FDA U.S. Agent for Foreign Drug Establishment Registration

When Drug Establishments Need a U.S. Agent (Plain Language)

If you're manufacturing drugs outside the U.S. and importing them here, you need a U.S. Agent. It's that simple. Here's when and why this requirement kicks in.

Foreign manufacturing is the main trigger. If you manufacture drugs outside the U.S. (maybe in India, China, Germany, wherever) and import them into the U.S., you must register your foreign establishment with FDA. Part of that registration is designating a U.S. Agent. This applies whether you're making prescription drugs, OTC drugs, or controlled substances. The location of your manufacturing facility determines the requirement, not the type of drug.

Repackaging and relabeling also require it. Even if you're not manufacturing the drug itself, if you're repackaging or relabeling drugs in a foreign facility for U.S. import, you need to register and designate a U.S. Agent. This catches companies that buy bulk drugs and repackage them for the U.S. market. FDA wants a U.S. contact point for these operations too.

Drug salvaging operations need agents too. If you're salvaging drugs (maybe recovering usable drugs from damaged shipments or expired products), and you're doing this outside the U.S., you need registration and a U.S. Agent. This is less common, but it's still covered by the regulation.

The regulation is 21 CFR 207.69. This is the drug equivalent of 21 CFR 807.40 (which applies to medical devices). The requirements are similar: physical U.S. address, availability during business hours, forwarding FDA communications. But the registration system is different (drugs use a different FDA system than devices), so make sure your agent understands drug registration processes.

FDA communications go through the agent. When FDA needs to reach you—whether it's a registration confirmation, renewal reminder, inspection notice, or regulatory correspondence—they send it to your U.S. Agent's address. The agent forwards it to you. This is the core function. Without a reliable agent, you'll miss FDA communications, which can cause compliance problems.

Inspection coordination is part of the role. FDA may contact your U.S. Agent to schedule inspections of your foreign facility. The agent helps coordinate dates, understands your time zone constraints, and ensures you're prepared. This is especially valuable if you're not familiar with FDA inspection processes. Some agents offer basic forwarding only, while others provide inspection coordination support (usually as an add-on service).

Important note: U.S. establishments don't need a U.S. Agent. Only foreign establishments (located outside the U.S.) must designate one. If your facility is in the U.S., you register directly without an agent. But if you're manufacturing abroad and importing, the agent requirement applies.

What the U.S. Agent Does in Practice (Communications)

For drug establishments, the U.S. Agent's job is straightforward but critical. Here's what actually happens day-to-day.

Receiving FDA communications is the core function. FDA sends all regulatory communications to your agent's address—registration confirmations, renewal reminders, inspection notices, deficiency letters, warning letters, you name it. The agent receives these (usually via postal mail, sometimes email) and forwards them to you. This sounds simple, but it's where many providers differ. Some forward within 24 hours, others might take 3-5 days. For urgent matters like recalls or inspection notices, that difference matters.

Forwarding speed varies significantly. The regulation doesn't specify how quickly agents must forward communications, so SLAs vary. Basic agents might guarantee 48-hour forwarding, premium ones offer same-day or even same-hour for urgent matters. We've seen drug companies miss deadlines because their agent was slow to forward FDA communications. Always get forwarding time commitments in writing.

Receipt code confirmation is mandatory. When you designate or change a U.S. Agent, FDA sends a notification receipt code to the agent's email. The agent must confirm receipt of this code to complete your registration. This sounds simple, but we've seen agents miss these emails (maybe they went to spam, or the agent doesn't check email regularly), which delays registration. Make sure your agent understands this is a critical step.

Inspection notices require fast forwarding. When FDA schedules an inspection of your foreign facility, they send the notice to your U.S. Agent. The agent forwards it to you, and ideally helps coordinate dates and logistics. This is where good agents earn their keep—they understand FDA inspection processes, help coordinate scheduling, and may even provide preparation guidance. Basic agents just forward the notice and say "good luck."

Regulatory correspondence can be complex. FDA sends various types of regulatory correspondence—maybe deficiency letters about your registration, warning letters about compliance issues, or requests for additional information. Your agent forwards these, but good agents can help you understand what they mean and how to respond. This isn't required (basic forwarding is enough), but it's valuable if you don't have internal regulatory staff.

Additional support is usually optional. Some providers offer inspection coordination, regulatory consulting, or document preparation assistance as add-on services. These cost extra (typically $300-1,000/year more), but they can be worth it if you need the help. Basic U.S. Agent service is just communication forwarding and receipt code confirmation. Everything else is optional.