FDA DSCSA Public Meeting Highlights Interdependence of Trading Partners

Background

The Drug Supply Chain Security Act (DSCSA), which Congress enacted on November 27, 2013, outlines requirements to enhance safety and security of the pharmaceutical supply chain by facilitating the identification and tracing of prescription drugs as they move through the supply chain. Implementation of the DSCSA has been staggered to allow trading partners — including drug and biological product manufacturers, wholesale distributors, dispensers, and repackagers — time to adopt the systems necessary to fulfill the “enhanced drug distribution security” requirements for interoperable, electronic tracing, under Section 582(g)(1) of the Food, Drug, and Cosmetic Act. The enhanced drug distribution security requirements became effective for manufacturers and repackagers on May 27, 2025, and for wholesale distributors on August 27, 2025. The next step is to bring dispensers into the system. Accordingly, on November 27, 2025, large dispensers (dispensers with 26 or more full-time employees) will be required to comply with DSCSA’s enhanced drug distribution security requirements to exchange information about drug products in an interoperable electronic manner. The information that large dispensers must receive from trading partners through the interoperable electronic system includes serial numbers for each package of drug product that is part of the transaction. Smaller dispensers have until November 27, 2026, to come into the fold.

In anticipation of the upcoming implementation deadline FDA held a joint town hall with PDG on September 24, 2025, that focused on DSCSA compliance for large dispensers. This was the third in a series of town halls, following sessions focused on manufacturers and wholesalers. The session included FDA remarks, trade association updates, and individual stakeholder comments.

DSCSA Compliance Trends and Challenges for Dispensers

After November 27, 2025, FDA will expect large dispensers to be fully compliant with the DSCSA unless granted a waiver, exception, or exemption. FDA urged entities to submit any waiver, exception, and exemption requests “as soon as possible.” This may be an important option, given that PDG shared a survey in which a quarter of pharmacies reported lacking the interoperable electronic systems and processes necessary to comply with the DSCSA requirements mandating the verification of the product identifiers of the products they receive. Furthermore, the American Pharmacists Association noted that its members had identified several potential barriers to DSCSA compliance, including a general lack of understanding about what needed to be implemented, the time to implement, and the most cost-effective options for compliance. The data presented did not separate large and small dispensers, leaving predictions about dispenser readiness for the November deadline decidedly murky.

An important theme of the discussion at the meeting was the interconnected nature of compliance obligations in this space. Dispenser non-compliance may affect the ability of manufacturers and wholesalers to remain compliant (e.g. in the case of returns), but FDA did not prescribe how manufacturers and wholesalers should address non-compliance from dispensers after the deadline. In the survey PDG shared, while 94% of manufacturers surveyed in September 2025 stated that they were routinely providing complete serialized data for their products to the vast majority of their customers (up from 58% in June 2024), only 72% of pharmacy respondents reported receiving transaction information from their trading partners. It remains to be seen whether – as was true for manufacturers – dispensers will more consistently receive required data once they are fully brought into the interoperable electronic system.

Ongoing Challenges

The town hall featured major dispensers and community health pharmacies sharing their challenges to compliance presented by the activities of their upstream partners.

• Several dispensers noted that the data they received were often incomplete or inaccurate and that manufacturers were often slow to respond to data concerns and reconcile data discrepancies, resulting in dispensing delays.
• Dispensers reported that contractual arrangements with trading partners failed to specify how data would be delivered, how to handle and manage any products subject to exceptions from the standard procedures, and who the appropriate contact person was for an upstream partner.
• Dispensers also expressed challenges with drop shipments and 340B transactions, prompting calls for consistent, clear guidance from upstream partners.

These comments provide a clear signal to manufacturers and distributors that downstream partners need not only accurate, timely data, but also structured agreements, designated points of contact, and clear guidance on receiving information for products that may not be subject to standard DSCSA data exchange practices. Proactive manufacturer and wholesale distributor involvement on these fronts will be essential to ensuring compliance and avoiding supply chain disruptions as the dispenser exemption ends.

Conclusion

As the end of the large dispenser exemption approaches on November 27, 2025, trading partners should take steps to be aware of the compliance challenges facing dispensers which, given the interconnected nature of the DSCSA system, are likely to also affect upstream trading partners. If you have any questions on how to comply with the requirements of the DSCSA or respond to a trading partner’s noncompliance, please contact either of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Elizabeth Jungman, David Horowitz, and Stephanie Agu