Mont. Admin. R. 24.174.1205 - MEDICAL GAS SUPPLIER

(1) Every person engaged in supplying medical gases 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 register annually with the board. Each applicant shall:

(a) register with the board as a wholesale drug distributor;

(b) file an application to register as a medical gas supplier on a form prescribed by the board; and

(c) pay the appropriate registration fee.

(2) The wholesale drug distributor license with the medical gas supplier endorsement shall be posted in a conspicuous place in the wholesaler's place of business for which it is issued.

(3) A medical gas supplier shall not:

(a) supply prescription medications, except medical gases, without appropriate licensure as a pharmacy;

(b) manufacture or distribute medical gases without appropriate licensure as a medical gas distributor; or

(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.

(4) A medical gas supplier shall supply 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 supply of, and complaints related to, medical gases.

(7) Records shall be retained for at least three years after supply to a patient or one year after the expiration date of the medical gas, whichever is longer.

(8) Records shall be readily available for review by the board or its inspector.

Notes

Mont. Admin. R. 24.174.1205

NEW, 2007 MAR p. 1936, Eff. 11/22/07.

37-1-134, 37-7-201, 37-7-610, MCA; IMP, 37-7-604, 37-7-605, MCA;