Requirements for US FDA Drug Establishment Registration and Drug Listing

The Food and Drug Administration is in charge of assuring the efficacy and safety of prescription pharmaceuticals marketed in the US.

To commercialise their products in the USA, all pharmaceutical companies must complete the FDA Drug Establishment Registration. All prescription, over-the-counter, and generic medications, whether made locally or overseas, must be registered.

Who Needs to Register with the FDA?

The producers of drugs

1. OTCP medicines
2. Homéopathic medicines
3. Medicines on prescription
4. Animal products
5. Biological products, such as derivatives of blood and plasma
6. Drugs covered under the Veterinary Feed Directive
7. Facilities for sterilisation
8. Distributors, distributors, and importers
9. Contracts with companies that produce raw materials or finished medications for the aforementioned goods.
10. Innovative or pioneering medications

If your facility is involved in the production, preparation, propagation, compounding, or processing of a drug product, it must be registered with the FDA. Without registration, a product cannot be sold even by the maker of a completed dosage form who does not have their own authorised application for sale.

How Do I Sign Up With The FDA?

Separate from submitting an application for a drug product is registering a facility. If your facility manufactures one or more medications, IBC can assist you in filling out and submitting an application for registration while your firm is still being built or right away after it opens for business.

Your business will be given a facility code if the registration is accepted. This number is used by FDA in discussions with your facility and in the product listing. This code must be entered on all drug labels and other documentation designating the organisation as an authorised producer of a certain drug product.

IBC assists organisations in completing the Facility Registration, NDC, SPL preparation, Drug Listing, annual renewal, submitting updates, etc.,

What Does the FDA Examine When a Drug is Registered with the US FDA?

Before granting the US FDA drug registration, the FDA inspects the facility. The goal of this examination is to ascertain whether or not the facility’s production procedures will permit it to produce a product that is both safe and efficient.

Housing, equipment support, construction materials used in the building and process areas, water, air, and waste system quality, production procedures and controls, hazardous waste disposal, security measures to prevent tampering with the product, and employee qualifications and training are some of the factors taken into account during an FDA inspection.

NDC Code: National Drug Code
Each firm that registers a drug product with the FDA receives a proprietary NDC code. The code, which is required to be on all labelling for prescription or human-use items in order for the medicine to be dispensed by a chemist, both identifies the producer of the drug and the product. The NDC labeler code, which is present on all over-the-counter (OTC) medications, is known as this.

FDA will issue you a facility/manufacturer code once you have successfully completed the US FDA drug registration procedure with IBC. This number serves as the agency’s only means of identifying your business and your product(s). Use this identifier to identify the product on all medicine labels and other paperwork.

What Constitutes NDC?
There are three segments to the NDC. The institution whose name comes in the 11th to 14th character position is identified by the first two or three numerals. The product is identified by the following four to seven numerals, and the package size is indicated by the last section.

FDA Drug Facility Registration Process in Steps:

1. An authorised facility representative completes the registration application and sends it to IBC along with payment.
2. IBC will start the US FDA medication registration procedure and guide you through it from beginning to end.
3. Your business is given an ID number by the FDA, which you must use in all future communications with them.
4. Our team will check your application for completeness after verifying your details.
5. Your facility is inspected by the FDA to make sure that it complies with current good manufacturing practises (CGMPs).
6. As soon as you receive your planned inspection date, please let our staff know.
7. IBC will assist you and offer a list of necessary papers you must send once your application has been approved, including an electronic version of your FDA registration.
8. We will assist you with the yearly renewal, which is a quick process that only requires a few minutes to complete.
9. Our staff will offer assistance at each stage, update information as needed, and guarantee prompt submission to the FDA in the event that any revisions or updates are necessary by the FDA prior to renewal.

Upon renewal, our staff will create a fresh list of needed paperwork for you to submit, along with an updated FDA registration file that you may upload.