How Does Modern-Day Compounding Create Uncertainty, Inconsistency & Risk to Patients?

In this episode of Derms and Conditions, host James Q. Del Rosso, DO is joined by Stefan Weiss, MD for a focused discussion on compounding in dermatology, an area that often operates with less visibility but carries important clinical implications. The conversation centers on the regulatory and practical differences between 503A and 503B compounding pharmacies, with particular attention to 503A facilities, where customized medications are prepared based on individual prescriptions. They outline key concerns with this model, including variability in formulation, lack of standardized testing, and limited oversight compared with FDA-approved therapies. Unlike commercially developed medications, compounded products are not required to undergo stability testing, penetration studies, or clinical trials, raising questions about consistency, efficacy, and safety. A recurring theme is the challenge of knowing exactly what patients receive. Without controls on formulation integrity or bioavailability, clinicians may encounter variability not only between pharmacies, but even between batches from the same source, highlighting how this uncertainty can complicate treatment decisions. The episode also contrasts compounded therapies with FDA-approved options, using topical clascoterone as an example of a rigorously tested, standardized formulation. While both speakers acknowledge that compounding has a role, particularly in addressing unmet or niche patient needs, they note that its use today has expanded beyond its original intent. Tune in to the episode to hear how clinicians can approach compounded therapies with greater scrutiny, balance their use against standardized treatments, and make more informed decisions in everyday dermatology practice.