FDA Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizers

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the current consumer difficulties accessing alcohol-based hand sanitizers, and in response to the many queries concerning compounding these products, the Food and Drug Administration (FDA) has issued a guidance to communicate its policy. The guidance, effective immediately, and available at https://www.fda.gov/media/136118/download is summarized below:

  • Such compounding is permitted by pharmacists in State-licensed pharmacies or federal facilities and registered outsourcing facilities (i.e. 503B).
  • Such compounding is permitted for the duration of the HHS Secretary-declared health Emergency.
  • Only United States Pharmacopoeia (USP) grade ingredients are to be used in the following formulation:
     
    • Alcohol (ethanol) (80% v/v) or isopropyl alcohol (75% v/v) in an aqueous solution
     
    • Glycerol (1.45% v/v)
     
    • Hydrogen peroxide (0.125% v/v)
     
    • Sterile distilled water or boiled cold water
  • No additional ingredients (active or inactive) may be added.¹
  • Labeling must follow the “Drug Facts Label” detailed in the guidance.
  • Advertising and promotion cannot be false or misleading and claims must be consistent with the current OTC Monograph on these products, e.g. pathogen-specific disease claims.²

¹ This guideline follows an FDA Final Rule in April 2019 that essentially banned 28 active ingredients (e.g. triclosan) from hand sanitizers. FDA stopped short of banning three ingredients- benzalkonium chloride, ethyl alcohol, and isopropyl alcohol, and requested industry provide further data to support safety and efficacy.

² Tentative Final Monograph. Topical Antimicrobial Drug Products for OTC Human Use. 59 FR 31402. June 17, 1994.

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