Bill > S05580

This bill requires the New York State Commissioner of Health to establish and publish a comprehensive list of generic drug products with specific criteria for inclusion. The bill defines a generic drug product as one that has been certified by the Federal Food and Drug Administration (FDA) as safe and effective, with an approved new-drug or abbreviated new-drug application, and is either pharmaceutically equivalent or an interchangeable biological product. Manufacturers of generic drugs must provide the Department of Health with detailed studies and data, including bioequivalence information, therapeutic equivalence data, and adverse event records, which the department will then make publicly available on its website. The bill also modifies prescription forms to clarify generic drug substitution rules, requiring prescribers to explicitly mark a box if they do not want a generic drug to be substituted, and removes references to an older paragraph of public health law. Additionally, the bill protects prescribers from civil liability when authorizing generic drug substitution and provides exceptions for medical emergencies or situations where generic drugs are unavailable. The changes will take effect 90 days after the bill becomes law, with immediate authorization for preparing necessary regulations.

Health and Social Services

https://www.nysenate.gov/legislation/bills/2025/S5580