What is FDA’s temporary policy for hand sanitizers?

The FDA’s temporary policy  defines several conditions which alcohol based hand sanitizers must follow.  FDA defined conditions include the following ; 


  1. Quality and source of  alcohol 
  2. Active and inactive composition 
  3. Product composition 
  4. Testing requirements 
  5. Labeling requirement   
  6. Manufacturing in sanitized condition with well maintained equipment  
  7. Establishment  registration and drug listing
  8. Specific dosage form (liquid only)


A summary of the temporary  policy is available on our website; you can also visit  fda.gov for the complete policy:


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