Exocrine Pancreatic Insufficiency Drug Products for Over-The- Counter Human Use

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The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) exocrine pancreatic insufficiency drug products (drug products used to treat pancreatic enzyme deficiency) are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule after considering public comments on the agency's notice of proposed rulemaking and all new information on OTC exocrine pancreatic insufficiency drug products that has come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA.