Hand Sanitizer

The FDA has issued guidance to allow in state licensed pharmacists to temporarily compound alcohol-based hand sanitizers for the duration of the public health emergency. 

Per CDC recommendations, hand washing with soap and water for at least 20 seconds is preferred whenever possible. This can help eliminate germs and chemicals on hands. The CDC also states that alcohol-based hand sanitizers, at least 60%, can help reduce bacteria on the skin however it does not eliminate all types of microorganisms (germs). In addition, hand washing has been found to be more effective than alcohol based hand sanitizers at eliminating the following germs: Cryptosporidum (causes watery diarrhea), norovirus (virus that causes vomiting and diarrhea) and Clostridium difficile (bacteria that causes severe diarrhea).

The two types of alcohol that the FDA is reviewing is isopropyl alcohol and ethyl alcohol. If a pharmacist selects to compound hand sanitizer strict regulations must be followed. Only USP grade ingredients must be used in the formulation consistent with World Health Organization (WHO) recommendations. The percentage in the final product formulation should be either: Alcohol (ethanol) 80% v/v  or Isopropyl Alcohol (75% v/v).  The hand sanitizer must be labeled consistent with the recommendations from the FDA. There are more restrictions and the FDA guidance that was issued in March 2020 can be found at FDA.gov.  Follow your state board pharmacy guidelines for additional guidance. If you are a compounding pharmacy the PCCA, Professional Compounding Centers of America, is sharing two hand sanitizer recipes to help alleviate the shortage. 

In addition, for safety precautions always keep hand sanitizers stored away and out of reach from children and pets. If accidently or intentionally swallowed poisoning may happen. If this occurs seek medical attention right away and call your nearest poison control center at 1-800-222-1222.

References:

1.    https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html. Accessed on March 26, 2020

2.    https://www.fda.gov/media/136118/download?mkt_tok=eyJpIjoiTm1VMU5HUTNNMlUyWW1ZNSIsInQiOiJCejFvTm5VdElBTmZraG1ZTjJ2YlVHT2RsRXpXUThxZE9SM0phY1RCaU5RQW9WanFhQ2JtRTZMYStXNnZyMFhVcUdPdEw3cjNTRm43b2ZYcEJPOWVCYnd3a1ZZRGZPaHVPQzk1WTJDSDJJR0lNdGowMTl0NjdwWGlTRm8yY00xYyJ9. Accessed on March 26, 2020

3.    www.pccarx.com. Accessed on March 26, 2020