FDA drug establishment registration renewal: deadlines and process

Every establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug must register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act — and that registration must be renewed every year.

The renewal window

The annual renewal period runs from October 1 through December 31. FDA does not accept renewals before the window opens, and there is no grace period after it closes. An establishment that has not renewed by December 31 is deactivated at the start of the new year.

Every registration carries the same expiration date — December 31 — so the deadline itself is not something any individual firm has to look up. What differs between firms during the window is whether FDA has processed their renewal yet.

Who must renew

• Domestic drug manufacturers, repackagers, and relabelers
• Private-label distributors that are also establishments
• Contract manufacturers
• Foreign establishments and their designated US Agents

How it is filed

Registration and renewal are submitted electronically through FDA's eDRLS system using Structured Product Labeling (SPL). You confirm establishment information, drug listings (NDCs), and — for foreign establishments — the US Agent. FDA charges no fee for the renewal itself.

Once the submission is accepted and processed, the establishment's entry in the public DECRS file rolls forward to December 31 of the following year. That roll-forward is the only public confirmation that the renewal actually went through.