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Drug Establishment Registration

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Drug-Establishment-Registration

As per 21 CFR 207, it is the manufacturer’s obligation to register their establishments with USFDA before marketing the drugs in the USA. The drug manufacturers are also required to list all the drugs manufactured at their establishment and intended for marketing in the US.

Foreign facilities are required to appoint the US Agent for FDA drug establishment registration purposes. He will do all kinds of communications with the FDA for the NON-US firms.

The timelines for the renewal of the Drug Establishment are from 1st of October to 31st of December of every year.

The FDA drug establishment registration is applicable to bulk drugs, OTC drugs, and prescription drugs, generic drugs both for domestic and foreign import.

Who is required to register?

All the drug establishments – foreign and domestic must register their establishments and list all their drug products that are in commercial distribution in the USA.

Drug establishment registration and listing are required for the new/investigational drugs, generic/OTC/homeopathic drugs, facilities like drug testing, sterilization, etc.

Types of US FDA Drug Establishments

Foreign establishments whose products are imported into the United States are required to appoint a US Agent. The US agent will physically be located in the US and will act as a liaison between the FDA and the firm.

Over-the-counter drugs (Non-prescription drugs) are categorized as “Generally Recognized as Safe and Effective (GRASE)” by the general public without seeking the advice of health professionals and they do not require FDA drug approvals such as NDA or ANDA. The structured Product Labelling (SPL) format needs to be followed to submit the drug establishment information for the registration. A coded data format (SPL), adopted by FDA is used for FDA drug establishment registration and drug listing. Drug Product Label & Drug Information in SPL format will have to be submitted in the process of OTC drug listing.

For each therapeutic class, an OTC drug monograph is developed and published by FDA.OTC monograph act as a “standard recipe’ which covers all the information like ingredients, dose, formulations, etc. Once an OTC monograph is implemented, manufacturers can make and market an OTC drug without FDA’s pre-approval.

Homeopathic drugs covered in Homeopathic Pharmacopeia of United States- HPUSP does not require FDA drug approval before they are marketed. Same regulations for Homeopathic drug products and OTC drugs will have to be followed.

Search FDA Drug Establishment Registration Database

https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases

This FDA database contains details of currently registered establishments that manufacture FDA-approved drugs. 

If I am required to register my drug facility and list my drug products, how do I proceed?

Basically, 3 steps to be followed, and in each step, you will have to submit the periodic updates to maintain an accurate and current status: 

Step 1 – Establishment registration

Step 2 – Labeller code

Step 3 – Drug product listing(s)  

US FDA Drug Establishment Registration Online

 FDA has picked up extensible mark-up language (XML) files in the SPL format for users to submit registration and listing data. Users may transmit the submission in the same format through FDA’s electronic submission gateway (ESG).

FDA Drug Establishment Registration Process

Create and submit an SPL document to register with FDA. 

The following has to be included for FDA Drug Establishment Registration:

Verification of the Name & DUN & Bradstreet, or Data Universal Numbering System (DUNS) number of the establishment 

Responsible person’s contact details for FDA communications  

All applicable business operations that the establishment performs

Name and DUNS of a U.S. agent and all importers required for foreign organizations 

Drug establishment current registration site-

https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site

If you wish to look at the already registered organizations that can distribute the compound/drug in the US, you can visit the above link. The data is updated on each business day.

The database will keep updating based on the registration inactivation by FDA in case of non-compliance. For incomplete/expired/deregistered registrations as well the removal from the database is done. 

National Drug Code (NDC Code)

Drug establishments have to report all the drugs manufactured at their facility to FDA. Drugs are identified by a three-segment number called National Drug Code. National Drug Code serves as FDA’s universal product identifier for drugs.

 National Drug Code Directory is published by FDA which lists the NDC number and is updated daily. National Drug Code Directory contains information on drugs that are submitted to FDA in structured product labelling (SPL) electronic listing files by the manufacturer. National Drug Code Directory contains data for all drugs- prescription drugs and over-the-counter drugs. 

The first group of numbers (mentioned in the coloured font) identifies the labeller- drug manufacturer, repackager, or distributer- 12345-6789-0

The second group of numbers is the product code which identifies strength, dosage forms, or formulation- 12345-6789-0

The third group of numbers is the package code which identifies package sizes and types.12345-6789-0

 Two main configurations:

5-4-1 example: 12345-6789-0

5-3-2 example: 12345-678-90

Where can you find an NDC number?

The USFDA maintains a searchable database for National drug code search on their website. 

https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm

The NDC code can also be found in the package insert and/or on the packaging. 

FAQ:

US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR 207 for all drug manufacturers who market drugs in the United States. It involves registering the drug manufacturing facility with the FDA and listing all drug products intended for commercial distribution in the US. Foreign facilities must appoint a US Agent to handle FDA communications. This requirement applies to bulk drugs, prescription drugs, over the counter drugs, and homeopathic products.

All domestic and foreign drug manufacturers, repackers, relabellers, and testing or sterilization facilities are required to register their establishments with the US FDA if they are involved in producing drugs for the United States market. This includes companies that manufacture prescription drugs, over the counter drugs, homeopathic products, and active pharmaceutical ingredients.

A US Agent plays a critical role in FDA drug registration for foreign drug manufacturers. They act as the primary point of contact between the FDA and the non US company, handling all official communications. The US Agent assists with establishment registration and drug listing submissions and ensures timely responses to FDA inquiries. Their presence helps streamline the registration process and ensures compliance with FDA regulations for importing drugs into the United States.

Structured Product Labeling or SPL is an electronic format required by the USFDA to submit drug establishment registration and product listing information. It ensures that all submitted drug data, including labeling, ingredients, dosage, and packaging details, follow a consistent and machine-readable structure. This format helps FDA review and manage drug information efficiently

The National Drug Code or NDC is a unique 10-digit or 11-digit number that identifies drugs in the United States. It is made up of three segments. The first segment identifies the labeler such as the manufacturer or distributor. The second segment represents the product including strength and dosage form. The third segment indicates the packaging details. This code helps the FDA track and manage all drug products available in the market.

The FDA drug establishment registration renewal must be completed between October 1 and December 31 every year. All domestic and foreign drug manufacturing facilities are required to renew their registration annually within this timeframe to remain compliant. Failure to renew during this period may lead to deregistration or removal from the FDA’s active database.

Drug listing is the process of submitting detailed information about the drug products that a registered establishment manufactures and intends to market in the United States. This includes product details like ingredients, dosage form, strength, and labeling. Yes, it is mandatory for both domestic and foreign drug manufacturers. All drugs marketed in the US including prescription, over the counter, and homeopathic drugs must be listed with the FDA after the facility is registered.

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