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FDA DUNS Number Requirement for Drug Establishments & Labelers
The U.S. Food and Drug Administration (FDA) requires all drug establishments and drug labelers to obtain a DUNS Number as part of FDA Drug Establishment Registration and drug listing requirements.
This requirement applies to both domestic and foreign facilities involved in the manufacturing, repacking, relabeling, storing, or distribution of drug products intended for the U.S. market.
What Is a DUNS Number?
A DUNS Number (Data Universal Numbering System) is a 9-digit unique identifier issued by Dun & Bradstreet (D&B). It is used by the FDA to identify the physical location of a business facility.
Important points to note:
Each physical address requires its own DUNS Number
A DUNS Number does not replace your FDA Registration number
It helps the FDA verify that a facility handling drug products is legitimate and traceable
Why the FDA Requires a DUNS Number
The FDA uses DUNS Numbers to:
Confirm the identity and physical location of drug facilities
Improve supply chain transparency
Strengthen regulatory oversight and inspections
Enhance drug quality monitoring and security
Failure to obtain and properly list a DUNS Number may result in:
Cancellation of FDA Drug Establishment Registration
Delays in drug listing or approval processes
Increased regulatory risk or enforcement action
DUNS Number Assistance Services
FDA Registration Assistance provides professional support to help drug establishments and labelers obtain a DUNS Number efficiently and correctly.
Our services include:
DUNS Number application assistance
Verification of facility name and address
Coordination with FDA Drug Establishment Registration
Ongoing compliance guidance
If you would like FDA Registration Assistance to help you obtain a DUNS Number, please contact us today.
Frequently Asked Questions (FAQ)
Is a DUNS Number required for FDA Drug Establishment Registration?
Yes. All drug establishments and labelers must have a valid DUNS Number listed in their FDA registration.
Does the DUNS Number replace my FDA Registration Number?
No. The DUNS Number is separate and is used only to identify the facility’s physical location.
Who needs a DUNS Number?
Any facility that manufactures, repacks, relabels, stores, or handles drug products for the U.S. market.
Is a separate DUNS Number required for each location?
Yes. Each physical facility address must have its own DUNS Number.
What happens if I don’t obtain a DUNS Number?
Failure to obtain or list a DUNS Number may result in FDA Drug Establishment Registration cancellation or enforcement action.
Can FDA Registration Assistance handle the DUNS application for me?
Yes. FDA Registration Assistance manages the DUNS request process and ensures it aligns with FDA requirements.
Contact FDA Registration Assistance
Ensure your drug establishment remains compliant with FDA DUNS requirements.
