Every drug establishment registered under section 510 of the FD&C Act has to review and update its registration between 1 October and 31 December — every single year. Not every other year. Not only when something changes.
This is set out in 21 CFR 207.29, which requires that the first review and update occur during the period beginning 1 October and ending 31 December of the year of initial registration, and annually in that same window thereafter.
“Nothing changed” is not a reason to skip it
This is where most lapses happen. The regulation gives registrants two ways to satisfy the requirement: report all changes that have occurred since the last review, or certify that no changes have occurred.
Both are active submissions. A year in which your address, ownership, contacts and operations were all completely static still requires you to log in and certify that fact. Doing nothing is not the same as certifying nothing changed, and FDA’s records cannot tell the difference between a registrant with no changes and a registrant who forgot.
Drug establishments are on a different cycle from food
It is worth being explicit about this, because firms holding both registrations get caught by it. Food facility registrations renew biennially, in even-numbered years. Drug establishment registrations renew annually. A company running a facility registered under both frameworks has to file every year for the drug registration, and in even years does both.
The submission is an SPL file
Drug establishment registration updates are submitted in Structured Product Labeling (SPL) format through FDA’s Electronic Submissions Gateway. This is the part that catches firms who handle their own filings: SPL is an XML standard, and a file that validates cleanly is a different thing from a file that contains the right information. Rejections at the gateway do not extend your deadline.
If you are submitting yourself, build in time for at least one rejected transmission. December is the busiest month of the year for the gateway and it is not the moment to discover a schema error.
Listings are a separate obligation
Registration and listing are frequently conflated. They are distinct requirements with distinct timing, and completing your annual registration review does not bring your drug listings up to date. If products have been discontinued, reformulated, relabelled or newly introduced since your last listing submission, those are separate filings.
What to do this month
- Confirm who holds your CDER Direct or ESG account credentials, and that the account is active
- Check whether anything has changed since your last review: establishment name, address, ownership, DUNS, business operations, contacts
- Confirm your U.S. Agent designation if you are a foreign establishment
- Review your listings independently of the registration renewal
- File in October or November, not in the last week of December
LMG prepares and submits drug establishment registrations, renewals and listings using our own SPL software. See FDA Drug Establishment Registration Renewal or contact our regulatory team.
Related: Drug Establishment Registration · FDA Drug Listing · NDC Labeler Code
Source: 21 CFR 207.29, Electronic Code of Federal Regulations.