FHIR Server FHIR Server Version n/a

Resource StructureDefinition/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (984 ms)

Package
hl7.fhir.us.pq-cmc-fda
Type
StructureDefinition
FHIR Version
Source
http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-excipient.html
Url
http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
Version
2.0.0
Status
active
Date
2025-06-19T20:23:28+00:00
Name
ExcipientRaw
Title
Excipient Drug Substance
Experimental
False
Realm
Authority
hl7
Description
Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
Type
SubstanceDefinition
Kind
resource
Resources that use this resource

StructureDefinition
cmc-ectd-document-32p32
CMC eCTD 32P32 Document
cmc-ectd-document-32s23
CMC eCTD 32S23 Document
cmc-ectd-document-sp4151
CMC eCTD SP4151 Document
pqcmc-dp-ingredient
Drug Product Batch Formula Ingredient
pqcmc-quality-specification
Quality Specification
Resources that this resource uses

StructureDefinition
cmc-organization
Basic Organization
codeable-concept-text-only
Text Only Codeable Concept
literal-reference
Literal Reference
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect
GENC and ISO 3166 Intersection
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
Quality Benchmark Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
Source Type Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type
Substance Name Type
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
Substance Classification
Narrative

Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-excipient
Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition	C	0..*	SubstanceDefinition	The detailed description of a substance, typically at a level beyond what is used for prescribing Constraints: cmc-when-unii-required, cmc-name-isbt, cmc-source-material
identifier		0..1	Identifier	optional user designated identifier
classification	S	1..1	CodeableConcept	Substance Type Binding: Substance Classification (required)
grade		1..*	CodeableConcept	Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer	S	0..*	LiteralReference(Basic Organization) {b }	The entity that creates, makes, produces or fabricates the substance
supplier	S	0..1	LiteralReference(Basic Organization) {b }	An entity that is the source for the substance. It may be different from the manufacturer
Slices for code	S	1..*	BackboneElement	Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:unii	S	0..1	BackboneElement	UNII
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt	S	0..1	BackboneElement	UniProt ID
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: http://terminology.hl7.org/NamingSystem/UniProt
Slices for name	SC	1..*	BackboneElement	Substance Name Slice: Unordered, Closed by value:type Constraints: cmc-name-preferred
name:All Slices				Content/Rules for all slices
type		0..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required)
preferred	S	0..1	boolean	True when the name type is Substance Name
name:sub	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	Generic Name
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C97054
display		1..1	string	Representation defined by the system Fixed Value: Generic Name
preferred	S	0..1	boolean	True when the name type is Substance Name
name:gsrs	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	GSRS Preferred Term
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C203355
display		1..1	string	Representation defined by the system Fixed Value: GSRS Preferred Term
preferred	S	0..1	boolean	True when the name type is Substance Name
name:isbt	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	ISBT-128 DIN
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C95517
display		1..1	string	Representation defined by the system Fixed Value: ISBT-128 DIN
preferred	S	0..1	boolean	True when the name type is Substance Name
sourceMaterial	S	1..1	BackboneElement	Material or taxonomic/anatomical source
type		1..1	CodeableConcept	Source Type Binding: Source Type Terminology (required)
genus	S	0..1	CodeableConceptTextOnly	Source Organism Genus
species	S	0..1	CodeableConceptTextOnly	Source Organism Species
part	S	0..1	CodeableConceptTextOnly	Source Organism Part
countryOfOrigin	S	0..1	CodeableConcept	Source Organism Country of Origin Binding: GENC and ISO 3166 Intersection (required)
Documentation for this format
Source

{
  "resourceType" : "StructureDefinition",
  "id" : "pqcmc-excipient",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition pqcmc-excipient</b></p><a name=\"pqcmc-excipient\"> </a><a name=\"hcpqcmc-excipient\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition\">SubstanceDefinition</a><a name=\"SubstanceDefinition\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-when-unii-required, cmc-name-isbt, cmc-source-material )\">C</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/substancedefinition.html\">SubstanceDefinition</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The detailed description of a substance, typically at a level beyond what is used for prescribing</span><br class=\"constraint\"/><span title=\"null\" class=\"constraint\">Constraints: </span><span style=\"font-weight:bold\" title=\"A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'\" class=\"constraint\">cmc-when-unii-required</span><span title=\"null\" class=\"constraint\">, </span><span style=\"font-weight:bold\" title=\"Name.type ISBT 128 required for blood products.\" class=\"constraint\">cmc-name-isbt</span><span title=\"null\" class=\"constraint\">, </span><span style=\"font-weight:bold\" title=\"IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.\" class=\"constraint\">cmc-source-material</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.identifier\">identifier</a><a name=\"SubstanceDefinition.identifier\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">optional user designated identifier</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.classification\" title=\"A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.\n[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]\">classification</a><a name=\"SubstanceDefinition.classification\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Substance Type<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-substance-classification.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification\" class=\"binding\">Substance Classification</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.grade\" title=\"The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard\">grade</a><a name=\"SubstanceDefinition.grade\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Quality Standard<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-pqcmc-quality-benchmark-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology\" class=\"binding\">Quality Benchmark Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.manufacturer\">manufacturer</a><a name=\"SubstanceDefinition.manufacturer\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-literal-reference.html\" title=\"Literal Reference\">LiteralReference</a>(<a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a>)<a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\"> {</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\" title=\"When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.\">b</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\">}</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The entity that creates, makes, produces or fabricates the substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.supplier\">supplier</a><a name=\"SubstanceDefinition.supplier\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-literal-reference.html\" title=\"Literal Reference\">LiteralReference</a>(<a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a>)<a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\"> {</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\" title=\"When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.\">b</a><a href=\"http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html\">}</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">An entity that is the source for the substance. It may be different from the manufacturer</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic; font-style: italic\" href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code\">Slices for code</a><a name=\"SubstanceDefinition.code\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">1</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic; opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">Codes associated with the substance</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by value:code.coding.system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii\" title=\"Slice unii: The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/\">code:unii</a><a name=\"SubstanceDefinition.code.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UNII</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code\">code</a><a name=\"SubstanceDefinition.code.code\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">http://fdasis.nlm.nih.gov</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt\" title=\"Slice uniProt: The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/\">code:uniProt</a><a name=\"SubstanceDefinition.code.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UniProt ID</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code\">code</a><a name=\"SubstanceDefinition.code.code.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">http://terminology.hl7.org/NamingSystem/UniProt</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic; font-style: italic\" href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name\" title=\"Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF\">Slices for name</a><a name=\"SubstanceDefinition.name\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-name-preferred )\">C</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">1</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic; opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Substance Name</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:type</span><br style=\"font-style: italic\" class=\"constraint\"/><span style=\"font-style: italic\" title=\"null\" class=\"constraint\">Constraints: </span><span style=\"font-weight:bold; font-style: italic\" title=\"Name.preferred: at most one = true\" class=\"constraint\">cmc-name-preferred</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> name:All Slices<a name=\"SubstanceDefinition.name.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1330.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name.type\">type</a><a name=\"SubstanceDefinition.name.type\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span><br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-pqcmc-substance-name-type.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type\" class=\"binding\">Substance Name Type</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1320.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">True when the name type is Substance Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub\" title=\"Slice sub\">name:sub</a><a name=\"SubstanceDefinition.name.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.name\" title=\"A non-branded nor registered name that meant for common use.\">name</a><a name=\"SubstanceDefinition.name.name\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Generic Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.type\">type</a><a name=\"SubstanceDefinition.name.type.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding\">coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C97054</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">Generic Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">True when the name type is Substance Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs\" title=\"Slice gsrs\">name:gsrs</a><a name=\"SubstanceDefinition.name.4\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.name\" title=\"Default display name identified within FDA Global Substance Registration System (GSRS).\">name</a><a name=\"SubstanceDefinition.name.name.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">GSRS Preferred Term</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.type\">type</a><a name=\"SubstanceDefinition.name.type.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding\">coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C203355</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">GSRS Preferred Term</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">True when the name type is Substance Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt\" title=\"Slice isbt\">name:isbt</a><a name=\"SubstanceDefinition.name.5\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.name\" title=\"It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]\">name</a><a name=\"SubstanceDefinition.name.name.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ISBT-128 DIN</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.type\">type</a><a name=\"SubstanceDefinition.name.type.4\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding\">coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Code defined by a terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">(complex)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C95517</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">ISBT-128 DIN</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.4\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">True when the name type is Substance Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial\">sourceMaterial</a><a name=\"SubstanceDefinition.sourceMaterial\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Material or taxonomic/anatomical source</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.type\" title=\"A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type \">type</a><a name=\"SubstanceDefinition.sourceMaterial.type\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Type<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-pqcmc-source-type-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology\" class=\"binding\">Source Type Terminology</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.genus\" title=\"The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.\">genus</a><a name=\"SubstanceDefinition.sourceMaterial.genus\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Genus</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.species\" title=\"The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.\">species</a><a name=\"SubstanceDefinition.sourceMaterial.species\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Species</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_datatype.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.part\" title=\"A fragment of the source organism. [Source: SME Defined]\nExamples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.\nIDMP 11238 definition &amp; examples: Entity of anatomical origin of source material within an organism.\nCartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal\">part</a><a name=\"SubstanceDefinition.sourceMaterial.part\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-codeable-concept-text-only.html\" title=\"CodeableConcept\">CodeableConceptTextOnly</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Part</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.countryOfOrigin\" title=\"The name of the country where the organism was reared. [Source: SME Defined]\">countryOfOrigin</a><a name=\"SubstanceDefinition.sourceMaterial.countryOfOrigin\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Country of Origin<br class=\"binding\"/><span style=\"font-weight:bold\" title=\"null\" class=\"binding\">Binding: </span><a href=\"ValueSet-pqcmc-genc-and-iso-intersect.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect\" class=\"binding\">GENC and ISO 3166 Intersection</a><span title=\"null\" class=\"binding\"> (</span><a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" class=\"binding\">required</a><span title=\"null\" class=\"binding\">)</span></td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 2,
      "_valueInteger" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use",
      "_valueCode" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.42.27"
    }
  ],
  "version" : "2.0.0",
  "name" : "ExcipientRaw",
  "title" : "Excipient Drug Substance",
  "status" : "active",
  "date" : "2025-06-19T20:23:28+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system" : "email",
          "value" : "brr@lists.HL7.org"
        }
      ]
    }
  ],
  "description" : "Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "fhirVersion" : "5.0.0",
  "mapping" : [
    {
      "identity" : "w5",
      "uri" : "http://hl7.org/fhir/fivews",
      "name" : "FiveWs Pattern Mapping"
    },
    {
      "identity" : "idmp-substance",
      "uri" : "https://www.iso.org/obp/ui/#iso:std:iso:11238",
      "name" : "IDMP Mapping (Substance)"
    },
    {
      "identity" : "rim",
      "uri" : "http://hl7.org/v3",
      "name" : "RIM Mapping"
    }
  ],
  "kind" : "resource",
  "abstract" : false,
  "type" : "SubstanceDefinition",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
  "derivation" : "constraint",
  "snapshot" : {
    "extension" : [
      {
        "url" : "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
        "valueString" : "5.0.0"
      }
    ],
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "short" : "The detailed description of a substance, typically at a level beyond what is used for prescribing",
        "definition" : "The detailed description of a substance, typically at a level beyond what is used for prescribing.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition",
          "min" : 0,
          "max" : "*"
        },
        "constraint" : [
          {
            "key" : "dom-2",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
            "expression" : "contained.contained.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-3",
            "severity" : "error",
            "human" : "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",
            "expression" : "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()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-4",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
            "expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-5",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
            "expression" : "contained.meta.security.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
                "valueBoolean" : true
              },
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
                "valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
              }
            ],
            "key" : "dom-6",
            "severity" : "warning",
            "human" : "A resource should have narrative for robust management",
            "expression" : "text.`div`.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "cmc-when-unii-required",
            "severity" : "error",
            "human" : "A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'",
            "expression" : "(classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()\nimplies code.where(\n  code.coding.exists(system = 'http://fdasis.nlm.nih.gov')\n).exists())\n and (classification.coding.where(\n  system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and\n  code = 'C17021'\n).exists() implies code.where(\n  code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt')\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-name-isbt",
            "severity" : "error",
            "human" : "Name.type ISBT 128 required for blood products.",
            "expression" : "classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl')",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-source-material",
            "severity" : "error",
            "human" : "IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.",
            "expression" : "sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()\nimplies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Entity, Role, or Act"
          },
          {
            "identity" : "w5",
            "map" : "administrative.medication"
          },
          {
            "identity" : "idmp-substance",
            "map" : "Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.id",
        "path" : "SubstanceDefinition.id",
        "short" : "Logical id of this artifact",
        "definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
        "comment" : "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta",
        "path" : "SubstanceDefinition.meta",
        "short" : "Metadata about the resource",
        "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.meta",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Meta"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.implicitRules",
        "path" : "SubstanceDefinition.implicitRules",
        "short" : "A set of rules under which this content was created",
        "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.",
        "comment" : "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.implicitRules",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : true,
        "isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.language",
        "path" : "SubstanceDefinition.language",
        "short" : "Language of the resource content",
        "definition" : "The base language in which the resource is written.",
        "comment" : "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).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.language",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        }
      },
      {
        "id" : "SubstanceDefinition.text",
        "path" : "SubstanceDefinition.text",
        "short" : "Text summary of the resource, for human interpretation",
        "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.",
        "comment" : "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.",
        "alias" : [
          "narrative",
          "html",
          "xhtml",
          "display"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "DomainResource.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Narrative"
          }
        ],
        "condition" : [
          "dom-6"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Act.text?"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.contained",
        "path" : "SubstanceDefinition.contained",
        "short" : "Contained, inline Resources",
        "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.",
        "comment" : "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.",
        "alias" : [
          "inline resources",
          "anonymous resources",
          "contained resources"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.contained",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Resource"
          }
        ],
        "condition" : [
          "dom-2",
          "dom-4",
          "dom-3",
          "dom-5"
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.extension",
        "path" : "SubstanceDefinition.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.modifierExtension",
        "path" : "SubstanceDefinition.modifierExtension",
        "short" : "Extensions that cannot be ignored",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "mustSupport" : false,
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.identifier",
        "path" : "SubstanceDefinition.identifier",
        "short" : "optional user designated identifier",
        "definition" : "Identifier by which this substance is known.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.identifier",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.version",
        "path" : "SubstanceDefinition.version",
        "short" : "A business level version identifier of the substance",
        "definition" : "A business level version identifier of the substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.version",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Version.Version_Number"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.status",
        "path" : "SubstanceDefinition.status",
        "short" : "Status of substance within the catalogue e.g. active, retired",
        "definition" : "Status of substance within the catalogue e.g. active, retired.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.classification",
        "path" : "SubstanceDefinition.classification",
        "short" : "Substance Type",
        "definition" : "A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.\n[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.classification",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.domain",
        "path" : "SubstanceDefinition.domain",
        "short" : "If the substance applies to human or veterinary use",
        "definition" : "If the substance applies to human or veterinary use.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.domain",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "MedicinalProductType"
            }
          ],
          "strength" : "example",
          "description" : "Applicable domain for this product (e.g. human, veterinary).",
          "valueSet" : "http://hl7.org/fhir/ValueSet/medicinal-product-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.grade",
        "path" : "SubstanceDefinition.grade",
        "short" : "Quality Standard",
        "definition" : "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
        "min" : 1,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.grade",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Specified_Substance_Group_3.Grade"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.description",
        "path" : "SubstanceDefinition.description",
        "short" : "Textual description of the substance",
        "definition" : "Textual description of the substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.description",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "markdown"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Comment"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.informationSource",
        "path" : "SubstanceDefinition.informationSource",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.informationSource",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Citation"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.note",
        "path" : "SubstanceDefinition.note",
        "short" : "Textual comment about the substance's catalogue or registry record",
        "definition" : "Textual comment about the substance's catalogue or registry record.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.note",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Annotation"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.manufacturer",
        "path" : "SubstanceDefinition.manufacturer",
        "short" : "The entity that creates, makes, produces or fabricates the substance",
        "definition" : "The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.manufacturer",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.supplier",
        "path" : "SubstanceDefinition.supplier",
        "short" : "An entity that is the source for the substance. It may be different from the manufacturer",
        "definition" : "An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.supplier",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety",
        "path" : "SubstanceDefinition.moiety",
        "short" : "Moiety, for structural modifications",
        "definition" : "Moiety, for structural modifications.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.moiety",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Moiety"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.id",
        "path" : "SubstanceDefinition.moiety.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.extension",
        "path" : "SubstanceDefinition.moiety.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.modifierExtension",
        "path" : "SubstanceDefinition.moiety.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.role",
        "path" : "SubstanceDefinition.moiety.role",
        "short" : "Role that the moiety is playing",
        "definition" : "Role that the moiety is playing.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.role",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Role"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.identifier",
        "path" : "SubstanceDefinition.moiety.identifier",
        "short" : "Identifier by which this moiety substance is known",
        "definition" : "Identifier by which this moiety substance is known.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.identifier",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.name",
        "path" : "SubstanceDefinition.moiety.name",
        "short" : "Textual name for this moiety substance",
        "definition" : "Textual name for this moiety substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.name",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Moiety_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.stereochemistry",
        "path" : "SubstanceDefinition.moiety.stereochemistry",
        "short" : "Stereochemistry type",
        "definition" : "Stereochemistry type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.stereochemistry",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceStereochemistry"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-stereochemistry"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Stereochemistry"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.opticalActivity",
        "path" : "SubstanceDefinition.moiety.opticalActivity",
        "short" : "Optical activity type",
        "definition" : "Optical activity type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.opticalActivity",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceOpticalActivity"
            }
          ],
          "strength" : "example",
          "description" : "The optical rotation type of a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-optical-activity"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Optical_Activity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.molecularFormula",
        "path" : "SubstanceDefinition.moiety.molecularFormula",
        "short" : "Molecular formula for this moiety (e.g. with the Hill system)",
        "definition" : "Molecular formula for this moiety of this substance, typically using the Hill system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.molecularFormula",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Molecular_Formula"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.amount[x]",
        "path" : "SubstanceDefinition.moiety.amount[x]",
        "short" : "Quantitative value for this moiety",
        "definition" : "Quantitative value for this moiety.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.amount[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          },
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Amount"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.measurementType",
        "path" : "SubstanceDefinition.moiety.measurementType",
        "short" : "The measurement type of the quantitative value",
        "definition" : "The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.measurementType",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceAmountType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-amount-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Amount.Amount_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization",
        "path" : "SubstanceDefinition.characterization",
        "short" : "General specifications for this substance",
        "definition" : "General specifications for this substance.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.characterization",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.id",
        "path" : "SubstanceDefinition.characterization.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.extension",
        "path" : "SubstanceDefinition.characterization.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.characterization.modifierExtension",
        "path" : "SubstanceDefinition.characterization.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
         "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.extension",
        "path" : "SubstanceDefinition.structure.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
      &n           "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.id",
        "path" : "SubstanceDefinition.code.code.id",
        "representation" : [        "base" : {
          "path" : "Coding.display",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "cod-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
         "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C203355",
              "display" : "GSRS Preferred Term"
            }
          ]
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C95517",
              "display" : "ISBT-128 DIN"
            }
          ]
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship",
        "path" : "SubstanceDefinition.relationship",
        "short" : "A link between this substance and another",
        "definition" : "A link between this substance and another, with details of the relationship.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Reference_Information.Relationship"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.id",
        "path" : "SubstanceDefinition.relationship.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.extension",
        "path" : "SubstanceDefinition.relationship.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.modifierExtension",
        "path" : "SubstanceDefinition.relationship.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "short" : "A pointer to another substance, as a resource or a representational code",
        "definition" : "A pointer to another substance, as a resource or just a representational code.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"
            ]
          },
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Related_Substance_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.type",
        "path" : "SubstanceDefinition.relationship.type",
        "short" : "For example \"salt to parent\", \"active moiety\"",
        "definition" : "For example \"salt to parent\", \"active moiety\", \"starting material\", \"polymorph\", \"impurity of\".",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceRelationshipType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-relationship-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Relationship_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.isDefining",
        "path" : "SubstanceDefinition.relationship.isDefining",
        "short" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships",
        "definition" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.isDefining",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Is_Defining"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.amount[x]",
        "path" : "SubstanceDefinition.relationship.amount[x]",
        "short" : "A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other",
        "definition" : "A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.amount[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "short" : "For use when the numeric has an uncertain range",
        "definition" : "For use when the numeric has an uncertain range.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Ratio"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity.High_Limit"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.comparator",
        "path" : "SubstanceDefinition.relationship.comparator",
        "short" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\"",
        "definition" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\".",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceAmountType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-amount-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.source",
        "path" : "SubstanceDefinition.relationship.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.nucleicAcid",
        "path" : "SubstanceDefinition.nucleicAcid",
        "short" : "Data items specific to nucleic acids",
        "definition" : "Data items specific to nucleic acids.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.nucleicAcid",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceNucleicAcid"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to add specifics of Nucleic Acids to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.polymer",
        "path" : "SubstanceDefinition.polymer",
        "short" : "Data items specific to polymers",
        "definition" : "Data items specific to polymers.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.polymer",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstancePolymer"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Polymers to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.protein",
        "path" : "SubstanceDefinition.protein",
        "short" : "Data items specific to proteins",
        "definition" : "Data items specific to proteins.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.protein",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceProtein"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Proteins to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial",
        "path" : "SubstanceDefinition.sourceMaterial",
        "short" : "Material or taxonomic/anatomical source",
        "definition" : "Material or taxonomic/anatomical source for the substance.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Source_Material"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.id",
        "path" : "SubstanceDefinition.sourceMaterial.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.extension",
        "path" : "SubstanceDefinition.sourceMaterial.extension",
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "path" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "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.",
        "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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type",
        "path" : "SubstanceDefinition.sourceMaterial.type",
        "short" : "Source Type",
        "definition" : "A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type ",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Source_Material_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus",
        "path" : "SubstanceDefinition.sourceMaterial.genus",
        "short" : "Source Organism Genus",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.genus",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialGenus"
            }
          ],
          "strength" : "example",
          "description" : "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-genus"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Organism.Genus"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species",
        "path" : "SubstanceDefinition.sourceMaterial.species",
        "short" : "Source Organism Species",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.species",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialSpecies"
            }
          ],
          "strength" : "example",
          "description" : "A species of origin a substance raw material.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-species"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Organism.Species"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.part",
        "path" : "SubstanceDefinition.sourceMaterial.part",
        "short" : "Source Organism Part",
        "definition" : "A fragment of the source organism. [Source: SME Defined]\nExamples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.\nIDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism.\nCartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.part",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialPart"
            }
          ],
          "strength" : "example",
          "description" : "An anatomical origin of the source material within an organism.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-part"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Part_Description.Part"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "short" : "Source Organism Country of Origin",
        "definition" : "The name of the country where the organism was reared. [Source: SME Defined]",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Country_Of_Origin"
          }
        ]
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "constraint" : [
          {
            "key" : "cmc-when-unii-required",
            "severity" : "error",
            "human" : "A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'",
            "expression" : "(classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()\nimplies code.where(\n  code.coding.exists(system = 'http://fdasis.nlm.nih.gov')\n).exists())\n and (classification.coding.where(\n  system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and\n  code = 'C17021'\n).exists() implies code.where(\n  code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt')\n).exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-name-isbt",
            "severity" : "error",
            "human" : "Name.type ISBT 128 required for blood products.",
            "expression" : "classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl')",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-source-material",
            "severity" : "error",
            "human" : "IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.",
            "expression" : "sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()\nimplies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.identifier",
        "path" : "SubstanceDefinition.identifier",
        "short" : "optional user designated identifier",
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.classification",
        "path" : "SubstanceDefinition.classification",
        "short" : "Substance Type",
        "definition" : "A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.\n[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"
        }
      },
      {
        "id" : "SubstanceDefinition.grade",
        "path" : "SubstanceDefinition.grade",
        "short" : "Quality Standard",
        "definition" : "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
        "min" : 1,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
        }
      },
      {
        "id" : "SubstanceDefinition.manufacturer",
        "path" : "SubstanceDefinition.manufacturer",
        "type" : [
          {
            "code" : "Reference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.supplier",
        "path" : "SubstanceDefinition.supplier",
        "max" : "1",
        "type" : [
          {
            "code" : "Reference",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"
            ],
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ],
            "aggregation" : [
              "bundled"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code",
        "path" : "SubstanceDefinition.code",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code.coding.system"
            }
          ],
          "rules" : "open"
        },
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "unii",
        "short" : "UNII",
        "definition" : "The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "http://fdasis.nlm.nih.gov",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "uniProt",
        "short" : "UniProt ID",
        "definition" : "The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "http://terminology.hl7.org/NamingSystem/UniProt",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name",
        "path" : "SubstanceDefinition.name",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type"
            }
          ],
          "description" : "Slice based on value pattern",
          "rules" : "closed"
        },
        "short" : "Substance Name",
        "definition" : "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-name-preferred",
            "severity" : "error",
            "human" : "Name.preferred: at most one = true",
            "expression" : "select(preferred = true).count() < 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name.type",
        "path" : "SubstanceDefinition.name.type",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"
        }
      },
      {
        "id" : "SubstanceDefinition.name.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "sub",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Generic Name",
        "definition" : "A non-branded nor registered name that meant for common use.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C97054",
              "display" : "Generic Name"
            }
          ]
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C203355",
              "display" : "GSRS Preferred Term"
            }
          ]
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "patternCodeableConcept" : {
          "coding" : [
            {
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C95517",
              "display" : "ISBT-128 DIN"
            }
          ]
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial",
        "path" : "SubstanceDefinition.sourceMaterial",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type",
        "path" : "SubstanceDefinition.sourceMaterial.type",
        "short" : "Source Type",
        "definition" : "A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type ",
        "min" : 1,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"
        }
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus",
        "path" : "SubstanceDefinition.sourceMaterial.genus",
        "short" : "Source Organism Genus",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species",
        "path" : "SubstanceDefinition.sourceMaterial.species",
        "short" : "Source Organism Species",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.part",
        "path" : "SubstanceDefinition.sourceMaterial.part",
        "short" : "Source Organism Part",
        "definition" : "A fragment of the source organism. [Source: SME Defined]\nExamples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.\nIDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism.\nCartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "short" : "Source Organism Country of Origin",
        "definition" : "The name of the country where the organism was reared. [Source: SME Defined]",
        "max" : "1",
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect"
        }
      }
    ]
  }
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.