Florida Statutes 499.86 – Examination of materials
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Terms Used In Florida Statutes 499.86
- 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
- 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
- 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
- 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. See Florida Statutes 499.82
(1) A wholesale distributor must visually examine a medical gas container upon receipt from the manufacturer in order to identify the medical gas stored within and to determine if the container has been damaged or is otherwise unfit for distribution. Such examination must occur in a manner that would reveal damage to the container which could suggest possible adulteration or misbranding.(2) A medical gas container that is found to be damaged or otherwise unfit pursuant to subsection (1) must be quarantined from the stock of medical gas until a determination is made that the medical gas in question is not misbranded or adulterated.(3) An outgoing shipment must be inspected to identify the medical gases in the shipment to ensure that medical gas containers that have been damaged in storage or held under improper conditions are not distributed or dispensed.(4) A wholesale distributor must review records documenting the acquisition of medical gas upon receipt for accuracy and completeness.