1. (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. (2) Out-of-state device facilities must comply with the following:

   1. (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;
   2. (b) maintain, in readily retrievable form, records of products dispensed to Montana patients pursuant to a prescription drug order;
   3. (c) supply, upon request, all information needed by the board to carry out the board’s responsibilities; and
   4. (d) upon application, provide verification of licensure in the state in which the facility is located and provide the home-state inspection report.

3. (3) A device facility must establish and implement policies and procedures for compliance with the following and be available upon inspection:

   1. (a) maintaining records pertaining to the acquisition and supply of, and complaints related to, devices, DME, and/or medical gases;
   2. (b) facility security;
   3. (c) product storage and security;
   4. (d) copy of prescription and records of dispensing pursuant to ARM 24.174.833;
   5. (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;
   6. (f) providing directions and/or educational information to the patient regarding the dispensed product;

   7. (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:

      1. (i) provide all supplies necessary to operate the equipment, and provide information on appropriate storage;
      2. (ii) deliver, unpack, and assemble equipment and perform safety and operational checks for a device;
      3. (iii) adapt, fit, or adjust medical equipment to meet patient need; and
      4. (iv) maintain, inspect, and test medical equipment;
   8. (h) provide emergency maintenance, replacement, or backup of medical equipment when needed; and
   9. (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.

Authorizing statute(s): 37-7-201, MCA

Implementing statute(s): 37-7-101, 37-7-102, 37-7-201, MCA

History: NEW, 2025 MAR, Notice No. 2025-206, Eff. 12/6/25.