NASEM Report Urges Tougher Oversight of 503A Pharmacies That Compound Topical Pain Creams

Compounded topical pain creams have become an increasingly popular alternative to oral pain medications in recent years, yet there is a lack of scientific evidence to support their safety and effectiveness, as well as a "disconcerting" lack of regulatory oversight for these products, asserts a 13 May report from the National Academies of Sciences, Engineering and Medicines (NASEM). The report recommends stricter oversight of 503A pharmacies by state pharmacy boards and a more robust system for reporting adverse events.

The report could bolster the US Food and Drug Administration’s moves to put stricter controls in place for drugs made at traditional compounding pharmacies, which are largely regulated by state pharmacy boards per Section 503A of the Food, Drug & Cosmetic Act. The agency has been taking action in recent years to hold these compounding pharmacies to higher quality standards. It recently signed a final memorandum of understanding with states that establishes expectations for states to monitor out-of-state distribution of pharmacy compounded drugs and report any adverse events to the FDA