Over-the-Counter Monograph Drug User Fee Amendments

This bill renews a program through 2030 that lets the Food and Drug Administration (FDA) charge fees to companies that make or sell certain over-the-counter drugs, like common medicines you can buy without a prescription. These drugs follow FDA rules called "monographs," which spell out what ingredients, doses, and other requirements are allowed. The bill updates how much the FDA can collect in fees, changes when those fees are due, and requires the FDA to publish fee amounts at least 60 days before each fiscal year starts. It also adds a new type of request that companies can make to update testing procedures for these drugs, though this type of request does not give the company exclusive rights to sell the product.

Your Vote