Overview: As of 2025, DSCSA compliance extends far beyond applying serialized barcodes. Pharma manufacturers and CMOs must demonstrate interoperability, maintain six years of transaction data, verify trading partners, and resolve exceptions quickly. Companies that invest in EPCIS adoption, partner coordination, and scalable technology will reduce supply chain risk and stay audit-ready.
The Drug Supply Chain Security Act (DSCSA) has entered a stricter phase. Enhanced requirements for electronic, interoperable tracing of prescription medicines took effect on Nov. 27, 2023, followed by a one-year stabilization period that ended in November 2024. As of May 27, 2025, manufacturers and repackagers are fully subject to these rules, and enforcement has expanded across the supply chain. Companies that lag risk shipment delays, partner friction, and regulatory consequences.
Compliance now requires continuous coordination across packaging lines, trading partners, data repositories, and verification systems. In 2025, the focus is on demonstrating that these systems work reliably together and that remaining gaps have been closed.
In the sections that follow, you’ll find:
The DSCSA, signed into law in 2013, has rolled out in stages over the past decade. In 2025, the U.S. pharmaceutical supply chain is expected to operate with full DSCSA compliance, meaning interoperable electronic systems must be in place to trace prescription drugs at the package level.
The FDA has emphasized that while the stabilization period allowed companies extra time to test and refine their systems, enforcement is underway. Guidance documents highlight:
Companies that only met earlier DSCSA milestones—such as serialization on packaging lines—must now evaluate whether data exchange, verification, and partner connectivity are working in practice.
Reaching DSCSA compliance in 2025 involves more than printing serialized barcodes. The FDA expects manufacturers, packagers, and distributors to prove that their systems work across every step of the supply chain. The following requirements are at the center of enforcement.
Every package and homogeneous case must carry a unique product identifier that includes:
The identifier must be encoded in a 2D DataMatrix barcode that can be scanned and verified at any point in the supply chain. Manufacturers must ensure printing and encoding equipment is accurate, consistent, and integrated with back-end systems that manage serial data.
The EPCIS standard is now the required format for sharing transaction data. EPCIS enables event-based reporting that goes beyond lot-level information, giving visibility into product movement and status. Systems must be able to send, receive, and interpret EPCIS files across all trading partners without errors or delays.
The Verification Router Service (VRS) is required for saleable returns. When distributors return prescription drugs to manufacturers or repackagers, the VRS enables quick verification of product identifiers. Without an operational VRS connection, companies risk non-compliance and shipment delays.
Manufacturers cannot transact with entities that fail to qualify as ATPs. Each partner must be licensed and registered, and companies must maintain procedures to confirm ATP status before shipping or receiving product.
Written procedures must be in place for investigating suspect product and reporting illegitimate product to the FDA and trading partners. This includes:
Even companies that invested early in serialization often encounter gaps when connecting systems and partners. DSCSA compliance demands operational discipline across packaging, warehousing, IT, and quality.
Manufacturers must integrate printers, vision systems, and rejection stations while ensuring barcodes scan correctly. CMOs face added complexity managing requirements for multiple clients.
EPCIS exchange depends on clean connections with ERP, WMS, and logistics systems. Data mismatches in lot, serial, or expiration fields remain a common source of exceptions that delay shipments.
Compliance also hinges on wholesalers, 3PLs, and dispensers. If trading partners cannot process EPCIS events or VRS requests, compliant companies still face disruptions.
Investigations and exception handling require trained staff and documented procedures. Without automation, errors multiply. Companies must also archive six years of transaction data in secure, auditable systems.
Reaching full DSCSA compliance requires a proactive approach. Companies that wait for trading partners or regulators to flag gaps often find themselves facing shipment delays or costly rework. A readiness plan should address both technology and process.
To maintain DSCSA compliance, pharma manufacturers and CMOs should be able to check off:
Pharma manufacturers and CMOs do not have to manage DSCSA compliance alone. Covectra’s solutions are built to meet the 2025 requirements while reducing operational complexity:
By combining serialization technology with integration expertise, Covectra helps companies maintain compliance while reducing the operational burden of managing multiple systems and partners.
What is the DSCSA compliance deadline?
The FDA set Nov. 27, 2023, as the deadline for interoperable electronic data exchange, with enforcement beginning in late 2024. Companies must now be fully compliant in 2025.
Who must comply with DSCSA?
Manufacturers, repackagers, wholesale distributors, and dispensers all share responsibility for compliance. Each must meet serialization, traceability, and verification requirements.
How does EPCIS support DSCSA compliance?
EPCIS provides a standardized format for event-based data exchange, enabling trading partners to share and interpret serialized information consistently across systems.
What happens if a company is not DSCSA compliant?
Non-compliance can result in shipment delays, supply chain interruptions, regulatory penalties, and reputational harm.
What role does VRS play in DSCSA compliance?
The Verification Router Service enables real-time verification of returned products, helping ensure only legitimate prescription drugs re-enter the supply chain.
DSCSA compliance in 2025 is a regulatory requirement that goes beyond printing barcodes. Manufacturers and CMOs must demonstrate interoperability, maintain audit-ready records, and coordinate effectively with trading partners. Companies that continue to treat serialization as a one-time project risk costly disruptions.
A readiness plan built on strong SOPs, EPCIS adoption, and trading partner coordination will reduce risk and streamline supply chain operations. Partnering with providers like Covectra ensures the right technology and expertise are in place to meet FDA expectations with confidence.
Protect your supply chain and simplify compliance. Connect with Covectra for solutions that align with DSCSA requirements and scale with your operations.