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 new User Fees.

MDF Facility Fees ($24,178), or CMO Facility Fees ($16,119). These fees are effective for the period from October 1, 2021, through September 30, 2022.

Manufacturers of hand sanitizers and alcohol wipes are no longer exempt.

 

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.
Recent New and Generic Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) provides assistance to developers on the necessary study design elements and other data needed in the drug application, to support a full and comprehensive assessment.

Here are the main types of drug applications:

  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Over-the-Counter Drugs (OTC)
  • Biologic License Application (BLA)

FDA’s role in the development of a new drug begins when the drug’s sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans.

The Investigational New Drug (IND) Application is the means through which the sponsor technically obtains the exemption from the FDA, to ship the drug to clinical investigators. CDER’s Pre-Investigational New Drug Application (IND) Consultation is strongly recommended. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials.

When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet FDA’s requirements for marketing approval, the sponsor submits a New Drug Application (NDA). The drug sponsor formally requests that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

If the person signing an NDA does not reside or have a place of business within the United States, it must be countersigned by an attorney, agent, or other authorized official who resides or maintains a place of business within the United States.

Generic drug applications are called Abbreviated New Drug Application (ANDA) because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent or performs in the same manner as the innovator drug.