On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration (“the Declaration”) related to COVID-19, in response to numerous requests for guidance from manufacturers, distributors, and health care providers. Although the Opinion is not binding law and does not answer every question about the Declaration, it does provide insight into the intended scope of the Declaration.