The coronavirus (COVID-19) pandemic has caused disruption in the supply of alcohol-based hand sanitizers—a vital tool for hand hygiene. Traditional producers are working to increase output, and now alcohol manufacturers have an opportunity to leverage their infrastructures to make these critical products, as well.
The U.S. Food & Drug Administration (FDA) made that official on Friday, March 20 when it released guidance on the production of alcohol-based hand sanitizer. The guidelines enable manufacturing firms to prepare alcohol-based hand sanitizers for use by consumers and by healthcare personnel.
FDA’s guidance spells out clear requirements for the following:
1. Type and concentration of ingredients, with a formula consistent with World Health Organization (WHO) recommendations.
2. Manufacturing environment, including sanitary conditions and well-maintained, fit-for-purpose equipment.
3. Accurate method for alcohol content verification prior to product distribution.
4. Product labeling submission to the FDA, which must be consistent with one of the four samples provided in the appendices:
- Labeling for Ethyl Alcohol Formulation Consumer Use,
- Labeling for Isopropyl Alcohol Formulation Consumer Use,
- Labeling for Ethyl Alcohol Formulation Health Care Personnel Handrub Use or
- Labeling for Isopropyl Alcohol Formulation Health Care Personnel Handrub Use.
5. Product listing and facility registration submission to the FDA. Manufacturers must complete the FDA’s Electronic Drug Registration and Listing (eDRL RPL) process. For submission of this data, FDA requires companies to use Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. Each SPL formatted submission must be sent via the FDA’s Electronic Submission Gateway (ESG). Note: The FDA guidance specifically asks manufacturers to list and register their alcohol-based hand sanitizer before beginning to manufacture and distribute it.
How Reed Tech Can Help You Meet FDA Requirements for Hand Sanitizer Product Labeling and Listing
We are experts in the FDA’s Structured Product Labeling (SPL) standard requirements and product listing and registration. Our team offers deep experience and proven resources to help you to navigate this submission process to the FDA.
As alcohol manufacturers step up to meet this urgent public health demand for hand sanitizer products, we are stepping up, too.
Our people are available and ready to guide you through every step of product label creation and registration submission to the FDA
Is your company preparing product labeling to meet the FDA’s Structured Product Labeling requirements and to be approved to go to market with an alcohol-based hand sanitizer? Get expert assistance relied on by over 800 pharmaceutical and OTC companies. Learn more about how Reed Tech can help by emailing [email protected] or calling 215-682-8279.