(1) Every person engaged in dispensing medical gases, including associated medical gas supplies, to the consuming public, or to a patient or a patient's agent, in the state of Montana that is not a licensed pharmacy shall obtain a medical gas supplier endorsement. Each applicant shall:
- (a) be licensed by the board as a wholesale drug distributor;
- (b) file an application on a form prescribed by the board; and
- (c) pay the appropriate endorsement application and annual renewal fees.
- (2) A licensee with a medical gas supplier endorsement shall post the license in a conspicuous place in the place of business for which it is issued.
(3) A medical gas supplier shall not:
- (a) dispense prescription medications, except medical gases, without appropriate licensure as a pharmacy;
- (b) manufacture or distribute medical gases without appropriate licensure and endorsement as a medical gas distributor;
- (c) instruct patients regarding clinical use of equipment, or provide any monitoring, assessment, or other evaluation of therapeutic effects without appropriate licensure as a respiratory care practitioner; or
- (d) dispense any device that requires a prescription for dispensing that is not a medical gas or medical gas supply, without licensure as a non-pharmacy device facility pursuant to ARM 24.174.2001 and 24.174.2002.
- (4) A medical gas supplier shall dispense medical gas only pursuant to prescription order by an authorized prescriber.
- (5) A medical gas supplier must label each medical gas container with the name, address, and telephone number of the supplier.
- (6) A medical gas supplier shall establish and implement written procedures for maintaining records pertaining to the acquisition and dispensing of, and complaints related to, medical gases.
- (7) Records shall be retained for at least three years, as required by the FDA, after dispensing to a patient or one year after the expiration date of the medical gas, whichever is longer.
- (8) Records shall be readily available for inspection by the board.
Authorizing statute(s): 37-1-134, 37-7-201, 37-7-610, MCA
Implementing statute(s): 37-7-604, 37-7-605, MCA
History: NEW, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2025 MAR, Notice No. 2025-206, Eff. 12/6/25.