US Product Track

US Product Track Overview

What is US Product Track

US Product Track enables lot-level track and trace of pharmaceuticals in compliance with the U.S. Title II of the Drug Quality and Security Act (DQSA), also cited as the Drug Supply Chain Security Act (DSCSA).

All Wholesale Distributors, Pharmaceutical Manufacturer, Repackagers, and Dispensers in the pharmaceutical supply chain are required to exchange specific product transaction information about a prescription drug and its ownership each time it is sold in the U.S. market. These companies also have to archive the data and provide features for verification compliance.

Product Track enables the exchange of the specifically required transaction information from buyer to seller trade partners in the supply chain and preserves the information for verification.

When Product Track refers to the "Transaction History" for a product, that includes the Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) for the product as it moves through the pharmaceutical supply chain.

How to Use US Product Track

Companies can use Product Track through:

TraceLink's Product Track User Interface (UI).
Asynchronous messages.
SOAP API integration.

US Product Track in TraceLink's Serialization Solution

Getting Started in US Product Track

Configuring Permissions/Access

Quantity Adjustment Model

To create new Transaction Histories when a user updates a product quantity, the Quantity Adjustment Model in Company Administration must be New Model.

Hover over the User Menu, then hover over Company Administration and select Services.
The Services screen displays.
Select US Product Track from the Service Type drop-down.
Select Publisher from the My Company's role drop-down.
Select the Search button.
The results display in the table.
Select the Configure Published Service link in the Actions column of the results table.
The Configure Published Service Settings screen displays.
Select the New Model radio button for the Quantity Adjustment Model field.
The New Model prompts US Product Track to create a new Transaction History when a user updates a product's quantity.
The Legacy Model does not create a new Transaction History when a user updates a product's quantity.
Select the Submit button.
The Services screen displays.

Enable the Automatic Assignment of Receipts by Location

Companies configured as Dispensers can configure US Product Track to automatically assign receipts to the correct location with the Ship To Location ID.

In Company Administration:
1. Hover over the User Menu, then hover over Company Administration and select Services.
  The Services screen displays.
2. Select US Product Track from the Service Type drop-down.
3. Select Publisher from the My Company's role drop-down.
4. Select the Search button.
  The results display in the table.
5. Select the Configure Published Service link in the Actions column of the results table.
  The Configure Published Service Settings screen displays.
6. Select the Inbound Transactions checkbox.
7. Select the Submit button.
  The Services screen displays. Product Track can now use the identifiers entered in Master Data Exchange and imported to Service Administration to associate receipts with the correct location.
In Management:
1. Hover over the User Menu, and then select Management.
2. Select the Receiving Location Identifiers button from the Management landing page.
  The Receiving Location Identifiers screen displays.
3. Select the Choose File button.
4. Browse for and select the desired CSV File containing the identifiers that trade partners use for the company's locations.
  The CSV file only needs to contain identifiers that are not already entered in Master Data Exchange. See the Management Online Help for the CSV file's format requirements.
5. Select the Submit button.
  The Applications screen displays.

Allow Dispensers to Resell Product

For Dispensers to resell product to another Dispenser, the US Product Track app must be configured to allow reselling in Company Administration .

Hover over the User Menu, then hover over Company Administration and select Services.
The Services screen displays.
Select US Product Track from the Service Type drop-down.
Select Publisher from the My Company's role drop-down.
Select the Search button.
The results display in the table.
Select the Configure Published Service link in the Actions column of the results table.
The Configure Published Service Settings screen displays.
Select the Can Resell Product checkbox under the Dispenser radio button for the Company Role field.
Select the Submit button.
The Services screen displays.

United States Requirements in Product Master Data

Some optional fields might be mandatory based on the United States' regulatory requirements. Download the Quick Reference Guide to view their specific required fields.

Available Functions

Transaction Exchanges

View Transaction Exchanges – Search for and view shipments and receipts with Transaction Histories.
View Transaction Exchange Details – View the details of a shipment or receipt.
View Confirmed Serialized Contents – View the serialized contents of a specific shipment or receipt transaction that is confirmed as being physically received.
View Transaction Exchange Details (Serialized) – View the details of a serialized shipment or receipt.
View Serialized Contents – View details about the top-level, or outermost, serialized contents of a shipment or receipt.
View Contents Level [n] – View details about the inner serialized contents of a shipment or receipt.

Transaction Histories

View Transaction Histories – Search for and view Transaction Histories of shipments and receipts.
View Transaction History Details – View the details of the Transaction History for a shipment or receipt.
Annotate Product Information – As a Dispenser, annotate the Lot Number and Expiration Date within a received Transaction History.
Download Reports – Download reports with data for multiple Transaction Histories.
Create Report – Create a report with data for multiple Transaction Histories.
Create Transaction History for Received Paper – Create a Transaction History within TraceLink for a received transaction with a paper Transaction History.
Resell Product – As a Dispenser, resell product to another Dispenser.

Receipts

Manage Receipts – Search for and view receipt transactions.
Receive Products in Shipment – Receive a shipment within TraceLink, comparing the product received against the Transaction History.

Void Transactions

Void Transactions – Search for and view shipments and receipts to void.
Void Transaction – Void a transaction.

Shipments

Manage Shipments – Search for and view shipments sent from the user's company.
Create Shipment – Create a shipment with Transaction Histories for either sale or transfer to another company location.
Update Shipment – Update an unsubmitted shipment created by the user's company.
View Completed Shipment – View the details of a completed and submitted shipment.

Initial Transactions

Manage Initial Transactions – Search for and view initial transactions created for inventory that existed before the DSCSA took affect or repackaged products.
Create Initial Inventory – Create Transaction Histories for inventory that existed before the DSCSA took affect.
Create Repackaged Product – Create Transaction Histories for products repackaged by the user's company.
View Initial Inventory Details – View the details of a Transaction History created for an initial inventory.
View Repackaged Product Details – View the details of a Transaction History create for a repackaged product.

Product Status

Manage Product Status – Download inventory reports created by the user.
Create Inventory Report – Create an inventory report containing Transaction History data.
Update Product Quantity – Update the quantity of a product in the user's company inventory.
Update Product Status – Update the status of a product in the user's company inventory.