Time and Extent Applications for Nonprescription Drug Products

This information collection supports certain FDA regulations in 21 CFR part 330 regarding over-the-counter (OTC) human drugs and associated guidance. Specifically, our regulations in §§ 330.14 and 330.15 (21 CFR 330.14 and 330.15), established additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. However, these regulations are not reflective of more-recently enacted statutory provisions that govern the regulation of OTC human drugs marketed without approved new drug applications, under the OTC drug review process, and accordingly, these regulations will be withdrawn. These regulations provided that OTC drug products introduced into the U.S. market after the OTC drug review began in 1972 and OTC drug products without any marketing experience in the United States could be evaluated under the OTC monograph system if the conditions (e.g., active ingredients) met certain ‘‘time and extent’’ criteria outlined in the regulations. The regulation in 21 CFR 330.14 allowed a sponsor to submit certain information to the Agency in a time and extent application (TEA) for use to determination the eligibility of a condition for consideration in the OTC monograph system.

The latest form for Time and Extent Applications for Nonprescription Drug Products expires 2027-01-31 and can be found here.