Florida Statutes 499.91 – Prohibited acts
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A person may not perform or cause the performance of, or aid and abet in, any of the following acts:
(1) The manufacture, sale, or delivery, or the holding or offering for sale, of a medical gas that is adulterated, misbranded, or is otherwise unfit for distribution.
(2) The adulteration or misbranding of a medical gas.
(3) The receipt of a medical gas that is adulterated, misbranded, stolen, or obtained by fraud or deceit, and the delivery or proffered delivery of such medical gas for pay or otherwise.
(4) The alteration, mutilation, destruction, obliteration, or removal of all or any part of the product labeling of a medical gas, or the willful commission of any other act with respect to a medical gas that results in its being misbranded.
(5) The purchase or receipt of a medical gas from a person not authorized to distribute or dispense medical gas or who is not exempted from permitting requirements to wholesale distribute medical gas to such purchaser or recipient.
(6) The knowing and willful sale or transfer of a medical gas to a recipient who is not legally authorized to receive a medical gas, except that a violation does not exist if a permitted wholesale distributor provides oxygen to a permitted medical oxygen retail establishment that is out of compliance with the notice of location change requirements of s. 499.833(3)(a), provided that the wholesale distributor with knowledge of the violation notifies the department of the transaction by the next business day.
(7) The failure to maintain or provide records required under this part and the rules adopted under this part.
(8) Providing the department or any of its representatives or any state or federal official with false or fraudulent records or making false or fraudulent statements regarding this part or the rules adopted under this part.
(9) The distribution of a medical gas that was:
(a) Purchased by a public or private hospital or other health care entity, except for the physical distribution of such medical gas to an authorized recipient at the direction of a hospital or other health care entity;
Terms Used In Florida Statutes 499.91
- 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
- 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
- Emergency use oxygen: means oxygen USP administered in emergency situations without a prescription for oxygen deficiency and resuscitation. See Florida Statutes 499.82
- Fraud: Intentional deception resulting in injury to another.
- 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 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. 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
- 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
(b) Donated or supplied at a reduced price to a charitable organization; or(c) Stolen or obtained by fraud or deceit.
(10) The failure to obtain a license or permit or operating without a valid license or permit, if one is required.
(11) The obtaining of, or attempt to obtain, a medical gas by fraud, deceit, or misrepresentation or engaging in misrepresentation or fraud in the distribution of a medical gas.
(12) Except for emergency use oxygen, the distribution of a medical gas to a patient without a prescription from a practitioner authorized by law to prescribe a medical gas.
(13) The distribution or dispensing of a medical gas that was previously dispensed by a pharmacy or a practitioner authorized by law to prescribe.
(14) The distribution or dispensing of a medical gas or medical gas-related equipment to a patient, unless the patient has been provided with the appropriate information and counseling on the use, storage, and disposal of the medical gas.
(15) Failure to report an act prohibited under this part or the rules adopted under this part.
(16) Failure to exercise due diligence as provided in s. 499.88.