The enhanced requirements of the Drug Supply Chain Security Act (DSCSA) took effect: secure, interoperable, electronic exchange of transaction data, with package-level identifiers.
Rx Tracking (DSCSA) for Odoo
DSCSA, built into Odoo.
Serial-level receiving and shipping, EPCIS tracing files, trading-partner checks and six-year records in your Odoo, without a separate track-and-trace platform.
For US prescription drug wholesale distributors.
Your Odoo
Purchase · Inventory · Sales
Rx Tracking (DSCSA)
- Suppliers to Odoo: EPCIS file in
- Odoo to Customers: T3 + EPCIS, customer portal
- Odoo and FDA & officials: records on request
FDA's wholesaler exemption has ended
FDA's exemption for eligible wholesale distributors ended. Verifying the product identifier, serial number included, on saleable returns is fully in effect.
Until then, small business dispensers (25 or fewer full-time pharmacists and pharmacy technicians) and their trading partners are exempt from certain requirements.
As of September 2026. FDA sources: DSCSA text, 2024 exemptions letter, 2026 dispenser letter.
What Rx Tracking covers
Receiving
Upload the supplier's EPCIS 1.2 file and scan each unit's DataMatrix barcode. Differences become discrepancies and the lot is quarantined.
Trading partners
Your staff record and verify partner licenses. Orders and transfers of DSCSA products are refused when a partner isn't authorized.
Shipping
Each DSCSA delivery you ship posts a frozen T3 PDF (transaction information, history and statement) to your customer portal. Serial-level shipments with complete location (GLN), address and drug code (NDC) data also get an EPCIS file.
Returns
A returned serial must match a unit you shipped to that customer, checked against your own records, not a Verification Router Service (VRS) query to the manufacturer. A manager then verifies or rejects it.
Suspect product
Quarantined lots can't be reserved or shipped, though they still count in forecasts. An optional Enterprise add-on adds investigations and a Form FDA 3911 data sheet your staff enter into FDA's system.
Records and requests
Posted documents can't be edited or deleted, are sealed in a hash chain and are kept for at least six years. Trace requests get a 24-hour due time and one zip your staff send.
How it fits inside Odoo
Receive
EPCIS file in, every unit scanned.
Verify
Partner licenses and returned serials.
Store
Serial-level ledger and quarantine holds.
Ship
T3 frozen at shipping, EPCIS file out.
Respond
Requests logged with a 24-hour due time.
Same buttons
Your team keeps using Odoo's Confirm and Validate buttons, plus serial scans on DSCSA transfers.
DSCSA products only
OTC items, devices and supplies behave as in standard Odoo, even on the same order.
Enforced on the server
Forms, imports, the API and the customer portal all go through the same checks.
Who it's for
US prescription drug wholesale distributors, including secondary wholesalers, that run Odoo.
You buy serialized product from manufacturers and larger wholesalers, and sell to pharmacies, physician offices and clinics.
Why inside Odoo, not a separate platform
One system of record
No second system and no sync to maintain.
Your data, your database
Records stay in your Odoo database (plus an optional archive in your own bucket), so there's no six-year export problem if you change vendors.
No extra platform required
The law asks for the right data, exchanged electronically and interoperably, kept and producible on request. It doesn't require a separate platform, a VRS subscription or AS2 file exchange.
Standard Odoo only
No third-party Odoo modules and no extra Python packages.
Software that supports your DSCSA processes; you remain responsible for your own compliance, SOPs and validation. Not legal advice.
See it on your own workflow
Available directly from Alpenglow. We typically reply in one business day.
Odoo consulting and development
Implementation, upgrades, custom modules and process refinement.
Implementation and support · Upgrades and migrations · Custom development and integrations
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