217.015 Definitions for KRS 217.005 to 217.215. For the purposes of KRS 217.005 to 217.215: <br>(1) "Advertisement" means all representations, disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to <br>induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; (2) "Bread" and "enriched bread" mean only the foods commonly known and described as white bread, white rolls, white buns, enriched white bread, enriched rolls, and <br>enriched white buns, as defined under the federal act. For the purposes of KRS <br>217.136 and 217.137, "bread" or "enriched bread" also means breads that may <br>include vegetables or fruit as an ingredient; (3) "Cabinet" means the Cabinet for Health and Family Services or its designee; <br>(4) "Color" means but is not limited to black, white, and intermediate grays; <br>(5) "Color additive" means a material that: (a) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without <br>intermediate or final change of identity, from a vegetable, animal, mineral, or <br>other source. Nothing in this paragraph shall be construed to apply to any <br>pesticide chemical, soil or plant nutrient, or other agricultural chemical solely <br>because of its effect in aiding, retarding, or otherwise affecting, directly or <br>indirectly, the growth or other natural physiological process of produce of the <br>soil and thereby affecting its color, whether before or after harvest; or (b) When added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable, alone or through reaction with another substance, <br>of imparting color. "Color additive" does not include any material that has <br>been or may in the future be exempted under the federal act; (6) "Contaminated with filth" means any food, drug, device, or cosmetic that is not securely protected from dust, dirt, and as far as may be necessary by all reasonable <br>means, from all foreign or injurious contaminants; (7) "Cosmetic" means: (a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, <br>beautifying, promoting attractiveness, or altering the appearance; and (b) Articles intended for use as a component of those articles, except that the term shall not include soap; (8) "Device," except when used in subsection (48) of this section, KRS 217.035(6), KRS 217.065(3), KRS 217.095(3), and KRS 217.175(10), means instruments, <br>apparatus, and contrivances, including their components, parts, and accessories, <br>intended: <br>(a) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (b) To affect the structure or any function of the body of man or other animals; (9) "Dispense" means to deliver a drug or device to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the packaging, <br>labeling, or compounding necessary to prepare the substance for that delivery; (10) "Dispenser" means a person who lawfully dispenses a drug or device to or for the use of an ultimate user; (11) "Drug" means: (a) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national <br>formulary, or any supplement to any of them; (b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (c) Articles, other than food, intended to affect the structure or any function of the body of man or other animals; and (d) Articles intended for use as a component of any article specified in this subsection but does not include devices or their components, parts, or <br>accessories; (12) "Enriched," as applied to flour, means the addition to flour of vitamins and other nutritional ingredients necessary to make it conform to the definition and standard <br>of enriched flour as defined under the federal act; (13) "Environmental Pesticide Control Act of 1972" means the Federal Environmental Pesticide Control Act of 1972, Pub. L. 92-516, and all amendments thereto; (14) "Fair Packaging and Labeling Act" means the Fair Packaging and Labeling Act as it relates to foods and cosmetics, 15 U.S.C. secs. 1451 et seq., and all amendments <br>thereto; (15) "Federal act" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301 et seq., 52 Stat. 1040 et seq., or amendments thereto; (16) "Filled milk" means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, frozen, powdered, dried, or desiccated, to which has been <br>added, or which has been blended or compounded with, any fat or oil other than <br>milk fat, except the fat or oil of contained eggs and nuts and the fat or oil of <br>substances used for flavoring purposes only, so that the resulting product is an <br>imitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or <br>frozen desserts, whether or not condensed, evaporated, concentrated, frozen, <br>powdered, dried, or desiccated, whether in bulk or in containers, hermetically sealed <br>or unsealed. This definition does not mean or include any milk or cream from which <br>no part of the milk or butter fat has been extracted, whether or not condensed, <br>evaporated, concentrated, powdered, dried, or desiccated, to which has been added <br>any substance rich in vitamins, nor any distinctive proprietary food compound not <br>readily mistaken for milk or cream or for condensed, evaporated, concentrated, <br>powdered, dried, or desiccated milk or cream, if the compound is prepared and <br>designed for the feeding of infants or young children, sick or infirm persons, and <br>customarily used on the order of a physician, and is packed in individual containers <br>bearing a label in bold type that the contents are to be used for those purposes; nor shall this definition prevent the use, blending, or compounding of chocolate as a <br>flavor with milk, cream, or skimmed milk, desiccated, whether in bulk or in <br>containers, hermetically sealed or unsealed, to or with which has been added, <br>blended or compounded no other fat or oil other than milk or butter fat; (17) "Flour" means only the foods commonly known as flour, white flour, wheat flour, plain flour, bromated flour, self-rising flour, self-rising white flour, self-rising <br>wheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour, <br>defined under the federal act; (18) "Food" means: (a) Articles used for food or drink for man or other animals; <br>(b) Chewing gum; and <br>(c) Articles used for components of any such article; (19) "Food additive" means any substance the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or <br>otherwise affecting the characteristics of any food, including any substance intended <br>for use in producing, manufacturing, packing, processing, preparing, treating, <br>packaging, transporting, or holding food; and including any source of radiation <br>intended for any of these uses, if the substance is not generally recognized, among <br>experts qualified by scientific training and experience to evaluate its safety, as <br>having been adequately shown through scientific procedures or, in the case of a <br>substance used in a food prior to January 1, 1958, through either scientific <br>procedures or experience based on common use in food to be safe under the <br>conditions of its intended use; except that the term does not include: <br>(a) A pesticide chemical in or on a raw agricultural commodity; <br>(b) A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; (c) A color additive; or <br>(d) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the <br>federal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.; or <br>the Meat Inspection Act of 1907; and amendments thereto; (20) "Food processing establishment" means any commercial establishment in which food is manufactured, processed, or packaged for human consumption, but does not <br>include retail food establishments, home-based processors, or home-based <br>microprocessors; (21) "Food service establishment" means any fixed or mobile commercial establishment that engages in the preparation and serving of ready-to-eat foods in portions to the <br>consumer, including but not limited to: restaurants; coffee shops; cafeterias; short <br>order cafes; luncheonettes; grills; tea rooms; sandwich shops; soda fountains; <br>taverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding <br>establishments; private, public or nonprofit organizations or institutions routinely <br>serving food; catering kitchens; commissaries; charitable food kitchens; or similar <br>places in which food is prepared for sale or service on the premises or elsewhere with or without charge. It does not include food vending machines, establishments <br>serving beverages only in single service or original containers, or retail food stores <br>which only cut, slice, and prepare cold-cut sandwiches for individual consumption; (22) "Food storage warehouse" means any establishment in which food is stored for subsequent distribution; (23) "Immediate container" does not include package liners; <br>(24) "Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, <br>practice, circumstance, or event creates a situation that requires immediate <br>correction or cessation of operation to prevent illness or injury based on: <br>(a) The number of potential illnesses or injuries; or <br>(b) The nature, severity, and duration of the anticipated illness or injury; (25) "Interference" means threatening or otherwise preventing the performance of lawful inspections or duties by agents of the cabinet during all reasonable times of <br>operation; (26) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of KRS <br>217.005 to 217.215 that any word, statement, or other information appearing on the <br>label shall not be considered to be complied with unless the word, statement, or <br>other information also appears on the outside container or wrapper, if any there be, <br>of the retail package of the article, or is easily legible through the outside container <br>or wrapper; (27) "Labeling" means all labels and other written, printed, or graphic matter: (a) Upon an article or any of its containers or wrappers; or <br>(b) Accompanying the article; (28) "Legend drug" means a drug defined by the Federal Food, Drug and Cosmetic Act, as amended, and under which definition its label is required to bear the statement <br>"Caution: Federal law prohibits dispensing without prescription."; (29) "Meat Inspection Act" means the Federal Meat Inspection Act, 21 U.S.C. secs. 71 et seq., 34 Stat. 1260 et seq., including any amendments thereto; (30) "New drug" means: (a) Any drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to <br>evaluate the safety of drugs as safe for use under the conditions prescribed, <br>recommended, or suggested in the labeling thereof; or (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under prescribed conditions, has <br>become so recognized, but which has not, otherwise than in the investigations, <br>been used to a material extent or for a material time under the conditions; (31) "Official compendium" means the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, official national formulary, or any <br>supplement to any of them; (32) "Person" means an individual, firm, partnership, company, corporation, trustee, association, or any public or private entity; (33) "Pesticide chemical" means any substance that alone in chemical combination, or in formulation with one or more other substances, is an "economic poison" within the <br>meaning of the Federal Insecticide, Fungicide and Rodenticide Act and amendments <br>thereto, and that is used in the production, storage, or transportation of raw <br>agricultural commodities; (34) "Poultry Products Inspection Act" means the Federal Poultry and Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq., Pub. L. 85-172, 71 Stat. 441, and any <br>amendments thereto; (35) "Practitioner" means medical or osteopathic physicians, dentists, chiropodists, and veterinarians who are licensed under the professional licensing laws of Kentucky to <br>prescribe and administer drugs and devices. "Practitioner" includes optometrists <br>when administering or prescribing pharmaceutical agents authorized in KRS <br>320.240(12) to (14), advanced practice registered nurses as authorized in KRS <br>314.011 and 314.042, physician assistants when administering or prescribing <br>pharmaceutical agents as authorized in KRS 311.858, and health care professionals <br>who are residents of and actively practicing in a state other than Kentucky and who <br>are licensed and have prescriptive authority under the professional licensing laws of <br>another state, unless the person's Kentucky license has been revoked, suspended, <br>restricted, or probated, in which case the terms of the Kentucky license shall <br>prevail; (36) "Prescription" means a written or oral order for a drug or medicine, or combination or mixture of drugs or medicines, or proprietary preparation, that is signed, given, or <br>authorized by a medical, dental, chiropody, veterinarian, or optometric practitioner, <br>and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of <br>disease in man or other animals; (37) "Prescription blank" means a document that conforms with KRS 217.216 and is intended for prescribing a drug to an ultimate user; (38) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural <br>form prior to marketing; (39) "Retail food establishment" means any food service establishment, retail food store, or a combination of both within the same establishment; (40) "Retail food store" means any fixed or mobile establishment where food or food products, including prepackaged, labeled sandwiches or other foods to be heated in <br>a microwave or infrared oven at the time of purchase, are offered for sale to the <br>consumer, and intended for off-premises consumption, but does not include <br>establishments which handle only prepackaged, snack-type, nonpotentially <br>hazardous foods, markets that offer only fresh fruits and vegetables for sale, food <br>service establishments, food and beverage vending machines, vending machine <br>commissaries, or food processing establishments; (41) "Salvage distributor" means a person who engages in the business of distributing, peddling, or otherwise trafficking in any salvaged merchandise; (42) "Salvage processing plant" means an establishment operated by a person engaged in the business of reconditioning, labeling, relabeling, repackaging, recoopering, <br>sorting, cleaning, culling or who by other means salvages, sells, offers for sale, or <br>distributes for human or animal consumption or use any salvaged food, beverage, <br>including beer, wine and distilled spirits, vitamins, food supplements, dentifices, <br>cosmetics, single-service food containers or utensils, containers and packaging <br>materials used for foods and cosmetics, soda straws, paper napkins, or any other <br>product of a similar nature that has been damaged or contaminated by fire, water, <br>smoke, chemicals, transit, or by any other means; (43) "Second or subsequent offense" has the same meaning as it does in KRS 218A.010; <br>(44) "Secretary" means the secretary of the Cabinet for Health and Family Services; <br>(45) "Temporary food service establishment" means any food service establishment which operates at a fixed location for a period of time, not to exceed fourteen (14) <br>consecutive days; (46) "Traffic" has the same meaning as it does in KRS 218A.010; <br>(47) "Ultimate user" has the same meaning as it does in KRS 218A.010; <br>(48) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, in determining whether <br>the labeling or advertisement is misleading, there shall be taken into account, <br>among other things, not only representations made or suggested by statement, word, <br>design, device, sound, or in any combination thereof, but also the extent to which <br>the labeling or advertisement fails to reveal facts that are material in the light of the <br>representations or material with respect to consequences which may result from the <br>use of the article to which the labeling or advertisement relates under the conditions <br>of use prescribed in the labeling or advertisement thereof or under the conditions of <br>use as are customary or usual; (49) The representation of a drug in its labeling or advertisement as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug <br>purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, <br>ointment, dusting powder, or other use involving prolonged contact with the body; (50) The provisions of KRS 217.005 to 217.215 regarding the selling of food, drugs, devices, or cosmetics shall be considered to include the manufacture, production, <br>processing, packing, exposure, offer, possession, and holding of those articles for <br>sale, the sale, dispensing, and giving of those articles, and the supplying or applying <br>of those articles in the conduct of any food, drug, or cosmetic establishment; (51) "Home" means a primary residence occupied by the processor, that contains only two (2) ranges, ovens, or double-ovens, and no more than three (3) refrigerators <br>used for cold storage. This equipment shall have been designed for home use and <br>not for commercial use, and shall be operated in the kitchen within the residence; (52) "Formulated acid food product" means an acid food in which the addition of a small amount of low-acid food results in a finished equilibrium pH of 4.6 or below that <br>does not significantly differ from that of the predominant acid or acid food; (53) "Acidified food product" means a low-acid food to which acid or acidic food is added and which has a water activity value greater than 0.85, and a finished <br>equilibrium pH of 4.6 or below; (54) "Low-acid food" means foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6, and a water activity value greater than 0.85; (55) "Acid food" means foods that have a natural pH of 4.6 or below; <br>(56) "Home-based processor" means a farmer who, in the farmer's home, produces or processes whole fruit and vegetables, mixed-greens, jams, jellies, sweet sorghum <br>syrup, preserves, fruit butter, bread, fruit pies, cakes, or cookies; (57) "Home-based microprocessor" means a farmer who, in the farmer's home or certified or permitted kitchen, produces or processes acid foods, formulated acid <br>food products, acidified food products, or low-acid canned foods, and who has a net <br>income of less than thirty-five thousand dollars ($35,000) annually from the sale of <br>the product; (58) "Certified" means any person or home-based microprocessor who: (a) Has attended the Kentucky Cooperative Extension Service's microprocessing program or pilot microprocessing program and has been identified by the <br>Kentucky Cooperative Extension Service as having satisfactorily completed <br>the prescribed course of instruction; or (b) Has attended some other school pursuant to 21 C.F.R. sec. 114.10; (59) "Farmer" means a person who is a resident of Kentucky and owns or rents agricultural land pursuant to subsection (9) of KRS 132.010 or horticultural land <br>pursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to <br>217.139, "farmer" also means any person who is a resident of Kentucky and has <br>grown the primary horticultural and agronomic ingredients used in the home-based <br>processed products which they have produced; and (60) "Farmers market temporary food service establishment" means any temporary food service establishment operated by a farmer who is a member of the market which <br>operates within the confines of a farmers market registered with the Kentucky <br>Department of Agriculture for the direct-to-consumer marketing of Kentucky-grown <br>farm products from approved sources for a period of time not to exceed two (2) <br>days per week for any consecutive six (6) months period in a calendar year. Effective: July 15, 2010 <br>History: Amended 2010 Ky. Acts ch. 85, sec. 41, effective July 15, 2010.-- Amended 2007 Ky. Acts ch. 97, sec. 1, effective March 23, 2007. -- Amended 2005 Ky. Acts <br>ch. 99, sec. 512, effective June 20, 2005. -- Amended 2003 Ky. Acts ch. 42, sec. 1, <br>effective June 24, 2003; and ch. 51, sec. 1, effective June 24, 2003. -- Amended 2002 <br>Ky. Acts ch. 130, sec. 35, effective July 15, 2002. - Amended 2000 Ky. Acts ch. 361, <br>sec. 17, effective July 14, 2000. -- Amended 1998 Ky. Acts ch. 7, sec. 1, effective <br>February 19, 1998, retroactive to January 1, 1998; ch. 228, sec. 7, effective July 15, <br>1998; ch. 297, sec. 1, effective July 15, 1998; ch. 301, sec. 1, effective July 15, 1998; and ch. 426, sec. 456, effective July 15, 1998. -- Amended 1996 Ky. Acts Ky. Acts <br>ch. 342, sec. 5, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 458, sec. 1, <br>effective July 13, 1990. -- Amended 1986 Ky. Acts ch. 12, sec. 4, effective July 15, <br>1986. -- Amended 1982 Ky. Acts ch. 247, sec. 10, effective July 15, 1982. -- <br>Amended 1978 Ky. Acts ch. 179, sec. 4, effective June 17, 1978; and ch. 292, sec. 1, <br>effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (10) <br>and (11). - Created 1960 Ky. Acts ch. 247, sec. 2.
217.015 Definitions for KRS 217.005 to 217.215. For the purposes of KRS 217.005 to 217.215: <br>(1) "Advertisement" means all representations, disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to <br>induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; (2) "Bread" and "enriched bread" mean only the foods commonly known and described as white bread, white rolls, white buns, enriched white bread, enriched rolls, and <br>enriched white buns, as defined under the federal act. For the purposes of KRS <br>217.136 and 217.137, "bread" or "enriched bread" also means breads that may <br>include vegetables or fruit as an ingredient; (3) "Cabinet" means the Cabinet for Health and Family Services or its designee; <br>(4) "Color" means but is not limited to black, white, and intermediate grays; <br>(5) "Color additive" means a material that: (a) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without <br>intermediate or final change of identity, from a vegetable, animal, mineral, or <br>other source. Nothing in this paragraph shall be construed to apply to any <br>pesticide chemical, soil or plant nutrient, or other agricultural chemical solely <br>because of its effect in aiding, retarding, or otherwise affecting, directly or <br>indirectly, the growth or other natural physiological process of produce of the <br>soil and thereby affecting its color, whether before or after harvest; or (b) When added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable, alone or through reaction with another substance, <br>of imparting color. "Color additive" does not include any material that has <br>been or may in the future be exempted under the federal act; (6) "Contaminated with filth" means any food, drug, device, or cosmetic that is not securely protected from dust, dirt, and as far as may be necessary by all reasonable <br>means, from all foreign or injurious contaminants; (7) "Cosmetic" means: (a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, <br>beautifying, promoting attractiveness, or altering the appearance; and (b) Articles intended for use as a component of those articles, except that the term shall not include soap; (8) "Device," except when used in subsection (48) of this section, KRS 217.035(6), KRS 217.065(3), KRS 217.095(3), and KRS 217.175(10), means instruments, <br>apparatus, and contrivances, including their components, parts, and accessories, <br>intended: <br>(a) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (b) To affect the structure or any function of the body of man or other animals; (9) "Dispense" means to deliver a drug or device to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the packaging, <br>labeling, or compounding necessary to prepare the substance for that delivery; (10) "Dispenser" means a person who lawfully dispenses a drug or device to or for the use of an ultimate user; (11) "Drug" means: (a) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national <br>formulary, or any supplement to any of them; (b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (c) Articles, other than food, intended to affect the structure or any function of the body of man or other animals; and (d) Articles intended for use as a component of any article specified in this subsection but does not include devices or their components, parts, or <br>accessories; (12) "Enriched," as applied to flour, means the addition to flour of vitamins and other nutritional ingredients necessary to make it conform to the definition and standard <br>of enriched flour as defined under the federal act; (13) "Environmental Pesticide Control Act of 1972" means the Federal Environmental Pesticide Control Act of 1972, Pub. L. 92-516, and all amendments thereto; (14) "Fair Packaging and Labeling Act" means the Fair Packaging and Labeling Act as it relates to foods and cosmetics, 15 U.S.C. secs. 1451 et seq., and all amendments <br>thereto; (15) "Federal act" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301 et seq., 52 Stat. 1040 et seq., or amendments thereto; (16) "Filled milk" means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, frozen, powdered, dried, or desiccated, to which has been <br>added, or which has been blended or compounded with, any fat or oil other than <br>milk fat, except the fat or oil of contained eggs and nuts and the fat or oil of <br>substances used for flavoring purposes only, so that the resulting product is an <br>imitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or <br>frozen desserts, whether or not condensed, evaporated, concentrated, frozen, <br>powdered, dried, or desiccated, whether in bulk or in containers, hermetically sealed <br>or unsealed. This definition does not mean or include any milk or cream from which <br>no part of the milk or butter fat has been extracted, whether or not condensed, <br>evaporated, concentrated, powdered, dried, or desiccated, to which has been added <br>any substance rich in vitamins, nor any distinctive proprietary food compound not <br>readily mistaken for milk or cream or for condensed, evaporated, concentrated, <br>powdered, dried, or desiccated milk or cream, if the compound is prepared and <br>designed for the feeding of infants or young children, sick or infirm persons, and <br>customarily used on the order of a physician, and is packed in individual containers <br>bearing a label in bold type that the contents are to be used for those purposes; nor shall this definition prevent the use, blending, or compounding of chocolate as a <br>flavor with milk, cream, or skimmed milk, desiccated, whether in bulk or in <br>containers, hermetically sealed or unsealed, to or with which has been added, <br>blended or compounded no other fat or oil other than milk or butter fat; (17) "Flour" means only the foods commonly known as flour, white flour, wheat flour, plain flour, bromated flour, self-rising flour, self-rising white flour, self-rising <br>wheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour, <br>defined under the federal act; (18) "Food" means: (a) Articles used for food or drink for man or other animals; <br>(b) Chewing gum; and <br>(c) Articles used for components of any such article; (19) "Food additive" means any substance the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or <br>otherwise affecting the characteristics of any food, including any substance intended <br>for use in producing, manufacturing, packing, processing, preparing, treating, <br>packaging, transporting, or holding food; and including any source of radiation <br>intended for any of these uses, if the substance is not generally recognized, among <br>experts qualified by scientific training and experience to evaluate its safety, as <br>having been adequately shown through scientific procedures or, in the case of a <br>substance used in a food prior to January 1, 1958, through either scientific <br>procedures or experience based on common use in food to be safe under the <br>conditions of its intended use; except that the term does not include: <br>(a) A pesticide chemical in or on a raw agricultural commodity; <br>(b) A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; (c) A color additive; or <br>(d) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the <br>federal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.; or <br>the Meat Inspection Act of 1907; and amendments thereto; (20) "Food processing establishment" means any commercial establishment in which food is manufactured, processed, or packaged for human consumption, but does not <br>include retail food establishments, home-based processors, or home-based <br>microprocessors; (21) "Food service establishment" means any fixed or mobile commercial establishment that engages in the preparation and serving of ready-to-eat foods in portions to the <br>consumer, including but not limited to: restaurants; coffee shops; cafeterias; short <br>order cafes; luncheonettes; grills; tea rooms; sandwich shops; soda fountains; <br>taverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding <br>establishments; private, public or nonprofit organizations or institutions routinely <br>serving food; catering kitchens; commissaries; charitable food kitchens; or similar <br>places in which food is prepared for sale or service on the premises or elsewhere with or without charge. It does not include food vending machines, establishments <br>serving beverages only in single service or original containers, or retail food stores <br>which only cut, slice, and prepare cold-cut sandwiches for individual consumption; (22) "Food storage warehouse" means any establishment in which food is stored for subsequent distribution; (23) "Immediate container" does not include package liners; <br>(24) "Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, <br>practice, circumstance, or event creates a situation that requires immediate <br>correction or cessation of operation to prevent illness or injury based on: <br>(a) The number of potential illnesses or injuries; or <br>(b) The nature, severity, and duration of the anticipated illness or injury; (25) "Interference" means threatening or otherwise preventing the performance of lawful inspections or duties by agents of the cabinet during all reasonable times of <br>operation; (26) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of KRS <br>217.005 to 217.215 that any word, statement, or other information appearing on the <br>label shall not be considered to be complied with unless the word, statement, or <br>other information also appears on the outside container or wrapper, if any there be, <br>of the retail package of the article, or is easily legible through the outside container <br>or wrapper; (27) "Labeling" means all labels and other written, printed, or graphic matter: (a) Upon an article or any of its containers or wrappers; or <br>(b) Accompanying the article; (28) "Legend drug" means a drug defined by the Federal Food, Drug and Cosmetic Act, as amended, and under which definition its label is required to bear the statement <br>"Caution: Federal law prohibits dispensing without prescription."; (29) "Meat Inspection Act" means the Federal Meat Inspection Act, 21 U.S.C. secs. 71 et seq., 34 Stat. 1260 et seq., including any amendments thereto; (30) "New drug" means: (a) Any drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to <br>evaluate the safety of drugs as safe for use under the conditions prescribed, <br>recommended, or suggested in the labeling thereof; or (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under prescribed conditions, has <br>become so recognized, but which has not, otherwise than in the investigations, <br>been used to a material extent or for a material time under the conditions; (31) "Official compendium" means the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, official national formulary, or any <br>supplement to any of them; (32) "Person" means an individual, firm, partnership, company, corporation, trustee, association, or any public or private entity; (33) "Pesticide chemical" means any substance that alone in chemical combination, or in formulation with one or more other substances, is an "economic poison" within the <br>meaning of the Federal Insecticide, Fungicide and Rodenticide Act and amendments <br>thereto, and that is used in the production, storage, or transportation of raw <br>agricultural commodities; (34) "Poultry Products Inspection Act" means the Federal Poultry and Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq., Pub. L. 85-172, 71 Stat. 441, and any <br>amendments thereto; (35) "Practitioner" means medical or osteopathic physicians, dentists, chiropodists, and veterinarians who are licensed under the professional licensing laws of Kentucky to <br>prescribe and administer drugs and devices. "Practitioner" includes optometrists <br>when administering or prescribing pharmaceutical agents authorized in KRS <br>320.240(12) to (14), advanced practice registered nurses as authorized in KRS <br>314.011 and 314.042, physician assistants when administering or prescribing <br>pharmaceutical agents as authorized in KRS 311.858, and health care professionals <br>who are residents of and actively practicing in a state other than Kentucky and who <br>are licensed and have prescriptive authority under the professional licensing laws of <br>another state, unless the person's Kentucky license has been revoked, suspended, <br>restricted, or probated, in which case the terms of the Kentucky license shall <br>prevail; (36) "Prescription" means a written or oral order for a drug or medicine, or combination or mixture of drugs or medicines, or proprietary preparation, that is signed, given, or <br>authorized by a medical, dental, chiropody, veterinarian, or optometric practitioner, <br>and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of <br>disease in man or other animals; (37) "Prescription blank" means a document that conforms with KRS 217.216 and is intended for prescribing a drug to an ultimate user; (38) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural <br>form prior to marketing; (39) "Retail food establishment" means any food service establishment, retail food store, or a combination of both within the same establishment; (40) "Retail food store" means any fixed or mobile establishment where food or food products, including prepackaged, labeled sandwiches or other foods to be heated in <br>a microwave or infrared oven at the time of purchase, are offered for sale to the <br>consumer, and intended for off-premises consumption, but does not include <br>establishments which handle only prepackaged, snack-type, nonpotentially <br>hazardous foods, markets that offer only fresh fruits and vegetables for sale, food <br>service establishments, food and beverage vending machines, vending machine <br>commissaries, or food processing establishments; (41) "Salvage distributor" means a person who engages in the business of distributing, peddling, or otherwise trafficking in any salvaged merchandise; (42) "Salvage processing plant" means an establishment operated by a person engaged in the business of reconditioning, labeling, relabeling, repackaging, recoopering, <br>sorting, cleaning, culling or who by other means salvages, sells, offers for sale, or <br>distributes for human or animal consumption or use any salvaged food, beverage, <br>including beer, wine and distilled spirits, vitamins, food supplements, dentifices, <br>cosmetics, single-service food containers or utensils, containers and packaging <br>materials used for foods and cosmetics, soda straws, paper napkins, or any other <br>product of a similar nature that has been damaged or contaminated by fire, water, <br>smoke, chemicals, transit, or by any other means; (43) "Second or subsequent offense" has the same meaning as it does in KRS 218A.010; <br>(44) "Secretary" means the secretary of the Cabinet for Health and Family Services; <br>(45) "Temporary food service establishment" means any food service establishment which operates at a fixed location for a period of time, not to exceed fourteen (14) <br>consecutive days; (46) "Traffic" has the same meaning as it does in KRS 218A.010; <br>(47) "Ultimate user" has the same meaning as it does in KRS 218A.010; <br>(48) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, in determining whether <br>the labeling or advertisement is misleading, there shall be taken into account, <br>among other things, not only representations made or suggested by statement, word, <br>design, device, sound, or in any combination thereof, but also the extent to which <br>the labeling or advertisement fails to reveal facts that are material in the light of the <br>representations or material with respect to consequences which may result from the <br>use of the article to which the labeling or advertisement relates under the conditions <br>of use prescribed in the labeling or advertisement thereof or under the conditions of <br>use as are customary or usual; (49) The representation of a drug in its labeling or advertisement as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug <br>purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, <br>ointment, dusting powder, or other use involving prolonged contact with the body; (50) The provisions of KRS 217.005 to 217.215 regarding the selling of food, drugs, devices, or cosmetics shall be considered to include the manufacture, production, <br>processing, packing, exposure, offer, possession, and holding of those articles for <br>sale, the sale, dispensing, and giving of those articles, and the supplying or applying <br>of those articles in the conduct of any food, drug, or cosmetic establishment; (51) "Home" means a primary residence occupied by the processor, that contains only two (2) ranges, ovens, or double-ovens, and no more than three (3) refrigerators <br>used for cold storage. This equipment shall have been designed for home use and <br>not for commercial use, and shall be operated in the kitchen within the residence; (52) "Formulated acid food product" means an acid food in which the addition of a small amount of low-acid food results in a finished equilibrium pH of 4.6 or below that <br>does not significantly differ from that of the predominant acid or acid food; (53) "Acidified food product" means a low-acid food to which acid or acidic food is added and which has a water activity value greater than 0.85, and a finished <br>equilibrium pH of 4.6 or below; (54) "Low-acid food" means foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6, and a water activity value greater than 0.85; (55) "Acid food" means foods that have a natural pH of 4.6 or below; <br>(56) "Home-based processor" means a farmer who, in the farmer's home, produces or processes whole fruit and vegetables, mixed-greens, jams, jellies, sweet sorghum <br>syrup, preserves, fruit butter, bread, fruit pies, cakes, or cookies; (57) "Home-based microprocessor" means a farmer who, in the farmer's home or certified or permitted kitchen, produces or processes acid foods, formulated acid <br>food products, acidified food products, or low-acid canned foods, and who has a net <br>income of less than thirty-five thousand dollars ($35,000) annually from the sale of <br>the product; (58) "Certified" means any person or home-based microprocessor who: (a) Has attended the Kentucky Cooperative Extension Service's microprocessing program or pilot microprocessing program and has been identified by the <br>Kentucky Cooperative Extension Service as having satisfactorily completed <br>the prescribed course of instruction; or (b) Has attended some other school pursuant to 21 C.F.R. sec. 114.10; (59) "Farmer" means a person who is a resident of Kentucky and owns or rents agricultural land pursuant to subsection (9) of KRS 132.010 or horticultural land <br>pursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to <br>217.139, "farmer" also means any person who is a resident of Kentucky and has <br>grown the primary horticultural and agronomic ingredients used in the home-based <br>processed products which they have produced; and (60) "Farmers market temporary food service establishment" means any temporary food service establishment operated by a farmer who is a member of the market which <br>operates within the confines of a farmers market registered with the Kentucky <br>Department of Agriculture for the direct-to-consumer marketing of Kentucky-grown <br>farm products from approved sources for a period of time not to exceed two (2) <br>days per week for any consecutive six (6) months period in a calendar year. Effective: July 15, 2010 <br>History: Amended 2010 Ky. Acts ch. 85, sec. 41, effective July 15, 2010.-- Amended 2007 Ky. Acts ch. 97, sec. 1, effective March 23, 2007. -- Amended 2005 Ky. Acts <br>ch. 99, sec. 512, effective June 20, 2005. -- Amended 2003 Ky. Acts ch. 42, sec. 1, <br>effective June 24, 2003; and ch. 51, sec. 1, effective June 24, 2003. -- Amended 2002 <br>Ky. Acts ch. 130, sec. 35, effective July 15, 2002. - Amended 2000 Ky. Acts ch. 361, <br>sec. 17, effective July 14, 2000. -- Amended 1998 Ky. Acts ch. 7, sec. 1, effective <br>February 19, 1998, retroactive to January 1, 1998; ch. 228, sec. 7, effective July 15, <br>1998; ch. 297, sec. 1, effective July 15, 1998; ch. 301, sec. 1, effective July 15, 1998; and ch. 426, sec. 456, effective July 15, 1998. -- Amended 1996 Ky. Acts Ky. Acts <br>ch. 342, sec. 5, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 458, sec. 1, <br>effective July 13, 1990. -- Amended 1986 Ky. Acts ch. 12, sec. 4, effective July 15, <br>1986. -- Amended 1982 Ky. Acts ch. 247, sec. 10, effective July 15, 1982. -- <br>Amended 1978 Ky. Acts ch. 179, sec. 4, effective June 17, 1978; and ch. 292, sec. 1, <br>effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (10) <br>and (11). - Created 1960 Ky. Acts ch. 247, sec. 2.
217.015 Definitions for KRS 217.005 to 217.215. For the purposes of KRS 217.005 to 217.215: <br>(1) "Advertisement" means all representations, disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to <br>induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; (2) "Bread" and "enriched bread" mean only the foods commonly known and described as white bread, white rolls, white buns, enriched white bread, enriched rolls, and <br>enriched white buns, as defined under the federal act. For the purposes of KRS <br>217.136 and 217.137, "bread" or "enriched bread" also means breads that may <br>include vegetables or fruit as an ingredient; (3) "Cabinet" means the Cabinet for Health and Family Services or its designee; <br>(4) "Color" means but is not limited to black, white, and intermediate grays; <br>(5) "Color additive" means a material that: (a) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without <br>intermediate or final change of identity, from a vegetable, animal, mineral, or <br>other source. Nothing in this paragraph shall be construed to apply to any <br>pesticide chemical, soil or plant nutrient, or other agricultural chemical solely <br>because of its effect in aiding, retarding, or otherwise affecting, directly or <br>indirectly, the growth or other natural physiological process of produce of the <br>soil and thereby affecting its color, whether before or after harvest; or (b) When added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable, alone or through reaction with another substance, <br>of imparting color. "Color additive" does not include any material that has <br>been or may in the future be exempted under the federal act; (6) "Contaminated with filth" means any food, drug, device, or cosmetic that is not securely protected from dust, dirt, and as far as may be necessary by all reasonable <br>means, from all foreign or injurious contaminants; (7) "Cosmetic" means: (a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, <br>beautifying, promoting attractiveness, or altering the appearance; and (b) Articles intended for use as a component of those articles, except that the term shall not include soap; (8) "Device," except when used in subsection (48) of this section, KRS 217.035(6), KRS 217.065(3), KRS 217.095(3), and KRS 217.175(10), means instruments, <br>apparatus, and contrivances, including their components, parts, and accessories, <br>intended: <br>(a) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (b) To affect the structure or any function of the body of man or other animals; (9) "Dispense" means to deliver a drug or device to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the packaging, <br>labeling, or compounding necessary to prepare the substance for that delivery; (10) "Dispenser" means a person who lawfully dispenses a drug or device to or for the use of an ultimate user; (11) "Drug" means: (a) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national <br>formulary, or any supplement to any of them; (b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (c) Articles, other than food, intended to affect the structure or any function of the body of man or other animals; and (d) Articles intended for use as a component of any article specified in this subsection but does not include devices or their components, parts, or <br>accessories; (12) "Enriched," as applied to flour, means the addition to flour of vitamins and other nutritional ingredients necessary to make it conform to the definition and standard <br>of enriched flour as defined under the federal act; (13) "Environmental Pesticide Control Act of 1972" means the Federal Environmental Pesticide Control Act of 1972, Pub. L. 92-516, and all amendments thereto; (14) "Fair Packaging and Labeling Act" means the Fair Packaging and Labeling Act as it relates to foods and cosmetics, 15 U.S.C. secs. 1451 et seq., and all amendments <br>thereto; (15) "Federal act" means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301 et seq., 52 Stat. 1040 et seq., or amendments thereto; (16) "Filled milk" means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, frozen, powdered, dried, or desiccated, to which has been <br>added, or which has been blended or compounded with, any fat or oil other than <br>milk fat, except the fat or oil of contained eggs and nuts and the fat or oil of <br>substances used for flavoring purposes only, so that the resulting product is an <br>imitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or <br>frozen desserts, whether or not condensed, evaporated, concentrated, frozen, <br>powdered, dried, or desiccated, whether in bulk or in containers, hermetically sealed <br>or unsealed. This definition does not mean or include any milk or cream from which <br>no part of the milk or butter fat has been extracted, whether or not condensed, <br>evaporated, concentrated, powdered, dried, or desiccated, to which has been added <br>any substance rich in vitamins, nor any distinctive proprietary food compound not <br>readily mistaken for milk or cream or for condensed, evaporated, concentrated, <br>powdered, dried, or desiccated milk or cream, if the compound is prepared and <br>designed for the feeding of infants or young children, sick or infirm persons, and <br>customarily used on the order of a physician, and is packed in individual containers <br>bearing a label in bold type that the contents are to be used for those purposes; nor shall this definition prevent the use, blending, or compounding of chocolate as a <br>flavor with milk, cream, or skimmed milk, desiccated, whether in bulk or in <br>containers, hermetically sealed or unsealed, to or with which has been added, <br>blended or compounded no other fat or oil other than milk or butter fat; (17) "Flour" means only the foods commonly known as flour, white flour, wheat flour, plain flour, bromated flour, self-rising flour, self-rising white flour, self-rising <br>wheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour, <br>defined under the federal act; (18) "Food" means: (a) Articles used for food or drink for man or other animals; <br>(b) Chewing gum; and <br>(c) Articles used for components of any such article; (19) "Food additive" means any substance the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or <br>otherwise affecting the characteristics of any food, including any substance intended <br>for use in producing, manufacturing, packing, processing, preparing, treating, <br>packaging, transporting, or holding food; and including any source of radiation <br>intended for any of these uses, if the substance is not generally recognized, among <br>experts qualified by scientific training and experience to evaluate its safety, as <br>having been adequately shown through scientific procedures or, in the case of a <br>substance used in a food prior to January 1, 1958, through either scientific <br>procedures or experience based on common use in food to be safe under the <br>conditions of its intended use; except that the term does not include: <br>(a) A pesticide chemical in or on a raw agricultural commodity; <br>(b) A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; (c) A color additive; or <br>(d) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the <br>federal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.; or <br>the Meat Inspection Act of 1907; and amendments thereto; (20) "Food processing establishment" means any commercial establishment in which food is manufactured, processed, or packaged for human consumption, but does not <br>include retail food establishments, home-based processors, or home-based <br>microprocessors; (21) "Food service establishment" means any fixed or mobile commercial establishment that engages in the preparation and serving of ready-to-eat foods in portions to the <br>consumer, including but not limited to: restaurants; coffee shops; cafeterias; short <br>order cafes; luncheonettes; grills; tea rooms; sandwich shops; soda fountains; <br>taverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding <br>establishments; private, public or nonprofit organizations or institutions routinely <br>serving food; catering kitchens; commissaries; charitable food kitchens; or similar <br>places in which food is prepared for sale or service on the premises or elsewhere with or without charge. It does not include food vending machines, establishments <br>serving beverages only in single service or original containers, or retail food stores <br>which only cut, slice, and prepare cold-cut sandwiches for individual consumption; (22) "Food storage warehouse" means any establishment in which food is stored for subsequent distribution; (23) "Immediate container" does not include package liners; <br>(24) "Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, <br>practice, circumstance, or event creates a situation that requires immediate <br>correction or cessation of operation to prevent illness or injury based on: <br>(a) The number of potential illnesses or injuries; or <br>(b) The nature, severity, and duration of the anticipated illness or injury; (25) "Interference" means threatening or otherwise preventing the performance of lawful inspections or duties by agents of the cabinet during all reasonable times of <br>operation; (26) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of KRS <br>217.005 to 217.215 that any word, statement, or other information appearing on the <br>label shall not be considered to be complied with unless the word, statement, or <br>other information also appears on the outside container or wrapper, if any there be, <br>of the retail package of the article, or is easily legible through the outside container <br>or wrapper; (27) "Labeling" means all labels and other written, printed, or graphic matter: (a) Upon an article or any of its containers or wrappers; or <br>(b) Accompanying the article; (28) "Legend drug" means a drug defined by the Federal Food, Drug and Cosmetic Act, as amended, and under which definition its label is required to bear the statement <br>"Caution: Federal law prohibits dispensing without prescription."; (29) "Meat Inspection Act" means the Federal Meat Inspection Act, 21 U.S.C. secs. 71 et seq., 34 Stat. 1260 et seq., including any amendments thereto; (30) "New drug" means: (a) Any drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to <br>evaluate the safety of drugs as safe for use under the conditions prescribed, <br>recommended, or suggested in the labeling thereof; or (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under prescribed conditions, has <br>become so recognized, but which has not, otherwise than in the investigations, <br>been used to a material extent or for a material time under the conditions; (31) "Official compendium" means the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, official national formulary, or any <br>supplement to any of them; (32) "Person" means an individual, firm, partnership, company, corporation, trustee, association, or any public or private entity; (33) "Pesticide chemical" means any substance that alone in chemical combination, or in formulation with one or more other substances, is an "economic poison" within the <br>meaning of the Federal Insecticide, Fungicide and Rodenticide Act and amendments <br>thereto, and that is used in the production, storage, or transportation of raw <br>agricultural commodities; (34) "Poultry Products Inspection Act" means the Federal Poultry and Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq., Pub. L. 85-172, 71 Stat. 441, and any <br>amendments thereto; (35) "Practitioner" means medical or osteopathic physicians, dentists, chiropodists, and veterinarians who are licensed under the professional licensing laws of Kentucky to <br>prescribe and administer drugs and devices. "Practitioner" includes optometrists <br>when administering or prescribing pharmaceutical agents authorized in KRS <br>320.240(12) to (14), advanced practice registered nurses as authorized in KRS <br>314.011 and 314.042, physician assistants when administering or prescribing <br>pharmaceutical agents as authorized in KRS 311.858, and health care professionals <br>who are residents of and actively practicing in a state other than Kentucky and who <br>are licensed and have prescriptive authority under the professional licensing laws of <br>another state, unless the person's Kentucky license has been revoked, suspended, <br>restricted, or probated, in which case the terms of the Kentucky license shall <br>prevail; (36) "Prescription" means a written or oral order for a drug or medicine, or combination or mixture of drugs or medicines, or proprietary preparation, that is signed, given, or <br>authorized by a medical, dental, chiropody, veterinarian, or optometric practitioner, <br>and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of <br>disease in man or other animals; (37) "Prescription blank" means a document that conforms with KRS 217.216 and is intended for prescribing a drug to an ultimate user; (38) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural <br>form prior to marketing; (39) "Retail food establishment" means any food service establishment, retail food store, or a combination of both within the same establishment; (40) "Retail food store" means any fixed or mobile establishment where food or food products, including prepackaged, labeled sandwiches or other foods to be heated in <br>a microwave or infrared oven at the time of purchase, are offered for sale to the <br>consumer, and intended for off-premises consumption, but does not include <br>establishments which handle only prepackaged, snack-type, nonpotentially <br>hazardous foods, markets that offer only fresh fruits and vegetables for sale, food <br>service establishments, food and beverage vending machines, vending machine <br>commissaries, or food processing establishments; (41) "Salvage distributor" means a person who engages in the business of distributing, peddling, or otherwise trafficking in any salvaged merchandise; (42) "Salvage processing plant" means an establishment operated by a person engaged in the business of reconditioning, labeling, relabeling, repackaging, recoopering, <br>sorting, cleaning, culling or who by other means salvages, sells, offers for sale, or <br>distributes for human or animal consumption or use any salvaged food, beverage, <br>including beer, wine and distilled spirits, vitamins, food supplements, dentifices, <br>cosmetics, single-service food containers or utensils, containers and packaging <br>materials used for foods and cosmetics, soda straws, paper napkins, or any other <br>product of a similar nature that has been damaged or contaminated by fire, water, <br>smoke, chemicals, transit, or by any other means; (43) "Second or subsequent offense" has the same meaning as it does in KRS 218A.010; <br>(44) "Secretary" means the secretary of the Cabinet for Health and Family Services; <br>(45) "Temporary food service establishment" means any food service establishment which operates at a fixed location for a period of time, not to exceed fourteen (14) <br>consecutive days; (46) "Traffic" has the same meaning as it does in KRS 218A.010; <br>(47) "Ultimate user" has the same meaning as it does in KRS 218A.010; <br>(48) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, in determining whether <br>the labeling or advertisement is misleading, there shall be taken into account, <br>among other things, not only representations made or suggested by statement, word, <br>design, device, sound, or in any combination thereof, but also the extent to which <br>the labeling or advertisement fails to reveal facts that are material in the light of the <br>representations or material with respect to consequences which may result from the <br>use of the article to which the labeling or advertisement relates under the conditions <br>of use prescribed in the labeling or advertisement thereof or under the conditions of <br>use as are customary or usual; (49) The representation of a drug in its labeling or advertisement as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug <br>purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, <br>ointment, dusting powder, or other use involving prolonged contact with the body; (50) The provisions of KRS 217.005 to 217.215 regarding the selling of food, drugs, devices, or cosmetics shall be considered to include the manufacture, production, <br>processing, packing, exposure, offer, possession, and holding of those articles for <br>sale, the sale, dispensing, and giving of those articles, and the supplying or applying <br>of those articles in the conduct of any food, drug, or cosmetic establishment; (51) "Home" means a primary residence occupied by the processor, that contains only two (2) ranges, ovens, or double-ovens, and no more than three (3) refrigerators <br>used for cold storage. This equipment shall have been designed for home use and <br>not for commercial use, and shall be operated in the kitchen within the residence; (52) "Formulated acid food product" means an acid food in which the addition of a small amount of low-acid food results in a finished equilibrium pH of 4.6 or below that <br>does not significantly differ from that of the predominant acid or acid food; (53) "Acidified food product" means a low-acid food to which acid or acidic food is added and which has a water activity value greater than 0.85, and a finished <br>equilibrium pH of 4.6 or below; (54) "Low-acid food" means foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6, and a water activity value greater than 0.85; (55) "Acid food" means foods that have a natural pH of 4.6 or below; <br>(56) "Home-based processor" means a farmer who, in the farmer's home, produces or processes whole fruit and vegetables, mixed-greens, jams, jellies, sweet sorghum <br>syrup, preserves, fruit butter, bread, fruit pies, cakes, or cookies; (57) "Home-based microprocessor" means a farmer who, in the farmer's home or certified or permitted kitchen, produces or processes acid foods, formulated acid <br>food products, acidified food products, or low-acid canned foods, and who has a net <br>income of less than thirty-five thousand dollars ($35,000) annually from the sale of <br>the product; (58) "Certified" means any person or home-based microprocessor who: (a) Has attended the Kentucky Cooperative Extension Service's microprocessing program or pilot microprocessing program and has been identified by the <br>Kentucky Cooperative Extension Service as having satisfactorily completed <br>the prescribed course of instruction; or (b) Has attended some other school pursuant to 21 C.F.R. sec. 114.10; (59) "Farmer" means a person who is a resident of Kentucky and owns or rents agricultural land pursuant to subsection (9) of KRS 132.010 or horticultural land <br>pursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to <br>217.139, "farmer" also means any person who is a resident of Kentucky and has <br>grown the primary horticultural and agronomic ingredients used in the home-based <br>processed products which they have produced; and (60) "Farmers market temporary food service establishment" means any temporary food service establishment operated by a farmer who is a member of the market which <br>operates within the confines of a farmers market registered with the Kentucky <br>Department of Agriculture for the direct-to-consumer marketing of Kentucky-grown <br>farm products from approved sources for a period of time not to exceed two (2) <br>days per week for any consecutive six (6) months period in a calendar year. Effective: July 15, 2010 <br>History: Amended 2010 Ky. Acts ch. 85, sec. 41, effective July 15, 2010.-- Amended 2007 Ky. Acts ch. 97, sec. 1, effective March 23, 2007. -- Amended 2005 Ky. Acts <br>ch. 99, sec. 512, effective June 20, 2005. -- Amended 2003 Ky. Acts ch. 42, sec. 1, <br>effective June 24, 2003; and ch. 51, sec. 1, effective June 24, 2003. -- Amended 2002 <br>Ky. Acts ch. 130, sec. 35, effective July 15, 2002. - Amended 2000 Ky. Acts ch. 361, <br>sec. 17, effective July 14, 2000. -- Amended 1998 Ky. Acts ch. 7, sec. 1, effective <br>February 19, 1998, retroactive to January 1, 1998; ch. 228, sec. 7, effective July 15, <br>1998; ch. 297, sec. 1, effective July 15, 1998; ch. 301, sec. 1, effective July 15, 1998; and ch. 426, sec. 456, effective July 15, 1998. -- Amended 1996 Ky. Acts Ky. Acts <br>ch. 342, sec. 5, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 458, sec. 1, <br>effective July 13, 1990. -- Amended 1986 Ky. Acts ch. 12, sec. 4, effective July 15, <br>1986. -- Amended 1982 Ky. Acts ch. 247, sec. 10, effective July 15, 1982. -- <br>Amended 1978 Ky. Acts ch. 179, sec. 4, effective June 17, 1978; and ch. 292, sec. 1, <br>effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (10) <br>and (11). - Created 1960 Ky. Acts ch. 247, sec. 2.
