By November 27, 2023, the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) will be fully implemented. We’ve been working with the boards of pharmacy, other regulators, and trading partners to prepare for the requirements included in Title II of the Act, which calls for product tracing at the package level.
Our DSCSA State Regulator Pilot project tested use cases and explored potential pathways for sharing this info between regulators and trading partners. The effort aimed to explore DSCSA interoperability and included:
- 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.
- 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.
The primary goals of this project? 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 network is expected to:
- Be consistent with the Uniform National Policy (Sec. 585) and 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 communications
- Ensure that only authorized regulators can access and make requests of authorized trading partners
- Protect confidential and/or proprietary information of participants
- Focus on the most critical patient safety use cases
We are continuing to collaborate with stakeholders across the pharmacy industry to develop this interoperable DSCSA network. Visit the DSCSA State Regulator Network section of our website for project updates and additional information about the pilot including the Report of the DSCSA State Regulator Pilot With the United States Pharmaceutical Supply Chain.