The Food and Drug Administration has issued an interim final rule, with a comment period, that makes changes to how pharmaceutical firms report drug shortages.
Under current law, companies that are the sole manufacturer of certain drug products must notify the FDA at least six months before discontinuing the manufacturing of a product. These include FDA-approved products that are life supporting, life sustaining or used to prevent debilitating diseases or conditions, and are not originally derived from human issue and replaced by a recombinant product.
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