FDA Drug U.S. Agent
Services
Foreign drug establishments that are required to register with FDA must designate a single U.S. Agent. Under 21 CFR 207.69, the U.S. Agent serves as the U.S.-based regulatory contact for FDA communications, questions about imported drugs, inspection scheduling, and certain documents when FDA cannot reach the foreign registrant promptly.
What Is an FDA Drug U.S. Agent?
Under 21 CFR 207.69, a foreign establishment subject to FDA drug establishment registration must designate a single U.S. Agent. The agent must reside or maintain a place of business in the United States and cannot be only a mailbox, answering service, or location where no agent is physically present.
The U.S. Agent reviews, routes, and responds to FDA communications—including emergency communications; responds to questions about drugs imported or offered for import; assists FDA in scheduling inspections; and may receive FDA information or documents when FDA cannot contact the foreign registrant directly or quickly.
- One designated U.S. Agent for each foreign establishment subject to 21 CFR Part 207
- U.S.-based physical presence required for the designated agent
- FDA communications and emergency communications routed through the agent
- Questions about imported or offered-for-import drugs handled through the agent
- FDA inspection scheduling assistance included in the regulatory role
Important: A Drug U.S. Agent is not the importer of record, customs broker, distributor, or an FDA approval. It is a regulatory contact role for a foreign drug establishment.
Core Drug U.S. Agent Responsibilities Under 21 CFR 207.69
Our annual service is built around the four U.S. Agent functions defined in the regulation, with practical support for maintaining the designation as part of your foreign establishment registration.
FDA Communications
Review, disseminate, route, and respond to FDA communications for the foreign establishment, including emergency communications.
Questions About Imported Drugs
Respond to FDA questions concerning drugs that are imported or offered for import into the United States from the foreign establishment.
Inspection Scheduling
Assist FDA in scheduling inspections of the foreign establishment and coordinate communication around scheduling and logistics.
Document Receipt & Annual Support
Receive FDA information or documents when FDA cannot contact the foreign registrant directly or expeditiously, and support annual registration coordination so the U.S. Agent information remains current.
Drug U.S. Agent Requirements at a Glance
The essential regulatory facts foreign drug establishments need to know before designating a U.S. Agent.
How Our FDA Drug U.S. Agent Service Works
A straightforward four-step process to establish and maintain annual U.S. Agent representation for your foreign drug establishment.
Submit Establishment Details
Provide the foreign establishment’s legal name, physical address, DUNS information, current FDA registration details if available, and primary contact information.
Designation Prepared
We prepare the U.S. Agent information for the establishment registration and coordinate the designation of FDA Registration Assistance as the single U.S. Agent.
FDA Communications Managed
During the service term, FDA communications received in the U.S. Agent role are reviewed, routed, and coordinated with your designated company contact.
Annual Representation Renewed
Your U.S. Agent service renews annually. We also support registration-renewal coordination during FDA’s October 1–December 31 annual establishment renewal period.
Complete the Foreign Drug Registration Process
These services are the most common companion filings for foreign drug establishments using annual U.S. Agent representation.
Drug Establishment Registration
Register or renew the foreign drug establishment with FDA and maintain the U.S. Agent and importer information required in the registration.
Labeler Code Registration
Request the FDA Labeler Code used as part of NDC construction before initial drug product listing.
NDC Code / Product Code
Prepare FDA drug listing information, including the proposed NDC and manufacturing establishment details.
DUNS Request Assistance
Obtain or verify the DUNS information used for the foreign establishment and other drug registration/listing data.
Frequently Asked Questions — FDA Drug U.S. Agent Services
Direct answers about the single-agent requirement, annual service, FDA communications, inspections, registration, and the U.S. Agent's legal role.
What is an FDA Drug U.S. Agent?
A Drug U.S. Agent is the single U.S.-based agent designated by a foreign drug establishment that is subject to 21 CFR Part 207. The agent serves as an FDA regulatory contact for communications, questions about imported drugs, inspection scheduling, and certain documents when FDA cannot reach the foreign registrant directly or expeditiously.
Who is required to designate a U.S. Agent?
A foreign drug establishment that is subject to FDA drug establishment registration under 21 CFR Part 207 must designate a single U.S. Agent. FDA’s current drug registration instructions also state that foreign establishments include the name and DUNS of the U.S. Agent in the establishment registration.
Can a foreign drug establishment have more than one U.S. Agent?
For drug establishment registration under 21 CFR 207.69, the foreign establishment must designate a single U.S. Agent. A company may use other consultants, importers, brokers, or commercial representatives for other purposes, but the FDA registration identifies one U.S. Agent for the establishment.
Where must the Drug U.S. Agent be located?
The U.S. Agent must reside or maintain a place of business in the United States. The regulation does not allow the designated agent to be only a mailbox, answering machine or service, or another place where a person acting as the U.S. Agent is not physically present.
What are the U.S. Agent's regulatory responsibilities?
The four core responsibilities in 21 CFR 207.69 are: reviewing, routing and responding to FDA communications including emergency communications; responding to questions about drugs imported or offered for import; assisting FDA in scheduling inspections; and receiving information or documents when FDA cannot contact the foreign registrant directly or expeditiously.
Does a Drug U.S. Agent replace the importer of record?
No. The Drug U.S. Agent is a regulatory contact for the foreign establishment. The importer of record, customs broker, distributor, and other supply-chain parties have separate commercial or customs roles.
Can FDA contact the foreign establishment directly?
Yes. FDA can communicate directly with the foreign registrant. If FDA is unable to contact the foreign registrant directly or expeditiously, the regulation allows FDA to provide information or documents to the U.S. Agent, and that is treated as equivalent to providing them to the foreign registrant.
How is a Drug U.S. Agent designated?
The U.S. Agent information is included in the foreign drug establishment's FDA registration. We collect the establishment data, prepare the U.S. Agent information, and coordinate the registration or update so FDA Registration Assistance is identified as the designated U.S. Agent.
How much does FDA Drug U.S. Agent service cost?
FDA Registration Assistance charges $849 USD per year for professional Drug U.S. Agent service. The annual fee covers the U.S. Agent representation, FDA communication handling within the regulatory role, inspection-scheduling support, and annual service continuity.
Is the $849 fee an FDA government fee?
No. The $849 annual amount is FDA Registration Assistance's professional U.S. Agent service fee. It should not be described as an FDA approval fee or as a government fee for appointing a U.S. Agent.
Can I change my Drug U.S. Agent?
Yes. A foreign establishment can change its designated U.S. Agent by updating the relevant establishment registration information. We can help coordinate the transition and update the registration data.
What happens if a foreign drug establishment does not designate a U.S. Agent?
A foreign establishment subject to 21 CFR Part 207 would not be meeting the U.S. Agent requirement in its registration. Because foreign establishments must register before their drugs are offered for import, incomplete or noncurrent registration information can create registration and import-compliance problems.
Is a U.S. Agent the same as an official contact?
No. 21 CFR 207.69 separately describes the official contact and the U.S. Agent. The official contact is responsible for registration/listing accuracy and FDA communications for the establishment, while a foreign registrant must also designate the single U.S. Agent with the specific duties assigned in the regulation.
What is the U.S. Agent's role during an FDA inspection?
The U.S. Agent assists FDA in scheduling inspections. Our service can coordinate communications and scheduling logistics, but the foreign establishment remains responsible for its own inspection readiness, records, operations, and regulatory compliance.
How often is Drug U.S. Agent service renewed?
Our Drug U.S. Agent service renews every year. Separately, FDA drug establishment registration must be renewed annually between October 1 and December 31, and the current U.S. Agent information should remain accurate in that registration.
Can FDA Registration Assistance serve as U.S. Agent for multiple foreign facilities?
Yes. We can provide annual U.S. Agent service for multiple foreign drug establishments. Each foreign establishment's FDA registration still identifies its own designated single U.S. Agent, so the facilities are handled as separate registration records.
Appoint FDA Registration Assistance as Your Drug U.S. Agent
Send your foreign establishment details and we’ll review the registration status, U.S. Agent information, and next steps for annual representation. Our professional Drug U.S. Agent service is $849 per year.
Thank You for Reaching Out!
We received your inquiry and will review the establishment details. For immediate assistance, call 928-275-8333.