Establishments

The “Establishments” tab provides the ability to view, create and list all Establishment in the data repository.  

1. To edit an existing Establishment, click on the Establishment’s name in the table and make modifications as needed. Then press the Save button.
2. To create a new Establishment press the “Create New Establishment” link. 

When creating a new Establishment you will need to populate the following data elements:

Additionally, you will also need to select the business operations performed by this Establishment.

Check the all appropriate operations for the Establishment. There are two separate columns of operations to choose from for each Establishment:

• The first column indicates that the operation should be included in an Establishment Registration file.
• The second column indicates that the operation should be included in a GDUFA self-identification file. If an operation should appear in both files, both checkboxes should be checked.
• When the Human Drug Compounding Outsourcing Facility operation is checked, 3 additional checkboxes will be displayed under the Drug Compounding Outsourcing Details area.

Note: once a business operation has been selected for an Establishment, unchecking the business operation and saving will automatically uncheck that business operation for all products that have that Establishment associated to it.

After checking the “This establishment is a Wholesale Drug Distributor” checkbox and/or the “This establishment is a Third Party Logistics Provider” checkbox and then clicking the Save button a “Wholesale Distributor/3rd Party Logistics Licenses” link will appear.

Clicking on the “Wholesale Distributor/3rd Party Logistics Licenses” link will cause a new window to open where the Establishment’s State Licenses can be entered individually.

After saving each State License for said Establishment exit out of the opened window and then click the “Back to List” button to be returned to the Establishment Tab of the Contacts/Entities section.

Click to select the “Registrants" tab, and then navigate to the Registrant associated to your Establishment.

After clicking to select the appropriate Registrant, that Registrant’s Registrant Detail page will be displayed where you can then click on the “Wholesale Distributor/3rd Party Logistics Files” link which will open a new window where Wholesale Distributor/3rd Party Logistics submissions files can be created and downloaded. 

Existing Wholesale Distributor/3rd Party Logistics submissions are listed in descending order based on version number.

To create a new report, populate the Effective Date field, and then click the “Create Wholesale Distributor/3^rd Party Logistics Report” button to create a new Wholesale Distributor/3rd Party Logistics report. The Version No field is automatically incremented by the application. Once the report is created, click the orange download icon  to download the file to your local machine.

To create an Establishment report in EXCEL, click on the “Create Excel Establishment List Report” link.

The Excel file contains all information about the Establishments.