National Drug Code (NDC) for Pharmacy and Over-the-Counter Product Registrations
We appreciate the feedback received regarding this recent update to WERCSmart’s registration process and we’ve made some adjustments to facilitate compliance with your organization’s processes.
Although the FDA may provide an NDC for a product, the commercialization of the NDC may be delayed for some time or the NDC may not yet be available in Daily Med. The current process in WERCSmart allows you to elect to import data for your product from Daily Med. If you elect to bypass the data import, there is still validation with Daily Med performed for the NDC you provide, which is causing delays in the registration process.
Therefore, the NDC value will remain as required, but if you choose to bypass the import of data from Daily Med, you may enter the NDC value at the product level, when Drug Facts labeling is indicated. This will allow you to set up your product and remove the validation of the NDC provided via Daily Med.
Recertification in Advance
We’ve made further improvements to this feature. Registrations identified as having incomplete data based on current requirements will now appear in this table and will not automatically have recertification applied, allowing you to review and update the data at your convenience.
Starting a Registration – User Experience Improvement
When starting a new registration in WERCSmart, the initial step appeared to display a default selection, which was misleading. To ensure a proper registration, we’ve updated this selection area, avoiding confusion.
Aerosol Registrations Require Relative Density
To ensure compliance with current regulations, all aerosol products must include relative density data. If your existing registrations are missing this required information, they will be flagged and available in the Recertification in Advance area on the Portal’s home page. This allows you to update the necessary data and maintain regulatory compliance.
Battery-Containing Products (BCPs) Validate Battery Included
As regulations surrounding batteries and battery-containing products continue to evolve, it is essential that all batteries included with registered products meet current safety and environmental standards.
To ensure compliance, registrations for battery-containing products will be reviewed periodically. If a product is found to include a non-compliant battery, you will receive notification via email through Alerts/messages in the Portal. These notifications will provide guidance on how to update your registration to align with regulatory requirements.
Editing UPCs Prohibits Retailer Removal – Archive Retailer from Product Actions Required
If a retailer is removed while editing UPCs in a registration, a message will appear explaining the correct procedure for removing retailers from registrations, which is to select archiving a retailer from the registration’s action options.