{"data":{"id":"us-ky/krs-217.015","jurisdiction":"us-ky","citation":"KRS 217.015","heading":"Definitions for KRS 217.005 to 217.215.","body":"For the purposes of KRS 217.005 to 217.215:\n(1) \"Advertisement\" means all representations, disseminated in any manner or by any\nmeans, other than by labeling, for the purpose of inducing, or which are likely to\ninduce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics;\n(2) \"Bread\" and \"enriched bread\" mean only the foods commonly known and described\nas white bread, white rolls, white buns, enriched white bread, enriched rolls, and\nenriched white buns, as defined under the federal ac t. For the purposes of KRS\n217.136 and 217.137, \"bread\" or \"enriched bread\" also means breads that may\ninclude vegetables or fruit as an ingredient;\n(3) \"Cabinet\" means the Cabinet for Health and Family Services or its designee;\n(4) \"Color\" means but is not limited to black, white, and intermediate grays;\n(5) \"Color additive\" means a material that:\n(a) Is a dye, pigment, or other substance made by a process of synthesis or similar\nartifice, or extracted, isolated, or otherwise derived, with or without\nintermediate or final change of identity, from a vegetable, animal, mineral, or\nother source. This paragraph shall not be construed to apply to any pesticide\nchemical, soil or plant nutrient, or other agricultural chemical solely because\nof its effect in aiding , retarding, or otherwise affecting, directly or indirectly,\nthe growth or other natural physiological process of produce of the soil and\nthereby affecting its color, whether before or after harvest; or\n(b) When added or applied to a food, drug, or cosmeti c, or to the human body or\nany part thereof, is capable, alone or through reaction with another substance,\nof imparting color. \"Color additive\" does not include any material that has\nbeen or may in the future be exempted under the federal act;\n(6) \"Contaminated with filth\" means any food, drug, device, or cosmetic that is not\nsecurely protected from dust, dirt, and as far as may be necessary by all reasonable\nmeans, from all foreign or injurious contaminants;\n(7) \"Cosmetic\" means:\n(a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into,\nor otherwise applied to the human body or any part thereof for cleansing,\nbeautifying, promoting attractiveness, or altering the appearance; and\n(b) Articles intended for use as a component of those articles, except that the term\nshall not include soap;\n(8) \"Device,\" except when used in subsection (48) of this section, KRS 217.035(6),\nKRS 217.065(3), KRS 217.095(3), and KRS 217.175(10), means instruments,\napparatus, and contriva nces, including their components, parts, and accessories,\nintended:\n(a) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease\nin man or other animals; or\n(b) To affect the structure or any function of the body of man or other animals;\n(9) \"Dispense\" means to deliver a drug or device to an ultimate user or research subject\nby or pursuant to the lawful order of a practitioner, including the packaging,\nlabeling, or compounding necessary to prepare the substance for that delivery;\n(10) \"Dispenser\" means a person who lawfully dispenses a drug or device to or for the\nuse of an ultimate user;\n(11) \"Drug\" means:\n(a) Articles recognized in the official United States pharmacopoeia, official\nhomeopathic pharmacopoeia of the United States, or o fficial national\nformulary, or any supplement to any of them;\n(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or\nprevention of disease in man or other animals;\n(c) Articles, other than food, intended to affect the structure or any function of the\nbody of man or other animals; and\n(d) Articles intended for use as a component of any article specified in this\nsubsection but does not include devices or their components, parts, or\naccessories;\n(12) \"Enriched,\" as applied to flour, mea ns the addition to flour of vitamins and other\nnutritional ingredients necessary to make it conform to the definition and standard\nof enriched flour as defined under the federal act;\n(13) \"Environmental Pesticide Control Act of 1972\" means the Federal Envi ronmental\nPesticide Control Act of 1972, Pub. L. 92-516, and all amendments thereto;\n(14) \"Fair Packaging and Labeling Act\" means the Fair Packaging and Labeling Act as it\nrelates to foods and cosmetics, 15 U.S.C. secs. 1451 et seq., and all amendments\nthereto;\n(15) \"Federal act\" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301\net seq., 52 Stat. 1040 et seq., or amendments thereto;\n(16) \"Filled milk\" means any milk, cream, or skimmed milk, whether or not condensed,\nevaporated, concentrated, frozen, powdered, dried, or desiccated, to which has been\nadded, or which has been blended or compounded with, any fat or oil other than\nmilk fat, except the fat or oil of contained eggs and nuts and the fat or oil of\nsubstances used for flavoring purpos es only, so that the resulting product is an\nimitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or\nfrozen desserts, whether or not condensed, evaporated, concentrated, frozen,\npowdered, dried, or desiccated, whether in bulk or i n containers, hermetically\nsealed or unsealed. This definition does not mean or include any milk or cream\nfrom which no part of the milk or butter fat has been extracted, whether or not\ncondensed, evaporated, concentrated, powdered, dried, or desiccated, t o which has\nbeen added any substance rich in vitamins, nor any distinctive proprietary food\ncompound not readily mistaken for milk or cream or for condensed, evaporated,\nconcentrated, powdered, dried, or desiccated milk or cream, if the compound is\nprepared and designed for the feeding of infants or young children, sick or infirm\npersons, and customarily used on the order of a physician, and is packed in\nindividual containers bearing a label in bold type that the contents are to be used for\nthose purposes; nor shall this definition prevent the use, blending, or compounding\nof chocolate as a flavor with milk, cream, or skimmed milk, desiccated, whether in\nbulk or in containers, hermetically sealed or unsealed, to or with which has been\nadded, blended or compounded no other fat or oil other than milk or butter fat;\n(17) \"Flour\" means only the foods commonly known as flour, white flour, wheat flour,\nplain flour, bromated flour, self -rising flour, self -rising white flour, self -rising\nwheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour,\ndefined under the federal act;\n(18) \"Food\" means:\n(a) Articles used for food or drink for man or other animals;\n(b) Chewing gum; and\n(c) Articles used for components of any such article;\n(19) \"Food additive\" means any substance the intended use of which results or may be\nreasonably expected to result, directly or indirectly, in its becoming a component or\notherwise affecting the characteristics of any food, including any substance\nintended for use in pro ducing, manufacturing, packing, processing, preparing,\ntreating, packaging, transporting, or holding food; and including any source of\nradiation intended for any of these uses, if the substance is not generally\nrecognized, among experts qualified by scient ific training and experience to\nevaluate its safety, as having been adequately shown through scientific procedures\nor, in the case of a substance used in a food prior to January 1, 1958, through either\nscientific procedures or experience based on common us e in food to be safe under\nthe conditions of its intended use; except that the term does not include:\n(a) A pesticide chemical in or on a raw agricultural commodity;\n(b) A pesticide chemical to the extent that it is intended for use or is used in the\nproduction, storage, or transportation of any raw agricultural commodity;\n(c) A color additive; or\n(d) Any substance used in accordance with a sanction or approval granted prior to\nthe enactment of the Food Additives Amendment of 1958, pursuant to the\nfederal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.;\nor the Meat Inspection Act of 1907; and amendments thereto;\n(20) \"Food processing establishment\" means any commercial establishment in which\nfood is manufactured, processed, or packaged for human consumption, but does not\ninclude retail food establishments, home -based processors, or home -based\nmicroprocessors;\n(21) \"Food service establishment\" means any fixed or mobile commercial establishment\nthat engages in the preparation and serving of ready -to-eat foods in portions to the\nconsumer, including but not limited to: restaurants; coffee shops; cafeterias; short\norder cafe s; luncheonettes; grills; tea rooms; sandwich shops; soda fountains;\ntaverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding\nestablishments; private, public or nonprofit organizations or institutions routinely\nserving food; caterin g kitchens; commissaries; charitable food kitchens; or similar\nplaces in which food is prepared for sale or service on the premises or elsewhere\nwith or without charge. It does not include food vending machines, establishments\nserving beverages only in sin gle service or original containers, or retail food stores\nwhich only cut, slice, and prepare cold-cut sandwiches for individual consumption;\n(22) \"Food storage warehouse\" means any establishment in which food is stored for\nsubsequent distribution;\n(23) \"Immediate container\" does not include package liners;\n(24) \"Imminent health hazard\" means a significant threat or danger to health that is\nconsidered to exist when there is evidence sufficient to show that a product,\npractice, circumstance, or event creates a situation that requires immediate\ncorrection or cessation of operation to prevent illness or injury based on:\n(a) The number of potential illnesses or injuries; or\n(b) The nature, severity, and duration of the anticipated illness or injury;\n(25) \"Interference\" means threatening or otherwise preventing the performance of lawful\ninspections or duties by agents of the cabinet during all reasonable times of\noperation;\n(26) \"Label\" means a display of written, printed, or graphic matter upon the immediate\ncontainer of any article; and a requirement made by or under authority of KRS\n217.005 to 217.215 that any word, statement, or other information appearing on the\nlabel shall not be considered to be complied with unless the word, statement, or\nother information also appears on the outside container or wrapper, if any there be,\nof the retail package of the article, or is easily legible through the outside container\nor wrapper;\n(27) \"Labeling\" means all labels and other written, printed, or graphic matter:\n(a) Upon an article or any of its containers or wrappers; or\n(b) Accompanying the article;\n(28) \"Legend drug\" means a drug defined by the Federal Food, Drug and Cosmetic Act,\nas amended, and under which definition its label is required to bear the statement\n\"Caution: Federal law prohibits dispensing without prescription.\";\n(29) \"Meat Inspection Act\" means the Federal Meat Inspection Act, 21 U.S.C. secs. 71\net seq., 34 Stat. 1260 et seq., including any amendments thereto;\n(30) \"New drug\" means:\n(a) Any drug the compo sition of which is such that the drug is not generally\nrecognized among experts qualified by scientific training and experience to\nevaluate the safety of drugs as safe for use under the conditions prescribed,\nrecommended, or suggested in the labeling thereof; or\n(b) Any drug the composition of which is such that the drug, as a result of\ninvestigations to determine its safety for use under prescribed conditions, has\nbecome so recognized, but which has not, otherwise than in the investigations,\nbeen used to a material extent or for a material time under the conditions;\n(31) \"Official compendium\" means the official United States pharmacopoeia, official\nhomeopathic pharmacopoeia of the United States, official national formulary, or\nany supplement to any of them;\n(32) \"Person\" means an individual, firm, partnership, company, corporation, trustee,\nassociation, or any public or private entity;\n(33) \"Pesticide chemical\" means any substance that alone in chemical combination, or in\nformulation with one or more other s ubstances, is an \"economic poison\" within the\nmeaning of the Federal Insecticide, Fungicide and Rodenticide Act and\namendments thereto, and that is used in the production, storage, or transportation of\nraw agricultural commodities;\n(34) \"Poultry Products I nspection Act\" means the Federal Poultry and Poultry Products\nInspection Act, 21 U.S.C. secs. 451 et seq., Pub. L. 85 -172, 71 Stat. 441, and any\namendments thereto;\n(35) \"Practitioner\" means medical or osteopathic physicians, dentists, chiropodists, and\nveterinarians who are licensed under the professional licensing laws of Kentucky to\nprescribe and administer drugs and devices. \"Practitioner\" includes optometrists\nwhen administering or prescribing pharmaceutical agents authorized in KRS\n320.240(12) to (14) , advanced practice registered nurses as authorized in KRS\n314.011 and 314.042, physician assistants when administering or prescribing\npharmaceutical agents as authorized in KRS 311.858, and health care professionals\nwho are residents of and actively pract icing in a state other than Kentucky and who\nare licensed and have prescriptive authority under the professional licensing laws of\nanother state, unless the person's Kentucky license has been revoked, suspended,\nrestricted, or probated, in which case the t erms of the Kentucky license shall\nprevail;\n(36) \"Prescription\" means a written or oral order for a drug or medicine, or combination\nor mixture of drugs or medicines, or proprietary preparation, that is signed, given,\nor authorized by a medical, advanced p ractice registered nurse, dental, chiropody,\nveterinarian, or optometric practitioner, and intended for use in the diagnosis, cure,\nmitigation, treatment, or prevention of disease in man or other animals;\n(37) \"Prescription blank\" means a document that con forms with KRS 217.216 and is\nintended for prescribing a drug to an ultimate user;\n(38) \"Raw agricultural commodity\" means any food in its raw or natural state, including\nall fruits that are washed, colored, or otherwise treated in their unpeeled natural\nform prior to marketing;\n(39) \"Retail food establishment\" means any food service establishment, retail food store,\nor a combination of both within the same establishment;\n(40) \"Retail food store\" means any fixed or mobile establishment where food or food\nproducts, including prepackaged, labeled sandwiches or other foods to be heated in\na microwave or infrared oven at the time of purchase, are offered for sale to the\nconsumer, and intended for off -premises consumption, but does not include\nestablishments whic h handle only prepackaged, snack -type, nonpotentially\nhazardous foods, markets that offer only fresh fruits and vegetables for sale, food\nservice establishments, food and beverage vending machines, vending machine\ncommissaries, food processing establishments, or home-based processors;\n(41) \"Salvage distributor\" means a person who engages in the business of distributing,\npeddling, or otherwise trafficking in any salvaged merchandise;\n(42) \"Salvage processing plant\" means an establishment operated by a person engaged in\nthe business of reconditioning, labeling, relabeling, repackaging, recoopering,\nsorting, cleaning, culling or who by other means salvages, sells, offers for sale, or\ndistributes for human or animal consumption or use any salvaged food, beverage,\nincluding beer, wine and distilled spirits, vitamins, food supplements, dentifices,\ncosmetics, single -service food containers or utensils, containers and packaging\nmaterials used for f oods and cosmetics, soda straws, paper napkins, or any other\nproduct of a similar nature that has been damaged or contaminated by fire, water,\nsmoke, chemicals, transit, or by any other means;\n(43) \"Second or subsequent offense\" has the same meaning as it does in KRS 218A.010;\n(44) \"Secretary\" means the secretary of the Cabinet for Health and Family Services;\n(45) \"Temporary food service establishment\" means any food service establishment\nwhich operates at a fixed location for a period of time, not to excee d fourteen (14)\nconsecutive days;\n(46) \"Traffic\" has the same meaning as it does in KRS 218A.010;\n(47) \"Ultimate user\" has the same meaning as it does in KRS 218A.010;\n(48) If an article is alleged to be misbranded because the labeling is misleading, or if  an\nadvertisement is alleged to be false because it is misleading, in determining whether\nthe labeling or advertisement is misleading, there shall be taken into account,\namong other things, not only representations made or suggested by statement, word,\ndesign, device, sound, or in any combination thereof, but also the extent to which\nthe labeling or advertisement fails to reveal facts that are material in the light of the\nrepresentations or material with respect to consequences which may result from the\nuse of the article to which the labeling or advertisement relates under the conditions\nof use prescribed in the labeling or advertisement thereof or under the conditions of\nuse as are customary or usual;\n(49) The representation of a drug in its labeling or advertisement as an antiseptic shall be\nconsidered to be a representation that it is a germicide, except in the case of a drug\npurporting to be, or represented as, an antiseptic for inhibitory use as a wet\ndressing, ointment, dusting powder, or other use inv olving prolonged contact with\nthe body;\n(50) The provisions of KRS 217.005 to 217.215 regarding the selling of food, drugs,\ndevices, or cosmetics shall be considered to include the manufacture, production,\nprocessing, packing, exposure, offer, possession, and holding of those articles for\nsale, the sale, dispensing, and giving of those articles, and the supplying or applying\nof those articles in the conduct of any food, drug, or cosmetic establishment;\n(51) \"Home\" means a primary residence occupied by the p rocessor, that contains only\ntwo (2) ranges, ovens, or double -ovens, and no more than three (3) refrigerators\nused for cold storage. This equipment shall have been designed for home use and\nnot for commercial use, and shall be operated in the kitchen within the residence;\n(52) \"Formulated acid food product\" means an acid food in which the addition of a small\namount of low -acid food results in a finished equilibrium pH of 4.6 or below that\ndoes not significantly differ from that of the predominant acid or acid food;\n(53) \"Acidified food product\" means a low -acid food to which acid or acidic food is\nadded and which has a water activity value greater than 0.85, and a finished\nequilibrium pH of 4.6 or below;\n(54) \"Low-acid food\" means foods, other than alcoholic  beverages, with a finished\nequilibrium pH greater than 4.6, and a water activity value greater than 0.85;\n(55) \"Acid food\" means foods that have a natural pH of 4.6 or below;\n(56) \"Home-based processor\" means a person who in his or her home, produces or\nprocesses pork lard or tallow -based cosmetic products or nonpotentially hazardous\nfoods, including but not limited to dried herbs, spices, nuts, candy, dried grains,\nwhole fruit and vegetables, mixed -greens, jams, jellies, sweet sorghum syrup,\npreserves, fr uit butter, bread, fruit pies, cakes, or cookies, and who has a gross\nincome of no more than sixty thousand dollars ($60,000) annually from the sale of\nthe products;\n(57) \"Home-based microprocessor\" means a farmer who, in the farmer's home or\ncertified or permitted kitchen, produces or processes foods, including but not\nlimited to acid foods, formulated acid food products, acidified food products, or\nlow-acid canned foods, and who has a gross income of no more than sixty thousand\ndollars ($60,000) annually from the sale of the product;\n(58) \"Certified\" means any person or home-based microprocessor who:\n(a) Has attended the Kentucky Cooperative Extension Service's microprocessing\nprogram or pilot microprocessing program and has been identified by the\nKentucky Cooperative Extension Service as having satisfactorily completed\nthe prescribed course of instruction; or\n(b) Has attended some other school pursuant to 21 C.F.R. sec. 114.10;\n(59) \"Farmer\" means a person who is a resident of Kentucky and owns or rents\nagricultural land pursuant to subsection (9) of KRS 132.010 or horticultural land\npursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to\n217.139, \"farmer\" also means any person who is a resident of Kentucky and has\ngrown the primary h orticultural and agronomic ingredients used in the home -based\nmicroprocessed products which they have produced; and\n(60) \"Farmers market temporary food service establishment\" means any temporary food\nservice establishment operated by a farmer who is a memb er of the market which\noperates within the confines of a farmers market registered with the Kentucky\nDepartment of Agriculture for the direct -to-consumer marketing of Kentucky -\ngrown farm products from approved sources for a period of time not to exceed two\n(2) days per week for any consecutive six (6) months period in a calendar year.","path":["KRS Chapter 217"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=57381","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:24Z","sha256":"5905b21ea8bf909c0c388dd3b4c893fc7d9913f87f7cee9ca6e96d3b0f047866","source_id":"us-ky","stale":false,"prev":"us-ky/krs-217.010","next":"us-ky/krs-217.020"},"notice":"GroundRules: Original legal text. Not legal advice."}