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Mary stated she occasionally drinks alcohol, but has not had a drink since she moved
In a 2018 guidance, FDA explained that it would consider a compounded drug to be essentially a copy of a commercially available drug if it has (i) the same API, (ii) the same or similar dosage, and (iii) the same route of administration, unless a prescriber determines that there is a change, made for an identified individual patient, which produces, for that patient, a significant difference from the commercially available drug product. The guidance also explains that, if a change is made for an identified patient, the prescriber should document the determination on the prescription, and the notations should be specific
10.1007/s00520-019-04997-6 13
Preventing the complications of uncontrolled diabetes, from kidney disease to neuropathy to cardiovascular events, changes lifetime health trajectories in ways that simple weight numbers cannot capture