This bill, the "Patients' Right to Know Their Medication Act of 2025," seeks to amend the Federal Food, Drug, and Cosmetic Act to ensure patients receive comprehensive prescription drug information. Congress highlights that adverse drug events are a significant risk for the nearly half of Americans using prescription drugs, and standardized paper patient medication information (PMI) could prevent these events and save billions in healthcare costs. The legislation underscores that a paper option is crucial because many patients lack access to electronic versions, and a federally required, standardized paper PMI is currently absent. The bill mandates the Secretary of Health and Human Services to issue regulations within one year, establishing requirements for printed PMI to be included with prescription drugs. This PMI must be scientifically accurate, approved by the Secretary, and developed by manufacturers as part of the drug approval process. Key content requirements include understandable plain language , graphics, a consistent standardized format , and specific details such as indications, directions, warnings, adverse reactions, and drug interactions. It must also provide information on proper use, storage, disposal, and a link for reporting adverse events. The regulations will specify that PMI be supplied by manufacturers in printed paper form, consistent with Current Good Manufacturing Practice, and be non-promotional. Most importantly, this printed PMI must be provided to a patient or their agent with each prescription dispensed , ensuring an adequate supply is available. The bill also stipulates that failure to provide PMI in accordance with these new requirements will result in the drug being considered misbranded.