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Drug shortages must be reported six months in advance

The new FDA rule also requires companies to notify them electronically in the same amount of time if the drug will be discontinued.

Drug shortages are no joke, and the FDA is not backing down when when it comes to managing issues surrounding them. 

A new rule now requires all drug and biological companies who manufacture medications to notify the FDA six months before discontinuing a drug or a projected shortage. 

Shortages can create havoc, and although it has decreased over the last decade, it is still a concern. 

A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage. The rule comes as ...

Read More at in-PharmaTechnologist

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