In response to the COVID-19 pandemic, FDA released guidance on March 14, 2020 allowing state licensed pharmacies, compounders, and certain federal facilities (referred to collectively as compounders) to manufacture hand sanitizers. In this guidance, FDA indicated that they are aware of people making their own sanitizers due to the shortage of sanitizers on the market, but there is concern over the methods and materials used for these sanitizers. Compounders are more familiar with standards and methods for producing drug products than untrained consumers, hence the issuance of the guidance. FDA stated that they do not intend to take action against compounders that prepare hand sanitizer for the duration of the public health emergency. The guidance states, in part:

To make the hand sanitizers, compounders must meet the following conditions:

  • The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
    • Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; 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

The compounder does not add other active or inactive ingredients. Different or additional ingredients may reduce the safety and effectiveness of the product.

  • The compounder pays particular attention to ensure that th ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used.
  • The hand sanitizer is prepared under conditions routinely used by your facility to compound similar nonsterile drugs.
  • The hand sanitizer is labeled consistent with the attached labeling in Appendix A (Labeling for Ethyl Alcohol Formulation) or Appendix B (Labeling for Isopropyl Alcohol Formulation)

 

We hope that appropriate facilities take advantage of this guidance to manufacture hand sanitizers to alleviate the current shortage.

If you are a business contemplating supplying hand sanitizers, and have some questions, please contact us at lcs@lachmanconsultants.com