• FDA Issues Draft Guidance for Notification of Issues That May Result in Prescription Drug Shortage
  • March 6, 2012 | Author: Frederick R. Ball
  • Law Firm: Duane Morris LLP - Boston Office
  • On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the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    FDA is seeking comment on the draft guidance by May 29, 2012.