What are FDA requirements for hand sanitizers?

Hand sanitizers are recognized by the FDA (Food and Drug Administration) as over the counter drug products due to their intended purpose of preventing disease. Being recognized as a drug product by the FDA, hand sanitizer products must comply with FDA drug regulations. To manufacture and sell hand sanitizers in the U.S. the following requirements must be met:

-Establishment Registration

-Drug listing

-Drug good manufacturing practices (GMP)

-FDA OTC Drug monograph requirements

-Labeling compliance

However, due to the current public health emergency posed by COVID-19, the FDA has established a temporary policy allowing certain entities who are not currently regulated by the FDA to  prepare alcohol-based hand sanitizers for consumer use and health care personnel rubs for the duration of the public health emergency provided these requirements are met:

  1. Hand sanitizers are prepared from the list of ingredients provided
  2. Alcohol ingredient is denatured
  3. Final product formula meets World Health Organization Recommendations
  4. Firm will not add in additional active ingredients (i.e. scents)
  5. Firm will ensure correct amounts of active ingredients
  6. The product is made in sanitary conditions
  7. Firms must use accurate analysis methods for sample testing
  8. Product must be an aqueous solution
  9. Labeling must meet product requirements
  10. Firms register their facility for making product

Additionally, Firms will need to have a way to accept adverse event reports for any products they manufacture and submit adverse event reports to FDA.


What can Labtopia do to Help You Meet Current and Future Requirements?

Labtopia provides full consulting support to organizations wishing to seek or maintain FDA GMP compliance. Labtopia’s consulting services consist of partial or turn-key solutions for every aspect of the quality assurance system. We offer customized solutions based on your specific needs and scope of work. Services include:

  • Assistance with Registration of the Establishment with the FDA
  • Assistance with Submitting Required Documentation
  • Ensuring Labeling Compliance
  • Interpretation of Monograph Requirements to Ensure Compliance
  • Assistance with Adverse Advents Reports to the FDA
  • Implementation of Good Manufacturing Practices (GMPs)
  • Internal Audits
  • Supplier/Vendor Qualification Audits
  • Accreditation Audit Support
  • Development of Corrective and Preventive Action Systems
  • Technical Writing
  • Manuals
  • Required Operating Procedures
  • Work Instructions
  • Document Control
  • Training
  • Corrective and Preventive Action Management
  • Interim and Part-Time Quality Assurance Support

Don’t Wait… Contact Labtopia today to help your business meet current requirements and prepare for the future changes!