What is US FDA Drug Establishment Registration?
The Food and Drug Administration is responsible for ensuring that prescription drugs marketed in the United States are safe and effective.
All drug manufacturers must complete the FDA Drug Establishment Registration to be marketed in the USA. This registration is required for generic, prescription, and non-prescription drugs that are manufactured domestically or from abroad.
Who Should Register With the FDA?
The drug manufacturers of:
- OTC drugs
- Homeopathic drugs
- Prescription drugs
- Animal drugs
- Biological products, including blood and plasma derivatives
- Veterinary Feed Directive (VFD) drugs
- Sterilization facilities
- Distributors, wholesalers, importers
- Contract manufacturers of drug substances or finished drugs for the above-listed products
- New or pioneer drugs
Your facility must be registered with the FDA if it is engaged in manufacturing, preparing, propagating, compounding, or processing a drug product. Even the manufacturer of a finished dosage form that does not itself have an approved application for sale cannot sell a product without registration.
How to Register With the FDA
The registration of a facility is separate from the filing of an application for a drug product. IAS helps to complete and submit an application for registration while your establishment is still under construction or immediately after it begins operations, provided the facility manufactures one or more drugs.
Once the registration has been completed, your establishment is assigned a facility code. This number is used by the FDA in product listing and other communications involving your facility, and on drug labeling and documents that identify the establishment.
IAS helps organizations successfully complete the online registration and related activities for facility registration, NDC request, SPL preparation, drug listing, annual renewal, submitting updates, and more.
Registration & FDA Inspections
Drug establishment registration is an electronic self-submission. Upon registration, the FDA assigns a Facility Establishment Identifier (FEI). The FDA does not inspect your facility before registration is granted — FDA inspections are risk-based and take place separately, not as a precondition for registration.
When the FDA does conduct a risk-based inspection, the factors considered include housing; equipment support; construction materials used in the building and process areas; quality of water, air, and waste systems; production procedures and controls; hazardous waste disposal; security measures to prevent tampering with the product; and employee qualifications/training.
National Drug Code (NDC)
The proprietary NDC code is assigned to each company that registers a drug product with the FDA. The code identifies the manufacturer of a drug as well as the product, and it must be placed on all labeling for prescription or human-use products in order for the medication to be dispensed by a pharmacist. This is called the NDC labeler code and it appears on all non-prescription (OTC) drugs.
Once you have successfully completed the US FDA drug registration process with IAS, you will receive a facility/manufacturer code from the FDA. This number is the unique designation that identifies your company and its product(s) to the agency.
What the NDC Consists Of
The NDC consists of a three-segment number: a labeler segment that identifies the facility, a product segment that identifies the drug, and a package segment that identifies the package size.
Step-by-Step FDA Drug Registration Process
Submit Application
An authorized official of the facility completes the registration application and submits it along with payment to IAS, who initiates and hand-holds you through the entire US FDA drug registration process.
ID Number Assigned
The FDA assigns an ID number for your company, which you will use on all future correspondence with them.
Application Review
Upon verification of your information, our team reviews the application for completeness.
Registration Completed
Drug establishment registration is an electronic self-submission; once submitted, your registration is on file with the FDA and a Facility Establishment Identifier (FEI) is assigned. The FDA does not inspect before registration is granted — any FDA inspections are risk-based and occur separately, not as a precondition.
Registration Documents
IAS works with you and provides a list of required documents, including an electronic copy of your FDA registration.
Annual Renewal
We help you prepare the annual renewal, a simple process that takes less than 10 minutes to complete.
Updates & Ongoing Support
If any changes or updates are required by the FDA before renewal, our team provides support at every stage, updating information as required and ensuring timely submission to the FDA.
