In life sciences and pharmaceutical manufacturing, compliance leaders face countless sector-specific challenges, but a primary concern is the complexity and high stakes of Drug Supply Chain Security Act (DSCSA) compliance. This regulation demands integration of various systems and processes to achieve full compliance and ensure supply chain visibility.
The following content aims to demystify the DSCSA, clarify its core requirements for manufacturers, and critically examine the role a pharmaceutical warehouse management system plays—and where its capabilities end.
What Is the DSCSA?
Technically considered Title II of the 2013 Drug Quality and Security Act, DSCSA is a U.S. law designed to create a secure, electronic, and interoperable system to track and trace prescription drugs. Its primary goal is to protect consumers from counterfeit, stolen, or harmful drugs, the final phase of which requires package-level traceability.
According to a special report from Supply Chain Brain: “Serialization of data using labeling with unique multi-value barcode identifiers enables supply chain partners and the FDA to quickly verify each drug’s chain of custody back to the manufacturer, with ready data access and information-sharing through a decentralized network of private repositories. The end goal: a documented, certified, secure chain of custody among vetted partners to catch counterfeit product and legitimate product stolen or diverted into the black market.”
All trading partners must meet the latest requirements or risk penalties, including supply chain disruption, monetary fines, and product seizures.
Key DSCSA Compliance Requirements for Manufacturers
Because manufacturers are at the heart of the supply chain, these organizations face specific, stringent requirements. Under DSCSA, all supply chain partners must provide documentation that includes both specific transaction information (product and lot identifiers, shipment volume, and dates) and a formal transaction statement, which essentially authorizes and verifies that particular step in the transfer process.
Key DSCSA requirements to note include:
Product Tracing & Data Exchange
Pharma manufacturers must create and maintain electronic records that cover the three T’s of product tracing: transaction information, transaction history, and transaction statements. This data must be captured electronically via Electronic Product Code Information Services (EPCIS) or other method with each transfer of ownership throughout the supply chain. Manufacturers can employ interoperable track-and-trace systems to exchange necessary product information with trading partners.
Product Verification & Handling Illegitimate Products
Additionally, under DSCSA, manufacturers are required to verify serialized product identifiers upon request, especially for suspect or returned products. A DSCSA verification router service assists in this effort by stringing product identifier information in a centralized database connected via a third-party routing service.
The Healthcare Distribution Alliance states, “Upon receiving a saleable return, the wholesale distributor captures the product data and sends the data to this third-party router service, which then routes the query to the appropriate manufacturer’s database to verify the product’s identifier.”
DSCSA Serialization
Pharmaceutical serialization compliance requires each saleable unit to have a unique product identifier—which includes the Global Trade Item Number, serial number, lot number, and expiration date—in a 2D Data Matrix barcode, similar to a QR code. This effort is the foundation of package-level traceability because it provides a uniquely identifying serial number for each product.
Authorized Trading Partners (ATPs)
Lastly, all supply chain partners, including wholesalers, third-party logistics (3PL) providers, and repackagers, must be verified as authorized trading partners (ATPs), meaning they are licensed and DSCSA compliant. To qualify as an ATP, a trading partner must meet specific state and federal licensing requirements that officially authorize it as an entity in the pharmaceutical supply chain.
How a WMS Can Support DSCSA Compliance
The complexity of the life sciences industry makes secure, compliant, and capable management software a critical operational tool. In a DSCSA context, the core functions of a WMS include:
- Data capture: Scanning and recording serialized barcodes at receiving, picking, packing, and shipping
- Inventory management: Providing real-time visibility of serialized inventory within the four walls of the warehouse
- Lot traceability: Managing lot traceability in pharmaceuticals by linking serial numbers to specific lots for efficient tracking and recall management
The right WMS successfully automates a number of warehousing processes, such as product tracing, identification, and pedigree verification, to help streamline compliance obligations. However, even the most efficient WMS needs supplementary tools and processes to support full DSCSA compliance.
Why a WMS Alone Isn’t Enough
While a WMS is essential for warehouse operations, DSCSA compliance is an enterprise-level challenge. This means that, to meet the specific challenges of the pharmaceutical industry, manufacturers must have a comprehensive system of tools that supports every aspect of DSCSA compliance.
The previously cited Supply Chain Brain report explains: “A typical WMS solution might support lot control and serialization but not necessarily a nested structure of serial numbers within serial numbers; a pharmacy may need to track the pill count in each bottle, while the WMS is only tracking the lowest unit of measure such as the serialized bottle.”
In other words, the WMS is a key part of your compliance system, but not the only part, as illustrated by the following limitations:
Limited Scope: Warehouse vs. Enterprise
DSCSA impacts procurement, regulatory reporting, and partner management—functions outside a WMS’s typical scope. As its name suggests, a WMS is designed to manage warehouse operations, not necessarily any additional aspects of the supply chain that fall outside of warehousing responsibilities.
The Data Exchange Gap
A WMS isn’t designed for the secure, interoperable data exchange (EPCIS events) required between trading partners and regulatory bodies. The highly detailed data involved in DSCSA serialization and traceability necessitates a specialized transfer system.
Incomplete Serialization Management
Pharmaceutical serialization compliance demands the highest level of traceability, which goes beyond designating serial numbers. While a WMS captures serial numbers, it doesn’t typically manage the entire lifecycle (generation, commissioning, aggregation, decommissioning) and often requires a specialized Level 4/5 serialization platform.
Lack of a Governance Framework
A WMS is a tool for execution, not a governance system. Compliance requires policies, standard operating procedures, and audits—a key differentiator for pharmaceutical compliance solutions. Relying on a WMS alone to manage and maintain DSCSA compliance will likely mean falling short of regulatory requirements due to a lack of a formal governance framework.
Building Your Complete Solution for DSCSA Compliance
A robust WMS sets the foundation for efficient warehouse management, but full compliance requires an integrated strategy—one that includes all the necessary subsystems and accommodates the limitations of a WMS when it comes to DSCSA. The necessary components for a complete solution include:
- Corporate policies and governance
- A dedicated serialization and traceability platform
- Secure electronic data exchange capabilities (EPCIS)
- Integration between WMS, enterprise resource planning, and partner systems
This is the ideal place to introduce the concept of a comprehensive life sciences compliance software ecosystem.
Achieving DSCSA compliance requires looking beyond the warehouse. Manufacturers need an integrated solution where the WMS works in conjunction with other enterprise systems. If you’re ready to build a complete DSCSA compliance strategy, get a preview of Datex® Footprint® WMS, designed for highly regulated and complex industries.
DSCSA Compliance FAQs
What is the final DSCSA deadline?
The final deadline for full implementation of DSCSA was Nov. 27, 2024, and enforcement began on May 27, 2025.
Who needs to comply with DSCSA?
All partners in the U.S. pharmaceutical supply chain must comply with DSCSA. This includes manufacturers, repackagers, wholesale distributors, 3PL providers, and dispensers (such as pharmacies and hospitals).
What are the three T’s in DSCSA product tracing?
The three T’s are the core components of DSCSA product tracing documentation that must be exchanged at each change of ownership. They are transaction information, transaction history, and transaction statement.
What is EPCIS in the context of DSCSA?
EPCIS is a global GS1 standard for sharing event-based data. For DSCSA, it is the primary method for trading partners to securely and interoperably exchange the required serialization and transaction data, enabling end-to-end traceability.