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The FDA allows the compounding of certain drugs if the commercially available version is in a verified shortage , which they define as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug. Although there is no exact threshold, this decision is usually based on disruptions in manufacturing and distribution as well as unexpected demand surges
Diabetologia (2022) 65:125161
doi: 10.1227/NEU.0b013e31820a1599 30 SobczukPTeteryczPCzarneckaAMwitajTKosea-PaterczykHKozakKet al
doi: 10.1371/journal.pone.0113840 338 PetrukGPuthiaMPetrlovaJSamsudinFStrmdahlA-CCerpsSet al
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