Preparing for compliance and interoperability.

With the new Drug Supply Chain Security Act (DSCSA) requirements that go into effect on November 27, 2023, we have been working with our member boards and stakeholders across the pharmacy industry to outline the use cases and explore potential pathways needed to implement and enforce these new requirements. 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. 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 and identified findings and gaps that can be used to develop 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 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 

The framework below shows how cross-industry communication is streamlined through the DSCSA network: 

Project Findings

Following the workshops and pilot project, we released the Report of the DSCSA State Regulator Pilot With the United States Pharmaceutical Supply Chain to outline the current state of DSCSA compliance within the industry and the proposed steps required for the development of an industry-wide interoperability framework. Read the report to learn more about our findings and recommendations. 

Key findings of the completed pilot project were documented in the following areas: 

• State Regulators: Outlined for state regulators to provide clarity for the upcoming phases 
• General Findings: Provided insights for all industry stakeholders to use as they implement solutions and processes 
• Training Needs: Highlighted areas of training needed to help state regulators, dispensers, and the larger industry sufficiently understand their DSCSA compliance requirements 
• Product Tracing Request and/or Response Template(s): Recommended improvements to the trace request and response spreadsheet form used in the pilot, which will be shared with standards groups for consideration 

Through the pilot and workshops, several broad solution or process gaps were identified that need to be addressed by the industry. We intend to develop solutions to address the following gap areas: 

Gap Name	Problem Description
Trace data exchange methods	Determine communication modes for users; may include standard messaging, email, and/or spreadsheets
Trading partner directory	There is no single directory in the whole industry and supply chain for all the ATPs; create and maintain a voluntary directory for industry
State regulator authorization	ATPs that receive trace requests desire proof that the requester is legitimate
Dispenser authorization	Similar to state regulators, the interoperable network should authenticate industry participants, whether part of a large or small organization
Product Global Trade Item Number (GTIN) to National Drug Code (NDC) crosswalk to manufacturers	There is a need to be able to correlate an NDC/GTIN to a manufacturer and have connection information for automated integration or manual forms of communication

These gaps will be addressed in two methods:  

1. Gaps will be recommended to the Partnership for DSCSA Governance and/or GS1.  
2. We will address some gaps in upcoming phases, including detail(s), design(s), pilot project(s), prototype(s), and/or implementation.