What happens when your registration expires

Drug establishment registration is not paperwork for its own sake — it is the switch that keeps your products legally in commerce. When it lapses, the consequences arrive in order, and usually without a warning letter.

1. The establishment is deactivated

If the annual renewal is not filed by December 31, FDA deactivates the establishment and it stops appearing in the active DECRS listing.

2. Every NDC is delisted

Drug listings depend on an active registration. When the establishment is deactivated, the associated National Drug Codes come off the NDC Directory.

3. Products become misbranded

A drug from an unregistered establishment, or carrying an unlisted NDC, is misbranded under the FD&C Act. Distributing it in the United States is unlawful.

4. Shipments are detained

For foreign establishments, imports tied to a deactivated registration can be held at the port of entry until the establishment re-registers.

Why it is usually discovered late

FDA does not send a warning before deactivating. There is no letter, no email, and no status change you are notified of — the establishment simply stops appearing in the file on January 1. In practice the first sign is commercial rather than regulatory: a customer questions an NDC, or a shipment is held.

That is also why filing is not the same as being done. A renewal that was submitted but not processed looks, from the outside, exactly like one that was never filed.