REGULATORY COMPLIANCE

DSCSA Compliance Automation

Pharmaceutical track-and-trace compliance, fully automated. Built for B2B distributors ahead of the November 2026 FDA enforcement deadline.

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// WHAT IS DSCSA

The regulatory mandate every distributor must meet

The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical distributors to electronically track and trace prescription drug products at the package level. The FDA's November 2026 enforcement deadline means every distributor must have compliant systems in place — or face operational shutdowns. Manual processes and spreadsheet-based tracking will not satisfy the requirement.

TI — Transaction Information Product identifier, quantity, lot number, expiration date, and trading partner data for every transaction

TH — Transaction History Complete chain of custody from manufacturer through every subsequent sale to current trading partner

TS — Transaction Statement Attestation that the product was lawfully acquired, not known to be counterfeit, and properly handled

// KEY CAPABILITIES

What compliance automation covers

Serialization tracking at package level — every unit accounted for

Electronic Product Information (ePI) generation and exchange

Trading partner verification and credentialing

Full TI / TH / TS triad — automated generation on every transaction

Suspicious order monitoring and regulatory reporting

Audit trail for all transactions — FDA-required, always current

// NOVEMBER 2026 FDA DEADLINE

Distributors who are not fully compliant by November 2026 face enforcement action including product seizure and operational shutdowns. FORGE can be fully deployed in 60–90 days — which means the window to begin implementation is closing now.

// ACCESS

Available as part of FORGE deployment

DSCSA compliance automation is available as part of FORGE deployment. Implementation takes 60–90 days. Existing Justice Ophthalmics production deployment demonstrates full compliance at scale across 1,829 customers and real-time serialization verification on every transaction.

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