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Form a Business

PHARMACISTS AND PHARMACIES

KRS tit. XXVI, ch. 315
in effect

KRS 315.002 Declarations of public policy -- Construction of chapter

315.002. Declarations of public policy -- Construction of chapter The practice of pharmacy within the Commonwealth is declared to be a professional practice affecting the public health, safety, and welfare, and is subject to regulation and control in the public interest. It is further declared to be a matter of public interest and concern that the practice of pharmacy, as defined in this chapter, should merit and receive the confidence of the public, and only qualified persons shall be permitted to engage in the practice of pharmacy and ensure the quality of drugs and related devices distributed within the Commonwealth. This chapter shall be liberally construed to carry out these objectives and purposes. The persons entrusted through this chapter to engage in the practice of pharmacy shall be pharmacists. They shall be recognized by the Commonwealth as health care professionals, and, within their statutory scope of practice, providers of pharmacy-related primary care. Effective: July 15, 1996 History: Created 1996 Ky. Acts ch. 257, sec. 1, effective July 15, 1996.

KRS 315.005 Purpose of chapter

315.005. Purpose of chapter The purpose of this chapter is to promote, preserve, and protect public health, safety, and welfare by and through effective control and regulation of the practice of pharmacy; the licensure of pharmacists; the licensure, control, and regulation of all sites or persons who are required to obtain a license, certificate, or permit from the Board of Pharmacy, whether located in or outside the Commonwealth, that distribute, manufacture, or sell drugs within the Commonwealth. Effective: July 15, 2016 History: Amended 2016 Ky. Acts ch. 103, sec. 16, effective July 15, 2016. -- Amended 2012 Ky. Acts ch. 73, sec. 10, effective July 12, 2012. -- Amended 2008 Ky. Acts ch. 148, sec. 6, effective July 15, 2008. -- Created 1996 Ky. Acts ch. 257, sec. 2, effective July 15, 1996.

KRS 315.010 Definitions for chapter

315.010. Definitions for chapter As used in this chapter, unless the context requires otherwise: (1) "Administer" means the direct application of a drug to a patient or research subject by injection, inhalation, or ingestion, whether topically or by any other means; (2) "Administrative activities of a pharmacy" means the following functions performed by a pharmacy adhering to all local, state, and federal patient privacy laws: (a) Investigating and researching a patient's insurance benefits and updating the patient profile regarding insurance coverage; (b) Billing and collections activities, including: 1. Contacting patients for copayments and coinsurance payments; and 2. Communicating with insurance companies; (c) Performing patient financial assistance activities and updating patient records accordingly; (d) Opening faxes and accessing electronic prescriptions for the purposes of setting up patient demographic and insurance profiles, excluding height, weight, and allergy information, so long as the activity does not involve the entering of a prescription order into the dispensing or medication management system; (e) Initiating insurance prior authorizations for submission to the licensed pharmacy, including communications with the prescribing physician to collect, record, and transmit information to insurance companies, so long as the activity does not include the authorization or receipt of new or refill prescription orders; (f) Answering and transferring telephone calls, whether or not such calls require accessing a patient record, so long as the call does not involve the interpretation, evaluation, or implementation of a drug order; and (g) Communicating with patients via telephone or electronically regarding refill reminders, so long as the communication does not involve the interpretation, evaluation, or implementation of a drug order and a pharmacist is readily available for patient consultation; (3) "Association" means the Kentucky Pharmacists Association; (4) "Board" means the Kentucky Board of Pharmacy; (5) "Collaborative care agreement" means a written a greement between a pharmacist or pharmacists and a practitioner or practitioners that outlines a plan of cooperative management of patients' drug-related health care needs where: (a) Patients' drug-related health care needs fall within the practitioner's o r practitioners' statutory scope of practice; (b) Patients are referred by the practitioner or practitioners to the pharmacist or pharmacists; and (c) The agreement: 1. Identifies the practitioner or practitioners and the pharmacist or pharmacists who are parties to the agreement; 2. Specifies the drug-related regimen to be provided, and how drug therapy is to be monitored; and 3. Stipulates the conditions for initiating, continuing, or discontinuing drug therapy and conditions which warrant modifications to dose, dosage regimen, dosage form, or route of administration; (6) "Compound" or "compounding" means the preparation or labeling of a drug pursuant to or in anticipation of a valid prescription drug order, including but not limited to packaging, intravenous admixture, or manual combination of drug ingredients. "Compounding," as used in this chapter, shall not preclude simple reconstitution, mixing, or modification of drug products prior to administration by nonpharmacists; (7) "Confidential information" means information which is accessed or maintained by a pharmacist in a patient's record, or communicated to a patient as part of patient counseling, whether it is preserved on paper, microfilm, magnetic media, electronic media, or any other form; (8) "Continuing education unit" means ten (10) contact hours of board approved continuing pharmacy education. A "contact hour" means fifty (50) continuous minutes without a break period; (9) "Dispense" or "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; (10) "Drug" means any of the following: (a) Articles recognized as drugs or drug products in any official compendium or supplement thereto; (b) Articles, other than food, intended to affect the structure or function of the body of man or other animals; (c) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; or (d) Articles intended for use as a component of any articles specified in paragraphs (a) to (c) of this subsection; (11) "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. Known allergies; 2. Rational therapy contraindications; 3. Appropriate dose and route of administration; 4. Appropriate directions for use; or 5. Duplicative therapies; (b) Evaluation of prescription drug orders and patient records for drug-drug, drug-food, drug-disease, and drug-clinical laboratory interactions; (c) Evaluation of prescription drug orders and patient records for adverse drug reactions; or (d) Evaluation of prescription drug orders and patient records for proper utilization and optimal therapeutic outcomes; (12) "Immediate supervision" means under the physical and visual supervision of a pharmacist; (13) "Manufacturer" or "virtual manufacturer" of a product means: (a) A person that holds an application approved under 21 U.S.C. sec. 355 or a license issued under 42 U.S.C. sec. 262 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product; (b) A co-licensed partner of the person described in paragraph (a) of this subsection that obtains the product directly from a person described in this paragraph or paragraph (a) of this subsection; (c) An affiliate of a person described in paragraph (a) or (b) of this subsection who receives the product directly from a person described in this paragraph or in paragraph (a) or (b) of this subsection; or (d) Any person, except a pharmacist compounding in the normal course of professional practice; (14) "Medical order" means a lawful order of a specifically identified practitioner for a specifically identified patient for the patient's health care needs. "Medical order" may or may not include a prescription drug order; (15) "Nonprescription drugs" means nonnarcotic medicines or drugs which may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government; (16) "Outsourcing facility" means a facility at one (1) geographic location or address that: (a) Is engaged in the compounding of human sterile drugs without a patient- specific prescription; (b) Has registered as an outsourcing facility with the secretary of the United States Department of Health and Human Services, Food and Drug Administration; and (c) Complies with all applicable state and federal requirements; (17) "Pharmacist" means a natural person licensed by this state to engage in the practice of the profession of pharmacy; (18) "Pharmacist intern" means a natural person who is: (a) Currently certified by the board to engage in the practice of pharmacy under the direction of a licensed pharmacist and who satisfactorily progresses toward meeting the requirements for licensure as a pharmacist; (b) A graduate of an approved college or school of pharmacy or a graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee (FPGEC) certificate, who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; (c) A qualified applicant awaiting examination for licensure as a pharmacist or the results of an examination for licensure as a pharmacist; or (d) An individual participating in a residency or fellowship program approved by the board for internship credit; (19) "Pharmacy" means every place where: (a) Drugs are dispensed under the direction of a pharmacist; (b) Prescription drug orders are compounded under the direction of a pharmacist; or (c) A registered pharmacist maintains patient records and other information for the purpose of engaging in the practice of pharmacy, whether or not prescription drug orders are being dispensed; (20) "Pharmacy-related primary care" means the pharmacists' activities in patient education, health promotion, and assistance in the selection and use of over-the- counter drugs and appliances for the treatment of common diseases and injuries, as well as those other activities falling within their statutory scope of practice; (21) "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; (22) "Practice of pharmacy" means interpretation, evaluation, and implementation of medical orders and prescription drug orders; responsibility for dispensing prescription drug orders, including radioactive substances; participation in drug and drug-related device selection; administration of medications or biologics in the course of dispensing or maintaining a prescription drug order; the administration of adult immunizations pursuant to prescriber-approved protocols; the administration of immunizations to individuals five (5) to seventeen (17) years of age pursuant to prescriber-approved protocols with the consent of a parent or guardian; the administration of immunizations to a child as defined in KRS 214.032, pursuant to protocols as authorized by KRS 315.500; drug evaluation, utilization, or regimen review; maintenance of patient pharmacy records; and provision of patient counseling and those professional acts, professional decisions, or professional services necessary to maintain and manage all areas of a patient's pharmacy-related care, including pharmacy-related primary care as defined in this section; (23) "Practitioner" has the same meaning given in KRS 217.015(35); (24) "Prescription drug" means a drug which: (a) Under federal law is required to be labeled with either of the following statements: 1. "Caution: Federal law prohibits dispensing without prescription"; 2. "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; 3. "Rx Only"; or 4. "Rx"; or (b) Is required by any applicable federal or state law or administrative regulation to be dispensed only pursuant to a prescription drug order or is restricted to use by practitioners; (25) "Prescription drug order" means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements or protocols authorized by the board. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice; (26) "Society" means the Kentucky Society of Health-Systems Pharmacists; (27) "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; and (28) "Wholesaler" means any person who legally buys drugs for resale or distribution to persons other than patients or consumers. Effective: July 15, 2024 History: Amended 2024 Ky. Acts ch. 11, sec. 1, effective July 15, 2024. -- Amended 2017 Ky. Acts ch. 44, sec. 1, effective June 29, 2107; and ch. 136, sec. 1, effective June 29, 2017. -- Amended 2016 Ky. Acts ch. 105, sec. 1, effective July 15, 2016. -- Amended 2015 Ky. Acts ch. 118, sec. 1, effective June 24, 2015. -- Amended 2011 Ky. Acts ch. 81, sec. 1, effective June 8, 201 1. -- Amended 2010 Ky. Acts ch. 22, sec. 5, effective July 15, 2010; and ch. 37, sec. 1, effective July 15, 2010. -- Amended 2007 Ky. Acts ch. 124, sec. 8, effective June 26, 2007. -- Amended 2005 Ky. Acts ch. 150, sec. 18, effective June 20, 2005. -- Amended 2004 Ky. Acts ch. 10, sec. 1, effective July 13, 2004. -- Amended 1998 Ky. Acts ch. 297, sec. 4, effective July 15, 1998; ch. 301, sec. 27, effective July 15, 1998; and ch. 531, sec. 3, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 257, sec. 3, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 1, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 1. -- Created 1960 Ky. Acts ch. 234, sec. 1. Legislative Research Commission Note (7/13/2004). 2004 Ky. Acts ch. 10, sec. 2, states that 2004 Ky. Acts ch. 10, sec. 1, which amends this section, shall be known as the Robert L. Barnett, Jr. R. Ph. Act. Legislative Research Commission Note (7/15/98). This section was amended by 1998 Ky. Acts chs. 297, 301, and 531 which do not a ppear to be in conflict and have been codified together. It is clear that the intent of both 1998 Ky. Acts ch. 297, sec. 4, and ch. 301, sec. 27, was to change the subsection reference in KRS 217.015 for the definition of practitioner. In codifying these A cts, that result has been effectuated. KRS 7.136(1)(e).

KRS 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 pharmacy after April 1, 2009, to be registered pharmacy technicians or exempt under KRS 315.135

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 pharmacy after April 1, 2009, to be registered pharmacy technicians or exempt under KRS 315.135 (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.

KRS 315.030 Permit required -- License required to represent oneself as pharmacist -- Registration required to represent oneself as pharmacy technician

315.030. Permit required -- License required to represent oneself as pharmacist -- Registration required to represent oneself as pharmacy technician (1) No person shall take, use or exhibit the title of drug, drug store, pharmacy or apothecary, or any combination of such names or titles, or any title, name or description of like import, or any form designed to take the place of such a title, or use any place with respect to which any of those terms are used in any advertisement or telephone directory listing, unless the facility has been issued a permit by the board. (2) No person shall call himself or hold himself out as or use the title of "pharmacist," "registered pharmacist," "licensed pharmacist," "druggist," or use the initials "R.Ph." or terms which would imply that he is a pharmacist, unless he is duly licensed under the provisions of KRS Chapter 315. (3) Effective April 1, 2009, a person shall not call himself or herself or hold himself or herself out as a or use the title of "pharmacy technician" unless the person is duly registered under KRS 315.136 or 315.138. Effective: July 15, 2008 History: Amended 2008 Ky. Acts ch. 148, sec. 9, effective July 15, 2008. -- Amended 1982 Ky. Acts ch. 191, sec. 3, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 3. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 1376t.

KRS 315.035 Permit required for operation of a pharmacy -- Application -- Fee -- Issuance -- Fee for failure to renew -- Premises covered by permit -- Rules and regulations -- Requirements for in-state pharmacy doing business through the Internet -- Board may waive permit requirements for out-of-state pharmacy -- Temporary operation of pharmacy during state of emergency

315.035. Permit required for operation of a pharmacy -- Application -- Fee -- Issuance -- Fee for failure to renew -- Premises covered by permit -- Rules and regulations -- Requirements for in-state pharmacy doing business through the Internet -- Board may waive permit requirements for out-of-state pharmacy -- Temporary operation of pharmacy during state of emergency (1) No person shall operate a pharmacy within this Commonwealth, physically or by means of the Internet, facsimile, phone, mail, or any other means, without having first obtained a permit as provided for in KRS Chapter 315. An application for a permit to operate a pharmacy shall be made to the board upon forms provided by it and shall contain such information as the board requires, which may include affirmative evidence of ability to comply with such reasonable standards and rules and regulations as may be prescribed by the board. Each application shall be accompanied by a reasonable permit fee to be set by administrative regulation promulgated by the board pursuant to KRS Chapter 13A, not to exceed two hundred fifty dollars ($250). (2) Upon receipt of an application of a permit to operate a pharmacy, accompanied by the permit fee not to exceed two hundred fifty dollars ($250), the board shall issue a permit if the pharmacy meets the standards and requirements of KRS Chapter 315 and the rules and regulations of the board. The board shall refuse to renew any permit to operate unless the pharmacy meets the standards and requirements of KRS Chapter 315 and the rules and regulations of the board. The board shall act upon an application for a permit to operate within thirty (30) days after the receipt thereof; provided, however, that the board may issue a temporary permit to operate in any instance where it considers additional time necessary for investigation and consideration before taking final action upon the application. In such event, the temporary permit shall be valid for a period of thirty (30) days, unless extended. (3) A separate permit to operate shall be required for each pharmacy. (4) Each permit to operate a pharmacy, unless sooner suspended or revoked, shall expire on June 30 following its date of issuance and be renewable annually thereafter upon proper application accompanied by such reasonable renewal fee as may be set by administrative regulation of the board, not to exceed two hundred fifty dollars ($250) nor to increase more than twenty-five dollars ($25) per year. An additional fee not to exceed the annual renewal fee may be assessed and set by administrative regulation as a delinquent renewal penalty for failure to renew by June 30 of each year. (5) Permits to operate shall be issued only for the premises and persons named in the application and shall not be transferable; provided however, that a buyer may operate the pharmacy under the permit of the seller pending a decision by the board of an application which shall be filed by the buyer with the board at least five (5) days prior to the date of sale. (6) The board may promulgate rules and regulations to assure that proper equipment and reference material is on hand considering the nature of the pharmaceutical practice conducted at the particular pharmacy and to assure reasonable health and sanitation standards for areas within pharmacies which are not subject to health and sanitation standards promulgated by the Kentucky Cabinet for Health and Family Services or a local health department. (7) Each pharmacy shall comply with KRS 218A.202. (8) Any pharmacy within the Commonwealth that dispenses more than twenty-five percent (25%) of its total prescription volume as a result of an original prescription order received or solicited by use of the Internet, including but not limited to electronic mail, shall, prior to obtaining a permit, receive and display in every medium in which it advertises itself a seal of approval for the National Association of Boards of Pharmacy certifying that it is a Verified Internet Pharmacy Practice Site (VIPPS) or a seal certifying approval of a substantially similar program approved by the Kentucky Board of Pharmacy. VIPPS, or any other substantially similar program approved by the Kentucky Board of Pharmacy, accreditation shall be maintained and remain current. (9) Any pharmacy within the Commonwealth doing business by use of the Internet shall certify the percentage of its annual business conducted via the Internet and submit such supporting documentation as requested by the board, and in a form or application required by the board, when it applies for permit or renewal. (10) A pharmacist may temporarily operate a pharmacy in an area not designated on the permit as authorized in KRS 315.500. Effective: July 15, 2010 History: Amended 2010 Ky. Acts ch. 22, sec. 6, effective July 15, 2010. -- Amended 2007 Ky. Acts ch. 124, sec. 9, effective June 26, 2007. -- Amended 2005 Ky. Acts ch. 150, sec. 19, effective June 20, 2005; ch. 61, sec. 1, effective June 20, 2005; and ch. 99, sec. 597, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 548, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 257, sec. 5, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 4, effective July 15, 1982. -- Amended 1974 Ky. Acts ch. 310, sec. 1. -- Created 1966 Ky. Acts ch. 260, sec. 6.

KRS 315.036 Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception

315.036. Permit to be acquired by manufacturer -- Fee -- Records required -- Report -- Exception (1) Except as provided in subsection (4) of this section, each manufacturer of drugs shall be required to register with and obtain a permit from the board. Such permit shall be issued in accordance with policy and procedure prescribed by regulations of the board. Each application shall be accompanied by a reasonable permit fee to be set by administrative regulation of the board, not to exceed two hundred fifty dollars ($250) annually or increase more than twenty-five dollars ($25) per year. (2) Manufacturers shall be required to maintain accurate records of all drugs manufactured, received and sold, as established by administrative regulation of the board. Such records shall be made available to agents of the board for inspection at reasonable times. The board may require by regulation that manufacturers periodically report to the board all drugs manufactured, received, and sold. (3) Failure to report to the board or willful submission of inaccurate information shall be grounds for disciplinary action under the provisions of KRS 315.131. (4) The provisions of subsection (1) of this section do not apply to a pharmacist who, in the normal course of professional practice, compounds reasonable quantities of drugs pursuant to or in anticipation of a valid prescription drug order. Effective: July 15, 2008 History: Amended 2008 Ky. Acts ch. 124, sec. 2, effective July 15, 2008. -- Amended 1996 Ky. Acts ch. 257, sec. 6, effective July 15, 1996. -- Created 1982 Ky. Acts ch. 191, sec. 5, effective July 15, 1982.

KRS 315.038 Definitions for section -- Ambulatory pharmacies -- Reporting requirements -- Data to be shared with commissioner of insurance -- Contract with third-party to collect or process data

315.038. Definitions for section -- Ambulatory pharmacies -- Reporting requirements -- Data to be shared with commissioner of insurance -- Contract with third-party to collect or process data (1) As used in this section: (a) "Ambulatory pharmacy" has the same meaning as in KRS 304.17A-595; and (b) "Commissioner" means the commissioner of the Department of Insurance. (2) An ambulatory pharmacy located in Kentucky and permitted under this chapter shall, by March 1, 2026, and by March 1 every other year thereafter, provide data to the board, in accordance with the requirements of KRS 304.17A -595 and subsection (3) of this section, relating to the pharmacy's dispensing costs for the previous calendar year. (3) The board shall promulgate an administrative r egulation in accordance with KRS Chapter 13A to implement and effectuate subsection (2) of this section, which shall include: (a) Incorporating the data elements to be collected from each pharmacy, as determined by the commissioner under KRS 304.17A -595(2)(c)2.c.i.; and (b) Establishing the reporting format, and the manner, of the data submission. (4) The data collected by the board under this section shall, within thirty (30) days of receipt, be shared with the commissioner for the purposes set forth in KR S 304.17A-595(2)(c)2. (5) In carrying out its duties under this section, the board shall cooperate and consult with the commissioner. (6) All information and data acquired by the board or the commissioner under this section or KRS 304.17A -595 shall: (a) Be deemed, and protected as, confidential and proprietary; and (b) Not be subject to disclosure under KRS 61.870 to 61.884. (7) The board or the commissioner may retain or contract with one (1) or more third - party vendors or contractors to collect or proce ss the data required under this section, or provide any other expertise, service, or function necessary to carry out the board's or commissioner's duties under this section or KRS 304.17A -595, if the vendor or contractor: (a) Agrees in a written or electro nic record to maintain the confidential and proprietary status of the data and all information relating to the data; and (b) Is not owned by or affiliated with a pharmacy benefit manager, as defined in KRS 304.9-020. Effective: July 15, 2024 History: Created 2024 Ky. Acts ch. 104, sec. 16, effective July 15, 2024. Legislative Research Commission Note (7/15/2024). 2024 Ky. Acts ch. 104, sec. 22, reads as follows: "On or before January 1, 2025, the Kentucky Board of Pharmacy shall promulgate any emergency and ordinary administrative regulations required under Section 16 of this Act [this statute]."

KRS 315.040 Exceptions to chapter

315.040. Exceptions to chapter (1) Nothing in this chapter shall be construed to prevent, restrict, or otherwise interfere with the sale of nonprescription drugs in their original packages by any retailer. No rule or regulation shall be adopted by the Board of Pharmacy under this chapter which shall require the sale of nonprescription drugs by a licensed pharmacist or under the supervision of a licensed pharmacist. (2) Nothing in this chapter shall interfere with the professional activities of any licensed practicing physician, or prevent the physician from keeping any drug or medicine that he or she may need in his or her practice, from compounding the physician's own medications, or from dispensing or supplying to patients any article that seems proper to the physician. (3) Nothing in this chapter pertaining to the use of collaborative care agreements shall apply in any hospital or other health facility operated by a hospital without the express written permission of the hospital's governing body. Collaborative care agreements may be restricted by the policies and procedures of the facility. (4) Nothing in this chapter shall interfere with the activities of a physician assistant as authorized in KRS Chapter 311. (5) Nothing in this chapter shall interfere with the activities of an advanced practice registered nurse as authorized in KRS Chapter 314. (6) Nothing in this chapter shall be construed to prevent, restrict, or otherwise interfere with the sale or distribution of dialysate solutions as defined in KRS 315.0351 or devices necessary to perform home peritoneal dialysis to patients with end-stage renal disease, provided that the requirements established in KRS 315.0351(2) are satisfied. No rule or administrative regulation shall be adopted or promulgated by the board under this chapter that requires the sale or distribution of dialysate solutions as defined in KRS 315.0351 or devices necessary to perform home peritoneal dialysis by a licensed pharmacist or under the supervision of a licensed pharmacist. Effective: June 27, 2019 History: Amended 2019 Ky. Acts ch. 157, sec. 2, effective June 27, 2019. -- Amended 2017 Ky. Acts ch. 80, sec. 23, effective June 29, 2017. -- Amended 2010 Ky. Acts ch. 85, sec. 67, effective July 15, 2010. -- Amended 2000 Ky. Acts ch. 391, sec. 22, effective July 14, 2000. -- Amended 1998 Ky. Acts ch. 228, sec. 6, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 257, sec. 7, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 482, sec. 12, effective July 13, 1990. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. secs. 1376t, 2625, 2632.

KRS 315.050 Qualifications of applicant for licensure -- Examination -- Standards for internship -- Certificate of internship

315.050. Qualifications of applicant for licensure -- Examination -- Standards for internship -- Certificate of internship (1) Every applicant for licensure as a pharmacist shall be not less than eighteen (18) years of age, of good mental health and moral character, a graduate of a school or college of pharmacy program approved by the board, and shall file proof satisfactory to the board, substantiated by proper affidavits, of completion of an approved internship. (2) After the applicant has passed a satisfactory examination conducted before the board under regulations prescribed by the board, he shall be entitled to a license as a pharmacist. (3) The examination for licensure shall be given by the board at least two (2) times during each year. The examination shall be prepared to measure the competency of the applicant to engage in the practice of pharmacy. The board may employ and cooperate with any organization or consultant in the preparation and grading of an appropriate examination, but shall retain the sole discretion and responsibility of determining which applicants have successfully passed such an examination. (4) The board shall by regulation establish standards for pharmacist intern certification and an approved internship program and shall determine appropriate qualifications for pharmacists supervising approved internship programs. (5) The board shall issue certificates of internship which shall be valid for six (6) years from date of issuance. The fee for a certificate shall be set by administrative regulation of the board, not to exceed fifty dollars ($50). Effective: June 24, 2015 History: Amended 2015 Ky. Acts ch. 113, sec. 17, effective June 24, 2015. -- Amended 1996 Ky. Acts ch. 257, sec. 8, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 443, sec. 23, effective July 13, 1990. -- Amended 1982 Ky. Acts ch. 191, sec. 6, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 120, sec. 8; and ch. 221, sec. 4. -- Amended 1946 Ky. Acts ch. 161, sec. 1. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2625.

KRS 315.060 Examination fee

315.060. Examination fee A reasonable examination fee shall be fixed by administrative regulation of the board, not to exceed three hundred dollars ($300) or increase more than twenty-five dollars ($25) per year, and shall be collected for each examination taken by an applicant. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 9, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 7, effective July 15, 1982. -- Amended 1974 Ky. Acts ch. 310, sec. 2. -- Amended 1970 Ky. Acts ch. 221, sec. 5. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2625.

KRS 315.065 Continuing education requirements

315.065. Continuing education requirements (1) Because of the continuous introduction of new therapeutic and diagnostic agents and changing concepts in the practice of pharmacy, it is essential that a pharmacist undertake a program of continuing education to maintain his professional competency to practice in the public interest. (2) No pharmacist's license shall be renewed until the license holder is able to submit written proof to the board that he has satisfactorily completed, in the previous renewal period, a continuing education program acceptable to the board. Such continuing education requirements shall be determined by regulation of the board, but they shall not require more than an average of one and one-half (1-1/2) continuing education units (CEU) per year. (3) The board shall adopt rules and regulations to carry out the provisions of this section, to include guidelines and criteria for reviewing and approving continuing education programs. Effective: June 24, 2015 History: Amended 2015 Ky. Acts ch. 113, sec. 18, effective June 24, 2015. -- Amended 2001 Ky. Acts ch. 61, sec. 11, effective June 21, 2001. -- Amended 1998 Ky. Acts ch. 531, sec. 4, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 257, sec. 10, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 443, sec. 10, effective July 13, 1990. -- Created 1982 Ky. Acts ch. 191, sec. 9, effective July 15, 1982.

KRS 315.070 Repealed, 1982

315.070. Repealed, 1982 Catchline at repeal: Pharmacist holding license on May 30, 1938 to secure renewal of license only. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2626.

KRS 315.080 Repealed, 1982

315.080. Repealed, 1982 Catchline at repeal: Licensed assistant pharmacists. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2625.

KRS 315.085 Repealed, 1982

315.085. Repealed, 1982 Catchline at repeal: Assistant pharmacists may be examined and licensed as licensed pharmacists. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Created 1942 Ky. Acts ch. 98, sec. 1.

KRS 315.090 Repealed, 1966

315.090. Repealed, 1966 Catchline at repeal: Wording required on license certificate. History: Repealed 1966 Ky. Acts ch. 260, sec. 13. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2625.

KRS 315.100 Repealed, 1982

315.100. Repealed, 1982 Catchline at repeal: False representations prohibited. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 6. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2628.

KRS 315.110 License expiration date -- Renewal fee -- Application and requirements -- Certificate -- Display -- Pocket certificate

315.110. License expiration date -- Renewal fee -- Application and requirements -- Certificate -- Display -- Pocket certificate (1) Each license to practice pharmacy, unless sooner suspended or revoked, shall expire on February 28 following its date of issuance. Every pharmacist who desires to continue to practice pharmacy shall pay to the executive director of the board a reasonable renewal fee to be set by administrative regulation of the board, but not to exceed one hundred seventy-five dollars ($175) annually or increase more than twenty-five dollars ($25) per year, and shall file with the board an application in such form and containing such data as the board may require for renewal of the license. A delinquent renewal penalty fee not to exceed the renewal fee may be assessed and set by administrative regulation for each renewal period the licensee fails to renew the license after expiration. (2) Every pharmacist shall keep his current certificate conspicuously displayed in his primary place of practice. (3) In addition to a current renewal certificate, each pharmacist shall be issued upon renewal a pocket certificate which shall be in the licensee's possession at all times when the licensee is engaged in the practice of pharmacy and which shall be exhibited by the licensee upon request from any member, inspector or agent of the board. Effective: June 20, 2005 History: Amended 2005 Ky. Acts ch. 61, sec. 2, effective June 20, 2005. -- Amended 1996 Ky. Acts ch. 257, sec. 11, effective July 15, 1996. --Amended 1982 Ky. Acts ch. 191, sec. 8, effective July 15, 1982. -- Amended 1974 Ky. Acts ch. 310, sec. 3. -- Amended 1970 Ky. Acts ch. 221, sec. 7. -- Amended 1966 Ky. Acts ch. 260, sec. 2. - - Created 1960 Ky. Acts ch. 234, sec. 2. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2627.

KRS 315.115 Renewal fees suspended for persons in Armed Forces

315.115. Renewal fees suspended for persons in Armed Forces All persons who are required to pay renewal fees to the board as registered pharmacists shall not be required to pay such fees during the time such persons are actively serving in the Armed Forces of the United States. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 12, effective July 15, 1996. -- Amended 1970 Ky. Acts ch. 221, sec. 8. -- Created 1942 Ky. Acts ch. 98, sec. 2.

KRS 315.120 Notification of failure to renew license -- Procedure for renewal of expired license -- Renewal after lapse of five or more years -- Inactive license

315.120. Notification of failure to renew license -- Procedure for renewal of expired license -- Renewal after lapse of five or more years -- Inactive license (1) Within thirty (30) days after the renewal period, the executive director shall notify all pharmacists who have failed to comply with license renewal requirements. (2) Any pharmacist who has failed to timely renew his license for any consecutive period up to five (5) years may renew his license only upon satisfying the continuing education regulations of the board and paying the cumulative penalty and renewal fees provided for in KRS 315.110. (3) Any pharmacist who has failed to timely renew his license for five (5) or more consecutive years may renew his license only upon satisfying the continuing education regulations of the board, passing a satisfactory examination before the board and paying the renewal and penalty fees provided for in KRS 315.110. (4) Any pharmacist not currently holding an active pharmacist's license in another jurisdiction who does not desire to meet the qualifications for active license renewal shall, upon application, be issued an inactive license. Such license shall entitle the license holder to use the term "pharmacist" but the license holder shall not be permitted to engage in the practice of pharmacy. An inactive license holder may apply for an active license as provided for by the regulations of the board. The inactive license renewal fee shall be set by administrative regulation of the board, not to exceed fifty dollars ($50) annually. Effective: June 20, 2005 History: Amended 2005 Ky. Acts ch. 61, sec. 3, effective June 20, 2005. -- Amended 1996 Ky. Acts ch. 257, sec. 13, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 10, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 9. - - Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2627.

KRS 315.121 Grounds for acting against licensee -- Notification to board of conviction required -- Petition for reinstatement -- Expungement

315.121. Grounds for acting against licensee -- Notification to board of conviction required -- Petition for reinstatement -- Expungement (1) The board may refuse to issue or renew a license, permit, or certificate to, or may suspend, temporarily suspend, revoke, fine, place on probation, reprimand, reasonably restrict, or take any combination of these actions against any licensee, permit holder, or certificate holder for the following reasons: (a) Unprofessional or unethical conduct; (b) Mental or physical incapacity that prevents the licensee, permit holder, or certificate holder from engaging or assisting in the practice of pharmacy or the wholesale distribution or manufacturing of drugs with reasonable skill, competence, and safety to the public; (c) Being convicted of, or entering an "Alford" plea or plea of nolo contendere to, irrespective of an order granting probation or suspending imposition of any sentence imposed following the conviction or entry of such plea, one (1) or more or the following, if in accordance with KRS Chapter 335B: 1. A crime as defined in KRS 335B.010; or 2. A violation of the pharmacy or drug laws, rules, or administrative regulations of this state, any other state, or the federal government; (d) Knowing or having reason to know that a pharmacist, pharmacist intern, or pharmacy technician is incapable of engaging or assisting in the practice of pharmacy with reasonable skill, competence, and safety to the public and failing to report any relevant information to the board; (e) Knowingly making or causing to be made any false, fraudulent, or forged statement or misrepresentation of a material fact in securing issuance or renewal of a license, permit, or certificate; (f) Engaging in fraud in connection with the practice of pharmacy or the wholesale distribution or manufacturing of drugs; (g) Engaging in or aiding and abetting an individual to engage or assist in the practice of pharmacy without a license or falsely using the title of "pharmacist," "pharmacist intern," "pharmacy technician," or other term which might imply that the individual is a pharmacist, pharmacist intern, or pharmacy technician; (h) Being found by the board to be in violation of any provision of this chapter, KRS Chapter 217, KRS Chapter 218A, or the administrative regulations promulgated pursuant to these chapters; (i) Violation of any order issued by the board to comply with any applicable law or administrative regulation; (j) Knowing or having reason to know that a pharmacist, pharmacist intern, or pharmacy technician has engaged in or aided and abetted the unlawful distribution of legend medications, and failing to report any relevant information to the board; (k) Failure to notify the board within fourteen (14) days of a change in one's home address; or (l) As provided in KRS 311.824(2), being convicted of a violation of KRS 311.823(2). (2) Unprofessional or unethical conduct includes but is not limited to the following acts of a pharmacist, pharmacist intern, or pharmacy technician: (a) Publication or circulation of false, misleading, or deceptive statements concerning the practice of pharmacy; (b) Divulging or revealing to unauthorized persons patient information or the nature of professional services rendered without the patient's express consent or without order or direction of a court. In addition to members, inspectors, or agents of the board, the following are considered authorized persons: 1. The patient, patient's agent, or another pharmacist acting on behalf of the patient; 2. Certified or licensed health-care personnel who are responsible for care of the patient; 3. Designated agents of the Cabinet for Health and Family Services for the purposes of enforcing the provisions of KRS Chapter 218A; 4. Any federal, state, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person; or 5. An agency of government charged with the responsibility of providing medical care for the patient, upon written request by an authorized representative of the agency requesting such information; (c) Selling, transferring, or otherwise disposing of accessories, chemicals, drugs, or devices found in illegal traffic when the pharmacist, pharmacy intern, or pharmacy technician knows or should have known of their intended use in illegal activities; (d) Engaging in conduct likely to deceive, defraud, or harm the public, demonstrating a willful or careless disregard for the health, welfare, or safety of a patient, or engaging in conduct which substantially departs from accepted standards of pharmacy practice ordinarily exercised by a pharmacist or pharmacy intern, with or without established proof of actual injury; (e) Engaging in grossly negligent professional conduct, with or without established proof of actual injury; (f) Except as provided in KRS 315.500, selling, transferring, dispensing, ingesting, or administering a drug for which a prescription drug order is required, without having first received a prescription drug order for the drug; (g) Willfully or knowingly failing to maintain complete and accurate records of all drugs received, dispensed, or disposed of in compliance with federal and state laws, rules, or administrative regulations; (h) Obtaining any remuneration by fraud, misrepresentation, or deception; (i) Accessing or attempting to access confidential patient information for persons other than those with whom a pharmacist has a current pharmacist-patient relationship and where such information is necessary to the pharmacist to provide pharmacy care; (j) Failing to exercise appropriate professional judgment in determining whether a prescription drug order is lawful; (k) Violating KRS 304.39-215; or (l) Engaging in conduct that is subject to the penalties under KRS 304.99-060(4) or (5). (3) Any licensee, permit holder, or certificate holder entering an "Alford" plea, pleading nolo contendere, or who is found guilty of a violation prescribed in subsection (1)(c) of this section shall within thirty (30) days notify the board of that plea or conviction. Failure to do so shall be grounds for suspension or revocation of the license, certificate, or permit. (4) Any person whose license, permit, or certificate has been revoked in accordance with the provisions of this section, may petition the board for reinstatement. The petition shall be made in writing and in a form prescribed by the board. The board shall investigate all reinstatement petitions, and the board may reinstate a license, permit, or certificate upon showing that the former holder has been rehabilitated and is again able to engage in the practice of pharmacy with reasonable skill, competency, and safety to the public. Reinstatement may be on the terms and conditions that the board, based on competent evidence, reasonably believes necessary to protect the health and welfare of the citizens of the Commonwealth. (5) Upon exercising the power of revocation provided for in subsection (1) of this section, the board may reasonably prohibit any petition for reinstatement for a period up to and including five (5) years. (6) Any licensee, permit holder, or certificate holder who is disciplined under this section for a minor violation may request in writing that the board expunge the minor violation from the licensee's, permit holder's, or certificate holder's permanent record. (a) The request for expungement may be filed no sooner than three (3) years after the date on which the licensee, permit holder, or certificate holder has completed disciplinary sanctions imposed and if the licensee, permit holder, or certificate holder has not been disciplined for any subsequent violation of the same nature within this period of time. (b) No person may have his or her record expunged under this section more than once. The board shall promulgate administrative regulations under KRS Chapter 13A to establish violations which are minor violations under this subsection. A violation shall be deemed a minor violation if it does not demonstrate a serious inability to practice the profession; assist in the practice of pharmacy; provide home medical equipment and services; adversely affect the public health, safety, or welfare; or result in economic or physical harm to a person; or create a significant threat of such harm. Effective:January 22, 2021 History: Amended 2021 Ky. Acts ch. 1, sec. 12, effective January 22, 2021. -- Amended 2019 Ky. Acts ch. 143, sec. 14, effective June 27, 2019. -- Amended 2017 Ky. Acts ch. 158, sec. 60, effective June 29, 2017. -- Amended 2016 Ky. Acts ch. 103, sec. 13, effective July 15, 2016. -- Amended 2012 Ky. Acts ch. 73, sec. 11, effective July 12, 2012. -- Amended 2010 Ky. Acts ch. 22, sec. 7, effective July 15, 2010. -- Amended 2008 Ky. Acts ch. 148, sec. 8, effective July 15, 2008. -- Amended 2005 Ky. Acts ch. 99, sec. 598, effective June 20, 2005. -- Amended 2003 Ky. Acts ch. 51, sec. 4, effective June 24, 2003. -- Amended 2002 Ky. Acts ch. 335, sec. 1, effective July 15, 2002. -- Amended 1998 Ky. Acts ch. 426, sec. 549, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 257, sec. 14, effective July 15, 1996. --Created 1982 Ky. Acts ch. 191, sec. 11, effective July 15, 1982. Legislative Research Commission Note (7/12/2012). Under the authority of KRS 7.136(1), the Reviser of Statutes has corrected manifest clerical or typographical errors in this statute during codification. The meaning of the text was not changed.

KRS 315.123 Repealed, 1982

315.123. Repealed, 1982 Catchline at repeal: Suspension or revocation of pharmacy permit, grounds. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Created 1966 Ky. Acts ch. 260, sec. 7.

KRS 315.125 Mental or physical examination ordered by board -- Effect of failure to submit to examination

315.125. Mental or physical examination ordered by board -- Effect of failure to submit to examination (1) When the board has probable cause to believe a pharmacist, pharmacy technician, licensee, certificate holder, or permit holder is suffering from a mental or physical condition that might impede that person's ability to practice competently, the board may order the individual to undergo a mental or physical examination by an appropriately-trained professional designated by the board. (2) Failure of a pharmacist, pharmacy technician, licensee, or permit holder to submit to such an examination when directed, unless the failure was due to circumstances beyond his or her control, shall constitute an admission that he or she has developed such a mental or physical disability, or other condition, that continued practice is dangerous to patients or to the public. Failure to attend the examination shall constitute a default, and a final order suspending, limiting, restricting, or revoking the license or permit may be entered without the taking of testimony or presentation of evidence. (3) A pharmacist, pharmacy technician, licensee, or permit holder whose license has been suspended, limited, restricted, or revoked pursuant to this section shall at reasonable intervals be afforded an opportunity, pursuant to KRS 315.121(4), to demonstrate that he can resume the competent practice of pharmacy with reasonable skill and safety to patients. Effective: July 15, 2016 History: Amended 2016 Ky. Acts ch. 103, sec. 15, effective July 15, 2016. -- Amended 2012 Ky. Acts ch. 73, sec. 12, effective July 12, 2012. -- Amended 2008 Ky. Acts ch. 148, sec. 5, effective July 15, 2008. -- Created 1996 Ky. Acts ch. 257, sec. 15, effective July 15, 1996. Legislative Research Commission Note (7/12/2012). Under the authority of KRS 7.136(1), the Reviser of Statutes has corrected manifest clerical or typographical errors in this statute during codification. The meaning of the text was not changed.

KRS 315.126 Pharmacist recovery network committee -- Administrative regulations -- Assessment -- Confidentiality -- Reporting restrictions

315.126. Pharmacist recovery network committee -- Administrative regulations -- Assessment -- Confidentiality -- Reporting restrictions (1) The board shall establish a pharmacist recovery network committee to promote the early identification, intervention, treatment, and rehabilitation of pharmacists and pharmacist interns who may be impaired by reason of illness, alcohol or drug abuse, or as a result of any other physical or mental condition. (2) The board may enter into a contractual agreement with a nonprofit corporation, pharmacy professional organization, or similar organization for the purpose of creating, supporting, and maintaining a pharmacist recovery network committee. (3) The board may promulgate administrative regulations pursuant to KRS Chapter 13A to effectuate and implement the provisions of this section. (4) Beginning July 15, 1998, the board shall collect an assessment of ten dollars ($10) to be added to each licensure renewal application fee payable to the board. This assessment shall be expended by the board on the operation of the pharmacist recovery network committee. (5) Members of a pharmacist recovery network committee, any administrator, staff member, consultant, agent, volunteer, or employee of the committee acting within the scope of his or her duties and without actual malice and all other persons who furnish information to the committee in good faith and without actual malice shall not be liable for any claim or damages as a result of any statement, decision, opinion, investigation, or action taken by the committee or by any individual member of the committee. (6) All information, interviews, reports, statements, memoranda, or other documents furnished to or produced by the pharmacist recovery network committee, all communications to or from the committee, and all proceedings, findings, and conclusions of the committee, including those relating to intervention, treatment, or rehabilitation, that in any way pertain or refer to a pharmacist or pharmacist intern who is or may be impaired shall be privileged and confidential. (7) All records and proceedings of the committee that pertain or refer to a pharmacist or pharmacist intern who is or may be impaired shall be privileged and confidential, used by the committee and its members only in the exercise of the proper function of the committee, not be considered public records, and not be subject to court subpoena, discovery, or introduction as evidence in any civil, criminal, or administrative proceedings, except as described in subsection (8) of this section. (8) The committee may only disclose the information relative to an impaired pharmacist or pharmacist intern if: (a) It is essential to disclose the information to persons or organizations needing the information in order to address the intervention, treatment, or rehabilitation needs of the impaired pharmacist or pharmacist intern; (b) The release is authorized in writing by the impaired pharmacist or pharmacist intern; or (c) The committee is required to make a report to the board pursuant to KRS 315.121. Effective: June 20, 2005 History: Amended 2005 Ky. Acts ch. 61, sec. 5, effective June 20, 2005. -- Created 1998 Ky. Acts ch. 531, sec. 1, effective July 15, 1998.

KRS 315.127 Repealed, 1982

315.127. Repealed, 1982 Catchline at repeal: Revocation or suspension of pharmacist's license. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 10. -- Created 1966 Ky. Acts ch. 260, sec. 3.

KRS 315.130 Repealed, 1966

315.130. Repealed, 1966 Catchline at repeal: Portion of fees to be turned over to association. History: Repealed 1966 Ky. Acts ch. 260, sec. 13. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2627.

KRS 315.131 Proceedings before fine, probation, suspension, revocation of license, permit, or certificate -- Appeals -- Emergency suspension prior to disciplinary hearing

315.131. Proceedings before fine, probation, suspension, revocation of license, permit, or certificate -- Appeals -- Emergency suspension prior to disciplinary hearing (1) Every proceeding imposing a fine or for probation, suspension, or revocation of a license, permit, or certificate issued pursuant to this chapter shall be conducted in accordance with KRS Chapter 13B. Upon failure of the licensee, permit holder, or certificate holder to respond to the complaint at or before the time of the hearing, the allegations set forth in the complaint shall be taken by the board as confessed. (2) All decisions revoking or suspending a license, permit, or certificate or placing a licensee, permit holder, or certificate holder on probation or imposing a fine shall be made by the board. (3) The board may when in its opinion the continued practice of the licensee or certificate holder or the continued operation of the permit holder would be dangerous to the health, welfare, and safety of the general public, issue an emergency order as provided in KRS 13B.125. (4) A licensee, permit holder, or certificate holder aggrieved by a final order of the board may within ten (10) days after notice thereof move the board to reconsider this order. A motion to reconsider based on newly-discovered material evidence must be made within one (1) year of the entry of the order. (5) A licensee, permit holder, or certificate holder aggrieved by a final order of the board may appeal to the Franklin Circuit Court in accordance with KRS Chapter 13B. (6) The board may, without benefit of a hearing, temporarily suspend a license, certificate, or permit for not more than sixty (60) days if the president of the board finds on the basis of reasonable evidence that a licensee, certificate holder, or permit holder: (a) Has violated a statute or administrative regulation the board is empowered to enforce, and continued practice or operation by the licensee, certificate holder, or permit holder would create imminent risk of harm to the public; or (b) Suffers a mental or physical condition that through continued practice or operation could create an imminent risk of harm to the public. The emergency suspension shall take effect upon receipt by the licensee, certificate holder, or permit holder of written notice, delivered by certified mail or in person, specifying the statute or administrative regulation violated. At the time the emergency suspension order issues, the board shall schedule a disciplinary hearing to be held in accordance with the provisions of KRS Chapter 13B within sixty (60) days thereafter. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 16, effective July 15, 1996; and ch. 318, sec. 271, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 12, effective July 15, 1982. -- Created 1966 Ky. Acts ch. 260, sec. 8. Legislative Research Commission Note (10/16/96). The initial 1996 codification of the amendments to this statute from the 1996 Regular Session has been revised with respect to subsection (5) of the statute. 1996 Ky. Acts ch. 257, sec. 16, made the venue for appeals "the Franklin Circuit Court" while 1996 Ky. Acts ch. 318, sec. 271, changed "permittee" to "permit holder," in existing language that set the venue for appeals as "the Circuit Court of the county in which the licensee, permittee or certificate holder conducts his practice or place of business." The changing of the word "permittee" to "permit holder" in this phrase was purely stylistic. Therefore, although Acts ch. 318 was a later enactment than Acts ch. 257 for purposes of KRS 446.250, the substantive amendment on this point in Acts ch. 257 prevails over the nonsubstantive, stylistic amendment in Acts ch. 318 pursuant to 1996 Ky. Acts ch. 318, sec. 358. The text of subsection (5) has been altered to reflect this determination. Legislative Research Commission Note (7/15/96). This section was amended by 1996 Ky. Acts chs. 257 and 318. Where these Acts are not in conflict, they have been codified together. Where a conflict exists, Acts ch. 318, which was last enacted by the General Assembly, prevails under KRS 446.250.

KRS 315.135 Registration as pharmacy technician required to assist in the practice of pharmacy -- Exemptions

315.135. Registration as pharmacy technician required to assist in the practice of pharmacy -- Exemptions (1) Effective April 1, 2009, a person shall not assist in the practice of pharmacy unless he or she is duly registered as a pharmacy technician under the provisions of this chapter or is exempt under subsection (2) of this section. (2) A person may assist in the practice of pharmacy without obtaining the registration required by this section if the person: (a) Has filed an application with the board in accordance with KRS 315.136 and no more than thirty (30) days has elapsed since the date the applicant was first employed by the pharmacy. The exemption shall not apply if: 1. The application has been denied; 2. The person is less than sixteen (16) years of age; or 3. The person has previously been denied a registration or has had a registration revoked or suspended in any jurisdiction and the registration has not yet been issued or reinstated; (b) Is in the employ of a son, daughter, spouse, parent, or legal guardian; or (c) Is participating in a work-study program through an accredited secondary or postsecondary educational institution. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 148, sec. 1, effective July 15, 2008.

KRS 315.136 Requirements for registration as pharmacy technician

315.136. Requirements for registration as pharmacy technician (1) Every applicant for registration as a pharmacy technician shall be sixteen (16) years of age and of good mental health and moral character and shall file with the board an application in such form and containing such data as the board may reasonably require. (2) The application fee shall be twenty-five dollars ($25). All applicants for registration as a pharmacy technician who serve only on a voluntary basis as a pharmacy technician with a pharmacy operated by a charitable provider as defined in KRS 142.301 shall not be required to pay the application fee. (3) The board shall issue a certificate of registration and a pocket registration card to an applicant who meets the requirements for registration. Effective: July 15, 2010 History: Amended 2010 Ky. Acts ch. 11, sec. 1, effective July 15, 2010. -- Created 2008 Ky. Acts ch. 148, sec. 2, effective July 15, 2008.

KRS 315.137 Denial of application for registration as pharmacy technician -- Hearing

315.137. Denial of application for registration as pharmacy technician -- Hearing (1) The board may deny an application for registration filed under KRS 315.136 if the applicant: (a) Submits an incomplete application; (b) Fails to submit the application fee; or (c) Violates or is deemed to be in violation of any of the provisions of KRS 315.121. (2) After denying an application for registration, the board shall set the matter for a hearing in accordance with KRS Chapter 13B, upon the written request of the applicant. The applicant's request shall be submitted to the board no later than thirty (30) days immediately following the date the letter of denial is postmarked. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 148, sec. 3, effective July 15, 2008.

KRS 315.138 Renewal of registration as pharmacy technician -- Display of registration certificate

315.138. Renewal of registration as pharmacy technician -- Display of registration certificate (1) Every pharmacy technician who wishes to renew his or her registration shall pay to the executive director of the board an annual renewal fee of twenty-five dollars ($25) and shall file with the board an application in such form and containing such information that the board reasonably determines necessary to renew the registration. Each pharmacy technician's registration shall expire on March 31 of each year. A delinquent renewal penalty fee not to exceed twenty-five dollars ($25) may be assessed for each renewal period the registrant fails to remove his or her registration after the expiration of the registration. (2) Every pharmacy technician shall keep his or her current certificate of registration conspicuously displayed in the technician's primary place of employment. (3) In addition to a current certificate of registration, each pharmacy technician shall be issued, upon renewal, a pocket registration card which shall be in the registrant's possession when the registrant is assisting in the practice of pharmacy. The pocket registration card shall be exhibited upon the request of any member, inspector, or agent of the board. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 148, sec. 4, effective July 15, 2008.

KRS 315.140 Repealed, 1982

315.140. Repealed, 1982 Catchline at repeal: Forfeiture of license. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 11. -- Amended 1966 Ky. Acts ch. 260, sec. 4. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. secs. 2625, 2627, 2628.

KRS 315.150 Board membership -- Appointment -- Term -- Vacancy -- Oath -- Quorum

315.150. Board membership -- Appointment -- Term -- Vacancy -- Oath -- Quorum (1) The board shall consist of six (6) members appointed by the Governor. Five (5) members shall be pharmacists licensed in this state. One (1) member shall be a citizen at large, who is not associated with or financially interested in the practice of pharmacy. (2) In any calendar year scheduled to be the last full calendar year of a member's regular term in office, the association shall select and submit to the Governor a list of five (5) pharmacists, each of whom has had at least five (5) years' experience in the practice of pharmacy, is a resident of the state and in good standing with the board. On or before March 1 of the same year, the society, other state pharmacy organizations, or individuals may submit recommendations to the association for its consideration in selecting the list to be submitted. The Governor shall, before October 1 of the same year, appoint no more than two (2) persons from each list so submitted, to take office on January 1 following. The citizen member shall be appointed by the Governor. No two (2) pharmacist members of the board shall be residents of the same county. (3) Beginning January 1, 2005, the term of each board member shall be four (4) years. Each member shall serve until his or her successor is appointed and qualified, unless removed for cause. No member shall be appointed to serve for more than two (2) full terms. (4) The Governor shall fill any vacancy of a pharmacist member from the names last submitted within sixty (60) days after such a vacancy occurs. Any member so appointed shall commence service at the next regularly-scheduled board meeting and shall serve for the remainder of the term vacated. (5) Each member shall take and subscribe to an oath before a competent officer to perform the duties of the office faithfully and impartially. The oath shall be inscribed upon the member's commission. (6) Four (4) members of the board shall constitute a quorum. Effective: July 13, 2004 History: Amended 2004 Ky. Acts ch. 96, sec. 4, effective July 13, 2004. -- Amended 1996 Ky. Acts ch. 257, sec. 17, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 13, effective July 15, 1982. -- Amended 1976 Ky. Acts ch. 206, sec. 8. - - Amended 1970 Ky. Acts ch. 221, sec. 12. -- Amended 1948 Ky. Acts ch. 222, sec. 6. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. secs. 2621, 2622.

KRS 315.155 Removal of board members

315.155. Removal of board members (1) The Governor may remove a member of the board for any of the following reasons: (a) Refusal or inability of a board member to perform his duties as a member of the board in an efficient, responsible and professional manner; (b) Misuse of the office by a member of the board to obtain personal, pecuniary, or material gain or advantage for himself or another; (c) Willful violation of any provision of KRS Chapter 315 or any rule or regulation promulgated thereunder. (2) Any person may file a complaint with the executive director of the board against a board member alleging specific facts which constitute grounds for removal from the board. The executive director shall transmit a copy of any such complaint to the Governor, the president of the board and the accused board member. Upon a written recommendation of the Governor or two-thirds (2/3) of the members of the board, a hearing shall be conducted before an impartial hearing officer pursuant to KRS Chapter 13B. (3) The hearing officer shall submit a transcript of the hearing to the Governor with a recommendation based on evidence presented in the hearing. The Governor shall review the transcript to determine if the evidence supports the recommendation, and he shall enter a finding in accordance with such determination. (4) In the event a board member is removed, his removal shall be effective as of the date of the Governor's finding and a vacancy shall be deemed to exist. Any board member so removed shall be entitled to appeal the removal in the Franklin Circuit Court. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 18, effective July 15, 1996. -- Created 1982 Ky. Acts ch. 191, sec. 19, effective July 15, 1982.

KRS 315.160 Election of officers -- Executive director -- Meetings

315.160. Election of officers -- Executive director -- Meetings (1) The board shall elect annually from its membership a president and such other officers as it deems necessary. These officers shall serve for a term of one (1) year and perform the duties prescribed by the board. No officer shall serve more than two (2) consecutive full terms in each office to which he is elected. (2) The board shall employ a pharmacist to serve as a full time employee of the board in the position of executive director. The executive director shall be responsible for the performance of the administrative functions of the board and such other duties as the board may direct. The board may employ, upon recommendation of the executive director, such additional assistance as necessary for the proper conduct of board business and in accordance with the rules and regulations of the Kentucky Personnel Cabinet. (3) The board shall meet at least four (4) times a year to transact business, at such place as it may determine. The board may also meet at the call of the president or a majority of the board members. Each board member shall be given adequate prior notice of any board meeting. Effective: July 15, 1998 History: Amended 1998 Ky. Acts ch. 154, sec. 89, effective July 15, 1998. -- Amended 1982 Ky. Acts ch. 191, sec. 14, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 13. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2622.

KRS 315.170 Repealed, 1966

315.170. Repealed, 1966 Catchline at repeal: Compensation and expenses of board members and secretary- treasurer. History: Repealed 1966 Ky. Acts ch. 260, sec. 13. -- Amended 1950 Ky. Acts ch. 170, sec. 1. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2623.

KRS 315.171 Compensation of board members and executive director

315.171. Compensation of board members and executive director (1) Beginning January 1, 1998, each member of the board shall receive not more than one hundred dollars ($100) for each day actively engaged in the service of the board. During the period between July 15, 1996, and January 1, 1998, each board member shall receive not more than seventy-five dollars ($75) for each day actively engaged in the service of the board. Each member shall receive his traveling expenses and all necessary expenses incurred in the performance of his official duties. (2) The executive director of the board shall receive a reasonable salary determined by the board. He shall also receive his traveling expenses and all necessary expenses incurred in the performance of his official duties. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 19, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 15, effective July 15, 1982. -- Created 1966 Ky. Acts ch. 260, sec. 5.

KRS 315.180 Executive director to keep record of persons issued licenses, permits or certificates

315.180. Executive director to keep record of persons issued licenses, permits or certificates The executive director shall keep a register of the names of those persons to whom a license, permit or certificate has been issued and the dates thereof. Effective: July 15, 1982 History: Amended 1982 Ky. Acts ch. 191, sec. 16, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 15. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2627.

KRS 315.190 Repealed, 1966

315.190. Repealed, 1966 Catchline at repeal: Functions of board. History: Repealed 1966 Ky. Acts ch. 260, sec. 13. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. secs. 2622, 2623, 2634.

KRS 315.191 Powers and duties of board -- Advisory council

315.191. Powers and duties of board -- Advisory council (1) The board is authorized to: (a) Promulgate administrative regulations pursuant to KRS Chapter 13A necessary to regulate and control all matters set forth in this chapter relating to pharmacists, pharmacist interns, pharmacy technicians, pharmacies, wholesale distributors, and manufacturers, to the extent that regulation and control of same have not been delegated to some other agency of the Commonwealth, but administrative regulations relating to drugs shall be limited to the regulation and control of drugs sold pursuant to a prescription drug order. However, except as provided in KRS 315.038, nothing contained in this chapter shall be construed as authorizing the board to promulgate any administrative regulations relating to prices or fees or to advertising or the promotion of the sales or use of commodities or services; (b) Issue subpoenas, schedule and conduct hearings, or appoint hearing officers to schedule and conduct hearings on behalf of the board on any matter under the jurisdiction of the board; (c) Prescribe the time, place, meth od, manner, scope, and subjects of examinations, with at least two (2) examinations to be held annually; (d) Issue and renew all licenses, certificates, and permits for all pharmacists, pharmacist interns, pharmacies, pharmacy technicians, wholesale distri butors, and manufacturers engaged in the manufacture, distribution, or dispensation of drugs; (e) Investigate all complaints or violations of the state pharmacy laws and the administrative regulations promulgated by the board, and bring all these cases to the notice of the proper law enforcement authorities; (f) Promulgate administrative regulations, pursuant to KRS Chapter 13A, that are necessary and to control the storage, retrieval, dispensing, refilling, and transfer of prescription drug orders within a nd between pharmacists and pharmacies licensed or issued a permit by it; (g) Perform all other functions necessary to carry out the provisions of law and the administrative regulations promulgated by the board relating to pharmacists, pharmacist interns, pharmacy technicians, pharmacies, wholesale distributors, and manufacturers; (h) Establish or approve programs for training, qualifications, and registration of pharmacist interns; (i) Assess reasonable fees, in addition to the fees specifically provided fo r in this chapter and consistent with KRS 61.870 to 61.884, for services rendered to perform its duties and responsibilities, including, but not limited to, the following: 1. Issuance of duplicate certificates; 2. Mailing lists or reports of data maintained by the board; 3. Copies of documents; or 4. Notices of meetings; (j) Seize any drug or device found by the board to constitute an imminent danger to public health and welfare; (k) 1. Establish an advisory council to advise the board on statutes, administrative regulations, and other matters within the discretion of the board pertinent to the practice of pharmacy and regulation of pharmacists, pharmacist interns, pharmacy technicians, pharmacies, drug distribution, and drug manufacturing. The council shall provide recommendations for updating policies and procedures, including administrative regulations relating to the practice of pharmacy. 2. The council shall consist of nine (9) pharmacists broadly representative of the profession of pharmacy. For purposes of this subparagraph, "broadly representative" means the following: a. Two (2) pharmacists appointed by the Kentucky Pharmacists Association; b. Two (2) pharmacists appointed by the Kentucky Independent Pharmacy Alliance; c. One (1) pharmacist who practices or specializes primarily in a mail order pharmacy appointed by the Kentucky Pharmacists Association; d. One (1) pharmacist who practices or specializes primarily in a long-term care pharmacy appointed by Kentuc ky Association of Health Care Facilities; e. One (1) pharmacist who practices or specializes primarily in a veterinary pharmacy appointed by the Kentucky Pharmacists Association; f. One (1) pharmacist who practices or specializes primarily in a hospital pharmacy appointed by the Kentucky Society of Health - System Pharmacists; and g. One (1) pharmacist who practices in a specialized pharmacy that solely or mostly provides medication to persons living with serious health conditions requiring complex therapies, appointed by the Kentucky Pharmacists Association. 3. Each pharmacist member shall be licensed by the board, a resident of Kentucky, and employed for at least two (2) consecutive years in the practice area he or she represents. 4. Members shall serve terms of up to four (4) years and may serve two (2) consecutive terms, but shall not serve on the council for more than two (2) consecutive terms. Members may continue to serve until their successors are appointed. 5. Members shall be confirmed by roll call vo te of the board at a meeting conducted in accordance with the Open Meetings Act, KRS 61.805 to 61.850; and (l) Promulgate administrative regulations establishing the qualifications that pharmacy technicians are required to attain prior to engaging in pharm acy practice activities outside the immediate supervision of a pharmacist. (2) The board shall have other authority as may be necessary to enforce pharmacy laws and administrative regulations of the board including, but not limited to: (a) Joining or participating in professional organizations and associations organized exclusively to promote improvement of the standards of practice of pharmacy for the protection of public health and welfare or facilitate the activities of the board; and (b) Receiving and expending funds, in addition to its biennial appropriation, received from parties other than the state, if: 1. The funds are awarded for the pursuit of a specific objective which the board is authorized to enforce through this chapter, or which the board is qualified to pursue by reason of its jurisdiction or professional expertise; 2. The funds are expended for the objective for which they were awarded; 3. The activities connected with or occasioned by the expenditure of the funds do not interfere with the performance of the board's responsibilities and do not conflict with the exercise of its statutory powers; 4. The funds are kept in a separate account and not commingled with funds received from the state; and 5. Periodic accountings of the funds are maintained at the board office for inspection or review. (3) In addition to the sanctions provided in KRS 315.121, the board or its hearing officer may direct any licensee, permit holder, or certificate holder found guilty of a charge involving pharmacy or drug laws, rules, or administrative regulations of the state, any other state, or federal government, to pay to the board a sum not to exceed the reasonable costs of investigation and prosecution of the case, not to exceed twenty-five thousand dollars ($25,000). (4) In an action for recovery of costs, proof of the board's order shall be conclusive proof of the validity of the order of payment and any terms for payment. Effective: July 15, 2024 History: Amended 2024 Ky. Acts ch. 104, sec. 17, effective July 15, 2024. -- Amended 2023 Ky. Acts ch. 136, sec. 1, effective June 29, 2023. -- Amended 2016 Ky. Acts ch. 103, sec. 14, effective July 15, 2016. -- Amended 2015 Ky. Acts ch. 56, sec. 3, effective June 24, 2015. -- Amended 2012 Ky. Acts ch. 73, sec. 13, effective July 12, 2012. -- Amended 2008 Ky. Acts ch. 148, sec. 10, effective July 15, 2008. -- Amended 2005 Ky. Acts ch. 61, sec. 4, effective June 20, 2005. -- Amended 1996 Ky. Acts ch. 257, sec. 20, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 17, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 16. -- Created 1966 Ky. Acts ch. 260, sec. 1. Legislative Research Commission Note (7/12/2012). The internal format of subsection (1)(d) of this statute has been modified by the Reviser of Statutes from the way it appeared in 2012 Ky. Acts ch. 73, sec. 13, under the authority of KRS 7.136(1). The words in the text were not changed.

KRS 315.192 Repealed, 2017

315.192. Repealed, 2017 Catchline at repeal: Board of Pharmacy not to prohibit sale and dispensing of laetrile. History: Repealed 2017 Ky. Acts ch. 80, sec. 58, effective June 29, 2017. -- Created 1980 Ky. Acts ch. 354, sec. 10, effective July 15, 1980.

KRS 315.193 Board members' immunity for official acts

315.193. Board members' immunity for official acts (1) Members of the board, its agents, and employees shall be immune from suit in any action, civil, or criminal, which is based upon any official act or acts performed by them in good faith. (2) Any pharmacist, whose duty it is to review or evaluate the acts of other pharmacists and who serves on any committee, board, commission or other entity affiliated with a governmental or quasi-governmental agency or with a medical facility, shall not be required to respond in damages for any official action taken by him in good faith as a member thereof. Effective: July 15, 1996 History: Amended 1996 Ky. Acts ch. 257, sec. 21, effective July 15, 1996. -- Created 1974 Ky. Acts ch. 310, sec. 4.

KRS 315.195 Agency fund -- Use

315.195. Agency fund -- Use (1) All license, permit, and certificate fees, charges, fines, and other moneys collected by the board under the provisions of this chapter, and the administrative regulations of the board, shall be deposited into the State Treasury and credited to a trust and agency fund to be used by the board in carrying out the provisions of this chapter, and are hereby appropriated for those purposes. (2) Notwithstanding KRS 45.229, any moneys remaining in the fund at the close of the fiscal year shall not lapse but shall be carried forward into the succeeding fiscal year. Effective: July 12, 2012 History: Amended 2012 Ky. Acts ch. 73, sec. 14, effective July 12, 2012. -- Amended 1996 Ky. Acts ch. 257, sec. 22, effective July 15, 1996. -- Amended 1982 Ky. Acts ch. 191, sec. 18, effective July 15, 1982. -- Created 1966 Ky. Acts ch. 260, sec. 11.

KRS 315.200 For whom prescriptions to be refilled

315.200. For whom prescriptions to be refilled No prescription shall be knowingly refilled except for the person for whom it was written. Effective: October 1, 1942 History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060a-6.

KRS 315.202 Exercise of judgment by pharmacist to dispense varying quantities of prescription drug per fill

315.202. Exercise of judgment by pharmacist to dispense varying quantities of prescription drug per fill (1) Notwithstanding any statute to the contrary, unless the practitioner has specified on the prescription drug order that dispensing a prescription for a noncontrolled maintenance drug in an initial amount followed by periodic refills is medically necessary, a pharmacist may exercise professional judgment to dispense varying quantities of the prescribed drug per fill up to the total number of dosage units as authorized by the practitioner on the prescription drug order, including any refills, up to a ninety (90) day supply. (2) This section does not apply to controlled substances or to any drugs for which a report is required to the electronic system for monitoring controlled substances established in KRS 218A.202. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 113, sec. 1, effective June 29, 2017.

KRS 315.205 Notification of immunization to minor's primary care provider

315.205. Notification of immunization to minor's primary care provider Upon the request of an individual or his or her parent or guardian, a pharmacist who administers an immunization to an individual who is five (5) to seventeen (17) years of age, as authorized in KRS 315.010(22), shall provide notification of the immunization to the individual's primary care provider. Effective: July 15, 2024 History: Amended 2024 Ky. Acts ch. 11, sec. 2, effective July 15, 2024. -- Amended 2017 Ky. Acts ch. 44, sec. 2, effective June 29, 2017; and ch. 136, sec. 11, effective June 29, 2017. -- Amended 2016 Ky. Acts ch. 105, sec. 3, effective July 15, 2016. -- Amended 2011 Ky. Acts ch. 81, sec. 2, effective June 8, 2011. -- Created 2010 Ky. Acts ch. 37, sec. 2, effective July 15, 2010.

KRS 315.208 Dispensing prescription issued by a practitioner who has died -- Limitations

315.208. Dispensing prescription issued by a practitioner who has died -- Limitations (1) Notwithstanding any other provision of law to the contrary, when a pharmacist is aware that a practitioner has died, a prescription issued by that practitioner may continue to be dispensed based on the pharmacist's professional judgment and no later than one hundred eighty (180) days following the date on which the practitioner died. (2) Nothing in this section authorizes the dispensing of a prescription that was issued for a controlled substance unless permitted under the federal Controlled Substances Act and regulations of the United States Drug Enforcement Administration. Effective: June 27, 2025 History: Created 2025 Ky. Acts ch. 161, sec. 1, effective June 27 , 2025.

KRS 315.210 Reciprocity

315.210. Reciprocity The board may exchange license certificates with other states so as to allow registered pharmacists of other states to practice pharmacy in this state under regulations prescribed by the board. History: Amended 1970 Ky. Acts ch. 221, sec. 17. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2619a-1.

KRS 315.220 Powers of representatives of board

315.220. Powers of representatives of board (1) For the purpose of enforcing the provisions of this chapter, officers, agents, and inspectors of the board shall have the power and authority to: (a) Administer oaths; (b) Enter upon premises of all facilities issued a permit or license by the board, at all reasonable times for the purpose of: 1. Making inspections and carrying out the provisions of this chapter; 2. Conducting investigations; 3. Requiring production of books, papers, documents, records, or other evidence for inspection or copying; 4. Seizing evidence; or 5. Securing oral or written statements; (c) Employ special investigators; (d) Expend funds for the purpose of obtaining evidence; and (e) Issue subpoenas. (2) As used in subsection (1) of this section, "records" includes, but is not limited to, patient records. (3) Any decision to inspect, copy, or seize books, papers, documents, records, or other evidence shall be at the discretion of the officer, agent, or inspector of the board. (4) Inspection, copying, or seizure of books, papers, documents, records, or other evidence does not affect the confidential nature of those records, and the board shall maintain the records so as to protect the confidentiality of the records. Effective: July 12, 2012 History: Amended 2012 Ky. Acts ch. 73, sec. 15, effective July 12, 2012. -- Amended 1996 Ky. Acts ch. 257, sec. 23, effective July 15, 1996. -- Created 1966 Ky. Acts ch. 260, sec. 9.

KRS 315.230 Restraint of violations -- Legal representation

315.230. Restraint of violations -- Legal representation (1) Notwithstanding the existence or pursuit of any other remedy (civil or criminal) the board is hereby authorized to institute and maintain actions to restrain and enjoin any violation of this chapter, or the rules and regulations of the board. (2) City, county and Commonwealth's attorneys, and the Attorney General, shall within their respective jurisdictions represent the board, its officers, agents, and inspectors, in the enforcement of the provisions of this chapter, and the rules and regulations of the board, but when the board deems it necessary, it may employ at its discretion, special attorneys to assist the board, or its officers, agents, or inspectors, and may pay reasonable compensation, fees and other costs from any unexpended funds. History: Created 1966 Ky. Acts ch. 260, sec. 10.

KRS 315.235 Attorney General's jurisdiction to investigate and prosecute violators of pharmacy laws

315.235. Attorney General's jurisdiction to investigate and prosecute violators of pharmacy laws (1) The Attorney General has concurrent jurisdiction with the Commonwealth's attorneys of this state for the enforcement of the provisions of this chapter. (2) The Attorney General may investigate and prosecute a practitioner or any other person who violates the provisions of: (a) This chapter; and (b) Any other statute if the violation is committed by the practitioner or person in the course of committing a violation described in paragraph (a) of this subsection. (3) When acting pursuant to this section, the Attorney General may commence his investigation and file a criminal action without leave of court, and the Attorney General has exclusive charge of the conduct of the prosecution. Effective: June 20, 2005 History: Created 2005 Ky. Acts ch. 150, sec. 16, effective June 20, 2005.

KRS 315.295 Automated pharmacy system in residential hospice facilities

315.295. Automated pharmacy system in residential hospice facilities (1) As used in this section and KRS 315.300: (a) "Automated pharmacy system" means a mechanical system that delivers prescribed over-the-counter and legend drugs, and controlled substances received from a pharmacy licensed in Kentucky that maintains transaction information; and (b) "Residential hospice facility" means a facility licensed under KRS Chapter 216B that provides residential skilled nursing care, pain management, and treatment for acute and chronic conditions for terminally ill patients. (2) A pharmacy may provide pharmacy services to a residential hospice facility through the use of an automated pharmacy system under the supervision of a licensed pharmacist pursuant to the policies, procedures, and protocol established by the Kentucky Board of Pharmacy. The supervising pharmacist shall not be required to be physically present at the location of the automated pharmacy system and supervision may be provided electronically. (3) Drugs stored in bulk or unit dose in an automated pharmacy system in a residential hospice facility shall be considered the inventory of the pharmacy providing services to the facility and drugs delivered through the automated pharmacy system shall be considered dispensed by the pharmacy. (4) The Kentucky Board of Pharmacy shall promulgate administrative regulations pursuant to KRS Chapter 13A to implement the provisions of this section that shall include but not be limited to: (a) Accuracy of the automated pharmacy system; (b) Security of the system; (c) Recordkeeping, including but not limited to electronic signatures of authorized users; (d) Inventory management; (e) Labeling or reporting requirements that include identification of the dispensing pharmacy, the prescription number, the name of the patient, and the name of the prescriber; and (f) Training for authorized users. (5) Nothing in this section shall be construed to limit or impede pharmacy practice in Kentucky. Effective: July 12, 2006 History: Created 2006 Ky. Acts ch. 153, sec. 1, effective July 12, 2006.

KRS 315.300 Placement of drugs by pharmacy with authorized employees of home health agencies and hospices -- Protocol -- Allowable legend drugs -- Administrative regulations

315.300. Placement of drugs by pharmacy with authorized employees of home health agencies and hospices -- Protocol -- Allowable legend drugs -- Administrative regulations (1) A pharmacy shall be allowed to place drugs with a home health agency's authorized employees and with a hospice's authorized employees for the betterment of public health. The pharmacy shall remain the legal owner of the drugs. (2) A written agreement between the pharmacy and home health agency or hospice shall document the protocol for the handling and storage of the drugs by authorized employees and shall be approved by the pharmacist in charge. (3) The pharmacist in charge shall review the protocol to assure that safe, secure and accountable handling of controlled legend drugs is maintained under the protocol before giving approval. (4) The pharmacist in charge or a pharmacist designee shall physically inspect and review the drug storage and handling at the home health agency and the hospice not less than annually. (5) The home health agency and the hospice protocol shall include but not be limited to the following: (a) Safe and secure storage of drugs; (b) Access to drugs limited to authorized employees; (c) Records of drugs checked out to authorized employees and records of drugs, amounts, and to whom and by whom administered; (d) Prompt notification of the pharmacy when a drug is used, including the prescriber, patient, drug, dosage form, directions for use and other pertinent information; (e) Billing information; (f) Procedures for handling drugs beyond their expiration date; and (g) Inventory control. (6) The following legend drugs shall be allowed under these agreements: (a) Sterile water for injection or irrigation; (b) Sterile saline solution for injection or irrigation; (c) Heparin flush solution; (d) Diphenhydramine injectable; (e) Epinephrine injectable; (f) Glucagon; (g) Influenza vaccine; and (h) Pneumonia vaccine. (7) As used in this section: (a) "Authorized employee" means any employee of a home health agency or hospice who, in the course of the employee's duties, is licensed by the employee's appropriate licensing agency to administer legend drugs; (b) "Home health agency" means an entity required to be licensed under KRS Chapter 216; and (c) "Hospice" means an entity authorized to hold itself out to the public as a hospice or as a licensed hospice pursuant to KRS Chapter 216. (8) The cabinet shall promulgate administrative regulations to implement the provisions of this section. (9) Nothing in this section shall preclude or prevent a pharmacy from providing pharmacy services through an automated pharmacy system to a residential hospice facility in accordance with KRS 315.295. Effective: July 12, 2006 History: Amended 2006 Ky. Acts ch. 153, sec. 2, effective July 12, 2006. -- Created 1998 Ky. Acts ch. 531, sec. 5, effective July 15, 1998.

KRS 315.310 Duty of treating pharmacist utilizing telehealth to ensure patient's informed consent and maintain confidentiality -- Board to promulgate administrative regulations -- Definition of "telehealth"

315.310. Duty of treating pharmacist utilizing telehealth to ensure patient's informed consent and maintain confidentiality -- Board to promulgate administrative regulations -- Definition of "telehealth" (1) A treating pharmacist who provides or facilitates the use of telehealth shall ensure: (a) That the informed consent of the patient, or another appropriate person with authority to make the health care treatment decision for the patient, is obtained before services are provided through telehealth; and (b) That the confidentiality of the patient's medical information is maintained as required by this chapter and other applicable law. At a minimum, confidentiality shall be maintained through appropriate processes, practices, and technology as designated by the board and that conform to applicable federal law. (2) The board shall promulgate administrative regulations in accordance with KRS Chapter 13A to implement this section and as necessary to: (a) Prevent abuse and fraud through the use of telehealth services; (b) Prevent fee-splitting through the use of telehealth services; and (c) Utilize telehealth in the provision of pharmacy services and in the provision of continuing education. (3) For purposes of this section, "telehealth" means the use of interactive audio, video, or other electronic media to deliver health care. It includes the use of electronic media for diagnosis, consultation, treatment, transfer of health or medical data, and continuing education. Effective: July 14, 2000 History: Created 2000 Ky. Acts ch. 376, sec. 15, effective July 14, 2000.

KRS 315.315 Presumption regarding prescription or medical order

315.315. Presumption regarding prescription or medical order Any prescription or medical order for a drug that is known to possibly cause an abortion shall be presumed by a pharmacy to be for indications other than for the termination of a pregnancy. A pharmacy dispensing such prescription or medical order shall not be required to verify that the prescription or medical order does not violate any provision of this chapter or KRS Chapter 216B. Effective:April 14, 2022 History: Created 2022 Ky. Acts ch. 210, sec. 30, effective April 14, 2022. Legislative Research Commission Note (4/14/2022). This statute was created by 2022 Ky. Acts ch. 210, sec. 30. Section 38 of that Act states, "Sections 1 to 31 of this Act may be cited as the Humanity in Healthcare Act of 2022."

KRS 315.320 Illegal operation of out-of-state pharmacy -- Exemption for lapsed license or permit -- Penalty -- Exceptions from section

315.320. Illegal operation of out-of-state pharmacy -- Exemption for lapsed license or permit -- Penalty -- Exceptions from section (1) A person or pharmacy is guilty of a Class C felony if the person or pharmacy, located inside or outside this Commonwealth, is not licensed by the Commonwealth of Kentucky to engage in the practice of pharmacy and knowingly: (a) Communicates with a person in this Commonwealth; and (b) Uses or attempts to use such communication or information, in whole, or in part, to: 1. Fill or refill a prescription for a prescription drug for the other person; or 2. Deliver, cause, allow, or aid in the delivery of a controlled substance, imitation controlled substance, counterfeit substance or prescription drug to the other person. (2) A person or pharmacy is guilty of a Class B felony if the substance or drug dispensed in subsection (1) of this section: (a) Is classified in Schedule I; or (b) Proximately causes serious physical injury or the death of the intended recipient of the substance or drug or any other person. (3) The court shall not grant probation to or suspend the sentence of a person punished pursuant to subsection (2) of this section. (4) A person who knowingly aids another in any act or transaction that violates the provisions of subsection (1) of this section is guilty of a Class C felony. (5) A person who knowingly aids another in any act or transaction that violates the provisions of subsection (2) of this section is guilty of a Class B felony. (6) A person or pharmacy may be prosecuted, convicted, and punished for a violation of this section whether or not the person is prosecuted, convicted, or punished for a violation of any other statute based upon the same act or transaction. (7) This section shall not apply to a licensed pharmacist or permitted pharmacy that inadvertently allows its license or permit issued by the Kentucky Board of Pharmacy to lapse for a period of less than thirty (30) days. (8) This section shall not apply to authorized agents of a pharmacy with a valid permit issued by the Kentucky Board of Pharmacy. (9) This section shall not apply to an authorized agent of a pharmacy that inadvertently allows its permit issued by the Kentucky Board of Pharmacy, to lapse for a period of less than thirty (30) days. (10) Unless a more specific penalty applies within this chapter, anyone who uses the Internet to communicate and facilitate the sale of controlled substances, except as specifically provided for in this chapter, may be prosecuted under KRS Chapter 218A. Effective: June 26, 2007 History: Amended 2007 Ky. Acts ch. 124, sec. 11, effective June 26, 2007. -- Created 2005 Ky. Acts ch. 150, sec. 14, effective June 20, 2005.

KRS 315.325 Exemption from pharmacy licensing requirements for common carriers transporting drugs

315.325. Exemption from pharmacy licensing requirements for common carriers transporting drugs The provisions of KRS 315.320 do not apply to a person who is: (1) A common or contract carrier or warehouseman, or any employee thereof, unless the person is acting outside of the usual course of his business or employment or knows or has reasonable cause to believe that the act or transaction is unlawful; or (2) An employee or agent of a pharmacist or pharmacy licensed or permitted pursuant to this chapter and acting in accordance with KRS Chapter 218A, unless the person is acting outside of the usual course of his business or employment or knows or has reasonable cause to believe that the act or transaction is unlawful; or (3) The intended recipient of a substance or drug, unless the intended recipient knows or has reasonable cause to believe that the act or transaction is unlawful. Effective: June 20, 2005 History: Created 2005 Ky. Acts ch. 150, sec. 15, effective June 20, 2005.

KRS 315.330 Seizure and forfeiture of illegal drug shipments

315.330. Seizure and forfeiture of illegal drug shipments (1) Any drug which is ordered or shipped in violation of any provision of this chapter or KRS Chapter 218A shall be considered as contraband and may be seized by any peace officer or any employee of the Board of Pharmacy designated to enforce the provisions of this chapter or KRS Chapter 218A. (2) The officer, prior to seizing the drug, shall make a reasonable effort to determine: (a) The person who ordered the drug; (b) The pharmacy from which the drug was ordered; (c) The shipper of the drug; (d) The intended recipient of the drug; and (e) Whether or not the shipment was legal. (3) Unless the matter is the subject of a criminal prosecution, if, after thirty (30) days of investigation, the officer seizing the drug cannot adequately determine the information required by subsection (2) of this section, the drug that has been seized shall be considered as abandoned and escheat to the Commonwealth. (4) If a drug seized pursuant to this section is the subject of a criminal investigation, the drug shall be retained as evidence and, if there is a conviction of any person or pharmacy relating to the ordering or shipment of the drug, the drug shall be forfeited to the Commonwealth. If the defendant is found not guilty or the charges are dismissed with prejudice, the drug shall be returned to the defendant. (5) Drugs which have been seized and which have been forfeited or abandoned and escheat to the Commonwealth shall be destroyed. Effective: June 20, 2005 History: Created 2005 Ky. Acts ch. 150, sec. 17, effective June 20, 2005.

KRS 315.335 Reporting of robbery, theft, or missing shipment of controlled substances

315.335. Reporting of robbery, theft, or missing shipment of controlled substances (1) A pharmacy located in Kentucky which has a robbery or theft of a controlled substance shall immediately following the robbery or discovery of the theft report the incident to a law enforcement agency serving the geographic area in which the pharmacy is located. (2) A pharmacy which has mailed or shipped a controlled substance to a location in Kentucky and learns that the mailing or shipment did not arrive shall within three (3) business days report that nonreceipt to: (a) The Department of Kentucky State Police; and (b) If applicable, the United States Postal Inspection Service. (3) (a) The reports required pursuant to subsections (1) and (2) of this section shall contain at a minimum, if known and applicable: 1. The name, National Drug Code, and quantity of each controlled substance involved; 2. A description of the circumstances of the loss; 3. The names and contact information of any witnesses; and 4. The name and description of any person suspected of committing the offense or causing the loss. (b) The Board of Pharmacy may by administrative regulation authorize a pharmacy to submit a completed DEA 106 form or a successor form in lieu of the data elements required by this subsection. Effective: March 4, 2013 History: Amended 2013 Ky. Acts ch. 2, sec. 5, effective March 4, 2013. -- Created 2012 (1st Extra. Sess.) Ky. Acts ch. 1, sec. 11, effective July 20, 2012.

KRS 315.340 Permit for operation of in-state outsourcing facility doing business in Kentucky -- Requirements -- Administrative regulations

315.340. Permit for operation of in-state outsourcing facility doing business in Kentucky -- Requirements -- Administrative regulations (1) (a) A person shall not operate an outsourcing facility within this Commonwealth, physically or by means of the Internet, facsimile, phone, mail, or any other means, without first obtaining a permit from the board. (b) An application for a permit to operate an outsourcing facility shall be made to the board upon forms provided by the board and shall contain such information as the board requires, which may include affirmative evidence of the ability to comply with the requirements of this chapter and the administrative regulations promulgated by the board. (c) Each application shall be accompanied by a nonrefundable permit fee to be set by administrative regulation promulgated by the board, not to exceed five hundred dollars ($500). (2) (a) As a prerequisite to obtaining or renewing a permit from the board, the outsourcing facility shall: 1. Register as an outsourcing facility with the United States Secretary of Health and Human Services in accordance with 21 U.S.C. sec. 353b; and 2. Submit a copy of a current inspection report resulting from an inspection conducted by the United States Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the United States Food and Drug Administration. (b) 1. The inspection report required pursuant to paragraph (a)2. of this subsection shall be deemed current for the purposes of this section if the inspection was conducted no more than: a. One (1) year prior to the date of submission of an application for a permit to the board; or b. Two (2) years prior to the date of submission of an application for renewal of a permit to the board. 2. If the outsourcing facility has not been inspected by the United States Food and Drug Administration within the period required under subparagraph 1. of this paragraph, the board may: a. Accept an inspection report or other documentation from another entity that is satisfactory to the board; or b. Cause an inspection to be conducted by its duly authorized agent and charge an inspection fee in an amount sufficient to cover the costs of the inspection. (3) (a) Upon receipt of an application for a permit to operate an outsourcing facility accompanied by the permit fee prescribed by administrative regulation, the board shall: 1. Issue a permit if the outsourcing facility meets the requirements of this chapter and the administrative regulations promulgated by the board; or 2. Refuse to issue or renew any permit to operate if the outsourcing facility fails to meet the requirements of this chapter and the administrative regulations promulgated by the board. (b) The board shall act upon an application for a permit to operate within thirty (30) days after the receipt of the application. The board may issue a temporary permit to operate in any instance where it considers additional time necessary for investigation and consideration before taking final action upon the application. The temporary permit shall be valid for a period of thirty (30) days, unless extended. (4) A separate permit to operate shall be required for each outsourcing facility. (5) (a) Each permit to operate an outsourcing facility, unless suspended or revoked, shall expire on June 30 following its date of issuance and be renewable annually thereafter upon proper application accompanied by the renewal fee as established by administrative regulations promulgated by the board. The renewal fee shall not exceed five hundred dollars ($500). (b) An additional nonrefundable fee not to exceed the annual renewal fee may be assessed and set by administrative regulation as a delinquent renewal penalty for failure to renew by June 30 of each year. (6) Permits to operate shall be issued only for the premises and persons named in the application and shall not be transferable, except that a buyer may operate the outsourcing facility under the permit of the seller pending a decision by the board on an application, which shall be filed by the buyer with the board at least five (5) days prior to the date of sale. (7) The board may promulgate administrative regulations to ensure: (a) That proper equipment and reference material is on hand considering the nature of the pharmaceutical practice conducted at the particular outsourcing facility; and (b) Health and sanitation standards for areas within outsourcing facilities that adhere to Current Good Manufacturing Practices published by the United States Food and Drug Administration. (8) Each outsourcing facility shall comply with KRS 218A.202. (9) Each outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the United States Food and Drug Administration. (10) A pharmacist may temporarily operate an outsourcing facility in an area not designated on the permit as authorized in KRS 315.500. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 2, effective June 29, 2017.

KRS 315.342 Permit for operation of out-of-state outsourcing facility doing business in Kentucky -- Requirements -- Administrative regulations

315.342. Permit for operation of out-of-state outsourcing facility doing business in Kentucky -- Requirements -- Administrative regulations (1) (a) Each out-of-state outsourcing facility that does business physically or by means of the Internet, facsimile, phone, mail, or any other means, inside this Commonwealth, shall hold a current outsourcing facility permit issued by the board. (b) An application for a permit to operate an out-of-state outsourcing facility shall be made to the board upon forms provided by it and shall contain such information as the board requires, which may include affirmative evidence of ability to comply with reasonable standards and regulations as may be prescribed by the board. (c) Each application shall be accompanied by a permit fee to be set by administrative regulation promulgated by the board. The fee shall not exceed: 1. Two hundred fifty dollars ($250); or 2. The current in-state outsourcing facility permit. (2) (a) As a prerequisite to obtaining or renewing a permit from the board, the out-of-state outsourcing facility shall: 1. Register as an outsourcing facility with the United States Secretary of Health and Human Services in accordance with 21 U.S.C. sec. 353b; and 2. Submit a copy of a current inspection report resulting from an inspection conducted by the United States Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the United States Food and Drug Administration. (b) 1. The inspection report required pursuant to paragraph (a)2. of this subsection shall be deemed current for the purposes of this section if the inspection was conducted no more than: a. One (1) year prior to the date of submission of an application for a permit to the board; or b. Two (2) years prior to the date of submission of an application for renewal of a permit to the board. 2. If the out-of-state outsourcing facility has not been inspected by the United States Food and Drug Administration within the required period required under subparagraph 1. of this paragraph, the board may: a. Accept an inspection report or other documentation from another entity that is satisfactory to the board; or b. Cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection. (3) (a) Upon receipt of an application for a permit to operate an out-of-state outsourcing facility, accompanied by the permit fee required by subsection (1) of this section, the board shall: 1. Issue a permit if the out-of-state outsourcing facility meets the requirements of this chapter and the administrative regulations promulgated by the board; or 2. Refuse to renew any permit to operate unless the out-of-state outsourcing facility meets the requirements of this chapter and the administrative regulations promulgated by the board. (b) The board shall act upon an application for a permit to operate within thirty (30) days after the receipt thereof. The board may issue a temporary permit to operate in any instance where it considers additional time necessary for investigation and consideration before taking final action upon the application. The temporary permit shall be valid for a period of thirty (30) days, unless extended. (4) A separate permit to operate shall be required for each out-of-state outsourcing facility. (5) Each out-of-state outsourcing facility granted an out-of-state outsourcing facility permit by the board shall disclose to the board the location, names, and titles of all its principal corporate officers and all its pharmacists who are dispensing prescription drugs to entities within the Commonwealth. A report containing this information shall be made to the board on an annual basis and within thirty (30) days after any change of office, corporate officer, or pharmacist. (6) (a) An out-of-state outsourcing facility granted an out-of-state outsourcing facility permit shall comply with all requests for information within three (3) business days of a written request by the board or its agents. (b) An out-of-state outsourcing facility shall maintain at all times a valid unexpired permit, license, or registration to conduct the outsourcing facility in compliance with the laws of the jurisdiction in which it is a resident. (c) As a prerequisite to seeking a permit from the board, the out-of-state outsourcing facility shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located. Thereafter, the out-of-state outsourcing facility granted a permit shall submit to the board a copy of any subsequent inspection report of the outsourcing facility conducted by the regulatory or licensing body of the jurisdiction in which it is located. (7) Each out-of-state outsourcing facility granted an out-of-state outsourcing facility permit by the board shall maintain records of any controlled substances or dangerous drugs. (8) Each out-of-state outsourcing facility shall, during its regular hours of operation, but not less than five (5) days per week and for a minimum of forty (40) hours per week, provide a toll-free telephone service directly to the pharmacist in charge of the out-of-state outsourcing facility for the purpose of facilitating communication. A toll-free number shall be placed on a label affixed to each container of drugs dispensed to an entity within the Commonwealth. (9) An out-of-state outsourcing facility shall comply with KRS 218A.202. (10) An out-of-state outsourcing facility doing business within the Commonwealth of Kentucky shall use the address on file with the board as the return address on the labels of any package shipped into or within the Commonwealth. The return address shall be placed on the package in a clear and prominent manner. (11) (a) A permit to operate an out-of-state outsourcing facility, unless suspended or revoked, shall expire on June 30 following its date of issuance and be renewable annually thereafter upon proper application accompanied by the nonrefundable renewal fee established by subsection (1) of this section. (b) An additional nonrefundable fee not to exceed the annual renewal fee may be assessed and set by administrative regulation as a delinquent renewal penalty for failure to renew by June 30 of each year. (12) Permits to operate shall be issued only for the premises and persons named in the application and shall not be transferable, except that a buyer may operate the out-of-state outsourcing facility under the permit of the seller pending a decision by the board on an application which shall be filed by the buyer with the board at least five (5) days prior to the date of sale. (13) The board may promulgate administrative regulations to ensure that proper equipment and reference material is on hand considering the nature of the pharmaceutical practice conducted at the particular out-of-state outsourcing facility. (14) Each out-of-state outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations, to include all applicable guidance documents and Current Good Manufacturing Practices published by the United States Food and Drug Administration. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 3, effective June 29, 2017.

KRS 315.0350 Administrative activities of a pharmacy

315.0350. Administrative activities of a pharmacy Administrative activities of a pharmacy do not constitute the practice of pharmacy and shall be performed in the United States in a pharmacy or in a location other than a pharmacy. Effective: July 15, 2016 History: Created 2016 Ky. Acts ch. 105, sec. 2, effective July 15, 2016.

KRS 315.350 License required for medical gas wholesaler operating within state -- Fee -- Recordkeeping -- Penalty for noncompliance -- Administrative regulations

315.350. License required for medical gas wholesaler operating within state -- Fee -- Recordkeeping -- Penalty for noncompliance -- Administrative regulations (1) A medical gas wholesaler, whether located within the Commonwealth or operating within the Commonwealth from a location outside the Commonwealth, shall be licensed by the board. Each license application shall be accompanied by a fee which shall: (a) Be prescribed by administrative regulation promulgated by the board in an amount not to exceed two hundred fifty dollars ($250); and (b) Not be increased by more than twenty-five dollars ($25) per year. (2) A medical gas wholesaler shall be required to maintain accurate records of all drugs handled. Records shall be made available to agents of the board for inspection upon request. (3) Failure to report to the board or willful submission of inaccurate information shall be grounds for disciplinary action under KRS 315.121. (4) The board shall promulgate administrative regulations to specify the criteria for licensure and discipline of a medical gas wholesaler. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 10, effective June 29, 2017. Legislative Research Commission Note (6/29/2017). In codification, the Reviser of Statutes has corrected a manifest clerical or typographical error by inserting the inadvertently omitted words "accompanied by" in subsection (1) of this statute as created in 2017 Ky. Acts ch. 136, sec. 10 under the authority of KRS 7.136(1)(h).

KRS 315.0351 Out-of-state pharmacy -- Permit -- Requests for information -- Records -- Toll-free telephone service -- Pharmacist on duty -- Requirements for out-of-state pharmacy doing business through the Internet -- Application to sale or distribution of dialysate solution or devices

315.0351. Out-of-state pharmacy -- Permit -- Requests for information -- Records -- Toll-free telephone service -- Pharmacist on duty -- Requirements for out-of-state pharmacy doing business through the Internet -- Application to sale or distribution of dialysate solution or devices (1) Except as provided in subsection (2) of this section: (a) Every person or pharmacy located outside this Commonwealth which does business, physically or by means of the Internet, facsimile, phone, mail, or any other means, inside this Commonwealth within the meaning of KRS Chapter 315, shall hold a current pharmacy permit as provided in KRS 315.035(1) and (4) issued by the Kentucky Board of Pharmacy. The pharmacy shall be designated an "out -of-state pharmacy" and the permit shall be designated an "out-of-state pharmacy permit." The fee for the permit shall not exceed the current in-state pharmacy permit fee as provided under KRS 315.035; (b) Every out-of-state pharmacy granted an out-of-state pharmacy permit by the board shall disclose to the board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescription drugs to residents of the Commonwealth. A report containing this information shall be made to the board on an annual basis and within thirty (30) days after any change of office, corporate officer, or pharmacist; (c) Every out-of-state pharmacy granted an out-of-state pharmacy permit shall comply with all statutorily-authorized directions and requests for information from any regulatory agency of the Commonwealth and from the board in accordance with the provisions of this section. The out -of-state pharmacy shall maintain at all times a valid unexpired permit, license, or registration to conduct the pharmacy in compliance with the laws of the jurisdiction in which it is a resident. As a prerequisite to seeking a permit from the Kentucky Board of Pharmacy, the out-of-state pharmacy shall submit a copy of the most recent inspection report resulting from an inspectio n conducted by the regulatory or licensing agency of the jurisdiction in which it is located. Thereafter, the out - of-state pharmacy granted a permit shall submit to the Kentucky Board of Pharmacy a copy of any subsequent inspection report on the pharmacy conducted by the regulatory or licensing body of the jurisdiction in which it is located; (d) Every out-of-state pharmacy granted an out-of-state pharmacy permit by the board shall maintain records of any controlled substances or dangerous drugs or devices dispensed to patients in the Commonwealth so that the records are readily retrievable from the records of other drugs dispensed; (e) Records for all prescriptions delivered into Kentucky shall be readily retrievable from the other prescription records of t he out-of-state pharmacy; (f) Each out-of-state pharmacy shall, during its regular hours of operation, but not less than six (6) days per week and for a minimum of forty (40) hours per week, provide a toll-free telephone service directly to the pharmacist in charge of the out-of-state pharmacy and available to both the patient and each licensed and practicing in-state pharmacist for the purpose of facilitating communication between the patient and the Kentucky pharmacist with access to the patient's prescription records. A toll-free number shall be placed on a label affixed to each container of drugs dispensed to patients within the Commonwealth; (g) Each out-of-state pharmacy shall have a pharmacist in charge who is licensed to engage in the practice of pharmacy by the Commonwealth that shall be responsible for compliance by the pharmacy with the provisions of this section and for the distribution and sale of dialysate solutions and devices pursuant to subsection (2) of this section; (h) Each out-of-state pharmacy shall comply with KRS 218A.202; (i) Any out-of-state pharmacy that dispenses more than twenty-five percent (25%) of its total prescription volume as a result of an original prescription order received or solicited by use of the Internet, including but not limited to electronic mail, shall receive and display in every medium in which it advertises itself a seal of approval for the National Association of Boards of Pharmacy certifying that it is a Verified Internet Pharmacy Practice Site (VIPPS) or a seal certifying approval of a substantially similar program approved by the Kentucky Board of Pharmacy. VIPPS, or any other substantially similar accreditation, shall be maintained and remain current; (j) Any out-of-state pharmacy doing business in the Commonwealth of Kentucky shall certify the percentage of its annual business conducted via the Internet and electronic mail and submit such supporting documentation as requested by the board, and in a form or application required by the board, when it applies for permit or renewal; (k) Any pharmacy doing business within the Commonwealth of Kentucky shall use the address on file with the Kentucky Board of Pharmacy as the return address on the labels of any package shipped into or within the Commonwealth. The return address shall be placed on the package in a clear and prominent manner; and (l) The Kentucky Board of Pharmacy may waive the permit requirements of this chapter for an out-of-state pharmacy that only does business within the Commonwealth of Kentucky in limited transactions. (2) (a) Only subsection (1)(g) of this section shall apply to the sale or distribution of dialysate solutions or devices necessary to perform home peritoneal kidney dialysis to patients with end-stage renal disease, if: 1. The dialysate solutions or devices are approved or cleared by the federal Food and Drug Administration, as required by federal law; 2. The dialysate solutions or devices are lawfully held by a manufacturer or manufacturer's agent that is properly registered with or licensed by the board as a manufacturer, wholesale distributer, or third-party logistics provider under this chapter; 3. The dialysate solutions or devices are held and delivered in their original, sealed packaging from a Food and Drug Administration- approved manufacturing facility; 4. The dialysate solutions or devices are only delivered upon receipt of a physician's prescription by a Kentucky licensed pharmacy and the transmittal of an order from the Kentucky licensed pharmacy to the manufacturer or manufacturer's agent; and 5. The manufacturer or manufacturer's agent delivers the dialysate solutions or devices directly to: a. A patient with end-stage renal disease or the patient's designee for the patient's self-administration of dialysis therapy; or b. A health-care provider or institution for administration or delivery of dialysis therapy to a patient with end -stage renal disease. (b) 1. A manufacturer or manufacturer's agent who sells or distributes dialysate solutions or devices under this subsection shall employ or contract with a pharmacist who is licensed to engage in the practice of pharmacy by the Commonwealth to conduct a retrospective audit on ten percent (10%) of the orders processed by that ma nufacturer or manufacturer's agent each month. 2. On or before February 1 of each year, an annual summary of the monthly audits shall be prepared and submitted to the board, in the form prescribed by the board. 3. On or before June 1 of each year, the boar d shall compile the summaries of monthly audits into a single report and submit that report to the Interim Joint Committee on Health Services. (c) Prescriptions and records of delivery for dialysate solutions or devices sold or distributed under this subsection shall be maintained by the manufacturer or manufacturer's agent for a minimum of two (2) years and shall be made available to the board upon request. (d) As used in this subsection, "dialysate solutions" means dextrose or icodextrin when used to perform home peritoneal kidney dialysis. (e) The Kentucky Board of Pharmacy will retain oversight of the distribution of dialysate solutions and devices under this section. Effective: June 29, 2023 History: Amended 2023 Ky. Acts ch. 25, sec. 34, effective June 29, 2023. -- Amended 2019 Ky. Acts ch. 157, sec. 1, effective June 27, 2019. -- Amended 2007 Ky. Acts ch. 124, sec. 10, effective June 26, 2007. -- Amended 2005 Ky. Acts ch. 150, sec. 20, effective June 20, 2005. -- Amended 2004 Ky. Acts ch. 107, sec. 4, effective July 13, 2004. -- Created 1990 Ky. Acts ch. 155, sec. 1, effective July 13, 1990.

KRS 315.400 Definitions for KRS 315.400 to 315.412

315.400. Definitions for KRS 315.400 to 315.412 As used in KRS 315.400 to 315.412: (1) "Authorized distributor of record" means a wholesale distributor that: (a) Has established an ongoing relationship with a manufacturer to distribute the manufacturer's prescription drug. An ongoing relationship exists between a wholesale distributor and a manufacturer if the wholesale distributor, including any affiliated group of the wholesale distributor as defined in Section 1504 of the Internal Revenue Code, has a written agreement for distribution in effect; and (b) Is listed on the manufacturer's current list of authorized distributors of record; (2) "Co-licensed product" means a prescription drug manufactured by two (2) or more co-licensed partners; (3) "Counterfeit prescription drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed the drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, the other drug manufacturer, processor, packer, or distributor; (4) "Dispenser" means: (a) A retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouse distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; but (b) Does not include a person who dispenses only products to be used in animals in accordance with 21 U.S.C. sec. 360b(a)(4) and (5); (5) "Distribution" or "distribute" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with Section 503(b)(1) of the federal Drug Quality and Security Act or the dispensing of a product approved under Section 512(b) of the federal Drug Quality and Security Act; (6) "Drop shipment" means a product not physically handled or stored by a wholesale distributor and that is exempt from Section 582 of the federal Drug Quality and Security Act, except the notification requirements under clauses (ii), (iii), and (iv) of subsection (c)(4)(B) of Section 582 of the federal Drug Quality and Security Act, provided that the manufacturer, repackager, or other wholesale distributor that distributes the product to the dispenser by means of a drop shipment for the wholesale distributor includes on the transaction information and transaction history to the dispenser the contact information of the wholesale distributor and provides the transaction information, transaction history, and transaction statement directly to the dispenser. Providing administrative services, including the processing of orders and payments, shall not by itself be construed as being involved in the handling, distribution, or storage of a product; (7) "Emergency medical reasons" includes but is not limited to: (a) Transfers of a prescription drug between health-care entities or between a health-care entity and a retail pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruptions of the regular distribution schedules; (b) Sales of drugs for use in the treatment of acutely ill or injured persons to nearby emergency medical services providers, firefighting organizations, or licensed health-care practitioners in the same marketing or service area; (c) The provision of emergency supplies of drugs to nearby nursing homes, home health agencies, or hospice organizations for emergency use when necessary drugs cannot be obtained; or (d) Transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage; (8) "End user" means a patient or consumer that uses a prescription drug as prescribed by an authorized health-care professional; (9) "Exclusive distributor" means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser; (10) "FDA" means the United States Food and Drug Administration and any successor agency; (11) "Illegitimate product" means a product for which credible evidence shows that the product: (a) Is counterfeit, diverted, or stolen; (b) Is intentionally adulterated so that the product would result in serious adverse health consequences or death to humans; (c) Is the subject of a fraudulent transaction; or (d) Appears otherwise unfit for distribution so that the product would be reasonably likely to result in serious adverse health consequences or death to humans; (12) "Manufacturer" means the same as defined in KRS 315.010; (13) "Medical gas wholesaler" means a person licensed to distribute, transfer, wholesale, deliver, or sell medical gases on drug orders to suppliers or other entities licensed to use, administer, or distribute medical gas; (14) "Pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of prescription drugs to a group of pharmacies under common ownership and control; (15) "Prescription drug" means the same as defined in KRS 315.010; (16) "Repackager" means a person who owns or operates an establishment that repacks and relabels a product or package for further sale, or distribution without a further transaction; (17) "Reverse distributor" means every person who acts as an agent for pharmacies, drug wholesalers, manufacturers, or other entities by receiving, taking inventory, and managing the disposition of outdated or nonsalable drugs; (18) "Third-party logistics provider" means an entity that contracts with a manufacturer, wholesale distributor, repackager, or dispenser to provide and coordinate warehousing or other logistics services on behalf of a manufacturer, wholesale distributor, repackager, or dispenser, but does not take title to the drug or have responsibility to direct the sale of the drug. A third-party logistics provider shall be considered as part of the normal distribution channel; (19) "Transaction" means the transfer of product between persons in which a change of ownership occurs, with the following exemptions: (a) Intracompany distribution of any product between members of an affiliate or within a manufacturer; (b) The distribution of a product among hospitals or other health care entities that are under common control; (c) The distribution of a product for emergency medical reasons, including a public health emergency declaration pursuant to Section 319 of the federal Public Health Service Act, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason; (d) The dispensing of a product pursuant to a prescription executed in accordance with Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act; (e) The distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with Section 503(d) of the Federal Food, Drug, and Cosmetic Act; (f) The distribution of blood or blood components intended for transfusion; (g) The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use; (h) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (i) The distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors; (j) The dispensing of a product approved under Section 512(c) of the Federal Food, Drug, and Cosmetic Act; (k) Products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by the state pursuant to an agreement with the commission under Section 274 of the federal Atomic Energy Act, 42 U.S.C. sec. 2021; (l) A combination product that is not subject to approval under Section 505 of the federal Drug Quality and Security Act or licensure under Section 351 of the federal Public Health Service Act, and that is: 1. A product composed of a device and one (1) or more other regulated components such as a drug or drug device, a biologic or biologic device, or a drug and biologic or drug and biologic device that are physically, chemically, or otherwise combined or mixed and produced as a single entity; 2. Two (2) or more separate products packaged together in a single package or as a unit and composed of a drug and device or device and biological product; or 3. Two (2) or more finished medical devices plus one (1) or more drug or biological products that are packaged together in what is referred to as a medical convenience kit as described in paragraph (m) of this subsection; (m) The distribution of a medical convenience kit or collection of finished medical devices which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user, if: 1. The medical convenience kit is assembled in an establishment that is registered with the federal Food and Drug Administration as a device manufacturer in accordance with Section 510(b)(2) of the Federal Food, Drug, and Cosmetic Act; 2. The medical convenience kit does not contain a controlled substance that appears in a schedule contained in the federal Comprehensive Drug Abuse Prevention and Control Act of 1970; 3. In the case of a medical convenience kit that includes a product, the person that manufacturers the kit: a. Purchased the product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and b. Does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and 4. In the case of a medical convenience kit that includes a product, the product is: a. An intravenous solution intended for the replenishment of fluids and electrolytes; b. A product intended to maintain the equilibrium of water and minerals in the body; c. A product intended for irrigation or reconstitution; d. An anesthetic; e. An anticoagulant; f. A vasopressor; or g. A sympathomimetic; (n) The distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes such as sodium, chloride, and potassium, or calories such as dextrose and amino acids; (o) The distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; (p) The distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection; (q) The distribution of a medical gas as defined in Section 575 of the Federal Food, Drug, and Cosmetic Act; or (r) The distribution or sale of any licensed product under Section 351 of the federal Public Health Service Act that meets the definition of a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act; (20) "Wholesale distribution" means the distribution of a prescription drug to persons other than an end user or to the end user pursuant to KRS 315.0351(2), but does not include: (a) Intracompany sales or transfers; (b) The sale, purchase, distribution, trade, or transfer of a prescription drug for emergency medical reasons; (c) The distribution of prescription drug samples by a manufacturer or authorized distributor; (d) Drug returns or transfers to the original manufacturer, original wholesale distributor, or transfers to a reverse distributor or third-party returns processor; (e) The sale, purchase, or trade of a drug pursuant to a prescription; (f) The delivery of a prescription drug by a common carrier; (g) The purchase or acquisition by a health-care entity or pharmacy that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization, or health-care entities or pharmacies that are members of the group organization; (h) The sale, purchase, distribution, trade, or transfer of a drug by a charitable health-care entity to a nonprofit affiliate of the organization as otherwise permitted by law; (i) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy with another pharmacy or pharmacies; or (j) The distribution of a prescription drug to a health-care practitioner or to another pharmacy if the total number of units transferred during a twelve (12) month period does not exceed five percent (5%) of the total number of all units dispensed by the pharmacy during the immediate twelve (12) month period; and (21) "Wholesale distributor" or "virtual wholesale distributer" means a person other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or repackager engaged in wholesale distribution as defined by 21 U.S.C. sec. 353(e)(4) as amended by the federal Drug Supply Chain Security Act. Effective: June 27, 2019 History: Amended 2019 Ky. Acts ch. 157, sec. 3, effective June 27, 2019. -- Amended 2017 Ky. Acts ch. 136, sec. 4, effective June 29, 2017. -- Created 2008 Ky. Acts ch. 124, sec. 3, effective July 15, 2008.

KRS 315.402 Licensure of wholesale distributors of prescription drugs -- Record retention -- Administrative regulations -- Confidentiality

315.402. Licensure of wholesale distributors of prescription drugs -- Record retention -- Administrative regulations -- Confidentiality (1) A wholesale distributor shall be licensed by the board under this section prior to engaging in the wholesale distribution of prescription drugs in the Commonwealth. Each license application shall be accompanied by a reasonable fee prescribed by administrative regulation not to exceed two hundred fifty dollars ($250) annually or increase more than twenty-five dollars ($25) per year. (2) A wholesale distributor shall be required to maintain accurate records of all drugs handled in accordance with KRS 315.400 to 315.412, and records shall be made available to agents of the board for inspection upon request. (3) Licensing requirements that exceed the requirements of federal law shall not apply to a manufacturer distributing its own FDA-approved drugs or co-licensed products, unless there is reasonable cause to believe that the manufacturer presents a special risk of distributing counterfeit prescription drugs in the Commonwealth. (4) Failure to report to the board or willful submission of inaccurate information shall be grounds for disciplinary action under the provisions of KRS 315.131. (5) The board shall promulgate an administrative regulation pursuant to KRS Chapter 13A to specify the criteria for licensure in conformity with the guidelines for state licensure of a wholesale prescription drug distributor issued by the FDA. (6) Pursuant to KRS 61.878, information provided by an applicant under this section and any related administrative regulation shall not be disclosed to any person or entity other than the board. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 4, effective July 15, 2008.

KRS 315.404 Returns or exchanges of prescription drugs

315.404. Returns or exchanges of prescription drugs (1) (a) A wholesale distributor may receive prescription drug returns or exchanges from a pharmacy, pharmacy warehouse, or other person authorized to distribute a prescription drug to an end user under the terms and conditions of an agreement between the parties. (b) Returns of expired, damaged, recalled, or otherwise nonsalable prescription drugs shall be distributed by the receiving wholesale distributor only to the original manufacturer, a third-party returns processor, or a reverse distributor licensed as a wholesale distributor. (c) Returns or exchanges of prescription drugs that may or may not be salable, including any redistribution by a receiving wholesaler, shall not be subject to the requirements of KRS 315.406 if they are exempt from the pedigree requirements of the federal regulations for the federal Prescription Drug Marketing Act of 1987 as amended by the Prescription Drug Amendments of 1992 and any amendments thereto. (2) A manufacturer or wholesale distributor shall supply prescription drugs only to a person or entity licensed to possess or distribute prescription drugs to an end user. (3) Prescription drugs supplied by a manufacturer or wholesale distributor shall be delivered only to the business address of the licensee or the address listed on the license, to the address of a health-care entity authorized by the licensee, or to an authorized person or agent of the licensee at the premises of the manufacturer or wholesale distributor if the identity and authority of the authorized agent is established. (4) A licensed wholesale distributor, pharmacy, or other person authorized by law to furnish prescription drugs to an end user shall be accountable for their returns process and shall ensure that all aspects of their operations are secure and do not permit the entry of adulterated or counterfeit prescription drugs. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 5, effective July 15, 2008.

KRS 315.406 Prescription drug pedigree for drugs leaving normal distribution channel - - Administrative regulations

315.406. Prescription drug pedigree for drugs leaving normal distribution channel - - Administrative regulations (1) (a) As of the date specified by an administrative regulation promulgated by the board pursuant to KRS Chapter 13A, each person or entity engaged in the wholesale distribution of prescription drugs that leave or that have ever left the normal distribution channel shall, prior to the distribution of the prescription drug, provide a pedigree to the person receiving the prescription drug. (b) A retail pharmacy or a pharmacy warehouse shall comply with paragraph (a) of this subsection only if it engages in wholesale distribution of prescription drugs. (2) The board shall specify the requirements for the contents and maintenance of a pedigree that are consistent with the federal requirements. (3) The board shall promulgate an administrative regulation pursuant to KRS Chapter 13A to implement the provisions of this section no later than one hundred eighty (180) days after July 15, 2008. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 6, effective July 15, 2008.

KRS 315.408 Electronic track and trace system

315.408. Electronic track and trace system (1) The board shall not require the use of an electronic track and trace system to initiate, provide, receive, or maintain a pedigree by a person or entity licensed to possess, distribute, dispense, or administer prescription drugs for use by an end user until the FDA develops and implements standards for identification, validation, authentication, and tracking and tracing of prescription drugs pursuant to 21 U.S.C. sec. 355e. The electronic track and trace system requirements by the board shall meet the FDA's standards for all prescription drugs covered by the FDA standards. (2) Upon implementation of FDA standards for an electronic track and trace system, the requirements relating to a pedigree in KRS 315.406 shall be superseded by the FDA standards and shall not apply to any prescription drugs specified in the FDA standards. (3) Prior to promulgation of any administrative regulation under KRS Chapter 13A that requires the use of an electronic track and trace system, the board shall consult with manufacturers, wholesale distributors, and pharmacies regarding implementation of the electronic track and trace system requirements and publish a report on its Web site about implementation issues, including but not limited to universal availability, technical and operational feasibility, and reliability for manufacturers, wholesale distributors, and pharmacies. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 7, effective July 15, 2008.

KRS 315.410 Order to cease distribution of prescription drugs -- Hearing

315.410. Order to cease distribution of prescription drugs -- Hearing (1) The board shall issue an order to the appropriate person or entity, including but not limited to wholesale distributors or retailers, to immediately cease distribution of prescription drugs within the Commonwealth if there are reasonable grounds to believe: (a) 1. The distribution of the prescription drug is in violation of KRS 315.406; 2. The prescription drug is accompanied by a falsified pedigree in violation of KRS 315.406; or 3. The prescription drug is a counterfeit prescription drug; and (b) Other procedures to intercede would result in an unreasonable delay. (2) A person in receipt of an order to cease distribution shall be notified in writing of the right to an administrative hearing to be conducted in accordance with KRS Chapter 13B no later than ten (10) days, excluding weekends and holidays, after the date of the order. If, after a hearing is conducted, the hearing officer determines that there are inadequate grounds to support the order, the order shall be vacated. Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 8, effective July 15, 2008.

KRS 315.412 Penalties for violation of KRS 315.400 to 315.410

315.412. Penalties for violation of KRS 315.400 to 315.410 (1) A person engaged in the wholesale distribution of prescription drugs who unknowingly violates any provision of KRS 315.400 to 315.410 may be fined not more than five thousand dollars ($5,000). (2) A person engaged in the wholesale distribution of prescription drugs who acts with gross negligence and violates any provision of KRS 315.400 to 315.410 may be fined not more than fifteen thousand dollars ($15,000). (3) A person engaged in the wholesale distribution of prescription drugs who knowingly violates any provision of KRS 315.400 to 315.410 may be fined not more than one hundred thousand dollars ($100,000). Effective: July 15, 2008 History: Created 2008 Ky. Acts ch. 124, sec. 9, effective July 15, 2008.

KRS 315.450 Definitions for KRS 315.450 to 315.460

315.450. Definitions for KRS 315.450 to 315.460 For the purposes of KRS 315.450 to 315.460: (1) "Controlled substance" has the same meaning as in KRS 218A.010; (2) "Dispense" has the same meaning as in KRS 217.015; (3) "Health care provider" has the same meaning as in KRS 304.17A-005; (4) "Health facility" has the same meaning as in KRS 216B.015; (5) "Legend drug" has the same meaning as in KRS 217.015; (6) "Pharmacist" has the same meaning as in KRS 315.010; and (7) "Prescription drug" has the same meaning as in KRS 315.010. Effective:June 29, 2017 History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 12, effective June 29, 2017 -- Created 2005 Ky. Acts ch. 136, sec. 1, effective June 20, 2005. Formerly codified as KRS 194A.450.

KRS 315.452 Legend Drug Repository Program to be established -- Purpose -- Permitted donations -- Voluntary participation -- Handling fee -- Distribution

315.452. Legend Drug Repository Program to be established -- Purpose -- Permitted donations -- Voluntary participation -- Handling fee -- Distribution (1) The board shall establish and maintain a legend drug repository program to support the donation of a legend drug or supplies needed to administer a legend drug for use by an individual who meets the eligibility criteria specified by an administrative regulation promulgated by the board. The repository program shall not accept any controlled substance. (2) Donations may be made on the premises of a health facility or pharmacy that elects to participate in the program and meets requirements specified by the board by an administrative regulation promulgated by the board. (3) The health facility may charge a handling fee to an individual who received a legend drug or supplies under the program established under this section, except that the fee shall not exceed the amount established by an administrative regulation promulgated by the board. (4) A health facility or pharmacy that receives a donated legend drug under this section may distribute the legend drug or supplies to another eligible health facility or pharmacy for use under the program created under this section. (5) Nothing in this section or KRS 315.454 shall require a health facility, pharmacy, pharmacist, or practitioner to participate in the program established in this section. Effective:June 29, 2017 History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 13, effective June 29, 2017 -- Created 2005 Ky. Acts ch. 136, sec. 2, effective June 20, 2005. Legislative Research Commission Note (6/20/2015). 2005 Ky. Acts chs. 11, 85, 95, 97, 98, 99, 123, and 181 instruct the Reviser of Statutes to correct statutory references to agencies and officers whose names have been changed in 2005 legislation confirming the reorganization of the executive branch. Such a correction has been made in this section. Formerly codified as KRS 194A.452.

KRS 315.454 Requirements for accepting and dispensing legend drug or administration supplies

315.454. Requirements for accepting and dispensing legend drug or administration supplies (1) A legend drug or supplies used to administer a legend drug may be accepted and dispensed under the program established in KRS 315.452 only if the following requirements are met: (a) The legend drug or supplies needed to administer the legend drug is in its original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened; (b) The legend drug is not classified as a controlled substance; (c) The legend drug or supplies needed to administer a legend drug is not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the health facility or pharmacy, who shall inspect the drug or supplies needed to administer a legend drug before the drug or supplies are dispensed; and (d) The legend drug or supplies needed to administer a legend drug are prescribed by a physician, advanced practice registered nurse, or physician assistant and dispensed by a pharmacist. (2) No legend drug or supplies needed to administer a legend drug that are donated for use under this section may be resold. Effective:June 29, 2017 History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 14, effective June 29, 2017 -- Amended 2010 Ky. Acts ch. 85, sec. 32, effective July 15, 2010 -- Created 2005 Ky. Acts ch. 136, sec. 3, effective June 20, 2005. Formerly codified as KRS 194A.454.

KRS 315.456 Immunity from civil liability -- Exceptions

315.456. Immunity from civil liability -- Exceptions (1) Unless the manufacturer of a legend drug or supply needed to administer a legend drug exercises bad faith or fails to exercise ordinary care, the manufacturer of a legend drug or supply shall not be subject to criminal or civil liability for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of the drug or supply under the legend drug repository created under KRS 315.452, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug or supply. (2) Health facilities, pharmacies, and health care providers shall be immune from civil liability for injury to or the death of an individual to whom a legend drug or supply is dispensed and shall not be subject to disciplinary action for unprofessional conduct for their acts or omissions related to donating, accepting, distributing, or dispensing a legend drug or supply under KRS 315.450 to 315.460, unless the act or omission involves reckless, wanton, or intentional misconduct or the act or omission results from failure to exercise ordinary care. Effective:June 29, 2017 History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 15, effective June 29, 2017 -- Created 2005 Ky. Acts ch. 136, sec. 4, effective June 20, 2005. Formerly codified as KRS 194A.456.

KRS 315.458 Required administrative regulations

315.458. Required administrative regulations The board shall promulgate administrative regulations to establish: (1) The requirements for health facilities and pharmacies to accept and dispense donated legend drugs or supplies needed to administer legend drugs under KRS 315.452 and 315.454, including all of the following: (a) Eligibility criteria for health facilities; (b) Standards and procedures for accepting, safely storing, and dispensing donated legend drugs or supplies needed to administer legend drugs; (c) Standards and procedures for inspecting donated legend drugs or supplies needed to administer legend drugs to determine if these are in their original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened; and (d) Standards and procedures for inspecting donated legend drugs or supplies needed to administer legend drugs to determine that these are not adulterated or misbranded; (2) Eligibility criteria for individuals to receive donated legend drugs or supplies needed to administer legend drugs dispensed under KRS 315.452 and 315.454; (3) Standards for prioritizing the dispensation to individuals who are uninsured or indigent, or to others if an uninsured or indigent individual is unavailable; (4) A means by which an individual who is eligible to receive a donated legend drug or supplies needed to administer a legend drug may indicate that eligibility; (5) Necessary forms for administration of the legend drug repository program; (6) The maximum handling fee that a health facility may charge for accepting, distributing, or dispensing donated legend drugs or supplies needed to administer legend drugs; (7) A list of legend drugs and supplies needed to administer legend drugs that the legend drug repository program may accept for dispensing; and (8) A list of legend drugs and supplies needed to administer legend drugs that the legend drug repository program shall not accept for dispensing, including the reason why the legend drug or supply is ineligible for donation. Effective:June 29, 2017 History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 16, effective June 29, 2017 -- Created 2005 Ky. Acts ch. 136, sec. 5, effective June 20, 2005. Legislative Research Commission (6/20/2015). 2005 Ky. Acts chs. 11, 85, 95, 97, 98, 99, 123, and 181 instruct the Reviser of Statutes to correct statutory references to agencies and officers whose names have been changed in 2005 legislation confirming the reorganization of the executive branch. Such a correction has been made in this section. Formerly codified as KRS 194A.458.

KRS 315.460 Restriction on acceptance or distribution of certain drugs

315.460. Restriction on acceptance or distribution of certain drugs Drugs that shall only be dispensed to a patient registered with the drug's manufacturer in accordance with federal Food and Drug Administration requirements shall not be accepted or distributed under the provisions of the program. Effective: June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 17, effective June 29, 2017.

KRS 315.500 Emergency authority for pharmacists during state of emergency -- Executive order -- Time limit -- Actions authorized -- Extension

315.500. Emergency authority for pharmacists during state of emergency -- Executive order -- Time limit -- Actions authorized -- Extension (1) When the Governor declares a state of emergency pursuant to KRS 39A.100, the Governor may issue an executive order for a period of up to thirty (30) days giving pharmacists emergency authority. The executive order shall designate the geographical area to which it applies. In the executive order, the Governor may vest pharmacists with the authority to: (a) Dispense up to a thirty (30) day emergency supply of medication; (b) Administer immunizations to children pursuant to protocols established by the Centers for Disease Control and Prevention, the National Institutes of Health, or the National Advisory Committee on Immunization Practices or determined to be appropriate by the commissioner of public health or his or her designee; (c) Operate temporarily, a pharmacy in an area not designated on the pharmacy permit; and (d) Dispense drugs as needed to prevent or treat the disease or ailment responsible for the emergency pursuant to protocols established by the Centers for Disease Control and Prevention or the National Institutes of Health or determined to be appropriate by the commissioner of public health or his or her designee to respond to the circumstances causing the emergency. (2) The provisions of this section may be extended, in writing, by the Governor if necessary to protect the lives or welfare of the citizens. (3) Nothing in this section shall be affected by the requirements of KRS 39A.090. Effective:February 2, 2021 History: Amended 2021 Ky. Acts ch. 6, sec. 8, effective February 2, 2021. -- Created 2010 Ky. Acts ch. 22, sec. 1, effective July 15, 2010.

KRS 315.505 Administrative regulations to effectuate authority granted in KRS 315.500(1)

315.505. Administrative regulations to effectuate authority granted in KRS 315.500(1) The Kentucky Board of Pharmacy may promulgate administrative regulations in accordance with KRS Chapter 13A to allow pharmacists to effectuate the authority granted in KRS 315.500(1). Effective: July 15, 2010 History: Created 2010 Ky. Acts ch. 22, sec. 2, effective July 15, 2010.

KRS 315.990 Penalties -- Extradition

315.990. Penalties -- Extradition (1) Except for the provisions of KRS 315.320, any person violating any provision of KRS Chapter 315 shall be fined for each offense not less than one hundred dollars ($100) nor more than one thousand dollars ($1,000) or imprisoned in the county jail for not more than six (6) months, or both. Each week that any provision of KRS 315.020, 315.030, or 315.035 is violated shall also constitute a separate offense. (2) Any person convicted of willfully resisting, preventing, impeding, obstructing, threatening, or interfering with the officers, agents, or inspectors of the board in the administration of the provisions of this chapter shall be guilty of a Class A misdemeanor. (3) The board may levy an administrative fine not to exceed five thousand dollars ($5,000) for each offense, for any violation of KRS 315.121. All such fines shall be deposited to the credit of the licensing board to be used by the board in carrying out the provisions of this chapter. (4) The board may refuse to issue or renew a permit, or may suspend, temporarily suspend, revoke, fine, or reasonably restrict any permit holder for any violation of KRS 315.0351. Any administrative fine levied by the board shall not exceed five thousand dollars ($5,000) for any violation of KRS 315.0351. All such fines shall be deposited to the credit of the licensing board to be used by the Board of Pharmacy in carrying out the provisions of this chapter. (5) For a violation of KRS 315.320, the Board of Pharmacy may, in addition to any other civil or criminal penalty, levy an administrative fine not exceeding one hundred thousand dollars ($100,000). All such fines shall be deposited to the credit of the Board of Pharmacy in carrying out the provisions of this chapter. (6) (a) Any person who intentionally, knowingly, or recklessly violates KRS 216B.200 to 216B.210 is guilty of a Class D felony. (b) Any person who violates KRS 216B.200 to 216B.210 shall be fined not more than one million dollars ($1,000,000). (c) Notwithstanding KRS 440.200, the Attorney General may demand from the Governor of any other state the surrender of any person found in the other state who is charged in Kentucky with the crime of violating KRS 216B.200 to 216B.210. The provisions for extradition under this subsection shall apply to any such demand even if the person whose surrender is demanded was not in Kentucky at the time of the commission of the crime. Neither the demand, the oath, nor any proceedings for extradition pursuant to this section need state or show that the person whose surrender is demanded has fled from justice, or at the time of the commission of the crime was in Kentucky or the other state. Effective:April 14, 2022 History: Amended 2022 Ky. Acts ch. 210, sec. 28, effective April 14, 2022. -- Amended 2005 Ky. Acts ch. 150, sec. 21, effective June 20, 2005. -- Amended 1996 Ky. Acts ch. 257, sec. 24, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 155, sec. 2, effective July 13, 1990. -- Amended 1982 Ky. Acts ch. 191, sec. 20, effective July 15, 1982. -- Amended 1970 Ky. Acts ch. 221, sec. 18. -- Amended 1950 Ky. Acts ch. 16, sec. 1. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. secs. 1376t-1, 2619, 2620, 2625, 2628. Legislative Research Commission Note (4/14/2022). This statute was amended by 2022 Ky. Acts ch. 210, sec. 28. Section 38 of that Act states, "Sections 1 to 31 of this Act may be cited as the Humanity in Healthcare Act of 2022."

KRS 315.991 Repealed, 1982

315.991. Repealed, 1982 Catchline at repeal: Penalties. History: Repealed 1982 Ky. Acts ch. 191, sec. 21, effective July 15, 1982. -- Created 1966 Ky. Acts ch. 260, sec. 12.

KRS 315.4102 License required for each facility of a third-party logistics provider

315.4102. License required for each facility of a third-party logistics provider (1) Each facility of a third-party logistics provider located within Kentucky shall be licensed by the board prior to shipping a prescription drug: (a) Within the borders of Kentucky; or (b) To a location outside the borders of Kentucky. (2) Licenses issued under subsection (1) of this section shall be renewed annually upon: (a) Completion of an application; and (b) Payment of a renewal fee as established by administrative regulations promulgated by the board. (3) A third-party logistics provider located in another state seeking to ship a prescription drug into Kentucky shall provide documentation upon request by the by the board or its staff that the third-party logistics provider is licensed as a third-party logistics provider by: (a) The state from which the third-party logistics provider ships, if that state licenses third-party logistics providers; or (b) The United States Food and Drug Administration. (4) A third-party logistics provider license shall be valid only for the name, ownership, and location listed on the license. Changes of name, ownership, or location shall require a new third-party logistics provider license. (5) Changes in information required for licensure shall be reported to the board, in writing, within ten (10) days of the change. (6) A third-party logistics provider shall not operate from a place of residence. (7) A third-party logistics provider facility shall be located apart and separate from any retail pharmacy licensed by the board. (8) A third-party logistics provider shall publicly display all licenses and have the most recent state and federal inspection reports readily available. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 5, effective June 29, 2017.

KRS 315.4104 Required license application information and fee for third-party logistics provider

315.4104. Required license application information and fee for third-party logistics provider (1) An applicant for licensure as a third-party logistics provider shall submit a satisfactorily completed board-approved application along with the required fee. New applicants shall provide, at minimum, the following: (a) The applicant's full name, all trade or business names used, full business address, and telephone number; (b) Type of ownership, whether individual, partnership, limited liability company, or corporation; (c) Name of the owner or owners, including: 1. If a person, the name, address, Social Security number, and date of birth; 2. If other than a person, the name, address, Social Security number, and date of birth of each partner, limited liability company member, or corporate officer and corporate director, and the federal employer identification number; 3. If a corporation, the state of incorporation; and 4. If a publicly traded corporation, the information described in subparagraph 2. of this paragraph is not required for corporate officers and corporate directors; and (d) Upon the board's written request, a list of all manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services. (2) The board may use a board-approved outside agency, if permitted by federal law, to inspect third-party logistics providers. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 6, effective June 29, 2017.

KRS 315.4106 Eligibility factors for initial licensure and renewal for third-party logistics provider

315.4106. Eligibility factors for initial licensure and renewal for third-party logistics provider (1) The board shall consider, at a minimum, the following factors in determining the eligibility for initial licensure and renewal of third-party logistics providers: (a) A finding by a law enforcement agency or regulatory agency that the applicant or any owners of an applicant has violated federal, state, or local laws; (b) Suspension, revocation, or any other sanction against a license currently or previously held by the applicant or any of its owners for a violation of federal or state law; (c) A finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating federal, state, or local laws; (d) The furnishing by the applicant of false or fraudulent material in any application; (e) Failure to maintain or make available to the board or to federal, state, or local law enforcement officials the records required to be maintained by third-party logistics providers; and (f) Any other factors or qualifications that the board considers relevant to and consistent with the public health and safety. Any factors inconsistent with federal standards shall not be applied. (2) A licensee who has no record of providing third-party logistics services involving prescription drugs during a routine inspection may have its subsequent renewal application referred to the board for review and possible discipline, and the board may require the licensee to appear before the board at the review. (3) A third-party logistics provider shall have and follow a diversion detection and loss prevention plan that includes all prescription drugs, which shall be immediately available to the board or its agents upon request. (4) The board shall have the right to deny licensure if it determines that granting the license would not be consistent with public health and safety. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 7, effective June 29, 2017.

KRS 315.4108 List of owners and designated representatives of third-party logistics provider subject to board inspection -- Persons disqualified from being owner or designated representative

315.4108. List of owners and designated representatives of third-party logistics provider subject to board inspection -- Persons disqualified from being owner or designated representative (1) Third-party logistics providers shall establish and maintain for board inspection a list of each partner, limited liability company member, and corporate officer and director, including a description of the duties and the qualifications of each. (2) A third-party logistics provider shall not have as an owner or designated representative anyone convicted of a felony for conduct relating to: (a) Providing third-party logistics services involving prescription drugs; (b) A violation of 21 U.S.C. sec. 331(i) or (k); or (c) A violation of 18 U.S.C. sec. 1365 relating to product tampering. (3) A third-party logistics provider shall not have, as an owner or designated representative, anyone who has violated federal or state requirements for third-party logistics provider licensure and presented a threat of serious adverse health consequences or death to humans. Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 8, effective June 29, 2017.

KRS 315.4110 Third-party logistics provider must comply with all laws and regulations -- Inspection access required -- Penalty for noncompliance

315.4110. Third-party logistics provider must comply with all laws and regulations -- Inspection access required -- Penalty for noncompliance (1) A third-party logistics provider shall operate in compliance with all applicable federal, state, and local laws and regulations, including but not limited to: (a) The Drug Supply Chain Security Act of 2013 and rules promulgated thereunder; and (b) The storage practices set out in 21 U.S.C. sec. 360eee-3(d)(2)(C). (2) A third-party logistics provider shall allow the board and authorized federal, state, and local law enforcement officials to enter and inspect its premises and delivery vehicles, to audit its records and written operating procedures, and to confiscate prescription drugs and records to the extent authorized by law, rule, or regulation. (3) Failure to operate in compliance with all applicable federal, state, and local laws and regulations shall constitute unprofessional conduct pursuant to KRS 315.121(1)(a). Effective:June 29, 2017 History: Created 2017 Ky. Acts ch. 136, sec. 9, effective June 29, 2017.
Source: Kentucky Legislative Research Commission (legislature.ky.gov)URL: https://apps.legislature.ky.gov/law/statutes/chapter.aspx?id=38825Fetched: 10/20/2026

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