(1) Prescription medications are important to 
the health and well-being of the American public. 
(2) According to the Centers for Disease Con-
trol and Prevention (CDC), 48.9 percent of Ameri-
cans used at least one prescription drug in the past 
30 days. 
(3) The utilization of prescription drugs can 
subject patients to adverse drug events; therefore, 
patient safety is of the utmost importance. 
(4) Studies indicate that paper format patient 
medication information (PMI) can help protect pa-
tients 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 hos-
pital 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 op-
tion. 
(7) The Government Accountability Office 
found that relying on electronic labeling as a com-
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plete 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.). 
SEC. 3. PATIENT MEDICATION INFORMATION FOR PRE-
SCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 505G (21 U.S.C. 355h) the 
following: 
‘‘SEC. 505H. PATIENT MEDICATION INFORMATION FOR PRE-
SCRIPTION DRUGS. 
‘‘(a) IN GENERAL.—The Secretary shall issue regula-
tions on the patient medication information that is re-
quired to be in the printed labeling of drugs subject to 
section 503(b)(1), including regulations regarding the au-
thorship, content, format, color, printing, and dissemina-
tion 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. 
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‘‘(b) CONTENT.—The regulations promulgated under 
subsection (a) shall require that the patient medication in-
formation with respect to a drug— 
‘‘(1) be scientifically accurate, include relevant 
patient safety information, and be approved by the 
Secretary; 
‘‘(2) include understandable plain language, 
and include graphics and pictures when applicable, 
and be provided in a consistent, standardized format 
and color for all drug products, and not be pro-
motional in tone or content, and contain at least— 
‘‘(A) the established name of the drug (or, 
if the drug is a biological product, the proper 
name of the biological product) and the national 
drug code for the drug; 
‘‘(B) indications for use approved by the 
Food and Drug Administration; 
‘‘(C) general directions for proper use; 
‘‘(D) contraindications, warnings, pre-
cautions, the most frequently occurring adverse 
reactions, and adverse reactions that are impor-
tant for other reasons (such as because they are 
serious), especially with respect to certain sub-
populations such as children, pregnant women, 
and the elderly; 
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‘‘(E) measures patients may be able to 
take, if any, to reduce the side effects and risks 
of the drug; 
‘‘(F) information about when a patient 
should contact his or her health care profes-
sional; 
‘‘(G) instructions not to share medications, 
and, if applicable, key storage requirements and 
recommendations relating to proper disposal of 
any unused portion of the drug; 
‘‘(H) known clinically important inter-
actions with other drugs, food, and other sub-
stances; 
‘‘(I) a statement of whether sufficient data 
are available concerning the use of the drug in 
specified subpopulations, such as women, preg-
nant women, lactating women, women and men 
of reproductive age, and pediatric, geriatric, ra-
cial, and ethnic minority groups; 
‘‘(J) the name of the manufacturer and a 
toll-free telephone number for consumers to 
contact the manufacturer of the drug; and 
‘‘(K) a current link to Form FDA 3500B 
for voluntary reporting for consumers of ad-
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verse events, product problems, and product use 
errors (or any successor form); and 
‘‘(3) be provided to a patient or agent of a pa-
tient in a printed format with each prescription dis-
pensed, 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 pre-
scriptions 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 medica-
tion to avoid patient confusion and harm; 
‘‘(3) include specifications for language, graph-
ics, format, color, and pictures required by sub-
section (b)(2), to be developed based upon docu-
mented patient research with one or more actual 
drug products that demonstrates improved patient 
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learning and understanding of safe and effective 
medication use; and 
‘‘(4) be based on a demonstrated causal connec-
tion between the enhanced patient medication infor-
mation required by the regulations and improved pa-
tient medication adherence and compliance for the 
purpose of reducing the cost of health care and im-
proving 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 accord-
ance with section 505H.’’. 
Æ 
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