Page:2021 North Dakota Session Laws.pdf/678

Foods, Drugs, Oils, and Compounds FOODS, DRUGS, OILS, AND COMPOUNDS

CHAPTER 170

HOUSE BILL NO. 1033

(Legislative Management)

(Health Care Committee)

AN ACT to amend and reenact section 19-02.1-14.3 of the North Dakota Century Code, relating to prescribing of biosimilar drugs.

BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:

SECTION 1. AMENDMENT. Section 19-02.1-14.3 of the North Dakota Century Code is amended and reenacted as follows:

19-02.1-14.3. 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 only ifunless 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;.