Updates from the HDA Traceability Seminar

November 2019

The Cardinal Health 3PL Services team attended the HDA Traceability Seminar, October 21-24, in Washington, D.C. to help you stay up-to-date with the latest DSCSA implementation milestones. Here is a summary of the primary discussion points and key FDA updates from the meeting.

Verification of Saleable Returns

In September, FDA announced a one-year delay in enforcement of the requirement for distributors to verify saleable returns prior to redistribution. The expectation from the recent HDA Traceability Seminar is that, based on this delay, wholesalers and distributors will not fully launch saleable returns verifications on November 27.  Results from industry tests have been promising, but the delay will help provide an assurance of smooth operations on the distributor side. However, in their September communication, FDA specifically stated that the delay, “…does not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor.” Manufacturers are still obligated to respond to verifications within 24 hours and treat any negative verifications as suspect product.

It important to understand the difference and ensure that Cardinal Health 3PL Services is prepared to answer inquiries on your behalf, if this is part of your DSCSA service agreement as a Tier 1 or Tier 2 customer. (A summary of our tiered DSCSA support services is included at the end of this article.) While initial responses may be performed manually, VRS or outbound EPCIS transmissions will be the standard for the future to ensure efficiency and accuracy. To help ensure that 3PL Services can answer verification requests on your behalf it is essential for you to provide complete serialization data for the products we support for your company.

Other points of interest:

• Inclusion of the NDC number within DSCSA labeling: The NDC, in the 3-segment format, must be printed somewhere on the label.  If it is present elsewhere, the FDA will allow the GTIN to be used in the human readable portion of the Product Identifier.
• Reporting of lost and stolen product: The FDA confirmed that stolen product is considered illegitimate and should be reported to the FDA via Form 3911.  Additional guidance from the FDA on this topic is forthcoming.
• Dispenser readiness for DSCSA requirements: Major players on the dispenser end of the supply chain expressed significant concerns about their readiness and the expense associated with complying with DSCSA requirements. Costs of new 2D scanners and the development of the accompanying software will be substantial. Many updates are needed at the dispenser level to prepare for 2023.
• Outbound EPCIS Transmissions: Across the industry, outbound scanning to send serialized data in support saleable returns verifications has seen minimal adoption at this point. That said, 3PL Services is prepared to offer outbound scanning today and anticipates a launch of the Verification Router Service as soon as late November 2019.
• Barcode Assessment: GS1 shared key results from the Barcode Assessment conducted with Cardinal Health, AmerisourceBergen and McKesson. The overall percentage of product in wholesalers’ distribution centers that was serialized with 2D barcodes and had 4 readable components of the product identifier increased from 20 percent to 74 percent over prior year. Barcode legibility was much improved and there was significant reduction of expiration date issues.

Cardinal Health 3PL Services leverages our proven supply chain expertise to develop comprehensive services that help meet your most pressing logistics needs. We offer configurable solutions to help your business prepare for DSCSA implementation—from serialization to creation and transfer of event data. For a complete overview the Cardinal Health services that can support your track and trace strategy and readiness, see our DSCSA Solutions Guide.