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.

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.

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

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.

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.

How to determine your eligibility for a Drug Establishment License?

Before you apply for your Drug Establishment License, it is crucial to determine if you are eligible for the license. You must first meet certain criteria to be approved. These include meeting specific requirements regarding manufacturing, labeling, and packaging standards; employing qualified personnel; and having a valid and complete federal drug registration number. You must also be able to provide proof of related business activities and demonstrate that the necessary facilities are compliant with state and federal laws.

How to submit your Drug Establishment Licensing Application and required documents?

Once you have determined that you meet the requirements for a Drug Establishment Licensing Application, you must then complete and submit the “Drug Establishment License Application Instructions” form. This is available from the Drug Establishment Licensing section of the FDA website. Along with your completed application, the required documents include proof of related business activity, a valid federal drug registration number, product labels, and descriptions of facilities. In addition to these items, drug establishment license applicants in certain states may need to provide additional information like proof of good standing with state licensing boards or a statement from an accredited laboratory verifying product quality standards.

How do register additional sites, locations, and organizations with the FDA's Drug Registration System (DRS)?

The DRS allows you to easily register any additional sites, locations, and organizations associated with your drug establishment license. Depending on the type of additional site or location you need to register, the forms may vary. For example, if you are registering a manufacturing facility, you will need to fill out Form FDA 3621, Application for Manufacturer’s License. On the other hand, if you are registering an import business, you will have to complete Form FDA 3542, Application for Importer’s License. To register with the DRS successfully, all required documents and forms must be completed accurately and submitted along with your registration application.

Why is it important to follow Good Manufacturing Practices for FDA drug compliance?

Good Manufacturing Practices, or GMP, are standards for the manufacture of drugs and medical products regulated by the FDA. Adhering to these guidelines allows drug establishments to produce safe and effective products that meet federal safety regulations. According to the World Health Organization (WHO), GMP is important in ensuring that a product “will be consistently manufactured with the well-defined requirements necessary for its intended use.” Following GMP guidelines can also help prevent adverse events associated with improper manufacturing practices.

How to maintain ongoing compliance with current drug products Quality Standards and Regulations?

One key step in maintaining compliance with GMP is to keep up with any changes in quality standards and regulations for drug products. While the GMP regulations are primarily focused on manufacturing process safety, manufacturers must also be constantly aware of changing regulatory requirements for handling, distributing, and labeling drug products. Manufacturers should also periodically review their quality assurance programs to ensure that their processes comply with current standards and regulations from the FDA. Lastly, an established record-keeping system is necessary to document all changes made in the production process.

Frequently Asked Questions

What information is 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

When is FDA Drug Establishment Registration required?

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.

When do drug facilities have to renew their FDA registration?

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.