499.014  Distribution of legend drugs by hospitals, health care entities, charitable organizations, and return or destruction companies; permits, general requirements.--

(1)  A restricted prescription drug distributor permit is required for any person that engages in the distribution of a legend drug, which distribution is not considered "wholesale distribution" under s. 499.012(1)(a)1.

(2)  A person who engages in the receipt or distribution of a legend drug in this state for the purpose of processing its return or its destruction must obtain a permit as a restricted prescription drug distributor if such person is not the person initiating the return, the prescription drug wholesale supplier of the person initiating the return, or the manufacturer of the drug.

(3)  Storage and handling, and recordkeeping of these distributions must comply with the requirements for wholesale distributors under s. 499.0121.

(4)  A person who applies for a permit as a restricted prescription drug distributor, or for the renewal of such a permit, must provide to the department the information required under s. 499.01.

(5)  The department may issue permits to restricted prescription drug distributors and may adopt rules regarding the distribution of prescription drugs by hospitals, health care entities, charitable organizations, or other persons not involved in wholesale distribution, which rules are necessary for the protection of the public health, safety, and welfare.