I 
112TH CONGRESS 
2D SESSION 
H. R. 4087 
To provide for the development and dissemination of best practices to ensure 
that visually-impaired and blind individuals in the United States have 
safe, consistent, reliable, and independent access to the information in 
prescription drug labeling. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 24, 2012 
Mr. MARKEY introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To provide for the development and dissemination of best 
practices to ensure that visually-impaired and blind indi-
viduals in the United States have safe, consistent, reli-
able, and independent access to the information in pre-
scription drug labeling. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug La-
beling Promotion Act of 2012’’. 
VerDate Mar 15 2010 
00:19 Feb 25, 2012
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4087.IH
H4087
jbell on DSK7SPTVN1PROD with BILLS
SEC. 2. ACCESSIBILITY OF INFORMATION IN PRESCRIP-
TION 
DRUG 
LABELING 
BY 
VISUALLY-IM-
PAIRED AND BLIND CONSUMERS. 
(a) ESTABLISHMENT OF WORKING GROUP.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’) shall establish a working group (in this 
section referred to as the ‘‘working group’’) to de-
velop and promulgate guidance constituting best 
practices on access to prescription drug labeling for 
the visually impaired. 
(2) MEMBERS.—The working group shall in-
clude representatives of national organizations rep-
resenting blind and visually impaired individuals, na-
tional organizations representing the elderly, and in-
dustry groups representing stakeholders, including 
pharmacists, who would be impacted by such best 
practices. Representation within the working group 
shall be divided equally between consumer and in-
dustry advocates. 
(3) GUIDANCE
ON
BEST
PRACTICES.—The 
working group shall promulgate, not later than 1 
year after the date of the enactment of this Act, 
guidance on best practices for pharmacies to ensure 
that blind and visually impaired individuals have 
safe, consistent, reliable, and independent access to 
VerDate Mar 15 2010 
00:19 Feb 25, 2012
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4087.IH
H4087
jbell on DSK7SPTVN1PROD with BILLS
the information in the labeling of prescription drugs. 
Such guidance shall be made available through pub-
lication in the Federal Register and posting on the 
Web site of the Food and Drug Administration. 
(4) CONSIDERATIONS.—In developing and pro-
mulgating such guidance on best practices, the 
working group shall consider— 
(A) the use of— 
(i) Braille; 
(ii) auditory means, such as— 
(I) ‘‘talking bottles’’ that provide 
audible label information; 
(II) digital voice recorders at-
tached to the prescription drug con-
tainer; and 
(III) radio frequency identifica-
tion (RFID) tags; and 
(iii) enhanced visual means, such as— 
(I) large font labels or large font 
‘‘duplicate’’ labels that are affixed or 
matched to a prescription drug con-
tainer; 
(II) high-contrast printing; and 
(III) sans-serf font; 
VerDate Mar 15 2010 
00:19 Feb 25, 2012
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4087.IH
H4087
jbell on DSK7SPTVN1PROD with BILLS
(B) whether there are technical, financial, 
manpower, or other factors unique to phar-
macies with 20 or fewer retail locations which 
may fundamentally impact the ability of such 
pharmacies to implement the best practices; 
and 
(C) such other factors as the working 
group determines to be appropriate. 
(5) INFORMATION CAMPAIGN.—Upon the pro-
mulgation of the guidance on best practices, the 
Commissioner of Food and Drugs, in consultation 
with the working group, shall conduct an informa-
tional and educational program designed to inform 
the public and pharmacists about such guidance and 
practices. 
(6) FACA WAIVER.—The Federal Advisory 
Committee Act shall not apply to the working group. 
(b) GAO STUDY.— 
(1) IN GENERAL.—Beginning 18 months after 
the publication of the guidance on best practices 
under subsection (a), the Comptroller General of the 
United States shall conduct a review of such guid-
ance, the extent to which pharmacies are complying 
with such best practices, and the extent to which 
VerDate Mar 15 2010 
00:19 Feb 25, 2012
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4087.IH
H4087
jbell on DSK7SPTVN1PROD with BILLS
barriers to accessible prescription drug labeling for 
blind and visually-impaired individuals continue. 
(2) REPORT.—Not later than September 30, 
2016, the Comptroller General shall submit to Con-
gress a report on the review conducted under para-
graph (1). Such report shall include recommenda-
tions for how best to reduce the barriers blind and 
visually-impaired individuals have to access prescrip-
tion drug labeling. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘pharmacy’’ includes a pharmacy 
that receives prescriptions, and dispenses prescrip-
tion drugs, through an Internet Web site. 
(2) The term ‘‘prescription drug’’ means a drug 
subject to section 503(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)). 
Æ 
VerDate Mar 15 2010 
00:19 Feb 25, 2012
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H4087.IH
H4087
jbell on DSK7SPTVN1PROD with BILLS