AN ACT relating to the regulation of pharmacists.

2026 Regular Session Introduced by Matt Koch

Delays Kentucky pedigree requirements for prescription drugs until FDA track-and-trace standards exist, then aligns Kentucky rules with those FDA standards.

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Summary of HB 735 (2026 Regular Session, Kentucky)

Purpose and intent

This act addresses the regulation of pharmacists with a focus on the use of electronic track and trace systems (pedigrees) for prescription drugs.

It aims to align Kentucky’s pedigree requirements with forthcoming federal standards, delaying state-imposed requirements until the FDA develops and implements its own identification, validation, authentication, and tracking/trace standards.

Key provisions

1) Delay and alignment with FDA standards for track and trace
- The Kentucky Board of Pharmacy must not require the use of an electronic track and trace system to initiate, provide, receive, or maintain a pedigree for prescription drugs until the FDA develops and implements its standards under 21 U.S.C. sec. 355e.
- When the FDA establishes its standards, the board’s pedigree requirements must meet those FDA standards for all prescription drugs covered by the FDA standards.

2) Supersession of state requirements by FDA standards
- Once FDA track-and-trace standards are implemented, any Kentucky pedigree requirements in KRS 315.406 are superseded and will not apply to prescription drugs specified in FDA standards.

3) Stakeholder consultation and reporting before rulemaking
- Before the board promulgates any administrative regulation under KRS Chapter 13A that would require an electronic track and trace system, the board must:
- Consult with manufacturers, wholesale distributors, and pharmacies about implementation.
- Publish a report on its website detailing implementation issues, including universal availability, technical and operational feasibility, and reliability for manufacturers, wholesalers, and pharmacies.

Who/what is affected

Regulatory body: Kentucky Board of Pharmacy

Prescriptions and supply chain participants: Pharmacists, wholesalers, manufacturers, and pharmacies involved in handling prescription drugs that would be subject to pedigree requirements.

End users: Ultimately patients, as end users are the beneficiaries of pedigree tracking, though the act itself focuses on regulatory alignment with federal standards.

Procedural and timeline aspects

The bill envisions that any state-mandated electronic track-and-trace requirements will wait for FDA standards before taking effect.

After FDA standards are established, Kentucky’s requirements must align with those standards and cannot exceed them for covered drugs.

Prior to any future administrative regulations mandating a track-and-trace system, the board must engage in stakeholder consultations and publish an implementation report on its website.

Practical impact and considerations

The bill reduces early-state regulatory burdens by delaying state-mandated pedigrees until federal standards are finalized.

It promotes consistency with federal tracking standards, potentially simplifying cross-state commerce and ensuring uniform requirements for prescription drugs within FDA scope.

The reporting requirement ensures transparency and gives stakeholders a chance to assess feasibility and reliability before any regulatory mandate is imposed within Kentucky.