US FDA Drug Establishment Registration and Drug Listing
FDA drug establishment registration is the legal requirement for every establishment that manufactures, repacks, relabels or salvages drugs for the United States to register with the Food and Drug Administration under 21 CFR Part 207. It is one of three linked submissions: the establishment registration, the NDC labeler code and the listing of each drug. Foreign manufacturers, including API producers, must complete registration before their drug is offered for import and must name a US Agent. This guide explains all three steps, the yearly renewal and what the FDA expects from manufacturers outside the USA.
Definition
What Is FDA Drug Establishment Registration?
FDA drug establishment registration tells the FDA which sites are involved in making drugs for the US market. It covers finished prescription and over-the-counter (OTC) drugs, active pharmaceutical ingredients (APIs), medicated products such as some sunscreens and antiseptics, and veterinary drugs.
The legal basis is section 510 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 207. All submissions are electronic, in Structured Product Labeling (SPL) format, and are sent through FDA Direct. Registered sites are published in the Drug Establishments Current Registration Site (DECRS).
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Three linked steps
How Do Registration, Labeler Code and Drug Listing Differ?
Many rejected submissions come from treating these three as one task. Each has its own SPL file and its own purpose.
| Submission | What it identifies | Key rule |
|---|---|---|
| Establishment registration | The physical site and its activities | Renewed every year; foreign sites name a US Agent and importers (FDA) |
| NDC labeler code | The company that markets the drug | Needed before the first listing; one code covers all of a company’s establishments (FDA) |
| Drug listing | Each drug: NDC, names, dosage form, ingredients, labeling and the establishments that make it | Updated when changes occur and certified every year (FDA) |
The National Drug Code (NDC) has three segments: the labeler code, the product code and the package code. The company proposes the product and package segments in its listing.
Scope
Who Must Complete FDA Drug Establishment Registration?
| Establishment | Register | List drugs |
|---|---|---|
| Finished dose manufacturer (prescription or OTC) | Yes | Yes |
| API manufacturer | Yes | Yes, as bulk ingredient listings |
| Contract manufacturer | Yes | Yes, for the drugs it makes |
| Repacker or relabeler | Yes | Yes |
| Contract testing laboratory that performs analysis for release | Yes | No |
| Private label distributor that does not manufacture | No | Listed under its own labeler code, usually by the manufacturer on its behalf |
| Wholesaler or pharmacy acting within normal practice | No | No |
The FDA asks that only establishments required to register do so. If a site makes a product that is a cosmetic or a medical device and not a drug, a different registration applies; see US FDA Registration Services for the comparison.
Outside the USA
How Do Foreign Drug Manufacturers Register with the FDA?
A domestic establishment registers within five days after it starts introducing drugs into commercial distribution. A foreign establishment has to finish registration before the drug is offered for import. Its registration must include the name and DUNS number of a US Agent and of every importer in the USA.
The US Agent under 21 CFR 207.69 must live or keep a place of business in the USA. The FDA uses the agent to reach the establishment, including when it schedules an inspection. I3CGLOBAL provides US FDA Agent Services for pharmaceutical establishments.
Indian pharmaceutical and API manufacturers
Formulation plants, API sites and contract manufacturers in India register each site separately with its own DUNS number. Sites that supply ANDA holders are named in those applications as well as in the registration.
Manufacturers elsewhere in Asia
OTC and private label producers usually list products under the labeler code of the US brand owner. Agree in writing who submits and certifies each listing.
Manufacturers in Europe
An EU GMP certificate or a Written Confirmation does not replace FDA registration and listing. The same sites must register and expect FDA inspection. The FDA also issues no registration certificate; our US FDA certificate guide explains what counts as proof of registration.
Process
How Does FDA Drug Establishment Registration Work?
- Confirm the product is a drugClaims decide the category. A product that treats or prevents disease is a drug even if it is sold as a cosmetic or supplement.
- Appoint a US AgentForeign establishments only.
- Find and check the DUNS numberEach site needs a DUNS number whose name and address match the registration exactly. The US Agent and importers also need DUNS numbers.
- Request an NDC labeler codeSubmit the labeler code request SPL. After the FDA assigns the code, send the updated SPL that carries the number; drugs cannot be listed before this.
- Submit the establishment registration SPLSite details, type of operation, US Agent and importers.
- List each drugSubmit one listing SPL per product with the proposed NDC, ingredients, labeling text and an image of the outer package.
- Renew and certify every yearBetween 1 October and 31 December.
Documentation
What Information Is Required for Registration and Listing?
| Information | Used in |
|---|---|
| Establishment name, address and DUNS number | Registration |
| Type of operation at the site, such as manufacture, API manufacture, pack, label, analysis | Registration |
| Contact person with email and telephone | Registration and labeler code |
| US Agent name and DUNS number | Registration (foreign sites) |
| Importer names and DUNS numbers | Registration (foreign sites) |
| Proposed NDC for each product and package | Listing |
| Proprietary and non-proprietary names, dosage form, route of administration | Listing |
| Active ingredients with strength; inactive ingredients | Listing |
| Current labeling text and an image of the principal display panel | Listing |
| Marketing category, for example ANDA number or OTC monograph | Listing |
Label content is checked against the listing. See FDA Labeling Requirements for drug label rules.
Maintenance
When Must Drug Registration and Listings Be Renewed?
Registration is renewed between 1 October and 31 December each year. A registration made or renewed in that period is valid until 31 December of the following year. In the same period every registrant must either update its listings or submit a blanket certification that no changes occurred.
| Event | What to do | When |
|---|---|---|
| Annual registration renewal | Resubmit the registration SPL | 1 October to 31 December |
| Annual listing certification | Update each listing or certify no change | 1 October to 31 December |
| Change to a listed drug | Update the listing | As soon as possible; at the latest the following June or December |
| Change to labeler contact or activity | Update the labeler code SPL | Within 30 days |
| New drug at a registered site | Submit a new listing | Before commercial distribution |
Listings that are not certified are inactivated by the FDA each January and removed from the NDC Directory. Service and US Agent fees are set out on our FDA drug establishment registration fee page.
Important distinction
Does FDA Drug Registration Mean the Drug Is Approved?
No. Under 21 CFR 207.77, registration of an establishment, listing of a drug or assignment of an NDC does not denote approval of the establishment or the drug, and saying otherwise is misleading.
A registered establishment record, a labeler code and active drug listings that appear in the NDC Directory.
For new drugs, an approved NDA or ANDA. For OTC drugs, conformity with the applicable monograph. For every site, current good manufacturing practice under 21 CFR Parts 210 and 211.
The different pre-market routes are explained in our FDA Approval Process guide, and Drug Master Files in US FDA DMF.
Work with I3CGLOBAL
How Does I3CGLOBAL Handle FDA Drug Registration and Listing?
I3CGLOBAL prepares and submits the complete set of FDA drug establishment registration and listing filings for foreign and US pharmaceutical and API manufacturers, and can act as the establishment’s US Agent. We confirm the product’s regulatory category, check the DUNS number, prepare the labeler code, registration and listing SPL files, and submit them electronically to the FDA. After acceptance we track the 1 October to 31 December renewal window and the June and December listing updates, so your registration and NDC listings stay active.
- Product classification check before any submission
- US Agent service for pharmaceutical and API establishments
- NDC labeler code request and SPL preparation
- Establishment registration and drug listing for each product
- Annual renewal, listing certification and updates
Start your drug establishment registration
Send us the site details, product list and current labels.
FAQs
FDA Drug Establishment Registration: Frequently Asked Questions
What is FDA drug establishment registration?
It is the registration with the US Food and Drug Administration of every establishment that manufactures, repacks, relabels or salvages drugs for commercial distribution in the United States. It is required by section 510 of the FD&C Act and 21 CFR Part 207 and is submitted electronically in Structured Product Labeling (SPL) format.
Is drug establishment registration the same as drug listing?
No. Registration identifies the establishment. Drug listing identifies each drug made there, with its National Drug Code, ingredients and labeling. A third step, the NDC labeler code request, comes before the first listing.
Do foreign drug and API manufacturers need to register with the FDA?
Yes. A foreign establishment must complete registration before its drug is offered for import into the USA, and the registration must name a US Agent and the US importers.
When must drug establishment registration be renewed?
Every year between 1 October and 31 December. During the same period each registrant must update its drug listings or certify that nothing has changed.
What is an NDC labeler code?
It is the first segment of the National Drug Code and identifies the company that markets the drug. The FDA assigns it on request, and one labeler code covers all establishments of the same company.
Does FDA registration mean a drug is FDA approved?
No. Registration, listing and assignment of an NDC do not denote approval of the establishment or the drug. New drugs still need an approved application, and OTC drugs must follow the applicable monograph.
Do API manufacturers have to list their products?
Yes. Establishments that make active pharmaceutical ingredients for drugs sold in the USA register and submit bulk ingredient listings.
What happens if drug listings are not certified?
Each January the FDA inactivates human drug listings that were not updated or certified during the 1 October to 31 December period and removes them from the NDC Directory.