315.036 Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception
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KY Code › Title XXVI › Chapter 315 › Section 315.036
Text
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 permit
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.
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.