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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

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

Gilbert, Rosenthal, March 2024

Audit your copy this week, replace brand comparisons with accurate descriptions, and treat certification as the compliance layer it is

Long-term digestive problems: Some users allege ongoing nausea, abdominal pain, food intolerance, and inability to eat normally