Product Data – Kit with Multiple Licensed Products

16.1 SPL Header

16.2.11 Product Data – Kit with Multiple Licensed Products

When the licensed product is only part of a kit, but the kit itself is not tracked as a “package lot”, the lot data is specified under the appropriate part of the kit, and all the validation procedures specified for fill lot, bulk lot and label lot apply as above.

<code code="1234-5679" codeSystem="2.16.840.1.113883.6.69"/> <name p:de="Trade Name">Multivax (MixKit)</name>

<part>

If in addition the kit itself is tracked as a “package lot”, then the package lot data is specified for the entire kit as follows:

<code code="1234-5679" codeSystem="2.16.840.1.113883.6.69"/> <name p:de="Trade Name">Multivax (MixKit)</name>

</part>

</productInstance>

Validation Procedures

16.2.11.1The rules for product code and name are as for simple products 16.2.11.2There is one or more parts, referencing label lots of these parts. 16.2.11.3There is a product event code

16.2.11.4There is a label lot specified elsewhere in the lot distribution report. 16.2.11.5There are one or more product events

16.2.11.6There is one distribution product event 16.2.11.7There may be one returned product event 16.2.11.8There is no other product event

17 Wholesale Drug Distributor/Third-Party Logistics Facility

Report

Wholesale Drug Distribution submissions have only header information with data for one or more reported facilities.

17.1 Header

17.1.1Document type

<code code="75030-7"

codeSystem="2.16.840.1.113883.6.1"

displayName="wholesale drug distributor/third-party logistics facility reporter"/>

Validation Procedures

17.1.1.1 Document type is “Wholesale Drug Distributor/Third-Party Logistics Facility Report” (75030-7)

17.1.1.2The effective time year matches the current year. 17.1.1.3 There is no title.

17.1.1.4If a document with the same set id has been previously submitted, then it is a

Wholesale Drug Distributor/Third-Party Logistics Facility Report (75030-7). 17.1.1.5For Withdrawal of Wholesale Drug Distributors and Third-Party Logistics

Facility Report (77573-4) the set ID in this document should be the same set id included in a previously submitted Wholesale Drug Distributors and Third- Party Logistics Facility Report (75030-7), with information about your establishment(s). 17.1.2Reporter information <document> <author> <assignedEntity> <representedOrganization>

<assignedEntity>

<id extension="100000002" root="1.3.6.1.4.1.519.1"/> <name>ACME Drug Logistics, Inc.</name>

Validation Procedures

17.1.2.1 If the document type is Wholesale Drug Distributor/Third-Party Logistics Facility Report (75030-7), then there is reporter information.

17.1.2.2 There is one id (the DUNS Number) and name as in Section 2.1.5. 17.1.2.3id (reporter’s DUNS Number) is not associated with any other set id of

document type Wholesale Drug Distributor/Third-Party Logistics Facility Report

17.1.2.4The set id is not associated with any other reporter id (DUNS Number). 17.1.2.5There is one contact party as in Section 2.1.8.

17.1.2.6Facility submission has no labeler information (no validation rules defined for it.)

17.1.3Facility Information <document> <author> <assignedEntity> <representedOrganization> <assignedEntity> <assignedOrganization>  <assignedEntity>

<addr>

<streetAddressLine>325 Good Hope Avenue</streetAddressLine> <city>Milwaukee</city>

<asNamedEntity>  <code code="C117113" displayName="doing business as" codeSystem="2.16.840.1.113883.3.26.1.1"/> <name>A.C.M.E. Logistic</name>

</asNamedEntity> <contactParty .../>

The confidentiality code “B” may be used at the facility level to indicate that the street address of this facility should be suppressed in public data releases.

Validation Procedures

17.1.3.1 If the document type is Wholesale Drug Distributor/Third-Party Logistics Facility Report (75030-7), then there are one or more facilities.

17.1.3.2Facility has a name and optionally one id (the DUNS Number,) as in Section 2.1.5.

17.1.3.3DUNS number, if present, is not associated with another facility in the same SPL file.

17.1.3.4DUNS number, if present, is not associated with any other set id for document type Wholesale Drug Distributor/Third-Party Logistics Facility Report

(75030-7)

17.1.3.5DUNS number, if present, along with the facility name and address information match the DUNS number record in the Dun and Bradstreet database

17.1.3.7 There is one contact party as in Section 2.1.8. 17.1.3.8There is no further assigned entity under the facility.

17.1.3.9 There may be zero or more “doing business as” names (DBA names).

17.1.3.10DBA names has code C117113 and code system 2.16.840.1.113883.3.26.1.1. 17.1.3.11DBA name has one name element.

17.1.3.12There may be a suffix beginning with space, and the abbreviation WDD or 3PL in square brackets.

17.1.3.13If the suffix is [WDD], then one business operation for this facility is Wholesale Drug Distributor (C118411).

17.1.3.14If the suffix is [3PL], then one business operation for this facility is Third- Party Logistics Provider (C118412).

17.1.3.15If the facility has the same “doing business as” (DBA) name regardless of business operation, then no suffix is specified.

17.1.3.16The facility should not have the same “doing business as” (DBA) name with the same business operation.

17.1.4Facility operation

<assignedEntity> <assignedOrganization>  <assignedEntity> <assignedOrganization>  </assignedOrganization> <performance> <actDefinition>

Validation Procedures

17.1.4.2 Act definition code is C118411 (Wholesale Drug Distributor) or C118412 Third-Party Logistics Provider)and code system is

2.16.840.1.113883.3.26.1.1.

17.1.4.3 Act definition display business operation name matches corresponding business operation code.

17.1.4.4Each business operation code is mentioned only once per facility. 17.1.4.5There is no product reference.

17.1.5License

<id extension="license number"

root="State license authority OID (see text)"/>

<code code="state code from ISO 3166-2, e.g. US-MD" codeSystem="1.0.3166.2"/> </territory> </territorialAuthority> </author> Example: <performance> <actDefinition>

<code code="C118411" displayName="wholesale drug distribution" codeSystem="2.16.840.1.113883.3.26.1.1"/> <subjectOf> <approval> <id extension="2013-WL-123456" root="1.3.6.1.4.1.32366.4.840.805"/> <code code="C118779" codeSystem="2.16.840.1.113883.3.26.1.1"

displayName="wholesale drug distribution license"/> <statusCode code="completed"/>

</territorialAuthority> </author>

Validation Procedures

17.1.5.1 There may be zero or more licenses.

17.1.5.2 License Code is from the License Type Code list. 17.1.5.3 Display name matches the code.

17.1.5.4 Code system is 2.16.840.1.113883.3.26.1.1.

17.1.5.5 Territorial authority indicates the state issuing the license using the ISO 3166-2 state codes with code system 1.0.3166.2.

17.1.5.6License has an id (license number). 17.1.5.7id has an extension, the license number.

17.1.5.8id has a root beginning with “1.3.6.1.4.1.32366.4.840” followed by a period “.” and ending in a decimal number equal to the value of the 2-letter ISO 3166-2 U.S. state code interpreted as a base 36 number with the digits 0-9 and A-Z, with the letter digits having the value of 9 added to the ordinal letter position (A: 1 + 9 = 10, B = 2 + 9 = 11, ..., Z = 26 + 9 = 35); e.g., Arizona, having the ISO 3166-2 “US-AZ”, i.e., the 2-letter state code “AZ” with (A =) (1 + 9) × 36 + (Z =) (26 + 9) = 10 × 36 + 35 = 395, resulting in

“1.3.6.1.4.1.32366.4.840.395”.

17.1.5.9License has a status code with values active, suspended, aborted (meaning “revoked”), or completed (meaning “expired”).

17.1.5.10License has an effective time high value (expiration date).

17.1.5.11License has no effective time low value (license issue date not reported). 17.1.5.12The effective time high boundary has at least the precision of day in the

format YYYYMMDD

17.1.5.13If the status code is completed, then the current date is later than the effective time high value.

17.1.5.14If the current date is later than the effective time high value, then the status code is not active.

17.1.6Business Operation Qualifier

17.1.6.1 There may be one business operation qualifier if the business operation is third-party logistics provider (C118412).

17.1.6.2There is no id.

17.1.6.3Business operation qualifier is warehouses human prescription drug products (C123274).

17.1.6.4Display name matches the code.

17.1.6.5Code system is 2.16.840.1.113883.3.26.1.1.

17.1.6.6Business operation is third-party logistics provider (C118412).

In document Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (Page 151-158)