Time：2020-03-28 Views：1476
Requirements for the export of hand sanitizer to the United States:
In the United States, wash free hand sanitizer belongs to OTC (over the counter) for local disinfection, which is supervised by the food and Drug Administration (FDA) as well as products such as dandruff shampoo, fluoride toothpaste, sunscreen, etc. Although it belongs to the pharmaceutical category, the compliance requirements of most OTC products are relatively simple. Generally speaking, FDA will review the active ingredients of OTC drugs and issue an OTC monograph. OTC monograph is equivalent to active substance standard. For OTC products, as long as the active ingredients meet the requirements of OTC monograph, they can be directly listed without FDA approval.
It should be noted that the absence of FDA approval does not mean there is no compliance obligation for OTC drug listing, and the product still needs to meet the specified requirements. The specific requirements are as follows:
01. The active ingredients in OTC drugs must have a ready-made OTC monograph, and the active ingredients used by the enterprise meet the requirements of the OTC monograph, otherwise, the product will be applied for new OTC drugs; For alcohol free hand sanitizers, there are corresponding OTC Monographs on alcohol in the United States, so as long as the alcohol used for production meets the requirements of the monograph, the product can be launched without FDA approval. 02. Manufacturers or importers and exporters of OTC drugs must register the FDA address. For enterprises outside the United States, they need to entrust agents within the United States to register the FDA address.
03. Apply for a national drug code (NDA) for OTC drugs.
04. The enterprise must make a list of all OTC drugs to enter the U.S. market and make a backup at FDA. After that, the list shall be updated at least twice a year in June and December.
05. The label of OTC drugs must conform to the corresponding label regulations.
06. The production plant must meet the requirements of cGMP