Rx Tracking: DSCSA support inside Odoo

An Odoo module that helps US prescription drug wholesale distributors meet DSCSA requirements in the Odoo they already run.

At a glance

Inside Odoo
Built on the standard Inventory, Purchase, Sales and Invoicing apps. The core works on Community or Enterprise; two optional add-ons need Enterprise.
In your own database
Records stay in your Odoo database, not an outside track-and-trace cloud. An optional archive copy goes to your own storage bucket.
Only products you flag
OTC items, devices and supplies behave as in standard Odoo, even on the same order.
Checked on the server
Forms, imports, the API, the portal and eCommerce orders hit the same rules. No bypass switch, even for managers.

What it does

Receiving

Upload the supplier's EPCIS 1.2 tracing file and scan each unit. Differences become discrepancies and the lots are quarantined; the receipt isn't blocked.

How receiving works

Trading partners

A license register your staff verify. DSCSA orders and transfers are refused when a partner isn't authorized.

How partner checks work

Shipping

Validating a delivery posts a frozen T3 PDF (transaction information, history and statement) to your customer portal, plus an EPCIS 1.2 file for serial-level shipments with complete location (GLN), address and drug code (NDC) data. Drop shipments get no document; the shipping supplier provides the transaction data.

How shipping works

Returns

Returned serials must match a unit you shipped to that customer, checked against your own shipment records; a manager then verifies or rejects them.

How returns work

Suspect product

Quarantined lots can't be reserved or shipped, though they still count in forecasts. An optional Enterprise add-on adds investigations that track the 24-hour notification deadline for illegitimate product, and a Form FDA 3911 data sheet your staff enter into FDA's system.

How suspect product works

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 of records for your staff to send.

How records work

More about Rx Tracking

Rx Tracking is software that supports DSCSA processes inside Odoo. It does not by itself make a business compliant. Each customer remains responsible for its own DSCSA compliance, standard operating procedures, validation of the system for its use, and regulatory decisions. This site is not legal advice.

See it on your own workflow

Tell us how you receive and ship, and we'll show you Rx Tracking on it.