Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: DrugProductComponent - Detailed Descriptions

Active as of 2024-04-04

Definitions for the pqcmc-component resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Ingredient
2. Ingredient.meta
4. Ingredient.meta.profile
Control1..1
Must Supporttrue
6. Ingredient.extension
SlicingThis element introduces a set of slices on Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Ingredient.extension:additional-info
    Slice Nameadditional-info
    Definition

    A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc.

    ShortDrug Product Component Additional Information
    Control0..1
    TypeExtension(Additional Information) (Extension Type: markdown)
    Must Supporttrue
    10. Ingredient.for
    ShortReference to MedicinalProductDefinition
    12. Ingredient.role
    BindingThe codes SHALL be taken from Drug Product Component Function Category Terminology
    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology)
    14. Ingredient.substance
    Invariantscmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ))
    16. Ingredient.substance.code
    ShortIngredient Substance
    TypeCodeableReference(Component Substance)
    Must Supporttrue
    18. Ingredient.substance.strength
    Control1..1
    Must Supporttrue
    20. Ingredient.substance.strength.extension
    Control1..?
    SlicingThis element introduces a set of slices on Ingredient.substance.strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 22. Ingredient.substance.strength.extension:strengthFactors
      Slice NamestrengthFactors
      Control1..1
      TypeExtension(Strength Extension) (Complex Extension)
      Must Supporttrue
      24. Ingredient.substance.strength.presentation[x]
      Control1..?
      TypeChoice of: Ratio, Quantity, RatioRange, CodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 26. Ingredient.substance.strength.presentation[x]:presentationRatio
        Slice NamepresentationRatio
        Control0..1
        TypeRatio
        [x] NoteSee Choice of Data Types for further information about how to use [x]
        Must Supporttrue
        28. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator
        Control1..?
        Must Supporttrue
        30. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.value
        Definition

        Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325

        ShortProduct Ingredient Amount Numeric Numerator
        Control1..?
        Must Supporttrue
        32. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.unit
        Definition

        The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg

        ShortProduct Ingredient Amount Numeric Numerator UOM
        Control1..?
        Must Supporttrue
        34. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code
        Control1..?
        BindingThe codes SHALL be taken from Units Of Measure Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
        Must Supporttrue
        36. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator
        Control1..?
        Must Supporttrue
        38. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.value
        Definition

        Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

        ShortProduct Ingredient Amount Numeric Denominator
        Control1..?
        Must Supporttrue
        40. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.unit
        Control1..?
        Must Supporttrue
        42. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code
        Control1..?
        BindingThe codes SHALL be taken from Units Of Measure Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
        Must Supporttrue
        44. Ingredient.substance.strength.presentation[x]:presentationQuantity
        Slice NamepresentationQuantity
        Control0..1
        TypeQuantity
        [x] NoteSee Choice of Data Types for further information about how to use [x]
        Must Supporttrue
        46. Ingredient.substance.strength.presentation[x]:presentationQuantity.value
        Definition

        TSpecifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325

        ShortProduct Ingredient Amount Numeric
        Control1..?
        Must Supporttrue
        48. Ingredient.substance.strength.presentation[x]:presentationQuantity.unit
        Control1..?
        50. Ingredient.substance.strength.presentation[x]:presentationQuantity.code
        Control1..?
        BindingThe codes SHALL be taken from Units Of Measure Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
        52. Ingredient.substance.strength.textPresentation
        Definition

        A written description of the strength of the ingredient. [Source: SME Defined]

        ShortStrength Textual
        Control1..?
        Must Supporttrue

        Guidance on how to interpret the contents of this table can be found here

        0. Ingredient
        Definition

        An ingredient of a manufactured item or pharmaceutical product.

        ShortAn ingredient of a manufactured item or pharmaceutical product
        Control0..*
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        ing-1: 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)
        2. Ingredient.meta
        Definition

        The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

        ShortMetadata about the resource
        Control0..1
        TypeMeta
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        4. Ingredient.meta.profile
        Definition

        A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

        ShortProfiles this resource claims to conform to
        Comments

        It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

        Control10..1*
        Typecanonical(StructureDefinition)
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        6. Ingredient.implicitRules
        Definition

        A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

        ShortA set of rules under which this content was created
        Comments

        Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

        Control0..1
        Typeuri
        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        8. Ingredient.contained
        Definition

        These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

        ShortContained, inline Resources
        Comments

        This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

        Control0..*
        This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
        TypeResource
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Alternate Namesinline resources, anonymous resources, contained resources
        10. Ingredient.extension
        Definition

        An Extension


        May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortExtensionAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 12. Ingredient.extension:additional-info
          Slice Nameadditional-info
          Definition

          A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc.

          ShortDrug Product Component Additional Information
          Control0..1
          TypeExtension(Additional Information) (Extension Type: markdown)
          Is Modifierfalse
          Must Supporttrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          14. Ingredient.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Must Supportfalse
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          16. Ingredient.status
          Definition

          The status of this ingredient. Enables tracking the life-cycle of the content.

          Shortdraft | active | retired | unknown
          Comments

          Allows filtering of ingredient that are appropriate for use versus not.

          Control1..1
          BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
          (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

          The lifecycle status of an artifact.

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. Ingredient.for
          Definition

          The product which this ingredient is a constituent part of.

          ShortReference to MedicinalProductDefinitionThe product which this ingredient is a constituent part of
          Control0..*
          TypeReference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. Ingredient.role
          Definition

          A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

          ShortPurpose of the ingredient within the product, e.g. active, inactive
          Control1..1
          BindingThe codes SHALL be taken from For example codes, see Drug Product Component Function Category Terminologyhttp://hl7.org/fhir/ValueSet/ingredient-role
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. Ingredient.substance
          Definition

          The substance that comprises this ingredient.

          ShortThe substance that comprises this ingredient
          Control1..1
          This element is affected by the following invariants: ing-1
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ))
          24. Ingredient.substance.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          26. Ingredient.substance.code
          Definition

          A code or full resource that represents the ingredient's substance.

          ShortIngredient SubstanceA code or full resource that represents the ingredient substance
          Control1..1
          This element is affected by the following invariants: ing-1
          BindingFor example codes, see SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes
          (example to http://hl7.org/fhir/ValueSet/substance-codes)

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

          TypeCodeableReference(Component Substance, SubstanceDefinition)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Ingredient.substance.strength
          Definition

          The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.

          ShortThe quantity of substance, per presentation, or per volume or mass, and type of quantity
          Control10..1*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Ingredient.substance.strength.extension
          Definition

          An Extension


          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortExtensionAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control10..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Ingredient.substance.strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 32. Ingredient.substance.strength.extension:strengthFactors
            Slice NamestrengthFactors
            Definition

            Values required in Ingredient.substance.strength

            ShortStrength Extension
            Control1..1
            TypeExtension(Strength Extension) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            34. Ingredient.substance.strength.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            36. Ingredient.substance.strength.presentation[x]
            Definition

            The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

            ShortThe quantity of substance in the unit of presentation
            Control10..1
            TypeChoice of: Ratio, Quantity, RatioRange, CodeableConcept
            [x] NoteSee Choice of Data Types for further information about how to use [x]
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesNo must-support rules about the choice of types/profiles
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 38. Ingredient.substance.strength.presentation[x]:presentationRatio
              Slice NamepresentationRatio
              Definition

              The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

              ShortThe quantity of substance in the unit of presentation
              Control0..1
              TypeRatio, RatioRange, Quantity, CodeableConcept
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              40. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator
              Definition

              The value of the numerator.

              ShortNumerator value
              Control10..1
              This element is affected by the following invariants: rat-1
              TypeQuantity
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.value
              Definition

              Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325


              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

              ShortProduct Ingredient Amount Numeric NumeratorNumerical value (with implicit precision)
              Comments

              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

              Control10..1
              Typedecimal
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Precision is handled implicitly in almost all cases of measurement.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.comparator
              Definition

              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > | ad - how to understand the value
              Control0..1
              BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              46. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.unit
              Definition

              The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg


              A human-readable form of the unit.

              ShortProduct Ingredient Amount Numeric Numerator UOMUnit representation
              Control10..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              48. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code
              Definition

              A computer processable form of the unit in some unit representation system.

              ShortCoded form of the unit
              Comments

              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

              Control10..1
              This element is affected by the following invariants: qty-3
              BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              50. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator
              Definition

              The value of the denominator.

              ShortDenominator value
              Control10..1
              This element is affected by the following invariants: rat-1
              TypeQuantity(SimpleQuantity)
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.value
              Definition

              Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1


              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

              ShortProduct Ingredient Amount Numeric DenominatorNumerical value (with implicit precision)
              Comments

              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

              Control10..1
              Typedecimal
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Precision is handled implicitly in almost all cases of measurement.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.comparator
              Definition

              Not allowed to be used in this context


              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > | ad - how to understand the value
              Control0..01
              BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.unit
              Definition

              A human-readable form of the unit.

              ShortUnit representation
              Control10..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              58. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code
              Definition

              A computer processable form of the unit in some unit representation system.

              ShortCoded form of the unit
              Comments

              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

              Control10..1
              This element is affected by the following invariants: qty-3
              BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              60. Ingredient.substance.strength.presentation[x]:presentationQuantity
              Slice NamepresentationQuantity
              Definition

              The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

              ShortThe quantity of substance in the unit of presentation
              Control0..1
              TypeQuantity, RatioRange, Ratio, CodeableConcept
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              62. Ingredient.substance.strength.presentation[x]:presentationQuantity.value
              Definition

              TSpecifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325


              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

              ShortProduct Ingredient Amount NumericNumerical value (with implicit precision)
              Comments

              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

              Control10..1
              Typedecimal
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              Precision is handled implicitly in almost all cases of measurement.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              64. Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator
              Definition

              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > | ad - how to understand the value
              Control0..1
              BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              66. Ingredient.substance.strength.presentation[x]:presentationQuantity.unit
              Definition

              A human-readable form of the unit.

              ShortUnit representation
              Control10..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. Ingredient.substance.strength.presentation[x]:presentationQuantity.code
              Definition

              A computer processable form of the unit in some unit representation system.

              ShortCoded form of the unit
              Comments

              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

              Control10..1
              This element is affected by the following invariants: qty-3
              BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. Ingredient.substance.strength.textPresentation
              Definition

              A written description of the strength of the ingredient. [Source: SME Defined]


              A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.

              ShortStrength TextualText of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
              Control10..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

              Guidance on how to interpret the contents of this table can be found here

              0. Ingredient
              Definition

              An ingredient of a manufactured item or pharmaceutical product.

              ShortAn ingredient of a manufactured item or pharmaceutical product
              Control0..*
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
              dom-6: A resource should have narrative for robust management (text.`div`.exists())
              ing-1: 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)
              2. Ingredient.id
              Definition

              The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

              ShortLogical id of this artifact
              Comments

              Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

              Control0..1
              Typeid
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              4. Ingredient.meta
              Definition

              The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

              ShortMetadata about the resource
              Control0..1
              TypeMeta
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              6. Ingredient.meta.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              8. Ingredient.meta.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Ingredient.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 10. Ingredient.meta.versionId
                Definition

                The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                ShortVersion specific identifier
                Comments

                The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                Control0..1
                Typeid
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                12. Ingredient.meta.lastUpdated
                Definition

                When the resource last changed - e.g. when the version changed.

                ShortWhen the resource version last changed
                Comments

                This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                Control0..1
                Typeinstant
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                14. Ingredient.meta.source
                Definition

                A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                ShortIdentifies where the resource comes from
                Comments

                The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

                This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                Control0..1
                Typeuri
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                16. Ingredient.meta.profile
                Definition

                A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                ShortProfiles this resource claims to conform to
                Comments

                It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                Control1..1
                Typecanonical(StructureDefinition)
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                18. Ingredient.meta.security
                Definition

                Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                ShortSecurity Labels applied to this resource
                Comments

                The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
                (extensible to http://hl7.org/fhir/ValueSet/security-labels)

                Security Labels from the Healthcare Privacy and Security Classification System.

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                20. Ingredient.meta.tag
                Definition

                Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                ShortTags applied to this resource
                Comments

                The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                Control0..*
                BindingFor example codes, see CommonTags
                (example to http://hl7.org/fhir/ValueSet/common-tags)

                Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                TypeCoding
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                22. Ingredient.implicitRules
                Definition

                A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                ShortA set of rules under which this content was created
                Comments

                Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

                Control0..1
                Typeuri
                Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                24. Ingredient.language
                Definition

                The base language in which the resource is written.

                ShortLanguage of the resource content
                Comments

                Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                Control0..1
                BindingThe codes SHALL be taken from AllLanguages
                (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                IETF language tag for a human language

                Typecode
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. Ingredient.text
                Definition

                A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                ShortText summary of the resource, for human interpretation
                Comments

                Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                Control0..1
                This element is affected by the following invariants: dom-6
                TypeNarrative
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Alternate Namesnarrative, html, xhtml, display
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                28. Ingredient.contained
                Definition

                These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                ShortContained, inline Resources
                Comments

                This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

                Control0..*
                This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                TypeResource
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Alternate Namesinline resources, anonymous resources, contained resources
                30. Ingredient.extension
                Definition

                An Extension

                ShortExtension
                Control0..*
                TypeExtension
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 32. Ingredient.extension:additional-info
                  Slice Nameadditional-info
                  Definition

                  A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc.

                  ShortDrug Product Component Additional Information
                  Control0..1
                  TypeExtension(Additional Information) (Extension Type: markdown)
                  Is Modifierfalse
                  Must Supporttrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  34. Ingredient.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                  Must Supportfalse
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  36. Ingredient.identifier
                  Definition

                  The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.

                  ShortAn identifier or code by which the ingredient can be referenced
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  38. Ingredient.status
                  Definition

                  The status of this ingredient. Enables tracking the life-cycle of the content.

                  Shortdraft | active | retired | unknown
                  Comments

                  Allows filtering of ingredient that are appropriate for use versus not.

                  Control1..1
                  BindingThe codes SHALL be taken from PublicationStatus
                  (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

                  The lifecycle status of an artifact.

                  Typecode
                  Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  40. Ingredient.for
                  Definition

                  The product which this ingredient is a constituent part of.

                  ShortReference to MedicinalProductDefinition
                  Control0..*
                  TypeReference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  42. Ingredient.role
                  Definition

                  A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

                  ShortPurpose of the ingredient within the product, e.g. active, inactive
                  Control1..1
                  BindingThe codes SHALL be taken from Drug Product Component Function Category Terminology
                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. Ingredient.function
                  Definition

                  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.

                  ShortPrecise action within the drug product, e.g. antioxidant, alkalizing agent
                  Control0..*
                  BindingFor example codes, see IngredientFunction
                  (example to http://hl7.org/fhir/ValueSet/ingredient-function)

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

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. Ingredient.group
                  Definition

                  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.

                  ShortA 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
                  Control0..1
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. Ingredient.allergenicIndicator
                  Definition

                  If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here.

                  ShortIf the ingredient is a known or suspected allergen
                  Control0..1
                  This element is affected by the following invariants: ing-1
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  50. Ingredient.comment
                  Definition

                  A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying.

                  ShortA place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
                  Control0..1
                  Typemarkdown
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  52. Ingredient.manufacturer
                  Definition

                  The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case.

                  ShortAn organization that manufactures this ingredient
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  54. Ingredient.manufacturer.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  56. Ingredient.manufacturer.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  58. Ingredient.manufacturer.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  60. Ingredient.manufacturer.role
                  Definition

                  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.

                  Shortallowed | possible | actual
                  Control0..1
                  BindingThe codes SHALL be taken from IngredientManufacturerRole
                  (required to http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0)

                  The way in which this manufacturer is associated with the ingredient.

                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  62. Ingredient.manufacturer.manufacturer
                  Definition

                  An organization that manufactures this ingredient.

                  ShortAn organization that manufactures this ingredient
                  Control1..1
                  TypeReference(Organization)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  64. Ingredient.substance
                  Definition

                  The substance that comprises this ingredient.

                  ShortThe substance that comprises this ingredient
                  Control1..1
                  This element is affected by the following invariants: ing-1
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = 'C75765' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ))
                  66. Ingredient.substance.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  68. Ingredient.substance.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  70. Ingredient.substance.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  72. Ingredient.substance.code
                  Definition

                  A code or full resource that represents the ingredient's substance.

                  ShortIngredient Substance
                  Control1..1
                  This element is affected by the following invariants: ing-1
                  BindingFor example codes, see SNOMEDCTSubstanceCodes
                  (example to http://hl7.org/fhir/ValueSet/substance-codes)

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

                  TypeCodeableReference(Component Substance)
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  74. Ingredient.substance.strength
                  Definition

                  The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.

                  ShortThe quantity of substance, per presentation, or per volume or mass, and type of quantity
                  Control1..1
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  76. Ingredient.substance.strength.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  78. Ingredient.substance.strength.extension
                  Definition

                  An Extension

                  ShortExtension
                  Control1..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on Ingredient.substance.strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 80. Ingredient.substance.strength.extension:strengthFactors
                    Slice NamestrengthFactors
                    Definition

                    Values required in Ingredient.substance.strength

                    ShortStrength Extension
                    Control1..1
                    TypeExtension(Strength Extension) (Complex Extension)
                    Is Modifierfalse
                    Must Supporttrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    82. Ingredient.substance.strength.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    84. Ingredient.substance.strength.presentation[x]
                    Definition

                    The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

                    ShortThe quantity of substance in the unit of presentation
                    Control1..1
                    TypeChoice of: Ratio, Quantity
                    [x] NoteSee Choice of Data Types for further information about how to use [x]
                    Is Modifierfalse
                    Must Supporttrue
                    Must Support TypesNo must-support rules about the choice of types/profiles
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 86. Ingredient.substance.strength.presentation[x]:presentationRatio
                      Slice NamepresentationRatio
                      Definition

                      The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

                      ShortThe quantity of substance in the unit of presentation
                      Control0..1
                      TypeRatio
                      [x] NoteSee Choice of Data Types for further information about how to use [x]
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      88. Ingredient.substance.strength.presentation[x]:presentationRatio.id
                      Definition

                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                      ShortUnique id for inter-element referencing
                      Control0..1
                      This element is affected by the following invariants: ele-1
                      Typeid
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      90. Ingredient.substance.strength.presentation[x]:presentationRatio.extension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      ShortAdditional content defined by implementations
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 92. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator
                        Definition

                        The value of the numerator.

                        ShortNumerator value
                        Control1..1
                        This element is affected by the following invariants: rat-1
                        TypeQuantity
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        94. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.id
                        Definition

                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                        ShortUnique id for inter-element referencing
                        Control0..1
                        This element is affected by the following invariants: ele-1
                        Typeid
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        96. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        ShortAdditional content defined by implementations
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x].numerator.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 98. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.value
                          Definition

                          Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325

                          ShortProduct Ingredient Amount Numeric Numerator
                          Comments

                          The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                          Control1..1
                          Typedecimal
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          Precision is handled implicitly in almost all cases of measurement.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          100. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.comparator
                          Definition

                          How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                          Short< | <= | >= | > | ad - how to understand the value
                          Control0..1
                          BindingThe codes SHALL be taken from QuantityComparator
                          (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                          How the Quantity should be understood and represented.

                          Typecode
                          Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                          Meaning if MissingIf there is no comparator, then there is no modification of the value
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          102. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.unit
                          Definition

                          The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg

                          ShortProduct Ingredient Amount Numeric Numerator UOM
                          Control1..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          104. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.system
                          Definition

                          The identification of the system that provides the coded form of the unit.

                          ShortSystem that defines coded unit form
                          Control0..1
                          This element is affected by the following invariants: qty-3
                          Typeuri
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Need to know the system that defines the coded form of the unit.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          106. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.code
                          Definition

                          A computer processable form of the unit in some unit representation system.

                          ShortCoded form of the unit
                          Comments

                          The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                          Control1..1
                          This element is affected by the following invariants: qty-3
                          BindingThe codes SHALL be taken from Units Of Measure Terminology
                          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
                          Typecode
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          108. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator
                          Definition

                          The value of the denominator.

                          ShortDenominator value
                          Control1..1
                          This element is affected by the following invariants: rat-1
                          TypeQuantity(SimpleQuantity)
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          110. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          112. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x].denominator.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 114. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.value
                            Definition

                            Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

                            ShortProduct Ingredient Amount Numeric Denominator
                            Comments

                            The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                            Control1..1
                            Typedecimal
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Precision is handled implicitly in almost all cases of measurement.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            116. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.comparator
                            Definition

                            Not allowed to be used in this context

                            Short< | <= | >= | > | ad - how to understand the value
                            Control0..0
                            BindingThe codes SHALL be taken from QuantityComparator
                            (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                            How the Quantity should be understood and represented.

                            Typecode
                            Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                            Meaning if MissingIf there is no comparator, then there is no modification of the value
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            118. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.unit
                            Definition

                            A human-readable form of the unit.

                            ShortUnit representation
                            Control1..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            120. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.system
                            Definition

                            The identification of the system that provides the coded form of the unit.

                            ShortSystem that defines coded unit form
                            Control0..1
                            This element is affected by the following invariants: qty-3
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to know the system that defines the coded form of the unit.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            122. Ingredient.substance.strength.presentation[x]:presentationRatio.denominator.code
                            Definition

                            A computer processable form of the unit in some unit representation system.

                            ShortCoded form of the unit
                            Comments

                            The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                            Control1..1
                            This element is affected by the following invariants: qty-3
                            BindingThe codes SHALL be taken from Units Of Measure Terminology
                            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            124. Ingredient.substance.strength.presentation[x]:presentationQuantity
                            Slice NamepresentationQuantity
                            Definition

                            The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

                            ShortThe quantity of substance in the unit of presentation
                            Control0..1
                            TypeQuantity
                            [x] NoteSee Choice of Data Types for further information about how to use [x]
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            126. Ingredient.substance.strength.presentation[x]:presentationQuantity.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typeid
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            128. Ingredient.substance.strength.presentation[x]:presentationQuantity.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            ShortAdditional content defined by implementations
                            Comments

                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 130. Ingredient.substance.strength.presentation[x]:presentationQuantity.value
                              Definition

                              TSpecifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Numerator = 325

                              ShortProduct Ingredient Amount Numeric
                              Comments

                              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                              Control1..1
                              Typedecimal
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Summarytrue
                              Requirements

                              Precision is handled implicitly in almost all cases of measurement.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              132. Ingredient.substance.strength.presentation[x]:presentationQuantity.comparator
                              Definition

                              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                              Short< | <= | >= | > | ad - how to understand the value
                              Control0..1
                              BindingThe codes SHALL be taken from QuantityComparator
                              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                              How the Quantity should be understood and represented.

                              Typecode
                              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                              Meaning if MissingIf there is no comparator, then there is no modification of the value
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              134. Ingredient.substance.strength.presentation[x]:presentationQuantity.unit
                              Definition

                              A human-readable form of the unit.

                              ShortUnit representation
                              Control1..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              136. Ingredient.substance.strength.presentation[x]:presentationQuantity.system
                              Definition

                              The identification of the system that provides the coded form of the unit.

                              ShortSystem that defines coded unit form
                              Control0..1
                              This element is affected by the following invariants: qty-3
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need to know the system that defines the coded form of the unit.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              138. Ingredient.substance.strength.presentation[x]:presentationQuantity.code
                              Definition

                              A computer processable form of the unit in some unit representation system.

                              ShortCoded form of the unit
                              Comments

                              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                              Control1..1
                              This element is affected by the following invariants: qty-3
                              BindingThe codes SHALL be taken from Units Of Measure Terminology
                              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology)
                              Typecode
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              140. Ingredient.substance.strength.textPresentation
                              Definition

                              A written description of the strength of the ingredient. [Source: SME Defined]

                              ShortStrength Textual
                              Control1..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supporttrue
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              142. Ingredient.substance.strength.concentration[x]
                              Definition

                              The strength per unitary volume (or mass).

                              ShortThe strength per unitary volume (or mass)
                              Control0..1
                              TypeChoice of: Ratio, RatioRange, CodeableConcept, Quantity
                              [x] NoteSee Choice of Data Types for further information about how to use [x]
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              144. Ingredient.substance.strength.textConcentration
                              Definition

                              A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.

                              ShortText of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              146. Ingredient.substance.strength.basis
                              Definition

                              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).

                              ShortA 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)
                              Control0..1
                              TypeCodeableConcept
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              148. Ingredient.substance.strength.measurementPoint
                              Definition

                              For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.

                              ShortWhen strength is measured at a particular point or distance
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              150. Ingredient.substance.strength.country
                              Definition

                              The country or countries for which the strength range applies.

                              ShortWhere the strength range applies
                              Control0..*
                              BindingFor example codes, see CountryValueSet
                              (example to http://hl7.org/fhir/ValueSet/country)

                              Jurisdiction codes

                              TypeCodeableConcept
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              152. Ingredient.substance.strength.referenceStrength
                              Definition

                              Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.

                              ShortStrength expressed in terms of a reference substance
                              Control0..*
                              TypeBackboneElement
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              154. Ingredient.substance.strength.referenceStrength.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              156. Ingredient.substance.strength.referenceStrength.extension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                              ShortAdditional content defined by implementations
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              158. Ingredient.substance.strength.referenceStrength.modifierExtension
                              Definition

                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                              Control0..*
                              TypeExtension
                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                              Summarytrue
                              Requirements

                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              160. Ingredient.substance.strength.referenceStrength.substance
                              Definition

                              Relevant reference substance.

                              ShortRelevant reference substance
                              Control1..1
                              BindingFor example codes, see SNOMEDCTSubstanceCodes
                              (example to http://hl7.org/fhir/ValueSet/substance-codes)

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

                              TypeCodeableReference(SubstanceDefinition)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              162. Ingredient.substance.strength.referenceStrength.strength[x]
                              Definition

                              Strength expressed in terms of a reference substance.

                              ShortStrength expressed in terms of a reference substance
                              Control1..1
                              TypeChoice of: Ratio, RatioRange, Quantity
                              [x] NoteSee Choice of Data Types for further information about how to use [x]
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              164. Ingredient.substance.strength.referenceStrength.measurementPoint
                              Definition

                              For when strength is measured at a particular point or distance.

                              ShortWhen strength is measured at a particular point or distance
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              166. Ingredient.substance.strength.referenceStrength.country
                              Definition

                              The country or countries for which the strength range applies.

                              ShortWhere the strength range applies
                              Control0..*
                              BindingFor example codes, see CountryValueSet
                              (example to http://hl7.org/fhir/ValueSet/country)

                              Jurisdiction codes

                              TypeCodeableConcept
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))