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Allows required FDA-approved prescribing information for certain prescription drugs to be provided electronically (online) instead of in paper form, if other labeling rules are followed. Drug makers must give prescribers and dispensers the option to keep receiving paper copies or to request paper copies as needed, and must supply requested paper at no extra cost. The Food and Drug Administration (HHS/FDA) must issue implementing rules within 1 year, hold a public workshop within 2 years, and limit the electronic-only option to drugs introduced into interstate commerce after a short waiting period.
Amend Section 502(f) of the FD&C Act to allow required prescribing information for drugs subject to section 503(b)(1) to be made available solely by electronic means, provided that (1) the labeling complies with all applicable requirements of law, (2) the manufacturer gives prescribers and dispensers the opportunity to elect to continue receiving paper copies or to request paper labeling as needed, and (3) after such a request the manufacturer promptly provides the requested paper information without additional cost.
The Secretary of Health and Human Services must issue final regulations not later than 1 year after enactment to implement the amendment allowing electronic-only prescribing information.
The required regulations must include instructions on how health care professionals can receive paper copies of prescribing information directly from the manufacturer or distributor if they want them.
The Secretary of HHS shall design the regulations to minimize adverse economic impacts of the regulations on prescribers and dispensers.
Not later than 2 years after enactment, the Secretary of HHS, acting through the Commissioner of Food and Drugs, must hold a public workshop with relevant stakeholders to discuss optimizing the format, accessibility, and usability of prescribing information.
Last progress June 11, 2025 (8 months ago)
Introduced on June 11, 2025 by Markwayne Mullin
Who is affected and how:
Drug manufacturers: Primary operational impact. They may reduce routine printing and mailing costs by shifting to electronic delivery for eligible products, but must implement systems for online delivery, recordkeeping, and a process to supply paper copies on request at no charge. They will also need to comply with FDA regulations issued under the bill.
Prescribers (physicians, nurse practitioners, other authorized prescribers): Will be offered electronic access to prescribing information as the default for eligible drugs but retain the right to receive paper copies or request them when needed. Providers with limited internet access or workflow preferences can obtain paper at no cost.
Dispensers (pharmacies, pharmacists, clinics): Similar effects as prescribers; pharmacies may rely on electronic labeling but must be able to request and receive printed copies without charge. Community and retail pharmacies with robust IT systems may adopt electronic workflows more easily than small or rural pharmacies.
Patients and the public: Indirect effect. Patients who rely on prescribers or pharmacists to explain drug information could see faster updates and easier distribution of up-to-date labeling. However, if providers do not request or print information when appropriate, some patients could face barriers to receiving printed drug information; the bill mitigates this risk by requiring manufacturers to supply printed copies on request.
FDA/HHS: Administrative workload to complete rulemaking within one year and to organize a public workshop within two years. The agency must set technical, procedural, and scope rules (which drugs qualify, acceptable electronic formats, required notices, and timelines).
Health systems and electronic health record (EHR) vendors: May need to integrate or link to FDA-approved electronic prescribing information in provider workflows to ensure convenient access and compliance. This could spur technical work and coordination.
Net effects and tradeoffs:
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Updated 1 week ago
Last progress June 25, 2025 (7 months ago)