Mich. Admin. Code R. 338.505 - Inspection of applicants and licensees
Rule 5.
(1) The
board, board inspector, board agent, or an entity approved under
R 338.532, may enter at reasonable
times, any building, place, or facility that is owned or controlled by any
applicant for, or holder of, a license to inspect to enable the board to
determine if the applicant possesses the qualifications and competence for the
license sought or to determine whether a license holder is and has been
complying with the code and rules. The inspection must concern only matters
relevant to the applicant's or license holder's practice of pharmacy,
manufacturing, and wholesale distribution of drugs and devices saleable by
prescription only.
(2) Inspections
in subrule (1) of this rule must not extend to any of the following
information, however, the following information is subject to a disciplinary
investigation:
(a) Financial data.
(b) Purchasing data, other than shipment
data, and the current and historical selling price of a drug.
(c) Personnel data, other than data as to the
qualifications of personnel performing functions subject to the acts and rules
enforced by the board.
(d) Research
data, other than research data that confirms the appropriate use of controlled
substances for research purposes, or research data for accountability for
reconciliation of prescription drug inventories.
(3) An applicant or license holder shall
allow and cooperate with the inspection.
Notes
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