(1) A wholesale distributor shall obtain, before the initial acquisition of medical gas, the following information from the supplying wholesale distributor or manufacturer:

(a) If a manufacturer is distributing to a wholesale distributor, evidence that the manufacturer is registered and the medical gas is listed with the United States Food and Drug Administration;

(b) If a wholesale distributor is distributing to a wholesale distributor, evidence that the wholesale distributor supplying the medical gas is legally authorized to distribute medical gas within or into the state;

(c) The name of the responsible facility contact person for the supplying manufacturer or wholesale distributor; and

(d) Certification that the manufacturer’s or wholesale distributor’s policies and procedures comply with this part.

(2) A wholesale distributor is exempt from obtaining the information from a manufacturer, as required under subsection (1), if the manufacturer is registered with the United States Food and Drug Administration in accordance with s. 510 of the federal act and the manufacturer provides:

(a) Proof of such registration; and

(b) Proof of inspection by the United States Food and Drug Administration or other regulatory body within the past 3 years demonstrating substantial compliance with current good manufacturing practices applicable to medical gases.

(3) A manufacturer or wholesale distributor that distributes to or acquires medical gas from another wholesale distributor shall provide to or obtain from the distributing or acquiring manufacturer or distributor the information required by s. 499.89(1), as applicable.

History.—s. 24, ch. 2014-89.