21 CFR 207.69 U.S. Agent (Drug Registration)

Plain-English Summary of 21 CFR 207.69

If you're reading 21 CFR 207.69, you're probably trying to figure out what FDA requires for drug establishment U.S. Agents. Here's the plain-English version.

Who needs one: Foreign drug establishments—manufacturers, repackers, relabelers, or salvagers located outside the U.S. If you're making drugs abroad and importing them here, you need a U.S. Agent. U.S. establishments don't need one; only foreign ones.

Who can serve: Anyone who lives or has a business in the U.S., with a physical address (not a PO box). It can be an individual person or a business entity. Many companies use regulatory service providers, but you could use an employee, importer, or consultant—as long as they meet the requirements.

Address requirement is strict. The agent must have a physical U.S. address where FDA can send mail. PO boxes are explicitly not acceptable. Virtual mailboxes usually don't work either, because FDA needs someone who can actually receive mail during business hours. This trips up a lot of companies who try to use cheap mailbox services.

Availability matters. The agent must be available during U.S. business hours to receive FDA communications. This isn't just about having an address—someone needs to be there (or checking mail regularly) to ensure nothing sits unopened. If your agent only checks email once a week, that's not enough.

Primary function is communication forwarding. The agent receives FDA communications and forwards them to you. This includes registration confirmations, renewal reminders, inspection notices, regulatory correspondence—basically everything FDA sends related to your establishment. The regulation doesn't specify how quickly they must forward (that's where SLAs come in), but they must forward them.

Receipt code confirmation is mandatory. When FDA sends a notification receipt code (after you designate or change an agent), the agent must confirm receipt. Without this confirmation, your registration isn't complete. This sounds simple, but we've seen agents miss these emails, which delays registration.

One agent per establishment, but same agent can serve multiple. Each foreign establishment must designate one U.S. Agent. You can't have multiple agents for the same establishment. But the same person or company can serve as agent for multiple establishments—they just need to be designated separately in each registration. Many providers offer multi-site discounts for this.

You can change agents anytime. There's no lock-in period. If your agent becomes unresponsive or you find a better option, you can switch. But you must notify FDA within 30 days of the change per 21 CFR 207.69(d). The switching process takes 2-3 business days typically.

Full Text of 21 CFR 207.69

§ 207.69 U.S. Agent for foreign establishments.

(a) A foreign establishment required to register under § 207.40 must designate a 
single U.S. agent.

(b) The U.S. agent must reside or maintain a place of business in the United States.

(c) The U.S. agent is responsible for assisting FDA in communications with the 
foreign establishment, responding to questions concerning the foreign establishment's 
drugs that are imported or offered for import into the United States, and assisting 
FDA in scheduling inspections of the foreign establishment. If the agency is unable 
to contact the foreign establishment directly or expeditiously, FDA may provide 
information or documents to the U.S. agent, and such an action shall be considered 
equivalent to providing the same information or documents to the foreign establishment.

(d) The foreign establishment or the U.S. agent must report changes in the U.S. 
agent's name, address, or other contact information to FDA within 30 calendar days 
of the change.

What is Required vs. Optional (Table)

Requirement	Required	Optional
Physical U.S. Address	Yes — Must have physical address (not PO box)	No — PO boxes are not acceptable
Business Hours Availability	Yes — Must be available during U.S. business hours	24/7 availability is optional (premium service)
Receipt Code Confirmation	Yes — Must confirm receipt codes	No — This is mandatory
Communication Forwarding	Yes — Must forward FDA communications	Forwarding speed varies (same-day, 24-hour, 48-hour)
Inspection Support	No — Basic forwarding is sufficient	Yes — Inspection coordination is optional add-on
Regulatory Consulting	No — Not required by 21 CFR 207.69	Yes — Available as add-on service
Written Contract	No — Not required by regulation	Yes — Highly recommended for clarity and SLA
Response Time SLA	No — Not specified in regulation	Yes — Recommended to get in writing

The "One U.S. Agent" Rule

21 CFR 207.69(a) requires each foreign drug establishment to designate a single U.S. Agent. Here's what this means:

ruleOne Agent Per Establishment: Each foreign drug establishment must designate one U.S. Agent. You cannot designate multiple agents for the same establishment.
businessSame Agent for Multiple Establishments: The same person or entity can serve as U.S. Agent for multiple establishments, provided each establishment designates them separately in their registration.
swap_horizCan Change Agents: You can change your U.S. Agent at any time, but you must notify FDA within 30 days of the change per 21 CFR 207.69(d).
warningPractical Implications: If your agent is unresponsive or unreliable, you're stuck until you switch. Choose carefully.

Compliance Checklist You Can Copy

Use this checklist to ensure your U.S. Agent meets 21 CFR 207.69 requirements:

check_circlePhysical U.S. Address: Agent has a physical U.S. address (not a PO box or virtual mailbox)
check_circleBusiness Hours Availability: Agent is available during U.S. business hours to receive FDA communications
check_circleReceipt Code Confirmation: Agent will confirm receipt codes when FDA sends notifications
check_circleCommunication Forwarding: Agent will forward FDA communications to you promptly
check_circleWritten SLA: Agent provides written Service Level Agreement for forwarding time
check_circleChange Notification: Agent understands they must notify FDA within 30 days if contact information changes
check_circleWritten Contract: You have a written contract specifying services, SLA, and terms
check_circleReliability: Agent has backup systems or redundancy to ensure communications aren't missed

Choosing a Compliant Agent (SLA + Escalation)

When selecting a U.S. Agent under 21 CFR 207.69, prioritize these factors:

scheduleResponse Time SLA: Get a written SLA for forwarding time (same-day, 24-hour, or 48-hour). This isn't required by regulation but is critical for compliance.
escalator_warningEscalation Procedures: What happens if the agent misses the SLA? Do they have backup systems? Redundancy?
location_onAddress Compliance: Verify the agent has a physical U.S. address (not a PO box). Ask for the address and verify it's staffed.
groupsTeam vs. Solo: Team operations offer better redundancy than solo consultants. If solo, ask about backup systems.
phoneCommunication Channels: Email forwarding is standard, but phone/SMS support for urgent matters is valuable.
descriptionWritten Contract: Get everything in writing: SLA, services, terms, cancellation policy.
support_agentInspection Support: While not required, inspection coordination support can be valuable for foreign establishments.

Sources: FDA + CFR Links

We are a comparison platform; providers respond directly. All information on this page is based on official FDA regulations and guidance documents.

Frequently Asked Questions

What does 21 CFR 207.69 require for U.S. Agents?

21 CFR 207.69 requires foreign drug establishments to designate a U.S. Agent who resides or maintains a place of business in the U.S. The U.S. Agent must have a physical U.S. address (not a PO box) and be available during business hours to receive FDA communications. The agent must also confirm receipt codes when FDA sends notifications.

Does 21 CFR 207.69 have a 'one U.S. Agent' rule like device registration?

Yes, 21 CFR 207.69 requires each foreign drug establishment to designate one U.S. Agent. However, the same person or entity can serve as U.S. Agent for multiple establishments, provided each establishment designates them separately in their registration.

Who can serve as a U.S. Agent under 21 CFR 207.69?

Anyone who resides or maintains a place of business in the U.S. can serve as a U.S. Agent, provided they have a physical U.S. address (not a PO box) and are available during business hours. This can be an individual, a company, a regulatory service provider, or even an internal employee if the foreign establishment has a U.S. presence.

What happens if my U.S. Agent is unresponsive under 21 CFR 207.69?

If your U.S. Agent is unresponsive, FDA communications may be missed, causing registration delays or compliance issues. You can change your U.S. Agent at any time through the FDA registration system. However, switching agents during active registration or inspections can cause delays, so choose a reliable agent from the start.

Can I switch U.S. Agents under 21 CFR 207.69?

Yes, you can change your U.S. Agent at any time through the FDA registration system. The process involves designating a new agent and ensuring they receive the notification receipt code. However, switching during active registration, inspections, or regulatory reviews can cause delays, so plan transitions carefully.

Related Resources

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21 CFR 207.69 U.S. Agent (Plain English)