Cardinal Health serialization

Cardinal Health Serialization As Part of Shipping Program

Cardinal Health Serialization is an option for now as Cardinal Health prepares for the upcoming Federal milestones, managing Serialized information in the ASN (should you choose not to use an EPCIS solution). Cardinal Health Serialization is applied as Cardinal Health is planning to support is an option data at the Pack and Item hierarchy levels before the end of 2016. HDMA changes made to the guideline to facilitate DSCSA compliance The below represents HDMA’s interpretation of the EDI segments that correlate with the information required for trading partners to pass Transaction Information (TI), Transaction History (TH) and the Transaction Statement (TS) under the Drug Supply Chain Security Act (DSCSA).

Shipment Level:

  • Four N1 loops are required to distinguish logistical movement from ownership transfer:
  1. Ship To
  2. Buyer
  3. Ship From
  4. Seller.
  • In each N1 loop, N3 and N4 are included in the guideline because it is mandatory to indicate the address of buyer and seller for DSCSA compliance
  • One YNQ segment is used to communicate the Transaction Statement (TS):
  • A compliant shipment level YNQ will show:
  1. YNQ02 = ’Y’
  2. YNQ05 must contain the Transaction Statement
  3. YNQ08 =‘99’
  4. YNQ09 = ‘TS’.
  • HDMA recommends the following text in YNQ05 as the Transaction Statement: Seller has complied with each applicable subsection of FDCA Sec. 581(27) (A)–(G).
  • A second YNQ segment may be used as a pointer for downstream segments to indicate that a direct purchase statement (DPS) or the receipt of a direct purchase statement applies to a product at item level. A DPS at the shipment level is effectively a flag to look for the item level YNQ:
    • Use of the shipment level DPS YNQ will show:

-YNQ02 = ’Y’

-YNQ05 must contain a direct purchase statement

-YNQ08 = ‘99’

– YNQ09= ‘DPS’.

  • HDMA recommends the following text in YNQ05 as the Direct Purchase Statement:
    • “As indicated below, product was purchased directly from the manufacturer, manufacturer’s exclusive distributor or repackager who purchased directly from a manufacturer.”

Item Level:

  • An N1 loop, including N3 and N4, is added for Transaction History (TH) required information, such as Original Manufacturer or Exclusive Distributor.
  • A YNQ segment for the item level allows the sender to indicate:
    • For items where product was purchased directly:
      • YNQ02 = ‘Y’
      • YNQ08 = ‘99’
      • YNQ09 = ‘DIR’
    • For transactions that require an indication that a direct purchase statement has been received:
      • YNQ02 = ‘Y’
      • YNQ08 = ‘99’
      • YNQ09 = ‘RDPS’
  • Transaction Information (TI) includes:
  1. Name of the product (Item-level PID segment – PID05)
  2. Strength and dosage form (Item-level PID segment – PID05)
  3. NDC (Item-level LIN segment – Pair qualifier with ID – multiple choices)
  4. Container size (Item-level PID segment – PID05)
  5. Number of containers (Item-level SN1 segment – SN102)
  6. Lot number (Item-level LIN segment – Pair qualifier with ID – multiple choices)
  7. Transaction date (BSN Segment – BSN03) – Shipment Date (Shipment-level DTM)*
  8. Name and address of the seller (Shipment-level “Seller” N1 loop, segments N1, N3, N4)
  9. Name and address of the purchaser (Shipment-level “Buyer” N1 loop, segments N1, N3, N4)

*Needed if shipment date is more than 24 hours after date of the transaction.

Hierarchical Levels:

  • Tare and Inner pack hierarchical levels are optional.
  • Cardinal Health does not support Tare or Inner Pack level segments.

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