§ 43-15.3-03 — Wholesale distributor licensing requirement - Minimum requirements for licensure

North Dakota § 43-15.3-03

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

Text

licensure.
1. A wholesale distributor that engages in the wholesale distribution of prescription drugs,
medical gases, or medical equipment shall pay the annual fee required by the board,

must be licensed by the board under this chapter, and must be properly licensed in
any other state in which the wholesale distributor engages in the distribution of
prescription drugs, medical gases, or medical equipment before engaging in wholesale
distributions of wholesale prescription drugs, medical gases, or medical equipment in
this state. The licensee shall operate in a manner prescribed by law and according to
rules adopted by the board. However, information and qualification requirements for
licensure beyond that required by federal law or regulation do not apply to
manufacturers distributing the manufacturers' own United States food and drug
administration-approved drugs, gases, or equipment, unless particular requirements
are deemed necessary and appropriate following rulemaking. The board may grant a
temporary license when the wholesale distributor or pharmacy distributor first applies
for a license to operate within this state. A temporary license is valid until the board
finds that the applicant meets the requirements for regular licensure.
2. A person may not engage in wholesale distributions of prescription drugs without
obtaining and maintaining accreditation or certification from the national association of
boards of pharmacy's verified accredited wholesale distributor or an accreditation body
approved by the board, obtaining and maintaining a license issued by the board, and
paying fees as may be required by the board.
3. The board shall require the following minimum information from each wholesale
distributor applying to get a license under subsection 1:
a. The name, full business address, and telephone number of the licensee.
b. All trade or business names used by the licensee.
c. Addresses, telephone numbers, and the names of contact persons for all facilities
used by the licensee for the storage, handling, and distribution of prescription
drugs.
d. The type of ownership or operation.
e. The name of every owner and operator of the licensee, including:
(1) If an individual, the name of the individual;
(2) If a partnership, the name of each partner, and the name of the partnership;
(3) If a corporation, the name and title of each corporate officer and director, the
corporate names, and the name of the state of incorporation; and
(4) If a sole proprietorship, the full name of the sole proprietor and the name of
the business entity.
f. A list of all licenses and permits issued to the applicant by any other state that
authorizes the applicant to purchase or possess prescription drugs, medical
gases, or medical equipment.
g. The name of the applicant's designated representative for the facility and for a
prescription drug wholesaler applicant, the personal information statement and
fingerprints required pursuant to subdivision h for the individual identified as the
prescription drug wholesaler applicant's designated representative for the facility.
h. Each individual identified by a prescription drug wholesaler applicant as a
designated representative for a facility and therefore required by subdivision g to
provide a personal information statement and fingerprints shall provide the
following information to the state:
(1) The individual's places of residence for the past seven years;
(2) The individual's date and place of birth;
(3) The individual's occupations, positions of employment, and offices held
during the past seven years;
(4) The principal business and address of any business, corporation, or other
organization in which each office of the individual was held or in which each
occupation or position of employment was carried on;
(5) Whether the individual has been, during the past seven years, the subject of
any proceeding for the revocation of any license or any criminal violation
and, if so, the nature of the proceeding and the disposition of the
proceeding;

(6) Whether, during the past seven years, the individual has been enjoined,
either temporarily or permanently, by a court of competent jurisdiction from
violating any federal or state law regulating the possession, control, or
distribution of prescription drugs or criminal violations, together with details
concerning any of those events;
(7) A description of any involvement by the individual with any business,
including any investments, other than the ownership of stock in a publicly
traded company or mutual fund, during the past seven years, which
manufactured, administered, prescribed, distributed, or stored
pharmaceutical products and any lawsuits in which the businesses were
named as a party;
(8) A description of any misdemeanor or felony criminal offense of which the
individual, as an adult, was found guilty, regardless of whether adjudication
of guilt was withheld or whether the individual pled guilty or nolo contendere.
If the individual indicates that a criminal conviction is under appeal and
submits a copy of the notice of appeal of that criminal offense, the applicant
must, within fifteen days after the disposition of the appeal, submit to the
state a copy of the final written order of disposition; and
(9) A photograph of the individual taken in the previous one hundred eighty
days.
4. The information required under subsection 3 must be provided under oath.
5. The board may not issue a wholesale distributor license to an applicant, unless the
board:
a. Inspects or appoints a third party recognized by the board for the purpose of
inspecting the wholesale distribution operations of the facility before initial
licensure and continues to inspect periodically thereafter in accordance with a
schedule to be determined by the board, but not less than every three years.
Manufacturing facilities are exempt from inspection by the board if the
manufacturing facilities are currently registered with the federal food and drug
administration in accordance with section 510 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301]; and
b. Determines that the designated representative meets the following qualifications:
(1) Is at least twenty-one years of age;
(2) Has been employed full time for at least three years in a pharmacy or with a
wholesale distributor in a capacity related to the dispensing and distribution
of, and recordkeeping relating to, prescription drugs, medical gases, or
medical equipment;
(3) Is employed by the applicant full time in a managerial level position;
(4) Is actively involved in and aware of the actual daily operation of the
wholesale distributor;
(5) Is physically present at the facility of the applicant during regular business
hours, except when the absence of the designated representative is
authorized, including sick leave and vacation leave;
(6) Is serving in the capacity of a designated representative for only one
applicant at a time, except where more than one licensed wholesale
distributor is colocated in the same facility and the wholesale distributors are
members of an affiliated group, as defined in section 1504 of the Internal
Revenue Code [26 U.S.C. 1504];
(7) Does not have any convictions under any federal, state, or local laws
relating to wholesale or retail prescription drug, medical gas, or medical
equipment distribution or distribution of controlled substances; and
(8) Does not have any felony conviction under federal, state, or local laws.
6. The board shall submit the fingerprints provided by an individual with a license
application for a statewide and nationwide criminal history background record check.
The nationwide criminal history background record check must be conducted in the

manner provided in section 12-60-24. All costs associated with the background check
are the responsibility of the applicant.
7. The board shall require every wholesale prescription drug distributor applying for a
license to submit a bond of at least one hundred thousand dollars, or other equivalent
means of security acceptable to the state, including an irrevocable letter of credit or a
deposit in a trust account or financial institution. Obtaining and maintaining
accreditation or certification from the national association of boards of pharmacy's
verified accredited wholesale distributor satisfies this requirement. A chain pharmacy
warehouse that is engaged only in intracompany transfers is not subject to the bond
requirement. The purpose of the bond is to secure payment of any fines or penalties
imposed by the state and any fees and costs incurred by the state regarding that
license which are authorized under state law and which the licensee fails to pay thirty
days after the fines, penalties, or costs become final. The state may make a claim
against the bond or security until one year after the licensee's license ceases to be
valid. A single bond may cover all facilities operated by the applicant in the state. Any
chain pharmacy warehouse that is engaged only in intracompany transfers is exempt
from the bond requirement.
8. If a wholesale distributor distributes prescription drugs, medical gases, or medical
equipment from more than one facility, the wholesale distributor shall obtain a license
for each facility.
9. If a manufacturer manufactures prescription drugs, medical gases, or medical
equipment in more than one facility but does not engage in wholesale distribution to
North Dakota from those facilities, the manufacturer is not required to obtain a license
for each facility.
10. The board shall mail or electronic mail a notice for license renewal to each licensee
before the first day of the month in which the license expires. If application for renewal
of the license, along with the required fee, is not received by the board before the first
day of the following month, the license expires on the last day of that month. Timely
renewal is the responsibility of the licensee.
11. In accordance with each licensure renewal, the board shall make available on the
board's website for each wholesale distributor licensed under this section the
information that the wholesale distributor provided pursuant to subsection 3. Within
thirty days of receiving the notice, the wholesale distributor shall identify and state
under oath to the state licensing authority all changes or corrections to the information
that was provided under subsection 3. Changes in, or corrections to, any information in
subsection 3 must be submitted to the board as required by that authority. The board
may suspend, revoke, or refuse to renew the license of a wholesale distributor if the
board determines that the wholesale distributor no longer qualifies for the license
issued under this section.
12. The designated representative identified pursuant to subdivision g of subsection 3
must receive and complete continuing training in applicable federal and state laws
governing wholesale distribution of prescription drugs, medical gases, or medical
equipment.
13. Information provided under subdivision h of subsection 3 may not be disclosed to any
person other than a government agency that needs the information for licensing or
monitoring purposes.