A shipment is ready to leave a packaging line. Serial numbers have been assigned, aggregation data is complete, and EPCIS files must be exchanged with trading partners before the product can move. Downstream, a wholesaler prepares to receive the shipment and verify that the identifiers match the data they expect to see. At the end of the chain, a pharmacy must confirm product authenticity at the point of receipt.
Every step relies on accurate, traceable data. Most DSCSA requirements are now in effect across manufacturers, repackagers, and wholesale distributors, and only one phase remains: smaller dispensers (25 or fewer full-time employees) have until Nov. 27, 2026. As the pharmaceutical supply chain moves through these final stages, organizations are evaluating whether their systems can reliably generate, exchange, and reconcile serialized event data.
This post outlines how pharmaceutical track and trace software supports DSCSA compliance and supply-chain continuity. We’ll cover:
The phrase “track and trace” is used across many industries, but in pharmaceuticals it has a specific meaning shaped by DSCSA and global serialization regulations. These systems manage:
Unlike general-purpose tracking tools, pharmaceutical track and trace software is built to manage the identifiers, data structures, and workflows required for regulated products.
Warehouse management and ERP systems track inventory movement, location, and fulfillment activities. They are not designed to ensure whether each saleable unit is legitimate, verified, and supported by accurate event data.
Pharma track and trace platforms must align serialized identifiers with:
Instead of simply recording where a product is, these systems document whether the product is authentic and whether its associated data meets regulatory standards.
DSCSA defines how prescription drugs must be serialized, verified, and traced as they move through the supply chain. Each phase of implementation introduces new expectations for how trading partners generate, exchange, and manage event-level data. With the November 2025 dispenser milestone, the focus has shifted to whether downstream partners can support verification and accurate data exchange.
Readiness varies across the supply chain. According to Regulatory Focus, wholesalers reached a median data-exchange accuracy rate of 98.5%. Requirements for manufacturers and repackagers took effect on May 27, 2025, and these trading partners now operate under the fully implemented serialization and data-exchange provisions of DSCSA.
Verification at the point of receipt remains an area with room for progress among dispensers, according to Pharmaceutical Commerce. Many pharmacies are still adjusting their workflows and systems to support serialized identifiers, event histories, and exceptions handling—especially those incorporating the new requirements into established operations.
Pharmaceutical Commerce also noted FDA discussions emphasizing the need for stronger interoperability and more efficient handling of incomplete or mismatched data during the stabilization period. These observations directly influence what trading partners need from track and trace platforms, including:
As the remaining DSCSA phases take effect, software helps trading partners maintain accurate, usable serialized data across manufacturers, wholesalers, 3PLs, and dispensers.
Pharma track and trace systems share common capabilities designed to support downstream compliance, upstream production, and collaboration across the supply chain.
Assigning unique identifiers at the unit, case, and pallet levels, including support for GS1 standards and regulatory data structures.
Connecting with packaging lines and printers to commission serial numbers and support changes in packaging formats.
Linking units to cases and pallets, maintaining parent–child relationships that must remain accurate as products move through facilities.
Creating, storing, and exchanging EPCIS 1.2 or EPCIS 2.0 event data for commissioning, packing, shipping, receiving, and decommissioning.
Receiving and responding to verification requests, including product identifier checks for dispensers and wholesalers.
Addressing mismatches in serial numbers, incomplete event histories, or errors that must be resolved before products can move.
Exchanging EPCIS data with contract manufacturers, wholesalers, 3PLs, and dispensers, ensuring that each partner receives accurate files.
Maintaining controlled access to sensitive data and documenting activities for inspection readiness.
Retrieving event histories to support recalls and investigations, allowing organizations to trace when and where issues occurred.
DSCSA requirements apply differently to manufacturers, wholesalers, and dispensers, which shapes how each group uses track and trace software.
Manufacturers handle serialization commissioning, aggregation, and most EPCIS event creation. Their systems must support packaging line integration and high-volume event generation for shipments to multiple trading partners.
Distributors receive large volumes of serialized data and must verify product identifiers when accepting, returning, or investigating products. With high throughput, wholesalers rely on accuracy and interoperability to move products without delays.
As noted by Regulatory Focus, distributors reported a median data-exchange accuracy rate exceeding 98% leading up to the Aug. 27, 2025 deadline, following the extended DSCSA stabilization period provided by the FDA.
Pharmacies and health systems verify product identifiers at the point of receipt. Pharmaceutical Commerce has identified this step as a continuing weak point for DSCSA compliance, requiring accurate event data provided by upstream partners.
Dispensers with 26 or more full-time employees must comply with DSCSA serialization and verification requirements by Nov. 27, 2025, extending the law’s provisions further downstream in the supply chain.
Selecting a track and trace system involves assessing how well the platform supports regulatory requirements and collaboration with trading partners.
Key considerations include:
A platform that supports these capabilities helps organizations maintain compliance and supply-chain continuity.
DSCSA workflows require systems that manage serialized identifiers and the full sequence of commissioning, packing, shipping, receiving, and verification events—not just inventory movement.
Upstream partners operate under requirements already in effect, while downstream partners—especially dispensers—are still adapting to serialized event data, making consistent EPCIS exchange essential.
Industry updates show ongoing work to support verification at the dispenser level, reinforcing the need for tools that can handle exceptions, mismatches, and incomplete data as products move downstream.
Covectra’s AuthentiTrack platform is an example of a system used for serialization management, aggregation, EPCIS event generation, and verification support. It helps trading partners exchange serialized data and maintain traceability across the pharmaceutical supply chain, supporting workflows required under DSCSA.
Interested in learning more?
Contact us at Covectra for more information and to discuss your organization’s needs.
Serialization assigns unique identifiers to individual saleable units, while track and trace systems manage the event data associated with those identifiers as products are commissioned, packed, shipped, received, verified, or decommissioned.
EPCIS is the format used for sharing serialized event information under DSCSA. Manufacturers, repackagers, wholesale distributors, and many dispensers rely on EPCIS files to document product movement and verification.
Verification tools compare the product identifier on a package against the serialized event data received from upstream partners. This helps dispensers confirm whether a product can be accepted, investigated, or returned.
Mismatches may trigger exceptions that must be resolved before products move downstream. Track and trace systems help identify missing events, incorrect identifiers, or aggregation issues so trading partners can correct them.
No. Warehouse and ERP systems track inventory locations and movements. Track and trace software manages serialized identifiers and the event histories required for DSCSA compliance and product verification.
Read More
Serialization in Pharma: Driving Compliance, Safety, and Traceability
EPCIS and DSCSA: How Serialization Supports Compliance
What Is Pharmaceutical Serialization and Why Is It Critical Today