Glossary
Core module Odoo Enterprise: Barcode app Odoo Enterprise: Quality app 3PL add-on For: Administrator, Compliance manager, Warehouse staff, Sales and purchasing Checked on 18.0.0.2.0, 18.0.1.0.0
Terms used in the Rx Tracking (DSCSA) documentation and screens, in alphabetical order. Abbreviations are listed under the abbreviation. Each entry gives the meaning in the software; where the screen uses another label, it is named in bold. Definitions of legal terms are summaries of the publisher's research, not legal definitions.
0–9
3PL (third-party logistics provider)
A company that stores and ships another company's goods without owning them. In the software, both a DSCSA Role of partners (Third-party logistics provider (3PL)) and the capacity in which your company holds owner stock once third-party logistics is switched on. See Owner stock and own stock.
24-hour deadline
A deadline of 24 hours that the software tracks in two places: for answering a trace request (Keep trace requests within the 24-hour deadline) and, with the Suspect Product add-on, for notifying FDA and trading partners of illegitimate product (Keep notifications within the 24-hour deadline).
A
Activity
An Odoo to-do attached to a record, shown in its chatter and in the user's activity list. Rx Tracking's reminders (a license expiring, a lot still quarantined, a trace request due) are activities. See Work the DSCSA activities in your to-do list.
Agent (issuing as the owner's agent)
Sending the documents issued in an owner's name to the owner's customer on the owner's behalf (3PL). The company setting Issue documents as the owner's agent (Only with the owner's written authorization, Always or Never) and the owner profile's Authorized Us to Issue Its Documents decide whether you send them (issuing mode B) or they go to the owner only (mode A). See Issuing mode and Choose the company's 3PL policies.
Allowed companies
The companies a user may work in, set on the user form (Access Rights tab, Allowed Companies) and chosen in the company switcher. Rx Tracking's records follow them. See Set up and work in a multi-company database.
ATP (authorized trading partner)
See Authorized trading partner.
Authorized trading partner
A partner with a DSCSA Role whose required licenses are recorded, verified and in force today. Shown as the Authorized Trading Partner checkbox on the contact's DSCSA tab; orders and transfers of DSCSA products with other partners are refused. See Authorized trading partners and the gates.
B
Barcode app
Odoo Enterprise's app for scanning in the warehouse. Rx Tracking (DSCSA) - Barcode makes it record DSCSA serials. On Odoo Community, use Scan Serials instead. See Barcode app and Scanning without Odoo Enterprise.
Block (title transfer)
A title transfer made by hand, usually from a title purchase order, for serials you select. Shown as Block in the transfer's Trigger; the other trigger is Just in time. See The title model.
C
CDER Direct
FDA's online portal where a 3PL facility's FDA annual report is filed. The software doesn't file anything there: after filing, you record the date, FDA's confirmation number and the receipt in Odoo. See Record a facility's FDA annual report and mark it submitted.
Chatter
The message and activity thread under (or beside) an Odoo form, with Send message, Log note and Activities. Rx Tracking writes its own notes there, for example "Lot quarantined: …".
Consignment (Odoo setting)
Odoo's own setting that lets stored products carry an owner (Inventory ‣ Configuration ‣ Settings, Traceability block, Consignment, "Set owner on stored products"). The 3PL add-on needs it: select it when you turn 3PL on, or no one sees Held for Owner. It is a different thing from a Consignor, which is a type of owner profile. See Turn on third-party logistics for a company.
Consignor
An owner whose goods you receive without buying them and sell as your own stock, each unit bought from the consignor when it ships. Shown as the owner profile type Consignor. See Take in and sell consignment stock.
Counterparty (of an owner)
The owner's supplier, customer or return designee on an owner transfer. Checked as a trading partner; a failure blocks by default or warns, under the 3PL policy Owner counterparties. See Authorized trading partners and the gates.
Custody receipt
A receipt of an owner's goods from the owner's own site or contract manufacturer: no sale takes place, so no transaction information is due and no DSCSA document is posted. See Receive the owner's own goods as a custody receipt.
Customer portal
The pages of Odoo's portal where your customers' users see and download their DSCSA documents. See Give a customer portal access to its DSCSA documents and the handout Your DSCSA documents in the customer portal.
D
D-U-N-S number
A company's nine-digit Data Universal Numbering System number, used as its facility identifier on Form FDA 3911 (Suspect Product add-on). See Set up investigations.
DataMatrix
The square 2D barcode (GS1 DataMatrix) printed on each saleable unit of a prescription drug. It carries the GTIN (Application Identifier 01), the expiry date (17), the lot (10) and the serial number (21). See Scan serial numbers onto a receipt.
DEA registration
A federal registration for controlled substances. It can be recorded as a license (type DEA registration) but never makes a partner an authorized trading partner. See Record and verify a trading partner's license.
Direct purchase
A purchase straight from the manufacturer (or its exclusive distributor, or a repackager that bought from the manufacturer). A document's Direct Purchase box and the T3's direct-purchase statement follow from the history. See How the transaction history and the direct-purchase flag are built.
Dispenser
A pharmacy, hospital pharmacy or practitioner that dispenses or administers drugs to patients. One of the DSCSA Role values; needs a State license. See Onboard a trading partner.
DSCSA (Drug Supply Chain Security Act)
The US federal law on tracing prescription drugs through the supply chain. The sources of what it asks of a wholesale distributor are listed by topic on Compliance background; these docs describe the software, not the law.
DSCSA document
Rx Tracking's frozen record of one transaction: Inbound (received) from a supplier's file, or Outbound (sent) for a shipment, with its T3 report and EPCIS file. Listed in Inventory ‣ Rx Tracking ‣ Documents. See DSCSA documents.
DSCSA product
A product whose DSCSA Product box (product form, DSCSA tab) is selected: a prescription drug covered by DSCSA. Only these products get serial capture, trading-partner checks and DSCSA documents; every other product works as in standard Odoo. See Set up a DSCSA product.
DSCSA role
A partner's place in the supply chain, which decides the licenses it needs: Manufacturer, Repackager, Wholesale distributor, Third-party logistics provider (3PL) or Dispenser (the contact's DSCSA Role). See Authorized trading partners and the gates.
E
EPCIS (Electronic Product Code Information Services)
The GS1 standard for exchanging supply-chain events as XML. Suppliers send an EPCIS file listing the units they shipped (Import the supplier's EPCIS file on the receipt); Rx Tracking writes one (EPCIS 1.2) for each outbound document (The outbound EPCIS 1.2 file).
Example database
The database the examples and screenshots in these docs come from: Odoo with the modules' demo data and the example records each page names. Record numbers and dates in yours differ. See How these docs are organized.
Expected (package)
A unit announced by a supplier's EPCIS file and not scanned yet: the package state Expected. See Packages and the serial ledger.
F
Facility
One of your warehouses, as a licensed site. With 3PL, each facility needs your licenses for the activities it carries out and a yearly FDA annual report record. See Record and verify our facility licenses.
FDA
The US Food and Drug Administration. It receives Form FDA 3911 notifications and may send trace requests.
FDA 503(e) annual report
A wholesale distributor's or 3PL's yearly report to FDA. As a partner license (type FDA 503(e) annual report) it is required only when the setting Wholesalers/3PLs need a 503(e) report is selected (Set whether wholesalers and 3PLs need an FDA 503(e) report). For your own 3PL facilities, the FDA Annual Reports records keep each year's report (Record a facility's FDA annual report).
FDA establishment registration
A manufacturer's or repackager's registration with FDA; the license type that makes a partner with one of those roles authorized.
Form FDA 3911
FDA's form for notifying it of illegitimate product. With the Suspect Product add-on, the software prepares its data sheet from the investigation; the form itself is submitted to FDA outside Odoo. See Complete and print the Form FDA 3911 data sheet.
G
Gate
A check that refuses an order or transfer of DSCSA products, for example with a partner that isn't authorized. See Authorized trading partners and the gates and What is checked where.
Gate Log
With 3PL, the list of every owner, counterparty and facility check, refusals and passes, for export to an inspector. Go to Inventory ‣ Rx Tracking ‣ Gate Log (in the 3PL ‣ Reports section). See Review the gate log and export it for an inspector.
GLN (Global Location Number)
The 13-digit GS1 number that identifies a company or a location (a warehouse, a receiving dock) in DSCSA data and EPCIS files. Shown as GLN on companies, warehouses and contacts; the check digit is verified. See Set the company's address, GLN and GS1 prefix length.
Goods before data
With 3PL, receiving an owner's goods before the supplier's transaction information arrives. The lots are held under a Supplier Data Pending discrepancy until the data or the owner's confirmation is recorded. See Receive an owner's goods before their data.
GS1
The standards organization behind GTIN, GLN, SSCC, DataMatrix and EPCIS.
GS1 Application Identifier
The two- to four-digit number in parentheses that says what follows in a GS1 barcode: (01) GTIN, (17) expiry date, (10) lot, (21) serial, (00) SSCC. Messages may call it "AI".
GS1 barcode nomenclature
Odoo's setting that reads barcodes as GS1 data. The Barcode app needs it for DSCSA scanning (Switch the company to the GS1 barcode nomenclature); Scan Serials reads GS1 data without it.
GS1 company prefix
The part of a GTIN or GLN that identifies the company that issued it. Its length (6 to 12 digits) is entered in GS1 Prefix Length or GS1 Company Prefix Length, for building EPCIS identifiers.
GS separator
The invisible character (ASCII 29, also called FNC1 or group separator) that ends a variable-length field in a GS1 barcode. How a scanner sends it matters for Scan Serials: see Set up a handheld scanner for Scan Serials.
GTIN (Global Trade Item Number)
The 14-digit GS1 product number of a saleable package, used in DSCSA files and barcodes. On the product's DSCSA tab, GTIN is computed from the NDC and can be overwritten, or captured from the first scan. See Set up a DSCSA product.
H
Hash chain
The link between the posted DSCSA documents of a company: each document's hash includes the previous one, so any later change breaks the chain. See Verify the integrity of the DSCSA documents.
Held for Owner
The field that marks stock, transfers and packages as an owner's (3PL). Empty means your own stock. See Owner stock and own stock.
Hold
Anything that stops DSCSA units from being reserved or shipped: a lot quarantine, an owner hold, a unit waiting in Returns to Verify. See Quarantine and holds.
I
Illegitimate product
As the modules read the law, product for which there is credible evidence (not only a reason to believe) that it is counterfeit, diverted, stolen or otherwise unfit; it is reported to FDA and trading partners (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background). With the Suspect Product add-on, an investigation's type Illegitimate product. See Handle illegitimate product and Form FDA 3911.
In-place document
A DSCSA document of a title transfer: a sale with no shipment. Its Transfer of Ownership in Place box is selected, it has no ship date, and its T3 prints "Transfer of ownership in place, no shipment". See The title model.
Inter-company transit
Odoo's virtual location for moving stock between two companies of one database. Rx Tracking doesn't handle it; DSCSA stock between your own companies is shipped as a sale. See Move DSCSA stock between two of our companies.
Investigation
With the Suspect Product add-on, a quality alert in Odoo's Quality app that records a suspect or illegitimate product case (Inventory ‣ Rx Tracking ‣ Suspect Investigations). See Investigate suspect product.
Issuing mode
On an owner profile, who receives the owner's outbound documents: Mode A (the owner only; it issues its own documents to its customer) or Mode B (you send them to the owner's customer, with the owner's authorization). See Know who receives an owner's documents: issuing mode A or B.
J
JIT (just in time)
A way of buying an owner's units: your own delivery takes them after your own units, and the software buys them from the owner when the delivery becomes Done. Shown as Just-in-Time Transfers on the owner profile and Just in time as a title transfer's Trigger. See Buy an owner's units just in time.
Jurisdiction
The state that issued a license: the Jurisdiction field of every license, and the column of the same name in the retention export. With the 3PL add-on, a jurisdiction record, under Inventory ‣ Rx Tracking ‣ Jurisdictions (in the 3PL ‣ Configuration section), records, once verified, that a state doesn't license 3PLs (Does Not License 3PLs). A facility license's jurisdiction is recorded but not compared with the facility's state. See Record and verify our facility licenses and Record that a state does not license 3PLs.
K
Keep At Least Until
On a DSCSA document's Retention tab, the transaction date plus six years. The software never deletes the document, before or after that date. See Records that are kept.
Keyboard-wedge scanner
A handheld scanner that types what it reads, as a keyboard would. It works with Scan Serials on Odoo Community and Enterprise. See Set up a handheld scanner for Scan Serials.
L
Ledger vs Stock
The report that compares the package ledger with Odoo's on-hand quantities, lot by lot (Inventory ‣ Rx Tracking ‣ Ledger vs Stock); with 3PL also per owner. See Check the package ledger against the stock.
Legal hold
A mark an Rx Tracking Manager places on DSCSA documents needed for litigation, an investigation or a subpoena; it is logged and carried to the off-site archive. See Place a legal hold on DSCSA documents.
License
A record of a partner's (or your own) state license, FDA registration, FDA 503(e) annual report or DEA registration, with its number, dates and verification (Inventory ‣ Rx Tracking ‣ Licenses). Written "license" in these docs; the 3PL menu shows Facility Licences. See Record and verify licenses.
Lot
Odoo's batch number of a product. DSCSA products are lot-tracked; the serial of each unit is kept in the package ledger. A lot also holds the Quarantine status.
Lot-level document
An outbound DSCSA document without serial numbers, for a small-dispenser customer while its exemption is in effect. See Ship at lot level to an exempt small dispenser.
M
Manufacturer
The company that makes the drug and owns its NDC. One of the DSCSA Role values; needs an FDA establishment registration. On a product, Manufacturer names it for the documents.
Missing (package)
A unit counted as gone in an inventory count: the package state Missing. A later count can find it. See Count stock and record the units that are gone.
N
NDC (National Drug Code)
The US drug product number, stored on the product's DSCSA tab as the 10-digit form with hyphens (the 11-digit billing form is accepted and converted). The GTIN is computed from it. See Set up a DSCSA product.
Non-saleable return
A return to the supplier of product that can't be sold (damaged, expired, recalled). A manager marks it Non-saleable return (§582(c)(1)(B)(ii)); it may ship held units and posts no DSCSA document. See Send a non-saleable return to the supplier.
O
Off-site archive
A write-once copy of the DSCSA documents and retention exports in an Amazon S3 bucket with Object Lock, sent by a scheduled job. See Set up the off-site archive.
Opening balance
Registering, once, the serials of DSCSA units already on your shelves when you start using Rx Tracking. Their packages have the origin Opening Balance. See Register the opening balance.
Own stock
With 3PL, stock your company owns: Held for Owner empty (or your own company). See Owner stock and own stock.
Owner
With 3PL, a company whose DSCSA stock you hold: your 3PL client. It needs an owner profile. See Owner stock and own stock.
Owner hold
With 3PL and the hold scope Per owner for documentation holds, a hold on one owner's units of a lot only (Owner Holds). See Follow and release owner holds.
Owner instruction
An owner's order or approval (to ship, return, scrap, release from hold, transfer title, recall), recorded before the operation that needs it (Owner Instructions). See Record an owner's instruction.
Owner notice
A message the software sends an owner about its units, for example when a lot holding them is put on hold or released (Owner Notices). See Read and send owner notices.
Owner order
The record of an owner's sale to its own customer (or of a custody return to the owner), from which you ship its goods (Owner Orders). See Ship owner orders.
Owner portal
The portal pages where an owner's contacts see its stock and documents and send its supplier's data. See the handout The owner portal: your stock and documents.
Owner profile
The record that makes a company an owner: its role, addresses, Transaction Statement, issuing mode, contacts, policies and title options. Go to Inventory ‣ Rx Tracking ‣ Owners (in the 3PL ‣ Configuration section). See Set up an owner profile.
Owner stock
With 3PL, stock you hold for an owner, marked Held for Owner. See Owner stock and own stock.
P
Package
Rx Tracking's record of one serialized unit of a DSCSA product (not an Odoo package, which is a container): its product, GTIN, serial, lot, expiry, state and history. See Packages and the serial ledger.
Package ledger
All packages together (Inventory ‣ Rx Tracking ‣ Packages): where each unit is, where it came from and where it went. See Look up a unit in the package ledger.
Posted
The state of a DSCSA document once it is frozen and part of the hash chain. A posted document can't be changed or deleted.
Product identifier
A unit's GTIN, serial number, lot and expiry date together, as printed in its DataMatrix and listed in DSCSA documents.
Q
Quarantine
A hold on a whole lot: its Quarantine status is Quarantined, and its units can't be reserved or shipped until an Rx Tracking Manager releases it. See Quarantine and release lots and Quarantine and holds.
R
Receiving discrepancy
A difference between what a supplier's file announced and what arrived (Missing, Extra, Duplicate Serial, Wrong Product, Wrong Lot, Wrong Expiry), or a missing statement (Transaction Statement Missing). It holds the lot until it is resolved and released. See Resolve receiving discrepancies.
Record rule
An Odoo rule that limits which records of a model a user can see, for example to the records of the user's companies. Rx Tracking's record rules are listed in Roles and permissions.
Repackager
A company that repackages or relabels a drug. One of the DSCSA Role values; needs an FDA establishment registration.
Retention export
The monthly pair of CSV files (the package ledger and the license register) that the software keeps, and can make on demand (Inventory ‣ Rx Tracking ‣ Retention Exports). See Get the monthly retention export, or export on demand.
Return designee
With 3PL, a party an owner names to receive its nonsaleable returns (Return Designees on the owner profile). See Send an owner's nonsaleable units to the owner or one of its return designees.
Returns to Verify
The list of customer-returned units waiting for a manager's decision (Inventory ‣ Rx Tracking ‣ Returns to Verify); they can't be reserved until then. See Verify returned units for resale, or reject and destroy them.
Reversion
With 3PL, a title transfer from your company back to an owner, in place (Us to owner (reversion)). See Sell units back to an owner in place (reversion).
S
S3 (Amazon S3) and Object Lock
Amazon's file storage service, where the off-site archive keeps its copies. Object Lock keeps each copy from being changed or deleted for a set period (Compliance mode, or Governance (test)). See Set up the off-site S3 archive.
Saleable return
A customer's return of units that may be sold again once verified. It must match your own sale of those serials to that customer. See Receive a saleable customer return with its serials.
Scan Serials
The button on receipts, deliveries and returns (Odoo Community and Enterprise) that opens the Scan DSCSA Serials dialog, where you scan units one per line. See Scan units onto a receipt with Scan Serials, and undo a scan.
SBDH (Standard Business Document Header)
The header of an EPCIS file that names its sender and receiver by GLN. See The outbound EPCIS 1.2 file.
Sealed case
A case whose seal is intact, received by one scan of its SSCC label when the supplier's EPCIS file lists its units. See Receive a sealed case by scanning its SSCC label.
Seller of record
With 3PL, on a shipped package, the party that sold it: the owner, or your company. Shown as Seller of Record.
SGLN
The EPCIS form of a location's GLN (urn:epc:id:sgln:…), used for the ship-from and ship-to in EPCIS files.
SGTIN
The EPCIS form of one unit's identity, built from its GTIN and serial (urn:epc:id:sgtin:…). Shown as SGTIN on the package.
Small dispenser
A dispenser customer flagged Small Business Dispenser, with the date it attested it. While the exemption is in effect (until the date in the setting Small-dispenser exemption), it gets lot-level documents. See Flag a small-dispenser customer and record its attestation.
SSCC (Serial Shipping Container Code)
The 18-digit GS1 number on a case or pallet label (Application Identifier 00). Stored on each unit received in that case. See Receive a sealed case by scanning its SSCC label.
State license
A license issued by a state (a pharmacy or wholesale license). The license type that makes a dispenser, wholesale distributor or 3PL authorized.
Supplier EPCIS file
A supplier's EPCIS file imported on a receipt (Inventory ‣ Rx Tracking ‣ Supplier EPCIS Files): it announces the units as Expected, and becomes the inbound document when the receipt becomes Done. See Review supplier EPCIS files and the inbound DSCSA document.
Suspect product
As the modules read the law, product there is reason to believe is counterfeit, diverted, stolen, adulterated or fraudulent; it is quarantined and investigated (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background). See Quarantine and holds and Suspect product without Odoo Enterprise.
T
T3 (Transaction Report)
The PDF report of a DSCSA document with its Transaction Information, Transaction History and Transaction Statement (the three "T"s): T3 Report (DSCSA). See The T3 report, and why a validated delivery can't be edited.
TH (Transaction History)
The chain of earlier sales of the shipped units, back to the manufacturer as far as your records go, on each outbound document's Transaction History tab. See How the transaction history and the direct-purchase flag are built.
TI (Transaction Information)
What a DSCSA document says about the transaction: the product, lots, quantities, dates, seller, buyer and the identifier of every package. See DSCSA documents.
TI business address
With 3PL, the owner's business address printed as the seller on its documents (TI Business Address on the owner profile), rather than your warehouse. See Set how the owner's documents are issued.
Title location
With 3PL, the company's virtual location Virtual Locations/DSCSA Title Transfer, through which a title transfer moves units for an
instant; always empty afterwards. See Title transfer rules.
Title purchase order
A purchase order to an owner with Title Transfer in Place selected: you buy units you already hold for it. See Create and approve a title purchase order.
Title transfer
With 3PL, a change of the owner of chosen serials in place, with no shipment. Go to Inventory ‣ Rx Tracking ‣ Title Transfers (in the 3PL ‣ Operations section). See The title model.
Trace request
A request from FDA, a state or a trading partner for the records of a serial, lot or product, logged and answered with a response zip (Inventory ‣ Rx Tracking ‣ Trace Requests). See Answer trace requests.
Transaction
As the modules read the law, a change of ownership of a drug between two companies. Receipts and shipments of an owner's goods by a 3PL change no ownership; a title transfer does (FD&C Act § 581(6), (22), (24), (26), (27); § 582(a)(1), (a)(7); § 584(d); see Compliance background).
TS (Transaction Statement)
The seller's statement about its authorization and conduct, part of every DSCSA document. Your text is set in the DSCSA settings; a supplier's comes with its file or is recorded by hand. See Review the Transaction Statement and the EPCIS legal notice and Record a missing Transaction Statement.
V
VRS (Verification Router Service)
A service through which a product identifier is checked with its manufacturer. The modules follow the reading that it is one way to verify a returned unit before resale, the other being a match against your own sales records (FD&C Act § 582(c)(1)(B), § 582(c)(4)(D); see Compliance background). The modules don't connect to a VRS: a saleable return is accepted only for units the package ledger shows you shipped to that customer, and your staff verify the units before resale. See Receive a saleable customer return with its serials and Verify returned units for resale, or reject and destroy them.
W
Wholesale distributor
A company that sells drugs to other companies, not to patients. One of the DSCSA Role values; needs a State license (and an FDA 503(e) annual report under the setting). With 3PL, your facility needs a wholesale license for title transfers and consignment.