Mich. Admin. Code 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prescription drugs or devices that are outdated, damaged, deteriorated,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.
Notes
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