315.340 Permit for operation of in-state outsourcing facility doing business in
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/ky/315-340A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Kentucky -- Requirements -- Administrative regulations.
(a)A person shall not operate an outsourcing facility within this
Commonwealth, physically or by means of the Internet, facsimile, phone,
mail, or any other means, without first obtaining a permit from the board.
(b)An application for a permit to operate an outsourcing facility shall be
made to the board upon forms provided by the board and shall contain
such information as the board requires, which may include affirmative
evidence of the ability to comply with the requirements of this chapter and
the administrative regulations promulgated by the board.
(c)Each application shall be accompanied by a nonrefundable permit fee to
be set by administrative regulation promulgated by the board, not to
exceed five hundred dollars ($500).
(a)As a prerequisite to obtaining or renewing a permit from the board, the
outsourcing facility shall:
1. Register as an outsourcing facility with the United States Secretary
of Health and Human Services in accordance with 21 U.S.C. sec.
353b; and
2. Submit a copy of a current inspection report resulting from an
inspection conducted by the United States Food and Drug
Administration that indicates compliance with the requirements of
state and federal law and regulations, including all applicable
guidance documents and Current Good Manufacturing Practices
published by the United States Food and Drug Administration.
(b)1. The inspection report required pursuant to paragraph (a)2. of this
subsection shall be deemed current for the purposes of this section
if the inspection was conducted no more than:
a. One
(1)year prior to the date of submission of an application
for a permit to the board; or
b. Two
(2)years prior to the date of submission of an application
for renewal of a permit to the board.
2. If the outsourcing facility has not been inspected by the United
States Food and Drug Administration within the period required
under subparagraph 1. of this paragraph, the board may:
a. Accept an inspection report or other documentation from
another entity that is satisfactory to the board; or
b. Cause an inspection to be conducted by its duly authorized
agent and charge an inspection fee in an amount sufficient to
cover the costs of the inspection.
(a)Upon receipt of an application for a permit to operate an outsourcing
facility accompanied by the permit fee prescribed by administrative
regulation, the board shall:
1. Issue a permit if the outsourcing facility meets the requirements of
this chapter and the administrative regulations promulgated by the
board; or
2. Refuse to issue or renew any permit to operate if the outsourcing
facility fails to meet the requirements of this chapter and the
administrative regulations promulgated by the board.
(b)The board shall act upon an application for a permit to operate within
thirty
(30)days after the receipt of the application. The board may issue a
temporary permit to operate in any instance where it considers additional
time necessary for investigation and consideration before taking final
action upon the application. The temporary permit shall be valid for a
period of thirty
(30)days, unless extended.
(4)A separate permit to operate shall be required for each outsourcing facility.
(a)Each permit to operate an outsourcing facility, unless suspended or
revoked, shall expire on June 30 following its date of issuance and be
renewable annually thereafter upon proper application accompanied by
the renewal fee as established by administrative regulations promulgated
by the board. The renewal fee shall not exceed five hundred dollars
($500).
(b)An additional nonrefundable fee not to exceed the annual renewal fee
may be assessed and set by administrative regulation as a delinquent
renewal penalty for failure to renew by June 30 of each year.
(6)Permits to operate shall be issued only for the premises and persons named in
the application and shall not be transferable, except that a buyer may operate
the outsourcing facility under the permit of the seller pending a decision by the
board on an application, which shall be filed by the buyer with the board at
least five
(5)days prior to the date of sale.
(7)The board may promulgate administrative regulations to ensure:
(a)That proper equipment and reference material is on hand considering the
nature of the pharmaceutical practice conducted at the particular
outsourcing facility; and
(b)Health and sanitation standards for areas within outsourcing facilities that
adhere to Current Good Manufacturing Practices published by the United
States Food and Drug Administration.
(8)Each outsourcing facility shall comply with KRS 218A.202.
(9)Each outsourcing facility shall compound in compliance with the requirements
of state and federal law and regulations, including all applicable guidance
documents and Current Good Manufacturing Practices published by the United
States Food and Drug Administration.
(10)A pharmacist may temporarily operate an outsourcing facility in an area not
designated on the permit as authorized in KRS 315.500.