Licensing and filings
Your process
- Your own state licensing and FDA annual reporting
- Filing Form FDA 3911 and notifying partners
- Cleared-product notices to FDA
DSCSA requirements coverage
The main DSCSA obligations of a wholesale distributor: what Rx Tracking does, where it lives in Odoo and what stays with you.
Requirement by requirement
Menu paths start at Inventory → Rx Tracking.
Status key
- Supported
- The module covers this.
- Partial
- Covers part of it; the row names the gap.
- Your process
- Your people, standard operating procedures (SOPs) and filings.
| DSCSA requirement | What Rx Tracking does | Where it lives in Odoo | Status |
|---|---|---|---|
| Product identifier on each package: NDC (National Drug Code), serial, lot and expiry, in a 2D data matrix | One DataMatrix scan captures GTIN (Global Trade Item Number), serial, lot and expiry. Receipts, deliveries and returns need a serial per unit (except dropships, internal steps, exempt small-dispenser deliveries). | Product form, DSCSA tab; Scan Serials on transfers; Barcode app (Enterprise add-on) | Supported |
| Receive transaction information and statements electronically from suppliers | Upload the supplier's EPCIS 1.2 XML tracing file and scan each unit, or a sealed case's SSCC label once staff confirm the seal. Differences become discrepancies due in 10 business days, as FDA recommends (weekends skipped, not holidays), and lots are quarantined. Receipts aren't blocked, even with no file; your SOP covers that. | Purchase order or receipt → Import EPCIS; Operations → Receiving Discrepancies | Supported |
| Give buyers electronic, package-level transaction information and statements with each sale | Validating a delivery posts a frozen T3 PDF (transaction information, history and statement) and an EPCIS 1.2 XML file listing units individually (no case aggregation). No EPCIS file for lot-level small-dispenser shipments or missing location (GLN), address or NDC data. Drop shipments get no document; the shipping supplier provides the transaction data. |
Delivery → DSCSA Documents; Operations → Documents; customer portal | Supported |
| Trade only with authorized trading partners | License register with source and evidence; your staff verify each license. DSCSA orders and transfers are refused if a partner isn't authorized for its role (DEA alone never counts). Can also require FDA annual licensure reporting from wholesalers and third-party logistics providers (3PLs); off by default. | Master Data → Licenses; contact form, DSCSA tab | Supported |
| Saleable returns: associate with your original transaction; verify the identifier, including serial, before resale | Each returned serial must match a unit you shipped to that customer, or the return is refused; a manager then verifies or rejects it. Partial: this checks your own shipment records, not a VRS (Verification Router Service) query to the manufacturer. |
Return button on a delivery; Operations → Returns to Verify | Partial |
| Quarantine suspect product and promptly investigate it with trading partners | Lot quarantine blocks reserving and shipping (stock still counts in forecasts); managers release it. Search by lot or serial. Investigations need an optional Enterprise add-on. | Lot form; Operations → Quarantined Lots, Suspect Investigations (Enterprise add-on) | Supported |
| Illegitimate product: notify FDA (Form FDA 3911) and immediate trading partners that may have received it within 24 hours of the determination | (Enterprise add-on) Tracks the determination time, 24-hour deadline and notification dates, and prefills a Form FDA 3911 data sheet. Partial: your staff file Form FDA 3911 and notify partners. The data sheet isn't the official form and isn't submitted electronically. Investigation records aren't under the module's deletion protection or legal hold. |
Operations → Suspect Investigations (Enterprise add-on) | Partial |
| Answer requests from FDA or other federal or state officials in a recall or investigation within 24 hours (or another reasonable time FDA sets) | Log requests with a 24-hour due time. Search by serial, lot, product or date range (serial or lot for returns), then build one zip of documents, statement evidence, checksums and unit movements. Your staff send it. | Operations → Trace Requests | Supported |
| Keep transaction information and statements for at least six years | Documents, files and statement evidence can't be deleted by anyone; six-year retention is fixed in code. Legal hold, monthly exports and an optional write-once archive in your own S3 bucket. | Configuration → Retention Exports; DSCSA settings | Supported |
| Small business dispensers and their trading partners: exempt from certain requirements until November 27, 2027 (as of September 2026) | Flag an exempt customer and record the attestation. Until the end date you set (default November 27, 2027), their deliveries can go out at lot level, with no EPCIS file. | Contact form, DSCSA tab; DSCSA settings | Supported |
| Verification requests from trading partners | Look up any serial in the package ledger or trace-request search. Partial: lookups are manual; no automated responder or VRS connection. |
Operations → Packages | Partial |
What stays with you
Procedures and decisions
Your process
- SOPs and staff training
- License verification decisions
- Legal review of your Transaction Statement wording
- Validating the system for your use
Sources
Summarized from section 582 of the FD&C Act and FDA guidance, checked September 25, 2026.
- DSCSA statute text (FDA)
- FDA guidance on interoperable exchange (PDF)
- FDA guidance on package-level security (PDF)
- FDA exemptions page
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.