Florida Statutes 499.90 – Policies and procedures
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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 associated with nitrous oxide. A wholesale distributor shall include in its written policies and procedures all of the following:
(1) A procedure for handling recalls and withdrawals of medical gas. Such procedure must deal with recalls and withdrawals due to:
(a) Action initiated at the request of the United States Food and Drug Administration or any federal, state, or local law enforcement or other government agency, including the department; or
Terms Used In Florida Statutes 499.90
- 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
- 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) Voluntary action by a manufacturer of medical gases to remove defective or potentially defective medical gases from the market.
(2) A procedure that includes preparation for, protection against, and responding to a crisis that affects the security or operation of a facility that stores medical gases in the event of a strike; a fire, flood, or other natural disaster; or other local, state, or national emergency.
(3) A procedure for reporting criminal or suspected criminal activity involving the inventory of nitrous oxide to the department and to applicable law enforcement agencies within 3 business days after becoming aware of the criminal or suspected criminal activity.