Nonprescription Drug Regulation in the United States

Abstract

In the United States, nonprescription drug products are regulated through implementation of laws enacted by Congress. The Food and Drug Administration (FDA) follows specific procedures that allow for public notice and comment when promulgating implementing regulations. Drug products may be marketed directly to consumers, unless they are limited to prescription use only because they meet certain criteria. Nonprescription drug products are marketed over the counter (OTC) pursuant to drug ingredient-use monographs or as approved new drugs for an OTC use. These United States regulatory pathways require evidence of safety, efficacy, and labeling that consumers can understand that renders the product not adulterated or misbranded. All new drugs are required to comply with specific postmarketing surveillance practices.