On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the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FDA is seeking comment on the draft guidance by May 29, 2012.

If you have any questions concerning this Alert, please contact Frederick R. Bal, any other attorney in the Pharmaceutical, Pharmacy and Food industry group or the attorney in the firm with whom you regularly work.

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