I 
118TH CONGRESS 
1ST SESSION H. R. 1503 
To provide for digital communication of prescribing information for drugs 
(including biological products), and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 9, 2023 
Mrs. HARSHBARGER (for herself and Ms. SHERRILL) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To provide for digital communication of prescribing informa-
tion for drugs (including biological products), and for 
other purposes. 
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 Informa-
tion Modernization Act of 2023’’. 
SEC. 2. DIGITAL COMMUNICATION OF FDA-APPROVED PRE-
SCRIBING INFORMATION FOR DRUGS (IN-
CLUDING BIOLOGICAL PRODUCTS). 
(a) IN GENERAL.—Section 502(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is 
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amended by adding at the end the following: ‘‘Required 
prescribing information for drugs subject to section 
503(b)(1) may be made available solely by electronic 
means provided that the labeling complies with all applica-
ble requirements of law, that the manufacturer affords 
prescribers and dispensers the opportunity to elect to also 
continue to receive all such information in paper form, or 
to request paper labeling on an as-needed basis, and after 
such request, and that the manufacturer promptly pro-
vides the requested information without additional cost.’’. 
(b) RULEMAKING.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services shall issue final reg-
ulations to— 
(A) implement the amendment made by 
subsection (a); and 
(B) provide instructions on how health 
care professionals can receive paper copies of 
prescribing information directly from the manu-
facturer or distributor if desired. 
(2) ECONOMIC
IMPACTS.—The Secretary of 
Health and Human Services shall design the regula-
tions required by paragraph (1) so as to minimize 
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the adverse economic impacts of such regulations on 
prescribers and dispensers. 
(c) PUBLIC WORKSHOP.—Not later than 2 years 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services, acting through the Com-
missioner of Food and Drugs, shall hold a public workshop 
with relevant stakeholders to discuss how to continue to 
optimize the format, accessibility, and usability of pre-
scribing information. 
(d) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to drugs introduced 
or delivered for introduction into interstate commerce on 
or after the sooner of— 
(1) the date that is 2 years after the date of the 
enactment of this Act; or 
(2) the effective date of the final regulations 
promulgated to implement such amendment. 
(e) DEFINITION.—In this section, the term ‘‘drug’’ 
has the meaning given to such term in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
Æ 
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