FDA drug establishment registration, renewal and DECRS search

FDA drug establishment registration

FDA drug establishment registration covers sites that manufacture, repack, relabel or salvage drugs for the US market, unless exempt (21 CFR 207.17). Domestic sites register no later than 5 calendar days after those operations begin, foreign sites before the drug is imported or offered for import, and all registrants renew annually between October 1 and December 31 (207.21; 207.29). Each registrant must also list its drugs with NDCs, and registration is not FDA approval.

Who must register

Part 207 covers human drugs, including drugs under a biologics license application, animal drugs and animal feed bearing or containing a new animal drug (21 CFR 207.17). A private label distributor that does not manufacture, repack, relabel or salvage does not register (21 CFR 207.17). 21 CFR 207.13 exempts other groups, with conditions:

• pharmacies, hospitals, clinics, other health care entities and public health agencies operating under local law that regularly dispense on valid prescriptions and only manufacture, repack, relabel or salvage in the regular course of dispensing or retail
• licensed practitioners who do this only for their own professional practice
• people making drugs only for research, teaching or chemical analysis, not for sale
• makers of harmless inactive ingredients, and carriers
• outsourcing facilities registered under section 503B

Deadlines and the annual renewal

For a domestic site, count those 5 calendar days from when you begin to manufacture, repack, relabel or salvage, not from commercial distribution (21 CFR 207.21; FDA's how-to page). Each year, between October 1 and December 31, you review and update all registration data. If nothing changed, you certify that. A first registration before October 1 is reviewed in that same window. Within 30 calendar days, report a closed or sold site, a new site name or address, or a change to the official contact or US agent. Only the registrant may name a new official contact or US agent (21 CFR 207.29).

A registration filed from October 1 to December 31 stays current through the end of the following year. One filed outside that window expires at the end of the current year. FDA's own example: filed October 1, 2025, current through December 31, 2026; filed September 30, 2025, current only through December 31, 2025 (FDA, DECRS). So a registration filed on September 30 expires that December 31 and must be filed again in the October to December window.

As of October 7, 2026, a July 13, 2026 proposal is not final. It would let a distributed manufacturing site register as one establishment, and would clarify that a foreign site must still register if another foreign site processes the drug before US import (Federal Register).

What a registration contains

21 CFR 207.25 lists the content: owner or operator details, the site's name, physical address and phone, all business names, any existing registration number, a Unique Facility Identifier, all types of operations and an official contact. Foreign sites add their US agent, each known US importer and each person who imports or offers the drug for import. FDA asks for the establishment's own DUNS number, "not one linked to the corporate headquarters" (FDA, how to register).

The US agent for a foreign site must live in the US or keep a place of business there, and be physically present. A mailbox or answering service does not qualify (21 CFR 207.69).

How to submit

All Part 207 information goes in electronically, in English (21 CFR 207.61). A waiver exists, but FDA grants it only if electronic filing is not reasonable, and asking for one does not excuse a late filing (21 CFR 207.65).

The format is Structured Product Labeling (SPL) XML. You can build files in FDA Direct, SPL Xforms or other software. Anything not sent through FDA Direct or Xforms goes through the Electronic Submissions Gateway Next Generation (ESG NextGen) (FDA, eDRLS instructions). There are three submission types: establishment registration, labeler code request and drug listing.

A FURLS login or FDA Industry Systems account is not the filing route. Use the SPL routes in FDA's eDRLS instructions.

If nothing changed, file a no change notification SPL. In FDA Direct, open the accepted registration, create a new version, set the document type to no change notification and submit. After an accepted submission, the firm appears on DECRS by the end of the next business day (FDA, how to register). The expiry year still depends on the filing window (FDA, DECRS).

FDA drug listing, labeler codes and NDCs

Each registrant lists every drug it manufactures, repacks, relabels or salvages for commercial distribution (21 CFR 207.41). Drugs in commercial distribution at initial registration must be listed no later than 3 calendar days after that registration (21 CFR 207.45). In June and December, update listings for new drugs, discontinuations (include the last lot's expiry), resumptions and material changes, or certify that nothing changed (21 CFR 207.57). Drugs not listed yet must be listed at annual registration.

Establishment renewal does not replace drug listing updates or no-change certification. FDA accepts one blanket no-change certification for listings per year, in the October 1 to December 31 window. FDA says it inactivates human drug listings each January if they were not certified during that window. Those listings drop out of the NDC Directory (FDA, how to list a drug).

Before your first listing you need a labeler code. It identifies the company marketing the drug. One code can cover all of a manufacturer's establishments, and a code with no listings may be deactivated after two years (FDA, labeler code). You can reserve an NDC up to two years before launch, but a reserved NDC is not a listed drug (FDA, reserve an NDC).

An NDC is 10 digits in three segments today. FDA keeps assigning 10-digit codes until March 7, 2033, when a final rule published March 5, 2026 switches to 12 digits (6-digit labeler, 4-digit product, 2-digit package). Labels may use the old format until March 6, 2036 (FDA, NDC format; Federal Register). The NDC Directory is updated daily, and inclusion is not verification or approval.

What "FDA registered" means

Registration or listing does not mean FDA approved the site or the drug, or that the drug may be legally marketed (21 CFR 207.77). It also does not mean FDA verified the information provided (FDA, DRLS and eDRLS). Implying official approval from registration, listing, an NDC, a registration number or a Unique Facility Identifier is misbranding (21 CFR 207.77).

How to search the FDA establishment registration database

For an FDA registered facility search, use the Drug Establishments Current Registration Site (DECRS) and search by firm name. FDA updates it each business day. Download files include an annual registration status zip, an "Excluded" zip, and FEI and DUNS numbers (FDA, DECRS).

A missing firm may never have registered, or the registration may have expired, been deregistered or been inactivated after a compliance case or enforcement action. DECRS also omits 503B outsourcing facilities unless registered for other operations, plus wholesale distributors and third-party logistics providers reporting licensure under DSCSA. Questions go to eDRLS@fda.hhs.gov (FDA, DECRS).

If you'd rather ask in plain English, RegAffairs AI has a cited answer on who registers, renewal, listing and searching DECRS.