ND HB1033

Pharmacies may substitute an FDA-approved interchangeable biosimilar product for a prescribed product if five requirements are met, including FDA interchangeability determination and lack of "brand medically necessary" indication from the prescriber.

Pharmacist or designee must inform the patient that a biosimilar substitution may occur and that the patient has the right to refuse, with the patient choosing not to refuse.

Pharmacist must notify the prescribing practitioner of the substitution within two business days using facsimile, telephone, electronic transmission, electronic medical record entry, or other accessible means, including the substituted product name and manufacturer.

Pharmacy and prescribing practitioner must retain records of interchangeable biosimilar substitutions for a minimum of five years.

Board of pharmacy must maintain on its public website a current list or internet link to the FDA-approved list of biosimilar biological products determined to be interchangeable.