H195 - Allow Substitution of Biosimilars (SL 2015-27)

Session Year 2015

Overview: S.L. 2015-27 amends the North Carolina Pharmacy Practice Act by doing the following:

  • Provides definitions for biological and interchangeable products.
  • Allows for the substitution of an interchangeable biological product for a prescribed drug product.
  • Requires communication between a pharmacist and prescriber under certain circumstances when a biological product is dispensed.
  • Requires the Board of Pharmacy to maintain a list of biological products determined by the FDA to be interchangeable with a specific biological product.
  • Extends the liability protection a pharmacist currently has for substituting a generic drug product for a prescribed drug product to the substitution of an interchangeable drug product for a prescribed drug product.

This act became effective October 1, 2015. The provisions of the act that require communication between a pharmacist and prescriber when a biological product is dispensed expire on October 1, 2020.

Additional Information: