Prescription Information Modernization Act of 2023

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Introduced in House (IH)]

&lt;DOC&gt;






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prescription Information 
Modernization Act of 2023''.

SEC. 2. DIGITAL COMMUNICATION OF FDA-APPROVED PRESCRIBING INFORMATION 
              FOR DRUGS (INCLUDING BIOLOGICAL PRODUCTS).

    (a) In General.--Section 502(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352(f)) is 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 applicable 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 provides 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 regulations 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 manufacturer or 
                distributor if desired.
            (2) Economic impacts.--The Secretary of Health and Human 
        Services shall design the regulations required by paragraph (1) 
        so as to minimize 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 Commissioner 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 prescribing 
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).
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