ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
DRUGS
DRUG PRODUCTS

The top five countries by number of drug manufacturing sites in the Fiscal Year 2020 were the United States, India, China, Germany, and Canada.

There was a significant increase in overall registered facilities with 6,743 new registrants in 2020, the majority of which were hand sanitizer manufacturers.

FDA conducts routine surveillance sampling and testing of drugs on the market as well as targeted sampling and testing of drugs with potential risks, based on information and data collected from inspections, manufacturers, distributors, wholesalers, and consumer complaints.

Companies selling products that fraudulently claim to prevent, treat or cure COVID-19 may be subject to legal action, including but not limited to seizure or injunction.

Drugs Approved or Authorized for Use

  • In a controversial decision, FDA approved the first new Alzheimer’s disease drug in nearly 20 years.
  • The FDA can also issue emergency use authorizations (EUAs) to allow healthcare providers to use products that are not yet approved, or that are approved for other uses, to treat patients with COVID-19 if certain legal requirements are met.
DRUG ESTABLISHMENT REGISTRATION

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of drugs for commercial distribution in the United States, is required to register with the FDA, and list its products.

Our service includes

  • Labeler Code
  • National Drug Code (NDC)
  • Establishment Registration
  • FDA Establishment Identification (FEI) Number
  • Product Listing
FDA USER FEES

User Fees are paid to the U.S. Treasury.

When an application is submitted, a fee is due.

Prescription drug product program fees are assessed annually for eligible products.

On March 27, 2020, the Over-the-Counter Monograph Safety, Innovation, and Reform Act was signed into law, and created a new $20,322.00 fee. Manufacturers of hand sanitizers and alcohol wipes are currently exempt, but that could change soon.

 

Prescription Drug User Fee Rates for Fiscal Year 2022

Application
Requiring clinical data $3,117,218
Not requiring clinical data $1,558,609
Program $369,413
PRESCRIPTION DRUGS | OTC DRUGS
ESTABLISHMENT REGISTRATION

LIMITED
OFFER

$350.00

ANNUAL SERVICE FEE
  • Company Registration
  • Product Listing
  • U.S. Agent Service

User Fee is extra.

HAND SANITIZERS ARE OTC DRUG PRODUCTS

FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.

MANUFACTURING REQUIREMENTS

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product

  • Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR Isopropyl Alcohol
  • Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)
  • Hydrogen peroxide
  • Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.
  • The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.