FDA issues final rule on drug shortage notification requirements
The Food and Drug Administration today issued a final rule requiring all manufacturers of certain medically important prescription drugs to notify the agency of permanent discontinuances or temporary interruptions in manufacturing that are likely to disrupt the supply of the product in the United States. Required by the Food and Drug Administration Safety and Innovation Act of 2012, the rule also would extend the early notification requirement to medically important biologic products. In comments on the proposed rule, AHA said the requirement would allow FDA to communicate more and better information to patients, hospitals and physicians.
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