Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

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 Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded expires 2023-12-31 and can be found here.