HDA 2023 Traceability Seminar: A Status Update

HDA 2023 Traceability Seminar session, “Onboarding the Industry: A Status Update and Call to Keep Moving.” August 31, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

The Traceability Seminar’s second-to-last session, “Onboarding the Industry: A Status Update and Call to Keep Moving,” consisted of a panel, whose speakers addressed the process, lessons learned, and how the industry ought to prepare itself for the start of Drug Supply Chain Security Act (DSCSA) enforcement by Nov. 27, 2024, which was the newly announced date after FDA ruled that it “does not intend to take action to enforce” the rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data.

Participants included:

• Riya Cao, CEO of LSPedia
• William Carney, VP, Operations, Genetco
• Blair Korman, senior director, digital identification & traceability, J&J Supply Chain
• David G. Mason, supply chain compliance and serialization lead, Sandoz
• Jaidalyn Rand, director, industry relations, Healthcare Distribution Alliance (HDA)
• Anil Suresh, product management, SAP SE

The value of communication and cooperation

Suresh noted that although volume has varied, we have come a long over the past couple of years; collaboration is key.

As a provider of end-to-end DSCSA compliance and supply chain software solutions, LSPedia has had success working with the entire supply chain, especially by establishing “provider to provider” connections, Cao commented, who added that constant communication makes sense.

Offering up a critique, Mason mentioned that cooperation with service providers has been great, but the same cannot be said in regard to downstream trading partners. It is important that they do not have consultants reach out on their behalf, as the consultants themselves are not authorized trading partners (ATPs). Carney chimed in, adding that getting data tested is critical; when one goes live with a manufacturer, it is not the same as a test.

What is to be expected from onboarding?

Korman of J&J noted that transaction information (TI) is of the utmost importance, along with lifecycle management (how to verify that manufacturers have a unique global trade item number, or GTIN.

Interestingly, Cao expressed that when data leaves your four walls, there are other requirements to be aware of. Sometimes, data can be sent out, but not necessarily received and utilized. It is important to work together to resolve data issues; in LSPedia’s case, the company found that resolution times have decreases from 22 to as few as three days.

Best practices for the industry

Carney kept it simple in stating that communication is key, whether it be positive and/or negative. Mason echoed the sentiment, adding that feedback—both inbound and outbound—is critical.