(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 to inspect wholesale distributors in this state or other states pursuant to a schedule to be determined by the department.
(2) The department may recognize another state’s inspections of a manufacturer or wholesale distributor located in that state if such state’s laws are deemed to be substantially equivalent to the laws of this state by the department.
(3) A manufacturing facility of medical gases is exempt from routine inspection by the department if:

(a) The manufacturing facility is currently registered with the United States Food and Drug Administration under s. 510 of the federal act and can provide proof of registration, such as a copy of the Internet verification page; and

Terms Used In Florida Statutes 499.93

  • 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
  • Federal act: means the Federal Food, Drug, and Cosmetic Act. 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
  • 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) The manufacturing facility can provide proof of inspection by the Food and Drug Administration, or if the facility is located in another state, inspection by the Food and Drug Administration or other governmental entity charged with regulation of good manufacturing practices related to medical gases in that state within the past 3 years, which demonstrates substantial compliance with current good manufacturing practices applicable to medical gases.
(4) A permitholder under this part shall exhibit or have readily available its state permits and its most recent inspection report administered by the department.
  Previous section
Next section  
 Part III Contents