Drug Establishment Registration

Drug Establishment Registration

Fee: $449 / Per Year
(Includes U.S Agent Fee)

Foreign and Domestic establishments that manufacture, repack, or re-label drug products for consumption/use in the United States are required to register with the Food and Drug Administration.

FDA relies on establishment registration and drug listing information for several key programs, including:

  • Drug establishment inspections
  • Post market surveillance
  • Counterterrorism
  • Recalls
  • Drug quality reports
  • Adverse event reports
  • Monitoring of drug shortages and availability
  • Supply chain security
  • Drug import and export
  • Identification of products that are marketed without an approved application

All facilities are also required to list every drug product that they plan to commercially distribute and market in the United States.

To have “FDA Registration Assistance” prepare your Drug Establishment Registration please CONTACT US.


Source: FDA

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