(1) A facility where a medical gas is received, stored, warehoused, handled, held, offered, marketed, displayed, or transported, to avoid any negative effect on the identity, strength, quality, or purity of the medical gas, must:

(a) Be of suitable construction to ensure that medical gases are maintained in accordance with the product labeling of the medical gas or in compliance with the USP-NF;

(b) Be of suitable size and construction to facilitate cleaning, maintenance, and proper permitted operations;

(c) Have adequate storage areas with appropriate lighting, ventilation, space, equipment, and security conditions;

(d) Have a quarantined area for storage of medical gases that are suspected of being misbranded, adulterated, or otherwise unfit for distribution;

(e) Be maintained in an orderly condition;

(f) Be located in a commercial location and not in a personal dwelling or residence location, except for a personal dwelling location used for on-call delivery of oxygen USP for home care use if the person providing on-call delivery is employed by or acting under a written contract with an entity that holds a medical oxygen retailer permit;

(g) Provide for the secure and confidential storage of patient information, if applicable, with restricted access and policies and procedures to protect the integrity and confidentiality of patient information; and

(h) Provide and maintain appropriate inventory controls to detect and document any theft of nitrous oxide.

(2) Medical gas shall be stored under appropriate conditions in accordance with the manufacturer’s recommendations on product labeling and department rules or, in the absence of rules, in accordance with applicable industry standards.

(3) Medical gas shall be packaged in accordance with official compendium standards, such as the USP-NF.

History.—s. 20, ch. 2014-89; s. 63, ch. 2015-2.