Manufacturers of OTC drugs approved in a new drug application are required to report quality defects (see 21 CFR 314.81). Manufacturers or distributors of OTC monograph drugs (these are drugs that are not approved in a product-specific application) are not required to submit quality defect reports. However, the manufacturer, packer, or distributor whose name appears on the label of an OTC drug without an approved application (i.e., OTC monograph drugs) must submit to FDA any report received of a serious adverse event associated with such drug when used in the United States (see section 760 of the Federal Food, Drug, and Cosmetic Act). Thus, if a serious adverse event is caused by a quality defect, FDA will receive a report about the event (see also the guidance for industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.
