(1) A wholesaler
that resides in this state must register with the board before engaging in the
wholesale distribution of prescription drugs in this state. A wholesaler that does not
reside in this state must be registered in this state prior to engaging in the
wholesale distribution of prescription drugs in this state.
(2) (a) The board may adopt rules to approve an accreditation body to
evaluate a wholesaler's operations to determine compliance with professional
standards and any other applicable laws and to perform inspections of each facility
and location where the wholesaler conducts wholesale distribution operations.
(b) An applicant for a registration shall pay any fee required by the
accreditation body or the board and comply with any rules promulgated by the
board.
(c) The board shall not issue or renew a registration to a wholesaler who
does not comply with this part 3.
(3) (a) An applicant for a wholesaler registration shall provide to the board
the following information, and any other information deemed appropriate by the
board, on a form provided by the board:
(I) The name, full business address, and telephone number of the applicant;
(II) The trade and business names used by the applicant;
(III) The addresses, telephone numbers, and names of the contact persons
for all facilities used by the applicant for the storage, handling, and distribution of
prescription drugs;
(IV) The type of ownership or operation of the applicant;
(V) The names of the owner and the operator of the applicant, including:
(A) The name of each partner if the applicant is a partnership;
(B) The name and title of each officer and director, the name of the
corporation, and the state of incorporation, if the applicant is a corporation;
(C) The name of the limited liability company, if the applicant is a limited
liability company, and the name of the parent company, if any, and the state of
incorporation or formation of both; or
(D) The name of the sole proprietor and the business entity if the applicant is
a sole proprietorship;
(VI) A list of the licenses, registrations, or permits issued to the applicant by
any other state that authorizes the applicant to purchase or possess prescription
drugs; and
(VII) The name of the applicant's designated representative for the facility,
the fingerprints of the designated representative, and a personal information
statement for the designated representative that includes information as required
by the board, including but not limited to the information in subsection (5) of this
section.
(b) A registrant shall complete and return a form approved by the board at
each renewal period. The board may suspend or revoke the registration of a
wholesaler if the board determines that the wholesaler no longer qualifies for a
registration.
(4) Prior to issuing a wholesaler registration to an applicant, the board, the
regulatory oversight body from another state, or a board-approved accreditation
body may conduct a physical inspection of the facility at the business address
provided by the applicant. Nothing in this subsection (4) precludes the board from
inspecting a wholesaler.
(5) The designated representative of an applicant for a wholesaler
registration shall:
(a) Be at least twenty-one years of age;
(b) Have at least three years of full-time employment history with a
pharmacy or a wholesaler in a capacity related to the dispensing and distribution of
and the record keeping related to prescription drugs;
(c) Be employed by the applicant in a full-time managerial position;
(d) Be actively involved in and aware of the actual daily operation of the
wholesaler;
(e) Be physically present at the facility of the applicant during regular
business hours, except when the absence of the designated representative is
authorized, including, but not limited to, sick leave and vacation leave;
(f) Serve in the capacity of a designated representative for only one
applicant or wholesaler at a time, except where more than one registered
wholesaler is co-located in the same facility and the wholesalers are members of an
affiliated group as defined by section 1504 of the federal Internal Revenue Code of
1986, as amended;
(g) Not have any convictions under federal, state, or local law relating to
wholesale or retail prescription drug distribution or a controlled substance, as
defined in section 18-18-102 (5);
(h) Not have any felony convictions pursuant to federal, state, or local law;
and
(i) Update all of the information required in this part 3 whenever changes
occur.
(6) A wholesaler shall obtain a registration for each facility it uses for the
distribution of prescription drugs.