FDA Authorizes Pharmacies to Compound Hand Sanitizers
Compounding pharmacies can produce 60 percent alcohol-based hand sanitizer products
The Food and Drug Administration (FDA) announced on March 13, 2020, without prior public comment, that it was authorizing pharmacies to compound hand sanitizer during the current Public Health Emergency.
As a result of confirmed cases of the COVID-19 disease, Alex M. Azar II, Secretary of Health and Human Services (HHS), determined that a national public health emergency has existed in the USA since January 27, 2020.
Hand hygiene is an important part of the response to COVID-19 disease outbreak in the USA. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom, before eating, and after coughing, sneezing or blowing one’s nose, says the FDA
If soap and water are not readily available, the US Centers for Disease Control and Prevention (CDC) recommends an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
The FDA says ‘We understand that some consumers are currently experiencing difficulties accessing alcohol-based hand sanitizers containing at least 60 percent alcohol.’
‘We are also aware of reports that some consumers are producing hand sanitizers for personal use; the Agency lacks information on the methods being used to prepare such products and whether they are safe for use on human skin.’
‘We further recognize that pharmacy compounders, relative to untrained consumers, are more familiar with standards and methods for producing drug products.’
‘This interim FDA policy does not extend to other types of products, such as products that use different active ingredients.’
In summary, the ‘FDA issued this new guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of this public health emergency.’
The FDA encourages both consumers and healthcare professionals to report adverse events experienced with the use of hand sanitizers to the FDA’s MedWatch Adverse Event Reporting program.
Pharmacy related news is published by Precision Vaccinations.
- US Department of HHS: Determination that a Public Health Emergency Exists
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
- FDA: Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency