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FDA explicitly notes that compounded drugs are not FDA-approved and should be used when a patients needs cannot be met by an available approved product or when an approved product is not commercially available

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Cham: Springer International Publishing (2015)

Caveat : this is a real, non-trivial preference point for some people, independent of anything on the evidence ledger

Our clinical staff is trained to monitor patients closely during and after the procedure for any signs of an adverse reaction