FDA’s Center for Drug Evaluation and Research (CDER) is responsible for handling the review of OTC medicines. Specifically, CDER’s Office of Nonprescription Drugs takes primary responsibility for reviewing OTCs. However, other experts and agencies within FDA are often called upon to assist in the effort. FTC has authority in the area of OTC advertising, just as it does for other consumer products. The U.S. Consumer Product Safety Commission (CPSC) has authority in the area of child-resistant closures, found on many OTC products.
