NASEM Assessment on the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
NASEM study leads: Andrew Pope, PhD, Director, Board on Health Sciences Policy, Health and Medicine Division; Leigh Miles Jackson, PhD, Senior Program Officer, Board on Health Sciences Policy
NASEM provided FDA with its analysis of compounded topical pain creams on May 13, 2020. NASEM’s report concludes, among other things, that there is limited evidence to support the use of compounded topical pain creams in the general adult population, and inadequate data to support conclusions regarding the safety of ingredients in these products gives rise to a substantial public health concern. The report also includes recommendations for state and federal regulators regarding oversight of compounded drugs and for health care professionals treating patients with compounded topical pain creams.
Compounded topical pain products typically contain multiple active pharmaceutical ingredients (APIs). Often at least one of the ingredients is also found in an FDA-approved topical pain cream, such as lidocaine. However, the remaining ingredients may be active ingredients in drugs approved by FDA for non-topical administration and/or for non-pain-related indications.
As with all compounded drugs, compounded topical pain creams are not FDA-approved, which means these products have not undergone an FDA assessment of safety, effectiveness and quality.
In September 2018, FDA asked NASEM to identify and analyze scientific data relating to ingredients used in compounded topical pain creams and to evaluate how those data translate to the safety and effectiveness of these products.
Please see NASEM’s website for more information.