21.0011.03000
Sixty-seventh
Legislative Assembly HOUSE BILL NO. 1033
of North Dakota
Introduced by
Legislative Management
(Health Care Committee)
1 A BILL for an Act to amend and reenact section 19-02.1-14.3 of the North Dakota Century
2 Code, relating to prescribing of biosimilar drugs.
3 BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA:
4 SECTION 1. AMENDMENT. Section 19-02.1-14.3 of the North Dakota Century Code is
5 amended and reenacted as follows:
6 19-02.1-14.3. Biosimilar biological products.
7 1. In this section:
8 a. "Biological product", "biosimilar", "interchangeable", "interchangeable biological
9 product", "license", and "reference product" mean the same as these terms mean
10 under section 351 of the federal Public Health Service Act [42 U.S.C. 262].
11 b. "Prescription" means a product that is subject to section 503(b) of the Federal
12 Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)].
13 2. A pharmacy may not substitute a prescription biosimilar product for a prescribed
14 product only ifunless each of the following requirements is met:
15 a. The biosimilar product has been determined by the United States food and drug
16 administration to be interchangeable with the prescribed product;.
17 b. The prescribing practitioner does not specifically indicate in the practitioner's own
18 handwriting "brand medically necessary" on a written prescription, does not
19 expressly indicate that an oral prescription is to be dispensed as communicated,
20 or has not taken a specific overt action to include the "brand medically
21 necessary" language with an electronically transmitted prescription;.
22 c. The pharmacist or the pharmacist's designee informs the individual receiving the
23 biological product that the biological product may be substituted with a biosimilar
Page No. 1 21.0011.03000
Sixty-seventh
Legislative Assembly
1 product and that the individual has a right to refuse the biosimilar product
2 selected by the pharmacist and the individual chooses not to refuse;.
3 d. The pharmacist notifies the prescribing practitioner orally, in writing, or by
4 electronic transmission within twenty-four hours of the substitution; andWithin two
5 business days following the dispensing of the biosimilar product, the pharmacist
6 or the pharmacist's designee notifies the prescribing practitioner of the
7 substitution. Notification under this subdivision must include the name of the
8 substitution product and the name of the manufacturer, and may be made using
9 facsimile, telephone, electronic transmission, an entry into an electronic records
10 system, or other prevailing means.
11 (1) An entry into an electronic records system may be made through:
12 (a) An interoperable electronic medical records system;
13 (b) An electronic prescribing technology;
14 (c) A pharmacy benefit management system; or
15 (d) A pharmacy record.
16 (2) An entry into an electronic records system is presumed to provide notice to
17 the prescribing physician.
18 e. The pharmacy and the prescribing practitioner retain a record of the
19 interchangeable biosimilar substitution for a period of no less than five years.
20 3. Subsection 2 does not apply to a biologic product refill prescription that is not changed
21 from the interchangeable biosimilar substitution dispensed on the previous filling of the
22 prescription.
23 4. The board of pharmacy shall maintain on itsthe board's public website a current list, or
24 an internet link to a United States food and drug administration-approved list, of
25 biosimilar biological products determined to be interchangeable under subdivision a of
26 subsection 2.
Page No. 2 21.0011.03000
Statutes affected: INTRODUCED: 19-02.1-14.3
FIRST ENGROSSMENT: 19-02.1-14.3
Enrollment: 19-02.1-14.3
PREFILED: 19-02.1-14.3