; and (K) a current link to Form FDA 3500B for voluntary reporting for consumers of adverse events, product problems, and product use errors (or any successor form); and (3) be provided to a patient or agent of a patient in a printed format with each prescription dispensed, such that a drug labeled for distribution shall be accompanied by printed labeling physically on or within the packaging from which the drug is to be dispensed, in an adequate supply of printed patient medication information to accommodate prescriptions dispensed therefrom. (c) Timeliness, consistency, accuracy, and effectiveness The regulations promulgated under subsection (a) shall— (1) provide for timely reviews, approvals, and updates of patient medication information as new drugs and new information become available; (2) provide for updates when appropriate to help communicate information that is shared by similar products or drugs within classes of medication to avoid patient confusion and harm; (3) include specifications for language, graphics, format, color, and pictures required by subsection (b)(2), to be developed based upon documented patient research with one or more actual drug products that demonstrates improved patient learning and understanding of safe and effective medication use; and (4) be based on a demonstrated causal connection between the enhanced patient medication information required by the regulations and improved patient medication adherence and compliance for the purpose of reducing the cost of health care and improving desired medical outcomes. . (b) Misbranding offense Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: (gg) If it is a drug subject to section 503(b)(1) and patient medication information is not provided in accordance with section 505H. .