Current through Supplement No. 394, October, 2024
North Dakota pharmacy inspectors may conduct onsite periodic
routine inspections during reasonable business hours of out-of-state pharmacies
registered to do business in North Dakota. Alternatively, the North Dakota
board of pharmacy may contract with the respective out-of-state regulatory
authorities to conduct and perfect periodic routine inspections.
1. To obtain a license as a nonresident
pharmacy, an applicant shall:
a. Have
submitted an application form prescribed by the board as required under section
61-08-01-02; and
b. Have paid the
fees specified by the board for the issuance of the license as specified in
article 61-11.
2. The
pharmacy owner, if an individual, and principals and owners who directly or
indirectly own greater than ten percent interest in the company, if the company
is not publically held, shall have undergone a state and federal
fingerprint-based criminal background check upon request by the
board.
3. The facility shall be
inspected in a manner and frequency prescribed by the board:
a. For nonresident pharmacies that prepare
and ship sterile or nonsterile compounded products, or sterile and nonsterile
compounded products into this state, the facility must be inspected at least
once every twenty-four months by:
(1) The
board or its duly authorized agent; or
(2) A duly authorized agent of a third party
approved by the board which is the national association of boards of pharmacy
verified pharmacy program.
b. For nonresident pharmacies that do not
ship sterile and nonsterile compounded products into this state, the facility
must be inspected at least once every two years by:
(1) The resident state board of pharmacy, if
the resident board's inspection is substantially equivalent to the inspection
in this state;
(2) The board or its
duly authorized agent; or
(3) A
duly authorized agent of a third party approved by the board, which is the
national association of boards of pharmacy verified pharmacy program.
c. Nonresident pharmacies that
dispense more than twenty-five percent of the pharmacy's total prescription
volume as a result of original prescriptions or refills solicited through the
internet, must be inspected by the national association of boards of pharmacy
verified pharmacy program
d. Costs
for inspections conducted by the board or an approved third party will be paid
by the applicant.
4. At
the time of renewal, the nonresident pharmacy shall:
a. Submit an application form prescribed by
the board;
b. Provide proof of a
recent inspection as outlined in subsection 3; and
c. Submit the national association of boards
of pharmacy e-profile identification (NABP e-Profile ID) of the pharmacy and
pharmacist-in-charge.
General Authority: NDCC 28-32-02,
43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-35, 43-15-36, 43-15-38
Law Implemented: NDCC 28-32-02,
43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-35, 43-15-36, 43-15-38
