‘‘(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-
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS
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 
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS
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: 
‘‘(ee) If it is a drug subject to section 503(b)(1) and 
patient medication information is not provided in accord-
ance with section 505G.’’. 
Æ 
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6301
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS