II 

118TH CONGRESS 

1ST SESSION S. 2916 

To provide for digital communication of prescribing information for drugs 

(including biological products), and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 26 (legislative day, SEPTEMBER 22), 2023 

Mr. BOOKER (for himself and Mr. MULLIN) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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’’. 


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•S 2916 IS

1 SEC. 2. DIGITAL COMMUNICATION OF FDA-APPROVED PRE2 SCRIBING INFORMATION FOR DRUGS (IN3 CLUDING BIOLOGICAL PRODUCTS). 

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

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

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

7 prescribing information for drugs subject to section 

8 503(b)(1) may be made available solely by electronic 

9 means, provided that the labeling complies with all appli10 cable requirements of law, that the manufacturer affords 

11 prescribers and dispensers the opportunity to elect to also 

12 continue to receive all such information in paper form or 

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

14 such request, that the manufacturer promptly provides the 

15 requested information without additional cost.’’. 

16 (b) RULEMAKING.— 

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

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

19 of Health and Human Services shall issue final reg20 ulations to— 

21 (A) implement the amendment made by 

22 subsection (a); and 

23 (B) provide instructions on how health 

24 care professionals can receive paper copies of 

25 prescribing information directly from the manu26 facturer or distributor if desired. 


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•S 2916 IS

1 (2) ECONOMIC IMPACTS.—The Secretary of 

2 Health and Human Services shall design the regula3 tions required by paragraph (1) so as to minimize 

4 the adverse economic impacts of such regulations on 

5 prescribers and dispensers. 

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

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

8 of Health and Human Services, acting through the Com9 missioner of Food and Drugs, shall hold a public workshop 

10 with relevant stakeholders to discuss how to continue to 

11 optimize the format, accessibility, and usability of pre12 scribing information. 

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

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

15 or delivered for introduction into interstate commerce on 

16 or after the sooner of— 

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

18 enactment of this Act; or 

19 (2) the effective date of the final regulations 

20 promulgated to implement such amendment. 

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

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

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

Æ 


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