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.—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.— (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 […]
499.831 Permit application.— (1) The department shall adopt rules to establish the form and content of the application to obtain a permit and to renew a permit listed under this part. (2) An applicant must be at least 18 years of age or be managed, controlled, or overseen, directly or indirectly, by a natural person who is at […]
499.832 Expiration and renewal of a permit.— (1) A permit issued under this part automatically expires 2 years after the last day of the month in which the permit was originally issued. (2) A permit issued under this part may be renewed by submitting an application for renewal on a form furnished by the department and paying the […]
499.833 Permitholder changes.— (1) A permit issued under this part is valid only for the person or entity to which it is issued and is not subject to sale, assignment, or other transfer, voluntarily or involuntarily. (2) A permit issued under this part is not valid for an establishment other than the establishment for which it was originally […]
499.834 Minimum qualifications.—The department shall consider all of the following factors in determining eligibility for, and renewal of, a permit for a person or entity under this part: (1) A finding by the department that the applicant has violated or been disciplined by a regulatory agency in any state for violating a federal, state, or local law […]
499.84 Minimum requirements for the storage and handling of medical gases.— (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 […]
499.85 Security.— (1) A permitholder that has a facility used for the distribution or retailing of medical gases shall protect such gases from unauthorized access by implementing all of the following security measures: (a) Keeping access from outside the premises well controlled and to a minimum. (b) Ensuring the outside perimeter of the premises is well lit. (c) Limiting access […]
499.86 Examination of materials.— (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 […]
499.87 Returned, damaged, and outdated medical gas.— (1) A medical gas that has left the control of the wholesale distributor may be returned to the wholesale distributor or manufacturer from which it was acquired, but may not be resold as a medical gas unless it is reprocessed by a manufacturer using proper and adequate controls to ensure […]
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 […]
499.89 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.—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.—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.— (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.— (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.—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.
