§ 43-15.3-08 — Prohibited acts - Penalty

North Dakota § 43-15.3-08

• Jurisdiction: North Dakota
• Title 43: Occupations and Professions
• Ch. 43-15.3: Wholesale Drug Pedigree

Text

1. Except as otherwise provided under section 43-15.3-09, it is a class B misdemeanor
for a person to perform or cause the performance of or aid and abet any of the
following acts in this state:
a. Failing to obtain a license under this chapter or operating without a valid license
when a license is required by this chapter.
b. If the requirements of subsection 1 of section 43-15.3-05 are applicable and are
not met, purchasing or otherwise receiving a prescription drug, medical gas, or
medical equipment from a pharmacy.
c. If a state license is required under subsection 2 of section 43-15.3-05, selling,
distributing, or transferring a prescription drug, medical gas, or medical
equipment to a person that is not authorized under the law of the jurisdiction in

which the person receives the prescription drug, medical gas, or medical
equipment to receive the prescription drug, medical gas, or medical equipment.
d. Failing to deliver prescription drugs, medical gases, or medical equipment to
specified premises, as required by subsection 3 of section 43-15.3-05.
e. Accepting payment or credit for the sale of prescription drugs, medical gases, or
medical equipment in violation of subsection 5 of section 43-15.3-05.
f. Failing to maintain or provide pedigrees as required by this chapter.
g. Failing to obtain, pass, or authenticate a pedigree, as required by this chapter.
h. Providing the board or any of the board's representatives or any federal official
with false or fraudulent records or making false or fraudulent statements
regarding any matter within the provisions of this chapter.
i. Obtaining or attempting to obtain a prescription drug, medical gas, or medical
equipment by fraud, deceit, misrepresentation, or engaging in misrepresentation
or fraud in the distribution of a prescription drug, medical gas, or medical
equipment.
j. Except for the wholesale distribution by manufacturers of a prescription drug,
medical gas, or medical equipment that has been delivered into commerce
pursuant to an application approved under federal law by the federal food and
drug administration, manufacturing, repacking, selling, transferring, delivering,
holding, or offering for sale any prescription drug, medical gas, or medical
equipment that is adulterated, misbranded, counterfeit, suspected of being
counterfeit, or has otherwise been rendered unfit for distribution.
k. Except for the wholesale distribution by a manufacturer of a prescription drug,
medical gas, or medical equipment that has been delivered into commerce under
an application approved under federal law by the federal food and drug
administration, adulterating, misbranding, or counterfeiting any prescription drug,
medical gas, or medical equipment.
l. Receiving any prescription drug, medical gas, or medical equipment that is
adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected of being counterfeit, and the delivery or proffered delivery of such
drug, gas, or equipment for pay or otherwise.
m. Altering, mutilating, destroying, obliterating, or removing the whole or any part of
the labeling of a prescription drug, medical gas, or medical equipment or the
commission of any other act with respect to a prescription drug, medical gas, or
medical equipment which results in the prescription drug, medical gas, or medical
equipment being misbranded.
2. The prohibited acts in subsection 1 do not include a prescription drug, medical gas, or
medical equipment manufacturer or agent of a prescription drug, medical gas, or
medical equipment manufacturer obtaining or attempting to obtain a prescription drug,
medical gas, or medical equipment for the sole purpose of testing the prescription
drug, medical gas, or medical equipment for authenticity.
3. a. For purposes of this subsection:
(1) "Contract pharmacy" means a pharmacy that has a contract with a covered
entity to receive and dispense drugs to the covered entity's patients on its
behalf.
(2) "Covered entity" means an entity participating or authorized to participate in
a federal drug discount program under 42 U.S.C. 256b.
(3) "Drug" means a drug purchased under reduced pricing under section 340B
of the federal Public Health Service Act [42 U.S.C. 201 et seq.] by a covered
entity.
b. Except as otherwise provided under section 43-15.3-09, it is a class B
misdemeanor for a manufacturer, an agent or affiliate of that manufacturer, virtual
manufacturer, or third-party logistics provider of a manufacturer's drugs, to:
(1) Directly or indirectly deny, restrict, prohibit, or otherwise interfere with the
acquisition of a drug by a contract pharmacy on behalf of a covered entity
unless receipt of the drug is prohibited by federal law.

(2) Prohibit a contract pharmacy from dispensing a drug by denying access to
the drug.
(3) Require a covered entity or contract pharmacy to submit any claims,
encounter, or utilization data as a condition for acquiring or receiving a drug,
unless the claims, encounter, or utilization data sharing is required by
federal law.
(4) Interfere with the ability of a covered entity or contract pharmacy to dispense
a drug to an eligible patient of the covered entity.
(5) Offer or otherwise make available a drug in the form of a rebate, unless in
the form of a discount at the time of sale and authorized under federal law.
c. This subsection does not apply to the limited distribution of a drug as required
under 21 U.S.C. 355-1.