Answer
Feb 28, 2025 - 12:46 AM
The FDA guidelines for over-the-counter (OTC) drugs require that these medications be safe and effective for use without a healthcare professional's supervision. They must comply with established monographs, which specify acceptable ingredients, doses, formulations, and labeling requirements. If a drug does not fit within an existing monograph, it must undergo the FDA's New Drug Application (NDA) process for approval.
