FDA Issues Final Rule on Drug Shortages

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The agency requires early notification of potential drug shortages.


On July 8, 2015, FDA issued its final rule on the discontinuance or interruption of the manufacture of certain drug products as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule, effective Sept. 8, 2015, requires that applicants of covered approved drugs or biologics electronically notify FDA six months in advance, or as soon as practicable, of a permanent discontinuance or manufacturing interruption of a product that may lead to a disruption of the drug’s supply in the United States. FDASIA also requires FDA to maintain a current list of drugs in shortage in the US that includes certain information about those shortages.


“This step is the latest in a series of changes FDA has made to significantly reduce drug shortages. Those efforts have helped to prevent 282 shortages in 2012, 170 in 2013, and 101 in 2014. This progress is but one example of how FDA’s work under FDASIA is making an important difference for patients and health care professionals who depend on these products,” said Stephen M. Ostroff, MD, FDA’s acting commissioner, in a blog post celebrating the anniversary of FDASIA. 

Source: FDA