OTCness

“OTCness” is the widespread availability of safe and effective nonprescription medicines for responsible self care by the consumer according to label directions, pursuant to the applicable laws, regulations, and voluntary industry codes affecting manufacturing, packaging, labeling, distribution, and sales of quality products and the advertising of those products in all media. The pivotal issues in determining the potential “OTCness”—or change in classification—of a prescription drug product by a Food and Drug Administration (FDA) advisory committee pertains to the safety, effectiveness, and labeling of the switch candidate, while manufacturing, packaging, advertising, and distribution issues are routinely not a part of such deliberations, notwithstanding their importance to “OTCness.” Because the European Union is interested in establishing a regulatory rationale for the classification of nonprescription medicines, this paper summarizes how “OTCness” is defined in the United States, based on current law, regulations, and regulatory practice.