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.
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
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
|Requiring clinical data||$3,117,218|
|Not requiring clinical data||$1,558,609|
- Company Registration
- Product Listing
- U.S. Agent Service
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.
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.