§ 43-15.3-01 — Definitions

North Dakota § 43-15.3-01

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

Text

As used in this chapter, unless the context otherwise requires:
1. "Authentication" means to affirmatively verify before any wholesale distribution of a
prescription drug occurs that each transaction listed on the pedigree has occurred.
2. "Authorized distributor of record" means a wholesale distributor or a third-party
logistics provider with whom a manufacturer has established an ongoing relationship
to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to
exist between the third-party logistics provider and the manufacturer or between the
wholesale distributor and a manufacturer when the third-party logistics provider or the
wholesale distributor, including any affiliated group of the wholesale distributor as
defined in section 1504 of the Internal Revenue Code [26 U.S.C. 1504], complies with
the following:
a. The wholesale distributor or a third-party logistics provider has a written
agreement currently in effect with the manufacturer evidencing the ongoing
relationship; and
b. The wholesale distributor or a third-party logistics provider is listed on the
manufacturer's current list of authorized distributors of record, which is updated
by the manufacturer on no less than a monthly basis.
3. "Board" means the state board of pharmacy.
4. "Broker" means a party that mediates between a buyer and a seller the sale or
shipment of prescription drugs, medical gases, or medical equipment.
5. "Chain pharmacy warehouse" means a physical location for prescription drugs,
medical gases, or medical equipment which acts as a central warehouse and performs
intracompany sales or transfers of the drugs, gases, or equipment to a group of chain
pharmacies that have the same common ownership and control.
6. "Colicensed product" means a prescription drug, medical gas, or medical equipment in
which two or more parties have the right to engage in the manufacturing or marketing
or in the manufacturing and marketing of the drug, gas, or equipment.
7. "Device" means an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including any component, part, or
accessory which:
a. Is recognized in the United States pharmacopeia or the official national formulary
is intended for use in the diagnosis of disease or other conditions or in the cure,
mitigation, treatment, or prevention of disease, in humans or other animals, or is
intended to affect the structure or any function of the body of humans or other
animals;
b. Does not achieve its primary intended purposes through chemical action within or
on the body of a human or other animal; and
c. Is not dependent upon being metabolized for the achievement of its primary
intended purposes.
8. "Drop shipment" means the sale of a prescription drug, medical gas, or medical
equipment to a wholesale distributor by the manufacturer of the prescription drug,
medical gas, or medical equipment or to that manufacturer's colicensed product
partner, that manufacturer's third-party logistics provider, or that manufacturer's
exclusive distributor, under the terms of which the wholesale distributor or chain
pharmacy warehouse takes title but not physical possession of the prescription drug,
medical gas, or medical equipment and the wholesale distributor invoices the
pharmacy or chain pharmacy warehouse, or other person authorized by law to
dispense or administer the drug, gas, or equipment to a patient, and the pharmacy or
chain pharmacy warehouse or other authorized person receives delivery of the
prescription drug, medical gas, or medical equipment directly from the manufacturer,
or that manufacturer's third-party logistics provider, or that manufacturer's exclusive
distributor.

9. "Durable medical equipment" means medical devices, equipment, or supplies that may
be used in a residence, including oxygen and oxygen delivery systems and supplies,
ventilators, respiratory disease management devices, continuous positive airway
pressure (CPAP) devices, electronic and computerized wheelchairs and seating
systems, apnea monitors, transcutaneous medical nerve stimulator (TENS) units, low
air cutaneous pressure management devices, sequential compression devices,
feeding pumps, home phototherapy devices, infusion delivery devices, distribution of
medical gases to end users for human consumption, hospital beds, nebulizers, and
other similar equipment as may be determined by the board by rule.
10. "Facility" means a facility of a wholesale distributor where prescription drugs, medical
gases, or medical equipment are stored, handled, repackaged, or offered for sale.
11. "Manufacturer" means a person licensed or approved by the federal food and drug
administration to engage in the manufacture of drugs, medical gases, or devices by
manufacturing the drugs, gases, or devices at the person's own facility or by
contracting for the manufacturing by others.
12. "Manufacturer's exclusive distributor" means any person that contracts with a
manufacturer to provide or coordinate warehousing, distribution, or other services on
behalf of a manufacturer and which takes title to that manufacturer's prescription drug,
medical gases, or medical equipment but which does not have general responsibility to
direct the sale or disposition of the manufacturer's prescription drug, medical gas, or
medical equipment. The manufacturer's exclusive distributor must be licensed as a
wholesale distributor under this chapter, and to be considered part of the normal
distribution channel also must be an authorized distributor of record.
13. "Medical device" means a product or equipment used to diagnose a disease or other
condition in order to cure, treat, or prevent disease.
14. "Medical equipment" means equipment prescribed or distributed by a practitioner used
in the course of treatment of home care.
15. "Medical gas” means any gaseous substance that meets medical purity standards and
has application in a medical environment.
16. "Normal distribution channel" means a chain of custody for a prescription drug which
goes, directly or by drop shipment, from a manufacturer of the prescription drug, from
that manufacturer to that manufacturer's colicensed partner, from that manufacturer to
that manufacturer's third-party logistics provider, or from that manufacturer to that
manufacturer's exclusive distributor to:
a. A pharmacy, to a patient or other designated person authorized by law to
dispense or administer the drug to a patient;
b. A wholesale distributor, to a pharmacy, to a patient or other designated person
authorized by law to dispense or administer the drug to a patient;
c. A wholesale distributor, to a chain pharmacy warehouse, to that chain pharmacy
warehouse's intracompany pharmacy, to a patient or other designated person
authorized by law to dispense or administer the drug to a patient; or
d. A chain pharmacy warehouse, to the chain pharmacy warehouse's intracompany
pharmacy, to a patient or other designated person authorized by law to dispense
or administer the drug to a patient.
17. "Outsourcing facility" means a facility at one geographic location or address which is
engaged in anticipatory compounding of sterile drugs and complies with section 503(b)
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)].
18. "Pedigree" means a document or an electronic file containing information that records
each distribution of any given prescription drug.
19. "Pharmacy distributor” means any pharmacy or hospital pharmacy licensed in this
state which is engaged in the delivery or distribution of prescription drugs, medical
gases, or medical equipment to any other pharmacy licensed in this state or to any
other person, including a wholesale drug distributor, engaged in the delivery or
distribution of prescription drugs, medical gases, or medical equipment and involved in
the actual, constructive, or attempted transfer of a drug, gas, or equipment in this state
to other than the ultimate consumer, when the financial value of the drugs, gases, or

equipment is equivalent to at least five percent of the total gross sales of the pharmacy
distributor.
20. "Prescription drug" means any drug, including any biological product, except for blood
and blood components intended for transfusion or biological products that are also
medical devices, required by federal law, including federal regulation, to be dispensed
only by a prescription, including finished dosage forms and bulk drug substances
subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
353(b)].
21. "Repackage" means repackaging or otherwise changing the container, wrapper, or
labeling to further the distribution of a prescription drug. The term does not include
actions completed by the pharmacists responsible for dispensing product to the
patient.
22. "Repackager" means a person that repackages.
23. "Third-party logistics provider" means a person that contracts with a wholesale
distributor or a prescription drug, medical gas, or medical equipment manufacturer to
provide or coordinate warehousing, wholesale distribution, or other services on behalf
of a manufacturer, but does not take title to the prescription drug, medical gas, or
medical equipment or have general responsibility to direct the prescription drug's,
medical gas's, or medical equipment's sale or disposition. The third-party logistics
provider must be licensed independently under this chapter and to be considered part
of the normal distribution channel must also be an authorized distributor of record.
24. "Trace" means the capability to identify the historical locations, the records of
ownership, and the packaging hierarchy for a particular traceable item. "Trace"
answers questions such as where has the item been, who previously owned the item,
and in what packaging hierarchy did the product exist at various locations.
25. "Track" means the capability to identify the current, and at the time of shipment the
intended future, location, ownership, and packaging hierarchy of a traceable item
through the supply chain as the traceable item moves between parties. "Track"
addresses both forward and reverse logistics operations. "Track" answers questions
such as where is the item currently, who is the next intended recipient, and what is the
current packaging hierarchy of the item.
26. "Virtual distributor" means a person that arranges for the distribution of a drug or
device and which may or may not take actual possession of the drug or device but
contracts with others for the distribution, purchase, and sale.
27. "Virtual manufacturer" means a person that owns the new drug application or
abbreviated new drug application for a drug or device and which contracts with others
for the actual manufacturing of the drug or device.
28. "Wholesale distribution" means distribution of prescription drugs, medical gases, or
medical equipment to persons other than a consumer or patient. The term does not
include:
a. Intracompany sales of prescription drugs, medical gases, or medical equipment,
meaning any transaction or transfer between any division, subsidiary, parent or
affiliated or related company under common ownership and control of a corporate
entity, or any transaction or transfer between colicensees of a colicensed product.
b. The sale, purchase, distribution, trade, or transfer of a prescription drug, medical
gas, or medical equipment or the offer to sell, purchase, distribute, trade, or
transfer a prescription drug, medical gas, or medical equipment for emergency
medical reasons.
c. The purchase or other acquisition by a hospital or other health care entity that is a
member of a group purchasing organization of a drug, gas, or equipment for the
hospital's or health care entity's own use from the group purchasing organization
or from other hospitals or health care entities that are members of such
organizations.
d. The sale, purchase, or trade of a drug, gas, or equipment or an offer to sell,
purchase, or trade a drug, gas, or equipment by a charitable organization

described in section 501(c)(3) of the Internal Revenue Code of 1954 to a
nonprofit affiliate of the organization to the extent otherwise permitted by law.
e. The sale, purchase, or trade of a drug, gas, or equipment or an offer to sell,
purchase, or trade a drug, gas, or equipment among hospitals or other health
care entities that are under common control.
f. The distribution of prescription drug samples by manufacturers' representatives.
g. Drug returns, when conducted by a hospital, health care entity, or charitable
institution in accordance with title 21, Code of Federal Regulations, section
203.23.
h. The sale of minimal quantities of prescription drugs, medical gases, or medical
equipment by retail pharmacies to licensed practitioners for office use.
i. The sale, purchase, or trade of a drug, gas, or equipment; an offer to sell,
purchase, or trade a drug, gas, or equipment; or the dispensing of a drug, gas, or
equipment pursuant to a prescription.
j. The sale, transfer, merger, or consolidation of all or part of the business of a
pharmacy from or with another pharmacy, whether accomplished as a purchase
and sale of stock or business assets.
k. The sale, purchase, distribution, trade, or transfer of a prescription drug, medical
gas, or medical equipment from one authorized distributor of record to one
additional authorized distributor of record when the manufacturer has stated in
writing to the receiving authorized distributor of record that the manufacturer is
unable to supply such prescription drug, medical gas, or medical equipment and
the supplying authorized distributor of record states in writing that the prescription
drug, medical gas, or medical equipment being supplied had until that time been
exclusively in the normal distribution channel.
l. The delivery of, or offer to deliver, a prescription drug, medical gas, or medical
equipment by a common carrier solely in the common carrier's usual course of
business of transporting prescription drugs, medical gases, or medical equipment
and the common carrier does not store, warehouse, or take legal ownership of
the prescription drug, medical gas, or medical equipment.
m. The sale or transfer from a retail pharmacy or chain pharmacy warehouse of
expired, damaged, returned, or recalled prescription drugs, medical gases, or
medical equipment to the original manufacturer or to a third-party returns
processor.
29. "Wholesale distributor" means anyone engaged in the wholesale distribution of
prescription drugs, medical gases, or medical equipment, including manufacturers;
virtual manufacturers; repackagers; own-label distributors; private-label distributors;
jobbers; brokers; virtual distributors and warehouses, including manufacturers' and
distributors' warehouses; manufacturers' exclusive distributors; authorized distributors
of record; drug, gas, or equipment wholesalers or distributors; independent wholesale
drug, gas, or equipment traders; specialty wholesale distributors; retail pharmacies
that conduct wholesale distribution; and chain pharmacy warehouses that conduct
wholesale distribution. To be considered part of the normal distribution channel, such
wholesale distributor must also be an authorized distributor of record.