FDA plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
As part of these efforts, FDA published three guidelines to help meet the increased demand for hand sanitizers during the Coronavirus Disease 2019 (COVID-19) public health emergency. During the COVID-19 public health emergency, entities that are not currently registered drug manufacturers can register as over-the-counter (OTC) drug manufacturers and make alcohol-based hand sanitizers, pharmacies and registered outsourcing facilities can compound certain alcohol-based hand sanitizers, and alcohol production firms can produce alcohol for making hand sanitizers provided they follow the conditions outlined in the FDA guidances for industry.
One measure of a “Green” sanitizer is the amount of biobased ingredients used in its formulation. Biobased content is derived from renewable, biological sources, as opposed to non-renewable, fossil sources. Managed by the U.S. Department of Agriculture, the BioPreferred program was created to increase the purchase and use of biobased products by agencies of the federal government. It has since become more widespread as one way to determine if a product can be considered “green” or “environmentally preferred”. Hand Sanitizers that are made up in whole or in significant part of renewable resources can be considered biopreferred. BioPreferred products contribute to environmental sustainability by reducing our consumption of non-renewable resources.
Most hand sanitizers have a 3-year shelf life. However, not all OTC FDA-regulated products, including hand sanitizers, require expiration dating on the package. As per the Code of Federal Regulations, no expiration date is required for products sold in the US upon successful completion of 3-month accelerated stability testing. If a sanitizer is analytically tested and maintains its active ingredient level beyond the industry standard of 3 years, it could still be considered effective.
Hand sanitizers can carry an expiration date up to the amount of time that testing has confirmed the stability and effectiveness of the active ingredient as stated on the label. A typical industry standard is 2 – 3 years.
When the amount of the sanitizer’s antibacterial agent drops below 90% of the stated level, it is considered expired. Although legally expired, a sanitizer may still have some effectiveness remaining, especially since these are “leave on” products.
If for aesthetic reasons, hand sanitizer dispensers are to be offered in the restroom, they should be placed as close to the exit as possible without being obtrusive, so that the user can still kill germs picked up by touching the door.
In schools, they should be placed in the classrooms where they are convenient for kids with colds. In offices, they should be placed in the lobby and hallways near conference rooms, doorways and elevators where there is heavy traffic.
Sanitizers should be placed at all entrances and exits, near meeting rooms or classrooms and some hallways if it doesn’t interfere with traffic and near elevators. Generally speaking, place sanitizers in high traffic areas where people frequently pass. The use of a stand will allow more visibility and signage can also help serve as a reminder to sanitize. Sanitizers should be used as a supplement to a proper hand hygiene program and should never take the place of proper hand washing with soap and water.