National Regulatory Uniformity for
Over-the-Counter (OTC) Medicines
The U.S. has an efficient national marketplace with goods moving freely and efficiently from state to state. An important segment of this dynamic marketplace is the wide variety of OTC medicines.
For decades, the U.S. Food and Drug Administration (FDA) has regulated the safety, effectiveness, and proper labeling of OTC medicines. The comprehensive FDA system means we do not need individual state rules that would impose inconsistent regulations or create disruptions in the national marketplace.
The Food and Drug Administration Modernization Act of 1997 included a national uniformity provision that prohibits states from adopting laws or regulations concerning OTC medicines that are different from or in addition to those required by FDA.
The landmark legislation received widespread support and passed Congress with overwhelming bipartisan backing. Nearly 100 national and state organizations, representing consumers, health professionals, seniors, and retailers, supported the national uniformity provisions.