How to get US FDA approval for Hand Sanitizers

Here is the answer to your question How to get US  FDA approval for Hand Sanitizers.

FDA  approval is not required for over the counter hand sanitizers. You can sell hand sanitizers by complying with “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry”.   You can find an overview of the FDA’s temporary policy on our website.  FDAbasics can assist you in complying with the below requirements.


How to get US FDA approval for Hand Sanitizers

FDA compliance requirements for alcohol-based hand sanitizers

  1. Drug establishment registration  – Our fee for hand sanitizer manufacturer registration is $ 299
  2. Obtaining the labeler code –  Labeler application assistance fee is $ 399
  3. Labeling compliance –  Labeling review for OTC drugs is $ 399 per product.
  4. NDC  Drug  Listing. $ 399 per product listing ( no additional fee for multiple pack sizes of the same product)

FDA does not charge fee for registration /listing.

You can find more information about how FDA regulates hand sanitizers at the below link.

FDA hand sanitizer registration, FDA requirements for hand sanitizer or   FDA  approval for hand sanitizer ; What is required?

If your hand sanitizer formulation does not comply with requirements mentioned in the temporary policy published by the FDA then you may have to comply with good manufacturing practice (GMP) requirements.



Disclaimer   – This article reflects the current understanding of FDAbasics LLC,  does not constitute legal bindings. FDAbasics LLC is a private regulatory not associated with the US FDA. 


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