Reminder: US FDA Drug Listing Renewals 2026

As the annual renewal period approaches, companies marketing drugs in the US should begin reviewing their FDA establishment registrations and drug listings. The annual renewal period runs from October 1 through December 31, 2026. During this period, companies should confirm that their establishment registration, product listings, NDC information, labeling, manufacturing sites, and other listing information remain accurate. For drug listings that have not been updated during the calendar year, a blanket “no changes” certification may be submitted to keep the listings active for the following year.

Companies should begin their portfolio review early to identify discontinued products, formulation or labeling changes, manufacturing-site updates and other changes that may require listing updates. Failure to complete the required annual certification or update during the renewal period can result in inactivation of drug listings, potentially affecting continued US distribution.

Our team can help you manage all your FDA renewals. Reach out to us for more information.