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While compounded medications may seem appealing because of their lower prices and easier access during drug shortages, they can come with real safety risks

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

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