Qualified Pandemic or Epidemic Product Law and Legal Definition

Qualified pandemic or epidemic product means a drug, biological product, or device that is manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic. It can also be used to limit harm that such pandemic or epidemic might otherwise cause. It thereby helps cure a serious or life-threatening disease or condition caused by a product that is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed and authorized for emergency use in accordance with section 564 of the Federal Food, Drug, and Cosmetic Act.