315.4102 License required for each facility of a third-party logistics provider

(1) Each facility of a third-party logistics provider located within Kentucky shall be licensed by the board prior to shipping a prescription drug: (a) Within the borders of Kentucky; or (b) To a location outside the borders of Kentucky

Licenses issued under subsection (1) of this section shall be renewed annually upon: (a) Completion of an application; and (b) Payment of a renewal fee as established by administrative regulations (2) promulgated by the board

(3) A third-party logistics provider located in another state seeking to ship a prescription drug into Kentucky shall provide documentation upon request by the by the board or its staff that the third-party logistics provider is licensed as a third-party logistics provider by: (a) The state from which the third-party logistics provider ships, if that state licenses third-party logistics providers; or (b) The United States Food and Drug Administration

(4) A third-party logistics provider license shall be valid only for the name, ownership, and location listed on the license. Changes of name, ownership, or location shall require a new third-party logistics provider license

(5) Changes in information required for licensure shall be reported to the board, in writing, within ten (10) days of the change

(6) A third-party logistics provider shall not operate from a place of residence

(7) A third-party logistics provider facility shall be located apart and separate from any retail pharmacy licensed by the board

(8) A third-party logistics provider shall publicly display all licenses and have the most recent state and federal inspection reports readily available

Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 5, effective June 29, 2017