NASEM Assessment on the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
In recent years, we’ve become aware of a rise in the use of compounded topical pain creams. FDA has been concerned that clinicians and patients may not be aware of potential safety risks, or the potential lack of effectiveness, associated with certain ingredients and combinations of ingredients in compounded topical pain creams. The agency asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to organize an ad hoc committee to review scientific data on the safety and effectiveness of ingredients commonly used in compounded topical creams to provide an independent assessment (see the button for the free PDF on the right side of NASEM’s report webpage).NASEM’s analysis and research findings on compounded topical pain creams, and 20 active pharmaceutical ingredients commonly used in these products, align with FDA’s concerns that these compounded pain creams pose a risk to patients. For example, NASEM concluded that inadequate data to support conclusions regarding the safety of the ingredients in these products gives rise to a substantial public health concern. Because compounded drugs are not FDA-approved, it’s important for patients and the medical community to have access to information about the quality of these products.FDA is reviewing NASEM’s findings and considering next steps to use them to inform our internal work on compounding. We will continue to work with compounders, regulators and patients to take steps to advance policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of poor quality compounded drugs.