title: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.
abstract: The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
mesh_terms: D001688:Biological Products / Q000600:supply & distribution*; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000600:supply & distribution*; D014481:United States
chemical_list: D001688:Biological Products; D004364:Pharmaceutical Preparations