This bill would authorize the required prescribing information for FDA-approved drugs and biological products to be provided exclusively through electronic means, while giving prescribers and dispensers the option to receive paper labeling on request at no additional cost. The change aims to modernize how labeling information is distributed while preserving access for those who need or prefer paper copies.
To implement the change, the bill requires the Secretary of Health and Human Services to issue final regulations within one year after enactment detailing how the amendment will operate and how to obtain paper copies from manufacturers or distributors. It also directs a regulatorily mindful approach intended to minimize adverse economic impacts on prescribers and dispensers.
In addition, a public workshop must be held within two years to discuss ongoing optimization of the format, accessibility, and usability of prescribing information. The amendment applies to drugs introduced into interstate commerce on or after the earlier of two years from enactment or the final regulations’ effective date, with the definition of “drug” aligned to the FD&C Act.
At a Glance
What It Does
The bill adds a mandate to allow electronic delivery of required prescribing information for drugs, with an option for paper copies on request and at no extra cost after the request. It also instructs the creation of final regulations and a mechanism for obtaining paper labeling.
Who It Affects
Pharmaceutical manufacturers and distributors, prescribers and dispensers, and health systems that integrate labeling data into workflows.
Why It Matters
It accelerates digital access to labeling while protecting those who rely on paper copies, balancing modernization with accessibility and cost considerations.
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What This Bill Actually Does
The Prescription Information Modernization Act of 2025 proposes a shift from paper-based prescribing information to electronic delivery for FDA-approved drugs and biological products. It requires manufacturers to make labeling available electronically, but guarantees that prescribers and distributors can request and receive paper labeling at no additional cost.
This setup preserves a traditional form of access for those who need it while embracing digital distribution.
To operationalize the change, the bill mandates final regulations within one year that lay out how the electronic labeling will work and how paper copies can be obtained from manufacturers or distributors. The regulations must be designed to minimize negative economic impacts on those who prescribe and dispense drugs.
Within two years, a public workshop will be convened by the Secretary of Health and Human Services, through the FDA, to discuss and refine the format, accessibility, and usability of prescribing information.The amendment applies to drugs introduced into interstate commerce on the sooner of two years after enactment or the final regulations’ effective date. The bill relies on the existing FD&C Act’s definition of “drug” for scope.
This is a transition plan that preserves access to information while moving toward digital labeling where feasible.
The Five Things You Need to Know
The bill amends the FD&C Act to allow electronic-only prescribing information for drugs, with paper copies available on request at no extra cost.
Final regulations to implement the amendment must be issued by HHS within one year of enactment.
Regulations must include instructions on how professionals can obtain paper labeling directly from manufacturers or distributors.
A public workshop will be held within two years to optimize the format, accessibility, and usability of prescribing information.
The amendment applies to drugs introduced into interstate commerce on the sooner of two years after enactment or the final regulations’ effective date (definition of “drug” aligned with FD&C Act).
Section-by-Section Breakdown
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Electronic labeling permitted with opt-out to paper
Section 2(a) adds to 502(f) of the FD&C Act a provision allowing required prescribing information for drugs to be made available solely by electronic means, so long as the labeling complies with all applicable law. It requires manufacturers to offer prescribers and dispensers the option to receive paper labeling or to request paper copies on an as-needed basis, and, after a request, to provide the information promptly at no additional cost.
Rulemaking to implement amendment
Section 2(b) directs the Secretary of Health and Human Services to issue final regulations within one year of enactment to implement the amendment and to provide instructions on how health care professionals can obtain paper copies from manufacturers or distributors if desired.
Public workshop
Section 2(c) requires a public workshop within two years after enactment, conducted by the Secretary through the FDA, with relevant stakeholders to discuss ongoing optimization of the format, accessibility, and usability of prescribing information.
Effective date
Section 2(d) provides that the amendment applies to drugs introduced into interstate commerce on or after the sooner of two years after enactment or the effective date of the final regulations promulgated to implement the amendment.
Definitions
Section 2(e) provides that the term “drug” has the meaning given to it in section 201 of the FD&C Act, preserving the statutory scope of the amendment.
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Who Benefits
- Prescribers and their office staff, who gain faster access to updated labeling through digital platforms and reduced manual search time.
- Pharmacists and dispensing personnel, who can integrate electronic labeling into workflow while still offering paper copies on request.
- Health systems and health IT/EHR vendors, which can streamline labeling data integration and distribution.
- Patients and caregivers who rely on paper labeling or need accessible formats, who retain the ability to obtain paper copies when desired.
- Drug manufacturers and distributors, which gain a standardized system for electronic labeling and must maintain dual-format access as required.
Who Bears the Cost
- Independent community pharmacies and small clinics, which may incur costs to provide paper copies on request and maintain dual labeling workflows.
- Pharmaceutical manufacturers and distributors, which must maintain both electronic labeling systems and paper copy availability, with associated operational costs.
- Health IT systems and software vendors required to support labeling integration and documentation workflows.
- Regulatory agencies and regulators tasked with overseeing compliance and enforcement of the dual-format labeling regime.
Key Issues
The Core Tension
Balancing digital modernization with universal access: moving prescribing information online improves speed and consistency but risks leaving providers or patients who rely on paper copies behind without a robust, costless option during the transition.
The bill explicitly addresses the transition to digital labeling by preserving a paper-on-demand option, but it also raises questions about implementation. The requirement to minimize adverse economic impacts provides a guardrail against abrupt cost shoves onto prescribers, dispensers, and suppliers.
However, the real-world costs of maintaining dual labeling formats, updating electronic content promptly, and ensuring accurate version control across manufacturers and distributors will require careful budgeting and coordination across the supply chain as the transition unfolds. Privacy, cybersecurity, and data integrity considerations will also need attention as more labeling content moves into electronic channels.
From a policy perspective, the central tension is how fast to migrate to digital labeling while ensuring equitable access and reliable dissemination of information in diverse practice settings. The law creates a transition framework with a two-year horizon for stakeholder engagement, then relies on final regulations to operationalize the change, which may leave questions about interim practices and compliance auditing until the regulations are in place.
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