§ 499.81 Administration and enforcement
§ 499.82 Definitions
§ 499.83 Permits
§ 499.831 Permit application
§ 499.832 Expiration and renewal of a permit
§ 499.833 Permitholder changes
§ 499.834 Minimum qualifications
§ 499.84 Minimum requirements for the storage and handling of medical gases
§ 499.85 Security
§ 499.86 Examination of materials
§ 499.87 Returned, damaged, and outdated medical gas
§ 499.88 Due diligence
§ 499.89 Recordkeeping
§ 499.90 Policies and procedures
§ 499.91 Prohibited acts
§ 499.92 Criminal acts
§ 499.93 Inspections
§ 499.931 Trade secret information
§ 499.94 Fees

Terms Used In Florida Statutes > Chapter 499 > Part III - Medical Gas

  • 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
  • Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
  • Appraisal: A determination of property value.
  • Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
  • Contract: A legal written agreement that becomes binding when signed.
  • Conviction: A judgement of guilt against a criminal defendant.
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Deed: The legal instrument used to transfer title in real property from one person to another.
  • Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
  • 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 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. 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
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Federal act: means the Federal Food, Drug, and Cosmetic Act. See Florida Statutes 499.82
  • Felony: A crime carrying a penalty of more than a year in prison.
  • Fraud: Intentional deception resulting in injury to another.
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
  • Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
  • 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
  • minor: includes any person who has not attained the age of 18 years. See Florida Statutes 1.01
  • 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
  • Mortgage: The written agreement pledging property to a creditor as collateral for a loan.
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Person: includes any natural person, firm, association, corporation, business trust, partnership, federal agency, state or political subdivision or agency thereof, or any body politic; and
(3) "Member" means each incorporator of a cooperative and each person admitted to and retaining membership therein, and shall include a husband and wife admitted to joint membership. See Florida Statutes 425.03
  • 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
  • Personal property: All property that is not real property.
  • political subdivision: include counties, cities, towns, villages, special tax school districts, special road and bridge districts, bridge districts, and all other districts in this state. 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
  • Statute: A law passed by a legislature.
  • Subpoena: A command to a witness to appear and give testimony.
  • 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
  • Wholesale distribution: means the distribution of medical gas to a person other than a consumer or patient. 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
  • writing: includes handwriting, printing, typewriting, and all other methods and means of forming letters and characters upon paper, stone, wood, or other materials. See Florida Statutes 1.01