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 information for drugs (including biological products), and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prescription Informa5 tion Modernization Act of 2023’’. 

6 SEC. 2. DIGITAL COMMUNICATION OF FDA-APPROVED PRE7 SCRIBING INFORMATION FOR DRUGS (IN8 CLUDING BIOLOGICAL PRODUCTS). 

9 (a) IN GENERAL.—Section 502(f) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is 


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1 amended by adding at the end the following: ‘‘Required 

2 prescribing information for drugs subject to section 

3 503(b)(1) may be made available solely by electronic 

4 means provided that the labeling complies with all applica5 ble requirements of law, that the manufacturer affords 

6 prescribers and dispensers the opportunity to elect to also 

7 continue to receive all such information in paper form, or 

8 to request paper labeling on an as-needed basis, and after 

9 such request, and that the manufacturer promptly pro10 vides the requested information without additional cost.’’. 

11 (b) RULEMAKING.— 

12 (1) IN GENERAL.—Not later than 1 year after 

13 the date of the enactment of this Act, the Secretary 

14 of Health and Human Services shall issue final reg15 ulations to— 

16 (A) implement the amendment made by 

17 subsection (a); and 

18 (B) provide instructions on how health 

19 care professionals can receive paper copies of 

20 prescribing information directly from the manu21 facturer or distributor if desired. 

22 (2) ECONOMIC IMPACTS.—The Secretary of 

23 Health and Human Services shall design the regula24 tions required by paragraph (1) so as to minimize 


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1 the adverse economic impacts of such regulations on 

2 prescribers and dispensers. 

3 (c) PUBLIC WORKSHOP.—Not later than 2 years 

4 after the date of the enactment of this Act, the Secretary 

5 of Health and Human Services, acting through the Com6 missioner of Food and Drugs, shall hold a public workshop 

7 with relevant stakeholders to discuss how to continue to 

8 optimize the format, accessibility, and usability of pre9 scribing information. 

10 (d) EFFECTIVE DATE.—The amendment made by 

11 subsection (a) shall apply with respect to drugs introduced 

12 or delivered for introduction into interstate commerce on 

13 or after the sooner of— 

14 (1) the date that is 2 years after the date of the 

15 enactment of this Act; or 

16 (2) the effective date of the final regulations 

17 promulgated to implement such amendment. 

18 (e) DEFINITION.—In this section, the term ‘‘drug’’ 

19 has the meaning given to such term in section 201 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

Æ 


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