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 2.0.0-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 2024-12-04

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.for
ShortReference to MedicinalProductDefinition
4. 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)
6. Ingredient.comment
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
Must Supporttrue
8. 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. (defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )))
10. Ingredient.substance.code
ShortIngredient Substance
TypeCodeableReference(Literal Coded Reference)(Component Substance)bundled
Must Supporttrue
12. Ingredient.substance.strength
Control2..2
Must Supporttrue
SlicingThis element introduces a set of slices on Ingredient.substance.strength. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • exists @ textConcentration
  • 14. Ingredient.substance.strength:amount
    Slice Nameamount
    Control1..1
    Must Supporttrue
    16. Ingredient.substance.strength:amount.extension
    Control1..?
    SlicingThis element introduces a set of slices on Ingredient.substance.strength.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 18. Ingredient.substance.strength:amount.extension:strengthFactors
      Slice NamestrengthFactors
      Control1..1
      TypeExtension(Strength Extension) (Extension Type: CodeableConcept)
      Must Supporttrue
      20. Ingredient.substance.strength:amount.concentration[x]
      Control1..?
      TypeChoice of: Ratio, Quantity
      [x] NoteSeeChoice of Data Typesfor 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.concentration[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • type @ $this
      • 22. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity
        Slice NameconcentrationQuantity
        Control0..1
        BindingThe codes SHALL be taken from Non-Percentage Units
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
        TypeQuantity
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        24. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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 Ingredient Total Amount Numeric = 325

        ShortIngredient Total Amount Numeric
        Control1..?
        Must Supporttrue
        26. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator
        Definition

        A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

        ShortIngredient Total Amount Operator
        Must Supporttrue
        28. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit
        Control1..?
        30. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
        Slice NameconcentrationRatio
        Control0..1
        TypeRatio
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        32. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator
        Definition

        Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]

        Control1..?
        BindingThe codes SHALL be taken from Non-Percentage Units
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
        Must Supporttrue
        34. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
        ShortIngredient Total Amount Numeric Numerator
        Control1..?
        Must Supporttrue
        36. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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

        ShortIngredient Total Amount Numeric Numerator UOM
        38. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code
        Control1..?
        Must Supporttrue
        40. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
        Control1..?
        BindingThe codes SHALL be taken from Non-Percentage Units
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
        Must Supporttrue
        42. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value
        Definition

        Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml

        ShortIngredient Total Amount Numeric Denominator
        Control1..?
        Must Supporttrue
        44. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
        ShortIngredient Total Amount Numeric Denominator UOM
        Control1..?
        Must Supporttrue
        46. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code
        Control1..?
        Must Supporttrue
        48. Ingredient.substance.strength:amount.textConcentration
        Definition

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

        ShortStrength Textual
        Control1..?
        Must Supporttrue
        50. Ingredient.substance.strength:percent
        Slice Namepercent
        Control1..1
        Must Supporttrue
        52. Ingredient.substance.strength:percent.concentration[x]
        Control1..?
        BindingThe codes SHALL be taken from Percentage Units
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units)
        TypeQuantity
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue
        54. Ingredient.substance.strength:percent.concentration[x].value
        Definition

        The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08

        ShortIngredient Total Amount Content Percent
        Control1..?
        Must Supporttrue
        56. Ingredient.substance.strength:percent.concentration[x].code
        ShortIngredient Total Amount Content Percent UOM
        Control1..?
        Must Supporttrue
        58. Ingredient.substance.strength:percent.textConcentration
        Control0..0
        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.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()))
        4. 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
        6. 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())
        8. 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()))
        10. 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()))
        12. 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()))
        14. Ingredient.comment
        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.


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

        ShortDrug Product Component Additional InformationA 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 Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. 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. (defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )))
        18. 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())
        20. Ingredient.substance.code
        Definition

        A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class).


        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(Literal Coded Reference)(Component Substance, SubstanceDefinition)bundled
        Is Modifierfalse
        Must Supporttrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. 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
        Control20..2*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        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. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • exists @ textConcentration
        • 24. 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())
          26. Ingredient.substance.strength:amount
          Slice Nameamount
          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()))
          28. Ingredient.substance.strength:amount.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 areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 30. Ingredient.substance.strength:amount.extension:strengthFactors
            Slice NamestrengthFactors
            Definition

            Strength Type (for API)

            ShortStrength Extension
            Control1..1
            TypeExtension(Strength Extension) (Extension Type: CodeableConcept)
            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())
            32. Ingredient.substance.strength:amount.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())
            34. Ingredient.substance.strength:amount.concentration[x]
            Definition

            The strength per unitary volume (or mass).

            ShortThe strength per unitary volume (or mass)
            Control10..1
            TypeChoice of: Ratio, Quantity, RatioRange, CodeableConcept
            [x] NoteSeeChoice of Data Typesfor 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.concentration[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 36. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity
              Slice NameconcentrationQuantity
              Definition

              The strength per unitary volume (or mass).

              ShortThe strength per unitary volume (or mass)
              Control0..1
              BindingThe codes SHALL be taken from For codes, see Non-Percentage Units
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
              TypeQuantity, RatioRange, Ratio, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor 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()))
              38. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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 Ingredient Total Amount Numeric = 325


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

              ShortIngredient Total 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()))
              40. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator
              Definition

              A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.


              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.

              ShortIngredient Total Amount Operator< | <= | >= | > | 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
              Must Supporttrue
              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()))
              42. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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()))
              44. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
              Slice NameconcentrationRatio
              Definition

              The strength per unitary volume (or mass).

              ShortThe strength per unitary volume (or mass)
              Control0..1
              TypeRatio, RatioRange, Quantity, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor 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()))
              46. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator
              Definition

              Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]


              The value of the numerator.

              ShortNumerator value
              Control10..1
              This element is affected by the following invariants: rat-1
              BindingThe codes SHALL be taken from For codes, see Non-Percentage Units
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
              TypeQuantity
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              48. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
              Definition

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

              ShortIngredient Total 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()))
              50. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
              52. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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.

              ShortIngredient Total Amount Numeric Numerator UOMUnit representation
              Control0..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()))
              54. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
              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()))
              56. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
              Definition

              The value of the denominator.

              ShortDenominator value
              Control10..1
              This element is affected by the following invariants: rat-1
              BindingThe codes SHALL be taken from For codes, see Non-Percentage Units
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
              TypeQuantity(SimpleQuantity)
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              58. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value
              Definition

              Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml


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

              ShortIngredient Total 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()))
              60. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
              62. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
              Definition

              A human-readable form of the unit.

              ShortIngredient Total Amount Numeric Denominator 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()))
              64. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
              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()))
              66. Ingredient.substance.strength:amount.textConcentration
              Definition

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


              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.

              ShortStrength TextualText of either the whole concentration strength or a part of it (rest being in Strength.concentration 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()))
              68. Ingredient.substance.strength:percent
              Slice Namepercent
              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()))
              70. Ingredient.substance.strength:percent.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.strength:percent.concentration[x]
              Definition

              The strength per unitary volume (or mass).

              ShortThe strength per unitary volume (or mass)
              Control10..1
              BindingThe codes SHALL be taken from For codes, see Percentage Units
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units)
              TypeQuantity, RatioRange, Ratio, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor 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()))
              74. Ingredient.substance.strength:percent.concentration[x].value
              Definition

              The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08


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

              ShortIngredient Total Amount Content PercentNumerical 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()))
              76. Ingredient.substance.strength:percent.concentration[x].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()))
              78. Ingredient.substance.strength:percent.concentration[x].code
              Definition

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

              ShortIngredient Total Amount Content Percent UOMCoded 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
              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()))
              80. Ingredient.substance.strength:percent.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..01
              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.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.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()))
              10. 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()))
              12. 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
              14. Ingredient.extension
              Definition

              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.

              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
              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())
              16. 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())
              18. 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()))
              20. 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()))
              22. 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()))
              24. 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()))
              26. 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()))
              28. 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()))
              30. 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()))
              32. Ingredient.comment
              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
              Typemarkdown
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              34. 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()))
              36. 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
              38. 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())
              40. 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())
              42. 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()))
              44. 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()))
              46. 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. (defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( strength .extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension') .extension.where( value.coding.where( code = 'C45420' and system = %system ).exists() ).exists() implies ( strength.presentation.ofType(Ratio).exists() and strength.presentation.numerator.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) ) or ( strength.presentation.ofType(Quantity).exists() and strength.presentation.where( code = '[arb\'U]' and system = 'http://unitsofmeasure.org' ) )))
              48. 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
              50. 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())
              52. 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())
              54. Ingredient.substance.code
              Definition

              A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class).

              ShortIngredient 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(Literal Coded Reference)(Component Substance)bundled
              Is Modifierfalse
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. 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
              Control2..2
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              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. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
              • exists @ textConcentration
              • 58. 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
                60. Ingredient.substance.strength.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())
                62. 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())
                64. 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
                Control0..1
                TypeChoice of: Ratio, RatioRange, CodeableConcept, Quantity
                [x] NoteSeeChoice of Data Typesfor 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()))
                66. Ingredient.substance.strength.textPresentation
                Definition

                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.

                ShortText of either the whole presentation strength or a part of it (rest being in Strength.presentation 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()))
                68. 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] NoteSeeChoice of Data Typesfor 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()))
                70. 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()))
                72. 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()))
                74. 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()))
                76. 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()))
                78. 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()))
                80. 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
                82. 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())
                84. 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())
                86. 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()))
                88. 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] NoteSeeChoice of Data Typesfor 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()))
                90. 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()))
                92. 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()))
                94. Ingredient.substance.strength:amount
                Slice Nameamount
                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()))
                96. Ingredient.substance.strength:amount.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
                98. Ingredient.substance.strength:amount.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 areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 100. Ingredient.substance.strength:amount.extension:strengthFactors
                  Slice NamestrengthFactors
                  Definition

                  Strength Type (for API)

                  ShortStrength Extension
                  Control1..1
                  TypeExtension(Strength Extension) (Extension Type: CodeableConcept)
                  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())
                  102. Ingredient.substance.strength:amount.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())
                  104. Ingredient.substance.strength:amount.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
                  Control0..1
                  TypeChoice of: Ratio, RatioRange, CodeableConcept, Quantity
                  [x] NoteSeeChoice of Data Typesfor 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()))
                  106. Ingredient.substance.strength:amount.textPresentation
                  Definition

                  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.

                  ShortText of either the whole presentation strength or a part of it (rest being in Strength.presentation 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()))
                  108. Ingredient.substance.strength:amount.concentration[x]
                  Definition

                  The strength per unitary volume (or mass).

                  ShortThe strength per unitary volume (or mass)
                  Control1..1
                  TypeChoice of: Ratio, Quantity
                  [x] NoteSeeChoice of Data Typesfor 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.concentration[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 110. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity
                    Slice NameconcentrationQuantity
                    Definition

                    The strength per unitary volume (or mass).

                    ShortThe strength per unitary volume (or mass)
                    Control0..1
                    BindingThe codes SHALL be taken from Non-Percentage Units
                    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
                    TypeQuantity
                    [x] NoteSeeChoice of Data Typesfor 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()))
                    112. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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
                    114. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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.concentration[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 116. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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 Ingredient Total Amount Numeric = 325

                      ShortIngredient Total 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()))
                      118. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator
                      Definition

                      A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

                      ShortIngredient Total Amount Operator
                      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
                      Must Supporttrue
                      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()))
                      120. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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()))
                      122. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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()))
                      124. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.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.

                      Control0..1
                      This element is affected by the following invariants: qty-3
                      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()))
                      126. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
                      Slice NameconcentrationRatio
                      Definition

                      The strength per unitary volume (or mass).

                      ShortThe strength per unitary volume (or mass)
                      Control0..1
                      TypeRatio
                      [x] NoteSeeChoice of Data Typesfor 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()))
                      128. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
                      130. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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.concentration[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 132. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator
                        Definition

                        Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined]

                        ShortNumerator value
                        Control1..1
                        This element is affected by the following invariants: rat-1
                        BindingThe codes SHALL be taken from Non-Percentage Units
                        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
                        TypeQuantity
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        134. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
                        136. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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.concentration[x].numerator.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 138. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
                          Definition

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

                          ShortIngredient Total 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()))
                          140. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
                          142. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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

                          ShortIngredient Total Amount Numeric Numerator UOM
                          Control0..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()))
                          144. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
                          146. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
                          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()))
                          148. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
                          Definition

                          The value of the denominator.

                          ShortDenominator value
                          Control1..1
                          This element is affected by the following invariants: rat-1
                          BindingThe codes SHALL be taken from Non-Percentage Units
                          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units)
                          TypeQuantity(SimpleQuantity)
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          150. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
                          152. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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.concentration[x].denominator.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 154. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value
                            Definition

                            Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml

                            ShortIngredient Total 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()))
                            156. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
                            158. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
                            Definition

                            A human-readable form of the unit.

                            ShortIngredient Total Amount Numeric Denominator 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()))
                            160. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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()))
                            162. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.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
                            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()))
                            164. Ingredient.substance.strength:amount.textConcentration
                            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()))
                            166. Ingredient.substance.strength:amount.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()))
                            168. Ingredient.substance.strength:amount.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()))
                            170. Ingredient.substance.strength:amount.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()))
                            172. Ingredient.substance.strength:amount.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()))
                            174. Ingredient.substance.strength:amount.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
                            176. Ingredient.substance.strength:amount.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())
                            178. Ingredient.substance.strength:amount.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())
                            180. Ingredient.substance.strength:amount.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()))
                            182. Ingredient.substance.strength:amount.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] NoteSeeChoice of Data Typesfor 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()))
                            184. Ingredient.substance.strength:amount.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()))
                            186. Ingredient.substance.strength:amount.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()))
                            188. Ingredient.substance.strength:percent
                            Slice Namepercent
                            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()))
                            190. Ingredient.substance.strength:percent.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
                            192. Ingredient.substance.strength:percent.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())
                            194. Ingredient.substance.strength:percent.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())
                            196. Ingredient.substance.strength:percent.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
                            Control0..1
                            TypeChoice of: Ratio, RatioRange, CodeableConcept, Quantity
                            [x] NoteSeeChoice of Data Typesfor 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()))
                            198. Ingredient.substance.strength:percent.textPresentation
                            Definition

                            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.

                            ShortText of either the whole presentation strength or a part of it (rest being in Strength.presentation 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()))
                            200. Ingredient.substance.strength:percent.concentration[x]
                            Definition

                            The strength per unitary volume (or mass).

                            ShortThe strength per unitary volume (or mass)
                            Control1..1
                            BindingThe codes SHALL be taken from Percentage Units
                            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units)
                            TypeQuantity
                            [x] NoteSeeChoice of Data Typesfor 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()))
                            202. Ingredient.substance.strength:percent.concentration[x].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
                            204. Ingredient.substance.strength:percent.concentration[x].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.concentration[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 206. Ingredient.substance.strength:percent.concentration[x].value
                              Definition

                              The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08

                              ShortIngredient Total Amount Content Percent
                              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()))
                              208. Ingredient.substance.strength:percent.concentration[x].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()))
                              210. Ingredient.substance.strength:percent.concentration[x].unit
                              Definition

                              A human-readable form of the unit.

                              ShortUnit representation
                              Control0..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()))
                              212. Ingredient.substance.strength:percent.concentration[x].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()))
                              214. Ingredient.substance.strength:percent.concentration[x].code
                              Definition

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

                              ShortIngredient Total Amount Content Percent UOM
                              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
                              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()))
                              216. Ingredient.substance.strength:percent.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..0
                              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()))
                              218. Ingredient.substance.strength:percent.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()))
                              220. Ingredient.substance.strength:percent.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()))
                              222. Ingredient.substance.strength:percent.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()))
                              224. Ingredient.substance.strength:percent.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()))
                              226. Ingredient.substance.strength:percent.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
                              228. Ingredient.substance.strength:percent.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())
                              230. Ingredient.substance.strength:percent.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())
                              232. Ingredient.substance.strength:percent.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()))
                              234. Ingredient.substance.strength:percent.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] NoteSeeChoice of Data Typesfor 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()))
                              236. Ingredient.substance.strength:percent.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()))
                              238. Ingredient.substance.strength:percent.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()))