{"data":{"id":"us-ky/krs-315.010","jurisdiction":"us-ky","citation":"KRS 315.010","heading":"Definitions for chapter.","body":"As used in this chapter, unless the context requires otherwise:\n(1) \"Administer\" means the direct application of a drug to a patient or research subject\nby injection, inhalation, or ingestion, whether topically or by any other means;\n(2) \"Administrative activities of a pharmacy\" means the following functions performed\nby a pharmacy adhering to all local, state, and federal patient privacy laws:\n(a) Investigating and researching a patient's insurance benefits and updating the\npatient profile regarding insurance coverage;\n(b) Billing and collections activities, including:\n1. Contacting patients for copayments and coinsurance payments; and\n2. Communicating with insurance companies;\n(c) Performing patient financial assistance activities and updating patient reco rds\naccordingly;\n(d) Opening faxes and accessing electronic prescriptions for the purposes of\nsetting up patient demographic and insurance profiles, excluding height,\nweight, and allergy information, so long as the activity does not involve the\nentering of a prescription order into the dispensing or medication management\nsystem;\n(e) Initiating insurance prior authorizations for submission to the licensed\npharmacy, including communications with the prescribing physician to\ncollect, record, and transmit information to insurance c ompanies, so long as\nthe activity does not include the authorization or receipt of new or refill\nprescription orders;\n(f) Answering and transferring telephone calls, whether or not such calls require\naccessing a patient record, so long as the call does not  involve the\ninterpretation, evaluation, or implementation of a drug order; and\n(g) Communicating with patients via telephone or electronically regarding refill\nreminders, so long as the communication does not involve the interpretation,\nevaluation, or imp lementation of a drug order and a pharmacist is readily\navailable for patient consultation;\n(3) \"Association\" means the Kentucky Pharmacists Association;\n(4) \"Board\" means the Kentucky Board of Pharmacy;\n(5) \"Collaborative care agreement\" means a written agreement between a pharmacist or\npharmacists and a practitioner or practitioners that outlines a plan of cooperative\nmanagement of patients' drug-related health care needs where:\n(a) Patients' drug -related health care needs fall within the practitioner's o r\npractitioners' statutory scope of practice;\n(b) Patients are referred by the practitioner or practitioners to the pharmacist or\npharmacists; and\n(c) The agreement:\n1. Identifies the practitioner or practitioners and the pharmacist or\npharmacists who are parties to the agreement;\n2. Specifies the drug-related regimen to be provided, and how drug therapy\nis to be monitored; and\n3. Stipulates the conditions for initiating, continuing, or discontinuing drug\ntherapy and conditions which warrant modifications t o dose, dosage\nregimen, dosage form, or route of administration;\n(6) \"Compound\" or \"compounding\" means the preparation or labeling of a drug\npursuant to or in anticipation of a valid prescription drug order, including but not\nlimited to packaging, intraven ous admixture, or manual combination of drug\ningredients. \"Compounding,\" as used in this chapter, shall not preclude simple\nreconstitution, mixing, or modification of drug products prior to administration by\nnonpharmacists;\n(7) \"Confidential information\" means information which is accessed or maintained by a\npharmacist in a patient's record, or communicated to a patient as part of patient\ncounseling, whether it is preserved on paper, microfilm, magnetic media, electronic\nmedia, or any other form;\n(8) \"Continuing education unit\" means ten (10) contact hours of board approved\ncontinuing pharmacy education. A \"contact hour\" means fifty (50) continuous\nminutes without a break period;\n(9) \"Dispense\" or \"dispensing\" means to deliver one (1) or more doses of a pres cription\ndrug in a suitable container, appropriately labeled for subsequent administration to\nor use by a patient or other individual entitled to receive the prescription drug;\n(10) \"Drug\" means any of the following:\n(a) Articles recognized as drugs or dru g products in any official compendium or\nsupplement thereto;\n(b) Articles, other than food, intended to affect the structure or function of the\nbody of man or other animals;\n(c) Articles, including radioactive substances, intended for use in the diagnosis,\ncure, mitigation, treatment or prevention of disease in man or other animals;\nor\n(d) Articles intended for use as a component of any articles specified in\nparagraphs (a) to (c) of this subsection;\n(11) \"Drug regimen review\" means retrospective, concurrent , and prospective review by\na pharmacist of a patient's drug -related history, including but not limited to the\nfollowing areas:\n(a) Evaluation of prescription drug orders and patient records for:\n1. Known allergies;\n2. Rational therapy contraindications;\n3. Appropriate dose and route of administration;\n4. Appropriate directions for use; or\n5. Duplicative therapies;\n(b) Evaluation of prescription drug orders and patient records for drug -drug,\ndrug-food, drug-disease, and drug-clinical laboratory interactions;\n(c) Evaluation of prescription drug orders and patient records for adverse drug\nreactions; or\n(d) Evaluation of pr escription drug orders and patient records for proper\nutilization and optimal therapeutic outcomes;\n(12) \"Immediate supervision\" means under the physical and visual supervision of a\npharmacist;\n(13) \"Manufacturer\" or \"virtual manufacturer\" of a product means:\n(a) A person that holds an application approved under 21 U.S.C. sec. 355 or a\nlicense issued under 42 U.S.C. sec. 262 for such product, or if such product is\nnot the subject of an approved application or license, the person who\nmanufactured the product;\n(b) A co -licensed partner of the person described in paragraph (a) of this\nsubsection that obtains the product directly from a person described in this\nparagraph or paragraph (a) of this subsection;\n(c) An affiliate of a person described in paragraph (a)  or (b) of this subsection\nwho receives the product directly from a person described in this paragraph or\nin paragraph (a) or (b) of this subsection; or\n(d) Any person, except a pharmacist compounding in the normal course of\nprofessional practice;\n(14) \"Medical order\" means a lawful order of a specifically identified practitioner for a\nspecifically identified patient for the patient's health care needs. \"Medical order\"\nmay or may not include a prescription drug order;\n(15) \"Nonprescription drugs\" means nonn arcotic medicines or drugs which may be sold\nwithout a prescription and are prepackaged and labeled for use by the consumer in\naccordance with the requirements of the statutes and regulations of this state and the\nfederal government;\n(16) \"Outsourcing faci lity\" means a facility at one (1) geographic location or address\nthat:\n(a) Is engaged in the compounding of human sterile drugs without a patient -\nspecific prescription;\n(b) Has registered as an outsourcing facility with the secretary of the United\nStates D epartment of Health and Human Services, Food and Drug\nAdministration; and\n(c) Complies with all applicable state and federal requirements;\n(17) \"Pharmacist\" means a natural person licensed by this state to engage in the practice\nof the profession of pharmacy;\n(18) \"Pharmacist intern\" means a natural person who is:\n(a) Currently certified by the board to engage in the practice of pharmacy under\nthe direction of a licensed pharmacist and who satisfactorily progresses\ntoward meeting the requirements for licensure as a pharmacist;\n(b) A graduate of an approved college or school of pharmacy or a graduate who\nhas established educational equivalency by obtaining a Foreign Pharmacy\nGraduate Examination Committee (FPGEC) certificate, who is currently\nlicensed by the board for the purpose of obtaining practical experience as a\nrequirement for licensure as a pharmacist;\n(c) A qualified applicant awaiting examination for licensure as a pharmacist or\nthe results of an examination for licensure as a pharmacist; or\n(d) An individual participating in a residency or fellowship program approved by\nthe board for internship credit;\n(19) \"Pharmacy\" means every place where:\n(a) Drugs are dispensed under the direction of a pharmacist;\n(b) Prescription drug orders are compounded unde r the direction of a pharmacist;\nor\n(c) A registered pharmacist maintains patient records and other information for\nthe purpose of engaging in the practice of pharmacy, whether or not\nprescription drug orders are being dispensed;\n(20) \"Pharmacy-related primary care\" means the pharmacists' activities in patient\neducation, health promotion, and assistance in the selection and use of over -the-\ncounter drugs and appliances for the treatment of common diseases and injuries, as\nwell as those other activities falling within their statutory scope of practice;\n(21) \"Pharmacy technician\" means a natural person who works under the immediate\nsupervision, or general supervision if otherwise provided for by statute or\nadministrative regulation, of a ph armacist for the purpose of assisting a pharmacist\nwith the practice of pharmacy;\n(22) \"Practice of pharmacy\" means interpretation, evaluation, and implementation of\nmedical orders and prescription drug orders; responsibility for dispensing\nprescription drug orders, including radioactive substances; participation in drug and\ndrug-related device selection; administration of medications or biologics in the\ncourse of dispensing or maintaining a prescription drug order; the administration of\nadult immunizations pursuant to prescriber -approved protocols; the administration\nof immunizations to individuals five (5) to seventeen (17) years of age pursuant to\nprescriber-approved protocols with the consent of a parent or guardian; the\nadministration of immunizations t o a child as defined in KRS 214.032, pursuant to\nprotocols as authorized by KRS 315.500; drug evaluation, utilization, or regimen\nreview; maintenance of patient pharmacy records; and provision of patient\ncounseling and those professional acts, professional  decisions, or professional\nservices necessary to maintain and manage all areas of a patient's pharmacy -related\ncare, including pharmacy-related primary care as defined in this section;\n(23) \"Practitioner\" has the same meaning given in KRS 217.015(35);\n(24) \"Prescription drug\" means a drug which:\n(a) Under federal law is required to be labeled with either of the following\nstatements:\n1. \"Caution: Federal law prohibits dispensing without prescription\";\n2. \"Caution: Federal law restricts this drug to use by, or on the order of, a\nlicensed veterinarian\";\n3. \"Rx Only\"; or\n4. \"Rx\"; or\n(b) Is required by any applicable federal or state law or administrative regulation\nto be dispensed only pursuant to a prescription drug order or is restricted to\nuse by practitioners;\n(25) \"Prescription drug order\" means an original or new order from a practitioner for\ndrugs, drug -related devices or treatment for a human or animal, including orders\nissued through collaborative care agreements or protocols authorized by the board.\nLawful prescriptions result from a valid practitioner -patient relationship, are\nintended to address a legitimate medical need, and fall within the prescribing\npractitioner's scope of professional practice;\n(26) \"Society\" means the Kentucky Society of Health-Systems Pharmacists;\n(27) \"Supervision\" means the presence of a pharmacist on the premises to which a\npharmacy permit is issued, who is responsible, in whole or in part, for the\nprofessional activities occurring in the pharmacy; and\n(28) \"Wholesaler\" means any person who legally buys drugs for resale or distribution to\npersons other than patients or consumers.","path":["KRS Chapter 315"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=54762","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:58:11Z","sha256":"1cf596431c0fc5f0b8d283c25200e95ac1ea4c80845c6f9223a1cb096f35f0d6","source_id":"us-ky","stale":false,"prev":"us-ky/krs-315.005","next":"us-ky/krs-315.020"},"notice":"GroundRules: Original legal text. Not legal advice."}