Drug establishments must renew their FDA registration every year between October 1 and December 31. Unlike medical devices, there's no FDA fee — but the SPL submission format and drug listing certification requirements trip up more companies than the deadline itself.
Start My Renewal → Renewal FAQQuick answer: If your facility manufactures, repackages, relabels, or salvages drugs for the U.S. market and is currently FDA-registered, you must renew that registration every year between October 1 and December 31 — an annual requirement, same schedule as medical devices. The FDA charges no fee for this renewal. Submissions must be in SPL format, and you must certify your drug listings even if nothing changed.
Drug establishment registration renews every single year, October 1 through December 31 — the same annual cadence as medical device registration, but without the government fee that devices carry. The real risk here isn't cost, it's format and completeness: renewal must be submitted electronically in Structured Product Labeling (SPL) format, using the same set-id as your original establishment registration SPL, via the FDA Electronic Submissions Gateway (ESG).
If nothing has changed about your drug listings since last year, you might assume there's nothing to submit. That's incorrect. Every labeler must submit a no-change certification during the renewal period confirming all previously listed drugs remain accurate — this applies to every drug reviewed by the labeler, even ones that genuinely haven't changed.
Any drug listing that isn't updated or certified between October 1 and December 31 is considered inactive and automatically removed from the FDA database — silently, without a separate warning. "Nothing changed, so I didn't submit anything" is exactly the mistake that causes an active drug listing to disappear.
To keep your establishment registration and NDC Labeler Code active, you must have at least one active drug listing on file with the FDA. If your establishment doesn't maintain at least one current listing through the renewal process, this can jeopardize your registration and labeler code together, not just the individual product listing.
Failure to renew on time can result in FDA canceling the establishment's registration entirely.
Drug products from an unregistered establishment may be treated as misbranded under the FD&C Act.
Foreign manufacturers' products may be detained at the port if registration lapses.
FDA removes expired facilities from the registration database, requiring a fresh registration to resume.
Every year, October 1 through December 31 — an annual requirement, same as medical devices.
No. Unlike medical device registration, drug establishment registration and renewal carry no FDA fee.
You still must submit a no-change certification. Skipping this causes your listing to be marked inactive and removed.
SPL (Structured Product Labeling) format, submitted via FDA's Electronic Submissions Gateway, using your original set-id.
Annual renewal — mark your calendar for every year, not just this one.
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