference product without the prescriber. Set only where every presentation of the product is interchangeable.