Credential Schema

In November 2013, the U.S. Congress enacted the Drug Supply Chain Security Act (DSCSA) in order to intercept drugs that may be counterfeit, stolen, contaminated, or otherwise harmful and better safeguard patient health. To ensure that only legitimate actors are part of the supply chain, the regulation establishes a definition of Authorized Trading Partners (ATPs) and associated licensing requirements for different types of stakeholders. Not only must U.S. pharmaceutical trading partners be authorized (as defined in the statute), but also to ensure that they only interact with other trading partners that are also authorized.

In addition, the U.S. pharmaceutical supply chain includes two other major groups: Authorities (e.g. federal and state regulators) and ATP-Equivalents (i.e. trading partners that are not required to register with the FDA or obtain a State license, such as the Veterans Administration, Department of Defense, etc.). Together, these "DSCSA Stakeholders" (or "Stakeholders") represent the three key groups for DSCSA interoperability.

The Open Credentialing Initiative (OCI) has come together to support the industry-wide implementation and adoption of the architecture demonstrated in the ATP Proof of Concept and Pilot conducted in 2020. This architecture supports the ATP requirements of the DSCSA and employs the use of W3C-standard Decentralized Identifiers, Verifiable Credentials, Verifiable Presentations, Credential Revocation Registries, and the necessary processes and information exchanges between DSCSA-defined Stakeholders to establish mutual verification of identity and licensure status.

This specification describes a Linked Data vocabulary for asserting organization-level identity verification and license status of manufacturers, repackagers, wholesalers, third-party logistics providers (3PLs), dispensers, ATP-Equivalents, and authorities used to verify a counterparty identity and to determine the ATP licenses of supply chain actors (where applicable). (Note that the JSON objects described later in this specification bear their own version numbers, as the changes in the 1.X.0 revision are limited to this specification document.)

Identity Credential

Identity Credential assures that the Credential Issuer performs an identity verification process and that the subject DID is a trusted entity.

Term	IdentityCredential
Full IRI	https://open-credentialing-initiative.github.io/schemas/credentials/IdentityCredential-v1.0.0.jsonld

Identity Credential Metadata

Term	Description	Full IRI
Credential Type	Declares what data to expect in the credential	https://www.w3.org/2018/credentials/v1
Credential ID	Identifier of the credential as a URN containing a unique UUID in version 4 UUID format such as the following example: urn:oci:uuid:6d7096c7-96ba-44e5-b448-ddd0364f6dc3	https://www.w3.org/2018/credentials/v1
Issuer DID	Decentralized Identifier of the credential issuer	https://www.w3.org/2018/credentials/v1
Credential Issuance Date	Issuance date	https://www.w3.org/2018/credentials/v1
Credential Expiration Date	Expiration date	https://www.w3.org/2018/credentials/v1
Revocation	Details about mechanisms to check the credential status.	vc-status-2021-ldap:RevocationStatus2021LDAP
Revocation ID	Location of revocation list	https://github.com/Spherity/vc-status-2021-ldap
Revocation Type	Method for accessing revocation list
Credential Claim Type	Property describing the type of the subject	IdentityCredential
Subject DID	Identifier of the subject holding the credential	https://www.w3.org/2018/credentials/v1
Issuer Signature	Digital proof mechanisms, a subset of which are digital signatures, are required to ensure the protection of a verifiable credential	https://www.w3.org/2018/credentials/v1

Claim: Subject Name

Subject company/organization legal name. Entity that is able to send requests to other trading partners might not be a legal entity itself.

Term	legalName
Full IRI	https://schema.org/legalName

Claim: Issuer Name

Credential Issuer company/organization legal name. Name of the legal Entity that issued the Credential to the subject.

Term	issuerName
Full IRI	https://schema.org/legalName

Claim: Subject Parent Organization

Legal entity of the Credential subjects parent organization.

Term	parentOrganization
Full IRI	https://schema.org/parentOrganization

Claim: Street Address

The street address is expressed as free form text. The street address is printed on paper as the first lines below the name. For example, the name of the street and the number in the street or the name of a building.

Term	streetAddress
Full IRI	https://schema.org/streetAddress

Claim: Address Locality

Text specifying the name of the locality; for example, a city.

Term	addressLocality
Full IRI	https://schema.org/addressLocality

Claim: Address Region

Text specifying a province or state in abbreviated format; for example, NJ.

Term	addressRegion
Full IRI	https://schema.org/addressRegion

Claim: Postal Code

Text specifying the postal code for an address.

Term	postalCode
Full IRI	https://schema.org/postalCode

Claim: Country

Text specifying the country for an address.

Term	addressCountry
Full IRI	https://schema.org/addressCountry

Example Identity Credential

            {
              "@context":[
                 "https://www.w3.org/2018/credentials/v1",
                 "https://open-credentialing-initiative.github.io/schemas/credentials/IdentityCredential-v1.0.0.jsonld",
                 "https://spherity.github.io/vc-status-2021-ldap/contexts/vc-status-2021-ldap/v1.jsonld",
                 "https://w3c-ccg.github.io/lds-jws2020/contexts/lds-jws2020-v1.json"
              ],
              "id":"http://example.gov/credentials/3732",
              "type":[
                 "VerifiableCredential"
              ],
              "issuer":{
                 "id":"did:ethr:0xb9c5714089478a327f09197987f16f9e5d936e8a"
              },
              "issuanceDate":"2020-03-10T04:24:12.164Z",
              "expirationDate":"2022-03-10T04:24:12.164Z",
              "credentialSubject":{
                 "id":"did:ethr:0xa9d5414089178a327f09197987f16f9e5d936e8a",
                 "type":"IdentityCredential",
                 "issuerName":"IssuerCompany Corp.",
                 "legalName":"Testcompany",
                 "parentOrganization":"Testparent",
                 "streetAddress":"Test Street 123",
                 "addressLocality":"Testlocality",
                 "addressRegion":"Testregion",
                 "postalCode":"12345",
                 "addressCountry":"USA"
              },
              "credentialStatus":{
                 "id":"ldaps://93.184.216.34:636/o=dolor,cn=ipsum,ou=lorem,dc=example,dc=com",
                 "type":"RevocationStatus2021LDAP",
                 "ssl":true,
                 "host":"93.184.216.34:636",
                 "query":"o={{0}},cn={{1}},ou={{2}},dc={{3}},dc={{4}}",
                 "params":[
                    "dolor",
                    "ipsum",
                    "lorem",
                    "example",
                    "com"
                 ]
              },
              "proof":{
                 "type":"JsonWebSignature2020",
                 "created":"2021-11-04T13:23:03.149Z",
                 "jws":"eyJhbGciOiJFUzI1NksiLCJiNjQiOmZhbHNlLCJjcml0IjpbImI2NCJdfQ..l8gFYIPwzhfNTONEtOomCNSDWhuMsl87_xnhTMPEkil7cdhCU-z49K984HPp_45_NnvmOqBWWjI5VaFcl4qXXg",
                 "proofPurpose":"assertionMethod",
                 "verificationMethod":"did:ethr:0xb9c5714089478a327f09197987f16f9e5d936e8a"
              }
           }

DSCSA Stakeholder Credential Schemas

As mentioned previously, there are three key groups for DSCSA interoperability: ATPs, ATP-Equivalents, and Authorities. Each Stakeholder type has its own distinct schema: (1) the DSCSA ATP Credential, which represents and verifies a subject as an authorized trading partner; (2) the DSCSA ATP-Equivalent Credential, which represents and verifies a subject as a trading partner that is not required to register with the FDA or obtain a State license; and (3) the DSCSA Authority Credential, which represents and verifies a subject as an authority as outlined under the statue or is generally recognized by industry (see OCI Conformance Criteria for Credential Issuers for more details).

Term	DSCSAATPCredential
Full IRI	https://open-credentialing-initiative.github.io/schemas/credentials/DSCSAATPCredential-v1.0.0.jsonld
Term	DSCSAATPEquivalentCredential
Full IRI	https://open-credentialing-initiative.github.io/schemas/credentials/DSCSAATPEquivalentCredential-v1.0.0.jsonld
Term	DSCSAAuthorityCredential
Full IRI	https://open-credentialing-initiative.github.io/schemas/credentials/DSCSAAuthorityCredential-v1.0.0.jsonld

While each credential type has its own schema, the same types of metadata and claims are shared across all three, unless otherwise noted below.

DSCSA Stakeholder Credential Metadata

Term	Description	Full IRI
Credential Type	Declares what data to expect in the credential	https://www.w3.org/2018/credentials/v1
Credential ID	Identifier of the credential as a URN containing a unique UUID in version 4 UUID format such as the following example: urn:oci:uuid:6d7096c7-96ba-44e5-b448-ddd0364f6dc3	https://www.w3.org/2018/credentials/v1
Issuer DID	Decentralized Identifier of the credential issuer	https://www.w3.org/2018/credentials/v1
Issuer	Name of the Credential Issuer	https://www.w3.org/2018/credentials/v1
Credential Issuance Date	Issuance date	https://www.w3.org/2018/credentials/v1
Credential Expiration Date	Expiration date	https://www.w3.org/2018/credentials/v1
Revocation	Details about mechanisms to check the credential status.	vc-status-2021-ldap:RevocationStatus2021LDAP
Revocation ID	Location of revocation list	https://github.com/Spherity/vc-status-2021-ldap
Revocation Type	Method for accessing revocation list
Credential Claim Type	Property describing the type of the subject	DSCSAATPCredential, DSCSAATPEquivalentCredential, or DSCSAAuthorityCredential
Subject DID	Identifier of the subject holding the credential	https://www.w3.org/2018/credentials/v1
Issuer Signature	Digital proof mechanisms, a subset of which are digital signatures, are required to ensure the protection of a verifiable credential	https://www.w3.org/2018/credentials/v1

Claim: Organization Type

Type of credential subject: can be Manufacturer, Repackager, Wholesaler, 3PL, or Dispenser. Note that this claim is not present in the Authority credential. For more information about how Organization Type is ascribed to ATPs and ATP-Equivalents, see section 5 of the Credential Issuer Conformance Criteria.

Under the DSCSA, a trading partner can fit into one or more categories, depending on their business practices. Only one Organization Type can be specified in a credential. In many cases, OCI expects that organizations will wish to have only a single Stakeholder credential with its single Organization Type. For example, a Wholesaler with 3PL and repackaging divisions may face up to the community as a Wholesaler, if that aligns with their business practices. This is because their primary business function is as a Wholesaler, and the sole use of a Wholesaler credential suits their needs (e.g. reduced complexity for IT and internal operations).

In other circumstances, a Stakeholder may select to have the option to present more than one role. If, for example, an entity is a Manufacturer and a Wholesaler, they may desire to have an ATP credential for each role (e.g. this may prevent the appearance that a manufacturer is seeking information on another manufacturer's products when it was their wholesale division seeking the information.) In this case, the Issuer would verify as part of their due diligence that the company is licensed for both roles, and issue two separate ATP credentials.

As this decision ultimately relies on Stakeholder business practices, OCI makes no recommendations with regard to multiple Stakeholder credentials.

Term	organizationType
Full IRI	https://schema.org/additionalType

Claim: Subject Name

Subject company/organization legal name. Entity that is able to send requests to other trading partners might not be a legal entity itself.

Term	legalName
Full IRI	https://schema.org/legalName

Claim: Issuer Name

Credential Issuer company/organization legal name. Name of the legal Entity that issued the Credential to the subject.

Term	issuerName
Full IRI	https://schema.org/legalName

Claim: Street Address

Term	streetAddress
Full IRI	https://schema.org/streetAddress

Claim: Address Locality

Text specifying the name of the locality; for example, a city.

Term	addressLocality
Full IRI	https://schema.org/addressLocality

Claim: Address Region

Text specifying a province or state in abbreviated format; for example, NJ.

Term	addressRegion
Full IRI	https://schema.org/addressRegion

Claim: Postal Code

Text specifying the postal code for an address.

Term	postalCode
Full IRI	https://schema.org/postalCode

Claim: Country

Text specifying the country for an address.

Term	addressCountry
Full IRI	https://schema.org/addressCountry

Claim: Subject Associated Identifier

This attribute pair is OPTIONAL. It can be used to associate one or more identifiers with the Subject DID of the credential. For example, a company's GLN may be inserted to associate the credential with PI Verification messages.

Term	identifier
Full IRI	https://schema.org/identifier

Example DSCSA-ATP-Credential

            {
              "@context":[
                 "https://www.w3.org/2018/credentials/v1",
                 "https://open-credentialing-initiative.github.io/schemas/credentials/DSCSAATPCredential-v1.0.0.jsonld",
                 "https://w3c-ccg.github.io/lds-jws2020/contexts/lds-jws2020-v1.json",
                 "https://spherity.github.io/vc-status-2021-ldap/contexts/vc-status-2021-ldap/v1.jsonld"
              ],
              "id":"http://example.gov/credentials/3732",
              "type":[
                 "VerifiableCredential"
              ],
              "issuer":{
                 "id":"did:ethr:0xb9c5714089478a327f09197987f16f9e5d936e8a"
              },
              "issuanceDate":"2020-03-10T04:24:12.164Z",
              "expirationDate":"2022-03-10T04:24:12.164Z",
              "credentialStatus":{
                 "id":"ldaps://93.184.216.34:636/o=dolor,cn=ipsum,ou=lorem,dc=example,dc=com",
                 "type":"RevocationStatus2021LDAP",
                 "ssl":true,
                 "host":"93.184.216.34:636",
                 "query":"o={{0}},cn={{1}},ou={{2}},dc={{3}},dc={{4}}",
                 "params":[
                         "urn:uuid:b01294e9-77f4-4980-900f-213506021e30",
                         "CRL 372",
                         "DSCSA Wholesaler ATP Credential",
                         "legisym",
                         "com"
                 ]
              },
              "credentialSubject":{
                 "id":"did:ethr:0xa9d5414089178a327f09197987f16f9e5d936e8a",
                 "type":"DSCSAATPCredential",
                 "issuerName":"IssuerCompany Corp.",
                 "legalName":"Testcompany",
                 "organizationType":"Wholesaler",
                 "identifier": [{
                    "@type":"PropertyValue",
                    "propertyID":"globalLocationNumber",
                    "value":"1234567890123"
                  },{
                    "@type":"PropertyValue",
                    "propertyID":"DUNSNumber",
                    "value":"987654321"
                  }],
                 "streetAddress":"Test Street 123",
                 "addressLocality":"Testlocality",
                 "addressRegion":"Testregion",
                 "postalCode":"12345",
                 "addressCountry":"USA"
              },
              "proof":{
                 "type":"JsonWebSignature2020",
                 "created":"2021-11-04T13:30:18.323Z",
                 "jws":"eyJhbGciOiJFUzI1NksiLCJiNjQiOmZhbHNlLCJjcml0IjpbImI2NCJdfQ..30rlK8Q7oSYxK_kAZbQa2UYUP3vU8_FPmVbG5j7pELJhceYz_agGrhjj7tep-YnIYbMvMuWtbV5n8Kpe-XF2bA",
                 "proofPurpose":"assertionMethod",
                 "verificationMethod":"did:ethr:0xb9c5714089478a327f09197987f16f9e5d936e8ad"
              }
           }

Verifiable Presentation of DSCSA Stakeholder Credentials

Verifiable Presentations may be used to combine and present credentials. They can be packaged in such a way that the authorship of the data is verifiable. OCI generates a Verifiable Presentation after [[vc-data-model]] specification.

Verifiable Presentation Metadata

Term	Description	Full IRI
jti	This field represents the id property of the verifiable presentation being generated.	https://w3c.github.io/vc-data-model/#jwt-encoding
iss	Represents the holder property of the verifiable presentation being generated.	https://w3c.github.io/vc-data-model/#jwt-encoding
aud	Verifiable Presentation Audience. We might include PI_Verification in this field to represent that this VP is used in this context We might include ATP_DSCSA in this field to represent that this VP is used in this context	https://w3c.github.io/vc-data-model/#jwt-encoding
iat	Issuance Date of the VP in EPOCH format \| Used for determining whether or not the VP is valid by including the OCI validity time frame defined in Digital Wallet Conformance Criteria	https://w3c.github.io/vc-data-model/#jwt-encoding
nbf	Issuance Date of the VC in EPOCH format	https://w3c.github.io/vc-data-model/#jwt-encoding
exp	Expiration Date of the VC in EPOCH format	https://w3c.github.io/vc-data-model/#jwt-encoding
vp	Contains the Verifiable Presentation	https://w3c.github.io/vc-data-model/#jwt-encoding
vp.type	The type property is required and expresses the type of presentation, such as VerifiablePresentation.	https://w3c.github.io/vc-data-model/#presentations-0
vp.verifiableCredential	The VerifiableCredential (including all attributes) that are represented by this VP	https://w3c.github.io/vc-data-model/#presentations-0
nonce	Contains the corrUUID for which the VP has been generated for.	https://www.iana.org/assignments/jwt/jwt.xhtml

Example Verifiable Presenations

              eyJ0eXAiOiJqd3QiLCJhbGciOiJFUzI1NkstUiIsImtpZCI6ImRpZDpldGhyOnJvcHN0ZW46MHgwM2Q
              2YzZkOGRlYjkyM2MzZGU1MWI5MWVmMjgzODkxZGEzNjk1MTQ5ZDNiYTczNGY4ZWNlMTcwY2U4ZGJlZGQ
              zMmUjY29udHJvbGxlcktleSJ9.eyJqdGkiOiJkaWQ6ZXRocjpyb3BzdGVuOjB4MmQ1ODA1NTgzOTdlZW
              ZiOTM1MzcyYjE0MWVhY2E5OWVmYzZkZWY0NCIsImlzcyI6ImRpZDpldGhyOnJvcHN0ZW46MHgwM2Q2Yz
              ZkOGRlYjkyM2MzZGU1MWI5MWVmMjgzODkxZGEzNjk1MTQ5ZDNiYTczNGY4ZWNlMTcwY2U4ZGJlZGQzMm
              UiLCJhdWQiOiIiLCJpYXQiOjE2MzU0MTM5NzcsIm5iZiI6MTYzNTQxMzk3Ny43MDEsInZwIjp7IkBjb2
              50ZXh0IjpbImh0dHBzOi8vd3d3LnczLm9yZy8yMDE4L2NyZWRlbnRpYWxzL3YxIl0sInR5cGUiOlsiVm
              VyaWZpYWJsZVByZXNlbnRhdGlvbiJdLCJ2ZXJpZmlhYmxlQ3JlZGVudGlhbCI6W3siQGNvbnRleHQiOl
              siaHR0cHM6Ly93d3cudzMub3JnLzIwMTgvY3JlZGVudGlhbHMvdjEiLCJodHRwczovL29wZW4tY3JlZG
              VudGlhbGluZy1pbml0aWF0aXZlLmdpdGh1Yi5pby9vY2kvY29udGV4dHMvb2NpLXYxLmpzb25sZCIsIm
              h0dHBzOi8vc3BoZXJpdHkuZ2l0aHViLmlvL29jaS9jb250ZXh0cy9jcmVkZW50aWFscy92MS1leHRlbn
              Npb25zIiwiaHR0cHM6Ly9zcGhlcml0eS5naXRodWIuaW8vdmMtc3RhdHVzLTIwMjEtbGRhcC9jb250ZX

              {
                "jti":"did:ethr:ropsten:0x2d580558397eefb935372b141eaca99efc6def44",
                "iss":"did:ethr:ropsten:0x03d6c6d8deb923c3de51b91ef283891da3695149d3ba734f8ece170ce8dbedd32e",
                "aud":"",
                "iat":1635413977,
                "nbf":1635413977.701,
                "vp":{
                   "@context":[
                      "https://www.w3.org/2018/credentials/v1"
                   ],
                   "type":[
                      "VerifiablePresentation"
                   ],
                   "verifiableCredential":[
                      {
                         "@context":[
                            "https://www.w3.org/2018/credentials/v1",
                            "https://open-credentialing-initiative.github.io/schemas/credentials/DSCSAATPCredential-v1.0.0.jsonld",
                            "https://w3c-ccg.github.io/lds-jws2020/contexts/lds-jws2020-v1.json",
                            "https://spherity.github.io/vc-status-2021-ldap/contexts/vc-status-2021-ldap/v1.jsonld"
                         ],
                         "type":[
                            "VerifiableCredential"
                         ],
                         "issuer":{
                            "type":"Issuer",
                            "id":"did:web:legisym-test-issuer-pre-prod.wallet.us.spherity.io",
                            "name":"Legisym (test)"
                         },
                         "credentialSubject":{
                            "id":"did:ethr:0xa9d5414089178a327f09197987f16f9e5d936e8a",
                            "type":"DSCSAATPCredential",
                            "issuerName":"IssuerCompany Corp.",
                            "legalName":"Testcompany",
                            "organizationType": "Wholesaler",
                            "identifier": {
                              "propertyID":"globalLocationNumber",
                              "value":"123456789"
                            },
                            "streetAddress":"Test Street 123",
                            "addressLocality":"Testlocality",
                            "addressRegion":"Testregion",
                            "postalCode":"12345",
                            "addressCountry":"Testcountry"
                         },
                         "issuanceDate":"2021-08-04T10:10:22.000Z",
                         "expirationDate":"2021-12-31T05:00:00.000Z",
                         "credentialStatus":{
                            "id":"ldaps://93.184.216.34:636/o=urn:uuid:b01294e9-77f4-4980-900f-213506021e30,cn=CRL 372,ou=DSCSAATPCredential,dc=legisym,dc=com",
                            "type":"RevocationStatus2021LDAP",
                            "ssl":true,
                            "host":"93.184.216.34:636",
                            "query":"o={{0}},cn={{1}},ou={{2}},dc={{3}},dc={{4}}",
                            "params":[
                               "urn:uuid:b01294e9-77f4-4980-900f-213506021e30",
                               "CRL 372",
                               "DSCSAATPCredential",
                               "legisym",
                               "com"
                            ]
                         },
                         "id":"did:web:0x4cbab8d5ba934135f363e9640218b5078a02da6f",
                         "proof":{
                            "type":"Ed25519Signature2018",
                            "created":"2021-08-04T10:10:24Z",
                            "jws":"eyJhbGciOiJFZERTQSIsImI2NCI6ZmFsc2UsImNyaXQiOlsiYjY0Il19..jxgLCZNri1EEK5dOZVeqTndAN_Le96QNbQs24X_50yOD7OgY_1vYQcRibTppqmxfhxOYDjtgFvEbzR6NabvvDg",
                            "proofPurpose":"assertionMethod",
                            "verificationMethod":"did:web:legisym-test-issuer-pre-prod.wallet.us.spherity.io#z6Mko38PtCXHZC2PLDxuoD3NiVmHyfU6wfgJ8JGEN5UQqmdN"
                         }
                      }
                   ]
                },
                  "nonce" : "31923d0c-b8ba-49e2-ba05-7b967bf4377b"
             }

v1.2.1

Status of this Document

Introduction

OCI Verifiable Credential Design Principles

Include credential attributes that do not relate to internal tracking or due diligence activities

Include attributes enabling credential consuming applications to perform logic and/or operational validation checks.

Enable credential integrity checks

Terminology

Vocabulary

Identity Credential

Identity Credential Metadata

Claim: Subject Name

Claim: Issuer Name

Claim: Subject Parent Organization

Claim: Street Address

Claim: Address Locality

Claim: Address Region

Claim: Postal Code

Claim: Country

Example Identity Credential

DSCSA Stakeholder Credential Schemas

DSCSA Stakeholder Credential Metadata

Claim: Organization Type

Claim: Subject Name

Claim: Issuer Name

Claim: Street Address

Claim: Address Locality

Claim: Address Region

Claim: Postal Code

Claim: Country

Claim: Subject Associated Identifier

Example DSCSA-ATP-Credential

Verifiable Presentation of DSCSA Stakeholder Credentials

Verifiable Presentation Metadata

Example Verifiable Presenations