§ 19-02.1-14.3 — Biosimilar biological products

North Dakota § 19-02.1-14.3

• Jurisdiction: North Dakota
• Title 19: Foods, Drugs, Oils, and Compounds
• Ch. 19-02.1: North Dakota Food, Drug, and Cosmetic Act

Text

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.
19-02.1-15. Drugs limited to dispensing on prescription.
1. Except as authorized and provided in chapter 19-03.1, a depressant, stimulant, or
hallucinogenic drug; or a drug intended for use by man which is a habit-forming drug to
which subsection 4 of section 19-02.1-14 applies; or a drug that, because of its toxicity
or other potentiality for harmful effect, or the method of its use, or the collateral
measures necessary to its use, is not safe for use except under the supervision of a
practitioner; or a drug limited by an approved application under section 505 of the
federal act or section 19-02.1-16 to use under the professional supervision of a
practitioner, must be dispensed by prescription of a practitioner, and such prescription
may not be filled or refilled after one year from the date on which such prescription
was issued; except that nothing herein may be construed as preventing a practitioner
from issuing a new prescription for the same drug either in writing or orally. Any oral
prescription for such drug must be promptly reduced to writing and filed by the
pharmacist.
2. Any drug dispensed by filling or refilling a written or oral prescription of a practitioner
licensed by law to administer such drug is exempt from the requirements of section
19-02.1-14, except subsection 1, subdivisions b and c of subsection 10, subsections
12 and 13, and the packaging requirements of subsections 8 and 9 of section
19-02.1-14, if the drug bears a label containing the name and address of the
dispenser, the serial number and date of the prescription or of its filling, the name of
the prescriber and, if stated in the prescription, the name of the patient, and the
directions for use and cautionary statements, if any, contained in such prescription.
This exemption does not apply to any drug dispensed in the course of the conduct of a
business of dispensing drugs pursuant to diagnosis by mail or electronic means, or to
a drug dispensed in violation of subsection 1.
3. The department may, by regulation, remove drugs subject to subsection 4 of section
19-02.1-14 and section 19-02.1-16 from the requirements of subsection 1 when such
requirements are not necessary for the protection of the public health. Drugs removed
from the prescription requirements of the federal act by regulations issued thereunder

may also, by regulations issued by the department, be removed from the requirements
of subsection 1.
4. A drug which is subject to subsection 1 must be deemed to be misbranded if at any
time prior to dispensing its label fails to bear the statement "Caution: Federal Law
Prohibits Dispensing Without Prescription", "Rx Only", or "Caution: State Law Prohibits
Dispensing Without Prescription". A drug to which subsection 1 does not apply must be
deemed to be misbranded if at any time prior to dispensing its label bears the caution
statement quoted in the preceding sentence.
5. Nothing in this section may be construed to relieve any person from any requirement
prescribed by or under authority of law with respect to drugs now included or which
may hereafter be included within the classifications of narcotic drugs or marijuana as
defined in the applicable federal and state laws relating to narcotic drugs and
marijuana.