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FDA may take regulatory action, however, if an outsourcing facility continues to fill new orders for the compounded drug after the approved drug is removed from FDAs drug shortage list, or if it continues to fill orders more than 60 days after the drug has been removed from FDAs drug shortage list

Consulting Medical Gastroenterologist MD

doi: 10.1016/S0140-6736(06)68699-6 25 LacroixAFeeldersRAStratakisCANiemanLK

Even within human studies, sample sizes tend to be small, often ranging from 10 to 50 participants, which reduces the statistical power and generalizability of the results

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