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CT SB00313

Bill

Status

Introduced

2/25/2016

Primary Sponsor

General Law Committee

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Origin

Senate

2016 General Assembly

AI Summary

  • Adds definition of "biological product" aligned with federal law (42 USC 262(i)) and establishes criteria for "interchangeable" biological products based on FDA determinations or therapeutic equivalence with A ratings.

  • Permits pharmacists to substitute prescribed biological products with interchangeable alternatives without patient or prescriber objection, mirroring existing generic drug substitution authority.

  • Requires prescribers to explicitly specify "brand medically necessary" or "no substitution" to prevent biological product substitution, with specific procedures for written, telephonic, and electronic prescriptions.

  • Mandates pharmacists notify prescribers and patients of biological product substitutions and provide cost savings information; requires labeling with the specific biological product name and manufacturer.

  • Requires pharmacists to electronically notify prescribers within five business days of which biological product was dispensed, accessible through electronic medical records, e-prescribing systems, or pharmacy records; effective October 1, 2016.

Legislative Description

An Act Concerning Biological Products.

Last Action

File Number 218

3/24/2016

Committee Referrals

General Law2/25/2016

Full Bill Text

No bill text available