(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;

Terms Used In Florida Statutes 499.84

  • 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. See Florida Statutes 499.82
  • Contract: A legal written agreement that becomes binding when signed.
  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.82
  • 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. See Florida Statutes 499.82
  • 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. See Florida Statutes 499.82
  • Medical oxygen: means oxygen USP which must be labeled in compliance with labeling requirements for oxygen under the federal act. See Florida Statutes 499.82
  • 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. See Florida Statutes 499.82
  • person: includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. See Florida Statutes 1.01
  • 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. See Florida Statutes 499.82
  • USP: means the United States Pharmacopeia. See Florida Statutes 499.82
  • USP-NF: means the United States Pharmacopeia-National Formulary. See Florida Statutes 499.82
(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.
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