499.014  Distribution of legend drugs by hospitals, health care entities, and charitable organizations; 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 made in accordance with and is not considered "wholesale distribution" under subparagraph (1)(a)1., subparagraph (1)(a)2., or subparagraph (1)(a)3. of s. 499.012.

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

(3)  The department 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.