(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). Such records must include all of the following information, which may be kept in two separate documents, one related to the distribution of medical gas and the other related to the receipt of medical gas:
(a) The dates of receipt and distribution or other disposition of the medical gas.
(b) The name, address, and license or permit number and its expiration date for the person or entity purchasing the medical gas from the wholesale distributor.
(c) The name, address, and license or permit number and its expiration date for the person or entity receiving the medical gas, if different from the information required under paragraph (b).
(d) Information sufficient to perform a recall of all medical gas received, distributed, or dispensed.
(2) Such records shall be made available for inspection and copying by an authorized official of any federal, state, or local governmental agency for a period of:
(a) Three years following the distribution date of high pressure medical gases.
(b) Two years following the distribution date for cryogenic or refrigerated liquid medical gases.
(3) Records kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by an authorized official of any state or federal governmental agency charged with enforcement of these rules.
(4) A wholesale distributor shall maintain records sufficient to aid in the mandatory reporting of any theft, suspected theft, or other significant loss of nitrous oxide to the department and other appropriate law enforcement agencies.
History.—s. 25, ch. 2014-89; s. 16, ch. 2016-212.
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