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: 

  1. 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. 
  2. 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: 

State Regulator DSCSA Interoperability Network

Explore how cross-industry communication is streamlined through the DSCSA network.

Graphic showing the State Regulator DSCSA Interoperability Network
Click to view the DSCSA Interoperability Network

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:  

Based on the findings of the newest pilot project, NABP intends to continue development, testing, and industry alignment in the following critical areas:

Critical FindingDescription
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: 

DSCSA Resources

For more information, contact info info@pulse.pharmacy.