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NC S197

Bill

Status

Introduced

3/5/2015

Primary Sponsor

Thomas Apodaca

Click for details

Origin

Senate

2015-2016 Session

AI Summary

Senate Bill 197 Summary

  • Adds new definition of "biological product" and "interchangeable biological product" to North Carolina pharmacy practice law, referencing FDA approval standards under federal law.

  • Permits pharmacists to substitute interchangeable biological products for brand-name prescribed drugs under the same conditions as generic drug substitution, including that the substitute must be lower in price.

  • Requires pharmacists to communicate to prescribers within a reasonable time the specific name and manufacturer of any biological product dispensed, through electronic medical records, e-prescribing, or other means like fax or phone, unless no FDA-approved alternative exists or it's an unchanged refill.

  • Directs the North Carolina Board of Pharmacy to maintain a website link to the current FDA list of interchangeable biological products.

  • Extends existing liability protections for pharmacists and prescribers to apply equally to substitutions of interchangeable biological products as they do for generic drugs; effective October 1, 2015.

Legislative Description

Allow Substitution of Biosimilars

Last Action

Ref To Com On Health Care

3/9/2015

Committee Referrals

Health Care3/9/2015

Full Bill Text

No bill text available