Bill > HB117

This bill updates the legal framework for pharmacists substituting biological products by modifying definitions and procedures. The bill provides new definitions for "biosimilar," clarifying that a biosimilar is a biological product that is highly similar to a reference product with no clinically meaningful differences in safety, purity, and potency. It revises the definition of "interchangeable biological product" to align with federal standards, specifically referencing 42 U.S.C. section 262(i)(3). The legislation allows pharmacists to substitute biological products when they meet the interchangeability criteria, with important patient protections: pharmacists must inform patients when substituting a product, and they cannot substitute if the prescriber marks the prescription as "medically necessary" or if the patient declines the substitution. Additionally, the bill requires pharmacists to electronically report the specific product dispensed to the prescriber within three business days, using methods like electronic medical records or pharmacy benefit management systems. The label for dispensed biological products must include the proper name and manufacturer. The bill aims to provide more flexibility in biological product dispensing while maintaining patient safety and prescriber communication. The legislation will take effect 60 days after its passage.

Health and Social Services

https://gc.nh.gov/bill_status/legacy/bs2016/bill_status.aspx?lsr=0075&sy=2025&sortoption=&txtsessionyear=2025&txtbillnumber=HB117