Article

FDA issues new rule on drug shortages


 

The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...

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