Time and Extent Applications for Nonprescription Drug Products

This information collection supports Food and Drug Administration (FDA or we) regulations regarding “Time and Extent Applications for Nonprescription Drug Products.” Respondents (private sector businesses) may submit to the Food and Drug Administration (FDA) a request that an active ingredient or ingredients be included in the over-the-¬counter (OTC) drug monograph system. FDA follows the procedures outlined in 21 CFR 330.10 for classifying active ingredients in OTC drug products as generally recognized as safe and effective (GRASE) and not misbranded.

The latest form for Time and Extent Applications for Nonprescription Drug Products expires 2023-12-31 and can be found here.