ALLOW SUBSTITUTION OF BIOSIMILARS.

View NCGA Bill Details2015-2016 Session
Senate Bill 197 (Public) Filed Thursday, March 5, 2015
AN ACT AMENDING THE NORTH CAROLINA PHARMACY PRACTICE ACT TO ALLOW FOR THE SUBSTITUTION OF AN INTERCHANGEABLE BIOLOGICAL PRODUCT.
Intro. by Apodaca, Hise.

Status: Ref To Com On Health Care (Senate Action) (Mar 9 2015)

SOG comments (1):

Identical bill

Bill as filed is identical to H 195 as filed 3/10/15.

Bill History:

S 197

Bill Summaries:

  • Summary date: Mar 5 2015 - More information

    Amends GS 90-85.27, the definitions section for use in GS 90-85.28 through GS 90-85.31, adding biological product and interchangeable biological product. Makes technical and organizational changes. 

    Amends GS 90-85.28 to authorize pharmacists dispensing a prescription for a drug product prescribed by its brand name to select any equivalent or interchangeable biological product which meets specified standards (previously, did not allow the substitution of a brand name drug with an interchangeable biological product). Amends the catchline of GS 90-85.28 to "Selection by pharmacists permissible; prescriber may permit or prohibit selection; price limit on selected drugs; communication of dispensed biological products under specified circumstances." Makes technical and conforming changes. Requires a pharmacist substituting an interchangeable biological product to communicate to the prescriber, within a reasonable time following the dispensing, the manufacturer of the specific biological product prescriber. Sets out authorized means of communication between the pharmacist and the prescriber as well as instances when such communication is not needed. Provides that the interchangeable biological product can only be selected if it is lower in price than the prescribed drug.

    Amends GS 90-85.31, providing that no greater liability is extended to pharmacists for selecting an interchangeable biological product as would be for selecting the prescribed drug. Makes conforming changes.

    Makes technical changes to GS 58-3-178(c)(4). 

    Effective October 1, 2015.


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