Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Resource Profile: DrugProductComponent - Detailed Descriptions

Draft as of 2024-03-04

Definitions for the pqcmc-component resource profile.

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

0. Ingredient
2. Ingredient.meta
4. Ingredient.meta.profile
Control0..1
Must Supporttrue
6. Ingredient.extension
SlicingThis element introduces a set of slices on Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
8. Ingredient.extension:additional-info
Slice Nameadditional-info
Definition

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

ShortDrug Product Component Additional Information
Control0..1
TypeExtension(Additional Information) (Extension Type: markdown)
Must Supporttrue
10. Ingredient.for
ShortReference to MedicinalProductDefinition
12. Ingredient.role
BindingThe codes SHALL be taken from Drug Product Component Function Category Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
14. Ingredient.substance
Invariantscmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not())))
cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists()))
16. Ingredient.substance.code
ShortIngredient Substance
TypeCodeableReference(Component Substance)
Must Supporttrue
18. Ingredient.substance.strength
Control1..1
Must Supporttrue
20. Ingredient.substance.strength.extension
Control1..?
SlicingThis element introduces a set of slices on Ingredient.substance.strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
22. Ingredient.substance.strength.extension:strengthFactors
Slice NamestrengthFactors
Control1..1
TypeExtension(Strength Extension) (Complex Extension)
Must Supporttrue
24. Ingredient.substance.strength.presentation[x]
Control1..?
TypeChoice of: Ratio, Quantity, RatioRange, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
SlicingThis element introduces a set of slices on Ingredient.substance.strength.presentation[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
26. Ingredient.substance.strength.presentation[x]:presentationRatio
Slice NamepresentationRatio
Control0..1
TypeRatio
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
28. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator
Control1..?
Must Supporttrue
30. Ingredient.substance.strength.presentation[x]:presentationRatio.numerator.value
Definition

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

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

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

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

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

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

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

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

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

ShortStrength Textual
Control1..?
Must Supporttrue

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

0. Ingredient
Definition

An ingredient of a manufactured item or pharmaceutical product.

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

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

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

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

ShortProfiles this resource claims to conform to
Comments

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

Control0..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Ingredient.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

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

ShortContained, inline Resources
Comments

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

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

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

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

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

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

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

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

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

Shortdraft | active | retired | unknown
Comments

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

Control1..1
BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Ingredient.for
Definition

The product which this ingredient is a constituent part of.

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

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

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

The substance that comprises this ingredient.

ShortThe substance that comprises this ingredient
Control1..1
This element is affected by the following invariants: ing-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not())))
cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists()))
24. Ingredient.substance.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

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

ShortIngredient SubstanceA code or full resource that represents the ingredient substance
Control1..1
This element is affected by the following invariants: ing-1
BindingFor example codes, see SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes
(example to http://hl7.org/fhir/ValueSet/substance-codes
TypeCodeableReference(Component Substance, SubstanceDefinition)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Ingredient.substance.strength
Definition

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

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

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

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

Values required in Ingredient.substance.strength

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

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

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

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

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

The value of the numerator.

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

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


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

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

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

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

Precision is handled implicitly in almost all cases of measurement.

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

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

Short< | <= | >= | > | ad - how to understand the value
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

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


A human-readable form of the unit.

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

The value of the denominator.

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

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


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

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

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

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

Precision is handled implicitly in almost all cases of measurement.

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

Not allowed to be used in this context


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

Short< | <= | >= | > | ad - how to understand the value
Control0..01
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

A human-readable form of the unit.

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

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

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

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


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

ShortProduct Ingredient Amount NumericNumerical value (with implicit precision)
Comments

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

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

Precision is handled implicitly in almost all cases of measurement.

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

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

Short< | <= | >= | > | ad - how to understand the value
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

A human-readable form of the unit.

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

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


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

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

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

0. Ingredient
Definition

An ingredient of a manufactured item or pharmaceutical product.

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

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

ShortLogical id of this artifact
Comments

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

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

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

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

ShortVersion specific identifier
Comments

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

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

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

ShortWhen the resource version last changed
Comments

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

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

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

ShortIdentifies where the resource comes from
Comments

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

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

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

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

ShortProfiles this resource claims to conform to
Comments

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

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

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

ShortSecurity Labels applied to this resource
Comments

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

Control0..*
BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
(extensible to http://hl7.org/fhir/ValueSet/security-labels
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Ingredient.meta.tag
Definition

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

ShortTags applied to this resource
Comments

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

Control0..*
BindingFor example codes, see CommonTags
(example to http://hl7.org/fhir/ValueSet/common-tags
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Ingredient.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Ingredient.text
Definition

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

ShortText summary of the resource, for human interpretation
Comments

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

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

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

ShortContained, inline Resources
Comments

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

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

An Extension

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

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

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

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

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

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

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

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

Shortdraft | active | retired | unknown
Comments

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

Control1..1
BindingThe codes SHALL be taken from PublicationStatus
(required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Ingredient.for
Definition

The product which this ingredient is a constituent part of.

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

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

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

A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.

ShortPrecise action within the drug product, e.g. antioxidant, alkalizing agent
Control0..*
BindingFor example codes, see IngredientFunction
(example to http://hl7.org/fhir/ValueSet/ingredient-function
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Ingredient.group
Definition

A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink.

ShortA classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
Control0..1
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Ingredient.allergenicIndicator
Definition

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

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

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

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

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

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

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

Shortallowed | possible | actual
Control0..1
BindingThe codes SHALL be taken from IngredientManufacturerRole
(required to http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Ingredient.manufacturer.manufacturer
Definition

An organization that manufactures this ingredient.

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

The substance that comprises this ingredient.

ShortThe substance that comprises this ingredient
Control1..1
This element is affected by the following invariants: ing-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C168628').exists() implies strength.ofType(Ratio).exists() or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthOperator').exists().not())))
cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (strength.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension').extension('strengthType').value.where(value = 'C45420').exists() implies ((strength.ofType(Ratio).exists() and strength.ofType(Ratio).numerator.code = 'C75765').exists()) or ((strength.ofType(Quantity).exists() and strength.ofType(Quantity).code = 'C75765' ).exists()))
66. Ingredient.substance.id
Definition

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

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

ShortIngredient Substance
Control1..1
This element is affected by the following invariants: ing-1
BindingFor example codes, see SNOMEDCTSubstanceCodes
(example to http://hl7.org/fhir/ValueSet/substance-codes
TypeCodeableReference(Component Substance)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Ingredient.substance.strength
Definition

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

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

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

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

An Extension

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

Values required in Ingredient.substance.strength

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

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

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

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

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

The value of the numerator.

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

ShortProduct Ingredient Amount Numeric Numerator
Comments

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

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

Precision is handled implicitly in almost all cases of measurement.

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

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

Short< | <= | >= | > | ad - how to understand the value
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

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

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

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

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

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

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

The value of the denominator.

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

ShortProduct Ingredient Amount Numeric Denominator
Comments

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

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

Precision is handled implicitly in almost all cases of measurement.

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

Not allowed to be used in this context

Short< | <= | >= | > | ad - how to understand the value
Control0..0
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

A human-readable form of the unit.

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

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

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

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

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

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

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

ShortProduct Ingredient Amount Numeric
Comments

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

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

Precision is handled implicitly in almost all cases of measurement.

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

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

Short< | <= | >= | > | ad - how to understand the value
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

A human-readable form of the unit.

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

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

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

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

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

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

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

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

ShortCoded form of the unit
Comments

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

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

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

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

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

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

The strength per unitary volume (or mass).

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

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

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

A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).

ShortA code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
Control0..1
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. Ingredient.substance.strength.measurementPoint
Definition

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

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

The country or countries for which the strength range applies.

ShortWhere the strength range applies
Control0..*
BindingFor example codes, see CountryValueSet
(example to http://hl7.org/fhir/ValueSet/country
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. Ingredient.substance.strength.referenceStrength
Definition

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

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

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

Relevant reference substance.

ShortRelevant reference substance
Control1..1
BindingFor example codes, see SNOMEDCTSubstanceCodes
(example to http://hl7.org/fhir/ValueSet/substance-codes
TypeCodeableReference(SubstanceDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. Ingredient.substance.strength.referenceStrength.strength[x]
Definition

Strength expressed in terms of a reference substance.

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

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

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

The country or countries for which the strength range applies.

ShortWhere the strength range applies
Control0..*
BindingFor example codes, see CountryValueSet
(example to http://hl7.org/fhir/ValueSet/country
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))