- (a) The limited retail drug distributor license shall be posted in a conspicuous place in the wholesaler's place of business for which it is issued.
(b) A medical gas supplier shall not:
- (1) Supply prescription medications, except medical gases, without appropriate licensure as a limited retail drug distributor;
- (2) Manufacture or distribute medical gases without appropriate licensure as a limited retail drug distributor; or
- (3) 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.
- (c) A medical gas supplier shall supply medical gas only pursuant to prescription order by an authorized prescriber.
- (d) A medical gas supplier shall label each medical gas container with the name, address, and telephone number of the supplier.
- (e) 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.
- (f) Records shall be retained for at least 3 years after supply to a patient or one year after the expiration date of the medical gas, whichever is longer.
- (g) Medical gases and equipment shall be secure from unauthorized entry and have a system to detect or deter entry after hours and provide protection against theft.
- (h) The facility shall be maintained in a clean and orderly condition, and only service animals shall be allowed.
(i) A policy and procedure shall be in place for:
- (1) Recalls;
- (2) Emergencies;
- (3) Shipping and receiving;
- (4) Returned goods; and
- (5) Outdates.
- (j) Records shall be readily available for review by the board or its inspector during regular business hours.
Source. #12335, eff 7-22-17