Mich. Admin. Code R. 338.573

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

Section R. 338.573 - Examination of materials; returned, damaged and outdated prescription drugs or devices

Rule 73.

(1) A wholesale distributor shall comply with both of the following provisions that pertain to the examination of materials:

(a) Each outside shipping container must be visually examined upon receipt for the identity of the prescription drug or devices and to prevent the acceptance of contaminated prescription drugs or devices or prescription drugs or devices otherwise unfit for distribution. The examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(b) Each outgoing shipment must be visually inspected for identity of the prescription drug products and to ensure that prescription drugs or devices that have been damaged in storage or held under conditions that are inconsistent with USP compendium standards are not delivered.

(2) All of the following provisions apply to returned, damaged, and outdated prescription drugs or devices:

(a) Prescription drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated, must be quarantined and physically separated from other prescription drugs or devices until they are destroyed or returned to the supplier.

(b) Any immediate or sealed outer or sealed secondary containers of any prescription drugs or devices that have been opened or used must be identified as such and the drugs or devices must be quarantined and physically separated from other prescription drugs or devices until they are either destroyed or returned to the supplier.

(c) If the conditions under which a prescription drug has been returned cast doubt on the drugs safety, identity, strength, quality, or purity, then the drug must be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which the drug has been returned cast doubt on the drugs safety, identity, strength, quality, or purity, the wholesale distributor shall consider the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.

(3) The recordkeeping requirements of R 338.569 must be followed.

Mich. Admin. Code R. 338.573

2020 MR 24, Eff. 12/22/2020