5 Reasons Why DSCSA ATP Digital Credentials Beat GLN Allow Lists

The Verification Router Service (VRS) Provider Network (PN) has outlined several issues with using Allow Lists as an optional capability for VRS customers.

This assessment points at why DSCSA (Drug Supply Chain Security Act) ATP (Authorized Trading Partner) digital credentials present a superior and more efficient alternative. Below, we explore why Allow Lists pose problems and how ATP digital credentials address these shortcomings effectively.

Why Allow Lists Are Problematic

Allow Lists, where a responding customer (e.g., a manufacturer or repackager) only responds to product identifier verification requests from Global Location Numbers (GLNs) explicitly listed, come with significant operational and security challenges:

1. Maintenance Challenges
   Keeping an Allow List comprehensive and up-to-date is a daunting task. The pharmaceutical supply chain involves numerous authorized trading partners, and new entities may enter the network frequently. Even with constant updates, the list may fail to include all legitimate requestors, leading to denied verification requests. This incompleteness can disrupt the supply chain by blocking valid transactions.
2. Impersonation Risks
   An Allow List does not inherently verify the identity of the requestor, it only checks if the GLN is on the list. A bad actor could impersonate an authorized entity by using a GLN from the Allow List, bypassing the system’s security. This vulnerability undermines the integrity of the verification process.
3. Compliance Issues with DSCSA
   DSCSA mandates that manufacturers and repackagers respond to verification requests from authorized trading partners within 24 hours or one business day, provided the partner has possession or control of the product. If a legitimate requestor’s GLN is not on the Allow List and the responder has no other information about the requestor, the response could be delayed or blocked entirely, risking non-compliance with this legal requirement.
4. Ambiguous Feedback
   When a verification request is denied because the GLN is not on the Allow List, the requestor receives vague feedback. This lack of clarity delays troubleshooting, whether it’s a matter of updating the list, addressing a security breach, or resolving a misunderstanding, further slowing down the verification process.
5. Hidden Local Administration
   Allow Lists are managed by each responder individually and not shared with other service providers or trading partners. Thus, there is no consistent approach to network and supply chain security across the industry. A bad actor just needs to find a responder that hasn’t blocked the abused GLN yet to break into the supply chain.

These issues collectively make Allow Lists burdensome to manage and inefficient, potentially undermining the VRS’ goal of streamlining product identifier verification.

Why ATP Digital Credentials Are a Better Solution

ATP digital credentials, which refer to an electronic authentication mechanism for Authorized Trading Partners as defined by PDG and OCI, offer a more robust and efficient alternative to Allow Lists. Here’s how they address the shortcomings:

1. Dynamic and Scalable Management
   Managing digital credentials is more flexible than maintaining a static Allow List. New partners can be issued credentials quickly, and credentials can be revoked if a partner is no longer authorized. This happens all without the constant manual updates required for a list. This scalability adapts to the dynamic nature of the supply chain.
2. Strong Authentication
   Digital credentials use cryptographic techniques to verify the identity of the requestor, ensuring that only genuine authorized trading partners can submit verification requests. Unlike Allow Lists, which rely solely on GLN recognition, digital credentials reduce the risk of impersonation by confirming the requestor’s authenticity, enhancing overall security.
3. Compliance Assurance
   By accurately and swiftly verifying the identity of requestors, ATP digital credentials enable manufacturers to respond promptly to legitimate requests. This ensures adherence to the DSCSA’s 24-hour/one business day response requirement, avoiding the delays or denials that might occur with an incomplete Allow List.
4. Clear Feedback Mechanisms
   If a verification request fails due to invalid or unrecognized credentials, the system can provide specific feedback (e.g., “Credential revoked” or “Issuer not trusted”). This clarity allows the requestor to address the issue efficiently, whether by renewing credentials or investigating a potential security problem, minimizing downtime compared to the ambiguous responses from an Allow List denial.
5. Shared Governance
   OCI-specified digital ATP credentials follow openly published, continuously managed quality and technology guidance. This is topped off with independent third-party audits. Altogether, this represents a transparent, well-documented, and coherent approach to network and supply chain security across the industry.

Conclusion

Allow Lists present significant drawbacks: they are difficult to keep current, vulnerable to impersonation, potentially non-compliant with DSCSA requirements, unclear in their feedback, and erratic. In contrast, ATP digital credentials provide a secure, scalable, and compliant solution through strong authentication, dynamic management, precise feedback, and industry-wide governance. By adopting ATP digital credentials, the VRS can enhance the efficiency and reliability of product identifier verification, better serving the needs of the pharmaceutical supply chain.