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NC H195

Bill

Status

Passed

5/21/2015

Primary Sponsor

Nelson Dollar

Click for details

Origin

House of Representatives

2015-2016 Session

AI Summary

House Bill 195 - Summary

  • 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.

  • 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.

  • 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.

  • Allows prescribers to prohibit substitution by indicating "Dispense as Written" on the prescription, consistent with existing rules for generic drug substitution.

  • 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

Committee Referrals

Health Care4/9/2015
Rules and Operations of the Senate4/6/2015
Health3/11/2015

Full Bill Text

No bill text available