US Drug Facility Registration and Renewal Form

Drug Establishment Registration can be a complex and involved process. To ensure that your business is compliant with the latest regulations, it’s important to understand the requirements around drug establishment registration.

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.

Drug Establishment Registration Application:

Once you have determined that your business needs to register with the FDA, you can begin submitting your registration application. This process involves submitting a form and relevant details about your business such as its name, address and contacts. You also need to provide information about the types of products being manufactured, whether drugs or medical devices, to complete the initial registration application.

Submit Additional Required Documentation and Fees:

After the initial registration application is submitted, you may need to provide additional required documents and pay any applicable fees. Depending on the type of product your business produces, you may be asked to submit specific documents such as labels, copies of product packaging, quality assurance plans and other forms of required documentation. In addition, you may need to pay annual fee for drug establishment registration.

Drug Establishment Registration
Drug Establishment Registration

The importance of keeping your records up-to-date and track deadlines for renewal applications:

In order to ensure that you remain compliant with the applicable drug establishment registration requirements, it’s important to track and maintain documentation related to your registration. This includes keeping records up-to-date, such as changes in contact information, and tracking deadlines for annual renewal applications. This will help ensure that your facility is properly registered at all times and any necessary fee payments are made on time.

US FDA Drug Establishment Registration

Drug Establishment Registration is mandatory for every drug manufacturing facility that intends on selling drug products in the USA. This includes understanding any applicable laws, regulations, guidance documents, applicable fees and any other items specified in the current drug establishment registration guidance.  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 & Requirements 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.
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