[Skip to Navigation]
September 2018

Prescription to Over-the-Counter Switch of Metronidazole and Azelaic Acid for Treatment of Rosacea

Author Affiliations
  • 1Department of Dermatology, Boston University School of Medicine, Boston, Massachusetts
  • 2Retired, Columbus, Ohio
JAMA Dermatol. 2018;154(9):997-998. doi:10.1001/jamadermatol.2018.1667

In 1951, the Durham-Humphrey Amendment to the US Federal Food, Drug, and Cosmetic Act of 1938 was enacted to label medications into 2 specific categories: prescription vs over the counter (OTC). This amendment required that any habit-forming or potentially harmful medications be dispensed under the direct guidance of a health care professional. “Rx to OTC switch” is defined as the transfer of prescription drugs to OTC status; it is a data-driven process, rigorously regulated by the US Food and Drug Administration (FDA). For the switch to occur, the candidate drug must demonstrate proven efficacy and a wide safety margin and bear understandable labeling for proper use. In recent decades, the increased demand by consumers to take charge of their own medical care has impelled the prescription to OTC switch of more than 100 medications that were previously available only by prescription. In this Viewpoint, we consider the possibility that the topical treatments for rosacea, specifically metronidazole and azelaic acid, should undergo review for the prescription to OTC switch. We outline the potential advantages and disadvantages of such a switch.