Kentucky Statutes 315.020 – Only pharmacists to supervise manufacturing of pharmaceuticals or practice pharmacy — Exceptions — Access to pharmacy electronic database allowed under specific conditions — Persons employed to assist practice of pharma…
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(1) No owner of a pharmacy who is not a pharmacist shall fail to place a pharmacist in charge of his or her pharmacy or shall permit any person to compound or dispense prescription drugs, medicines, or pharmaceuticals in his or her place of business except in the presence and under the immediate supervision of a pharmacist.
(2) No manufacturer of pharmaceuticals who is not a pharmacist shall fail to place a pharmacist in charge of his or her place of business or shall permit any person to compound prescription drugs, medicines, or pharmaceuticals in his or her place of business, except as provided by the board through the promulgation of administrative regulations pursuant to KRS Chapter 13A.
(3) Except as provided in subsection (4) of this section, no person shall engage in the practice of pharmacy unless licensed to practice under the provisions of KRS Chapter 315.
(4) The provisions of subsection (3) of this section shall not apply to:
(a) Pharmacist interns performing professional practice activities under the immediate supervision of a licensed pharmacist. The nature and scope of the activities referred to in this paragraph shall be determined by the board through administrative regulation promulgated pursuant to KRS Chapter 13A;
(b) Pharmacist interns and pharmacy technicians performing specifically identified pharmacy practice activities while under the supervision of a pharmacist. The nature and scope of the activities referred to in this paragraph shall be determined by the board through administrative regulation promulgated pursuant to KRS Chapter 13A;
(c) Other licensed health care professionals practicing within the statutory scope of their professional practices; or
(d) Volunteer health practitioners providing services under KRS § 39A.350 to
39A.366.
(5) (a) As used in this subsection:
1. “Order entry” means the process by which pharmacy personnel validate prescription data and enter that data into a pharmacy’s dispensing or medication management system. Prescription data includes but is not limited to patient demographics, prescriber demographics, drug name, strength, dosage form, quantity, the directions for use, refill authorization, or any clarifications of the same; and
2. “Order entry verification” means the process by which a pharmacist verifies prescription data entered in a pharmacy’s dispensing or medication management system after order entry has been completed.
(b) Nothing in this chapter shall prohibit a pharmacist licensed in Kentucky, or a pharmacy technician registered in Kentucky or a pharmacy intern certified in
Kentucky who is working under the supervision of the pharmacist, from accessing the electronic database of the pharmacy, from inside or outside of the pharmacy, to perform order entry, order entry verification, or drug regimen review as defined in KRS § 315.010, if:
1. The pharmacy has established controls to protect the confidentiality and integrity of protected health information;
2. No part of the pharmacy’s database is duplicated, downloaded, or removed from the electronic database; and
3. The pharmacy is located in Kentucky and is permitted by the board.
(c) Supervision required by paragraph (b) of this subsection may include electronic supervision.
(d) This subsection shall only apply to:
1. Pharmacies that are not open to the public and do not dispense to walk- in patients in a retail setting; or
2. Hospitals licensed under KRS Chapter 216B.
(e) Nothing in this subsection shall be construed to authorize final product verification and dispensing of a prescription from a location outside of or other than a pharmacy.
(f) Nothing in this subsection permits pharmacists, pharmacy technicians, or pharmacy interns to receive hard copy prescriptions outside of the premises of a permitted pharmacy.
(6) Effective April 1, 2009, an owner of a pharmacy shall not employ a person to assist in the practice of pharmacy unless the person is registered as a pharmacy technician by the board or exempt under KRS § 315.135.
Effective: July 14, 2022
History: Amended 2022 Ky. Acts ch. 72, sec. 1, effective July 14, 2022. — Amended
2021 Ky. Acts ch. 56, sec. 3, effective June 29, 2021. — Amended 2008 Ky. Acts ch.
148, sec. 7, effective July 15, 2008. — Amended 2007 Ky. Acts ch. 96, sec. 15, effective June 26, 2007. — Amended 1996 Ky. Acts ch. 257, sec. 4, effective July 15,
1996. — Amended 1982 Ky. Acts ch. 191, sec. 2, effective July 15, 1982. — Amended
1970 Ky. Acts ch. 221, sec. 2. — Recodified 1942 Ky. Acts ch. 208, sec. 1, effective
October 1, 1942, from Ky. Stat. secs. 2619, 2620, 2628, 2631.
(2) No manufacturer of pharmaceuticals who is not a pharmacist shall fail to place a pharmacist in charge of his or her place of business or shall permit any person to compound prescription drugs, medicines, or pharmaceuticals in his or her place of business, except as provided by the board through the promulgation of administrative regulations pursuant to KRS Chapter 13A.
Terms Used In Kentucky Statutes 315.020
- Board: means the Kentucky Board of Pharmacy. See Kentucky Statutes 315.010
- dispensing: means to deliver one (1) or more doses of a prescription drug in a suitable container, appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug. See Kentucky Statutes 315.010
- Drug: means any of the following:
(a) Articles recognized as drugs or drug products in any official compendium or supplement thereto. See Kentucky Statutes 315.010 - Drug regimen review: means retrospective, concurrent, and prospective review by a pharmacist of a patient's drug-related history, including but not limited to the following areas:
(a) Evaluation of prescription drug orders and patient records for:
1. See Kentucky Statutes 315.010 - Owner: when applied to any animal, means any person having a property interest in such animal. See Kentucky Statutes 446.010
- Pharmacist: means a natural person licensed by this state to engage in the practice of the profession of pharmacy. See Kentucky Statutes 315.010
- Pharmacy: means every place where:
(a) Drugs are dispensed under the direction of a pharmacist. See Kentucky Statutes 315.010 - Pharmacy technician: means a natural person who works under the immediate supervision, or general supervision if otherwise provided for by statute or administrative regulation, of a pharmacist for the purpose of assisting a pharmacist with the practice of pharmacy. See Kentucky Statutes 315.010
- Practice of pharmacy: means interpretation, evaluation, and implementation of medical orders and prescription drug orders. See Kentucky Statutes 315.010
- Supervision: means the presence of a pharmacist on the premises to which a pharmacy permit is issued, who is responsible, in whole or in part, for the professional activities occurring in the pharmacy. See Kentucky Statutes 315.010
(3) Except as provided in subsection (4) of this section, no person shall engage in the practice of pharmacy unless licensed to practice under the provisions of KRS Chapter 315.
(4) The provisions of subsection (3) of this section shall not apply to:
(a) Pharmacist interns performing professional practice activities under the immediate supervision of a licensed pharmacist. The nature and scope of the activities referred to in this paragraph shall be determined by the board through administrative regulation promulgated pursuant to KRS Chapter 13A;
(b) Pharmacist interns and pharmacy technicians performing specifically identified pharmacy practice activities while under the supervision of a pharmacist. The nature and scope of the activities referred to in this paragraph shall be determined by the board through administrative regulation promulgated pursuant to KRS Chapter 13A;
(c) Other licensed health care professionals practicing within the statutory scope of their professional practices; or
(d) Volunteer health practitioners providing services under KRS § 39A.350 to
39A.366.
(5) (a) As used in this subsection:
1. “Order entry” means the process by which pharmacy personnel validate prescription data and enter that data into a pharmacy’s dispensing or medication management system. Prescription data includes but is not limited to patient demographics, prescriber demographics, drug name, strength, dosage form, quantity, the directions for use, refill authorization, or any clarifications of the same; and
2. “Order entry verification” means the process by which a pharmacist verifies prescription data entered in a pharmacy’s dispensing or medication management system after order entry has been completed.
(b) Nothing in this chapter shall prohibit a pharmacist licensed in Kentucky, or a pharmacy technician registered in Kentucky or a pharmacy intern certified in
Kentucky who is working under the supervision of the pharmacist, from accessing the electronic database of the pharmacy, from inside or outside of the pharmacy, to perform order entry, order entry verification, or drug regimen review as defined in KRS § 315.010, if:
1. The pharmacy has established controls to protect the confidentiality and integrity of protected health information;
2. No part of the pharmacy’s database is duplicated, downloaded, or removed from the electronic database; and
3. The pharmacy is located in Kentucky and is permitted by the board.
(c) Supervision required by paragraph (b) of this subsection may include electronic supervision.
(d) This subsection shall only apply to:
1. Pharmacies that are not open to the public and do not dispense to walk- in patients in a retail setting; or
2. Hospitals licensed under KRS Chapter 216B.
(e) Nothing in this subsection shall be construed to authorize final product verification and dispensing of a prescription from a location outside of or other than a pharmacy.
(f) Nothing in this subsection permits pharmacists, pharmacy technicians, or pharmacy interns to receive hard copy prescriptions outside of the premises of a permitted pharmacy.
(6) Effective April 1, 2009, an owner of a pharmacy shall not employ a person to assist in the practice of pharmacy unless the person is registered as a pharmacy technician by the board or exempt under KRS § 315.135.
Effective: July 14, 2022
History: Amended 2022 Ky. Acts ch. 72, sec. 1, effective July 14, 2022. — Amended
2021 Ky. Acts ch. 56, sec. 3, effective June 29, 2021. — Amended 2008 Ky. Acts ch.
148, sec. 7, effective July 15, 2008. — Amended 2007 Ky. Acts ch. 96, sec. 15, effective June 26, 2007. — Amended 1996 Ky. Acts ch. 257, sec. 4, effective July 15,
1996. — Amended 1982 Ky. Acts ch. 191, sec. 2, effective July 15, 1982. — Amended
1970 Ky. Acts ch. 221, sec. 2. — Recodified 1942 Ky. Acts ch. 208, sec. 1, effective
October 1, 1942, from Ky. Stat. secs. 2619, 2620, 2628, 2631.