H.R. 4132House119th Congress (2025-2027)In Committee

Prescription Information Modernization Act of 2025

AI-Generated Summary

Updated November 23, 2025 at 11:47 PM UTC

The Prescription Information Modernization Act of 2025 updates the law so that drug prescribing information can be delivered electronically instead of on paper, while still giving doctors and pharmacists the option to request paper copies at no cost. It directs the Health and Human Services Department to issue rules within a year, hold a stakeholder workshop within two years, and set an effective date two years after enactment (or when the rules take effect). The changes affect drug manufacturers, prescribers, dispensers, and ultimately patients who receive medication information.

Key Provisions

Amends the FD&C Act so that required prescribing information for FDA‑approved drugs (including biologics) can be provided only electronically, as long as the labeling meets all legal requirements.
Manufacturers must still let prescribers and dispensers choose to receive paper copies, either routinely or on an as‑needed basis, and must provide requested paper copies promptly at no extra cost.
Within one year of enactment, HHS must issue final regulations to implement the electronic‑only option and to explain how health‑care professionals can obtain paper copies directly from manufacturers or distributors.
The regulations must be designed to minimize any negative economic impact on prescribers and dispensers.
Within two years, HHS (through the FDA Commissioner) must hold a public workshop with stakeholders to discuss improving the format, accessibility, and usability of prescribing information.
The new electronic‑only requirement takes effect for drugs entering interstate commerce either two years after the law’s enactment or when the final regulations become effective, whichever occurs first.

Legislative Activity

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HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

June 25, 2025

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HouseIntro Referral

Introduced in House

June 25, 2025

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

June 25, 2025

Bill Text

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Introduced in HouseIssued June 25, 2025

119th CONGRESS

1st Session

H. R. 4132

IN THE HOUSE OF REPRESENTATIVES

June 25, 2025

Mrs. Harshbarger (for herself, Ms. Sherrill, Mr. Valadao, Mr. Davis of North Carolina, Mr. Calvert, Ms. Ross, Ms. Letlow, Mr. Peters, Mr. Schneider, Mr. Womack, and Mr. Tonko) 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.

Short title

This Act may be cited as the Prescription Information Modernization Act of 2025.

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).