FDA is exploring representing SPL is FHIR and is developing a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. Currently, vendors submit their drug labels using the HL7 V3 SPL standard.   This Implementation guide provides details on how future submissions can be made using the FHIR specification.


 The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.  The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case.  Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project.

Project Status

  • ACTIVE  (Status Date: 10/2022)


FHIR Resources 

Last Updated: 10/2022

Along with the Medication Definition resources, this Implementation Guide also uses the Bundle, Composition and Organization resources.

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