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DSCSA documents

Core module 3PL add-on For: Administrator, Compliance manager, Warehouse staff Checked on 18.0.0.2.0, 18.0.1.0.0

A DSCSA document is Rx Tracking's record of one transaction of DSCSA products: what was sold, by whom, to whom, with which serials, the seller's statement and the earlier sales. The software keeps one for each supplier file it receives and one for each shipment it makes, and freezes it so that it reads the same years later.

What it is​

Each document carries three kinds of information. DSCSA and the software call them by these names:

NameShortWhat it holds
Transaction InformationTIthe product (name, strength, dosage form, container size, NDC), the lots and quantities, the transaction and shipment dates, the seller and the buyer with their addresses, and the identifier of every package (GTIN, serial, lot, expiry)
Transaction StatementTSthe seller's statement about its own authorization and conduct, printed as the software's Transaction Statement text, plus a direct-purchase statement when it applies
Transaction HistoryTHthe chain of earlier sales of the same units back to the manufacturer, as far as your records go

Documents are listed in Inventory ‣ Rx Tracking ‣ Documents, numbered by direction:

  • Inbound (received), DSCSA/IN/YYYY/NNNNN: posted when a receipt with an imported supplier EPCIS file becomes Done. It keeps the supplier's file as sent, the supplier's Transaction Statement and its history. A receipt without a supplier file posts no inbound document. See Review supplier EPCIS files and the inbound DSCSA document.
  • Outbound (sent), DSCSA/OUT/YYYY/NNNNN: posted when a delivery of DSCSA products to a customer, or a saleable return to a supplier, becomes Done. It has two files rendered from its content: the T3 Report (DSCSA), a PDF for people, and the EPCIS file, an XML file (EPCIS 1.2) for the buyer's software. See Open the DSCSA document a delivery posted.

A customer return, a non-saleable return to the supplier and a delivery of non-DSCSA products post no document.

How the software builds and keeps a document​

  1. At validation, the content is frozen. The seller, buyer, products, lots, serials, the Transaction Statement text as set in the settings at that moment, and the transaction history are copied into the document. The T3 PDF and the EPCIS file are rendered once and stored with a checksum; nothing regenerates them later, so downloading a document twice gives the same file. See The T3 report, and why a validated delivery can't be edited.
  2. The history is built from the ledger. Your own sale comes first; the earlier sales are copied from the supplier's inbound document that listed each unit, or reconstructed from the receipt when there was no supplier file. The Direct Purchase flag follows from those hops. See How the transaction history and the direct-purchase flag are built.
  3. The document joins the hash chain. Each posted document of a company is linked to the one before it by a hash. An Rx Tracking Manager can recompute the chain and the stored files at any time with Verify Document Integrity (Verify the integrity of the DSCSA documents).
  4. The document is kept. A posted document can't be edited or deleted by anyone; only its chatter, the customer's link, the legal hold and the off-site archive fields still change. Its Retention tab shows Keep At Least Until (the transaction date plus six years). A manager can place it on legal hold, and the off-site archive can keep a write-once copy outside Odoo. See Records that are kept.

Because the documents are built from the transfer, the DSCSA lines of a Done receipt, delivery or return can't be changed afterwards, even after unlocking the transfer. To correct a shipment, take the units back on a return and ship them again.

Variants of an outbound document​

How the buyer gets it​

The buyer can see and download its documents in the customer portal, open a link you send for one document, or receive the T3 and EPCIS files attached to Odoo's delivery confirmation email when that setting is on. See Find and send DSCSA documents, Send the DSCSA files with delivery confirmation emails and the handout Your DSCSA documents in the customer portal.

A missing Transaction Statement on a supplier's file​

When a supplier's EPCIS file carries no affirmed Transaction Statement, the import warns, and you record where the statement came from (the T3, the supplier's portal, an email, EDI) before validating. If the receipt is made Done first, its lots are held until the statement is recorded. See Record a missing Transaction Statement. The software's own texts cite "§581(27)" for the statement.

With the 3PL add-on: documents in the owner's name​

When you hold stock for an owner, the documents about the owner's units are the owner's, not yours:

  • An owner receipt posts an inbound document with the owner as the buyer; an owner's shipment posts an outbound document with the owner as the seller, the owner's Transaction Statement, and your company and warehouse as the ship-from third-party logistics provider. Owner documents carry the owner's code in their number, for example DSCSA/NWG/OUT/2026/00001, and join your company's hash chain.
  • The owner profile's Issuing Mode decides who receives the outbound documents: Mode A: to the owner only (the owner issues its own documents to its customer), or Mode B: sent to the customer (you send them, which the software allows only with the owner's authorization recorded, unless the company setting says otherwise). The mode is frozen on each document. See Know who receives an owner's documents: issuing mode A or B.
  • A custody receipt (the owner's own goods from its own site) posts no document, and a title transfer posts in-place documents without a ship date (The title model).

Why it exists​

Background: the modules follow the reading that a seller provides the Transaction Information and the Transaction Statement to the buyer before or at the time of the transaction, electronically, and that the transaction history has not been required since November 2023 (FD&C Act § 582(g)(1); FDA exemption letters of 2024-10-09 and 2026-08-06; FD&C Act § 582(c)(1)(A)(ii)–(iii), § 582(g)(1)(A)–(B); § 581(22), (24), (26), (27); see Compliance background), that a buyer takes ownership only with the seller's TI and TS (FD&C Act § 582(c)(1)(A)(i), § 582(g)(1); FDA interoperable exchange guidance (September 2023); see Compliance background) and that the records are kept at least six years (FD&C Act § 582, record-keeping provisions; see Compliance background). The modules answer these with EPCIS files in and out, a stored history, a hash-chained record, files frozen at validation, a T3 report, portal access for your customers, and retention with legal hold and an off-site archive. For owner stock, the documents name the owner, and the owner's customer receives them from you only with the owner's authorization (FD&C Act § 582(c)(1)(A)(ii)–(iii), § 582(g)(1)(A)–(B); § 581(22), (24), (26), (27); see Compliance background). This is how the modules read the law; it has not been reviewed by counsel. See the disclaimer.

Your procedure decides the wording of your Transaction Statement (the software ships a default text that you review, Review the Transaction Statement and the EPCIS legal notice) and how long your business keeps its records; the software never deletes a document.

Where to go next​