1. (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 be licensed by the board. Each applicant shall:

   1. (a) if a medical gas manufacturer, provide proof of registration with the Food and Drug Administration (FDA) as a medical gas manufacturer, comply with all FDA requirements, and be licensed by the board as a manufacturer, pursuant to ARM 24.174.1203;
   2. (b) if a medical gas distributor, be licensed by the board as a wholesale drug distributor;
   3. (c) file an application for the medical gas distributor/manufacturer endorsement on a form prescribed by the board; and
   4. (d) pay the appropriate endorsement application and annual renewal fees.
2. (2) The license with the medical gas distributor/manufacturer endorsement shall be posted in a conspicuous place in the licensee’s place of business for which it is issued to the wholesaler, manufacturer, or both if in the same location.

3. (3) A medical gas distributor or manufacturer 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.

   1. (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.
   2. (b) Records shall be readily available for review by the board, its inspector, or the FDA.

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.