As used in this part, the term:(1) “Adulterated” means a medical gas that:(a) Consists, in whole or in part, of impurities or deleterious substances exceeding normal specifications;
(b) Is produced, prepared, packed, or held under conditions whereby the medical gas may have been contaminated causing it to be rendered injurious to health; or if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to ensure that the medical gas meets the requirements of this part as to safety and has the identity and strength and meets the quality and purity characteristics that the medical gas is represented to possess;
(c) Is held in a container with an interior that is composed in whole or in part of a poisonous or deleterious substance that may render the contents injurious to health; or
(d) Is represented as having a strength differing from, or quality or purity falling below, the standard set forth in the USP-NF. A medical gas defined in the USP-NF may not be deemed to be adulterated under this paragraph merely because it differs from the standard of strength, quality, or purity set forth in the USP-NF if its difference in strength, quality, or purity from that standard is plainly stated on its label. The determination as to strength, quality, or purity shall be made:1. In accordance with the tests or methods of assay in the USP-NF or its validated equivalent; or
2. In the absence or inadequacy of such tests or methods of assay, in accordance with the tests or methods of assay prescribed under the federal act.
(2) “Department” means the Department of Business and Professional Regulation.
(3) “Distribute” or “distribution” means to sell; offer to sell; deliver; offer to deliver; transfer by either the passage of title, physical movement, or both; broker; or give away a medical gas. The term does not include:(a) The dispensing or administration of a medical gas;
(b) The delivery of, or an offer to deliver, a medical gas by a common carrier in its usual course of business; or
(c) Sales activities taking place in a location owned, controlled, or staffed by persons employed by a person or entity permitted in this state to distribute a medical gas, if that location is not used to physically store or move a medical gas.
(4) “Emergency medical reasons” include:(a) Transfers between wholesale distributors or between a wholesale distributor and a retail pharmacy or health care entity to alleviate a temporary shortage of a medical gas arising from a long-term delay or interruption of regular distribution schedules.
(b) Sales, purchases, trades, transfers, or use of a medical gas acquired by a medical director or licensed emergency medical services provider for use by the emergency medical services provider and its permitted transport and nontransport vehicles in accordance with the provider’s license under part III of chapter 401.
(c) The provision of emergency supplies of medical gases to nursing homes during the hours of the day when necessary medical gases cannot normally be obtained from the nursing home’s regular distributors.
(d) The transfer of medical gases between retail pharmacies to alleviate a temporary shortage.
(5) “Emergency use oxygen” means oxygen USP administered in emergency situations without a prescription for oxygen deficiency and resuscitation. The container must be labeled in accordance with requirements of the United States Food and Drug Administration.
(6) “Federal act” means the Federal Food, Drug, and Cosmetic Act.
(7) “Medical gas” means a liquefied or vaporized gas that is a prescription drug, whether alone or in combination with other gases, and as defined in the federal act.
(8) “Medical gas-related equipment” means a device used as a component part or accessory used to contain or control the flow, delivery, or pressure during the administration of a medical gas, such as liquid oxygen base and portable units, pressure regulators and flow meters, and oxygen concentrators.
(9) “Misbranded” means having a label that is false or misleading; a label without the name and address of the manufacturer, packer, or distributor and without an accurate statement of the quantities of active ingredients; or a label without an accurate monograph for the medical gas, except in the case of mixtures of designated medical gases where the label identifies the component percentages of each designated medical gas used to make the mixture.
(10) “Medical oxygen” means oxygen USP which must be labeled in compliance with labeling requirements for oxygen under the federal act.
(11) “Product labeling” means the labels and other written, printed, or graphic matter upon an article, or the containers or wrappers that accompany an article, except for letters, numbers, and symbols stamped into the container as required by the federal Department of Transportation.
(12) “USP” means the United States Pharmacopeia.
(13) “USP-NF” means the United States Pharmacopeia-National Formulary.
(14) “Wholesale distribution” means the distribution of medical gas to a person other than a consumer or patient. Wholesale distribution of medical gases does not include:(a) The sale, purchase, or trade of a medical gas; an offer to sell, purchase, or trade a medical gas; or the dispensing of a medical gas pursuant to a prescription;
(b) Activities exempt from the definition of wholesale distribution in s. 499.003; or (c) The sale, purchase, or trade of a medical gas or an offer to sell, purchase, or trade a medical gas for emergency medical reasons.
(15) “Wholesale distributor” means any person or entity engaged in wholesale distribution of medical gas within or into this state, including, but not limited to, manufacturers; own-label distributors; private-label distributors; warehouses, including manufacturers’ and distributors’ warehouses; and wholesale medical gas warehouses.
