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NC H195
Bill
Status
5/21/2015
Primary Sponsor
Nelson Dollar
Click for details
AI Summary
House Bill 195 - Summary
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Amends North Carolina pharmacy practice law to permit pharmacists to substitute interchangeable biological products (biosimilars) for prescribed brand-name biological products, matching existing authority for generic drugs.
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Defines "interchangeable biological product" as any biological product determined by the FDA to meet standards under 42 U.S.C. § 262(k)(4) or deemed therapeutically equivalent by the FDA.
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Requires pharmacists to communicate the specific biological product name and manufacturer dispensed to the prescriber within a reasonable time using electronic medical records, e-prescribing systems, pharmacy benefit management systems, or other prevailing means.
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Allows prescribers to prohibit substitution by indicating "Dispense as Written" on the prescription, consistent with existing rules for generic drug substitution.
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Effective October 1, 2015, with the communication requirements expiring October 1, 2020.
Legislative Description
Allow Substitution of Biosimilars
Last Action
Ch. SL 2015-27
5/21/2015