In PQ/CMC project, we have 2 levels of Ingredient Roles or functions

Ingredient Function Category – A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active, Inactive, etc.  This is a coded list.  We have mapped this to Ingredient.role and therefore supported in FHIR.

Ingredient Function - A classification of components identifying its purpose/role in the drug product. [Source: SME Defined]  Example: Antioxidant, Alkalizing Agent, etc.

FDA plans to use the following coded list for this ingredient function element – https://www.medicinescomplete.com/mc/excipients/current/239884.htm       

Request a new element in Ingredient Resource - Ingredient.function to support ingredient function. Its a CodeableConcept and 1..*.  See definition above.