The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers, repackagers, wholesalers, and dispensers to serialize prescription drug products at the package level and participate in an interoperable electronic track-and-trace system. The final enforcement deadline passed in November 2024, and FDA has begun aggressive enforcement in 2025 and 2026. Your quality management system must govern serialization processes, suspect product investigations, trading partner data exchange, and the records required to demonstrate compliance during an inspection.

What DSCSA requires

DSCSA was enacted in 2013 and has been phased in over a decade. The law’s end goal is a fully interoperable electronic system that traces prescription drug packages from manufacturer to dispenser, enabling rapid identification and removal of counterfeit, stolen, or otherwise compromised product from the supply chain.

The core technical requirements include four elements.

Product identifiers. Each saleable unit of a prescription drug must carry a standardized numeric identifier (SNI) that encodes the National Drug Code, serial number, lot number, and expiration date. This is typically encoded in a 2D data matrix barcode (GS1 DataMatrix) on the package.

Serialization. Each package-level unit must carry a unique serial number. Manufacturers must generate, assign, and manage serial numbers for every unit they produce. Serial numbers must be unique across a company’s entire product portfolio, not just within a single product or lot.

Electronic product tracing. Trading partners must exchange Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) electronically for every transfer of ownership. The standard format is EPCIS (Electronic Product Code Information Services), which enables interoperable data exchange across different companies’ systems.

Verification. Trading partners must be able to verify the product identifier on any package before accepting it into their inventory or dispensing it. This requires connectivity to the manufacturer’s verification system or a third-party verification router.

Current enforcement posture

FDA’s full enforcement of DSCSA interoperability requirements went into effect after a one-year stabilization period that ended in November 2024. As of 2025 and 2026, FDA and state pharmacy boards are conducting inspections that include DSCSA compliance elements. Pharmaceutical commerce reporting from May 2026 confirms that DSCSA enforcement is among the most active areas of pharma supply chain oversight, with FDA treating non-compliant trading partner transactions as suspect product situations requiring investigation (Pharmaceutical Commerce, 2026).

The most common enforcement gaps found during inspections involve incomplete transaction data, failure to investigate suspect product flags within required timeframes, and inadequate documentation of verification activities.

How DSCSA connects to your QMS

Many pharmaceutical quality teams treat DSCSA as an IT or supply chain problem rather than a quality problem. That framing creates compliance gaps. DSCSA requires quality management processes in several areas that belong squarely in your QMS.

Serialization process validation

The process of applying product identifiers to packages is a manufacturing process that must be validated. Label application, barcode printing, camera-based verification of barcode readability, and aggregation into case and pallet identifiers all require documented validation evidence. FDA inspectors reviewing DSCSA compliance will ask for validation records demonstrating that the serialization system reliably generates accurate, readable product identifiers. This is an extension of your existing process validation program, not a separate IT exercise.

Suspect product investigation

DSCSA requires trading partners to quarantine and investigate product with a suspect product identifier within defined timeframes. An illegitimate product determination must be reported to FDA within 24 hours. The investigation workflow is a quality process: it requires an investigation protocol, root cause analysis, disposition decisions, records of the investigation outcome, and a formal determination of whether the product is legitimate, suspect, or illegitimate.

If your QMS does not have a formal suspect product investigation workflow, FDA will find that gap during an inspection. The investigation records must demonstrate that you followed a documented procedure and made product disposition decisions based on evidence, not convenience.

Trading partner qualification

DSCSA only permits transfers of drug product between “authorized trading partners”: companies that have met FDA’s licensing and registration requirements and have the systems to exchange compliant transaction data. Before you sell to a new customer or buy from a new supplier, you must verify their authorized trading partner status. This is a supplier qualification activity that belongs in your supplier quality management program, with documented verification records and periodic re-verification.

Transaction data records

DSCSA requires companies to maintain transaction records (TI, TH, TS) for six years and make them available to FDA upon request within 24 hours or within a reasonable timeframe specified by the agency. These records must be maintained in a system that is secure, accessible, and capable of producing records in the format FDA requests. Data integrity requirements under CGMP apply to DSCSA transaction records just as they apply to batch records and test results.

The audit trail for transaction data must show when records were received, whether they were verified, what action was taken on any discrepancies, and who authorized that action. An audit trail that has been altered or that lacks timestamps is a data integrity violation that compounds the original DSCSA compliance issue.

Change control for serialization systems

Serialization systems are software systems used in GMP manufacturing. Changes to serialization software, label formats, barcode standards, or trading partner data exchange formats require a formal change control process, including an assessment of whether revalidation is needed. Companies that allow IT teams to update serialization systems without quality change control create a documentation gap that FDA will find during an inspection.

The process change notification requirements under DSCSA add another layer: if a change to your serialization process affects the product identifiers you provide to trading partners, they may need notification of that change before it takes effect.

Building DSCSA compliance into your QMS

Create a DSCSA-specific SOP structure

Your QMS should include SOPs covering at minimum: serialization process operations and verification, suspect product identification and investigation, authorized trading partner verification, transaction data receipt and storage, and DSCSA reporting to FDA. These SOPs should reference your general deviation, CAPA, and change control procedures where those procedures apply to DSCSA activities.

Integrate suspect product investigations with your deviation system

A suspect product flag from a trading partner or a verification failure at your facility is a deviation from your expected product flow. Route these events through your deviation management system so they get a formal investigation, root cause analysis, and disposition decision with documentation. This integration ensures that suspect product events are tracked, trended, and closed in the same system as your other quality events.

Maintain an authorized trading partner register

Create and maintain a register of all trading partners, with documented verification of their authorized trading partner status, the date of verification, the method of verification, and the next re-verification date. Link this register to your supplier qualification records. Before any drug product transfer, the receiving or shipping trading partner’s status should be confirmed against this register.

Establish transaction record retention in a validated system

Transaction data (TI, TH, TS) must be stored in a validated system with controlled access, data integrity protections, and a documented retention schedule. If your current document management system cannot accommodate electronic EPCIS transaction records, evaluate whether a dedicated DSCSA data management module or integration is required. Any system used to store DSCSA records is a computer system subject to CSA assessment.

Include serialization in your annual product quality review

Serialization process performance should be reviewed as part of your annual product quality review. Review metrics should include the rate of barcode readability failures, the number of suspect product investigations initiated, the timeliness of investigation closure, and any trading partner data exchange failures. Trending these metrics over time supports continuous improvement and provides evidence of an effective DSCSA compliance program.

Common gaps FDA finds during DSCSA inspections

Based on inspection observation patterns and industry reporting from 2024 and 2025, the most frequently cited DSCSA compliance gaps include: serialization systems not included in the validated computer system inventory; suspect product investigations not completed within the 24-hour reporting timeline for illegitimate product determinations; transaction records maintained in unvalidated or unsecured systems; trading partner status verifications not documented or not current; and changes to serialization systems implemented without quality change control review.

Each of these gaps has the same root cause: the company treated DSCSA as an IT implementation project rather than a quality management requirement. The difference shows in inspections.

What this means for your eQMS

An eQMS that can centralize your deviation and CAPA management, supplier qualification, document control, and change control processes gives you the infrastructure to build a compliant DSCSA program without creating a parallel paper-based system. Cloudtheapp’s platform, with 60+ configurable quality applications, lets you configure suspect product investigation workflows, authorized trading partner registers, and serialization change control processes within your existing quality infrastructure. Request a demo to see how Cloudtheapp supports pharmaceutical supply chain quality compliance.

Frequently asked questions

Does DSCSA apply to compounded drugs?

Compounded drug products are generally exempt from DSCSA requirements because they are produced pursuant to a prescription and are not commercially distributed in the same sense as manufactured prescription drugs. However, 503B outsourcing facilities that manufacture compounded drugs in bulk are subject to CGMP requirements and should assess their specific DSCSA obligations with regulatory counsel.

What happens if a trading partner sends you product without a valid product identifier?

Under DSCSA, you should not accept product without a valid product identifier unless you have a documented process for handling such exceptions, which in most cases means treating the product as suspect until the identifier can be verified through the manufacturer. Accepting product with a known identifier deficiency without documentation creates a DSCSA compliance violation on your end, regardless of whether the problem originated with your trading partner.

How long do I need to keep DSCSA transaction records?

DSCSA requires transaction records to be maintained for six years from the date of the transaction. These records must be available to FDA upon request within 24 hours or within a reasonable timeframe the agency specifies. Electronic records are preferred and must meet data integrity requirements applicable to CGMP computer systems.

Conclusion

DSCSA has moved from a phased implementation project to an actively enforced compliance obligation. Pharmaceutical companies that built their serialization programs as standalone IT deployments are finding that FDA expects to see quality management wrapped around every aspect of their track-and-trace program, from serialization process validation to suspect product investigation to trading partner qualification. The companies that will pass DSCSA-focused inspections are those that integrated these requirements into their QMS from the start, not those still trying to bridge the gap between their serialization system and their quality system after the fact.

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