Between October 1 and December 31 every year, FDA expects two separate filings from companies that manufacture or list drugs for the US market. The establishment registration must be renewed, and every drug listing that was not submitted or updated during the calendar year must be updated or certified as unchanged. Both filings fall in the same three-month window and are often prepared by the same person, so they are easy to treat as one task. They are not. Renewing the establishment does not certify its listings, and certifying the listings does not renew the establishment. A foreign manufacturer that completes only one of them can still see its listings expire in January.
Establishment registration: renewed every year, October 1 to December 31
FDA's drug registration instructions state that establishments must renew their registration between October 1 and December 31 each year. Drug establishment registration is annual, unlike food facility registration, which is renewed in even-numbered years. The renewal confirms the establishment's current details: its name and address, the DUNS number for that specific site rather than one linked to the corporate headquarters, the business operations performed there and its contacts. A foreign establishment must also identify its U.S. agent, including the U.S. agent's DUNS number, and the importers of its drugs. FDA notes that a foreign establishment has to complete registration before its drugs can be offered for import into the United States.
After a successful submission, FDA states that the establishment's information appears in the Drug Establishments Current Registration Site (DECRS) by the end of the next business day, with an expiration date of December 31 of the following year. DECRS is public, so importers and customers can check an establishment's status themselves. An establishment that misses the renewal window no longer has a current registration to show.
Drug listings: update when something changes, certify when nothing does
Drug listing is a separate obligation under 21 CFR part 207. Each registrant must review and update its listing information no later than June and December of each year, covering newly manufactured drugs, discontinued drugs, drugs whose manufacture has resumed and any material change to information already submitted. FDA also encourages registrants to update a listing at the time a change happens. A listing that is newly submitted or updated during the calendar year counts as certified through December 31 of the following calendar year.
For listings that were not submitted or updated during the calendar year, 21 CFR 207.57(b)(2) requires an update or a certification that nothing has changed since the last update. FDA accepts that certification as a blanket no-changes certification, filed as a structured product labeling (SPL) submission. It can only be submitted between October 1 and December 31, the same window as establishment renewal. Outside that window, certifying a listing requires an updated or revised listing SPL for each NDC.
What happens in January to listings that were not certified
FDA's listing instructions state that every January, FDA inactivates any human drug listings that were not certified during the October 1 to December 31 period, and that inactivated listings are removed from the NDC Directory and other listing publications. In FDA's own training material, uncertified listings are described as expired in January and liable to be inactivated and removed from databases. In practice, the product stops appearing in the public reference that supply-chain partners use to look up NDCs, and bringing it back requires a listing submission rather than a late certification.
Inactivation is not a substitute for delisting. FDA's guidance to registrants is to delist a product that is no longer in US commercial distribution, and FDA points out that an inactivated listing is not in compliance even when the drug has been discontinued.
Plan the two filings separately
A company with several establishments and many NDCs should treat year-end as two work streams: one renewal for each establishment, and one decision for each listing — update it, certify it, or delist the product if it is no longer marketed in the United States. Keeping the streams separate also makes it easier to see when an establishment change, such as a new U.S. agent or importer, has consequences for the listings.
Year-end checklist for foreign drug establishments
- Confirm the establishment's legal name, physical address, site-specific DUNS number and business operations.
- Confirm the U.S. agent and the importers named in the registration, including the U.S. agent's DUNS number.
- Review every active NDC: was it submitted or updated this calendar year, does it need an update, or can it go into the blanket no-changes certification?
- Delist products that are no longer in US commercial distribution instead of letting their listings expire.
- Keep the submission acknowledgments, the DECRS result and the NDC Directory entries with your compliance records.
Related guidance
The underlying requirements are explained in what foreign manufacturers must file for drug establishment registration and how foreign manufacturers submit drug listings under 21 CFR 207. NDC structure is covered in what an NDC number is and how foreign drug manufacturers obtain one, and FDA's move to a single twelve-digit NDC format is explained in the twelve-digit NDC final rule guide. The separate July 2026 proposal that would widen which foreign establishments must register is discussed in the 2026 proposed rule on foreign drug establishment registration.
How FDABridge supports year-end drug filings
FDABridge's drug establishment registration service includes U.S. agent coverage for the first year and annual re-registration support. Drug listings are prepared per product as SPL drug listing submissions, and NDC labeler code applications are handled as a separate service. U.S. agent arrangements are described on the U.S. Agent service page. Registration and listing do not mean that FDA has approved an establishment or its drugs.
Sources: FDA, How to Register a Drug Establishment (https://www.fda.gov/drugs/drug-registration-and-listing-instructions/how-register-drug-establishment); FDA, How to List a Drug (https://www.fda.gov/drugs/drug-registration-and-listing-instructions/how-list-drug); FDA, Listing Updates and Blanket No Changes Certification Demo, SBIA 2024 (https://www.fda.gov/media/184341/download).