Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
315.020,
315.035,
315.0351,
315.191,
315.300,
315.335,
21 C.F.R.
1301.76(b)
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
315.191(1) authorizes the
board to promulgate administrative regulations pursuant to KRS Chapter 13A
necessary to regulate and control all matters relating to pharmacists,
pharmacist interns, pharmacy technicians, pharmacies, wholesale distributors,
and manufacturers. KRS 315.020(1)
and 315.0351(1)(g)
require applicants for pharmacy permits to place a pharmacist in charge as a
prerequisite to compounding and dispensing privileges granted by the Kentucky
Board of Pharmacy. This administrative regulation establishes the requirements
relating to a pharmacist-in-charge.
Section
1. Definition. "Pharmacist-in-charge" means a pharmacist licensed
in the Commonwealth of Kentucky, who accepts responsibility for the operation
of a pharmacy in conformance with all laws and administrative regulations
pertinent to the practice of pharmacy and the distribution of prescription
drugs and who is personally in full and actual charge of the
pharmacy.
Section 2. Duties and
Responsibilities.
(1) The
pharmacist-in-charge shall be so designated in the Application for Permit to
Operate a Pharmacy in Kentucky and in the Application for Non-Resident Pharmacy
Permit, and in each Application for Resident Pharmacy Renewal and Application
for Non-Resident Pharmacy Permit Renewal, as incorporated by reference in
201 KAR 2:050, and submitted for
the renewal of that permit thereafter.
(2) A pharmacist shall not serve as a
pharmacist-in-charge:
(a) For more than one
(1) pharmacy at a time, except upon written approval from the Kentucky Board of
Pharmacy; and
(b) Unless he or she
is physically present in that pharmacy for a minimum of ten (10) hours per week
or the amount of time appropriate to provide supervision and control.
(3) The pharmacist-in-charge shall
be responsible for:
(a) Quality assurance
programs for pharmacy services designed to objectively and systematically
monitor care, pursue opportunities for improvement, resolve identified problems
as may exist, and detect and prevent drug diversion;
(b) The procurement, storage, security, and
disposition of drugs and the provision of pharmacy services;
(c) Assuring that all pharmacists and interns
employed by the pharmacy are currently licensed;
(d) Providing notification in writing to the
Board of Pharmacy within fourteen (14) calendar days of any change in the:
1. Employment of the
pharmacist-in-charge;
2. Employment
of staff pharmacists; or
3.
Schedule of hours for the pharmacy;
(e) Making or filing of any reports required
by state or federal laws and regulations;
(f) Responding to the Kentucky Board of
Pharmacy regarding identified violations or deficiencies; and
(g) Filing of any report of a theft or loss
to:
1. The U. S. Department of Justice Drug
Enforcement Administration as required by
21 C.F.R.
1301.76(b);
2. The Department of the Kentucky State
Police as required by
KRS
315.335;
3. The board by providing a copy to the board
of each report submitted; and
4.
The Cabinet for Health and Family Services.
STATUTORY AUTHORITY:
KRS
315.020(1),
315.0351,
315.191(1)
