Frequently asked questions

No software does that on its own. Rx Tracking supports your DSCSA processes inside Odoo. You remain responsible for your own compliance, standard operating procedures (SOPs), validation of the system for your use, and regulatory decisions.

Rx Tracking currently runs on Odoo 18, Community or Enterprise. Support for newer Odoo versions is coming soon. The core module needs only standard Odoo modules. Two optional add-ons, Barcode-app scanning and suspect-product investigations, need Enterprise.

No. Custom modules are not available on standard Odoo Online, so Rx Tracking runs on Odoo you host yourself or on Odoo.sh. See deployment, data and licensing.

No. Only products you flag as DSCSA products are affected. OTC items, devices and supplies behave exactly as in standard Odoo, even on the same order or transfer.

EPCIS 1.2 XML. EPCIS is the GS1 standard FDA recommends for exchanging tracing data; 1.2 is the version the GS1 US DSCSA implementation guideline (Release 1.3) builds on. Outbound files follow that guideline's structure and list each unit individually, with no case aggregation. EPCIS 2.0 files (XML or JSON) are not supported; the import refuses them.

A user uploads the supplier's file on the purchase order or receipt, and the units it announces show up as expected. There is no automatic transfer.

VRS (Verification Router Service) is an industry practice, not a statutory requirement. Rx Tracking checks each returned serial against the units you shipped to that customer and holds it until a manager verifies it. This is not a VRS query to the manufacturer.

Through your customer portal. After Odoo's standard portal invitation, they log in to download their T3 PDFs (transaction information, history and statement) and EPCIS files. They can search by document number, PO, lot or NDC (National Drug Code) and download all their files at once, as zip files of up to 250 documents each. You can also attach the files to Odoo's delivery confirmation email (off by default).

As of September 2026, FDA exempts small business dispensers and their trading partners from certain requirements until November 27, 2027 (FDA letter of August 6, 2026). Flag an exempt customer and record their attestation; until the end date you set, their deliveries can go out at lot level, with lot-level documents and no EPCIS file. Talk to your counsel about how the exemption applies to your transactions; see DSCSA deadlines.

Rx Tracking creates no outbound document or serial scan for dropship orders. The supplier that physically ships the product provides the transaction data.

No. The suspect investigations add-on (Odoo Enterprise) tracks the 24-hour notification deadline for illegitimate product and prepares a Form FDA 3911 data sheet prefilled from the lot and product. The data sheet is not the official form and is not submitted electronically: your staff enter it into FDA's system and notify trading partners.

DSCSA requires answers to FDA and other federal or state officials in a recall or investigation within 24 hours, or another reasonable time FDA sets. Rx Tracking logs each request with a 24-hour due time and builds one zip with the stored documents, Transaction Statement evidence, a checksummed index and every movement of every unit. Your staff send the zip; the module doesn't transmit it.

In your own Odoo database; the module does not sync your records to an outside track-and-trace cloud. Optionally, posted documents and retention exports are also copied to a write-once archive in your own Amazon S3 (or S3-compatible) bucket, with your credentials.

They stay in your own Odoo database, and stored files can be downloaded through the portal. The monthly CSV exports and the optional archive copy in your own bucket are yours too.

DSCSA does not require a GLN (Global Location Number), but many trading partners use GLNs in EPCIS data. Rx Tracking stores GLNs on your company, warehouses and trading partners, with check-digit validation. They must be set before shipping for the EPCIS file to be produced.

No. Rx Tracking is provided directly by Alpenglow, not through the Odoo Apps Store. Start with a demo request.

Onboarding includes migrating your data from your existing service, training and verification. It can take as little as 10 to 15 days.

Yes. We handle Odoo implementations, version upgrades and edition migrations across Community and Enterprise, on Odoo.sh or on-premise. See upgrades and migrations.