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
(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.
