Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. When a shortage is listed as current on the Drug Shortage Database, the FDA is aware of the supply situation and is working with the manufactures on efforts to mitigate the supply disruption. FDA also continue to work with manufacturers on shortage prevention efforts for drugs not yet listed on the Drug Shortage Database.
The Federal Food, Drug, and Cosmetic Act defines a drug shortage as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug. FDA tracks shortages at the national level and receives information from manufacturers about their ability to supply the market. We consider a drug to be in shortage when, on a nationwide level, supply is not meeting current demand, or if supply is not forecasted to meet projected demand.
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