DSCSA Readiness Update

Cardinal Health 3PL continues to work to support our client’s efforts to meet the upcoming requirements of the Drug Supply Chain Security Act (DSCSA).

 

Our Goals

 

✔  Completed: Testing for inbound serialized product and data receipt via EPCIS

✔  Completed: Offering data/reporting services for clients seeking a solution for data retention and verification

    In Progress: Developing data integration services for clients who need a solution outside of 3PL

Currently we are testing EPCIS data exchange and setting up connectivity with several clients.  We can accept and store EPCIS data using our serialization platform.  We are offering high-level reconciliation services for product aggregated to the pallet level.  

Reporting

 

  • We have deployed reporting in our Smart Data web portal to provide visibility to the inbound serialized data and reconciliation results.
  • Our reports will be available to assist clients in identification and verification of serialized product that is returned and intended for resale.

We are also developing a customer facing web-based portal to ensure our clients meet the regulatory requirement  for providing Transaction Information, Transaction History and Transaction Statement electronically by November 2017. The portal primarily supports companies that do not have EDI capabilities and are currently relying on paper packing slips. Most companies in the pharma supply chain are EDI capable and will not be impacted by this change. Cardinal Health 3PL will continue to send lot level DSCSA transaction data via EDI ASN 856 to customers that can receive the files electronically until 2023.

If you are not currently engaged with Cardinal Health 3PL as a component of your DSCSA readiness program, we encourage you to contact your Client Relationship Manager to identify which Cardinal Health 3PL services may be of value to you. If you plan to  integrate with the Cardinal Health 3PL data repository, please allow 90 days for connectivity testing and data validation. Please  contact your Client Relationship Manager to schedule testing.

Bar Codes & Serialization

 

Cardinal Health 3PL encourages our clients to follow GS1 US standards and HDA guidelines for barcodes and serialization to ensure compliance with DSCSA requirements.  We can test your barcodes to insure they meet specifications. Please send your request to barcodes@cardinalhealth.com.

Publisher

Document Title

HDA

HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain Quick Start Guide.
This guide, published by the Healthcare Distribution Alliance (HDA), provides a comprehensive and succinct list of information needed to understand the data elements at play for DSCSA as well as encode them on products governed under DSCSA.

GS1 US

GS1 US Healthcare Implementation Guide.
Reference guide for applying GS1 EPCIS standards to U.S. Pharmaceutical Supply Chain to support DSCSA.

 

Saleable Returns

 

Cardinal Health 3PL continues to plan and prepare to support the 2019 Saleable Returns requirement, which mandates that wholesale distributors verify the product identifier before re-distributing a returned product. We are developing services that will support both industry-recommended solutions to verify serial numbers:

  1. Outbound EPCIS serialized data transmission to wholesale distributors with each shipment.
  2. Verification Router Service, which will allow for serial number verification through a cloud based query system.

We will provide updates and details regarding both these solutions as they become available.

We look forward to helping you meet the 2017 DSCSA requirements. Please reach out to your Client Relationship Manager with any DSCSA related questions.

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