Hand sanitizers are regulated as over the counter (non-prescription) drugs by the U.S. Food and Drug Administration. The FDA has issued warnings to consumers about hand sanitizer products containing methanol. According to the CDC, Alcohol-based hand sanitizers should only contain ethanol or isopropanol, but some products have been found to contain methanol. Ethanol is a valid active ingredient, but methanol, even in small amounts, can lead to patient adverse events.
Hand Sanitizer Testing Requirements
503A pharmacies and 503B outsourcing facilities that procure hand sanitizer API (ethanol or isopropanol) must perform testing before compounding regardless of what is on the API vendor's certificate of analysis. This requirement falls under the enforcement discretion described in the FDA's guidance updated on August 7, 2020, to ensure compounded hand sanitizer is free of contamination.
According to the FDA, the new guidance clarifies that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).
ARL Bio Pharma is inspected by the FDA, CGMP compliant, and provides testing on ethanol and IPA according to USP monographs.
Hand Sanitizer Formulations
The United States Pharmacopeia created a document in April 2020, outlining recommendations from its Compounding Expert Committee. This document includes three formulations for compounding hand sanitizer and appropriate ingredient substitutions based on shortage issues.
- Formulation 1 - starting ingredient of ethanol 96% for final product concentration of ethanol 80% (v/v)
- Formulation 2 - starting ingredient of isopropyl alcohol 99% for final product concentration of isopropyl alcohol 75% (v/v)
- Formulation 3 - starting ingredient of isopropyl alcohol 91% for final product concentration of isopropyl alcohol 75% (v/v)
The starting ingredients for Formulations 2 and 3 provide alternatives to WHO's formula using isopropyl alcohol 99.8%, due to shortage concerns.
Hand sanitizer should be prepared under conditions routinely used to compound similar nonsterile drugs (USP General Chapter <795>).
- USP FAQs: Alcohol and Dehydrated Alcohol
- Download the resource of USP-NF and FCC standards related to alcohol-based hand sanitizers. In addition to the monographs themselves, it also includes standards referenced within the monographs.
For more information on testing ethanol or isopropanol API, contact firstname.lastname@example.org or 800-393-1595