§ 499.87 — Returned, damaged, and outdated medical gas

Florida § 499.87

• Jurisdiction: Florida
• Title: XXXIII
• Ch. 499: FLORIDA DRUG AND COSMETIC ACT

Text

(1) A medical gas that has left the control of the wholesale distributor may be returned to the wholesale distributor or manufacturer from which it was acquired, but may not be resold as a medical gas unless it is reprocessed by a manufacturer using proper and adequate controls to ensure the identity, strength, quality, and purity of the reprocessed medical gas.

(2) A medical gas that has been subjected to improper conditions, such as a fire, accident, or natural disaster, may not be salvaged or reprocessed.

(3) A medical gas, including its container, which is damaged, misbranded, or adulterated must be quarantined from other medical gases until it is destroyed or returned to the manufacturer or wholesale distributor from which it was acquired. External contamination of a medical gas container or closure system which does not impact the integrity of the medical gas is not considered damaged or adulterated for purposes of this subsection. If a medical gas is adulterated or misbranded or suspected of being adulterated or misbranded, notice shall be provided to the manufacturer or wholesale distributor from which the medical gas was acquired and to the appropriate boards and federal regulatory bodies.

(4) A medical gas container that has been opened or used but is not adulterated or misbranded is considered empty and must be quarantined from nonempty medical gas containers and returned to the manufacturer or wholesale distributor from which it was acquired for destruction or reprocessing.

(5) A medical gas, its container, or its associated documentation or labeling that is suspected of being used in criminal activity must be retained until its disposition is authorized by the department or an applicable law enforcement agency.

Legislative History

s. 23, ch. 2014-89.