FDA reveals new initiatives to deal with drug shortages

BMJ 2013; 347 doi: (Published 04 November 2013) Cite this as: BMJ 2013;347:f6646
  1. Michael McCarthy
  1. 1Seattle, USA

Under proposed rules announced on 31 October by the US Food and Drug Administration, drug makers will be required to notify the government at least six months in advance, or as far in advance as practical, if they intend to stop making a medically important drug. This rule will also apply to any interruption in a drug’s manufacture that is likely to lead to a disruption in supply.1

The rules were drawn up to deal with shortages of drugs that have sent doctors and hospitals in the US scrambling to find new suppliers or alternatives. Shortages peaked in 2011, when more than 250 drugs and biological products were reported to …

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