US Agent for FDA Drug Establishment Registration

Who Needs Drug Establishment Registration?

• Manufacturers of finished drugs, including OTC monograph drugs
• Active pharmaceutical ingredient (API) manufacturers
• Homeopathic medicine manufacturers
• Contract manufacturers, repackers and relabelers
• Testing laboratories that test drugs for the US market
• Makers of medicated creams, lotions and other topical products regulated as drugs in the US

Registration and Drug Listing Requirements

Drug establishment registration and drug listing are submitted electronically to FDA in Structured Product Labeling (SPL) format. A typical submission includes:

• Establishment name, address and DUNS number
• Business operations performed at the facility
• Official contact and US Agent details (foreign establishments)
• Labeler code and National Drug Code (NDC) for each listed product
• Product labels and ingredient information for drug listing

Some facilities also owe FDA user fees, for example under the OTC monograph (OMUFA) or generic drug (GDUFA) programs. FDA – How to register a drug establishment

Annual Renewal and Listing Updates

Drug establishment registration must be renewed every year between October 1 and December 31. Drug listings must be reviewed and updated at least each June and December, and changes such as new products or discontinued products must be reported. If a registration is not renewed, it can expire and products may be refused at the US border.

US Agent for Drug Establishment Registration

Under 21 CFR 207.69, every foreign drug establishment must name a US Agent who lives in, or keeps a place of business in, the United States. FDA contacts the US Agent to confirm the appointment and may send communications through the agent. MedDeviceCorp acts as your US FDA Agent for drug establishment registration.

Our Drug Establishment Registration Process

1. Assessment – we confirm your product type, business operations and fees that apply.
2. DUNS and labeler code – we check your DUNS number and request an NDC labeler code if needed.
3. SPL preparation – we prepare your registration and listing SPL files.
4. Submission – we submit the files through FDA's electronic gateway.
5. US Agent confirmation – we confirm our appointment as your US Agent.
6. Annual support – renewal each year and listing updates every June and December.

OTC Monograph Drugs and User Fees

Many foreign manufacturers export OTC monograph drugs such as antiseptics, sunscreens, antacids and pain relievers. These products do not need a pre-approved application if they meet the applicable monograph, but the facility must still complete drug establishment registration and list each product. Facilities that make OTC monograph drugs may also have to pay an annual OTC monograph drug facility fee (OMUFA). Generic drug and API facilities may owe a generic drug facility fee (GDUFA). Unpaid fees can lead FDA to refuse products at the border.

Common Errors in Drug Registration and Listing

• DUNS address mismatch – the establishment address in the SPL must match the DUNS record.
• Incorrect business operations – for example listing a facility as a manufacturer when it only packs or tests.
• Missing labeler code or NDC errors – each listed product needs a valid NDC built on your labeler code.
• US Agent not confirmed – FDA contacts the US Agent, and an unconfirmed agent delays the registration.
• Listings not updated – discontinued or changed products not reported in the June and December update cycles.

After Registration: cGMP and FDA Inspections

Registered drug establishments must follow current good manufacturing practice (cGMP) under 21 CFR Parts 210 and 211, and FDA can inspect foreign drug facilities. Labels must meet US requirements, including the Drug Facts label for OTC products. A registration that is accurate and current makes it easier for FDA and your importer to clear shipments. FDA – How to register a drug establishment

How Long Does Drug Establishment Registration Take?

The time needed depends mostly on how quickly the supporting details are ready. A typical project runs in four stages:

• DUNS number – if your facility does not have one, obtaining or correcting it is often the longest step.
• Labeler code – a new labeler code request is reviewed by FDA before products can be listed.
• SPL preparation – registration and listing files are prepared and validated before submission.
• FDA processing and US Agent confirmation – FDA processes the submission and contacts your US Agent to confirm.

When the DUNS record and labeler code are already in place, registration and listing usually move quickly. We give you a clear timeline after reviewing your products and documents, so you can plan your first shipment.

Why Choose MedDeviceCorp for Drug Establishment Registration?

At MedDeviceCorp, one team of regulatory specialists prepares your drug establishment registration and drug listing, acts as your US FDA Agent and tracks every renewal date, so you are not juggling separate providers.

• Registration prepared and checked by regulatory specialists, not a form-filling service
• US Agent confirmation handled promptly when FDA sends the request
• Renewal reminders well before each FDA window opens
• Support with related FDA, EU Representative and UK Responsible Person requirements

Drug Establishment Registration FAQs

Related services: FDA Registration · US FDA Agent · Food Facility Registration · Cosmetic Facility Registration · Medical Device Establishment Registration