FDA Extends Compliance Deadline for Updated DSCSA Requirements

For many manufacturers, the holidays arrived early – in the form of a DSCSA waiver.

The U.S. Food and Drug Administration (FDA) recently announced a revised timeline for compliance with specific updated Drug Supply Chain Security Act (DSCSA) requirements. These extensions provide additional time for key stakeholders to implement systems and processes supporting “interoperability” requirements, highlighting compliance struggles the industry has been quite vocal about. While many stakeholders have made progress in implementing systems and data exchange requirements with their partners, numerous entities are still encountering data accuracy and completeness issues.

As a result, the FDA has granted waivers to stakeholders who have already begun implementing DSCSA requirements and are still facing delays in complying with the new regulations. Specifically, “the exemptions apply to any product transacted by eligible trading partners who have initiated their systems and processes, […] including electronic DSCSA data connections (which may include portals) with their immediate trading partners by November 27, 2024.”

Originally scheduled for a November 27, 2023 deadline, in August 2023, the FDA announced a one-year stabilization period until November 27, 2024, to allow trading partners to implement, troubleshoot, and mature their electronic interoperable systems to meet DSCSA requirements. The stabilization period was intended to avoid disrupting the supply chain and ensure continued patient access to drug products as trading partners worked to fully implement the enhanced drug security requirements.

The FDA provided similar reasoning when announcing an additional timeline change on October 9, 2024. The change extends compliance deadlines by stakeholder type in a staggered approach over the next twelve months.

Key Changes to the Timeline

The FDA has revised the compliance deadlines as follows:

• Manufacturers/Repackagers: Have until May 27, 2025
• Wholesale serialDistributors: Have until August 27, 2025
• Larger Dispensers (26+ employees): Have until November 27, 2025

The FDA notes that this waiver will automatically apply to all entities—trading partners who will leverage the extended timeline do not need to submit a notice or waiver for review.

Key Takeaway: Suspect Product Reporting Remains Mandatory

While the FDA has extended the deadlines for certain DSCSA requirements, it is important to note that this does not exempt the market from following new processes for suspect product reporting. Stakeholders are still required to report suspect products to the FDA, even if they have not yet implemented the full suite of interoperability with their immediate trading partners.

Additionally, the FDA is maintaining its timeline for the final integrated/accurate serialized data requirements. This means stakeholders must still submit accurate and complete serialized product information, even if the data is shared manually between trading partners.

What Do These Changes Mean for Stakeholders?

The FDA’s decision to extend the compliance deadlines provides some relief for stakeholders who may have been struggling to meet the previous setup requirements and timeline. However, it is crucial to recognize that the extensions are temporary, and entities must still comply with the updated DSCSA regulations by the new deadlines. The FDA reiterates the exemptions “should not be viewed as providing a justification for delaying efforts to implement” the DSCSA requirements. The FDA also released a detailed document outlining the specific DSCSA transactions covered by this exemption.