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15.8 Resource Ingredient - Content

Biomedical Research and Regulation icon

Work Group

Maturity Level: 2

Trial Use

Security Category: Anonymous

Compartments: No defined compartments

An ingredient of a manufactured item or pharmaceutical product.

15.8.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

A material used in the preparation of a medicinal/pharmaceutical product, within the context of a particular use or role.

An ingredient is part of a product, either alone or in combination with other ingredients. It is essentially a substance with the addition of the specific role it is playing in the product, or in preparation of the product which may include whether it is an active or inactive substance and what the strength is (the quantity of substance compared to the whole product). The ingredient is represented in the context of a given product, because its role and strength are a function of what it is used in/for. It is expected that the same substance used in a different role, or with a different strength, would be a different Ingredient resource instance. Resource instances may however be shared by very similar products (e.g. different pack sizes of the same "product").

Some other resources, such as Medication and Substance allow specifying a basic ingredient representation. When more detail is needed such as for manufacturing or regulatory use, use the Ingredient resource.

Ingredient is represented as a resource, instead of, for example, a backbone or a datatype within other resources, due to some practical considerations for certain use cases. In some situations, an ingredient could have been represented "in line" within another resource (e.g. embedded within MedicinalProductDefiniton or ManufacturedItemDefinition). However there are cases where it is necessary to refer to an ingredient from another resource - for example when the ingredient associated with a product also has an authorization, or when a multi-part tablet needs to state which ingredient is contained in which component of that tablet (as well as linking the ingredient to the whole tablet and/or the whole product). These cases can only be served by representing the ingredient as an externally referenceable entity, that can be linked from other resources, hence the rationale for Ingredient being a resource in its own right. If such cases are not in scope of a given project, and it is preferred to avoid ingredient being a separate resource, then there is the option for that project to represent an ingredient using a contained Ingredient resource. Even simpler situations, where only a coded or free text ingredient is necessary, can use attributes such as MedicinalProductDefinition.ingredient.

15.8.2 References to this Resource

Resource References: ActivityDefinition, ManufacturedItemDefinition and RegulatedAuthorization

15.8.3 Resource Content

Structure

Name	Flags	Card.	Type	Description & Constraints
Ingredient	TU		DomainResource	An ingredient of a manufactured item or pharmaceutical product + Rule: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft \| active \| retired \| unknown Binding: PublicationStatus (Required)
for	Σ	0..*	Reference(MedicinalProductDefinition \| AdministrableProductDefinition \| ManufacturedItemDefinition)	The product which this ingredient is a constituent part of
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Ingredient Role (Example)
function	Σ	0..*	CodeableConcept	Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: Ingredient Function (Example)
group	Σ	0..1	CodeableConcept	A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator	Σ C	0..1	boolean	If the ingredient is a known or suspected allergen
comment		0..1	markdown	A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
role	Σ	0..1	code	allowed \| possible \| actual Binding: Ingredient Manufacturer Role (Required)
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	Σ C	1..1	BackboneElement	The substance that comprises this ingredient
code	Σ C	1..1	CodeableReference(SubstanceDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMED CT Substance Codes (Example)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
textPresentation	Σ	0..1	string	Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
concentration[x]	Σ	0..1		The strength per unitary volume (or mass)
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
textConcentration	Σ	0..1	string	Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
basis	Σ	0..1	CodeableConcept	A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: Country ValueSet (Example)
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMED CT Substance Codes (Example)
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: Country ValueSet (Example)
Documentation for this format

See the Extensions for this resource

XML Template

<Ingredient xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier An identifier or code by which the ingredient can be referenced --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <for><!-- 0..* Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) The product which this ingredient is a constituent part of --></for>
 <role><!-- 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive --></role>
 <function><!-- 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent --></function>
 <group><!-- 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink --></group>
 <allergenicIndicator value="[boolean]"/><!-- I 0..1 If the ingredient is a known or suspected allergen -->
 <comment value="[markdown]"/><!-- 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying -->
 <manufacturer>  <!-- 0..* An organization that manufactures this ingredient -->
  <role value="[code]"/><!-- 0..1 allowed | possible | actual -->
  <manufacturer><!-- 1..1 Reference(Organization) An organization that manufactures this ingredient --></manufacturer>
 </manufacturer>
 <substance>  <!-- I 1..1 The substance that comprises this ingredient -->
  <code><!-- I 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance --></code>
  <strength>  <!-- 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity -->
   <presentation[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The quantity of substance in the unit of presentation --></presentation[x]>
   <textPresentation value="[string]"/><!-- 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) -->
   <concentration[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The strength per unitary volume (or mass) --></concentration[x]>
   <textConcentration value="[string]"/><!-- 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) -->
   <basis><!-- 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) --></basis>
   <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
   <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   <referenceStrength>  <!-- 0..* Strength expressed in terms of a reference substance -->
    <substance><!-- 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance --></substance>
    <strength[x]><!-- 1..1 Ratio|RatioRange|Quantity Strength expressed in terms of a reference substance --></strength[x]>
    <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
    <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   </referenceStrength>
  </strength>
 </substance>
</Ingredient>

JSON Template

{
  "resourceType" : "Ingredient",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
  "status" : "<code>", // R!  draft | active | retired | unknown
  "for" : [{ Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
  "role" : { CodeableConcept }, // R!  Purpose of the ingredient within the product, e.g. active, inactive
  "function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
  "group" : { CodeableConcept }, // A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
  "allergenicIndicator" : <boolean>, // I If the ingredient is a known or suspected allergen
  "comment" : "<markdown>", // A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  "manufacturer" : [{ // An organization that manufactures this ingredient
    "role" : "<code>", // allowed | possible | actual
    "manufacturer" : { Reference(Organization) } // R!  An organization that manufactures this ingredient
  }],
  "substance" : { // I R!  The substance that comprises this ingredient
    "code" : { CodeableReference(SubstanceDefinition) }, // I R!  A code or full resource that represents the ingredient substance
    "strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
      // presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
      "presentationRatio" : { Ratio },
      "presentationRatioRange" : { RatioRange },
      "presentationCodeableConcept" : { CodeableConcept },
      "presentationQuantity" : { Quantity },
      "textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      // concentration[x]: The strength per unitary volume (or mass). One of these 4:
      "concentrationRatio" : { Ratio },
      "concentrationRatioRange" : { RatioRange },
      "concentrationCodeableConcept" : { CodeableConcept },
      "concentrationQuantity" : { Quantity },
      "textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      "basis" : { CodeableConcept }, // A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
      "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
      "country" : [{ CodeableConcept }], // Where the strength range applies
      "referenceStrength" : [{ // Strength expressed in terms of a reference substance
        "substance" : { CodeableReference(SubstanceDefinition) }, // R!  Relevant reference substance
        // strength[x]: Strength expressed in terms of a reference substance. One of these 3:
        "strengthRatio" : { Ratio },
        "strengthRatioRange" : { RatioRange },
        "strengthQuantity" : { Quantity },
        "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
        "country" : [{ CodeableConcept }] // Where the strength range applies
      }]
    }]
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Ingredient;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier [ Identifier ] ; # 0..1 An identifier or code by which the ingredient can be referenced
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:for  ( [ Reference(AdministrableProductDefinition|ManufacturedItemDefinition|
  MedicinalProductDefinition) ] ... ) ; # 0..* The product which this ingredient is a constituent part of
  fhir:role [ CodeableConcept ] ; # 1..1 Purpose of the ingredient within the product, e.g. active, inactive
  fhir:function  ( [ CodeableConcept ] ... ) ; # 0..* Precise action within the drug product, e.g. antioxidant, alkalizing agent
  fhir:group [ CodeableConcept ] ; # 0..1 A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
  fhir:allergenicIndicator [ boolean ] ; # 0..1 I If the ingredient is a known or suspected allergen
  fhir:comment [ markdown ] ; # 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  fhir:manufacturer ( [ # 0..* An organization that manufactures this ingredient
    fhir:role [ code ] ; # 0..1 allowed | possible | actual
    fhir:manufacturer [ Reference(Organization) ] ; # 1..1 An organization that manufactures this ingredient
  ] ... ) ;
  fhir:substance [ # 1..1 I The substance that comprises this ingredient
    fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 I A code or full resource that represents the ingredient substance
    fhir:strength ( [ # 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity
      # presentation[x] : 0..1 The quantity of substance in the unit of presentation. One of these 4
        fhir:presentation [  a fhir:Ratio ; Ratio ]
        fhir:presentation [  a fhir:RatioRange ; RatioRange ]
        fhir:presentation [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:presentation [  a fhir:Quantity ; Quantity ]
      fhir:textPresentation [ string ] ; # 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      # concentration[x] : 0..1 The strength per unitary volume (or mass). One of these 4
        fhir:concentration [  a fhir:Ratio ; Ratio ]
        fhir:concentration [  a fhir:RatioRange ; RatioRange ]
        fhir:concentration [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:concentration [  a fhir:Quantity ; Quantity ]
      fhir:textConcentration [ string ] ; # 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      fhir:basis [ CodeableConcept ] ; # 0..1 A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
      fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
      fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      fhir:referenceStrength ( [ # 0..* Strength expressed in terms of a reference substance
        fhir:substance [ CodeableReference(SubstanceDefinition) ] ; # 1..1 Relevant reference substance
        # strength[x] : 1..1 Strength expressed in terms of a reference substance. One of these 3
          fhir:strength [  a fhir:Ratio ; Ratio ]
          fhir:strength [  a fhir:RatioRange ; RatioRange ]
          fhir:strength [  a fhir:Quantity ; Quantity ]
        fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
        fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      ] ... ) ;
    ] ... ) ;
  ] ;
]

Structure

Name	Flags	Card.	Type	Description & Constraints
Ingredient	TU		DomainResource	An ingredient of a manufactured item or pharmaceutical product + Rule: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..1	Identifier	An identifier or code by which the ingredient can be referenced
status	?!Σ	1..1	code	draft \| active \| retired \| unknown Binding: PublicationStatus (Required)
for	Σ	0..*	Reference(MedicinalProductDefinition \| AdministrableProductDefinition \| ManufacturedItemDefinition)	The product which this ingredient is a constituent part of
role	Σ	1..1	CodeableConcept	Purpose of the ingredient within the product, e.g. active, inactive Binding: Ingredient Role (Example)
function	Σ	0..*	CodeableConcept	Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: Ingredient Function (Example)
group	Σ	0..1	CodeableConcept	A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
allergenicIndicator	Σ C	0..1	boolean	If the ingredient is a known or suspected allergen
comment		0..1	markdown	A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
manufacturer	Σ	0..*	BackboneElement	An organization that manufactures this ingredient
role	Σ	0..1	code	allowed \| possible \| actual Binding: Ingredient Manufacturer Role (Required)
manufacturer	Σ	1..1	Reference(Organization)	An organization that manufactures this ingredient
substance	Σ C	1..1	BackboneElement	The substance that comprises this ingredient
code	Σ C	1..1	CodeableReference(SubstanceDefinition)	A code or full resource that represents the ingredient substance Binding: SNOMED CT Substance Codes (Example)
strength	Σ	0..*	BackboneElement	The quantity of substance, per presentation, or per volume or mass, and type of quantity
presentation[x]	Σ	0..1		The quantity of substance in the unit of presentation
presentationRatio			Ratio
presentationRatioRange			RatioRange
presentationCodeableConcept			CodeableConcept
presentationQuantity			Quantity
textPresentation	Σ	0..1	string	Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
concentration[x]	Σ	0..1		The strength per unitary volume (or mass)
concentrationRatio			Ratio
concentrationRatioRange			RatioRange
concentrationCodeableConcept			CodeableConcept
concentrationQuantity			Quantity
textConcentration	Σ	0..1	string	Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
basis	Σ	0..1	CodeableConcept	A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: Country ValueSet (Example)
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
substance	Σ	1..1	CodeableReference(SubstanceDefinition)	Relevant reference substance Binding: SNOMED CT Substance Codes (Example)
strength[x]	Σ	1..1		Strength expressed in terms of a reference substance
strengthRatio			Ratio
strengthRatioRange			RatioRange
strengthQuantity			Quantity
measurementPoint	Σ	0..1	string	When strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	Where the strength range applies Binding: Country ValueSet (Example)
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<Ingredient xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier An identifier or code by which the ingredient can be referenced --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <for><!-- 0..* Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) The product which this ingredient is a constituent part of --></for>
 <role><!-- 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive --></role>
 <function><!-- 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent --></function>
 <group><!-- 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink --></group>
 <allergenicIndicator value="[boolean]"/><!-- I 0..1 If the ingredient is a known or suspected allergen -->
 <comment value="[markdown]"/><!-- 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying -->
 <manufacturer>  <!-- 0..* An organization that manufactures this ingredient -->
  <role value="[code]"/><!-- 0..1 allowed | possible | actual -->
  <manufacturer><!-- 1..1 Reference(Organization) An organization that manufactures this ingredient --></manufacturer>
 </manufacturer>
 <substance>  <!-- I 1..1 The substance that comprises this ingredient -->
  <code><!-- I 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance --></code>
  <strength>  <!-- 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity -->
   <presentation[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The quantity of substance in the unit of presentation --></presentation[x]>
   <textPresentation value="[string]"/><!-- 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) -->
   <concentration[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The strength per unitary volume (or mass) --></concentration[x]>
   <textConcentration value="[string]"/><!-- 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) -->
   <basis><!-- 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) --></basis>
   <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
   <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   <referenceStrength>  <!-- 0..* Strength expressed in terms of a reference substance -->
    <substance><!-- 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance --></substance>
    <strength[x]><!-- 1..1 Ratio|RatioRange|Quantity Strength expressed in terms of a reference substance --></strength[x]>
    <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
    <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   </referenceStrength>
  </strength>
 </substance>
</Ingredient>

JSON Template

{
  "resourceType" : "Ingredient",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
  "status" : "<code>", // R!  draft | active | retired | unknown
  "for" : [{ Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
  "role" : { CodeableConcept }, // R!  Purpose of the ingredient within the product, e.g. active, inactive
  "function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
  "group" : { CodeableConcept }, // A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
  "allergenicIndicator" : <boolean>, // I If the ingredient is a known or suspected allergen
  "comment" : "<markdown>", // A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  "manufacturer" : [{ // An organization that manufactures this ingredient
    "role" : "<code>", // allowed | possible | actual
    "manufacturer" : { Reference(Organization) } // R!  An organization that manufactures this ingredient
  }],
  "substance" : { // I R!  The substance that comprises this ingredient
    "code" : { CodeableReference(SubstanceDefinition) }, // I R!  A code or full resource that represents the ingredient substance
    "strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
      // presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
      "presentationRatio" : { Ratio },
      "presentationRatioRange" : { RatioRange },
      "presentationCodeableConcept" : { CodeableConcept },
      "presentationQuantity" : { Quantity },
      "textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      // concentration[x]: The strength per unitary volume (or mass). One of these 4:
      "concentrationRatio" : { Ratio },
      "concentrationRatioRange" : { RatioRange },
      "concentrationCodeableConcept" : { CodeableConcept },
      "concentrationQuantity" : { Quantity },
      "textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      "basis" : { CodeableConcept }, // A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
      "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
      "country" : [{ CodeableConcept }], // Where the strength range applies
      "referenceStrength" : [{ // Strength expressed in terms of a reference substance
        "substance" : { CodeableReference(SubstanceDefinition) }, // R!  Relevant reference substance
        // strength[x]: Strength expressed in terms of a reference substance. One of these 3:
        "strengthRatio" : { Ratio },
        "strengthRatioRange" : { RatioRange },
        "strengthQuantity" : { Quantity },
        "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
        "country" : [{ CodeableConcept }] // Where the strength range applies
      }]
    }]
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Ingredient;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier [ Identifier ] ; # 0..1 An identifier or code by which the ingredient can be referenced
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:for  ( [ Reference(AdministrableProductDefinition|ManufacturedItemDefinition|
  MedicinalProductDefinition) ] ... ) ; # 0..* The product which this ingredient is a constituent part of
  fhir:role [ CodeableConcept ] ; # 1..1 Purpose of the ingredient within the product, e.g. active, inactive
  fhir:function  ( [ CodeableConcept ] ... ) ; # 0..* Precise action within the drug product, e.g. antioxidant, alkalizing agent
  fhir:group [ CodeableConcept ] ; # 0..1 A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
  fhir:allergenicIndicator [ boolean ] ; # 0..1 I If the ingredient is a known or suspected allergen
  fhir:comment [ markdown ] ; # 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  fhir:manufacturer ( [ # 0..* An organization that manufactures this ingredient
    fhir:role [ code ] ; # 0..1 allowed | possible | actual
    fhir:manufacturer [ Reference(Organization) ] ; # 1..1 An organization that manufactures this ingredient
  ] ... ) ;
  fhir:substance [ # 1..1 I The substance that comprises this ingredient
    fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 I A code or full resource that represents the ingredient substance
    fhir:strength ( [ # 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity
      # presentation[x] : 0..1 The quantity of substance in the unit of presentation. One of these 4
        fhir:presentation [  a fhir:Ratio ; Ratio ]
        fhir:presentation [  a fhir:RatioRange ; RatioRange ]
        fhir:presentation [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:presentation [  a fhir:Quantity ; Quantity ]
      fhir:textPresentation [ string ] ; # 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      # concentration[x] : 0..1 The strength per unitary volume (or mass). One of these 4
        fhir:concentration [  a fhir:Ratio ; Ratio ]
        fhir:concentration [  a fhir:RatioRange ; RatioRange ]
        fhir:concentration [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:concentration [  a fhir:Quantity ; Quantity ]
      fhir:textConcentration [ string ] ; # 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      fhir:basis [ CodeableConcept ] ; # 0..1 A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
      fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
      fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      fhir:referenceStrength ( [ # 0..* Strength expressed in terms of a reference substance
        fhir:substance [ CodeableReference(SubstanceDefinition) ] ; # 1..1 Relevant reference substance
        # strength[x] : 1..1 Strength expressed in terms of a reference substance. One of these 3
          fhir:strength [  a fhir:Ratio ; Ratio ]
          fhir:strength [  a fhir:RatioRange ; RatioRange ]
          fhir:strength [  a fhir:Quantity ; Quantity ]
        fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
        fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      ] ... ) ;
    ] ... ) ;
  ] ;
]

Changes from both R4 and R4B

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.8.3.1 Terminology Bindings

Path	ValueSet	Type	Documentation
Ingredient.status	PublicationStatus	Required	The lifecycle status of an artifact.
Ingredient.role	IngredientRole	Example	A classification of the ingredient identifying its purpose within the product.
Ingredient.function	IngredientFunction	Example	A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
Ingredient.manufacturer.role	IngredientManufacturerRole	Required	The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.
Ingredient.substance.code	SNOMEDCTSubstanceCodes	Example	This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Ingredient.substance.strength.country	CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code )	Example	This value set defines a base set of codes for countries. Note: The codes for countries are taken from ISO 3166 .
Ingredient.substance.strength.referenceStrength.substance	SNOMEDCTSubstanceCodes	Example	This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Ingredient.substance.strength.referenceStrength.country	CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code )	Example	This value set defines a base set of codes for countries. Note: The codes for countries are taken from ISO 3166 .

Path

ValueSet

Type

Documentation

Ingredient.status

PublicationStatus

Required

The lifecycle status of an artifact.

Ingredient.role

IngredientRole

Example

A classification of the ingredient identifying its purpose within the product.

Ingredient.function

IngredientFunction

Example

A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).

Ingredient.manufacturer.role

IngredientManufacturerRole

Required

The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.

Ingredient.substance.code

SNOMEDCTSubstanceCodes

Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

Ingredient.substance.strength.country

CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon

)

Example

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon .

Ingredient.substance.strength.referenceStrength.substance

SNOMEDCTSubstanceCodes

Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

Ingredient.substance.strength.referenceStrength.country

CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon

)

Example

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon .

15.8.3.2 Constraints

UniqueKey

Level

Location

Description

Expression

ing-1

Rule

(base)

If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource

Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

15.8.4 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
for	reference	The product which this ingredient is a constituent part of	Ingredient.for (AdministrableProductDefinition, ManufacturedItemDefinition, MedicinalProductDefinition)
function	token	A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: Antioxidant, Alkalizing Agent	Ingredient.function
identifier	token	An identifier or code by which the ingredient can be referenced	Ingredient.identifier
manufacturer	reference	The organization that manufactures this ingredient	Ingredient.manufacturer.manufacturer
role	token	A classification of the ingredient identifying its purpose within the product, e.g. active, inactive	Ingredient.role
status	token	The status of this ingredient. Enables tracking the life-cycle of the content	Ingredient.status
strength-concentration-denominator	quantity	Ingredient concentration strength denominator (mainly for use in strength-concentration-ratio)	Ingredient.substance.strength.concentration.ofType(Ratio).denominator
strength-concentration-numerator	quantity	Ingredient concentration strength numerator (mainly for use in strength-concentration-ratio)	Ingredient.substance.strength.concentration.ofType(Ratio).numerator
strength-concentration-quantity	quantity	Ingredient concentration strength as quantity	Ingredient.substance.strength.concentration.ofType(Quantity)
strength-concentration-ratio	composite	Ingredient concentration strength as ratio, numerator and denominator parameter pair	On Ingredient.substance.strength.concentration.ofType(Ratio): numerator: strength-concentration-numerator denominator: strength-concentration-denominator
strength-presentation-denominator	quantity	Ingredient presentation strength denominator (mainly for use in strength-presentation-ratio)	Ingredient.substance.strength.presentation.ofType(Ratio).denominator
strength-presentation-numerator	quantity	Ingredient presentation strength numerator (mainly for use in strength-presentation-ratio)	Ingredient.substance.strength.presentation.ofType(Ratio).numerator
strength-presentation-quantity	quantity	Ingredient presentation strength as quantity	Ingredient.substance.strength.presentation.ofType(Quantity)
strength-presentation-ratio	composite	Ingredient presentation strength as ratio, numerator and denominator parameter pair	On Ingredient.substance.strength.presentation.ofType(Ratio): numerator: strength-presentation-numerator denominator: strength-presentation-denominator
substance	reference	Reference to a resource (by instance)	Ingredient.substance.code.reference
substance-code	token	Reference to a concept (by class)	Ingredient.substance.code.concept
substance-definition	reference	Reference to a resource (by instance)	Ingredient.substance.code.reference