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Renewal invoices: what's real and what isn't

Every autumn, registered drug establishments receive mail about their annual registration renewal. Some of it is from legitimate service providers. Some of it is designed to be mistaken for a bill from FDA. Telling them apart is easier than it looks, because one fact settles most cases.

FDA does not charge for drug establishment registration

Registration and annual renewal under section 510 of the FD&C Act are filed through FURLS/eDRLS at no cost. There is no filing fee, no renewal fee, and no late fee. If an invoice arrives for your registration renewal, it is not from FDA.

That does not automatically make the sender fraudulent — plenty of consultants legitimately charge for doing the filing on your behalf, and US Agent services are a real and necessary expense for foreign establishments. The problem is the mail that is written to look like the government asking for money.

What the lookalikes have in common

  • It is formatted as an invoice or a notice, not an offer. A due date, an amount, a remittance address, and no clear statement that you are being sold a service.
  • Official-adjacent naming. Company names and logos built from words like "US", "Federal", "Drug Registration", or "Compliance Office", sometimes with a seal-like mark.
  • Your real registration details are quoted back to you. Your firm name, address, and FEI number are in a public file that anyone can download, so seeing your own correct details proves nothing at all about who sent the letter.
  • A deadline pressed harder than the statute does. The real deadline is December 31, it is the same for every establishment in the country, and it does not move.
  • Fine print that contradicts the front page. Lookalike notices frequently carry a disclaimer somewhere saying they are not affiliated with FDA — which is often the fastest thing to look for.

How to check without paying anyone

Your establishment's registration status is public. FDA rebuilds the Drug Establishments Current Registration Site file every business day, and it lists every registered establishment with its current expiration date.

You can look your own establishment up here in a few seconds — no account, no payment — or download the file directly from FDA and search it yourself. If your record is there with the expected expiration date, nothing is wrong, whatever the letter says.

If you have already paid one

Paying a lookalike invoice does not affect your registration either way — the registration is filed through FURLS, not bought. Report the solicitation to the FTC and to FDA, and check your record to confirm nobody has filed anything under your establishment.

Where StayListed sits, plainly

We are a monitoring service, and we should be held to the same test as anything else in your mail:

  • We never ask for your FURLS or eDRLS login. There is nothing to connect.
  • We do not file your renewal and we are not your US Agent.
  • We do not invoice you for your FDA registration. If you pay us, you are paying for a daily comparison of FDA's public file against yesterday's copy — nothing else.
  • The lookup is free and needs no account, so you can verify what we say about your establishment before deciding whether we are worth anything to you.

If a message claiming to be from us ever asks for credentials or a registration fee, it is not from us.