As noted in our prior post, in response to the demand for hand sanitizers created by the COVID 19 crisis, the FDA announced it would not pursue actions during the pendency of the crisis against state-licensed pharmacies or Federal facilities or registered outsourcing facilities for the compounding of alcohol-based hand sanitizers, provided the resulting products met formula requirements specified in the guidance. Subsequently, the FDA issued two additional guidances that further open the door to companies interested in responding to the current demand for hand sanitizers and for the alcohol needed for their formulation. The second guidance entitled Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) announces that for the duration of the crisis the agency will not pursue actions against any company that prepares alcohol-based hand sanitizers for use by consumers and health care personnel, provided the products are manufactured and labeled in accordance with requirements specified in the guidance, and developed a method to record and forward to the FDA information about adverse reactions. Companies not already registered with the FDA as drug manufacturers who want to start producing hand sanitizers in accordance with the guidance will need to register their facility and list their products with the FDA, but will receive automatic confirmation of acceptance from the agency and will not need to wait for further communications.
The third guidance entitled Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) is targeted at alcohol manufacturers interested in producing alcohol for use in hand sanitizers during the crisis. Specifically, the agency announced it would not pursue actions against such manufacturers during the crisis who produced ethyl alcohol and ethanol for use in hand sanitizers, provided they complied with specifications set forth in the guidance. This guidance for alcohol producers also includes labeling specifications and requires alcohol producers to register their facility and products with the FDA.
These three quickly issued guidances show unprecedented flexibility by the FDA to encourage rapid response to the need for hand sanitizing products. However, the guidances also reflect the agencies intent even during an emergency to maintain standards for products allowed in the marketplace. Companies seeking to take advantage of the opportunities presented should keep counsel in the loop to make certain all of the requirements, including those for labeling and reporting, are met.
From our families to yours…stay safe, stay healthy, and stay home to the extent possible.