1. (1) A facility must obtain a device facility license from the board when the facility exclusively dispenses products that are devices, durable medical equipment (DME), medical gas, including medical gas supplies, directly to a patient in Montana pursuant to a prescription drug order, as defined in 37-7-101, MCA.
2. (2) If the scope of practice is limited to (1), and does not include the dispensing of prescription drugs, then a device facility license type is sufficient and a separate pharmacy, out-of-state mail-order pharmacy, or wholesale distributor license is not required.
3. (3) Facilities that comply with (1) and supply medical gas and/or medical gas supplies must apply for a medical gas supplier endorsement.
4. (4) A device facility must identify a person-in-charge responsible for complying with board laws and regulations. The person-in-charge does not need to be a pharmacist. If a person-in-charge changes, the board must be notified of a new person-in-charge within 30 days.

5. (5) A device facility must:

   1. (a) submit an application and pay the required application, endorsement, and annual renewal fees as required by the board;
   2. (b) submit with the application a description of the device facility’s scope of service, floor plan, security measures, list of device types or categories to be dispensed, list of policies and procedures in place necessary to comply with the provisions listed in ARM 24.174.2002(3), and product storage;
   3. (c) apply for separate licenses to operate, maintain, open, or establish more than one device facility at separate locations;
   4. (d) provide a toll-free telephone number in the information dispensed to a patient to the location that has access to the patient’s records. A toll-free telephone number shall also be provided to the board to allow for compliance with all information requests by the board;

   5. (e) comply with board rules related to:

      1. (i) location change, ARM 24.174.803;
      2. (ii) ownership change, ARM 24.174.804;
      3. (iii) license posting, ARM 24.174.806; and
      4. (iv) closure, ARM 24.174.807;
   6. (f) comply with all applicable state and federal laws and regulations.
6. (6) No license may be issued to any device facility whose intended place of business is a personal residence.

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.