DSCSA State Regulator Tools
Since the fall of 2021, NABP has been collaborating with state regulators and trading partners to build an interoperable system to support stakeholders in meeting the Drug Supply Chain Security Act (DSCSA) requirements that were set to go into effect in November 2023. Since that time, the groups working on this effort have seen many successes. Drawing on the information and insights from several pilot projects, NABP developed the new platform, Pulse by NABP™, which is an inclusive, accessible, and secure digital platform that simplifies the process of achieving DSCSA compliance.
Our endeavor to explore DSCSA interoperability marks the first time a broad representation of industry leaders, including manufacturers, distributors, dispensers, and state regulators, have collaborated.
Preparing for Compliance and Interoperability
In November 2023, Food and Drug Administration announced a 1-year stabilization period for DSCSA requirements. We are using this time to continue working with our member boards and stakeholders across the pharmacy industry to further align on requirements, systems, and integrations needed to comply with these new requirements once enforcement begins.
As part of our efforts, we:
- Held a series of workshops to inform, assess, and outline the use cases required for all state regulators and the entities they oversee to meet the upcoming federal law requirements.
- Hosted an industry-wide pilot project that explored the use cases, identified findings and gaps, and developed a roadmap to implementation.
DSCSA Project Goal
The primary goal of our DSCSA efforts is to ensure the creation of an interoperable framework to facilitate state regulator communication with trading partners as they carry out their regulatory responsibilities to protect the prescription drug supply chain. The DSCSA network, now called Pulse by NABP™, is expected to:
- Be consistent with the Uniform National Policy (Section 585) and Food and Drug Administration (FDA) Guidance
- Create a uniform request/response standard for state regulators incorporating DSCSA requirements and FDA Guidance
- Create an interoperable framework for state regulator and/or trading partner communication
- Ensure that only authorized regulators can access and make requests of authorized trading partners (ATPs)
- Protect confidential and/or proprietary information of participants
- Focus on the most critical patient safety use cases
Pilot Project Findings
The findings of NABP’s most recent product tracing pilot can be found in the 2024 Report of the DSCSA State Regulator & Dispenser Tracing Pilot With the United States Pharmaceutical Supply Chain to which outlines the current state of DSCSA compliance within the industry and the proposed steps required for the development of an industry-wide interoperability framework. Key findings of the most recently completed pilot project were documented in the following areas:
Critical Industry Alignment
There were 5 key findings (outlined below) related to the need for an authoritative trading partner information source, alignment of foundational identification data, expected adoption usage growth, reasonable technological barriers to product safety, and alignment on tracing messaging formats.
Standards & Best Practices Alignment
There were 24 findings that were related to topics that should be shared with industry and worked on with organizations such as PDG, GS1, HDA and other industry alignment groups.
General Findings
There were 20 findings that provided insights for NABP, its state members, and regulatory groups in the further development of tools such as Pulse for DSCSA compliance.
Next Steps for Pulse
Based on the findings of the newest pilot project, NABP intends to continue development, testing, and industry alignment in the following critical areas:
| Critical Finding | Description |
|---|---|
| Trading partner directory | State regulators need an authoritative directory and functional application to engage with trading partners. All stakeholders need an aligned trading partner directory confirmed by data owners. |
| Expect Growing Tracing Volume | Expect average adoption times and request volumes to be established as paper transaction history sunsets and serialized transaction information data expands throughout supply chain. |
| Achievable and Aligned Security | There is a need for equitable technological approaches that will enable adoption from the most at-risk small dispensers. Most manufacturers highlighted the importance of reducing restrictions for requestors, while others highlighted the need for more technology-enabled security. |
| Foundational and Confirmed Data | Start with foundational state and federal license/registration data and allow actual trading partners to confirm information, including identifiers assigned such as GS1’s Global Location Numbers (GLNs). |
| Request/Response Messaging | PDG drafted JSON message structures for product tracing requests and response work with some suggested improvements. NABP should continue to monitor as related functions are added to Pulse. |
NABP expects to continue working with industry stakeholders and alignment groups as they continue to address interoperability alignment findings. Development and Deployment plans to address the gaps identified during the pilot project have been initiated. In addition, NABP will:
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Convene an advisory group to help guide and inform the development process and to build on the collaborative efforts between trading partners and state regulators.
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Convene regular meetings with Pulse Partner Program participants to ensure that solutions providers are on a path toward interoperability for any required interactions with the platform, such as directory searches, license/ATP status checks, product tracing, or product verification messaging.
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Continue to engage with PDG and GS1 to help inform standards development or to participate in future workshops, pilots, and other activities as necessary.
