Mich. Admin. Code R. 338.534 - Out-of-state pharmacy licensure inspection; in-state pharmacy licensure renewal inspection
Rule 34.
(1) A
pharmacy located outside of this state that applies for licensure in this state
as a pharmacy that will not ship compounded sterile pharmaceutical products
into this state shall submit to the department a copy of its most recent
resident state board of pharmacy inspection or an NABP-VPP inspection that was
performed within the last 2 years before the date of application.
(2) Unless accredited by a national
accrediting organization, recognized by the board, an applicant for renewal of
an in-state pharmacy license, or an applicant for an initial or renewal of an
out-of-state pharmacy license, that will provide sterile compounded
pharmaceuticals in this state shall have an inspection and submit the
inspection report to the department, completed no more than 18 months before
the date of application, that demonstrates compliance with all applicable
standards that are adopted by reference in
R 338.533. The inspection must be
conducted by 1 of the following:
(a) The
department.
(b) The
NABP-VPP.
(c) An accrediting
organization according to
R 338.532.
(d) A state licensing agency of the state in
which the applicant is a resident and in accordance with the NABP's multistate
pharmacy inspection blueprint program.
Notes
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