Mich. Admin. Code R. 338.571

Current through Vol. 24-18, October 15, 2024

Section 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(c) Have a quarantine area for the storage of prescription drugs or devices that are outdated, damaged, deteriorated, misbranded, adulterated, or that are in immediate or sealed secondary containers that are opened.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.

Mich. Admin. Code R. 338.571

2020 AACS; 2024 MR 5, Eff. 2/29/2024