Drug Supply Chain Security Act (DSCSA) – US Pharma Serialization & Traceability

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Serialization, EPCIS Events, Interoperable Exchange • QA/RA, Manufacturing, Distribution, IT/OT

DSCSA is the United States’ end‑to‑end traceability framework for prescription drugs. It pushes the industry from paper lot‑level tracking to package‑level identity, electronic interoperability, and rapid verification. In practice, DSCSA is not “just a label”; it is a system of identity (Serialization), event publication (EPCIS), and operational controls in WMS/MES that make the wrong shipment, wrong market, or unverifiable return physically impossible. DSCSA also forces disciplined data integrity: configuration under Document Control, audit trails, role‑based access, and validated integrations (GAMP 5/CSV, Part 11 expectations).

“Under DSCSA, traceability isn’t a spreadsheet—it’s a living chain of serialized events that proves custody, location, and legitimacy in seconds.”

1) Scope—Who Must Comply and What’s In

In scope: manufacturers, repackagers, wholesale distributors, dispensers (pharmacies), and 3PLs moving prescription drugs in the U.S. The act governs serialized product identifiers, interoperable exchange of transaction information, verification of returns and suspect product, and readiness for investigations/recalls. Packaging hierarchies (unit → case → pallet) must be traceable with SSCC and event publication.

Out of scope: non‑covered products and internal process minutiae not tied to distribution security. That said, your QMS still governs training, SOPs, MOC, and internal audit—because DSCSA evidence must be consistent, attributable, and retrievable.

2) Product Identifier—What Must Be on the Package

Each saleable unit requires a 2D DataMatrix encoding a DSCSA product identifier: a GTIN (derived from NDC), a unique serial number, lot number, and expiration date. These are carried using GS1 Application Identifiers (AIs) such as (01) for GTIN, (21) for serial, (10) for lot, and (17) for expiry. Print quality and data accuracy are non‑negotiable—use governed templates (Labeling Control) and enforce on‑line Label Verification to stop unreadable or mis‑encoded codes.

For cases and pallets, print GS1‑128 case labels and assign SSCC. Maintain aggregation—the explicit membership of child units inside a parent—so shipments and verifications can be proven without opening every box.

3) Interoperability—EPCIS vs. EDI and Why Both Matter

DSCSA’s enhanced security hinges on interoperable electronic exchange. Two streams typically run in parallel:

• Business documents (orders, invoices, ASNs) via EDI.
• Serialized events (commission, pack, ship, receive, decommission) via EPCIS, which encodes what (GTIN/serial), when, where, and why (business step + disposition).

ASNs say “what’s coming”; EPCIS proves the serialized custody chain actually occurred. Your systems must reconcile both—if EPCIS shows a different count than the ASN or physical scan, the WMS should quarantine on arrival (Quarantine/Hold) until resolved.

4) Verification—Suspect, Illegitimate, and Saleable Returns

Trading partners must verify product identifiers on request and prior to reselling certain returns. Operationalize verification as a scan‑first gate: if a unit’s GTIN/serial/lot/expiry cannot be verified against authoritative data, block movement with hard gates and open a guided NCR/RCA flow.

All suspect product should be segregated physically and in system (Hold/Release), investigated with documented checks, and dispositioned under CAPA. For returns, build an automated verification step—before re‑stocking—to protect downstream patients and partners.

5) Warehouse Truth—How WMS Makes DSCSA Real

DSCSA lives or dies in the warehouse. Make the WMS the system of control for identity and movement:

• Directed Put‑Away into status‑controlled zones (Directed Put‑Away, Quarantine).
• Directed Picking with FEFO/FIFO enforcement (Directed Picking, FEFO/FIFO).
• Scan challenges that validate GTIN/serial/lot/expiry at each move (Barcode Validation).
• Aggregation integrity from unit to case/pallet using GS1‑128 and SSCC.
• Pack & Ship that reconciles physical scans to pick lists and outbound docs (Pack & Ship, Shipping Manifest, BOL).

Every acceptance or rejection should create evidence—transaction, user, time, device—captured in the audit trail for defensible investigations and recalls.

6) Master Data—The Source of Serialization Truth

Lock down masters: NDC↔GTIN mapping, packaging hierarchies, shelf‑life and temperature classes, AIs used in each barcode, and market‑specific label claims controlled under Document Control. Keep serial number policies, ranges, and commissioning rules versioned; connect lot genealogy to production via eBMR/genealogy.

Where you manage potency/special recipes, ensure MES produces consistent lot identifiers and expiry logic (potency adjustment, recipe versioning) so DSCSA data matches released product realities.

7) Printing, Scanning & Aggregation—Get the Physics Right

Serialization lives on printers and scanners. Qualify devices (IQ/OQ/PQ), maintain calibration status, and validate imaging/grade checks with Label Verification. For aggregation, close parents only when child membership is complete and verified; publishing EPCIS without correct parent‑child links creates recall headaches later.

On returns, de‑aggregate and verify: a case could be genuine but contain non‑verified units. Your WMS/MES should make such mismatches impossible to ignore.

8) Data Integrity & Validation—Proving It End‑to‑End

Operate serialized systems under GAMP 5 risk‑based CSV with Part 11 expectations: unique users, electronic signatures with meaning, time synchronization, and tamper‑evident audit trails. Keep configurations, label templates, and partner mappings under Document Control; retain records per your Record Retention & Archival policy.

Integration tests should include negative paths: unreadable codes, wrong AIs, duplicate serials, orphaned children, time drifts, and EPCIS/physical mismatches. Sign off in FAT and at go‑live with UAT.

9) Exception Handling—When Reality and Data Disagree

Design for exceptions, not around them. Common DSCSA exceptions include EPCIS count mismatch vs. physical, aggregation gaps, serials that fail verification, and duplicate serials. The antidote is an interlocked workflow:

• Auto‑quarantine inventory (Hold) and block shipment.
• Open a tracked Deviation/NCR with RCA.
• Correct data or rework physical aggregation; capture e‑signatures and audit trail.
• Release only after independent QA review (Lot Release).

Do not allow “manual patching” of serials without governance—every change must be attributable and reversible.

10) Recall Readiness—Seconds, Not Days

DSCSA shifts recalls from audit projects to data queries. With end‑to‑end genealogy, EPCIS events, and WMS scans, you should list all shipped serials by customer and logistics unit within hours. Practice with periodic drills (Recall Readiness) and ensure your Pack & Ship process consistently records BOL/manifest links for custody proof.

11) Metrics That Prove DSCSA Control

• EPCIS↔Physical Match Rate at inbound and outbound (by lane, partner).
• Aggregation Accuracy (orphan/overage/shortage rates) and time‑to‑correction.
• Verification Response Time for suspect/returns (seconds/minutes target).
• Unreadable Code Rate and label reprint ratio (verification pass rate).
• Quarantine Release Lead Time after exceptions (Hold/Release effectiveness).
• Recall Drill Duration to full customer list (from trigger to final output).
• Audit‑trail review completion and blocked unauthorized changes (UAM effectiveness).

Publish these KPIs and review in management review alongside OTIF, OEE, and cost‑to‑serve to keep serialization from becoming a silo.

12) Failure Patterns (and Antidotes)

• Spreadsheet serialization. Serials issued/managed in offline files. Antidote: govern in MES/label engine with audit trails and approvals.
• Label drift. Local template edits per product/market. Antidote: centralized Labeling Control and on‑line verification.
• Aggregation loose ends. Closing parents with missing scans. Antidote: block case/pallet close until child completeness is proven; reconcile on ship.
• EPCIS/EDI misalignment. Partners receive goods that data doesn’t match. Antidote: reconcile ASN vs. EPCIS vs. physical at each dock; hold mismatches.
• Weak exception governance. “We’ll fix it later.” Antidote: auto‑open NCR, require RCA, and verify CAPA effectiveness.
• Access sprawl. Shared logins; no segregation of duties. Antidote: tighten UAM and review logs in internal audits.

13) How This Fits with V5 by SG Systems Global

V5 Label & Serialization. The governed label engine (under Labeling Control) prints DSCSA product identifiers with validated AIs; Label Verification blocks bad codes. MES commissions serials and ties them to eBMR genealogy.

V5 WMS & EPCIS. The V5 WMS enforces status, FEFO, and scan gates; it maintains unit↔case↔pallet aggregation (GS1‑128, SSCC) and publishes/consumes EPCIS events to partners.

V5 QMS & Governance. The V5 QMS governs SOPs, deviations, CAPA, supplier quality, and training, all with attributable e‑signatures and audit trails. Bottom line: V5 makes DSCSA compliance a by‑product of normal work rather than a parallel project.

14) FAQ

Q1. Do we need both EPCIS and EDI for DSCSA?
Yes—EDI moves commercial documents (PO, invoice, ASN), while EPCIS conveys serialized events required for interoperable traceability. Your WMS should reconcile them at each custody change.

Q2. What’s the minimum data the 2D code must carry?
GTIN, serial number, lot, and expiry via GS1 AIs. Use governed templates and on‑line verification to ensure accuracy/grade.

Q3. How should we handle saleable returns verification?
Make verification a gate prior to re‑stock: scan the 2D, confirm against authoritative data, and block if unverifiable. Treat failures as NCRs and quarantine immediately.

Q4. Is lot‑level traceability enough under DSCSA?
No. DSCSA requires package‑level identity and interoperable electronic exchange. Lot‑only data won’t satisfy verification or investigation needs.

Q5. How long must DSCSA records be retained?
Maintain DSCSA‑relevant records per your Record Retention & Archival policy and partner agreements, ensuring ready retrieval for inspections and investigations.

Related Reading
• Identity & Codes: Serialization | GS1 GTIN | GS1 AIs | GS1‑128 Case Label | SSCC
• Events & Exchange: EPCIS | EDI | ASN
• Operations & Control: WMS | Directed Put‑Away | Directed Picking | Hard Gating | Pack & Ship
• Quality & Governance: QMS | Document Control | Audit Trail | CSV | 21 CFR Part 11
• Traceability & Risk: End‑to‑End Traceability | Recall Readiness | Lot Genealogy