The OTC monograph is developed for therapeutic classes of ingredients that are generally recognized as safe and effective (GRASE).

• A. True
• B. False
• C. Not sure
• D. It depends

Answer: (A)

The main idea is that OTC drug monographs organize self-care products by therapeutic categories that the FDA has determined to be safe and effective for general use. GRASE stands for Generally Recognized As Safe and Effective, a status based on available safety data, historical use, and evidence that supports the intended OTC use. When an ingredient appears in an OTC monograph, it means that, under the specified conditions of use (such as how much to use, in which forms, with proper labeling and warnings), that ingredient is considered safe and effective for its OTC purpose. This framework lets products be marketed without a separate premarket approval, as long as they conform to the monograph’s rules. So the statement is true.