ALLOW SUBSTITUTION OF BIOSIMILARS.

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View NCGA Bill Details2015-2016 Session
House Bill 195 (Public) Filed Tuesday, March 10, 2015
AN ACT AMENDING THE NORTH CAROLINA PHARMACY PRACTICE ACT TO ALLOW FOR THE SUBSTITUTION OF AN INTERCHANGEABLE BIOLOGICAL PRODUCT.
Intro. by Dollar, S. Martin, Avila, Lambeth.
Status: Ch. SL 2015-27 (House Action) (May 21 2015)

Bill History:

H 195/S.L. 2015-27

Bill Summaries:

  • Bill H 195 (2015-2016)
    Summary date: May 21 2015 - View Summary

    AN ACT AMENDING THE NORTH CAROLINA PHARMACY PRACTICE ACT TO ALLOW FOR THE SUBSTITUTION OF AN INTERCHANGEABLE BIOLOGICAL PRODUCT. Enacted May 21, 2015. Effective October 1, 2015.

    Health and Human Services, Health, Health Care Facilities and Providers
    GS 58, GS 90
  • Bill H 195 (2015-2016)
    Summary date: Apr 1 2015 - View Summary

    House committee substitute makes the following changes to the 1st edition.

    GS 90-85.28, as amended in the 1st edition, requires in subsection (b2) that a pharmacist or the pharmacist's designee communicate to the prescriber the product name and manufacturer of the specific interchangeable biological product dispensed to a patient.

    Amends subsection GS 90-85.28(b2) to clarify that the communication must be done by making an entry into an interoperable electronic medical records system, electronic prescribing technology, or a pharmacy record that can be electronically accessed by the provider. Adds that the communication may also be made via a pharmacy benefit management system.

    Adds a new subsection (b4) to GS 90-85.28 to provide that if the state mandates electronic medical records between a pharmacist and a prescriber as described in subsection (b2), then the pharmacist is only required to communicate the biological product dispensed through an electronic medical records system when such a system is in place and the information is accessible by the prescriber.

    Provides that GS 90-85.28(b2) and GS 90- 85.28(b4) expire on October 1, 2020.

    Health and Human Services, Health, Health Care Facilities and Providers
    GS 58, GS 90
  • Bill H 195 (2015-2016)
    Summary date: Mar 10 2015 - View Summary

    Identical to S 197, filed 3/5/15.

    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.

    Health and Human Services, Health, Health Care Facilities and Providers
    GS 58, GS 90
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