ARM 24.174.2002. DEVICE NON-PHARMACY FACILITY REQUIREMENTS

(1) In-state device facilities shall be inspected by the board and the board reserves the right to inspect out-of-state device facilities for cause. (2) Out-of-state device facilities must comply with the following: (a) be a legal entity registered and in good standing with the Montana Secretary of State with a registered agent in Montana for services of process; (b) maintain, in readily retrievable form, records of products dispensed to Montana patients pursuant to a prescription drug order; (c) supply, upon request, all information needed by the board to carry out the board’s responsibilities; and (d) upon application, provide verification of licensure in the state in which the facility is located and provide the home-state inspection report. (3) A device facility must establish and implement policies and procedures for compliance with the following and be available upon inspection: (a) maintaining records pertaining to the acquisition and supply of, and complaints related to, devices, DME, and/or medical gases; (b) facility security; (c) product storage and security; (d) copy of prescription and records of dispensing pursuant to ARM 24.174.833; (e) labeling of a dispensed product pursuant to ARM 24.174.832 that includes on the device, container, or in the educational information the name, address, and telephone number of the facility; (f) providing directions and/or educational information to the patient regarding the dispensed product; (g) procedures for ensuring patient safety for the appropriate patient care, treatment, and service response requirements for devices dispensed to a patient. The device facility must address how it will perform the following functions for a device provided to a patient: (i) provide all supplies necessary to operate the equipment, and provide information on appropriate storage; (ii) deliver, unpack, and assemble equipment and perform safety and operational checks for a device; (iii) adapt, fit, or adjust medical equipment to meet patient need; and (iv) maintain, inspect, and test medical equipment; (h) provide emergency maintenance, replacement, or backup of medical equipment when needed; and (i) for ventilators, life-sustaining infusions, or oxygen, the device facility must provide a backup system, means to provide a duplicate, or a power supply that provides a minimum of three times the licensee’s response time to a patient.