Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods throughout the year for various electronic drug product submissions. These include Drug Sample Distribution Reports, GDUFA Self-Identification submissions, Establishment Registrations and No Change notifications for Drug Product Listings.
ACA 6004 Drug Sample Distribution Reports
As part of the Affordable Care Act, drug product manufacturers and distributors are required to report their distributions of prescription drug samples in the U.S. annually to FDA. This electronic submission is done in an XML format. Companies required to report have until April 1 of each year to report on the previous calendar year’s distribution.
The Generic Drug User Fee Amendments (GDUFA) require certain types of generic industry facilities to identify themselves to FDA annually in Structured Product Labeling (SPL) format. Affected companies must self-identify between May 1 and June 1 each year for the coming U.S. Government Fiscal Year, which runs from October 1 to September 30.
All sites engaged in manufacturing or related business operations (such as pack or label) for Rx and OTC drug products distributed in the U.S. must register annually with FDA in SPL format. These submissions must be made between October 1 and December 31 for the coming calendar year. (Please note, changes to existing Establishment Registration information should be submitted throughout the year as they occur. However, this does not change the requirement for all sites to submit during the reporting period each year.)
Drug Product No Change Notification
In updates to eDRL requirements announced in late 2016, FDA indicated that it would soon begin requiring annual submissions to certify that any products not updated during the course of a year had no changes to report. These submissions will occur during the same reporting period as Establishment Registrations (October 1 to December 31). More information is expected from FDA in the coming months.
Reed Tech has been assisting drug product manufacturers and distributors in fulfilling FDA’s electronic submission requirements since 2005. If you have questions about whether these requirements apply to your company, or how to meet those that do, contact Reed Tech. Our team of experts is ready to help.