315.342 Permit for operation of out-of-state outsourcing facility doing
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/ky/315-342A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
business in Kentucky -- Requirements -- Administrative regulations.
(a)Each out-of-state outsourcing facility that does business physically or by
means of the Internet, facsimile, phone, mail, or any other means, inside
this Commonwealth, shall hold a current outsourcing facility permit issued
by the board.
(b)An application for a permit to operate an out-of-state outsourcing facility
shall be made to the board upon forms provided by it and shall contain
such information as the board requires, which may include affirmative
evidence of ability to comply with reasonable standards and regulations
as may be prescribed by the board.
(c)Each application shall be accompanied by a permit fee to be set by
administrative regulation promulgated by the board. The fee shall not
exceed:
1. Two hundred fifty dollars ($250); or
2. The current in-state outsourcing facility permit.
(a)As a prerequisite to obtaining or renewing a permit from the board, the
out-of-state 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 out-of-state outsourcing facility has not been inspected by the
United States Food and Drug Administration within the required
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 may 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 out-of-state
outsourcing facility, accompanied by the permit fee required by
subsection
(1)of this section, the board shall:
1. Issue a permit if the out-of-state outsourcing facility meets the
requirements of this chapter and the administrative regulations
promulgated by the board; or
2. Refuse to renew any permit to operate unless the out-of-state
outsourcing facility meets 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 thereof. 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 out-of-state outsourcing
facility.
(5)Each out-of-state outsourcing facility granted an out-of-state outsourcing facility
permit by the board shall disclose to the board the location, names, and titles of
all its principal corporate officers and all its pharmacists who are dispensing
prescription drugs to entities within the Commonwealth. A report containing this
information shall be made to the board on an annual basis and within thirty
days after any change of office, corporate officer, or pharmacist.
(a)An out-of-state outsourcing facility granted an out-of-state outsourcing
facility permit shall comply with all requests for information within three
business days of a written request by the board or its agents.
(b)An out-of-state outsourcing facility shall maintain at all times a valid
unexpired permit, license, or registration to conduct the outsourcing
facility in compliance with the laws of the jurisdiction in which it is a
resident.
(c)As a prerequisite to seeking a permit from the board, the out-of-state
outsourcing facility shall submit a copy of the most recent inspection
report resulting from an inspection conducted by the regulatory or
licensing agency of the jurisdiction in which it is located. Thereafter, the
out-of-state outsourcing facility granted a permit shall submit to the board
a copy of any subsequent inspection report of the outsourcing facility
conducted by the regulatory or licensing body of the jurisdiction in which it
is located.
(7)Each out-of-state outsourcing facility granted an out-of-state outsourcing facility
permit by the board shall maintain records of any controlled substances or
dangerous drugs.
(8)Each out-of-state outsourcing facility shall, during its regular hours of
operation, but not less than five
(5)days per week and for a minimum of forty
(40)hours per week, provide a toll-free telephone service directly to the
pharmacist in charge of the out-of-state outsourcing facility for the purpose of
facilitating communication. A toll-free number shall be placed on a label affixed
to each container of drugs dispensed to an entity within the Commonwealth.
(9)An out-of-state outsourcing facility shall comply with KRS 218A.202.
(10)An out-of-state outsourcing facility doing business within the Commonwealth of
Kentucky shall use the address on file with the board as the return address on
the labels of any package shipped into or within the Commonwealth. The return
address shall be placed on the package in a clear and prominent manner.
(a)A permit to operate an out-of-state 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 nonrefundable renewal fee established by subsection
(1)of this
section.
(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.
(12)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 out-of-state 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.
(13)The board may promulgate administrative regulations to ensure that proper
equipment and reference material is on hand considering the nature of the
pharmaceutical practice conducted at the particular out-of-state outsourcing
facility.
(14)Each out-of-state outsourcing facility shall compound in compliance with the
requirements of state and federal law and regulations, to include all applicable
guidance documents and Current Good Manufacturing Practices published by
the United States Food and Drug Administration.