In response to high demand for hand sanitizer products associated with the COVID-19 outbreak in the United States, the U.S. Food and Drug Administration (FDA) published two guidance documents outlining conditions under which compounding pharmacies and firms not typically regulated by FDA may prepare alcohol-based hand sanitizers for use by consumers and healthcare professionals.

The Agency states that it does not intend to take enforcement action against companies that do not comply with certain regulations, such as current good manufacturing practice requirements, provided the firms adhere to the recommendations in these temporary policies.  The policies will remain in effect for the duration of the public health emergency brought on by COVID-19.

What are the Policy Conditions?

FDA’s documents outline several key guidelines to which hand sanitizer products under these policies should conform:

• Manufacturers should prepare hand sanitizer only from a specific formulation using United States Pharmacopoeia (USP) grade ingredients:
  • Isopropyl Alcohol (75%, v/v) in an aqueous solution or Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution.
    • Alcohol (ethanol) should be denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in CFR part 20.
  • Glycerol (1.45% v/v)
  • Hydrogen peroxide (0.125% v/v)
  • Sterile distilled water or boiled cold water
• Manufacturers should ensure their sanitizers contain the proper amount of ethanol or isopropyl alcohol. Firms should use the most accurate method available to analyze the alcohol content of their finished products prior to distributing each batch.
• The sanitizers should be prepared in sanitary conditions with appropriate equipment.
• Product labeling should be consistent with specific content and formatting outlined in FDA’s guidance documents.
• Firms that are not compounding pharmacies must register with FDA and list their sanitizers prior to marketing them in the U.S.
• Firms must have a space on their label that includes a U.S. based address or phone number to receive reports of adverse events as well as a method to submit those reports to FDA.

Products that do not meet these conditions may need to comply with FDA’s standard drug requirements such as conformance to an FDA monograph or FDA approval of a new drug application (NDA).  Marketing other types of hand sanitizers not in compliance with applicable FDA requirements may result in enforcement action, including detentions, refusals, Warning Letters, and more.

Registrar Corp assists with U.S. FDA compliance.  Our Regulatory Specialists can help you register and list sanitizers and other drug products with FDA, review your labeling for compliance, and more.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7.