US FDA Drug Establishment Registration and Drug Listing Requirements

The Food and Drug Administration is responsible for ensuring that prescription drugs marketed in the United States are safe and effective.

All drug manufacturers must complete the FDA Drug Establishment Registration to be marketed in the USA. This registration is required for both generic, prescription, and non-prescription drugs which are manufactured domestically or from abroad.

Who Should Register With FDA?

The drug manufacturers of

1. OTC drugs
2. Homeopathic drugs
3. Prescription drugs
4. Animal drugs
5. Biological products, including blood and plasma derivatives
6. Veterinary Feed Directive (VFD) drugs
7. Sterilization facilities
8. Distributors, wholesalers, importers
9. Contract manufacturers of drug substances or finished drugs for the above-listed products.
10. new or Pioneer drugs

Your facility must be registered with the FDA if it is engaged in manufacturing, preparing, propagating, compounding, or processing a drug product. Even the manufacturer of a finished dosage form that does not itself have an approved application for sale cannot sell a product without registration.

How to Register With FDA?

The registration of a facility is separate from the filing of an application for a drug product. IAS helps to complete and submit an application for registration while your establishment is still under construction or immediately after it begins operations, provided the facility manufactures one or more drugs.

Once the registration has been approved, your establishment will be assigned a facility code. This number is used by FDA in the product listing and other communications involving your facility. You must use this code on all drug labeling, and any other documents that identify the establishment as an approved manufacturer for a given drug product.

IAS helps organizations to successfully complete the Online registration and related activities for Facility Registration, NDC request, SPL preparation, Drug Listing, annual renewal, submitting updates, etc.,

What Does FDA Look at During the US FDA Drug Registration?

The FDA inspects the facility before the US FDA drug registration is granted. The purpose of this inspection is to determine whether or not the manufacturing practices at that facility will allow it to make a safe and effective product.

Some of the factors considered during an FDA inspection include Housing, equipment support, construction materials used in the building and process areas, quality of water, air, and waste systems, production procedures and controls, hazardous waste disposal, and security measures to prevent tampering with the product, employee qualifications/ training.

National Drug Code (NDC Code)

The proprietary NDC code is assigned to each company that registers a drug product with the FDA. The code identifies the manufacturer of a drug as well as the product, and it must be placed on all labeling for prescription or human-use products in order for the medication to be dispensed by a pharmacist. This is called the NDC labeler code and it appears on all non-prescription drugs (OTC).

Once you have successfully completed the US FDA drug registration process with IAS, you will receive a facility/manufacturer code from FDA. This number is the unique designation that identifies your company and its product(s) to the agency. Use this code on all drug labeling and any other documents that identify the establishment as an approved manufacturer for a given drug product.

What Does NDC Consist of?

The NDC consists of a three-segment number. The first two or three numbers identify the facility whose name appears in the 11th to 14th character position. The next four to seven numbers identify the product, and the last segment identifies the package size.

Step by Step FDA Drug Facility Registration Process:

1. An authorized official of the facility completes the registration application and submits it along with payment to IAS who will initiate and handhold through the entire US FDA drug registration process.
2. FDA assigns an ID number for your company which you will use on all future correspondences with them.
3. Upon verification of your information, our team will review the application for completeness.
4. FDA conducts an inspection of your facility to ensure compliance with current good manufacturing practices (CGMPs). It is critical that our team be notified as soon as you receive your scheduled inspection date.
5. Upon approval, IAS will work with you and provide a list of required documents you must submit, including an electronic copy of your FDA registration.
6. We will help you in preparing the annual renewal which is a simple process and takes less than 10 minutes to complete.
7. In case of any changes or updates required by the FDA before renewal, our team will provide support at every stage; update information as / when required, and ensure timely submission to FDA.

Upon renewal, our team will generate a new list of required documents for you to submit and upload the FDA registration file with the updated information.

Contact us today to know more about US FDA Drug Registration!

Also visit our US FDA certification frequently asked questions page to learn more!