The Misuse of Drug Compounding in the United States

This commentary examines the regulatory, clinical, and ethical aspects of pharmaceutical drug compounding misuse in the United States (US), with a focus on dermatologic practice and associated patient safety risks. Drug compounding remains an essential component of clinical care when US Food and Drug Administration (FDA)-approved therapies are unavailable, unsuitable, or discontinued. However, expansion of compounding beyond these limited indications has been accompanied by documented quality failures, inconsistent regulatory oversight, commercialization pressures, and avoidable patient harm. In the US, a hybrid federal-state framework governs compounding, creating regulatory gaps that can be exploited by high-volume compounders operating at the boundary between pharmacy practice and manufacturing. Evidence from statutory history, regulatory actions, clinical studies of compounded topical preparations, and public health investigations demonstrates that compounded products often lack validated manufacturing consistency, stability, labeling standardization, and systematic safety surveillance. Dermatology illustrates these risks because compounded combination topical therapies are frequently promoted as cash-pay alternatives, sometimes with physician dispensing and inadequate disclosure of limitations in safety, efficacy, costs, and conflicts of interest. Compounded drugs should be reserved for patient-specific indications when approved therapies cannot reasonably meet clinical needs. Policies that clarify the boundary between 503A compounding and 503B outsourcing, strengthen enforcement consistency, and require meaningful informed consent and disclosure can reduce preventable harm while preserving appropriate access.