Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
315.002,
315.005,
315.010(16),
315.191(1)(a),
315.340,
315.342
NECESSITY, FUNCTION AND CONFORMITY:
KRS
315.340 establishes requirements for in-state
outsourcing facilities doing business in Kentucky, requires the board to set
fees, and requires the board to promulgate administrative regulations relating
to in-state permit applicants for licensure and renewal.
KRS
315.342 establishes requirements for
out-of-state outsourcing facilities doing business in Kentucky, requires the
board to set fees, and requires the board to promulgate administrative
regulations relating to in-state permit applicants for licensure and renewal.
This administrative regulation establishes further licensure, renewal, and
general requirements for in-state and out-of-state outsourcing
facilities.
Section 1. Application
Requirements for Initial Licensure and Renewal.
(1) An applicant for initial licensure or
renewal as an outsourcing facility shall submit:
(a) A nonrefundable initial licensure or
renewal fee of $250 by check or money order made payable to the Kentucky State
Treasurer;
(b) A complete, sworn,
and notarized Application to Operate as an Outsourcer Facility;
(c) Unless previously provided, proof of
registration as an outsourcing facility with the secretary of the U. S.
Department of Health and Human Services, Food and Drug
Administration;
(d)
1. Unless previously provided, a copy of the
current inspection report conducted by the United States Food and Drug
Administration pursuant to
KRS
315.340(2)(a) 2. and (b)1.
or
KRS
315.342(2)(a) 2. and (b)1.,
if applicable; or
2. If a current
inspection report is not available from the United States Food and Drug
Administration, the applicant shall submit an inspection report by:
a. The National Association of Boards of
Pharmacy (NABP); or
b. The board's
authorized agent;
(e) A confirmation statement of the previous
owner if ownership changed;
(f)
Legal proof of any name change, if applicable;
(g) An explanation if an applicant, owner,
officer, or pharmacist-in-charge has ever been convicted of a felony or had a
professional license or permit disciplined under federal, state, or local law;
and
(h) Ownership information for
each owner or officer, including:
1. Name and
title;
2. Address;
3. Phone number;
4. Social security number; and
5. Date of birth.
(2) An applicant applying for any
ownership or address change shall submit a non-refundable ownership change fee
of $100 and a change of address fee of $100.
(3) A license shall expire on June 30
following date of issuance, unless earlier suspended or revoked. There shall be
a delinquent renewal fee of $250 for failure to renew by June 30 of each
year.
Section 2.
Qualifications for License.
(1) The board
shall consider the following in determining whether to grant a license:
(a) A felony conviction related to:
1. The practice of pharmacy;
2. Drugs; or
3. Federal or state medical assistance
programs;
(b) The
furnishing of false or fraudulent information in any application;
(c) Suspension or revocation of a license or
permit by federal, state, or local government;
(d) Compliance with a previously granted
license or permit; and
(e) Failure
to maintain and make readily available those records required to be maintained
by an outsourcing facility.
(2) The board shall have the right to deny a
license to an applicant if, in considering the factors listed in subsection 1
of this Section, it determines that granting such a license would not be
consistent with public health and safety.
(3) If the board considers denying or
resolves to deny an application based solely on an applicant's prior conviction
of a crime, the board shall follow the notification and procedure requirements
in
KRS
335B.030(2).
Section 3. General Requirements.
An outsourcing facility shall:
(1) Permit, to
the extent authorized by laws or rules, board agents to enter and inspect its
premises and delivery vehicles, to audit its records and written operating
procedures, and to confiscate prescription drugs and records; and
(2) Follow closure procedures established in
201
KAR 2:106 Section 2.
Section 4. Incorporation by Reference.
(1) "Application to Operate as an Outsourcer
Facility", July 2017, is incorporated by reference.
(2) This material may be inspected, copied,
or obtained, subject to applicable copyright law, at the Kentucky Board of
Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort,
Kentucky 40601-8024, Monday through Friday, 8:00 a.m. to 4:30 p.m.
STATUTORY AUTHORITY:
KRS
315.010(16),
315.340,
315.342
