Drug Shortages

Drug shortages have challenged regulatory and supply chain stakeholders alike in recent years. While there are many factors that may result in a product being in short supply, HDA pharmaceutical distributor members play a central role in exchanging and coordinating information when a shortage occurs.

To help alleviate the impact of drug shortages, the HDA-supported Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted in 2012, and included a requirement that manufacturers notify FDA of a discontinuance or interruption in the production of certain prescription drugs that are lifesaving, life-sustaining or intended for use in the prevention or treatment of a debilitating disease or condition.

Since the passage of FDASIA, HDA and its members have continued to work with policymakers, regulators and supply chain stakeholders to tackle complex drug supply issues and ensure the availability of safe and effective drugs.

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