Mont. Admin. R. 24.174.1202 - MANUFACTURER AND REPACKAGER LICENSING
(1) Every person seeking licensure or renewal
as a manufacturer or repackager, as defined in
37-7-602,
MCA, 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.
(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 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) Applicants 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 where drugs or devices are stored,
repackaged, and/or directly distributed to Montana. For manufacturers, a
license shall be issued to a facility meeting the requirements that is located
in Montana.
(7) Licensees shall
operate in compliance with applicable federal, state, and local laws and
regulations. Licensees who distribute controlled substances shall register with
the board, obtain an appropriate dangerous drug endorsement, register with the
DEA, and shall comply with all applicable state, local, and DEA
regulations.
Notes
AUTH: 37-7-201, 37-7-610, MCA; IMP: 37-7-201, 37-7-604, 37-7-605, 37-7-610, MCA
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