Mont. Admin. R. 24.174.1201 - WHOLESALE DISTRIBUTOR AND THIRD-PARTY LOGISTICS PROVIDER LICENSING
(1) Every person engaged in wholesale
distribution of drugs or prescription devices, which includes reverse wholesale
distribution, medical gases, or as a third-party logistics provider (3PL), as
defined in
37-7-602,
MCA, shall be licensed annually by the board. Each applicant shall:
(a) be a legal entity registered and in good
standing with the Montana Secretary of State;
(b) file an application on a form prescribed
by the board;
(c) pay the
appropriate licensing and registration fees;
(d) meet the requirements of
37-7-604,
MCA; and
(e) designate a
person-in-charge of the facility and for purposes of meeting requirements of
37-7-611,
MCA, regarding a criminal background check at time of initial licensure or any
change in person-in-charge, complete the requirements included on a form
prescribed by the board.
(i) The
person-in-charge must notify the board of any changes or termination of
services.
(ii) Within 72 hours of
termination of services, a new person-in-charge must be designated in writing
on the appropriate board-approved forms and filed with the board.
(2) The board will
independently verify the applicant's standing through the National Practitioner
Data Bank (NPDB) and National Association of Boards of Pharmacy
Clearinghouse.
(3) The license
shall be posted in a conspicuous place in the wholesaler's place of business
for which it is issued.
(4) No
license may be issued to any applicant whose intended place of business is a
personal residence.
(5) Wholesale
distributors located in Montana, applying for initial licensure, shall pass an
inspection by a pharmacy inspector or other agent of the Board of Pharmacy
before a license is issued.
(6) A
separate license is required for each separate location, in-state and/or
out-of-state, where drugs or devices are stored and directly distributed to
Montana.
(7) Wholesale distributors
shall operate in compliance with applicable federal, state, and local laws and
regulations. Wholesale distributors who distribute controlled substances shall
register with the board, to obtain an appropriate dangerous drug endorsement,
and with the DEA.
(8) Wholesale
distributors shall submit proof of surety bond upon initial licensure and at
time of renewal as identified on forms prescribed by the board in compliance
with state and federal requirements.
Notes
AUTH: 37-7-201, 37-7-610, MCA; IMP: 37-7-603, 37-7-604, 37-7-605, 37-7-606, 37-7-611, 37-7-612, MCA
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