Responding to stakeholders across the pharmaceutical supply chain, the US Food and Drug Administration (FDA) announced it will provide additional time to meet enhanced distribution security requirements under the Drug Supply Chain Security Act (DSCSA). 

DSCSA requires that trading partners (i.e., prescription drug manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers, primarily pharmacies) implement an interoperable, electronic tracing of certain prescription drugs as they are distributed in the US.  

DSCSA, which has been phased in over a 10-year period since being signed into law in 2013, requires trading partners to provide, receive, and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser. The first phase of traceability requirements, which have phased in over time, now generally require products to be traceable at the lot level. The second phase of requirements, which FDA refers to as “enhanced distribution security requirements” require the interoperable, electronic tracing of products at the package level, and compliance to these requirement had been set to go into effect November 27, 2024, following a one-year stabilization period to accommodate trading partners’ ability to implement, troubleshoot, and mature their interoperable electronic systems and processes to meet the DSCSA requirements..  

With that November 27, 2024, deadline approaching, FDA announced this week (October 9, 2024), it is granting an exemption from the enhanced drug distribution security requirements for a specified period of time to any product transacted by “eligible” trading partners. The agency defines “eligible” trading partners as they who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data. The duration of the exemption varies depending on the type of eligible trading partner as outlined below:  

• Manufacturers and Repackagers: May 27, 2025; 

• Wholesale Distributors: August 27, 2025; and 

• Dispensers with 26 or more full-time employees: November 27, 2025 

Trading partners who utilize these exemptions do not need to notify FDA. 

“FDA understands that many trading partners have made considerable progress with implementing enhanced drug distribution security requirements and initiating their systems and processes, particularly in establishing the data connections necessary to exchange electronic DSCSA transaction information and transaction statements with one another,” said FDA in an October 9, 2024, letter outlining the exemption. “Nevertheless, the Agency continues to receive comments and feedback from trading partners across the pharmaceutical distribution supply chain, who, despite having established or attempted to establish the necessary connections to facilitate secure, interoperable, electronic DSCSA data exchange with their trading partners, express concerns with readiness to properly meet the FD&C Act [Federal Drug & Cosmetics Act] requirements…at the conclusion of the stabilization period on November 27, 2024. Specifically, such trading partners describe challenges resolving issues involving missing or erroneous data in electronic DSCSA transaction information and transaction statements without significantly delaying product distribution, including products that are in shortage. FDA recognizes that trading partners, who have initiated their systems and processes and have established  electronic DSCSA data connections with their trading partners, may need additional time.” 

FDA heeds input from stakeholders 
The Healthcare Distribution Alliance (HDA), a national organization representing healthcare distributors, supported FDA’s decision to issue a broad exemption to extend the deadline for DSCSA implementation. “HDA and our pharmaceutical distributor members applaud the FDA’s decision to grant an exemption for the DSCSA’s enhanced drug distribution security (EDDS) requirements for eligible trading partners,” said HAD President and CEO Chester “Chip” Davis, Jr., in an October 9, 2024, statement. “While many in the supply chain have made significant progress throughout the stabilization period, some are still struggling to establish data connections. Given the interdependency of the pharmaceutical supply chain, FDA’s phased-in approach will allow supply chain partners to better align their data exchange processes to ultimately achieve full implementation and also acknowledges the progress made thus far. HAD and other industry groups, such as the National Association of Chain Drug Stores (NACDS), as well as 21 members of Congress recently advocated for additional time to stabilize the complex processes necessary for compliance.”  

Source: HDA and US Food and Drug Administration