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

At this time, there are no FDA-approved drug products to treat Coronavirus Disease 2019 (COVID-19).

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.

On March 27, 2020, the Over-the-Counter Monograph Safety, Innovation, and Reform Act was signed into law. The FDA will estimate the number of OTC monograph drug facilities registered as of December 30, 2020, for purposes of setting fees.

DRUG ESTABLISHMENT REGISTRATION

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of drugs for commercial distribution in the U.S., 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

Lowest SERVICE FEES available here. See our offer, below.

Government fees or User Fees are paid to the U.S. Treasury, when required. Drug application fees are due when an application is submitted. Prescription drug product program fees are assessed annually for eligible products.

Prescription Drug User Fee Rates for Fiscal Year 2021

Application
Requiring clinical data $2,875,842
Not requiring clinical data $1,437,921
Program $336,432
PRESCRIPTION DRUGS | OTC DRUGS
FDA ESTABLISHMENT REGISTRATION
LIMITED OFFER
$350.00 | ANNUAL SERVICE FEE
HAND SANITIZER

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.

Hand sanitizers are OTC drug products.