Proposed FDA Rule Requires Notice of Short Supply or Discontinuation

November 15, 2013 | Strategic Insights for Ambulatory Care


A new rule proposed by the U.S. Food and Drug Administration (FDA) would require manufacturers of medically important prescription medications or biologic products to give notice electronically of any discontinuation in manufacturing, either temporary or permanent, that could potentially lead to a shortage. “The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.” FDA is enacting the plan called for in the Food and Drug Administration Safety and Innovation Act of 2012 to manage drug shortages by sustaining quality manufacturing.

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