FDA Biennial Registration Renewal: Deadlines, Process, and What Happens If You Miss It

FDA facility registration is not a one-time filing. Food facilities, cosmetic facilities, and drug establishments all face renewal or update obligations that, if missed, result in immediate compliance consequences. For food facilities, the stakes are particularly clear: a lapsed registration means every shipment from your facility can be refused admission at a US port. No warnings, no grace period — just a hold on your goods and a conversation with your buyer that no exporter wants to have. Understanding the renewal timeline, the process, and the consequences of delay is essential for every foreign manufacturer that sells into the United States.

Food facility biennial registration renewal

Under the FDA Food Safety Modernization Act, all food facility registrations — both domestic and foreign — must be renewed biennially during the period from October 1 to December 31 of each even-numbered year. The next renewal window is October 1 – December 31, 2026. If your facility was registered in any prior year and you do not renew during this window, your registration expires on January 1 of the following year. Once expired, your facility is no longer considered registered with the FDA, and any food offered for import from your facility will be subject to refusal. The renewal is submitted through the FDA's FURLS (FDA Unified Registration and Listing System) and requires you to review and confirm your facility's registration information, including the facility name, address, product categories, US Agent information, and emergency contact details.

Cosmetic facility registration renewal under MoCRA

Under MoCRA, cosmetic facility registrations must be renewed every two years. Unlike food registrations, which all renew in the same October–December window, cosmetic registration renewal dates are based on the initial registration date. If your facility was first registered on March 15, 2024, your renewal is due by March 15, 2026. This individualized timeline means there is no single industry-wide renewal deadline — each facility must track its own renewal date. Missing the renewal means your facility's registration lapses, and the FDA considers your facility unregistered. Product listings associated with an unregistered facility also lose their valid status.

Drug establishment annual registration

Drug establishments operate on a different cycle. Under 21 CFR Part 207, drug establishments must register and update their registration annually between October 1 and December 31 of each year — not biennially. This means drug establishments must confirm or update their registration every year without exception. The annual registration requires updating establishment information, confirming or revising drug listings, and ensuring the designated US Agent (for foreign establishments) is still current. Failure to maintain an active registration can result in drugs from the facility being considered misbranded, with all the enforcement consequences that implies.

Common renewal mistakes and how to avoid them

The most common renewal mistake is simply forgetting. The renewal window opens months after the original registration, and for manufacturers managing dozens of regulatory obligations across multiple markets, the FDA renewal is easy to overlook. The second mistake is submitting the renewal with outdated information — a US Agent that is no longer available, a facility address that changed, or product categories that no longer reflect what the facility actually produces. The FDA requires the information to be current at the time of renewal, and submitting outdated data creates compliance issues even if the renewal itself is processed. The third mistake is waiting until the last week of December. The FURLS system can experience slowdowns during peak renewal periods, and a technical issue on December 30 can mean your renewal does not process before the deadline.

How FDABridge manages renewal for our clients

FDABridge tracks renewal deadlines for every client and initiates the renewal process well before the deadline. We verify all registration data, confirm US Agent status, update product categories if needed, and submit the renewal through FURLS with time to spare. Our clients never miss a renewal deadline. Visit fdabridge.com/contact to learn how we manage ongoing compliance for foreign manufacturers.