Introduction to OTC Approval
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating over-the-counter (OTC) products. These products, which are available without a prescription, must meet strict requirements to ensure they are safe and effective for consumers. OTC approval involves several steps, including reviewing ingredients, labeling, and manufacturing processes.
How the Registration Process Works
The OTC product registration process with the FDA begins with submitting a detailed description of the product, including its intended use and the scientific data that supports its safety and effectiveness. Manufacturers must also ensure that their manufacturing facilities comply with the Good Manufacturing Practices (GMP) established by the FDA. After a thorough review, the FDA either approves the product for marketing or requests more information. Through this process, the FDA ensures that consumers have access to safe and effective OTC products. FDA OTC Registration