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What we know: Compounded formulations can use the same active pharmaceutical ingredients when properly compounded with base forms Molecular structure can be identical with base forms Mechanism of action is the same What creates uncertainty: Whether compounded formulations achieve identical bioavailability Whether different inactive ingredients affect efficacy Whether quality and potency are consistent Whether beyond-use dates reflect actual stability FDA has specifically warned some compounded products use problematic salt forms The regulatory reality: Compounded medications haven't been studied in controlled trials FDA doesn't verify quality, potency, or efficacy before receipt Quality depends on individual pharmacy practices Patients bear quality variability risk This is the fundamental trade-off: You gain affordability and access

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doi: 10.1146/annurev-physiol-021115-104948 166 ObradovicMSudar-MilovanovicESoskicSEssackMAryaSStewartAJet al

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