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

254 words·~1 min read·/ky/chapter-315/315-4102

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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.

(2)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

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.