US Drug Facility Registration and Renewal Form

Get a range of solutions for US Drug Facility Registration and Renewal from a single source. We provide solutions for drug establishment registration and renewal, using the FDA’s Electronic Submissions Gateway (ESG). Contact us today to learn more.

US FDA Drug Establishment Registration

Drug Establishment Registration is mandatory for every drug manufacturing facility that intends on selling drug products in the USA. The activities that require facility registration are manufacturing, packaging, testing, and propagation of finished bulk drugs. This means that every establishment involved in manufacturing, propagation, testing, and packaging of finished and bulk drugs, including OTC and prescription drugs, must be registered with the FDA.

Drug Facility Registration Renewal

The FDA requires all domestic and foreign drug facilities to renew their registration every year. Facilities with no valid FDA registration risk refusal of imports of products by the FDA or the U.S. Customs and Border Protection (CBP). In addition, any foreign establishment is required to hold FDA registration. For this, they can appoint a US Agent for establishment registration or renewal purposes. The US Agent works as a point of contact for the FDA to communicate with the foreign facility. 

  • Drug Establishment site renewals are required every year (October 1 to December 31) 
  • Failure to renew in that time period may result in cancellation registration and the establishment will be removed from the FDA registration database
Drug Facility Registration Renewal
Drug Facility Registration

Information Required for Drug Facility Registration

The below information is required by the FDA to meet the Drug Facility Registration requirements.

  • Name of the company/facility/establishment
  • Address of manufacturing /Processing /Packaging /Testing facility
  • DUNS number for the establishment
  • Telephone, email and name of the contact person
  • US Agent information for foreign companies
  • Business operation information

Remember that Drug Facility Registration and FDA approval are two different aspects.

  • Registration is a mandatory requirement for manufacturing, testing, process, and packing facilities
  • FDA approval is required before a drug is imported into US

How We Help With Drug Facility Registration and Renewal

Our former FDA officials help in filing establishment registrations on behalf of your company and submitting them to the FDA through the electronic submissions gateway. If you are a non-US company, we can serve as a US Agent service provider. If required, we will be available to work as a US agent for your company.

Required for Drug Facility Registration

Frequently Asked Questions

The below information is required by the FDA to meet the Drug Facility Registration requirements.

  • Name of the company/facility/establishment
  • Address of manufacturing /Processing /Packaging /Testing facility
  • DUNS number for the establishment
  • Telephone, email, and name of the contact person
  • US Agent information for foreign companies
  • Business operation information

Remember that Drug Facility Registration and FDA approval are two different aspects.

  • Registration is a mandatory requirement for manufacturing, testing, process, and packing facilities
  • FDA approval is required before a drug is imported into US

Drug Establishment Registration or FDA registration is mandatory for every facility involved in the drug manufacturing process. The activities that require facility registration are manufacturing, packaging, testing, and propagation of finished bulk drugs.

This means that every establishment involved in manufacturing, propagation, testing, and packaging finished and bulk drugs, including OTC and prescription drugs must be registered with the FDA. The FDA drug establishment registration process may take 4 to 5 working days.

The FDA requires all domestic and foreign drug facilities to renew their registration every year. Facilities with no valid FDA registration risk refusal of imports of products by FDA or border patrol. In addition, any foreign establishment is required to file an establishment registration with the FDA. For this, they can appoint a US Agent for establishment registration or renewal purposes. The US Agent works as a point of contact for the FDA to communicate with regarding the foreign facility. 

  • Drug establishment registration renewals are required every year (between October 1 to December 31) 
  • Failure to renew in that time period may result in cancellation of the registration and the establishment will be removed from the FDA registration database.
Need Help for Drug Facility Registration and Renewal?

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest
0/5 (0 Reviews)
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.