| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | StructureDefinition |
| Id | pq-overage-extension |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pq-overage-extension.html |
| URL | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension |
| Version | 2.0.0 |
| Status | active |
| Date | 2025-07-03T13:07:08+00:00 |
| Name | OverageExtension |
| Title | Overage Extension |
| Realm | us |
| Authority | hl7 |
| Description | Extension for measurements related to excess for ingredients in the batch formula. |
| Type | Extension |
| Kind | complex-type |
| StructureDefinition | |
| pqcmc-product-batch-formula | Drug Product Batch Formula |
No resources found
| Resource | Version |
|---|---|
| hl7.fhir.us.pq-cmc-fda#current:Bundle/BatchFormulaBundle2Layer | R5 |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pq-overage-extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension | C | 0..* | Extension | Overage Extension Constraints: cmc-overage-percent-limit |
  extension | 2..* | Extension | Extension | |
 Slices for extension | Content/Rules for all slices | |||
   extension:proportionDecimal | S | 1..1 | Extension | Extension |
  extension | 0..0 | |||
| url | 1..1 | uri | "proportionDecimal" | |
  value[x] | 0..1 | decimal | Overage Percent | |
 extension:justification | S | 1..1 | Extension | Extension |
 extension | 0..0 | |||
| url | 1..1 | uri | "justification" | |
| value[x] | 0..1 | markdown | Overage Justification | |
| url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension" | |
 value[x] | 0..0 | |||
| Documentation for this format | ||||
FHIR{
"resourceType": "StructureDefinition",
"id": "pq-overage-extension",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-bind"
},
{
"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/pq-overage-extension",
"identifier": [
{
"system": "urn:ietf:rfc:3986",
"value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.66"
}
],
"version": "2.0.0",
"name": "OverageExtension",
"title": "Overage Extension",
"status": "active",
"date": "2025-07-03T13:07:08+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": "Extension for measurements related to excess for ingredients in the batch formula.",
"jurisdiction": [
{
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "US",
"display": "United States of America"
}
]
}
],
"fhirVersion": "5.0.0",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "ManufacturedItemDefinition.component.constituent"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "5.0.0"
}
],
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Overage Extension",
"definition": "Extension for measurements related to excess for ingredients in the batch formula.",
"min": 0,
"max": "*",
"base": {
"path": "Extension",
"min": 0,
"max": "*"
},
"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"
},
{
"key": "cmc-overage-percent-limit",
"severity": "error",
"human": "Overage percent must be less than 1.0",
"expression": "extension.where(url='proportionDecimal').single().value < 1",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension"
}
],
"isModifier": false
},
{
"id": "Extension.id",
"path": "Extension.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": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 2,
"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
},
{
"id": "Extension.extension:proportionDecimal",
"path": "Extension.extension",
"sliceName": "proportionDecimal",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"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"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:proportionDecimal.id",
"path": "Extension.extension.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": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:proportionDecimal.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"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
},
{
"id": "Extension.extension:proportionDecimal.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "proportionDecimal",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:proportionDecimal.value[x]",
"path": "Extension.extension.value[x]",
"short": "Overage Percent",
"definition": "Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.\nNote: This is not for stability loss, and generally not permitted.\nExample: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API.\nThe value is entered as a decimal value less then one.",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "decimal"
}
],
"condition": [
"ext-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"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:justification",
"path": "Extension.extension",
"sliceName": "justification",
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "1",
"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"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:justification.id",
"path": "Extension.extension.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": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:justification.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"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
},
{
"id": "Extension.extension:justification.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "justification",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:justification.value[x]",
"path": "Extension.extension.value[x]",
"short": "Overage Justification",
"definition": "The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]",
"min": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "markdown"
}
],
"condition": [
"ext-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"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"min": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"short": "Value of extension",
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).",
"min": 0,
"max": "0",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "base64Binary"
},
{
"code": "boolean"
},
{
"code": "canonical"
},
{
"code": "code"
},
{
"code": "date"
},
{
"code": "dateTime"
},
{
"code": "decimal"
},
{
"code": "id"
},
{
"code": "instant"
},
{
"code": "integer"
},
{
"code": "integer64"
},
{
"code": "markdown"
},
{
"code": "oid"
},
{
"code": "positiveInt"
},
{
"code": "string"
},
{
"code": "time"
},
{
"code": "unsignedInt"
},
{
"code": "uri"
},
{
"code": "url"
},
{
"code": "uuid"
},
{
"code": "Address"
},
{
"code": "Age"
},
{
"code": "Annotation"
},
{
"code": "Attachment"
},
{
"code": "CodeableConcept"
},
{
"code": "CodeableReference"
},
{
"code": "Coding"
},
{
"code": "ContactPoint"
},
{
"code": "Count"
},
{
"code": "Distance"
},
{
"code": "Duration"
},
{
"code": "HumanName"
},
{
"code": "Identifier"
},
{
"code": "Money"
},
{
"code": "Period"
},
{
"code": "Quantity"
},
{
"code": "Range"
},
{
"code": "Ratio"
},
{
"code": "RatioRange"
},
{
"code": "Reference"
},
{
"code": "SampledData"
},
{
"code": "Signature"
},
{
"code": "Timing"
},
{
"code": "ContactDetail"
},
{
"code": "DataRequirement"
},
{
"code": "Expression"
},
{
"code": "ParameterDefinition"
},
{
"code": "RelatedArtifact"
},
{
"code": "TriggerDefinition"
},
{
"code": "UsageContext"
},
{
"code": "Availability"
},
{
"code": "ExtendedContactDetail"
},
{
"code": "Dosage"
},
{
"code": "Meta"
}
],
"condition": [
"ext-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"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
}
]
},
"differential": {
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Overage Extension",
"definition": "Extension for measurements related to excess for ingredients in the batch formula.",
"constraint": [
{
"key": "cmc-overage-percent-limit",
"severity": "error",
"human": "Overage percent must be less than 1.0",
"expression": "extension.where(url='proportionDecimal').single().value < 1",
"source": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension"
}
]
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"min": 2
},
{
"id": "Extension.extension:proportionDecimal",
"path": "Extension.extension",
"sliceName": "proportionDecimal",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:proportionDecimal.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:proportionDecimal.url",
"path": "Extension.extension.url",
"fixedUri": "proportionDecimal"
},
{
"id": "Extension.extension:proportionDecimal.value[x]",
"path": "Extension.extension.value[x]",
"short": "Overage Percent",
"definition": "Overage is the proportion of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.\nNote: This is not for stability loss, and generally not permitted.\nExample: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API.\nThe value is entered as a decimal value less then one.",
"type": [
{
"code": "decimal"
}
]
},
{
"id": "Extension.extension:justification",
"path": "Extension.extension",
"sliceName": "justification",
"min": 1,
"max": "1",
"mustSupport": true
},
{
"id": "Extension.extension:justification.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:justification.url",
"path": "Extension.extension.url",
"fixedUri": "justification"
},
{
"id": "Extension.extension:justification.value[x]",
"path": "Extension.extension.value[x]",
"short": "Overage Justification",
"definition": "The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]",
"type": [
{
"code": "markdown"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}