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.