FDA – Drugs
Establishment Registration + FEI (One Package)
Fee: $599 / year
Foreign establishments that ship drugs to the United States and drug establishments in the United States register with FDA. The registration is reviewed and updated each year between October 1 and December 31; changes such as closure or a change of address are reported within 30 days. A facility identifier is required in the registration. FDA has published a proposed rule that changes the registration requirements for foreign drug establishments (July 2026); if it is finalized, we will update this page.
Who Is Obligated?
Establishments that manufacture, repack or relabel drugs. Private label distributors that only distribute do not register. A foreign establishment designates a single US Agent physically located in the United States and provides the details of its US importers in the registration.
What We Do
- We assess your establishment’s registration obligation.
- We obtain the FEI number and file the registration on your behalf.
- We serve as your designated US Agent.
- We track the annual update period and change notifications.
What You Receive
- FEI number
- Establishment registration details
- Annual update reminder
FDA Drug Establishment Registration and FEI Application
Facility, activity, and product type details for the FDA registration of your drug establishment (initial registration or annual update) and its FEI number.
Frequently Asked Questions
- When is drug establishment registration updated?
- The registration is reviewed and updated each year between October 1 and December 31. Changes such as closure or a change of address are reported within 30 days.
- I only distribute. Do I need to register?
- Private label distributors that only distribute do not register. Establishments that manufacture, repack or relabel drugs do.
- Does the registration ask for details of my US importers?
- Yes. A foreign establishment provides the details of its US importers in the registration and designates a single US Agent physically located in the United States; in this package we are designated as your US Agent.
- What does my fee cover, and when is it renewed?
- Our fee is for the US Agent service and is renewed annually. Drug establishment registration is also renewed annually; we handle the annual update and the change notifications during the year as part of our US Agent service.
- Will the rules change?
- FDA has published a proposed rule that changes the registration requirements for foreign drug establishments (July 2026). If it is finalized, we will update this page.
Sources: 21 CFR 207.17; 21 CFR 207.25; 21 CFR 207.29; 21 CFR 207.69; Federal Register: Drug establishment registration proposed rule (13.07.2026).