KRS 315.036: Permit to be acquired by manufacturer -- Fee -- Records required --

Report -- Exception.

(1) Except as provided in subsection (4) of this section, each manufacturer of drugs

shall be required to register with and obtain a permit from the board. Such p ermit

shall be issued in accordance with policy and procedure prescribed by regulations of

the board. Each application shall be accompanied by a reasonable permit fee to be

set by administrative regulation of the board, not to exceed two hundred fifty dollars

($250) annually or increase more than twenty-five dollars ($25) per year.

(2) Manufacturers shall be required to maintain accurate records of all drugs

manufactured, received and sold, as established by administrative regulation of the

board. Such records shall be made available to agents of the board for inspection at

reasonable times. The board may require by regulation that manufacturers

periodically report to the board all drugs manufactured, received, and sold.

(3) Failure to report to the board or willful submission of inaccurate information shall

be grounds for disciplinary action under the provisions of KRS 315.131.

(4) The provisions of subsection (1) of this section do not apply to a pharmacist who, in

the normal course of professional practice , compounds reasonable quantities of

drugs pursuant to or in anticipation of a valid prescription drug order.