Supply Chain Traceability

Pharmaceutical traceability
and DSCSA serialisation.

ProtectCode meets DSCSA unit-level serialisation requirements for pharmaceutical products sold into the US market. Every pharmaceutical unit carries a unique serialised QR code that creates a verifiable chain of custody from manufacture through to dispense.

Unit-level serialisation
GS1 Digital Link ready
Self-service dashboard

Traceability at unit level

End-to-end

From production line to consumer scan - every touchpoint captured

26

Countries with active deployment

Real-time

Data, no processing lag

DPP-ready infrastructure

EU Digital Product Passport infrastructure built and ready. Compliant when delegated acts land in 2027.

What traceability means

The Drug Supply Chain Security Act (DSCSA) requires every ph... at the unit level.

The Drug Supply Chain Security Act (DSCSA) requires every pharmaceutical product unit sold in the US to carry a unique product identifier - a serialised code that enables end-to-end traceability from manufacturer to dispenser.

ProtectCode serialised QR codes meet this requirement while simultaneously providing consumer authentication and brand engagement capabilities. The same unit-level code that satisfies DSCSA requirements opens a consumer-facing brand experience when scanned with a smartphone.

DSCSA-compliant unit-level serialisation for US market entry

Pharmaceutical Medicines Directive (FMD) compliant for EU markets

Chain of custody documentation generated from scan data automatically

Consumer authentication at point of dispense

API integration with pharmacy and healthcare ERP systems

Rules-based monitoring for diversion and grey market detection

Traceability capabilities

Unit level

Every individual product tracked, not just batches or shipments

Chain of custody

Verifiable scan record at every supply chain touchpoint

Consumer endpoint

Traceability extends to the consumer scan, not just the retail shelf

Applications

Where supply chain traceability
makes the difference.

ProtectCode traceability is used across regulated and premium product categories where the chain of custody matters commercially, operationally, and legally.

DSCSA compliance

Unit-level serialisation and scan data infrastructure meets Drug Supply Chain Security Act requirements for pharmaceutical manufacturers selling into the US market.

EU Falsified Medicines Directive

FMD-compliant serialisation for pharmaceutical manufacturers selling into EU member state markets.

Consumer authentication

Patients and pharmacists can verify pharmaceutical product authenticity at the point of dispense using any smartphone camera.

Diversion and grey market monitoring

Rules-based monitoring detects pharmaceutical products appearing in unexpected markets or distribution channels.

Chain of custody documentation

Automatically generated chain of custody documentation from scan data satisfies regulatory audit requirements.

Wholesale and pharmacy integration

REST API connects ProtectCode serialisation data with pharmacy management systems and wholesale distribution ERP.

Common questions answered.

Does ProtectCode meet DSCSA serialisation requirements?

Yes. ProtectCode serialised QR codes meet DSCSA unit-level product identifier requirements for pharmaceutical products sold into the US market. The platform generates the chain of custody documentation required under DSCSA from scan data automatically.

Does ProtectCode meet EU Falsified Medicines Directive requirements?

Yes. ProtectCode serialisation meets FMD requirements for pharmaceutical manufacturers selling into EU member state markets.

Can ProtectCode serialised codes work at pharmacy dispensing?

Yes. ProtectCode QR codes work with standard smartphone cameras for consumer and pharmacist authentication at the point of dispense.

How does pharmaceutical serialisation pricing work?

ProtectCode pharmaceutical serialisation is priced by code volume. See the Pricing page for tier details or book a demo for a custom pharmaceutical volume quote.

End-to-end traceability, starting today.

Book a 30-minute demo and see how ProtectCode delivers unit-level supply chain traceability for your product category.