What is the 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.

Why is record keeping important for drug facility renewals?

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.

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.

US Drug Facility Registration and Renewal Compliance Solutions

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.

Registering a drug testing and manufacturing facility with the U.S. Food and Drug Administration (FDA) involves compliance with specific regulations and requirements. The FDA’s oversight of drug testing and manufacturing facilities is aimed at ensuring the safety, efficacy, and quality of pharmaceutical products.

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. 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 Process

1. Drug Establishment Registration: Manufacturers, repackers, relabelers, and other entities involved in the manufacturing or testing of drugs are required to register their establishments with the FDA. This includes both domestic and foreign facilities that produce drugs for the U.S. market. The registration process typically involves the following steps:

Obtain a DUNS Number: The Drug Establishment Registration process often requires a DUNS (Data Universal Numbering System) number, which is provided by Dun & Bradstreet. This unique identifier is used to track and identify your facility.
Submit Establishment Registration: Use the FDA’s Electronic Drug Registration and Listing System (eDRLS) to submit the establishment registration information, including details about the facility, products manufactured or tested, and contact information.
Pay User Fees: Depending on the type of facility and the activities conducted, you may need to pay user fees as required by the FDA.

2. Drug Listing: In addition to establishment registration, manufacturers and other entities need to list their drug products with the FDA. This involves providing detailed information about each drug product, including its active ingredients, strength, dosage form, and labeling.

3. Current Good Manufacturing Practices (cGMP) Compliance: Manufacturing facilities must adhere to Current Good Manufacturing Practices (cGMP) regulations, which establish quality standards for the manufacturing, processing, packaging, and holding of drugs. Compliance with cGMP requirements is essential to ensure the quality and safety of pharmaceutical products.

4. Inspections and Audits: The FDA conducts inspections and audits of drug manufacturing facilities to assess compliance with regulatory requirements. Inspections may be preannounced or unannounced and may focus on various aspects of facility operations, including quality control, record-keeping, and adherence to cGMP guidelines.

5. Reporting Requirements: Drug manufacturers and other regulated entities have reporting obligations to the FDA. This includes adverse event reporting, recalls, and other safety-related information.

It’s important to emphasize that the process and requirements can vary based on factors such as the type of drugs being manufactured or tested, the facility’s location, and the specific activities conducted. Therefore, it’s crucial to thoroughly review the FDA’s guidance documents, regulations, and requirements pertaining to drug establishment registration, drug listing, cGMP compliance, and reporting.

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 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 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.

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.

GMP components for FDA drug facility registration

Quality Management System (QMS): Establish and maintain a comprehensive Quality Management System that outlines the organizational structure, responsibilities, processes, and procedures for ensuring product quality and safety.
Personnel: Ensure that personnel involved in drug manufacturing, testing, packaging, and labeling are adequately trained, qualified, and have the necessary skills to perform their tasks effectively.
Facilities and Equipment: Design, construct, and maintain facilities and equipment to meet GMP standards. Ensure that equipment is calibrated, validated, and properly maintained to prevent contamination and ensure accurate results.
Documentation and Record Keeping: Maintain accurate and complete documentation, including batch records, standard operating procedures (SOPs), and protocols. Records should demonstrate the manufacturing, testing, and control of each batch of drug product.
Quality Control: Establish and implement a robust quality control system to monitor and verify that products meet predetermined specifications. This includes testing raw materials, in-process materials, and finished products.
Production: Follow defined procedures and processes for drug production to ensure consistency, safety, and efficacy. Batch records should accurately document the steps taken during production.
Validation and Qualification: Validate critical manufacturing processes to ensure that they consistently produce products meeting predetermined specifications. Qualify equipment and systems to ensure their suitability for their intended use.

8. Laboratory Controls: Implement controls for laboratory testing and analysis to ensure accurate and reliable results. Analytical methods should be validated, and equipment should be properly calibrated.

9. Packaging and Labeling: Ensure that drug products are properly packaged and labeled according to established specifications. Labels should accurately reflect the contents, dosages, and usage instructions.

10. Stability Testing: Conduct stability testing to evaluate the shelf life and storage conditions of drug products. This helps ensure that products remain safe and effective throughout their intended shelf life.

11. Out-of-Specification (OOS) and Corrective Actions: Establish procedures for handling out-of-specification (OOS) results and non-conforming products. Implement corrective and preventive actions to address deviations and prevent recurrence.

12. Adverse Event Reporting: Establish procedures for reporting adverse events, including any unexpected side effects or adverse reactions associated with the use of the drug product.

13. Regulatory Compliance and Inspections: Prepare for and facilitate regulatory inspections by maintaining readiness, cooperating with inspectors, and addressing any observations or findings promptly.

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.

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.