24.174.1204    MEDICAL GAS DISTRIBUTOR

(1) Every person engaged in the manufacture or distribution of medical gases other than to the consuming public or a patient, in the state of Montana, shall register annually with the board. Each applicant shall:

(a) provide proof of registration with the Food and Drug Administration (FDA) as a medical gas manufacturer and comply with all FDA requirements;

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

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

(d) pay the appropriate registration fee.

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

(3) A medical gas distributor shall establish and implement written procedures for maintaining records pertaining to medical gas production, processing, labeling, packaging, quality control, distribution, complaints, and any information required by federal or state law.

(a) Records shall be retained for at least two years after distribution or one year after the expiration date of the medical gas, whichever is longer.

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

History: 37-1-134, 37-7-201, 37-7-610, MCA; IMP, 37-7-604, 37-7-605, MCA; NEW, 2007 MAR p. 1936, Eff. 11/22/07.