On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the U.S. market or potential disruption in the supply. The FDA identified potential issues that may lead to a shortage or disruption, including:

  • Product quality problems;
  • Interruptions or adjustments in manufacturing;
  • Delays in acquiring critical raw materials or components;
  • Transfer of manufacturing to an alternative facility;
  • Loss of production line or production capacity;
  • Production problems that occur during or after manufacturing that can result in supply disruptions;
  • Import delays;
  • Unexpected increases in demand; and
  • Product discontinuances.

FDA is seeking comment on the draft guidance by May 29, 2012.