; therefore, patient safety is of the utmost importance. (4) Studies indicate that paper format patient medication information (PMI) can help protect patients and prevent the majority of costly adverse drug events. (5) In addition to bolstering patient safety, the mandatory use of a standardized PMI provided to all patients in nonhospital settings could reduce costs associated with emergency room visits and hospital admissions related to adverse drug events by $14.6 to $26.2 billion dollars annually. (6) Many patients cannot access electronic versions of PMI, thereby necessitating a paper option. (7) The Government Accountability Office found that relying on electronic labeling as a complete substitute for paper labeling could adversely impact public health. (8) A congressionally mandated paper PMI is needed because no standardized PMI in a single page, paper copy, proven patient-friendly format is currently available to patients or required by the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). 3. Patient medication information for prescription drugs (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by inserting after section 505G ( 21 U.S.C. 355h ) the following: 505H. Patient medication information for prescription drugs (a) In general The Secretary shall issue regulations on the patient medication information that is required to be in the printed labeling of drugs subject to section 503(b)(1), including regulations regarding the authorship, content, format, color, printing, and dissemination requirements for such patient medication information. The Secretary shall issue final regulations pursuant to the preceding sentence not later than 1 year after the date of enactment of this section. (b) Content The regulations promulgated under subsection (a) shall require that the patient medication information with respect to a drug— (1) be scientifically accurate, include relevant patient safety information, and be approved by the Secretary