Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:205 - Pharmacist-in-charge

Current through Register Vol. 51, No. 1, July 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.