Who needs to register a drug establishment with FDA?

Companies and facilities that manufacture, prepare, propagate, compound, process, package, or label drug products for the United States may be required to register, depending on their role and product type.

Is Drug Establishment Registration the same as drug product listing?

They are related but different. Establishment registration identifies the facility, while drug product listing provides FDA details about the drug products and associated establishments. Many businesses need to complete both.

How often does FDA Drug Establishment Registration need to be renewed?

FDA Drug Establishment Registration generally requires periodic renewal/updates according to FDA requirements. Businesses should keep registration information current to avoid compliance issues.

Can a foreign drug manufacturer register directly with FDA?

Foreign establishments may register with FDA, but they must ensure all required fields are completed correctly and maintain accurate U.S. contact details where applicable. Many foreign firms use a compliance consultant to reduce errors and delays.

Drug Establishment Registration | FDA Registration Assistance

Q: What is FDA Drug Establishment Registration?

FDA Drug Establishment Registration is a required listing for certain facilities involved in manufacturing, processing, packing, or holding drug products for the U.S. market. Registration helps FDA identify facilities and support oversight activities.

Fee: $449 / Per Year
(Includes U.S Agent Fee)

FDA Drug Establishment Registration & Drug Listing Services

Foreign and domestic establishments that manufacture, repack, or relabel drug products intended for commercial distribution or use in the United States are required to register with the U.S. Food and Drug Administration (FDA).

In addition to establishment registration, facilities must list every drug product they intend to market or distribute in the U.S. Failure to properly register and list products may result in regulatory enforcement action or market access restrictions.

Why FDA Drug Establishment Registration Matters

The FDA relies on drug establishment registration and drug listing information to support several critical regulatory and public health programs, including:

Drug establishment inspections
Post-market surveillance
Counterterrorism and supply chain security
Drug recalls and quality reporting
Adverse event monitoring
Monitoring drug shortages and availability
Oversight of drug import and export activities
Identification of drugs marketed without an approved application

Accurate and up-to-date registration and listing information is essential for maintaining compliance and ensuring uninterrupted market access.

FDA Drug Listing Requirements

All registered drug establishments must submit drug listings for each product they plan to commercially distribute in the United States. Drug listings must include accurate product, labeling, and manufacturing information and must be updated as required by FDA regulations.

Drug Establishment Registration Services

FDA Registration Assistance provides professional support to help drug manufacturers, repackers, and relabelers comply with FDA Drug Establishment Registration and Drug Listing requirements.

Our services include: