North Dakota Code 19-02.1-14.3 – Biosimilar biological products
1. In this section:
Terms Used In North Dakota Code 19-02.1-14.3
- following: when used by way of reference to a chapter or other part of a statute means the next preceding or next following chapter or other part. See North Dakota Code 1-01-49
- Individual: means a human being. See North Dakota Code 1-01-49
- United States: includes the District of Columbia and the territories. See North Dakota Code 1-01-49
- written: include "typewriting" and "typewritten" and "printing" and "printed" except in the case of signatures and when the words are used by way of contrast to typewriting and printing. See North Dakota Code 1-01-37
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.