Title 201 | Chapter 002 | Regulation 205


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201 KAR 2:205.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 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 Agency as required by 21 C.F.R. 1301.76(b);

2.

The Department of the Kentucky State Police as required by KRS 315.335; and

3.

The board by providing a copy to the board of each report submitted.

Section 3.

Incorporation by Reference.

(1)

The following material is incorporated by reference:

(a)

"Application for Permit to Operate a Pharmacy in Kentucky" Form 1, 5/2020;

(b)

"Application for Non-Resident Pharmacy Permit", Form 3, 5/2020;

(c)

"Application for Resident Pharmacy Renewal", Form 2, 5/2020; and

(d)

"Application for Non-Resident Pharmacy Permit Renewal", Form 4, 5/2020.

(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 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.

HISTORY: (19 Ky.R. 1018; Am. 1340; eff. 11-30-92; 27 Ky.R. 194; 738; eff. 9-11-2000; 39 Ky.R. 508; eff. 2-1-2013; 47 Ky.R. 2031; 48 Ky.R. 23; eff. 7-21-2021.)

CONTACT PERSON: Larry Hadley, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Larry.Hadley@ky.gov.

7-Year Expiration: 7/21/2028

Last Updated: 3/11/2022


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