How do I ensure my serialized product tracking workflow with a track-and-trace platform is DSCSA compliant?

To make a serialized product tracking workflow DSCSA-compliant, focus on traceability, data exchange, verification, and partner governance across the supply chain. Here’s a practical checklist.

1) Make sure every saleable unit is serialized

Under DSCSA, prescription drug packages must carry a product identifier that includes:

• NDC or equivalent product code
• Serial number
• Lot number
• Expiration date

Your workflow should ensure these data elements are created, printed, captured, and preserved accurately.

2) Capture and store EPCIS data at each transaction

Use your track-and-trace platform to exchange and retain serialization events such as:

• Commission
• Pack
• Ship
• Receive
• Aggregate / disaggregate
• Decommission
• Return verification

Best practice is to use GS1 EPCIS/CBV standards so data is interoperable with trading partners.

3) Exchange transaction information, history, and statements

For product transfers, DSCSA requires the ability to provide:

• Transaction Information (TI)
• Transaction History (TH) — note: this has been phased out under enhanced DSCSA requirements, but many workflows still reference legacy documentation
• Transaction Statement (TS)

Your platform should retain and transmit the required pedigree/traceability records for each saleable transaction.

4) Verify authorized trading partners

Only transact with Authorized Trading Partners (ATPs):

• Manufacturers
• Repackagers
• Wholesale distributors
• 3PLs
• Dispensing pharmacies, etc.

Your workflow should validate partner status before shipping, receiving, or exchanging data.

5) Build exception handling for suspect and illegitimate product

Your workflow must support DSCSA investigation and quarantine processes for:

• Mismatched serials
• Duplicate serial numbers
• Unrecognized product
• Expired product
• Tamper evidence issues
• Missing or invalid event data

Include documented procedures for:

• Quarantine
• Investigation
• Notification
• Disposition

6) Support product verification requests

DSCSA requires verification capabilities for:

• Saleable returns verification
• Suspect product investigation
• Recall/trace queries
• Authorized trading partner inquiries

Your platform should be able to respond quickly with serialized status and event history.

7) Maintain data integrity and audit trails

Your system should provide:

• Immutable event logs
• User access controls
• Timestamped records
• Versioning/change history
• Retention policies aligned to DSCSA requirements

This is important for audit readiness and investigation support.

8) Manage aggregation and deaggregation correctly

If you ship cases/pallets with aggregated units:

• Maintain parent-child relationships
• Preserve serialized identities through repacking or split shipments
• Record aggregation/disaggregation events accurately

Incorrect aggregation is a common compliance failure point.

9) Validate labeling and scan quality

Ensure:

• Barcodes are GS1-compliant
• Labels are readable and durable
• Scanners can capture serial, lot, and expiration reliably
• Label application processes prevent mislabeling

10) Align SOPs, training, and qualification

Technology alone isn’t enough. You need:

• Written SOPs for serialization, shipping, receiving, recalls, returns, and investigations
• Training for warehouse, QA, customer service, and compliance staff
• Trading partner onboarding and data-validation procedures
• Periodic mock audits and trace exercises

11) Use a platform that supports DSCSA-specific workflows

When evaluating your track-and-trace platform, confirm it supports:

• EPCIS 1.2/2.0 or partner-required format
• Serialized event capture
• ATP validation
• Exception management
• Returns verification
• Recall and investigation workflows
• Reporting and audit exports

12) Test end-to-end before go-live

Run scenario testing for:

• Normal shipment/receipt flow
• Partial shipments
• Returns
• Recalls
• Serial query/verification
• Partner data rejection/reconciliation
• Aggregation errors
• Duplicate or missing events

This helps you catch compliance gaps before a regulator or customer does.

---

A simple compliance model

A DSCSA-compliant workflow usually looks like this:

1. Serialize and label product at packaging
2. Capture EPCIS event at each process step
3. Validate partner authorization before transfer
4. Exchange TI/TS and serialized event data with the recipient
5. Receive and reconcile with scanning and automated checks
6. Quarantine and investigate any exceptions
7. Respond to verification requests for saleable returns or suspect product
8. Retain records and audit trails for regulatory review

---

Common pitfalls to avoid

• Missing or duplicate serial numbers
• Incomplete event capture
• Non-standard data formats across partners
• Unverified trading partners
• Poor aggregation management
• Weak SOPs around exceptions and returns
• Lack of evidence retention for audits

---

If you want, I can also provide:

1. a DSCSA compliance checklist for your workflow,
2. a sample SOP outline, or
3. a system requirements list for selecting a track-and-trace platform.