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FDA enforcement deadline: November 27, 2026

DSCSA compliance that
doesn't slow you down

Automated serialization, T3 documents, and FDA inspection readiness, built into your daily workflow instead of bolted on. Built for the mid-market distributors the enterprise vendors ignore.

The stakes

What DSCSA requires, and what compliance usually costs

The requirement

The Drug Supply Chain Security Act mandates package-level tracking of every prescription drug through the supply chain. By November 27, 2026, small dispensers must exchange transaction data electronically, verify product identifiers, and maintain complete chain-of-custody records. Non-compliance means FDA enforcement actions, shipment holds, and lost trading partner agreements.

The market problem

Existing compliance platforms run $42,000 to $250,000 per year in software licensing (sourced: PharmBusinessHub, AWS Marketplace, GetLatka), with implementation timelines of 3 to 12 months (sourced: PharmBusinessHub). Peer-reviewed analysis puts total cost of ownership routinely above six figures annually (PMC/NIH, 2024). That pricing was designed for the top of the market. FORGE was designed for everyone else.

Pharmaceutical packages moving through a tracked supply chain
Capabilities

Everything you need for DSCSA, one platform

FORGE ships with 12 built-in DSCSA compliance features, an 8-point pre-ship compliance gate, and one-click 11-section FDA inspection packets.

Serial Number Tracking

Every unit is tracked by NDC, serial, lot, and expiration at every handoff point. Scan, verify, ship. A complete chain of custody from manufacturer to customer with no manual spreadsheets.

T3 Document Management

Transaction Information, Transaction History, and Transaction Statements auto-generate when you ship, archive with the order, and stay instantly searchable. No filing cabinets.

AI Anomaly Detection

Six pattern types continuously monitor transaction flow: unusual quantities, atypical destinations, serial irregularities, velocity anomalies, suspect product indicators, and partner behavior changes.

Suspect Product Workflow

Quarantine, investigate, and document suspect product events with the audit trail DSCSA requires, from flag to resolution.

FDA Inspection Packets

One click generates a complete inspection packet: every transaction, serial number, T3 document, and anomaly flag with its resolution. Organized, timestamped, exportable. Answers in minutes, not days.

Built Into the Workflow

Compliance data is captured during receiving, picking, and shipping, not reconstructed afterward. Your team does their job and the audit trail builds itself.

Timeline

The deadline math

With published implementation timelines of 3 to 12 months for incumbent platforms, distributors starting late face a hard choice. FORGE deployments are measured in weeks because compliance is native to the platform, not an integration project.

Nov 27
2026 FDA enforcement deadline for small dispensers
$42K-$250K
Annual licensing on existing platforms
PharmBusinessHub, AWS Marketplace, GetLatka
3-12 mo
Typical incumbent implementation timelines
PharmBusinessHub
1-click
FDA inspection packet generation

Don't wait for the deadline to start preparing

Schedule a DSCSA-focused demo and see how FORGE keeps you compliant without slowing down operations.

Schedule a DSCSA Demo