FDA – Drugs
DUNS Number Assistance
Fee: $99
Drug establishment registration requires a unique facility identifier (UFI). FDA’s preferred UFI is the DUNS number issued by Dun & Bradstreet; DUNS numbers are issued to drug establishments free of charge.
Who Is Obligated?
Domestic and foreign drug establishments that will register with FDA.
What We Do
- We check your establishment’s existing DUNS record and whether its details match the FDA registration.
- If there is no DUNS number, we prepare and follow up on the application.
- We update the record when your address or company name changes.
What You Receive
- DUNS number
- Summary of the registered company information
DUNS Number Application
Company details required by Dun & Bradstreet so that we can obtain the DUNS number needed for FDA registrations on your company's behalf.
Frequently Asked Questions
- Why is a DUNS number required for drug establishment registration?
- The registration must include a unique facility identifier (UFI), and FDA’s preferred UFI is the DUNS number.
- Is there a charge for a DUNS number?
- Dun & Bradstreet issues DUNS numbers to drug establishments free of charge. Our fee is for preparing and following up on the application.
- If my address changes, does the DUNS record need updating too?
- Yes, the DUNS details must match the information in the FDA registration. We make the update when your address or company name changes.
Sources: 21 CFR 207.25; FDA Guidance: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.