Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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

Page standards status: Trial-use | Maturity Level: 2

Definitions for the pqcmc-component resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

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

0. Ingredient
Definition | An ingredient of a manufactured item or pharmaceutical product.
Short | An ingredient of a manufactured item or pharmaceutical product
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Contained, 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
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 Names | extensions, user content
Invariants | ele-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.
Short | draft | active | retired | unknown
Comments | Allows filtering of ingredient that are appropriate for use versus not.
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus http://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.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Reference to MedicinalProductDefinitionThe product which this ingredient is a constituent part of
Control | 0..*
Type | Reference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Purpose of the ingredient within the product, e.g. active, inactive
Control | 1..1
Binding | The codes SHALL be taken from For example codes, see Drug Product Component Function Category Terminology http://hl7.org/fhir/ValueSet/ingredient-role (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Drug 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
Control | 0..1
Type | markdown
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-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.
Short | The substance that comprises this ingredient
Control | 1..1 This element is affected by the following invariants: ing-1
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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 code or full resource that represents the ingredient's substance.
Short | Ingredient SubstanceA code or full resource that represents the ingredient substance
Control | 1..1 This element is affected by the following invariants: ing-1
Binding | For example codes, see SNOMEDCTSubstanceCodes http://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.
Type | CodeableReference(Literal Coded Reference)(Component Substance, SubstanceDefinition)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 20..2*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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 Name | amount
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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 10..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | ExtensionAdditional 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.
Control | 10..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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())
Slicing | This 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 Name | strengthFactors
Definition | Strength Type (for API)
Short | Strength Type
Control | 1..1
Type | Extension(Strength Type) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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).
Short | The strength per unitary volume (or mass)
Control | 10..1
Type | Choice of: Ratio, Quantity, RatioRange, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This 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 Name | concentrationQuantity
Definition | The strength per unitary volume (or mass).
Short | The strength per unitary volume (or mass)
Control | 0..1
Binding | The 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` )
Type | Quantity, RatioRange, Ratio, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Ingredient 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).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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.
Short | Ingredient Total Amount Operator< | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Unit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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 Name | concentrationRatio
Definition | The strength per unitary volume (or mass).
Short | The strength per unitary volume (or mass)
Control | 0..1
Type | Ratio, RatioRange, Quantity, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Numerator value
Control | 10..1 This element is affected by the following invariants: rat-1
Binding | The 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` )
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Ingredient 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).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Ingredient Total Amount Numeric Numerator UOMUnit representation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | Coded 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.
Control | 10..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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.
Short | Denominator value
Control | 10..1 This element is affected by the following invariants: rat-1
Binding | The 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` )
Type | Quantity(SimpleQuantity)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Ingredient 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).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..01
Binding | The codes SHALL be taken from QuantityComparator http://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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Ingredient Total Amount Numeric Denominator UOMUnit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | Coded 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.
Control | 10..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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.
Short | Strength TextualText of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Ingredient.substance.strength:percent
Slice Name | percent
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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 10..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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).
Short | The strength per unitary volume (or mass)
Control | 10..1
Binding | The codes SHALL be taken from For codes, see Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | Quantity, RatioRange, Ratio, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Ingredient 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).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Ingredient 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.
Control | 10..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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.
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Control | 0..01
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-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 foundhere

0. Ingredient
2. Ingredient.for
Short | Reference to MedicinalProductDefinition
4. Ingredient.role
Binding | The 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.
Short | Drug Product Component Additional Information
Must Support | true
8. Ingredient.substance
Invariants | 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' ) ))`)
10. Ingredient.substance.code
Short | Ingredient Substance
Type | CodeableReference(Literal Coded Reference)(Component Substance)bundled
Must Support | true
12. Ingredient.substance.strength
Control | 2..2
Must Support | true
Slicing | This 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 Name | amount
Control | 1..1
Must Support | true
16. Ingredient.substance.strength:amount.extension
Control | 1..?
Slicing | This 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 Name | strengthFactors
Control | 1..1
Type | Extension(Strength Type) (Extension Type: CodeableConcept)
Must Support | true
20. Ingredient.substance.strength:amount.concentration[x]
Control | 1..?
Type | Choice of: Ratio, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Slicing | This 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 Name | concentrationQuantity
Control | 0..1
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
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
Short | Ingredient Total Amount Numeric
Control | 1..?
Must Support | true
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.
Short | Ingredient Total Amount Operator
Must Support | true
28. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit
Control | 1..?
30. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio
Slice Name | concentrationRatio
Control | 0..1
Type | Ratio
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
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]
Control | 1..?
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Must Support | true
34. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value
Short | Ingredient Total Amount Numeric Numerator
Control | 1..?
Must Support | true
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
Short | Ingredient Total Amount Numeric Numerator UOM
38. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code
Control | 1..?
Must Support | true
40. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator
Control | 1..?
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Must Support | true
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
Short | Ingredient Total Amount Numeric Denominator
Control | 1..?
Must Support | true
44. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit
Short | Ingredient Total Amount Numeric Denominator UOM
Control | 1..?
Must Support | true
46. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code
Control | 1..?
Must Support | true
48. Ingredient.substance.strength:amount.textConcentration
Definition | A written description of the strength of the ingredient. [Source: SME Defined]
Short | Strength Textual
Control | 1..?
Must Support | true
50. Ingredient.substance.strength:percent
Slice Name | percent
Control | 1..1
Must Support | true
52. Ingredient.substance.strength:percent.concentration[x]
Control | 1..?
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
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
Short | Ingredient Total Amount Content Percent
Control | 1..?
Must Support | true
56. Ingredient.substance.strength:percent.concentration[x].code
Short | Ingredient Total Amount Content Percent UOM
Control | 1..?
Must Support | true
58. Ingredient.substance.strength:percent.textConcentration
Control | 0..0
Must Support | true

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

0. Ingredient
Definition | An ingredient of a manufactured item or pharmaceutical product.
Short | An ingredient of a manufactured item or pharmaceutical product
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-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.
Short | Logical 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.
Control | 0..1
Type | id
Is Modifier | false
Must Support | false
Summary | true
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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Language 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).
Control | 0..1
Binding | The 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
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-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.
Short | Text 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.
Control | 0..1 This element is affected by the following invariants: dom-6
Type | Narrative
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-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.
Short | Contained, 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
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 Names | extensions, user content
Invariants | ele-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.
Short | An identifier or code by which the ingredient can be referenced
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | draft | active | retired | unknown
Comments | Allows filtering of ingredient that are appropriate for use versus not.
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus (required to `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` ) The lifecycle status of an artifact.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Reference to MedicinalProductDefinition
Control | 0..*
Type | Reference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Purpose of the ingredient within the product, e.g. active, inactive
Control | 1..1
Binding | The 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` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Precise action within the drug product, e.g. antioxidant, alkalizing agent
Control | 0..*
Binding | For 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).
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | 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
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | If the ingredient is a known or suspected allergen
Control | 0..1 This element is affected by the following invariants: ing-1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Meaning if Missing | If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
Invariants | ele-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.
Short | Drug Product Component Additional Information
Control | 0..1
Type | markdown
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-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.
Short | An organization that manufactures this ingredient
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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.
Short | allowed | possible | actual
Control | 0..1
Binding | The 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.
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | An organization that manufactures this ingredient
Control | 1..1
Type | Reference(Organization)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | The substance that comprises this ingredient
Control | 1..1 This element is affected by the following invariants: ing-1
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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 code or full resource that represents the ingredient's substance.
Short | Ingredient Substance
Control | 1..1 This element is affected by the following invariants: ing-1
Binding | For 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.
Type | CodeableReference(Literal Coded Reference)(Component Substance)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 2..2
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This 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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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').
Short | The quantity of substance in the unit of presentation
Control | 0..1
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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).
Short | The strength per unitary volume (or mass)
Control | 0..1
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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).
Short | 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)
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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.
Short | Relevant reference substance
Control | 1..1
Binding | For 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.
Type | CodeableReference(SubstanceDefinition)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 1..1
Type | Choice of: Ratio, RatioRange, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. Ingredient.substance.strength:amount
Slice Name | amount
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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 1..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
98. Ingredient.substance.strength:amount.extension
Definition | An Extension
Short | Extension
Control | 1..*
Type | Extension
Is Modifier | false
Summary | false
Invariants | ele-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()`)
Slicing | This 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 Name | strengthFactors
Definition | Strength Type (for API)
Short | Strength Type
Control | 1..1
Type | Extension(Strength Type) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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').
Short | The quantity of substance in the unit of presentation
Control | 0..1
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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).
Short | The strength per unitary volume (or mass)
Control | 1..1
Type | Choice of: Ratio, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This 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 Name | concentrationQuantity
Definition | The strength per unitary volume (or mass).
Short | The strength per unitary volume (or mass)
Control | 0..1
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This 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
Short | Ingredient 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).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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.
Short | Ingredient Total Amount Operator
Control | 0..1
Binding | The 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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Unit representation
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-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.
Short | Coded 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.
Control | 0..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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.
Invariants | ele-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 Name | concentrationRatio
Definition | The strength per unitary volume (or mass).
Short | The strength per unitary volume (or mass)
Control | 0..1
Type | Ratio
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This 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]
Short | Numerator value
Control | 1..1 This element is affected by the following invariants: rat-1
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This 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.
Short | Ingredient 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).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..1
Binding | The 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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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
Short | Ingredient Total Amount Numeric Numerator UOM
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-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.
Short | Coded 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.
Control | 1..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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.
Short | Denominator value
Control | 1..1 This element is affected by the following invariants: rat-1
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | Quantity(SimpleQuantity)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This 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
Short | Ingredient 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).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..0
Binding | The 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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Ingredient Total Amount Numeric Denominator UOM
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-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.
Short | Coded 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.
Control | 1..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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]
Short | Strength Textual
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-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).
Short | 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)
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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.
Short | Relevant reference substance
Control | 1..1
Binding | For 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.
Type | CodeableReference(SubstanceDefinition)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 1..1
Type | Choice of: Ratio, RatioRange, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
188. Ingredient.substance.strength:percent
Slice Name | percent
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.
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity
Control | 1..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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').
Short | The quantity of substance in the unit of presentation
Control | 0..1
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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).
Short | The strength per unitary volume (or mass)
Control | 1..1
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
Slicing | This 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
Short | Ingredient 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).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-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
Control | 0..1
Binding | The 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.
Type | code
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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 Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-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.
Short | Unit representation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-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.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-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.
Short | Ingredient 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.
Control | 1..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
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.
Invariants | ele-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.
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Control | 0..0
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-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).
Short | 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)
Control | 0..1
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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.
Short | Relevant reference substance
Control | 1..1
Binding | For 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.
Type | CodeableReference(SubstanceDefinition)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | Strength expressed in terms of a reference substance
Control | 1..1
Type | Choice of: Ratio, RatioRange, Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | When strength is measured at a particular point or distance
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Where the strength range applies
Control | 0..*
Binding | For example codes, see CountryValueSet (example to `http://hl7.org/fhir/ValueSet/country` ) Jurisdiction codes
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)