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National Academies of Science, Engineering, and Medicine (NASEM) Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Products

National Academies of Science, Engineering, and Medicine (NASEM) Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Products

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

Project Start: September 2018

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.

Compounded topical pain creams are not FDA-approved, which means these products have not undergone an FDA assessment of safety, effectiveness and quality.

NASEM will identify and analyze the available scientific data relating to the ingredients used in compounded topical pain creams and evaluate how those data translate to the safety and effectiveness of these products. NASEM will provide recommendations regarding the treatment of patients with compounded topical pain creams based on its research.

Please see the NASEM website for more information.