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CT SB00313
Bill
Status
2/25/2016
Primary Sponsor
General Law Committee
Click for details
AI Summary
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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.
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Permits pharmacists to substitute prescribed biological products with interchangeable alternatives without patient or prescriber objection, mirroring existing generic drug substitution authority.
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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.
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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.
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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