Patients’ Right to Know Their Medication Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to require that standardized, printed patient medication information (PMI) be included with all prescription drugs dispensed in nonhospital settings. It mandates that the Secretary of Health and Human Services issue regulations within one year to govern the content, format, and distribution of this information.

Sec. 3, Patient medication information for prescription drugs: This section adds a new section 505H to the FD&C Act. It requires the Secretary to issue regulations on PMI for prescription drugs, including authorship, content, format, color, printing, and dissemination. The regulations must ensure PMI is scientifically accurate, uses plain language and graphics, is provided in a consistent format and minimum font size, and is printed on paper. The PMI must include the drug's name, approved uses, directions, warnings, side effects, interactions, manufacturer contact info, and a link for reporting adverse events. It must be provided to the patient or their agent with each prescription dispensed, physically on or within the packaging, in an adequate supply. The regulations must also provide for timely updates, consistency across similar drugs, and be based on research showing improved patient understanding and adherence.

Sec. 3, Misbranding offense: This section amends section 502 of the FD&C Act to add that a prescription drug is misbranded if PMI is not provided in accordance with the new section 505H.