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The first 30 minutes: configure Rx Tracking

Core module For: Administrator, Compliance manager Checked on 18.0.0.2.0

After installing, work through this checklist once, in order, on the database you work in. Each item links to the procedure that does it. When you finish, the license checks, serial scans and DSCSA documents work for your company, and your staff can start receiving and shipping.

Configure Rx Tracking in the first 30 minutes​

Who: Administrator (Administration: Settings) who is also Inventory Administrator and Rx Tracking Manager, as the administrator is after installation. The compliance manager (Rx Tracking Manager) can do items 7 and 8 on their own.

Requires: Rx Tracking (DSCSA), installed as in Install Rx Tracking (DSCSA). Works in Odoo Community and Enterprise.

Before you start: have at hand your company's GLN (Global Location Number) and licenses, the NDC (National Drug Code) of each prescription product you sell, and for each trading partner its DSCSA role, GLN and licenses, with where you checked them. The glossary explains the abbreviations. The order matters: each item needs the ones above it. Timed on a database without demo data, items 1 to 9 and 12 took about 30 minutes for one product and two partners; items 10 and 11 depend on how much stock and how many customers you have.

  1. ☐ Give staff the right Rx Tracking access: the DSCSA (Rx Tracking) settings block and the Rx Tracking menus appear only for users with the right access.
  2. ☐ Set the company GLN, GS1 prefix length and address, in the DSCSA settings of your company. The same procedure completes the company's name and address (street, city, state, ZIP, country) in Settings ‣ Users & Companies ‣ Companies. Suppliers' EPCIS (Electronic Product Code Information Services) files are checked against the GLN, and your outbound EPCIS files name your company by its GLN and address: without either, your deliveries post their DSCSA documents without an EPCIS file, and nothing warns you about a missing address beforehand.
  3. ☐ Review the Transaction Statement and the EPCIS legal notice, then set whether wholesalers and 3PLs need an FDA 503(e) report and set the small-dispenser exemption end date. Your procedure decides the wording and the policy; the software prints what these settings hold. The default texts have not been reviewed by counsel (see the disclaimer).
  4. ☐ Only if they apply: give a warehouse its own GLN when a site has a GLN of its own, and set the company time zone used for lot expiry dates when your company's contact has no time zone.
  5. ☐ Record our own company's licenses: they are printed on your outbound documents.
  6. ☐ Set up a DSCSA product for each prescription product, with its NDC. Stop here for products you already have in stock: enter their quantities first, then mark them as DSCSA products, as Go live with stock and records you already have explains. With many products, partners and licenses, do items 6 to 8 from spreadsheets instead: Load products, trading partners and licenses from a spreadsheet.
  7. ☐ Onboard a trading partner: DSCSA role, GLN and address for each supplier and customer, and flag a small-dispenser customer where it applies.
  8. ☐ Record and verify a trading partner's license for each partner, then check whether a partner is an authorized trading partner, and why not.
  9. ☐ Set up a handheld scanner for Scan Serials at each receiving and shipping station.
  10. ☐ Go live with stock and records you already have: register the units already on your shelves.
  11. ☐ Only if you use them: give a customer portal access to its DSCSA documents, send the DSCSA files with delivery confirmation emails, choose who receives the DSCSA reminder activities, and set up the off-site S3 archive, trying it in test mode first.
  12. ☐ Check the setup, as below.

Result: the database is ready for its first DSCSA purchase and sale. Records: the users' access rights, the company GLN, address and settings, your own licenses, the DSCSA products, the trading partners with their roles, GLNs and verified licenses, and (item 10) the opening-balance packages.

With the 3PL add-on​

If you also hold DSCSA stock for other companies, do the 3PL setup after item 5 and before any owner stock is entered: see Go live as a 3PL: the setup order, and owner stock you already hold.

With the Enterprise add-ons​

If you installed the Enterprise add-ons (Install the Enterprise add-ons), add these items:

With several companies in one database​

Each company needs its own GLN, licenses and settings: work through the list once per company, with that company selected. See Set up and work in a multi-company database.

Known issue

Known issue (PF-W04-01): a sale from one of your companies to another company of the same database ships through Odoo's inter-company transit location with no trading-partner check, no serial count and no DSCSA document, unless the first part of Move DSCSA stock between two of our companies was done. Do it before the companies trade DSCSA products with each other.

Check your setup​

Do these checks as the last item of the list, with your own data. A Sales user makes the orders; an Rx Tracking Manager fixes what they find.

  1. Create a quotation for a DSCSA product for a customer whose license you haven't recorded, and select Confirm. It is refused, for example:

    S00001 can't be confirmed: it contains DSCSA products (Demoprazole 20 mg Delayed-Release Capsules, 30 count).
    Riverside Community Pharmacy (dispenser) has no valid state license: none on file.

  2. Record and verify that customer's license (MD-08) and select Confirm again. The quotation is a Sales Order.

  3. Create a request for quotation of a DSCSA product from a licensed supplier and select Confirm Order. It is a Purchase Order, and its receipt has the buttons Scan Serials and Import EPCIS.

  4. Only with the Barcode add-on (Odoo Enterprise), as a warehouse user (Rx Tracking User): go to the Barcode app, select Operations, then your warehouse's Receipts, open a Ready receipt of a DSCSA product, and scan one unit's DataMatrix. The product's line shows the lot with its expiry date in brackets, for example BPSMS2509C (09/30/2028), and the quantity 1. Carry on receiving that receipt as usual (Receive DSCSA units in the Barcode app). "This product doesn't exist." means the company isn't on the GS1 nomenclature yet: see Switch the company to the GS1 barcode nomenclature.

Then prove the whole chain once, with a real or a test shipment: Prove the whole chain once after go-live. To see the full flow first on a demo database, follow the quick start.

What happens when something is missing​

Most setup gaps show up as a refusal with the reason. Four don't show up at all, so check them on purpose.

MissingWhat you seeFix
DSCSA Product not selected on a prescription productnothing: no license check, no serial scans, no documentSet up a DSCSA product
The partner's DSCSA Roleevery order or transfer with DSCSA products is refused: "… has no DSCSA role set, so it is not an authorized trading partner."Error: "… has no DSCSA role set …"
A license (none, unverified, expired or not in force yet)the order is refused and names the license and the reason, for example "… has no valid state license: none on file."Error: "… can't be confirmed: it contains DSCSA products …"
The company GLN, or the customer'sa warning when the sales order is confirmed and on the delivery; the document posts without an EPCIS fileWarning: "The DSCSA document of this shipment …"
The company's address (street, city, state, ZIP, country)nothing beforehand; the document posts without an EPCIS file, with the banner "No EPCIS file was generated: sender.street is required." (or sender.city, sender.state, sender.zip) (Known issue PF-A03-01)Set the company GLN, GS1 prefix length and address; see Warning: "No EPCIS file was generated: …"
The product's NDC (or the prefix length of a typed GTIN, Global Trade Item Number)nothing beforehand; the document posts without an EPCIS file (Known issue PF-A01-02)Set up a DSCSA product
The Transaction Statement, emptied in the settingsnothing beforehand; documents post without a statement (Known issue PF-A01-01)Documents show an empty Transaction Statement or have no EPCIS file
The opening balance of stock you already hadthose units can't be shipped or scrapped: the delivery refuses their serials ("Serial … is not in the package ledger …")Go live with stock and records you already have

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