Section R. 338.588 - Automated devicesRule 88.
(1) "Automated device" means a mechanical system that performs an operation or activity, other than compounding or administration, relating to the storage, packaging, dispensing, or delivery of a drug and that collects, controls, and maintains transaction information.(2) An automated device may be used only in the following locations:(a) A pharmacy, or at the same physical address as the pharmacy if the location of the automated device is owned and operated by the same legal entity as the pharmacy.(c) A county medical care facility.(f) Other skilled nursing facility, as that term is defined in section 20109 of the code, MCL 333.20109.(g) An office of a dispensing prescriber, where the device is operated by the dispensing prescriber, not a pharmacy.(h) A location affiliated with a hospital, but not at the same physical address as the pharmacy, which is owned and operated by the hospital, consistent with section 17760 of the code, MCL 333.17760.(i) A location other than subdivisions (a) to (h) of this subrule, where the automated device acts as an extension of a pharmacy. In addition to the requirements in this rule, the automated device must meet the requirements in R 338.588a.(3) Records and electronic data maintained by automated devices must meet all of the following requirements: (a) All events involving access to the contents of the automated devices must be recorded electronically.(b) Records must be maintained for 5 years by the pharmacy or dispensing prescriber and must be retrievable on demand for review by an agent of the board. The records must include all of the following information:(i) The unique identifier of the automated device accessed.(ii) Identification of the individual accessing the automated device.(iii) The type of transaction.(iv) The name, strength, dosage form, quantity, and name of the manufacturer of the drug accessed.(v) The name of the patient for whom the drug was ordered.(vi) Identification of the pharmacist responsible for the accuracy of the medications to be stocked or restocked in the automated device.(4) Except for devices allowed under R 388.588a(2), policy and procedures for the use of the automated device must include a requirement for pharmacist review of the prescription or medication order before removal of any medication. This subrule does not apply to the following situations:(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R 338.486(4)(j). A pharmacist shall review the orders and authorize any further dispensing within 48 hours.(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c). A pharmacist shall review the orders and authorize any further dispensing within 48 hours.(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order. A pharmacist shall review the orders and authorize any further dispensing within 48 hours.(d) The automated device is located in a dispensing prescriber's office to facilitate dispensing by the dispensing prescriber.(5) A copy of all policies and procedures related to the use of an automated device must be maintained at the pharmacy responsible for the device's specific location or at the dispensing prescriber's office and be available for review by an agent of the board.Mich. Admin. Code R. 338.588
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024