(6) The records described in subrules (1) to (5), and (8) of this rule and section of
17748e of the code, MCL 333.17748e, must be made available for inspection and
photocopying by the department, board, authorized federal, state, or local law
enforcement agency officials. The records that are maintained on-site or that are
immediately retrievable by computer or other electronic means must be readily available
for an authorized inspection during the retention period described in subrules (5) and (7)
of this rule. Records that are maintained at a central location apart from the site must be
made available for inspection within 2 working days after a request.
(7) A wholesale distributor shall retain the records described in this rule for a
minimum of 2 years after the disposition of the prescription drugs or devices.
(8) A purchasing pharmacy using a wholesale distributor-broker to facilitate a
transaction from a pharmacy that is not licensed in this state shall request the transaction
history, transaction statement, or transaction information for the drugs supplied.
History: 2020 AACS; 2022 AACS; 2024 MR 5, Eff. Feb. 29, 2024.
R 338.571 Facility requirements.
Rule 71. (1) A wholesale distributor that has physical custody or control of the
prescription drugs or devices shall satisfy all of the following facility requirements:
(a) Be of suitable size and construction to facilitate cleaning, maintenance, and
proper operations.
(b) Have storage areas that are designed to provide adequate lighting, ventilation,
temperature, sanitation, humidity, space, equipment, and security conditions.
(c) Have a quarantine area for the storage of prescription drugs or devices that are
outdated, damaged, deteriorated, misbranded, adulterated, or that are in immediate or
sealed secondary containers that are opened.
(d) Be maintained in a clean and orderly condition.
(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.
(f) Be secure from unauthorized entry by complying with all of the following:
(i) Access from outside the premises must be kept to a minimum and be well-
controlled. The outside perimeter of the premises must be well-lighted. Entry into areas
where prescription drugs or devices are held must be limited to authorized personnel.
(ii) Be equipped with an alarm system to detect entry after hours.
(iii) Be equipped with a security system that provides protection against theft and
diversion. If appropriate, the security system must provide protection against theft or
diversion that is facilitated or hidden by tampering with computers or electronic records.
(2) All prescription drugs or devices must be stored at temperatures and under
appropriate conditions under the label requirements pursuant to the requirements set forth
in the current edition of the USP compendium. If storage requirements are not established
for a prescription drug, the drug may be held at a controlled room temperature to help
ensure that its identity, strength, quality, and purity are not adversely affected.
Appropriate manual, electromechanical, or electronic temperature and humidity recording
equipment devices, or logs must be utilized to document the proper storage of
prescription drugs or devices.
History: 2020 AACS; 2024 MR 5, Eff. Feb. 29, 2024.
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