What the August 27 Wholesaler Deadline Means for Your Pharmacy
With the August 27 DSCSA wholesaler deadline now in effect, wholesalers must now exchange serialized EPCIS data, verify returns, and meet traceability requirements—changes that directly impact pharmacy operations. Pharmacies need a clear understanding of what this enforcement milestone means for their daily operations – and the impact on future preparedness in meeting dispenser deadlines.
Understanding the DSCSA Timeline
The Drug Supply Chain Security Act (DSCSA), enacted by Congress in 2013, established a national framework to enhance the security and integrity of the U.S. pharmaceutical supply chain. Prior to DSCSA, individual states maintained a patchwork of pedigree and tracking laws, leading to inconsistencies in how prescription drugs were traced and verified across the country. DSCSA replaced these fragmented systems with a unified national standard designed to better protect patients by improving supply chain visibility and preventing counterfeit, stolen, or otherwise illegitimate products from entering the market.
The law set forth a 10-year implementation roadmap aimed at achieving unit-level traceability—requiring each prescription drug package to be serialized and verifiable—by November 2023. This ambitious goal represented a significant shift for all stakeholders.
As the 2023 milestone approached, it became evident that that many trading partners would be unable to fully meet the requirements. In response, the FDA announced a yearlong stabilization period to allow supply chain participants additional time to refine systems, coordinate interoperability, and resolve operational challenges to ensure compliance by November 2024.
Even still, many sectors of the supply chain continued to face barriers to implementation, resulting in the FDA roll-out of phased-in exemptions in 2025 and 2026:
- Manufacturers: Exemptions ended in May 2025, requiring manufacturers to be fully compliant.
- Wholesale Distributors: The exemption period just ended with the August 27th deadline
- Dispensers: Exemptions are being phased in, with one deadline in November 2025 for large dispensers and another extending into November 2026 for small dispensers
While much attention is placed on the November deadlines, it is equally important for pharmacies to remain diligent in meeting the requirements already in effect today to ensure compliance readiness.
The August 27, 2025 Wholesaler Deadline
The August 2025 milestone ensures wholesale distributors are compliant in how they both manage and share data, which includes:
Upstream and downstream data exchange: Wholesalers must receive serialized product data from their upstream suppliers and transmit that same data downstream to pharmacies. This represents a major transition from lot-level tracing to unit-level serialization, ensuring that each package is tied to its unique identifier. Pharmacies should confirm with their wholesalers that EPCIS or equivalent data exchange processes are in place and functioning consistently.
Sellable returns verification: Another critical change involves returns. Starting August 27th, wholesalers are now required to verify the product identifier—the 2D barcode containing the serial number—before restocking returned products. Pharmacies returning inventory should anticipate stricter controls: invoices must match product identifiers precisely, and any discrepancies may result in returns being denied. Understanding these requirements now can help pharmacies avoid delays and financial losses later.
Regulatory response capabilities: Wholesalers are also responsible for providing regulators with complete traceability data, documenting both the source and sale of individual packages. While pharmacies are not typically required to generate downstream data in this way, it is vital to recognize the distinction: if a pharmacy transfers product to another entity outside of patient-specific dispensing, it may inadvertently cross into wholesale distribution, triggering additional compliance obligations. Pharmacies should review their practices to ensure they are not engaging in activities that would reclassify them as distributors.
How Dispensers Can Ensure Pharmacy Preparedness
Although the August 27th deadline pertains to wholesalers, pharmacies will feel the downstream effects. The transition to serialized data and stricter return verification will change how pharmacies receive, manage, and return products. To prepare for the November deadline, pharmacies should:
Step 1: Lock In Your Data Delivery Pattern
Confirm how you’ll receive DSCSA data for every ship-to location, a direct EPCIS connection from each wholesaler and direct manufacturer partner, a solution-provider hub, and/or distributor portals as a temporary backstop. Ensure your Global Location Numbers (GLNs) and master data are correct with each partner so EPCIS files route cleanly. Track exceptions when data stops or is incomplete.
Pharmacies can obtain their GLNs through GS1 US. Some organizations may already have a GS1 company prefix that can generate GLNs for multiple locations, so check internally before registering. Each ship-to location typically requires its own GLN, and keeping these identifiers current ensures EPCIS data routes cleanly. GLNs can be up in the GS1 Global Registry.
Step 2: Build (and Test) Your Receiving & Exception Workflows
Document how staff verify product to serialized data (e.g., scan-to-EPCIS checking), , and how to respond to manufacturer and partner notifications of illegitimate product.
Plan for damaged or unscannable product. If a barcode is unreadable due to damage, establish a workflow to manually reconcile against EPCIS data and invoices. Staff should know how to quarantine these products, request verification from the wholesaler or manufacturer, and document the exception for auditing purposes.
Step 3: Prepare for Returns in a Serialized World
Expect wholesalers to require return-to-invoice matching with the correct serial number. It’s essential to train staff to retrieve the right invoice and capture serial numbers at the point of return to minimize friction.
Step 4: Check the Edge Cases
Some drop ship scenarios – especially multi-intermediary or certain 340B transactions – can complicate who receives which data and when. FDA’s “eligible trading partner” exemption was designed to keep product moving while connections mature, but pharmacies should still plan local workflows for visibility. Coordinate with covered entities and contract pharmacies on where DSCSA data will live and who needs access to operationalize it.
The stabilization period provides time to test, adjust, and refine these processes before dispenser-specific enforcement begins in November 2025 for large dispensers and November 2026 for small dispensers. Pharmacies that proactively engage with their wholesalers now will be better positioned to ensure uninterrupted operations and compliance when their own deadlines arrive.
Step 5: Evaluate a Solution Provider for EPCIS Data Management
Managing serialized EPCIS data at scale can quickly overwhelm manual processes. Pharmacies should identify a solution provider to help centralize EPCIS ingestion, reconcile shipments across multiple wholesalers and manufacturers, and surface exceptions in real time. A strong partner can also provide dashboards, audit trails, and automated alerts to reduce compliance risk. When evaluating providers, look for:
- Proven DSCSA expertise and existing trading partner integrations
- Support for multiple data delivery channels (direct connections, hubs, portals)
- Clear exception-handling workflows
- Scalable reporting tools for audits and regulatory requests
Engaging a solution provider early ensures pharmacies are not only compliant but also efficient in managing the volume and complexity of serialized data.
Looking Ahead
Between now and November 27, 2025, large dispensers should treat each new purchase, partner, and ship-to as an opportunity to validate EPCIS connectivity, clean up master data, and fine-tune exception handling. Small dispensers benefit from extra time to implement interoperable exchange but should still use this time to standardize processes so they’re audit-ready when their exemption ends on November 27, 2026.D
