NASEM Report: Safety and Effectiveness of Ingredients in Compounded Topical Pain Creams

NASEM Report: Safety and Effectiveness of Ingredients in Compounded Topical Pain Creams

Overall Conclusions and Recommendations

The National Academies of Science, Engineering and Medicine committee, including John Farrar, MD, PhD, came to three overarching conclusions regarding the safety, effectiveness, and regulation of compounded topical pain creams:

• There is limited evidence to support the use of compounded topical pain creams to treat pain conditions in the general adult population. The few active pharmaceutical ingredients (APIs) that show potential effectiveness in compounded topical pain creams (i.e., doxepin, naproxen, lidocaine) are already available in FDA-approved topical products used to treat pain.

• In context of the recent rise in supply and demand of compounded preparations, lack of evidence regarding systemic absorption of ingredients used in compounded topical pain creams gives rise to a substantial public health concern. It is important to consider the potential effects of all organic compounds (including APIs and excipients) that may permeate the skin.

• There is an opportunity for the U.S. Department of Health and Human Services to provide additional oversight to ensure the safety of compounded pain creams, with prioritized focus on those containing APIs that, when applied topically, cross the skin barrier to enter the bloodstream and act systemically within the body.

Find the full report publication (scroll down).

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