Biosimilar biological products
N.D. Cent. Code § 19-02.1-14.3
in effect19-02.1-14.3. Biosimilar biological products
1. In this section:
a. "Biological product", "biosimilar", "interchangeable", "interchangeable biological
product", "license", and "reference product" mean the same as these terms mean
under section 351 of the federal Public Health Service Act [42 U.S.C. 262].
b. "Prescription" means a product that is subject to section 503(b) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)].
2. A pharmacy may not substitute a prescription biosimilar product for a prescribed
product unless each of the following requirements is met:
a. The biosimilar product has been determined by the United States food and drug
administration to be interchangeable with the prescribed product.
b. The prescribing practitioner does not specifically indicate in the practitioner's own
handwriting "brand medically necessary" on a written prescription, does not
expressly indicate that an oral prescription is to be dispensed as communicated,
or has not taken a specific overt action to include the "brand medically necessary"
language with an electronically transmitted prescription.
c. The pharmacist or the pharmacist's designee informs the individual receiving the
biological product that the biological product may be substituted with a biosimilar
product and that the individual has a right to refuse the biosimilar product
selected by the pharmacist and the individual chooses not to refuse.
d. Within two business days following the dispensing of the biosimilar product, the
pharmacist or the pharmacist's designee notifies the prescribing practitioner of
the substitution. Notification under this subdivision must include the name of the
substitution product and the name of the manufacturer, and may be made using
facsimile, telephone, electronic transmission, an entry into an interoperable
electronic medical record accessible by the prescribing practitioner, or other
prevailing means accessible by the prescribing practitioner.
e. The pharmacy and the prescribing practitioner retain a record of the
interchangeable biosimilar substitution for a period of no less than five years.
3. Subsection 2 does not apply to a biologic product refill prescription that is not changed
from the interchangeable biosimilar substitution dispensed on the previous filling of the
prescription.
4. The board of pharmacy shall maintain on the board's public website a current list, or
an internet link to a United States food and drug administration-approved list, of
biosimilar biological products determined to be interchangeable under subdivision a of
subsection 2.
Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://ndlegis.gov/cencode/t19c02-1.pdf#nameddest=19-02p1-14p3Fetched: 10/16/2026