OCI’s Open Comment at the 2025 PDG-FDA Town Hall: Wholesale Distributor Exemption
OCI’s Executive Director, Bob Celeste, presented the following open comment at the PDG-FDA town hall on June 25, 2025. Industry stakeholders came together at this joint townhall to discuss DSCSA implementation efforts in advance of the wholesale distributor exemption expiry.
Good afternoon, and thank you for the opportunity to share a brief comment.
I am Bob Celeste, Executive Director of the nonprofit Open Credentialing Initiative, or OCI. OCI is not a commercial solution. OCI developed and maintains open specifications for corporate identity and Authorized Trading Partner status. Adoption or use of these open specifications is voluntary and not mandatory.
I would like to specifically address secondary wholesalers (wholesalers that source their products from other wholesalers) and dispensers who may not be deeply involved in the ongoing DSCSA interoperability efforts led by PDG, GS1 US, HDA, OCI, and others. Thankfully, for more than twenty years, these organizations have been studying the details and envisioning challenges you may encounter. They have been actively developing and testing standards and open specifications to enable interoperable solutions, whether you develop them yourself or use commercial solutions.
It is encouraging to hear how the beginning of the supply chain has been working diligently to normalize and improve systems and processes for managing serialized products and related DSCSA data.
The result of this is that you can expect to receive more consistent DSCSA data from your suppliers. As implementations progress, you may be involved in other interactions that utilize DSCSA data, such as Product Information Verification and Tracing.
If these interactions happen infrequently, handling them manually might be enough. But if managing them becomes overwhelming, you may ask if there's a better way.
While the DSCSA envisioned an electronic network of sorts, it did not specify specific technology to be used in the network. This is by design. The industry specifically requested that the DSCSA not prescribe technology. It recognized that technology changes over time and that flexibility and options are needed as systems mature.
The exchange of serialized Transaction Information between a buyer and a seller, while not without its challenges, is pretty understandable. For every serialized product transacted, serialized Transaction Information must be provided.
Product Information Verification and Tracing interactions are unusual because, for example, you may need to verify the Product Information of a saleable return with a manufacturer you don’t buy from directly. You might also participate in a product ownership trace with others with whom you don’t have a direct relationship.
As the network matures, trading partners may opt to verify who is requesting a Verification or Trace before responding. Providing this information digitally, as part of your request, can make the process more efficient.
OCI has published open specifications for using digital credentials for Authorized Trading Partner status. Using a credential is like presenting a notarized corporate document that others can trust, independent of whether a business relationship exists.
Credentials are already used within the Verification Router Service (VRS) network by various trading partners. Credentials are not a requirement; they are simply a standards-based option that some stakeholders have begun to adopt.
We realize you must first focus on serialized product and Transaction Information. However, we suggest that secondary wholesalers and dispensers review their current verification and tracing plans, consider the volume of future verifications and traces as you prepare for these new interactions.
Thank you again for the opportunity to share with the group.
— End of Comment —
Find out more about 2025 PDG-FDA Town Halls: DSCSA implementation progress at https://dscsagovernance.org/2025-pdg-fda-town-halls/
