Core guide: Rx Tracking (DSCSA)

The guide for the core module: configuration, master data, receiving, shipping, returns, exceptions and records. Warehouse, compliance, sales and purchasing staff and administrators use it.

Abbreviations on this page: EPCIS (Electronic Product Code Information Services), GLN (Global Location Number), GTIN (Global Trade Item Number), NDC (National Drug Code), SSCC (Serial Shipping Container Code), T3 (Transaction Report).

Requires: Rx Tracking (DSCSA). Works in Odoo Community and Enterprise.

Configure

All of it: Configure

• Set up the company and warehouses for DSCSA
  • Open the DSCSA settings of a company
  • Set the company's address, GLN and GS1 prefix length
  • Give a warehouse its own GLN
  • Set the company time zone used for lot expiry dates
• Set up DSCSA documents and delivery emails
  • Review the Transaction Statement and the EPCIS legal notice
  • Set whether wholesalers and 3PLs need an FDA 503(e) report
  • Set the small-dispenser exemption end date
  • Send the DSCSA files with delivery confirmation emails
• Give staff and customers access
  • Give staff the right Rx Tracking access
  • Give a customer portal access to its DSCSA documents
• Use Rx Tracking in a multi-company database
  • Set up and work in a multi-company database
  • Move DSCSA stock between two of our companies
• Check scheduled jobs and reminders
  • Check that a DSCSA job ran, and run it by hand
  • Tune the jobs through system parameters
  • Choose who receives the DSCSA reminder activities
  • Work the DSCSA activities in your to-do list

Master data

All of it: Master data

• Set up DSCSA products
  • Set up a DSCSA product
  • Stop treating a product as DSCSA, duplicate it or archive it
  • Find a product by NDC or GTIN, or a partner by GLN
• Set up trading partners
  • Onboard a trading partner: DSCSA role, GLN and address
  • Check whether a partner is an authorized trading partner, and why not
  • Flag a small-dispenser customer and record its attestation
  • Fix a missing GLN before shipping
• Record and verify licenses
  • Record and verify a trading partner's license
  • Record our own company's licenses
  • Renew, correct or retire a verified license
  • Act on license-expiry reminders

Receive

All of it: Receive

• Buy DSCSA product from a supplier
  • Confirm a purchase of DSCSA product from an authorized supplier
  • Record or find a receipt by the supplier's document number
• Receive with the supplier's EPCIS file
  • Import the supplier's EPCIS file on the receipt
  • Receive a sealed case by scanning its SSCC label
  • Validate a DSCSA receipt
  • Receive part of a shipment
• Scan serial numbers onto a receipt
  • Set up a handheld scanner for Scan Serials
  • Scan units onto a receipt with Scan Serials, and undo a scan
  • Capture a product's GTIN from the first scan
• Receive without an EPCIS file, or in several steps
  • Receive without a supplier EPCIS file
  • Receive through a two- or three-step route
• Review supplier EPCIS files
  • Review supplier EPCIS files and the inbound DSCSA document
  • Read the warnings of an imported supplier EPCIS file
• Correct a supplier file or a receipt
  • Replace a supplier file with a corrected one before validation
  • Cancel a supplier file, or a receipt that has scans or a file
  • Correct a receipt after validation
• Record a missing Transaction Statement
  • Record the supplier's Transaction Statement before validating
  • Record a missing Transaction Statement after validation and release the lots
• Resolve receiving discrepancies
  • Work a receiving discrepancy to resolution
  • Handle a duplicate serial at receipt

Ship

All of it: Ship

• Sell DSCSA products
  • Confirm a sales order for DSCSA products
  • Let a customer accept or pay an order online
  • Sell DSCSA product by dropship
• Scan and ship deliveries
  • Scan the serials of a delivery and validate it
  • Ship part of a delivery, or ship in pick, pack and ship steps
  • Correct the scans of an open delivery
  • Ship at lot level to an exempt small dispenser
• Find and send DSCSA documents
  • Open the DSCSA document a delivery posted
  • Find, view, download and print DSCSA documents
  • Handle a document posted without an EPCIS file
  • Send one document's link to a customer

Returns

All of it: Returns

• Take back customer returns
  • Receive a saleable customer return with its serials
  • Verify returned units for resale, or reject and destroy them
  • Take back units shipped at lot level to a small dispenser
• Return product to the supplier
  • Return saleable product to the supplier
  • Send a non-saleable return to the supplier

Exceptions: quarantine, scrap, trace requests

All of it: Exceptions: quarantine, scrap, trace requests

• Quarantine and release lots
  • Quarantine a lot so it can't be reserved or shipped
  • Release a lot from quarantine
  • Review the lots on hold, and why they are held
  • Move quarantined stock to a quarantine shelf
• Scrap DSCSA units
  • Scrap DSCSA units, naming each unit's serial
• Answer trace requests
  • Log a trace request from the FDA, a state or a trading partner
  • Search the records a trace request asks for
  • Respond to a trace request with the response zip, and send it
  • Cancel a trace request that needs no answer
  • Keep trace requests within the 24-hour deadline

Records

All of it: Records

• Register the opening balance
  • Register the opening balance for stock that predates the package ledger
  • Check the package ledger against the stock (Ledger vs Stock)
• Count DSCSA stock
  • Count stock and record the units that are gone
  • Record units found in a count
• Look up units in the package ledger
  • Look up a unit in the package ledger
  • Correct a lot's number or expiry after documents were posted
• Keep, export and verify DSCSA records
  • Place a legal hold on DSCSA documents
  • Release a legal hold
  • Get the monthly retention export, or export on demand
  • Verify the integrity of the DSCSA documents
• Set up the off-site archive
  • Set up the off-site S3 archive
  • Try the archive in test mode, then switch to compliance mode
  • Prove the archive end to end on the real bucket
  • Keep a staging or restored copy from writing to the archive
• Run the off-site archive
  • Watch the archive queue and each record's archive state
  • Fix and retry failed archive uploads
  • Queue records posted before the archive was switched on
  • Get a record back from the off-site archive and check it

Reference

All of it: Reference

• DSCSA settings
  • DSCSA settings and record numbering
• Fields and statuses the core module adds
  • Fields and statuses the core module adds to Odoo screens
• DSCSA documents: T3, EPCIS file and transaction history
  • The T3 report, and why a validated delivery can't be edited
  • The outbound EPCIS 1.2 file
  • How the transaction history and the direct-purchase flag are built
• What is checked where
  • Which outbound paths are refused or skipped
• Records that are kept
  • What is kept, and what can never be deleted or changed

When something goes wrong

• Configuration
• Products, partners and licenses
• Receiving
• Supplier files, statements and discrepancies
• Selling and shipping
• Returns and the customer portal
• Quarantine, scrap and trace requests
• Opening balance, counts and records
• Off-site archive and scheduled jobs
• Access, companies and setup

Related guides

• Customers' side: Your DSCSA documents in the customer portal
• With Odoo Enterprise: Barcode app, Suspect product
• Holding stock for other companies: 3PL guide
• Ideas behind the features: Concepts