US Drug Supply Chain

Following the final rule approved by Trump Administration and published by Food and Drug Administration (FDA) in 2020, states can now submit proposals to establish their own wholesale prescription drug importation program from Canada.

As of January 2024, Florida has become the first state that FDA has authorized to import drugs from Canada, causing concern for over 75 pharmacy organizations. While we understand the desire to decrease the costs of prescription drugs, as discussed in the joint statement, states may face challenges while ensuring patient safety and securing the global supply chain.

We work to support the boards of pharmacy and educate and protect the public about state drug importation plans by: 

• providing guidance to state and federal governments and other policy makers on the risks associated with prescription drug importation and the necessary regulatory oversight process to help mitigate those risks;  
• working with state and federal regulators to implement the Drug Supply Chain Security Act (DSCSA), including providing education and other tools to regulators and supply chain participants to assist in implementation; and  
• educating the public about the risks associated with purchasing prescription drugs from unknown sources online and through social media.  

The Drug Supply Chain Security Act requires electronic, interoperable product tracing at the package level, across the pharmaceutical supply chain. Passed under the Drug Quality and Security Act of 2013, a 10-year timeline for full implementation of the DSCSA requirements was established. In November of 2023, FDA announced a stabilization period would go into effect for trading partners to comply with DSCSA regulations. The stabilization period will end November 27, 2024.

For several years before the implementation deadline, we have worked with an industry-wide network of regulators and stakeholders to create a solution to support implementation of the requirements. We conducted pilot programs to uncover interoperability gaps between industry participants and state regulators, as well as to understand business requirements and the tools and processes needed to meet DSCSA requirements.

In early 2023, we announced our solution for the supply chain: Pulse by NABP^TM.

Pulse is an inclusive, accessible, and secure digital platform that simplifies the process of achieving DSCSA compliance. Pulse provides access to user-friendly tools and a comprehensive network of verified relationships, enabling consistent communication with trusted partners across the supply chain from manufacturers to dispensers.