How does the CDER Drug Shortage Program verify that a shortage exists?
The CDER Drug Shortage team utilizes information from manufacturers, distributors and market share data to determine if a shortage exists. (DSP defines a drug shortage as follows: The total supply of all versions of the approved product available at the user level will not meet the current demand. A registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.