FDA drug establishment registration
Your registration expires December 31.So does everyone's.
That date is public and identical for every registered drug establishment — a calendar handles it. What a calendar cannot tell you is whether FDA has actually processed your renewal, or whether your establishment quietly dropped out of the file last week. StayListed reads FDA's file every business day and emails you the day your record changes.
Free lookup — no account
No number to hand? and watch a real record come back.
- Source
- DECRS
- public file
- Establishments
- 9,825
- in today's copy
- Refreshed
- 2026-08-13
- each business day
How it works
No integration, no data entry beyond one number, nothing to install.
- 01
We download FDA's file every business day
FDA rebuilds the drug establishment registration file each business day. We take the whole file — not a sample, not a search — and parse every row.
- 02
We compare it against yesterday's copy
Expiration date, address, registrant, contact, US Agent, and whether your row is still in the file at all. A row disappearing is itself the deactivation signal.
- 03
You get an email the day something moves
Plain text, with the old value and the new one. Nothing to log in and check.
October 1 – December 31
What the file reveals during the renewal window
Renewal can only be filed between October 1 and December 31. Not before, and there is no grace period afterwards. As FDA processes each renewal, that establishment's expiration date rolls forward a year. The ones still waiting stay put.
So from the middle of October the file answers a question a deadline reminder never can: has mine actually gone through?
Every January 1
What follows a lapsed registration
FDA deactivates every establishment that did not renew, without a warning letter or an email. The consequences run in order:
- 01
Establishment deactivated
The registration is no longer active in FDA's system.
- 02
Every NDC delisted
Each drug listed under that establishment comes off the NDC directory.
- 03
Products misbranded
Unlisted drugs are misbranded under the FD&C Act — domestic distribution becomes unlawful.
- 04
Imports detained
Foreign shipments tied to the establishment can be held at the port until it re-registers.
Plainly stated
What StayListed is not
Worth saying outright, because firms on this list get a lot of official-looking mail.
We never ask for your FURLS or eDRLS login
There is nothing to connect. StayListed reads a public file that FDA publishes for anyone to download.
We don't file anything on your behalf
We are not your US Agent and not a regulatory consultant. You file your own renewal, and FDA charges nothing for it.
We don't invoice you for your FDA registration
Renewal itself is free. If a bill for it arrives, it is not from FDA and it is not from us.
We can lag, and we tell you when
FDA's file can trail your submission by a business day or two. A record that hasn't updated yet isn't proof of a problem, and our emails say which day's file they're based on.
Pricing
Billed once a year, because the obligation is once a year.
Free
no card requiredLook up any establishment whenever you want, and get the reminder when the renewal window opens.
Where the line sits: free covers what the public file already tells you — look up any establishment, and get the reminder when the window opens. The paid plans add the part that only exists because we keep yesterday's copy: the daily comparison that says whether FDA has processed your renewal, and whether your record changed.
Founding
limited$49/year
Up to 3 establishments
The first 30 subscribers. This price holds for as long as the subscription runs.
- Up to 3 establishments
- Daily change alerts on every field
- Renewal-processed confirmation, October to December
- Price locked for life
- Direct line for feature requests
Standard
$99/year
Up to 5 establishments
For a firm watching its own establishments.
- Up to 5 establishments
- Daily change alerts on every field
- Renewal-processed confirmation, October to December
- Alert if an establishment leaves the file
Portfolio
$249/year
Up to 25 establishments
For multi-site manufacturers and small consultancies.
- Up to 25 establishments
- Everything in Standard
- A label on each site, so alerts name the plant
- Alerts to up to 5 colleagues, on one thread
- Bulk import from a pasted list
- Priority support
US Agent
$699/year
Up to 250 establishments
For agents and consultancies watching a book of client establishments.
- Up to 250 client establishments
- Everything in Portfolio
- A label per client, so alerts name the account
- One digest a day, not one email per client
- We help you load the client list
Watching more than 250 establishments? Email us and we'll work out the right arrangement.
Questions
The things people ask first
How often does a drug establishment registration have to be renewed?
Every year. FDA requires drug establishment registration to be renewed between October 1 and December 31 annually under section 510 of the FD&C Act. There is no grace period and no early filing.
What happens if my registration expires?
FDA deactivates the establishment and delists every associated NDC. Products become misbranded, domestic distribution is unlawful, and foreign shipments can be detained at the port until the establishment re-registers.
Where does StayListed get its data?
From DECRS — the FDA's public Drug Establishments Current Registration Site — which FDA rebuilds every business day. We download the whole file, compare it against the previous day, and email you when your establishment's record changes.
Do you need access to my FURLS or eDRLS account?
No. StayListed reads a public file. There is no account to connect, no credential to share, and nothing for us to submit on your behalf.
Does StayListed file my renewal for me?
No. You file your own renewal through FURLS/eDRLS, and FDA charges nothing for it. StayListed is monitoring only — it tells you what FDA's file currently says about your establishment.
Is StayListed regulatory advice?
No. StayListed is an informational monitoring tool. It is not a consultant, not a US Agent, and not legal or regulatory advice.
Check an establishment before you decide anything.
The lookup is free, needs no account, and runs against the same file the paid monitoring reads.
Check a registration