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Regulatory Focus™ > News Articles > Government Issues Rule to Minimize Drug-Supply Disruption

Government Issues Rule to Minimize Drug-Supply Disruption

Posted 21 December 2011 | By

An interim final rule issued by the Obama administration requires sole producers of critically needed medicines to report any manufacturing interruption to the US Food and Drug Administration (FDA). Companies that are the sole suppliers of drugs that "life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition" will now be required to report all interruptions. Meanwhile, the Generic Pharmaceutical Association called for a real-time communication system to improve the exchange of information among manufacturers, wholesalers and government about drug shortages. (in-pharmatechnologist)


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