ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
Drugs

Prescription, Over-the-Counter (OTC) Drugs

FDA DRUG ESTABLISHMENT REGISTRATION

Before you export any drug product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

Is your company manufacturing, exporting, importing, distributing Hand Sanitizers and Alcohol Wipes?

WHAT IS A DRUG PRODUCT?

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

■ Fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, hand sanitizers that are considered “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.

Annual Registration Renewal

All Drug Establishments must renew their registration between October 1 and December 31, 2022.

DRUG ESTABLISHMENT REGISTRATION

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

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA. There are exemptions.

LIMITED OFFER

DRUG
FACILITY
REGISTRATION

$350.00

ANNUAL SERVICE FEE
  • Company registration
  • Product listing
  • U.S. Agent Service for foreign companies
  • Available at extra cost: Label Review or Update, U.S. Toll Free Number with international call forwarding, Certificate of FDA Registration

FDA User Fees are not included.

USER FEES

These fees apply to the period from October 1, 2021, through September 30, 2022, and are paid to the U.S. Treasury. An account is required.

User Fee Type2021
Application Fee – Clinical Data Required$2,875,842
Application Fee – No Clinical Data Required$1,437,921
Program Fee$336,432
User Fee Type2022
Application Fee – Clinical Data Required$3,117,218
Application Fee – No Clinical Data Required$1,558,609
Program Fee$369,413
Emergency Use Authorization (EUA)

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.

Recent FDA-Approved Drugs

List of final approvals and tentative approvals of original and supplemental applications for the past two weeks. Click here to search all approved drug database