Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
315.010(9),
315.020,
315.035,
315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
315.035 authorizes the Board of Pharmacy
issue a permit to a pharmacy.
KRS
315.191(1)(a) authorizes the
Board of Pharmacy to promulgate administrative regulations with minimum
requirements for the permitting of those entities that provide non-dispensing
pharmacy services. This administrative regulation establishes the requirements
for the Special limited pharmacy permit - Clinical practice.
Section 1. Definitions.
(1) "Special limited pharmacy permit" means a
permit issued to a pharmacy that provides miscellaneous specialized pharmacy
service and functions.
(2) "Special
limited pharmacy permit - clinical practice" means a permit issued to a
pharmacy that maintains patient records and other information for the purpose
of engaging in the practice of pharmacy and does not dispense prescription drug
orders.
Section 2.
General Requirements.
(1) An applicant for a
special limited pharmacy permit - clinical practice shall:
(a) Prepare and adopt a policy and procedure
manual that is updated annually;
(b) Maintain pharmacy references as outlined
in 201 KAR 2:090;
(c) Maintain a physical pharmacy
address;
(d) Designate a
Pharmacist-in-Charge (PIC) without a required minimum number of hours of
physical presence;
(e)
1. Maintain patient records for five (5)
years in a manner that shall provide adequate safeguards against improper
manipulation or alteration of the records; and
2. Abide by the standard that a computer
malfunction or data processing services' negligence is not a defense against
the charges of improper recordkeeping; and
(f) Maintain patient records by establishing:
1. A patient record system to be maintained
for patients for whom non-dispensing pharmacy services and functions are being
performed;
2. A procedure for
obtaining, recording, and maintaining information required for a patient record
by a pharmacist, pharmacist intern, or pharmacy technician; and
3. A procedure for a patient record to be
readily retrievable by manual or electronic means.
(2) An applicant for a special
limited pharmacy permit - clinical practice shall be exempt from the following:
(a) Prescription equipment requirements of
201 KAR 2:090, Section
1;
(b) Pharmacy sanitation
requirements of
201 KAR 2:180; and
(c) Security and control of drugs and
prescriptions requirements of
201 KAR 2:100, Sections 1, 2, 3,
and 4.
Section
3. Pharmacy Closure. The permit holder shall provide notification
to the board fifteen (15) days prior to permanent pharmacy closure.
Section 4. License Fees; Renewals. An
applicant shall submit:
(1) An initial or
renewal application for a special limited pharmacy permit - clinical practice
on either the:
(a)
1. Application for Special Limited Pharmacy
Permit - Clinical Practice; or
2.
Application for Special Limited Pharmacy Permit - Clinical Practice Renewal;
or
(b)
1. Non-Resident Application for Special
Limited Pharmacy Permit - Clinical Practice; or
2. Non-Resident Application for Special
Limited Pharmacy Permit - Clinical Practice Renewal; and
(2) As appropriate, the:
(a) Initial application fee established by
201 KAR 2:050, Section 1(9);
or
(b) Renewal application fee
established by
201 KAR 2:050, Section
1(10).
Section
5. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Application for Special
Limited Pharmacy Permit - Clinical Practice", June 2023;
(b) "Application for Special Limited Pharmacy
Permit - Clinical Practice Renewal", June 2023;
(c) "Non-Resident Application for Special
Limited Pharmacy Permit - Clinical Practice", September 2023; and
(d) "Non-Resident Application for Special
Limited Pharmacy Permit - Clinical Practice Renewal", September 2023.
(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, Monday through Friday, 8:00 a.m. to 4:30
p.m. This material is also available on the board's Web site at
https://pharmacy.ky.gov/Businesses/Pages/Pharmacy.aspx.
STATUTORY AUTHORITY:
KRS
315.035,
315.191(1)(a)
