Current through Vol. 24-22, December 15, 2024
Section R. 338.505 - Inspection of applicants and licenseesRule 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:(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.Mich. Admin. Code R. 338.505
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024