Requires pharmacists to include lot numbers or unique identifying numbers on prescription containers

2025 Regular Session Introduced by Dave McDonough

Requires pharmacists to place lot numbers or unique identifiers on prescription containers to improve medication traceability during recalls and safety investigations.

REFERRED TO HIGHER EDUCATION

Legislative Bill Summary — A 4198

Overview

Bill Number: A 4198

Title / Purpose: Requires pharmacists to include lot numbers or unique identifying numbers on prescription containers. The bill aims to enhance traceability of medications by ensuring lot or other unique identifiers appear on the containers dispensed to patients.

Status: Referred to Higher Education (committee stage).

Introduced: January 31, 2025

Sponsor (primary): David McDonough

Classification: Bill

Key Provisions (as described)

Pharmacists would be required to place a lot number or some form of unique identifying number on prescription containers.

The provision seeks to improve traceability for medication recalls, safety monitoring, and adverse event investigations by enabling easier identification of specific product lots.

Note: The summary reflects the information available. The text does not provide detailed definitions of “lot number” versus “unique identifying number,” nor specifics on labeling format, placement, or enforcement mechanisms.

Affected Parties and Impacts

Pharmacists and Pharmacies: Would need to adjust labeling practices and potentially their dispensing software and workflow to ensure lot numbers or unique identifiers are included on containers.

Patients: Could benefit from improved traceability in the event of recalls or safety notices.

Regulatory/Educational Bodies: May be responsible for implementing or clarifying standards related to labeling requirements if the bill advances.

Procedural and Timeline Context

The bill has been introduced and immediately referred to the Higher Education committee.

Legislative actions show the same date entered as “REFERRED TO HIGHER EDUCATION” (two entries in the provided record, suggesting a cross-check or duplicate log in the record).

No additional dates (e.g., committee hearings, amendments, or potential floor action) are provided in the current information.

Related Legislation

Related Bills (prior-session): A 9659, A 6455, A 3867. These may address similar labeling or pharmacovigilance topics and could influence or inform A 4198’s approach if enacted in different sessions.

Additional Context and Considerations

The bill’s impact will depend on the final text, including:

Definition of “unique identifying number” (whether it includes batch/lot numbers, National Drug Code, or other identifiers).
Any exemptions (e.g., certain medications, compounded drugs, or small-volume dispensations).
Enforcement, penalties for noncompliance, and a timeline for compliance.
Implementation guidance for pharmacies of varying sizes.

If you’d like, I can tailor this summary to a specific audience (e.g., policymakers, pharmacists, or health systems) or compare A 4198 to the related prior-session bills for a more contextual view.