ARM 24.174.1205
ARM 24.174.1205. MEDICAL GAS SUPPLIER
Cite as Mont. Admin. R. 24.174.1205
(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.