FDA OTC Classification Risk Factors US Market in 2023 – Insight 5 FDA OTC Classification Risk Factors US Market in 2023 – Insight 5 Step 1: Understanding OTC Classification Over-the-counter (OTC) products are those that can be sold directly to consumers without a prescription. In the U.S., the FDA oversees the classification of these products, differentiating them from prescription (Rx) drugs based on criteria such as safety and efficacy. The OTC monograph system provides a framework for these determinations, streamlining the approval process for certain medications. To successfully navigate the OTC landscape, it’s crucial to grasp the fundamental distinctions between…