FDA defines drugs as
- a substance recognized by an official pharmacopoeia or formulary.
- a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- a substance (other than food) intended to affect the structure or any function of the body.
- a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
FDA’s Center for Drug Evaluation and Research (CDER) regulates:
▪ Over-the-counter and prescription drugs including biological therapeutics and generic drugs.
▪ Prescription Drugs: medicines or any drug product that requires a doctor’s authorization for purchase.
▪ Generic Drugs: drug products equivalent to brand name products in terms of quality and performance. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
▪ Over-the-Counter (OTC) Drugs: drug products are available to consumers without a doctor’s prescription.
Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act.
Establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) must register their establishments and submit listing information for all drugs in commercial distribution.
Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Failure to register is a prohibited act. Also, a drug is misbranded if it is manufactured in an establishment not duly registered.
A foreign company or registrant must provide:
• The name, address, and phone number of the foreign registrant’s U.S. Agent such as ITB HOLDINGS LLC.
• Each importer that is known to the establishment. This means each U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment’s drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or patient.
• Also, the name of each person who imports or offers for import such drug, including each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
▪ Drug Establishment Registration.
▪ Drug Product Listing.
▪ Investigational New Drug (IND) Application.
▪ New Drug Application (NDA).
▪ Abbreviated New Drug Application (ANDA): Generics.
▪ U.S. Agent Service.
▪ Label Review.
▪ Label Design.
- Company registration
- Product listing
- U.S. Agent Service for foreign companies
Available upon request:
- Label Review or Update.
- U.S. Toll Free Number with international call forwarding.
- Certificate of FDA Registration.
These fees apply to the period from October 1, 2023, through September 30, 2024, and are paid to the U.S. Treasury. An account is required.
|User Fee Type||2024|
|Application Fee – Clinical Data Required||$4,048,695|
|Application Fee – No Clinical Data Required||$2,024,348|
|User Fee Type||2023|
|Application Fee – Clinical Data Required||$3,242,026|
|Application Fee – No Clinical Data Required||$1,621,013|
The United States Food and Drug Administration may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including there are no adequate, approved, and available alternatives.