KRS 315.342: Permit for operation of out-of-state outsourcing facility doing

business in Kentucky -- Requirements -- Administrative regulations.

(1) (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.

(2) (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.

(3) (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 (30)

days after any change of office, corporate officer, or pharmacist.

(6) (a) An out-of-state outsourcing facility granted an out-of-state outsourcing

facility permit shall comply with all requests for information within three (3)

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.

(11)(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.