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When Compounded Drugs Are Not Considered Copies The FDA recognizes three situations where a compounded drug will not be considered a copy of a commercially available product: The drug has been discontinued and is no longer marketed The drug is not readily available and is listed on the FDAs drug shortage list There is a specific change made for an identified patient whose medical needs cannot be met by the commercially available product [2] The Significant Difference Requirement For 503A compounding pharmacies, the third exception requires documentation that the prescriber has determined the compounded drug has a change that produces a significant difference for a specific patient
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Reuters, Al Jazeera, and contemporaneous reporting confirm that the organization showed no signs of awareness
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Kidney function monitoring becomes essential when both drugs are used concurrently
