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
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
person-in-charge of the facility and for purposes of meeting requirements of
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.
person-in-charge must notify the board of any changes or termination of
(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
(3) The license
shall be posted in a conspicuous place in the wholesaler's place of business
for which it is issued.
license may be issued to any applicant whose intended place of business is a
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.
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
(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.
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.
Mont. Admin. R. 24.174.1201
NEW, 1992 MAR p. 2135,
Eff. 8/14/92; AMD, 1999 MAR p. 2438, Eff. 10/22/99; TRANS, from Commerce, 2002
MAR p. 904; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff.
11/22/07; AMD, 2010 MAR p. 2968, Eff. 12/24/10; AMD, 2012 MAR p. 506, Eff.
MAR p. 1842, Eff.