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Drugs

DRUG PRODUCTS

At this time, there are no FDA-approved drug products to treat Coronavirus Disease 2019 (COVID-19). The FDA is working with drug manufacturers and investigational new drug sponsors to expedite the development and availability of COVID-19 treatments.

  • FDA approved Xpert Xpress SARS-CoV-2 test made by Cepheid Inc under the Emergency Use Authorization (EUA)
  • FDA concluded that Xpert Xpress SARS-CoV-2 test may be effective in diagnosing COVID-19, and that the known and potential benefits of Xpert Xpress SARS-CoV-2 test when used for diagnosing COVID-19, outweigh the known and potential risks of Xpert Xpress SARS-CoV-2 test
  • There is no adequate, approved, and available alternative to the emergency use of Xpert Xpress SARS-CoV-2 test
FDA ENFORCEMENT

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.

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.

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
a. Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR Isopropyl Alcohol
b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)
c. Hydrogen peroxide
d. 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.

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 fees available here.