Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018

Bill 115 hr 5333, also known as the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, is a piece of legislation that aims to modernize the way over-the-counter (OTC) drugs are regulated in the United States. The bill was introduced in the House of Representatives on March 15, 2018, by Representative Bob Latta.

The main goal of the bill is to streamline the process for approving and regulating OTC drugs, which are medications that can be purchased without a prescription. Currently, OTC drugs are regulated under the monograph system, which is a set of rules and guidelines established by the Food and Drug Administration (FDA). However, this system has not been updated in over 40 years, leading to inefficiencies and delays in bringing new OTC drugs to market.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 seeks to address these issues by giving the FDA more flexibility and authority to regulate OTC drugs. The bill would allow the FDA to review and approve new ingredients and formulations for OTC drugs more quickly, while still ensuring that they are safe and effective for consumers. Additionally, the bill includes provisions to improve the safety and quality of OTC drugs, such as requiring manufacturers to register their products with the FDA and adhere to good manufacturing practices. It also establishes a user fee program to help fund the FDA's oversight of OTC drugs. Overall, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 aims to modernize the regulation of OTC drugs in the United States, making it easier for consumers to access safe and effective medications without a prescription.