DSCSA Compliance 2025: What Pharma Companies Need to Know Now

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.

Why DSCSA Compliance 2025 Demands Attention

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:

• Key regulatory milestones shaping 2025
• Core serialization and traceability requirements
• Operational challenges facing manufacturers and CMOs
• Best practices and a readiness checklist
• How Covectra supports compliance with integrated solutions

Regulatory Milestones and FDA Expectations for 2025

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.

Key Milestones Shaping 2025

• Nov. 27, 2023: Deadline for interoperable electronic data exchange between trading partners, using the Electronic Product Code Information Services (EPCIS) standard. The FDA issued a one-year stabilization period through November 27, 2024, after which enforcement began in stages.
• Verification Requirements: Manufacturers, repackagers, wholesale distributors, and dispensers must verify product identifiers and investigate suspect or illegitimate products.
• Authorized Trading Partners (ATP): All entities in the supply chain must confirm their status as authorized trading partners before engaging in transactions.
• Record Retention: Traceability and transaction records must be stored for at least six years for regulatory review.

What the FDA Expects Now

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:

• EPCIS adoption as the data standard for event-based traceability.
• Interoperability across systems so manufacturers, distributors, and dispensers can exchange and interpret serialized data consistently.
• Investigation and notification protocols for suspect or illegitimate product cases, with clear escalation processes.
• Audit readiness through accurate, accessible, and complete transaction data.

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.

Serialization and Traceability Requirements Under DSCSA

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.

Serialization and Product Identifiers

Every package and homogeneous case must carry a unique product identifier that includes:

• National Drug Code (NDC)
• Serial number
• Lot number
• Expiration date

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.

EPCIS for Data Exchange

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.

Verification Router Service (VRS)

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.

Authorized Trading Partners

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.

Suspect and Illegitimate Product Handling

Written procedures must be in place for investigating suspect product and reporting illegitimate product to the FDA and trading partners. This includes:

• Isolating questionable product
• Conducting investigations within prescribed timelines
• Notifying the FDA and partners when illegitimate product is confirmed
• Documenting all findings and actions for audit purposes

Pharma Compliance Challenges: Packaging, Data, and Partners

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.

Packaging Line Demands

Manufacturers must integrate printers, vision systems, and rejection stations while ensuring barcodes scan correctly. CMOs face added complexity managing requirements for multiple clients.

Data Integration Gaps

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.

Partner Readiness

Compliance also hinges on wholesalers, 3PLs, and dispensers. If trading partners cannot process EPCIS events or VRS requests, compliant companies still face disruptions.

Exception Management and Audits

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.

Best Practices and Readiness Steps for Drug Traceability

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.

Roadmap and Training

• Perform a gap assessment against DSCSA requirements.
• Assign clear ownership for serialization, EPCIS exchange, and VRS connectivity.
• Train staff on exception management and audit protocols.

Partner Coordination

• Confirm all trading partners qualify as Authorized Trading Partners.
• Test EPCIS data exchange and set communication protocols for exceptions.

Scalable Technology

• Use EPCIS-compliant repositories to handle data growth.
• Automate verification to speed VRS responses.
• Choose cloud solutions that simplify data retention and access.

Readiness Checklist

To maintain DSCSA compliance, pharma manufacturers and CMOs should be able to check off:

• Every unit and case carries a valid 2D DataMatrix barcode with product identifier
• EPCIS events are generated, transmitted, and received without error
• Verification Router Service is operational and tested with distributors
• Authorized Trading Partner status is confirmed for all supply chain partners
• SOPs exist for investigating suspect and illegitimate products
• Six years of traceability data is archived and accessible
• Staff are trained on exception management and audit protocols

Covectra Solutions for Pharma Serialization and Traceability

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:

• AuthentiTrack Serialization – an end-to-end serialization platform that integrates with packaging lines, manages EPCIS event data, connects with trading partners, and supports Verification Router Service (VRS) connectivity.
• Engineering and Integration Services – expert support for packaging line upgrades, system integration, and ongoing compliance audits.
• StellaGuard® Security Labels – mobile-enabled labels that add brand protection and product authentication beyond regulatory compliance.

By combining serialization technology with integration expertise, Covectra helps companies maintain compliance while reducing the operational burden of managing multiple systems and partners.

Frequently Asked Questions on DSCSA Compliance

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.

Staying Audit-Ready in 2025 and Beyond

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.

Contact Covectra Today

Protect your supply chain and simplify compliance. Connect with Covectra for solutions that align with DSCSA requirements and scale with your operations.