499.89 – Recordkeeping.
499.89 Recordkeeping.— (1) A permitholder under this part shall establish and maintain a record of transactions regarding the receipt and the distribution, or other disposition, of medical gases, as applicable. Such records constitute an audit trail and must contain information sufficient to perform a recall of medical gas in compliance with 21 C.F.R. ss. 211.196 and 820.160(b). […]
499.90 – Policies and procedures.
499.90 Policies and procedures.—A wholesale distributor shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, transport, shipping, and distribution of medical gases and shall establish, maintain, and adhere to procedures for maintaining inventories; for identifying, recording, and reporting losses or thefts; and for correcting all errors and inaccuracies in inventories […]
499.91 – Prohibited acts.
499.91 Prohibited acts.—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. […]
499.92 – Criminal acts.
499.92 Criminal acts.— (1) A person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, if he or she: (a) Adulterates or misbrands a medical gas with intent to defraud or deceive; (b) Knowingly purchases or receives a medical gas from a person not legally authorized to distribute or dispense […]
499.93 – Inspections.
499.93 Inspections.— (1) The department may require a facility that engages in the manufacture, retail sale, or wholesale distribution of medical gas to undergo an inspection in accordance with a schedule to be determined by the department, including inspections for initial permitting, permit renewal, and a permitholder’s change of location. The department may recognize a third party […]
499.94 – Fees.
499.94 Fees.—A fee collected for a permit under this part shall be deposited into the Professional Regulation Trust Fund. Moneys collected under this part shall be used for administering this part. The department shall maintain a separate account in the trust fund for the Drugs, Devices, and Cosmetics program. History.—s. 31, ch. 2014-89.
499.88 – Due diligence.
499.88 Due diligence.— (1) A wholesale distributor shall obtain, before the initial acquisition of medical gas, the following information from the supplying wholesale distributor or manufacturer: (a) If a manufacturer is distributing to a wholesale distributor, evidence that the manufacturer is registered and the medical gas is listed with the United States Food and Drug Administration; (b) If a […]
499.81 – Administration and enforcement.
499.81 Administration and enforcement.— (1) This part is cumulative and shall be construed and applied as being in addition to and not in substitution for or limiting any powers, duties, or authority of the department under any other law of this state; except that, with respect to the regulation of medical gas, this part controls over any […]
499.82 – Definitions.
499.82 Definitions.—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 […]
499.83 – Permits.
499.83 Permits.— (1) A person or entity that intends to distribute medical gas within or into this state, unless exempted under this part, must obtain the applicable permit before operating as: (a) A medical gas wholesale distributor; (b) A medical gas manufacturer; or (c) A medical oxygen retail establishment. (2) The following permits are established: (a) Medical gas wholesale distributor permit.—A medical […]