Overview of FDA process to switch birth control pills from prescription-only to over-the-counter status

After nearly two decades of coalition-driven advocacy, research, and organizing efforts, the first-ever application for an over-the-counter (OTC) birth control pill was submitted to the US Food and Drug Administration (FDA) in 2022. Typically, the research and other activities involved in developing and submitting an Rx-to-OTC switch application, and the regulatory review can take multiple years to complete. This submission is the next step in the regulatory process and initiated the typical 10-month timeline during which the FDA reviews the data and makes a decision on whether to approve the product for OTC use. 

Our fact sheet walks through the FDA Rx-to-OTC switch process, including key steps leading up to submission and the typical 10-month timeline for agency review and decision.