The two-class drug distribution system in the United States serves the needs of American consumers, ensuring convenient access to proven medicines.

The distribution of medicine in the United States is based on a two-class system: prescription and nonprescription (or over-the-counter) medicines. A nonprescription drug is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the product’s labeling. In the absence of physician supervision, FDA requires a wider margin of safety for nonprescription medicines than for prescription drugs.

This two-class system empowers consumers with a widening choice of safe and effective medicinal healthcare options conveniently available at competitive prices. This emphasis on consumer empowerment in matters of healthcare directly serves two of the most fundamental demands of any workable healthcare system: access and affordability.

Under the U.S. system, medicine makers and the FDA have room for flexibility and innovation, as well. Medicine makers can, and do, develop inventive and novel ways to ensure consumers can have access to even more resources for safe and effective nonprescription medicines. Web site information centers, point-of-sale kiosks, audio tapes, or distribution restrictions are a few examples of approaches in the market today with nonprescription medicines.