KRS ch. 217 | Kentucky Revised Statutes, Chapter 217 — Foods, Drugs, and Poisons

Title XVIII — Public Health

Includes enactments through the 2026 Regular Session.

The KRS database was last updated on 2026-09-01.

Title XVIII Public Health

Chapter 217 Foods, Drugs, and Poisons

217.002 Individuals exempt from application of chapter.

The provisions of this chapter shall not apply to common carriers or to warehousemen, while engaged in lawfully transporting or storing legend drugs, or to any of their employees acting within the scope of their employment; or to public officers or their employees in the performance of their official duties requiring possession or control of legend drugs; or to temporary incidental possession by employees or agents of persons lawfully entitled to possession, or by persons whose possession is for the purpose of aiding public officers in performing their official duties.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 28, effective July 15, 1998.

Food, Drug and Cosmetic Act Food, Drug and Cosmetic Act

217.005 Citation of KRS 217.005 to 217.215.

KRS 217.005 to 217.215 may be cited as the Kentucky Food, Drug and Cosmetic Act.

Effective: History through 1968: Created 1960 Ky. Acts ch. 247, sec. 1.

217.006 Applicability of definitions in KRS 516.010 to KRS 217.207, 217.208, and 217.209.

For purposes of KRS 217.207, 217.208, and 217.209, the definitions found in KRS 516.010 apply.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 7, effective July 15, 1998.

217.007 Applicability of penalties in KRS Chapter 506 to KRS 217.005 to 217.215.

Unless this chapter provides a specific penalty for the same act, the provisions of KRS Chapter 506 shall apply to offenses under KRS 217.005 to 217.215.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 10, effective July 15, 1998.

217.010 Repealed, 1960.

[Repealed]

217.015 Definitions for KRS 217.005 to 217.215.

For the purposes of KRS 217.005 to 217.215:

(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 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 enriched white buns, as defined under the federal act. For the purposes of KRS 217.136 and 217.137, "bread" or "enriched bread" also means breads that may include vegetables or fruit as an ingredient;

(3) "Cabinet" means the Cabinet for Health and Family Services or its designee;

(4) "Color" means but is not limited to black, white, and intermediate grays;

(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 intermediate or final change of identity, from a vegetable, animal, mineral, or other source. This paragraph shall not be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the 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, of imparting color. "Color additive" does not include any material that has 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 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, 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, apparatus, and contrivances, including their components, parts, and accessories, intended:

(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, 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 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;

(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 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 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 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 added, or which has been blended or compounded with, any fat or oil other than milk fat, except the fat or oil of contained eggs and nuts and the fat or oil of substances used for flavoring purposes only, so that the resulting product is an imitation or semblance of milk, cream, skimmed milk, ice cream mix, ice cream, or frozen desserts, whether or not condensed, evaporated, concentrated, frozen, powdered, dried, or desiccated, whether in bulk or in containers, hermetically sealed or unsealed. This definition does not mean or include any milk or cream from which no part of the milk or butter fat has been extracted, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has been added any substance rich in vitamins, nor any distinctive proprietary food compound not readily mistaken for milk or cream or for condensed, evaporated, concentrated, powdered, dried, or desiccated milk or cream, if the compound is prepared and designed for the feeding of infants or young children, sick or infirm persons, and customarily used on the order of a physician, and is packed in individual containers 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 flavor with milk, cream, or skimmed milk, desiccated, whether in bulk or in containers, hermetically sealed or unsealed, to or with which has been added, 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 wheat flour, phosphated flour, phosphated white flour, and phosphated wheat flour, defined under the federal act;

(18) "Food" means:

(a) Articles used for food or drink for man or other animals;

(b) Chewing gum; and

(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 otherwise affecting the characteristics of any food, including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any of these uses, if the substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food to be safe under the conditions of its intended use; except that the term does not include:

(a) A pesticide chemical in or on a raw agricultural commodity;

(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;

(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 federal act; the Poultry Products Inspection Act, 21 U.S.C. secs. 451 et seq.; or 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 include retail food establishments, home-based processors, or home-based 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 consumer, including but not limited to: restaurants; coffee shops; cafeterias; short order cafes; luncheonettes; grills; tea rooms; sandwich shops; soda fountains; taverns; bars; cocktail lounges; nightclubs; roadside stands; industrial feeding establishments; private, public or nonprofit organizations or institutions routinely serving food; catering kitchens; commissaries; charitable food kitchens; or similar 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 serving beverages only in single service or original containers, or retail food stores 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;

(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, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent illness or injury based on:

(a) The number of potential illnesses or injuries; or

(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 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 217.005 to 217.215 that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of the article, or is easily legible through the outside container 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

(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 "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 evaluate the safety of drugs as safe for use under the conditions prescribed, 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 become so recognized, but which has not, otherwise than in the investigations, 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 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 meaning of the Federal Insecticide, Fungicide and Rodenticide Act and amendments thereto, and that is used in the production, storage, or transportation of raw 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 amendments thereto;

(35) "Practitioner" means medical or osteopathic physicians, dentists, chiropodists, and veterinarians who are licensed under the professional licensing laws of Kentucky to prescribe and administer drugs and devices. "Practitioner" includes optometrists when administering or prescribing pharmaceutical agents authorized in KRS 320.240(12) to (14), advanced practice registered nurses as authorized in KRS 314.011 and 314.042, physician assistants when administering or prescribing pharmaceutical agents as authorized in KRS 311.858, and health care professionals who are residents of and actively practicing in a state other than Kentucky and who are licensed and have prescriptive authority under the professional licensing laws of another state, unless the person's Kentucky license has been revoked, suspended, restricted, or probated, in which case the terms of the Kentucky license shall 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 authorized by a medical, advanced practice registered nurse, dental, chiropody, veterinarian, or optometric practitioner, and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of 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 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 a microwave or infrared oven at the time of purchase, are offered for sale to the consumer, and intended for off-premises consumption, but does not include establishments which handle only prepackaged, snack-type, nonpotentially hazardous foods, markets that offer only fresh fruits and vegetables for sale, food service establishments, food and beverage vending machines, vending machine commissaries, food processing establishments, or home-based processors;

(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, sorting, cleaning, culling or who by other means salvages, sells, offers for sale, or distributes for human or animal consumption or use any salvaged food, beverage, including beer, wine and distilled spirits, vitamins, food supplements, dentifices, cosmetics, single-service food containers or utensils, containers and packaging materials used for foods and cosmetics, soda straws, paper napkins, or any other product of a similar nature that has been damaged or contaminated by fire, water, smoke, chemicals, transit, or by any other means;

(43) "Second or subsequent offense" has the same meaning as it does in KRS 218A.010;

(44) "Secretary" means the secretary of the Cabinet for Health and Family Services;

(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) consecutive days;

(46) "Traffic" has the same meaning as it does in KRS 218A.010;

(47) "Ultimate user" has the same meaning as it does in KRS 218A.010;

(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 the labeling or advertisement is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts that are material in the light of the representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under the conditions of 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 purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, 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, processing, packing, exposure, offer, possession, and holding of those articles for sale, the sale, dispensing, and giving of those articles, and the supplying or applying 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 used for cold storage. This equipment shall have been designed for home use and 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 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 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;

(56) "Home-based processor" means a person who in his or her home, produces or processes pork lard or tallow-based cosmetic products or nonpotentially hazardous foods, including but not limited to dried herbs, spices, nuts, candy, dried grains, whole fruit and vegetables, mixed-greens, jams, jellies, sweet sorghum syrup, preserves, fruit butter, bread, fruit pies, cakes, or cookies, and who has a gross income of no more than sixty thousand dollars ($60,000) annually from the sale of the products;

(57) "Home-based microprocessor" means a farmer who, in the farmer's home or certified or permitted kitchen, produces or processes foods, including but not limited to acid foods, formulated acid food products, acidified food products, or low-acid canned foods, and who has a gross income of no more than sixty thousand dollars ($60,000) annually from the sale of 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 Kentucky Cooperative Extension Service as having satisfactorily completed 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 pursuant to subsection (10) of KRS 132.010. For the purposes of KRS 217.136 to 217.139, "farmer" also means any person who is a resident of Kentucky and has grown the primary horticultural and agronomic ingredients used in the home-based microprocessed 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 operates within the confines of a farmers market registered with the Kentucky Department of Agriculture for the direct-to-consumer marketing of Kentucky- grown farm products from approved sources for a period of time not to exceed two

(2) days per week for any consecutive six (6) months period in a calendar year.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 52, sec. 1, effective July 15, 2026. -- Amended 2019 Ky. Acts ch. 181, sec. 3, effective March 26, 2019. -- Amended 2018 Ky. Acts ch. 77, sec. 1, effective July 14, 2018. -- Amended 2015 Ky. Acts ch. 117, sec. 7, effective June 24, 2015. -- 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 ch. 99, sec. 512, effective June 20, 2005. -- Amended 2003 Ky. Acts ch. 42, sec. 1, effective June 24, 2003; and ch. 51, sec. 1, effective June 24, 2003. -- Amended 2002 Ky. Acts ch. 130, sec. 35, effective July 15, 2002. - Amended 2000 Ky. Acts ch. 361, sec. 17, effective July 14, 2000. -- Amended 1998 Ky. Acts ch. 7, sec. 1, effective February 19, 1998, retroactive to January 1, 1998; ch. 228, sec. 7, effective July 15, 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 ch. 342, sec. 5, effective July 15, 1996. -- Amended 1990 Ky. Acts ch. 458, sec. 1, effective July 13, 1990. -- Amended 1986 Ky. Acts ch. 12, sec. 4, effective July 15, 1986. -- Amended 1982 Ky. Acts ch. 247, sec. 10, effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 179, sec. 4, effective June 17, 1978; and ch. 292, sec. 1, effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (10) and (11). - Created 1960 Ky. Acts ch. 247, sec. 2.

217.020 Repealed, 1960.

[Repealed]

217.025 When food deemed adulterated.

A food shall be deemed to be adulterated:

(1) (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this subsection if the quantity of such substance in such food does not ordinarily render it injurious to health; or

(b) If it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of KRS 217.045; or

(c) If it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or

(d) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome, or injurious to health; or

(e) If it is the product of a diseased animal or an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or

(f) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(2) (a) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or

(b) If any substance has been substituted wholly or in part therefor; or

(d) If any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is;

(3) If it is confectionery and it bears or contains any nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent (0.4%), harmless natural wax not in excess of four- tenths of one percent (0.4%), harmless natural gum, and pectin; provided that this subsection shall not apply to any chewing gum by reason of its containing harmless nonnutritive masticatory substances;

(4) If it bears or contains a coal-tar color other than one from a batch which has been certified under authority of the federal act;

(5) If it is filled milk.

Effective: June 17, 1978

History: Amended 1978 Ky. Acts ch. 292, sec. 2, effective June 17, 1978. -- Created 1960 Ky. Acts ch. 247, sec. 3, effective June 16, 1960.

Legislative Research Commission Note. Although this section was included in Acts 1978, ch. 292, § 2, as having been amended, there appears to be no change in this section.

217.030 Repealed, 1960.

[Repealed]

217.035 When food deemed misbranded.

A food shall be deemed to be misbranded:

(1) If its labeling is false or misleading in any particular or its labeling or packaging fails to conform with the requirements of KRS 217.037;

(2) If it is offered for sale under the name of another food;

(3) If it is an imitation of another food for which a definition and standard of identity has been prescribed by regulations as provided by KRS 217.135; or if it is an imitation of another food that is not subject to subsection (7) of this section, unless its label bears in type of uniform size and prominence, the word, imitation, and, immediately thereafter, the name of the food imitated;

(4) If its container is so made, formed, or filled as to be misleading;

(5) If in package form, unless it bears a label containing:

(a) The name and place of business of the manufacturer, packer, or distributor;

(b) An accurate statement of the net quantity of the contents in terms of weight, measure, or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided that reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the secretary;

(6) If any word, statement, or other information required by or under authority of KRS 217.005 to 217.215 to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by KRS 217.135 unless:

(a) It conforms to such definition and standard; and

(b) Its label bears the name of the food specified in the definition and standard, and insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;

(8) If it purports to be or is represented as:

(a) A food for which a standard of quality has been prescribed by regulations as provided by KRS 217.135 and its quality falls below such standard unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(b) A food for which a standard or standards of fill of container have been prescribed by regulation as provided by KRS 217.135 and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(9) If it is not subject to the provisions of subsection (7) of this section, unless it bears labeling clearly giving:

(a) The common or usual name of the food, if any there be; and

(b) In case it is fabricated from two (2) or more ingredients, the common or usual name of each such ingredient, except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings, without naming each; provided that, to the extent that compliance with this subsection is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the secretary;

(10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the secretary determines to be, and by regulations prescribes as, necessary in order to fully inform purchasers as to its value for such uses;

(11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact; provided that to the extent that compliance with the requirements of this subsection is impracticable, exemptions shall be established by regulations promulgated by the secretary;

(12) If it is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded;

(13) If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical; provided, however, that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade;

(14) If it is a color additive unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of the federal act; or

(15) If it purports to be or is represented as meat or a meat product and it contains any cultured animal tissue produced from in vitro animal cell cultures outside of the organism from which it is derived.

Effective: June 27, 2019

History: Amended 2019 Ky. Acts ch. 42, sec. 1, effective June 27, 2019. -- Amended 1978 Ky. Acts ch. 292, sec. 3, effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 247, sec. 4, effective June 16, 1960.

217.037 Fair packaging and labeling.

Fair packaging and labeling provisions:

(1) All labels of foods and cosmetics, as defined by KRS 217.015, shall conform with the requirements for the declaration of net quantity of contents of Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. secs. 1451 et seq.) and the regulations promulgated pursuant thereto. Food and cosmetics exempted from the requirements of Section 4 of the Fair Packaging and Labeling Act shall also be exempt from this subsection;

(2) The label of any package of food which bears a representation as to the number of servings of such food contained in such package shall bear a statement of the net quantity (in terms of weight, measure, or numerical count) of each such serving;

(3) No person shall distribute or cause to be distributed in commerce any packaged food or cosmetic if any qualifying words or phrases appear in conjunction with the separate statement of the net quantity of contents. Supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure or count that tends to exaggerate the amount of food or cosmetic contained in the package;

(4) Whenever the secretary determines that regulations containing prohibitions or requirements other than those prescribed by this section are necessary to prevent the deception of consumers or to facilitate value comparisons as to any food or cosmetic, the secretary shall promulgate with respect to that food or cosmetic regulations effective to:

(a) Establish and define standards for the characterization of the size of a package enclosing any food or cosmetic which may be used to supplement the label statement of net quantity of contents of packages containing such food or cosmetic, but this paragraph shall not be construed as authorizing any limitation on the size, shape, weight, dimensions, or number of packages which may be used to enclose any food or cosmetics;

(b) Regulate the placement upon any package containing any food or cosmetic or upon any label affixed to such food or cosmetic, of any printed matter stating or representing by implication that such food or cosmetic is offered for retail sale at a price lower than the ordinary and customary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents;

The common or usual name of such food or cosmetic, if any; and
In case such food or cosmetic consists of two (2) or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or

(d) Prevent the nonfunctional slack-fill of packages containing food or cosmetics;

(e) For the purpose of paragraph (d) of this subsection, a package shall be deemed to be nonfunctionally slack-filled if it is filled of substantially less than its capacity for reasons other than:

Protection of the contents of such package; or
The requirements of machines used for enclosing the contents in such package; provided, that the secretary may adopt any regulations promulgated to comply with the Fair Packaging and Labeling Act.

Effective: June 17, 1978

History: Created 1978 Ky. Acts ch. 292, sec. 5, effective June 17, 1978.

217.039 Ingestible or cosmetic cannabidiol products -- Manufacturer or processor to be permitted -- Labeling and certificate of analysis requirements -- Cannabis-infused beverages.

(1) As used in this section:

(a) "Cannabidiol" means a non-psychoactive cannabinoid found in the hemp plant Cannabis sativa which has the chemical name 2-[(1R,6R)-3-methyl-6- prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol;

(b) "Certificate of analysis" means a document produced by a laboratory that has been accredited pursuant to standards of the International Organization for Standardization, attesting to the composition of a product. The certificate of analysis shall include but not be limited to the amount of delta-9 tetrahydrocannabinol, the amount of other cannabinoids, the amount of pesticide residues, the amount of heavy metal traces, the amount of mycotoxin contaminants, the amount of residual solvents, and the amount of microbiological contaminants;

(d) "Quick response code" or "QR code" means a type of machine-readable, two

(2) dimensional bar code that stores information about a product.

(2) A manufacturer or processor of ingestible or cosmetic cannabidiol products located in Kentucky shall:

(a) Be permitted as a food manufacturer or a cosmetic manufacturer by the cabinet and shall provide the following information:

The name of the manufacturer or processor and the physical address where production or processing occurs; and
A listing of the cannabidiol products to be produced or processed; and

(b) Obtain a certificate of analysis for all cannabidiol products to be sold or otherwise distributed in the Commonwealth.

(3) All ingestible or cosmetic cannabidiol products sold or otherwise distributed in the Commonwealth shall bear labeling to allow the consumer to access information on the product, including a certificate of analysis for the product, the location where the hemp was grown, and the address and phone number of the manufacturer or distributor using the following:

(a) A scannable bar code, including the batch number or serial number of the product;

(b) A QR code; or

(4) Any product labeling or advertising material for any ingestible or cosmetic cannabidiol product sold or otherwise distributed in the Commonwealth shall not bear any claims stating that the product can diagnose, treat, cure, or prevent any disease.

(5) The cabinet shall promulgate administrative regulations in accordance with KRS Chapter 13A to establish labeling requirements for ingestible or cosmetic cannabidiol products in accordance with of this section.

(6) (a) The cabinet shall regulate and license manufacturers of cannabis-infused beverages.

(b) After the Department of Alcoholic Beverage Control has promulgated administrative regulations under KRS 243.401 or July 1, 2026, whichever is earlier, this section shall not apply to any distributor or retailer of cannabis- infused beverages licensed under KRS Chapters 241 to 244. The distribution and retail sale of cannabis-infused beverages shall then be regulated solely by the Department of Alcoholic Beverage Control under KRS Chapter 243 and the administrative regulations promulgated thereto.

Effective: March 25, 2025

History: Amended 2025 Ky. Acts ch. 82, sec. 32, effective March 25, 2025. -- Created 2021 Ky. Acts ch. 68, sec. 1, effective June 29, 2021.

217.040 Repealed, 1960.

[Repealed]

217.045 Unsafe food additives.

Any poisonous or deleterious substance added to any food except where such substance is required in the production thereof or cannot be avoided by good production or manufacturing practice shall be deemed to be unsafe for purposes of the application of KRS 217.025(1)(b), unless a tolerance for such substance has been prescribed under the federal act or the Federal Environmental Pesticide Control Act of 1972 and the quantity of such substance in or on the food is within the tolerance so prescribed or the substance has been exempted from the requirement of a tolerance under the provisions of the federal act or the Federal Environmental Pesticide Control Act of 1972.

Effective: June 17, 1978

History: Amended 1978 Ky. Acts ch. 292, sec. 4, effective June 17, 1978. -- Created 1960 Ky. Acts ch. 247, sec. 5, effective June 16, 1960.

217.050 Repealed, 1960.

[Repealed]

217.055 When drug deemed adulterated.

A drug or device shall be deemed to be adulterated:

(1) (a) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or

(b) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) If it is a drug and its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) If it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified under the authority of the federal act;

(2) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;

(3) If it is not subject to the provisions of subsection (2) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

(4) If it is a drug and any substance has been:

(a) Mixed or packed therewith so as to reduce its quality or strength; or

(b) Substituted wholly or in part therefor.

Effective:

History: Created 1960 Ky. Acts ch. 247, sec. 6.

217.060 Repealed, 1960.

[Repealed]

217.065 When drug or device deemed misbranded.

Except for violations of KRS 218A.350, a drug or device shall be deemed to be misbranded:

(1) If its labeling is false or misleading in any particular;

(2) If in package form unless it bears a label containing:

(a) The name and place of business of the manufacturer, packer, or distributor, except that, in the case of a prescription drug, it shall bear the name and place of business of the manufacturer, and the name and place of business of the packer, or distributor, if other than the manufacturer; and

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided that reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the secretary;

(3) If any word, statement, or other information required by or under authority of KRS 217.005 to 217.215 to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, synthetic drugs, salvia, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any chemical derivative of such substance, which derivative has been by the secretary after investigation, found to be, and by regulations under KRS 217.005 to 217.215 designated as, habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning -- May be habit- forming";

(5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:

(a) The common or usual name of the drug, if such there be; and

(b) In case it is fabricated from two (2) or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including whether active or not the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; provided that to the extent that compliance with this subsection is impracticable, exemptions shall be established by regulations promulgated by the secretary;

(6) Unless its labeling bears:

(a) Adequate directions for use; and

(b) Such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users; provided that where any requirement of subsection (a) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the secretary shall promulgate regulations exempting such drug or device from such requirements;

(7) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; provided that the method of packing may be modified with a consent of the cabinet. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia;

(8) If it has been found by the cabinet to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the secretary shall by administrative regulations require as necessary for the protection of public health. No such administrative regulation shall be established for any drug recognized in an official compendium until the secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements;

(9) (a) If it is a drug and its container is so made, formed, or filled as to be misleading; or

(b) If it is an imitation of another drug; or

(10) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof;

(11) If:

(a) It is a drug intended for use by man which is a habit forming drug to which subsection (4) of this section applies; or because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner, and is not dispensed upon a prescription unless prior to dispensing its label bears the statement "Caution: Federal law prohibits dispensing without prescription"; or

(b) It is a drug or device and its label (as originally packed) directs that it is to be dispensed or sold only on prescription, unless it is dispensed or sold on a prescription of an authorized practitioner and its label (as dispensed) bears the name and place of business of the dispenser or seller, the serial number and date of such prescription, and the name of such licensed practitioner. Such prescriptions shall not be refilled except on the specific authorization of the prescribing practitioner; provided that where any requirement of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the secretary shall promulgate regulations exempting such drug or device from such requirement;

(12) A drug sold on a prescription of a practitioner (except a drug sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail) shall be exempt from the requirements of this section if:

(a) Such practitioner is licensed by law to administer such drug; and

(b) Such drug bears a label containing the name and place of business of the seller, the serial number and date of such prescription, and the name of such practitioner.

(13) It is not the intention of subsection (2)(a) of this section as amended herein to require the name and place of business of the wholesaler to appear upon the label of the package unless otherwise required by this section.

Effective: April 11, 2012

History: Amended 2012 Ky. Acts ch. 108, sec. 2, effective April 11, 2012. -- Amended 2011 Ky. Acts ch. 45, sec. 5, effective March 16, 2011. -- Amended 2010 Ky. Acts ch. 149, sec. 6, effective April 13, 2010.; and ch. 160, sec. 6, effective April 26, 2010. -- Amended 1982 Ky. Acts ch. 419, sec. 2, effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 322, sec. 1, effective January 1, 1979. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11), (22). -- Amended 1972 Ky. Acts ch. 208, sec. 11. -- Created 1960 Ky. Acts ch. 247, sec. 7.

217.070 Repealed, 1960.

[Repealed]

217.075 Restrictions on handling of new drugs.

(1) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless:

(a) An application with respect thereto has become effective under the federal act; or

(b) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the cabinet an application setting forth: full reports of investigations which have been made to show whether or not such drug is safe for use; a full list of the articles used as components of such drug; a full statement of the composition of such drug; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; such samples of such drug and of the articles used as components thereof as the cabinet may require; and specimens of the labeling proposed to be used for such drug.

(2) An application provided for in subsection (1)(b) of this section shall become effective on the sixtieth day after the filing thereof, except that if the cabinet finds after due notice to the applicant and giving him an opportunity for a hearing, conducted in accordance with KRS Chapter 13B, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, it shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(3) This section shall not apply:

(a) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs provided the drug is plainly labeled "For investigational use only"; or

(b) To a drug sold in the state at any time prior to the enactment of KRS 217.005 to 217.215 or introduced into interstate commerce at any time prior to the enactment of the federal act; or

(c) To any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902, and any amendments thereto. (42 U.S.C. secs. 262 et seq., and amendments thereto).

(4) An order refusing to permit an application under this section to become effective may be revoked by the cabinet.

Effective: July 15, 1996

History: Amended 1996 Ky. Acts ch. 318, sec. 122, effective July 15, 1996. -- Created 1960 Ky. Acts ch. 247, sec. 8.

217.080 Repealed, 1960.

[Repealed]

217.085 When cosmetic deemed adulterated.

A cosmetic shall be deemed to be adulterated:

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual; provided that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution -- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness," and the labeling of which bears adequate directions for such preliminary testing. For the purpose of this subsection and subsection (5) of this section, the term "hair dye" shall not include eyelash dyes or eyebrow dyes;

(2) If it consists in whole or in part of any filthy, putrid or decomposed substance;

(3) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(4) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(5) If it is not a hair dye and it bears or contains a coal-tar color other than one from a batch which has been certified under authority of the federal act.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 247, sec. 9, effective June 16, 1960.

217.090 Repealed, 1960.

[Repealed]

217.095 When cosmetic deemed misbranded.

A cosmetic shall be deemed to be misbranded:

(1) If its labeling is false or misleading in any particular or if its labeling or packaging fails to conform with the requirements of KRS 217.037;

(2) If in package form unless it bears a label containing:

(a) The name and place of business of the manufacturer, packer, or distributor; and

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided that reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the secretary;

(3) If any word, statement, or other information required by or under authority of KRS 217.005 to 217.215 to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) If its container is so made, formed or filled as to be misleading;

(5) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of the federal act. This subsection shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes as defined in KRS 217.085;

(6) A cosmetic which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, is exempted from the affirmative labeling requirements of KRS 217.037 while it is in transit in commerce from the one establishment to the other, if such transit is made in good faith for such completion purposes only; but it is otherwise subject to all applicable provisions of KRS 217.005 to 217.215.

Effective: June 17, 1978

History: Amended 1978 Ky. Acts ch. 292, sec. 6, effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 247, sec. 10, effective June 16, 1960.

217.100 Repealed, 1960.

[Repealed]

217.105 When advertising deemed false.

(1) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.

(2) For the purpose of KRS 217.005 to 217.215 the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecytitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, venereal disease, shall also be deemed to be false, except that no advertisement not in violation of subsection (1) of this section shall be deemed to be false under this subsection if it is disseminated only to practitioners or appears only in the scientific periodicals of these practitioners, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices; provided that whenever the secretary determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the secretary shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the secretary may deem necessary in the interests of public health; provided that this subsection shall not be construed as indicating that self-medication for diseases other than those named herein is safe or efficacious.

Effective:

History: Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 247, sec. 11.

217.110 Repealed, 1960.

[Repealed]

217.115 Detention or quarantine of articles that violate KRS 217.005 to 217.215.

(1) Whenever a duly authorized agent of the cabinet finds or has probable cause to believe, that any food, drug, device, or cosmetic is adulterated, or misbranded within the meaning of KRS 217.005 to 217.215, he shall affix to such article a tag or other appropriate marking, giving notice that such article is, or is suspected of being, adulterated or misbranded and has been detained or quarantined and warning all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by such agent or the court. It shall be unlawful for any person to remove or dispose of such detained or quarantined article by sale or otherwise without such permission.

(2) When an article detained or quarantined under subsection (1) of this section has been found by such agent to be adulterated, or misbranded, he shall petition the judge of the District Court in whose jurisdiction the article is detained or quarantined for an order for condemnation of such article; provided that nothing in this section shall require that the cabinet or its agent shall go to court if destruction of the quarantined article is accomplished by agreement made in writing with the owner of the property. When such agent has found that an article so detained or quarantined is not adulterated or misbranded, he shall remove the tag or other marking.

(3) If the court finds that a detained or quarantined article is adulterated or misbranded, such article shall, after entry of the order, be destroyed at the expense of the claimant thereof, under the supervision of such agent, and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of such article or his agent; provided that when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the order and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that such article shall be so labeled or processed, has been executed, may by order direct that such article be delivered to the claimant thereof for such labeling or processing under the supervision of an agent of the cabinet. The expense of such supervision shall be paid by the claimant. Such bond shall be returned to the claimant of the article on representation to the court by the cabinet that the article is no longer in violation of KRS 217.005 to 217.215, and that the expenses of such supervision have been paid.

(4) Whenever the cabinet or any of its authorized agents, after a state of emergency has been declared, shall find in any room, building, vehicle of transportation, or other structure, any food, drug, cosmetic, or device, which is unsound or which contains any filthy, decomposed, or putrid substance, or which may be poisonous or deleterious to health or otherwise unsafe, the same being hereby declared to be a nuisance, the cabinet or its authorized agent shall forthwith condemn or destroy the same or in other manner render the same unfit for human use.

Effective: January 2, 1978

History: Amended 1976 (1st Extra. Sess.) Ky. Acts ch. 14, sec. 206, effective January 2, 1978. -- Created 1960 Ky. Acts ch. 247, sec. 12, effective June 16, 1960.

217.120 Repealed, 1960.

[Repealed]

217.125 Authority of secretary and cabinet to promulgate administrative regulations -- Permits required for food establishment, service, processing, storage, and distribution operations -- Fees.

(1) The authority to promulgate regulations for the efficient administration and enforcement of KRS 217.005 to 217.215 is hereby vested in the secretary. The secretary may make the regulations promulgated under KRS 217.005 to 217.215 consistent with those promulgated under the federal act and the Fair Packaging and Labeling Act. Regulations promulgated may require permits to operate and include provisions for regulating the issuance, suspension, and reinstatement of permits. The authority to promulgate regulations pursuant to KRS 217.005 to 217.205 is restricted to the Cabinet for Health and Family Services.

(2) No person shall operate a food processing establishment, food storage warehouse, salvage distributor, or salvage processing plant without having obtained an annual permit to operate from the cabinet. An application for the permit to operate shall be made to the cabinet upon forms provided by it and shall be accompanied by the required fee as shall be provided by regulation. The secretary shall promulgate administrative regulations to establish a fee schedule not to exceed costs of the program to the cabinet. Fees collected by the cabinet shall be deposited in the State Treasury and credited to a revolving fund account for use by the cabinet in carrying out the provisions of KRS 217.025 to 217.390 and the regulations adopted by the secretary pursuant thereto. The balance of the account shall lapse to the general fund at the end of each biennium.

(3) No person shall operate a retail food establishment without having obtained a permit to operate from the cabinet. An application for a permit to operate any retail food establishment shall be made to the cabinet upon forms provided by it and shall contain the information the cabinet may reasonably require.

(4) (a) Except as otherwise provided in subsection (11) of this section, each application for a temporary food service establishment or for an annual permit to operate a retail food establishment shall be accompanied by the required

fee. The secretary shall promulgate administrative regulations to establish a fee schedule not to exceed costs to the cabinet.

(b) The total fees for permitting and inspection:

Shall be the total of the operational and administrative costs of the programs to the cabinet and to agencies as defined in KRS 211.185;
Beginning on March 17, 2020, until December 31, 2020, shall not increase more than twenty-five percent (25%) of the fee amount on March 17, 2020; and
Beginning on or after January 1, 2021, shall not increase more than five percent (5%) for each year thereafter.

(5) Except as otherwise provided in subsection (11) of this section, each application for a farmers market temporary food service establishment shall be accompanied by the required fee of at least fifty dollars ($50). The secretary shall establish a fee schedule by promulgation of administrative regulation. Fees collected by the cabinet shall be used to carry out duties related to farmers market temporary food service establishments, including but not limited to inspections and the issuance of permits.

(6) An applicant for a permit to operate a farmers market temporary food service establishment must provide documentation of successful completion of a food safety training program offered by either the state, a local health department, or other entity approved by the cabinet to conduct food safety training. Each certification of food safety training shall expire after a period of twenty-four (24) months from the date of issuance. Permits issued shall be posted in a conspicuous place in the establishment, and a person who has completed the food safety training for farmers market temporary food service establishments shall be present at all times during the operation of the establishment.

(7) Upon expiration of a temporary food service establishment permit, any subsequent permits shall not be issued to the same operator to operate at the same location until a period of thirty (30) days has elapsed.

(8) Upon receipt of an application for a permit to operate a food processing establishment, food storage warehouse, salvage distributor, or salvage processing plant or a retail food establishment accompanied by the required fee, the cabinet shall issue a permit if the establishment meets the requirements of KRS 217.005 to 217.215 and regulations adopted by the cabinet. Retail food establishments holding a valid and effective permit on January 1, 1973, even though not fully meeting the construction requirements of KRS 217.005 to 217.215 and the regulations adopted pursuant thereto, may continue to be eligible for permit renewal if in good repair and capable of being maintained in a safe and sanitary manner.

(9) Permits shall not be issued to operate a temporary food service establishment and a farmers market temporary food service establishment simultaneously at the same location and by the same operator.

(10) In all instances of permit issuance for either a temporary food service establishment permit or a farmers market temporary food service establishment permit, any subsequent permits shall not be issued until a period of thirty (30) days has elapsed.

(11) Private, parochial, and public school cafeterias or lunchroom facilities through the twelfth grade, charitable food kitchens, and all facilities operated by the Cabinet for Health and Family Services or Department of Corrections shall be exempt from the payment of fees, but shall comply with all other provisions of KRS 217.005 to 217.215 and the state retail food establishment code. For this subsection, the term "charitable food kitchens" means a not-for-profit, benevolent food service establishment where more than one-half (1/2) of the employees are volunteers.

(12) Each annual permit to operate a food processing establishment, food storage warehouse, salvage distributor, or salvage processing plant or a retail food establishment, unless previously suspended or revoked, shall expire on December 31 following its date of issuance, and be renewable annually upon application accompanied by the required fee, except as otherwise provided in subsection (11) of this section, and if the establishment is in compliance with KRS 217.005 to 217.215 and regulations of the cabinet.

(13) Each permit to operate a food processing establishment, food storage warehouse, salvage distributor, salvage processing plant, or a retail food establishment shall be issued only for the premises and person named in the application and shall not be transferable. Permits issued shall be posted in a conspicuous place in the establishment.

Effective: March 17, 2020

History: Amended 2020 Ky. Acts ch. 21, sec. 8, effective March 17, 2020. -- Amended 2018 Ky. Acts ch. 136, sec. 12, effective July 1, 2019. -- Amended 2007 Ky. Acts ch. 97, sec. 2, effective March 23, 2007. -- Amended 2005 Ky. Acts ch. 99, sec. 62, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 7, sec. 2, effective February 19, 1998, retroactive to January 1, 1998; and ch. 426, sec. 457, effective July 15, 1998. -- Amended 1992 Ky. Acts ch. 211, sec. 79, effective July 14, 1992. -- Amended 1990 Ky. Acts ch. 458, sec. 2, effective July 13, 1990. -- Amended 1982 Ky. Acts ch. 247, sec. 11. effective July 15, 1982. -- Amended 1978 Ky. Acts ch. 292, sec. 7, effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 247, sec. 13.

217.1255 Prohibition against requiring permit for or inspecting warehouses containing alcoholic beverages.

Nothing in this chapter shall be construed as requiring a permit for the operation of warehouses containing alcoholic beverages as defined in KRS 241.010 or as authorizing the inspection of such warehouses by the cabinet.

Effective: July 14, 1992

History: Created 1992 Ky. Acts ch. 37, sec. 1, effective July 14, 1992.

217.126 Denial, suspension, or revocation of permit.

(1) The cabinet shall suspend the permit to operate a retail food establishment immediately upon notice to the permit holder without a conference when:

(a) An inspection of an establishment reveals that any of the following conditions are present:

Sewage is standing in the food preparation, food storage, utensil washing, or storage areas;
Gross rodent or insect activity exists resulting in contamination of food or food equipment;
The water supply is contaminated or cut off with no approved alternative plan;
The establishment is operating in blatant disregard for safe cooking or holding temperatures for potentially hazardous foods; or
There is an infiltration of toxic or noxious gases, dust, or other irritants or contaminants causing apparent illness of employees or patrons; or

(b) The permit holder or authorized agent has interfered, as defined in KRS 217.015(25), with the cabinet in the performance of its duties, after its agents have duly and officially identified themselves and the interference has been verified by the inspector's supervisor;

(d) An inspection reveals that an imminent health hazard as defined in KRS 217.015(24) still exists and the hazard has been verified by the agent's supervisor.

(2) In all other instances not covered by subsection (1) of this section, after notice to the applicant or holder of a permit to operate and after an opportunity for a hearing as provided by administrative regulations of the secretary, the cabinet or local health department concerned may deny, suspend, or revoke a permit to operate in any case where it finds that there has been a failure to comply with the requirements of KRS 217.005 to 217.215 or the administrative regulations of the secretary. Any administrative hearing conducted under this section shall be conducted in accordance with KRS Chapter 13B.

Effective: July 15, 1998

History: Amended 1998 Ky. Acts ch. 297, sec. 2, effective July 15, 1998. -- Amended 1996 Ky. Acts ch. 318, sec. 123, effective July 15, 1996. -- Created 1990 Ky. Acts ch. 458, sec. 3, effective July 13, 1990.

217.127 Regulations -- State retail food code -- Donation of food -- Charitable food donor.

(1) The secretary shall adopt regulations for the effective administration and enforcement of KRS 217.005 to 217.215.

(2) The secretary shall adopt a state retail food code which shall include, among other things, provisions for regulating the issuance, suspension, and revocation of permits to operate; submission of plans for construction and equipment layout including plumbing, lighting, ventilation, water supply, sewage disposal, and other facilities; food supply source and protection; health, disease control and cleanliness of personnel; design, construction, installation, and cleanliness of equipment and utensils; toilet and hand-washing facilities; solid waste disposal and vermin control; and any other matters deemed necessary to insure a safe and sanitary operation of a retail food establishment. Standards for construction, plumbing, lighting, and ventilation of fixed retail food establishments shall be effective only if they are approved by the Department of Housing, Buildings and Construction and are included in the Uniform State Building Code, or if they conform to the State Plumbing Code in the case of plumbing fixtures. Any review of plans for construction, plumbing, lighting, and ventilation required before construction of a fixed retail food establishment shall be conducted by the Department of Housing, Buildings and Construction or authorized local building official pursuant to KRS Chapter 198B.

(3) The donation of safe and apparently wholesome food by a retail food establishment or any other entity regulated under subsections (1) and (2) of this section shall be exempt from any further inspection or regulation if the donated food has been inspected under subsections (1) and (2) of this section.

(4) (a) As used in this subsection, "charitable food donor" means:

A nonprofit or religious organization that is recognized as tax exempt under Section 501(c)(3) of the Internal Revenue Code; or
A home-based processor; that produces food solely for the purpose of distributing the food for free at a homeless shelter to individuals in need or for distribution to individuals displaced due to a declared natural disaster.

(b) A charitable food donor shall be exempt from the licensing requirements of KRS 217.005 to 217.215 and administrative regulations pertaining to the State Plumbing Code promulgated under subsections (1) and (2) of this section as long as:

The donation is safe and apparently wholesome food as defined in KRS 411.240; and
The charitable food donor is in compliance with any other applicable provisions of KRS 217.005 to 217.215 and administrative regulations promulgated thereunder.

(c) This subsection shall not be construed to exempt any other entity, including a retail food establishment or home-based microprocessor, from the requirements of KRS 217.005 to 217.215 and the state retail food code adopted under subsection (2) of this section regulating the production of food for, or donation of food to, a homeless shelter or individuals displaced due to a declared natural disaster.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 30, sec. 1, effective July 15, 2026. -- Amended 2010 Ky. Acts ch. 24, sec. 321, effective July 15, 2010. -- Amended 2006 Ky. Acts ch. 64, sec. 1, effective July 12, 2006. -- Created 1990, Ky. Acts ch. 458, sec. 4, effective July 13, 1990.

Legislative Research Commission Note (6/29/2017). 2017 Ky. Acts ch. 169, a reorganization of the Department of Housing, Buildings and Construction, in part abolished the Board of Housing, Buildings and Construction and transferred all of the board's duties to the department. This statute was not included in 2017 Ky. Acts ch. 169, but contained a reference to the board that was changed in codification by the Reviser of Statutes to reference the department under the authority of KRS 7.136(2).

217.128 Enforcement of state fire regulations.

The state fire marshal or other duly authorized agents or representatives or other authorized agents pursuant to KRS Chapter 227 shall administer and enforce all state fire regulations, laws, standards of safety, and regulations adopted by the commissioner of housing, buildings and construction relating to retail food establishments.

Effective: July 15, 2010

History: Amended 2010 Ky. Acts ch. 24, sec. 322, effective July 15, 2010. -- Created 1990 Ky. Acts ch. 458, sec. 5, effective July 13, 1990.

217.130 Repealed, 1960.

[Repealed]

217.135 Setting food standards by regulation.

Whenever in the judgment of the secretary such action will promote honesty and fair dealing in the interest of consumers, the secretary may promulgate regulations fixing and establishing for any food or class of food: a reasonable definition and standard of identity, a reasonable standard of quality, and fill of container. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the secretary shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. The definitions and standards so promulgated shall conform so far as practicable to the definitions and standards promulgated under authority of the federal act, the Federal Meat Inspection Act, or the Federal Poultry Products Inspection Act.

Effective:

History: Amended 1974 Ky. Acts ch. 74, Art.VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 247, sec. 14.

217.136 Home-based processors of food and cosmetic products -- Exemption from permit requirement and fair packaging and labeling laws -- Production, labeling, and sales of home-processed products -- Inspections -- Registration with cabinet.

(1) A home-based processor shall be exempt from KRS 217.035, 217.037, and 217.095 if the following conditions are met:

(a) All finished product containers are clean, sanitary, and properly labeled pursuant to subsection (3) of this section;

(b) All home-processed foods or pork lard or tallow-based cosmetic products produced under this exemption are neither adulterated nor misbranded pursuant to subsection (4) of this section; and

(c) All glass containers for jams, jellies, preserves, fruit butter, and similar products are provided with suitable rigid metal covers.

(2) A home-based processor shall not produce or process for sale acid foods, acidified food products, formulated acid food products, or low-acid canned foods.

(3) A home-based processor shall label each of its food or cosmetic products and include the following information on the label of each of its food or cosmetic products:

(a) The name and address of the home-based processing operation;

(b) The common or usual name of the food or cosmetic product;

(d) The net weight and volume of the food or cosmetic product by standard measure, or numerical count;

(e) The following statement in ten (10) point type: "This product is home- produced and processed"; and

(f) The date the product was processed.

(4) Food or cosmetic products identified in KRS 217.015(56) and not labeled in accordance with subsection (3) of this section are deemed misbranded.

(5) Food or cosmetic products identified in KRS 217.015(56) and produced, processed, and labeled in accordance with subsection (3) of this section are acceptable food or cosmetic products that may only be offered for sale directly to consumers within this state, including from the home-based processor's home, whether by pick-up or delivery, at a market, roadside stand, community event, or online. These food products may be used in preparing and serving food.

(6) Food products identified in KRS 217.015(56) and labeled in accordance with subsection (3) of this section shall not be required to be tested in determining whether or not the food product is an acid food, acidified food product, formulated acid food product, or low-acid food.

(7) The processing facilities of a home-based processor may be inspected annually by the cabinet.

(8) A home-based processor shall be subject to product sampling and inspection if it is determined that its product is misbranded pursuant to subsection (4) of this section or adulterated, or if a consumer complaint has been received.

(9) If the cabinet has reason to believe that an imminent health hazard exists it may invoke cessation of production until it deems that the hazardous situation has been addressed to the satisfaction of the cabinet.

(10) The cabinet shall promulgate administrative regulations to further delineate which food or cosmetic products are subject to the definition of home-based processor, as defined in KRS 217.015(56).

(11) A home-based processor shall be registered with the cabinet and include the following information:

(a) The name of the home-based processor and the physical address where production or processing will occur; and

(b) A listing of the food or cosmetic products to be produced or processed.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 52, sec. 2, effective July 15, 2026. -- Amended 2019 Ky. Acts ch. 181, sec. 1, effective March 26, 2019. -- Amended 2018 Ky. Acts ch. 77, sec. 2, effective July 14, 2018. -- Created 2003 Ky. Acts ch. 42, sec. 2, effective June 24, 2003.

217.137 Administrative regulations on home-based microprocessors.

(1) The secretary shall promulgate administrative regulations to accommodate the specific circumstances of home-based microprocessors. In order to protect public health while encouraging the marketing of home-processed foods, the administrative regulations shall include, at a minimum, standards for:

(a) Installation, design, location, and maintenance of toilet rooms;

(b) Installation and maintenance of hand-washing facilities;

(d) Installation and location of equipment;

(e) Construction and covering of floors; and

(f) Construction, materials, and maintenance of walls and ceilings.

(2) Food products that are produced or processed by a home-based microprocessor and in compliance with administrative regulations promulgated pursuant to subsection (1) of this section are acceptable food products that may only be offered for sale by farmers markets, certified roadside stands, or on the processor's farm. These food products may be used in preparing and serving food.

(3) The cabinet shall promulgate administrative regulations to further delineate which food products are subject to the definition of home-based microprocessor, as defined in KRS 217.015(57).

Effective:March 26, 2019

History: Amended 2019 Ky. Acts ch. 181, sec. 2, effective March 26, 2019. -- Created 2003 Ky. Acts ch. 42, sec. 3, effective June 24, 2003.

217.138 Kentucky Cooperative Extension Service to administer home-based microprocessor program -- Certification by cabinet.

(1) The Kentucky Cooperative Extension Service shall develop, implement, and administer a program to train home-based microprocessors or personnel in compliance with 21 C.F.R. sec. 114.10.

(2) The cabinet shall evaluate and certify home-based microprocessors or personnel who have completed the pilot microprocessing program or the microprocessing program.

(3) The cabinet shall by June 30, 2003:

(a) Establish certification terms, conditions, and length of time the certification is valid;

(b) Establish terms, conditions, and standards for recertification;

(d) Develop a certification document.

(4) The cabinet and the Kentucky Cooperative Extension Service shall by June 30, 2003:

(a) Develop an examination document;

(b) Establish examination subject matter;

(d) Establish fees for the pilot microprocessing program and the microprocessing program.

(5) The certification document shall be made in triplicate, with one (1) copy given to the home-based microprocessor or personnel, one (1) copy given to the Kentucky Cooperative Extension Service, and one (1) copy given to the cabinet.

(6) Upon completion of the program, home-based microprocessors and personnel shall be deemed to be certified and to have met the training requirements pursuant to 21 C.F.R. sec. 114.10.

Effective: June 24, 2003

History: Created 2003 Ky. Acts ch. 42, sec. 4, effective June 24, 2003.

217.139 Pilot microprocessing program.

(1) The Kentucky Cooperative Extension Service shall establish and administer a pilot microprocessing program to train home-based microprocessors and personnel for supervising or giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls, and critical factors in acidification.

(2) The pilot microprocessing program shall be established by August 1, 2003, and implemented no later than September 1, 2003. There shall be no less than four (4) program workshops offered to home-based microprocessors and personnel, and each shall be held in a separate and distinct geographical location within the state.

Effective: June 24, 2003

History: Created 2003 Ky. Acts ch. 42, sec. 5, effective June 24, 2003.

217.140 Repealed, 1960.

[Repealed]

217.145 When additives deemed unsafe.

(1) A food additive shall with respect to any particular use or intended use of such additive, be deemed to be unsafe within the meaning of KRS 217.025(1)(b) and 217.045, unless it and its use or intended use conform to the terms of an exemption as provided under the federal act, or, a regulation issued under the federal act prescribing the conditions under which such additive may be safely used.

(2) Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not recognized by the cabinet as safe for use, added to a raw agricultural commodity, shall be deemed unsafe within the meaning of KRS 217.025(1)(b), unless a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed under the federal act or the Federal Environmental Pesticide Control Act of 1972 and the quantity of such pesticide chemical in or on the raw agricultural commodity is within the tolerance so prescribed or the pesticide chemical has been exempted from the requirement of a tolerance under provisions of the federal act or the Federal Environmental Pesticide Control Act of 1972.

(3) A color additive shall with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or cosmetics, be deemed unsafe for the purposes of the application of KRS 217.025(4), 217.055(1)(d), or 217.085(5), as the case may be, unless there is in effect, and such color additive and such use are in conformity with a regulation as provided under the federal act, or such color additive and such use conform to the terms of an exception under the federal act.

Effective: June 17, 1978

History: Amended 1978 Ky. Acts ch. 292, sec. 8, effective June 17, 1978. -- Created 1960 Ky. Acts ch. 247, sec. 15.

217.150 Repealed, 1960.

[Repealed]

217.155 Cabinet's right of inspection and to carry out statutory provisions and regulations through local health departments -- Requirement that drug inspector be a pharmacist.

(1) The cabinet or its duly authorized agent shall have free access at all reasonable times to any factory, warehouse, or establishment in which foods, drugs, devices, or cosmetics are manufactured, processed, packed, or held for sale, or are held after receipt in commerce, or to enter any vehicle being used to transport or hold the foods, drugs, devices, or cosmetics in commerce, for the purpose:

(a) Of inspecting the factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling thereon, to determine if any of the provisions of KRS 217.005 to 217.215 are being violated;

(b) Of securing samples or specimens of any food, drug, device, or cosmetic after paying or offering to pay for the sample. The cabinet shall make or cause to be made examinations of samples secured under the provisions of this section to determine whether or not any provision of KRS 217.005 to 217.215 is being violated; and

(c) Of examining or reproducing books, papers, documents, or other evidence pertaining to the foods, drugs, cosmetics, or devices.

(2) Any inspector appointed for the purpose of administering and carrying out the provisions of KRS 217.005 to 217.215 insofar as they relate to drugs in a retail pharmacy shall be a registered pharmacist and a graduate of a school recognized as in good standing by the Kentucky Board of Pharmacy.

(3) The cabinet may carry out the provisions of KRS 217.005 to 217.215 and regulations relating to food processing establishments, food storage warehouses, salvage distributors, or salvage processing plants or retail food establishments through local health departments.

Effective: July 13, 1990

History: Amended 1990 Ky. Acts ch. 458, sec. 7, effective July 13, 1990. -- Created 1960 Ky. Acts ch. 247, sec. 16.

217.160 Repealed, 1960.

[Repealed]

217.165 Publication of reports and information.

(1) The cabinet may cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under KRS 217.005 to 217.215, including the nature of the charge and the disposition thereof.

(2) The cabinet may also cause to be disseminated such information regarding food, drugs, devices, and cosmetics as the cabinet deems necessary in the interest of public health and the protection of the consumer against fraud. Nothing in this section shall be construed to prohibit the cabinet from collecting, reporting, and illustrating the results of the investigations of the cabinet.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 247, sec. 17, effective June 16, 1960.

217.170 Repealed, 1960.

[Repealed]

217.175 Prohibited acts.

The following acts and the causing thereof within the Commonwealth of Kentucky are hereby prohibited:

(1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded;

(2) The adulteration or misbranding of any food, drug, device, or cosmetic;

(3) The receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

(4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of KRS 217.075;

(5) The dissemination of any false advertisement;

(6) The refusal to permit entry or inspection, or to permit the taking of a sample or to permit access to records or evidence, as authorized by KRS 217.155;

(7) The giving of a guaranty or undertaking which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the Commonwealth of Kentucky from whom he received in good faith the food, drug, device, or cosmetic;

(8) The removal or disposal of a detained or quarantined article in violation of KRS 217.115;

(9) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being adulterated or misbranded;

(10) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of KRS 217.005 to 217.215;

(11) The using, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that any application with respect to such drug is effective under KRS 217.075, or that such drug complies with the provisions of such section;

(12) The manufacture, sale or exchange of any filled milk;

(13) The manufacture, mixing, compounding, selling, or offering for sale of any flour unless the same is enriched; provided that this prohibition shall not apply to flour sold to bakeries or other commercial secondary processors, which flour is used only in the production of enriched flour or enriched bread or in the manufacture of products not required to be enriched;

(14) The manufacture, baking, sale, or offering for sale of any bread except bread conforming to the definition of enriched bread.

Effective: June 17, 1978

History: Amended 1978 Ky. Acts ch. 292, sec. 9, effective June 17, 1978. -- Created 1960 Ky. Acts ch. 247, sec. 18.

Legislative Research Commission Note. Although this section was included in Acts 1978, ch. 292, § 9, as having been amended, there appears to be no change in this section.

217.177 Sale and disposal of hypodermic syringes or needles.

(1) No person engaged in sales at retail shall display hypodermic syringes or needles in any portion of the place of business which is open or accessible to the public.

(2) Pharmacies offering retail sale of hypodermic syringes or needles shall make available:

(a) Written or electronic educational materials on safe and proper disposal of hypodermic needles and syringes;

(b) Written or electronic educational or referral information for syringe exchange service programs and substance use disorder treatment; and

(c) A verbal, physical, or electronic offer to provide a prescription for an opioid antagonist as defined in KRS 217.186.

(3) Nothing in this section shall apply to the sale of hypodermic syringes or needles dispensed as a prescription or in conjunction with a prescription medication that requires reconstitution or administration with a syringe.

(4) Any physician, other licensed medical person, hospital, or clinic disposing of hypodermic syringes or needles shall render the instrument incapable of further use.

Effective: July 14, 2022

History: Amended 2022 Ky. Acts ch. 154, sec. 2, effective July 14, 2022. -- Amended 2021 Ky. Acts ch. 56, sec. 1, effective June 29, 2021. -- Amended 2005 Ky. Acts ch. 99, sec. 513, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 458, effective July 15, 1998. -- Created 1974 Ky. Acts ch. 404, sec. 1.

217.180 Repealed, 1960.

[Repealed]

217.181 Theft of a legend drug.

(1) A person is guilty of theft of a legend drug when he unlawfully takes or exercises control over a legend drug that is not a controlled substance, belonging to another person, with the intent to deprive him thereof.

(2) Theft of a legend drug is:

(a) For a first offense a Class D felony, if the legend drug has a value of three hundred dollars ($300) or less; or

(b) For a second or subsequent offense, or a value of greater than three hundred dollars ($300), a Class C felony.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 2, effective July 15, 1998.

217.182 Sale, distribution, administration, prescription, or possession of legend drugs -- Penalty.

(1) A duly licensed manufacturer, distributor, or wholesaler may sell or distribute a legend drug to any of the following:

(a) A manufacturer, wholesaler, or distributor;

(b) A pharmacy;

(d) The administrator in charge of a hospital, but only for use by or in that hospital; and

(e) A person in charge of a laboratory, but only for use in that laboratory for scientific and medical research purposes.

(2) A pharmacist may sell or distribute a legend drug:

(a) Pursuant to a prescription that conforms to the requirements of this chapter; or

(b) To a person licensed to administer, dispense, distribute, or possess a legend drug.

(3) A practitioner may:

(a) Administer, dispense, or prescribe a legend drug for a legitimate medical purpose and in the course of professional practice; or

(b) Distribute a legend drug to a person licensed to administer, dispense, distribute, or possess a legend drug.

(4) Possession or control of legend drugs obtained as authorized by this section shall be lawful if it occurred in the regular course of business, occupation, profession, employment, or duty of the possessor.

(5) No person shall traffic in any legend drug except as authorized by this section.

(6) No person shall dispense, prescribe, distribute, or administer any legend drug except as authorized by this section.

(7) No person shall possess any legend drug except as authorized by this section.

(8) Unless another specific penalty is provided in KRS 217.005 to 217.215, any person who violates any provision of subsections (1) to (6) of this section shall be guilty of a Class A misdemeanor for the first offense and a Class D felony for subsequent offenses.

(9) Unless another specific penalty is provided in KRS 217.005 to 217.215, any person who violates the provision of subsection (7) of this section shall be guilty of a Class B misdemeanor.

(10) A person to whom or for whose use a legend drug has been prescribed or dispensed may lawfully possess it.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 8, effective July 15, 1998.

217.184 Enforcement of sections governing legend drugs.

(1) All police officers and deputy sheriffs, directly employed full-time by state, county, city, or urban-county governments, the Department of Kentucky State Police, the Cabinet for Health and Family Services, the offices of all city, county, and Commonwealth's attorneys, the Office of the Attorney General, and any of their officers and agents, within their respective jurisdictions, shall enforce KRS 217.207, 217.208, 217.209, 217.181, and 217.182 relating to legend drugs and cooperate with all agencies charged with the enforcement of the laws of the United States, of this state, and of all other states relating to legend drugs.

(2) Designated agents of the Cabinet for Health and Family Services and the Kentucky Board of Pharmacy are empowered to remove from the files of any pharmacy or other custodian any prescription or other legend drug record upon tendering a receipt. The receipt shall be sufficiently detailed to accurately identify the record and a copy of the records seized shall be returned to the pharmacist within a reasonable amount of time.

Effective: June 26, 2007

History: Amended 2007 Ky. Acts ch. 85, sec. 251, effective June 26, 2007. -- Amended 2005 Ky. Acts ch. 99, sec. 514, effective June 20, 2005. -- Created 1998 Ky. Acts ch. 301, sec. 11, effective July 15, 1998.

217.185 Duty of local prosecuting attorneys.

It shall be the duty of each Commonwealth's attorney, county attorney, or city attorney to whom the cabinet or its agents report any violation of KRS 217.005 to 217.215, to cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law. Before any violation of KRS 217.005 to 217.215 is reported to any such attorney for the institution of a criminal proceeding, the person against whom such proceeding is contemplated may be given appropriate notice and an opportunity to present his views before the cabinet or its designated agent, either orally or in writing, in person, or by attorney, with regard to such contemplated proceeding.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 247, sec. 19, effective June 16, 1960.

217.186 Definition -- Provider prescribing or dispensing opioid antagonist -- Administration by third party -- Use of opioid antagonist by person or agency authorized to administer medication -- Immunity from liability -- Administrative regulations -- Use of opioid antagonist by schools -- Use of opioid antagonist by licensed health care provider.

(1) As used in this section, "opioid antagonist" means naloxone or any other United States Food and Drug Administration-approved drug designed to reverse the effects of an opioid overdose.

(2) A licensed health-care provider who, acting in good faith, directly or by standing order, prescribes or dispenses an opioid antagonist to a person or agency who, in the judgment of the health-care provider, is capable of administering the drug for an emergency opioid overdose, shall not, as a result of his or her acts or omissions, be subject to disciplinary or other adverse action under KRS Chapter 311, 311A, 314, or 315 or any other professional licensing statute. As used in this subsection, "licensed health-care provider" includes a pharmacist as defined in KRS 315.010 who holds a separate certification issued by the Kentucky Board of Pharmacy authorizing the initiation of the dispensing of an opioid antagonist under subsection

(6) of this section.

(3) A prescription for an opioid antagonist may include authorization for administration of the drug to the person for whom it is prescribed by a third party, if the prescribing instructions indicate the need for the third party, upon administering the drug, to immediately notify a local public safety answering point of the situation necessitating the administration.

(4) A person or agency, including a peace officer, jailer, firefighter, paramedic, or emergency medical technician or a school employee authorized to administer medication under KRS 156.502, may:

(a) Receive a prescription for an opioid antagonist;

(b) Possess an opioid antagonist pursuant to this subsection and any equipment needed for its administration;

(d) Provide, as part of a harm reduction program, an opioid antagonist to persons who have been trained on the mechanism and circumstances of its administration.

(5) A person acting in good faith who provides or administers an opioid antagonist received under this section shall be immune from criminal and civil liability for the provision or administration, unless personal injury results from the gross negligence or willful or wanton misconduct of the person providing or administering the drug.

(6) (a) The Board of Pharmacy, in consultation with the Kentucky Board of Medical Licensure, shall promulgate administrative regulations to establish certification, educational, operational, and protocol requirements to implement this section.

(b) Administrative regulations promulgated under this subsection shall:

Require that any dispensing under this section be done only in accordance with a physician-approved protocol and specify the minimum required components of any such protocol;
Require education as to the mechanism and circumstances for the administration of an opioid antagonist for the person to whom an opioid antagonist is dispensed; and
Require that a record of the dispensing be made available to a physician signing a protocol under this subsection, if desired by the physician.

A supplemental educational or training component for a pharmacist seeking certification under this subsection; and
A limitation on the forms of the opioid antagonist and means of its administration that may be dispensed pursuant to this subsection.

(7) (a) The board of each local public school district and the governing body of each private and parochial school or school district may permit a school to keep an opioid antagonist on the premises and regulate the administration of an opioid antagonist to any individual suffering from an apparent opiate-related overdose.

(b) In collaboration with local health departments, local health providers, and local schools and school districts, the Kentucky Department for Public Health shall develop clinical protocols to address supplies of an opioid antagonist kept by schools under this section and to advise on the clinical administration of an opioid antagonist.

(8) Notwithstanding any provision of law to the contrary, a licensed health care provider, including a pharmacist who is utilizing a protocol established by this section, may dispense an opioid antagonist to any person or agency who, as part of a harm reduction program, provides training to the public on the mechanism and circumstances for the administration of an opioid antagonist, regardless of whom the ultimate user of the opioid antagonist may be. The documentation of the dispensing of an opioid antagonist to any person or agency operating a harm reduction program shall satisfy any general documentation or recording requirements found in administrative regulations regarding legend drugs promulgated pursuant to this chapter.

Effective: July 14, 2022

History: Amended 2022 Ky. Acts ch. 154, sec. 3, effective July 14, 2022. -- Amended 2019 Ky. Acts ch. 130, sec. 1, effective June 27, 2019. -- Amended 2015 Ky. Acts ch. 66, sec. 8, effective March 25, 2015. -- Created 2013 Ky. Acts ch. 118, sec. 10, effective June 25, 2013.

217.187 Persons selling less than 500 gallons of pure and unadulterated honey in a year.

If a person sells less than five hundred (500) gallons of pure and unadulterated honey in a year that he or she produced in Kentucky, the person shall not be required to process the honey in a certified honey house or food processing establishment, nor shall the person be required to obtain a permit from the cabinet. The person shall be required to comply with the other provisions of KRS 217.005 to 217.215 as those provisions apply.

Effective: June 27, 2025

History: Amended 2025 Ky. Acts ch. 21, sec. 1, effective June 27, 2025. -- Created 2002 Ky. Acts ch. 134, sec. 1, effective July 15, 2002.

217.188 Administrative regulations regarding poultry sold on farms, at farmers markets, and at roadside stands.

(1) For the purposes of this section, "end consumer" means a person who is the last person to purchase any food product and who does not resell the food product.

(2) Notwithstanding any other provisions of law to the contrary, the secretary shall promulgate administrative regulations in accordance with KRS Chapter 13A to:

(a) Exclude slaughtering and processing of poultry on a farm for the purpose of conducting sales under 9 C.F.R. sec. 381.10 if the slaughtered and processed poultry or poultry products are sold to an end consumer on a farm, at a farmers market, or at a roadside stand;

(b) Require that poultry or poultry products processed under this section that are sold on a farm be refrigerated at the point of sale and labeled in compliance with the requirements of 9 C.F.R. sec. 381.10; and

(c) Require that poultry or poultry products processed under this section that are sold at a farmers market or at a roadside stand be frozen at the point of sale and labeled in compliance with the requirements of 9 C.F.R. sec. 381.10.

(3) Notwithstanding any other provisions of law to the contrary, a local governmental agency shall not require any additional certification or inspection of poultry or poultry products of a farmer acting in compliance with the administrative regulations promulgated pursuant to this section.

Effective: July 15, 2026

History: Created 2026 Ky. Acts ch. 52, sec. 3, effective July 15, 2026.

217.190 Repealed, 1960.

[Repealed]

217.195 Cabinet is not required to prosecute.

Nothing in KRS 217.005 to 217.215 shall be construed as requiring the cabinet to report for the institution of proceedings under KRS 217.005 to 217.215, violations of KRS 217.005 to 217.215, whenever the cabinet believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.

Effective:

History: Created 1960 Ky. Acts ch. 247, sec. 20.

217.200 Repealed, 1960.

[Repealed]

217.205 Cabinet's power to enjoin violations.

Notwithstanding the existence or pursuit of any other remedy (civil or criminal) the cabinet may maintain, in its own name, an action to restrain or enjoin any violation of KRS 217.005 to 217.215, irrespective of whether or not there exists an adequate remedy at law.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 247, sec. 21, effective June 16, 1960.

217.207 Theft, criminal possession, trafficking, or unlawful possession of a prescription blank.

(1) A person is guilty of theft of a prescription blank when he unlawfully takes or exercises control over a prescription blank belonging to another.

(2) A person is guilty of criminal possession of a prescription blank when, with knowledge that he has no lawful authority to possess a prescription blank, he possesses a prescription blank with the intent to make or utter a forged prescription or sell or transfer the prescription blank to another person for that purpose.

(3) A person is guilty of trafficking in prescription blanks when he knowingly and unlawfully traffics in a prescription blank or a forged prescription for a legend drug.

(4) The knowing, with intent to violate this chapter, possession of a prescription blank by a person other than a pharmacist, practitioner, or other person authorized by law to prescribe or dispense a legend drug, a manufacturer, wholesaler, or distributor, or by a person lawfully printing or reproducing prescription blanks, shall be prima facie evidence that the prescription blank was possessed for the purpose of making or uttering a forged prescription or for sale or transfer to another person for that purpose.

(5) Any person who violates any subsection of this section shall be guilty of a Class A misdemeanor for the first offense and a Class D felony for a second or subsequent offense.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 3, effective July 15, 1998.

217.208 Forgery of a prescription.

(1) A person is guilty of forgery of a prescription when, with intent to defraud, deceive, or injure another, he falsely makes, completes, or alters a written instrument which is or purports to be or which is calculated to become or to represent a prescription for a legend drug when completed.

(2) Forgery of a prescription is:

(a) For a first offense, a Class D felony.

(b) For a second or subsequent offense, a Class C felony.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 4, effective July 15, 1998.

217.209 Criminal possession of a forged prescription.

(1) A person is guilty of criminal possession of a forged prescription when, with knowledge that it is forged and with intent to defraud, deceive, or injure another, he possesses a forged prescription.

(2) Criminal possession of a forged prescription is:

(a) For a first offense, a Class A misdemeanor.

(b) For second or subsequent offense, a Class D felony.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 5, effective July 15, 1998.

217.210 Repealed, 1956.

[Repealed]

217.211 Electronic prescribing.

(1) Electronic prescribing of a drug or device under this chapter shall not interfere with a patient's freedom to select a pharmacy.

(2) Electronic prescribing software used by a practitioner to prescribe a drug or device under this chapter may include clinical messaging and messages in pop-up windows directed to the practitioner regarding a particular drug or device that supports the practitioner's clinical decision making.

(3) Drug information contained in electronic prescribing software to prescribe a drug or device under this chapter shall be consistent with Food and Drug Administration- approved information regarding a particular drug or device.

(4) (a) Electronic prescribing software used by a practitioner to prescribe a drug or device under this chapter may show information regarding a payor's formulary, copayments, or benefit plan, provided that nothing in the software is designed to preclude a practitioner from selecting any particular pharmacy or drug or device.

(b) If electronic prescribing software does show information regarding a payor's formulary, payments, or benefit plan under paragraph (a) of this subsection, the information shall be updated at least quarterly to ensure its accuracy.

(5) Each governmental unit of the Commonwealth promulgating administrative regulations relating to electronic prescribing shall include in the regulations electronic prior authorization standards meeting the requirements of KRS 304.17A- 167 in its implementation of health information technology improvements as required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009.

Effective: January 1, 2020

History: Amended 2019 Ky. Acts ch. 190, sec. 3, effective January 1, 2020. -- Created 2012 Ky. Acts ch. 136, sec. 1, effective July 12, 2012.

217.214 Seizure of unlawful prescription.

(1) A pharmacist, practitioner, or other person authorized by law to dispense legend drugs, or an employee of that person, may seize and retain any prescription which he has reasonable suspicion for believing is forged, altered, or possessed in violation of KRS 217.207, 217.208, or 217.209.

(2) Seizure and retention shall be for a reasonable period of time to make reasonable inquiry as to whether the prescription is forged, altered, or illegally possessed.

(3) If after reasonable inquiry the pharmacist, practitioner, or other person determines that the prescription is forged, altered, or stolen, he shall report the seizure to a law enforcement officer and shall surrender the prescription to the officer upon the request of the officer.

Effective: July 15, 1998

History: Created 1998 Ky. Acts ch. 301, sec. 6, effective July 15, 1998.

217.215 Pharmacy board's powers as to drugs -- Regulations on prescription records and on refilling prescriptions in emergency.

(1) The Board of Pharmacy, its agents and inspectors shall have the same powers of inspection and enforcement as the cabinet under KRS 217.005 to 217.215, insofar as it relates to drugs in licensed pharmacies.

(2) The Board of Pharmacy may establish regulations relating to the storage and retrieval of prescription records in licensed pharmacies, including regulations regarding computerized recordkeeping systems.

(3) (a) No prescription for any drug may be refilled by a pharmacist unless authorized by the prescribing practitioner, except that, in emergency situations in which such authorization may not be readily or easily obtained from the practitioner, a pharmacist may:

Dispense up to a seventy-two (72) hour supply of maintenance medication;
Dispense greater than a seventy-two (72) hour supply of maintenance medication if:

a. The standard unit of dispensing for the drug exceeds a seventy-two

(72) hour supply;

b. The pharmacist dispenses a supply of the drug that is equal to the standard unit of dispensing for the drug; and

c. The drug is used for insulin therapy or the treatment of chronic respiratory diseases; and

Dispense up to a thirty (30) day supply of maintenance medication in emergency situations as authorized by KRS 315.500.

(b) Emergency refills dispensed under this subsection shall not be authorized for any controlled substance or for any drug which is not essential to maintenance of life or continuation of therapy in chronic disease conditions.

Effective: June 27, 2019

History: Amended 2019 Ky. Acts ch. 185, sec. 1, effective June 27, 2019. -- Amended 2010 Ky. Acts ch. 22, sec. 4, effective July 15, 2010. -- Amended 1982 Ky. Acts ch. 147, sec. 1, effective July 15, 1982. -- Created 1960 Ky. Acts ch. 247, sec. 22, effective June 16, 1960.

217.216 Prescription blanks to include prescribing practitioner's name, telephone number, and business address.

(1) Every prescription order written by a practitioner authorized by statute to prescribe under this chapter and KRS Chapter 218A shall bear upon the prescription blank the name, telephone number, and business address of the prescribing practitioner.

(2) In order to provide a pharmacist sufficient information to meet the communication requirements of KRS 217.822(10)(c), every prescription order written by a practitioner authorized by statute to prescribe a biological product under this chapter shall bear upon the prescription blank the name, telephone number, and business address of the prescribing practitioner in a clear and legible manner.

Effective: July 15, 2016

History: Amended 2016 Ky. Acts ch. 73, sec. 3, effective July 15, 2016. -- Created 1992 Ky. Acts ch. 127, sec. 1, effective July 14, 1992.

217.217 No restriction on donation of game meat to or from certain entities for specified purposes -- Conditions.

(1) As used in this section:

(a) "Cooperative extension agency" means the University of Kentucky Cooperative Extension Service and the Kentucky State University Cooperative Extension Program;

(b) "Not-for-profit organization" means an organization duly organized and validly existing as a not-for-profit organization under the laws of the Commonwealth and exempt under Section 501(c)(3) of the Internal Revenue Code;

(d) "Wildlife" has the same meaning as in KRS 150.010.

(2) Notwithstanding any provision of law to the contrary, no state or local government entity, including any local health department, shall restrict the donation of game meat to or from a not-for-profit organization, cooperative extension agency, the Kentucky Department of Fish and Wildlife Resources, or any government agency for the purposes of education, promotion of hunting or fishing, or free meal distribution to individuals in need if the game meat came from fish or wildlife that was:

(a) Taken within the Commonwealth;

(b) Properly field dressed and processed; and

Effective: June 29, 2021

History: Amended 2021 Ky. Acts ch. 33, sec. 1, effective June 29, 2021. -- Created 2015 Ky. Acts ch. 35, sec. 1, effective June 24, 2015.

217.218 Construction of chapter regarding donation of food.

Nothing in this chapter shall be construed to prohibit or regulate the donation of safe and apparently wholesome food by a retail food establishment, a nonprofit or religious organization that is recognized as tax exempt under Section 501(c)(3) of the Internal Revenue Code, or a home-based processor in accordance with KRS 217.127.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 30, sec. 2, effective July 15, 2026. -- Created 2006 Ky. Acts ch. 64, sec. 2, effective July 12, 2006.

217.220 Repealed, 1956.

[Repealed]

Kratom Extracts and Products Kratom Extracts and Products

217.2201 Definitions for KRS 217.2201 to 217.2209.

As used in KRS 217.2201 to 217.2209:

(1) "Department" means the Department for Public Health;

(2) "Food" has the same meaning as in KRS 217.015 and includes any beverage, dietary ingredient, dietary supplement, or food additive as defined in KRS 217.015 intended for human consumption;

(3) "Kratom" means any part of the plant Mitragyna speciosa;

(4) "Kratom extract" means any food, food product, or dietary ingredient containing any part of the leaf of the plant Mitragyna speciosa that has been extracted and concentrated in order to provide more standardized dosing;

(5) "Kratom processor" means any person or entity that prepares, manufactures, distributes, or maintains kratom extracts or kratom products or advertises, represents, or claims to sell, prepare, or maintain kratom extracts or kratom products;

(6) "Kratom product" means a food, powder, capsule, pill, or any other product intended for oral consumption that contains any part of the leaf of the plant Mitragyna speciosa or any extract thereof; and

(7) "Kratom retailer" means any person or entity that sells or advertises, represents, or claims to sell kratom extracts or kratom products.

Effective: July 15, 2024

History: Created 2024 Ky. Acts ch. 44, sec. 1, effective July 15, 2024.

Legislative Research Commission Note (7/15/2026). KRS 217.2209, referenced in this statute, was repealed by 2026 Ky. Acts ch. 161, sec. 134, effective July 15, 2026.

217.2202 Kratom processors and retailers -- Prohibitions. (Effective until July 1, 2027)

A kratom processor or kratom retailer shall not:

(1) Distribute, dispense, sell, or make available for sale any kratom extract or kratom product to an individual who is under twenty-one (21) years of age; or

(2) Prepare, manufacture, distribute, dispense, sell, or make available for sale any kratom extract or kratom product that:

(a) Is adulterated with a dangerous nonkratom substance that affects the quality or strength of the kratom extract or kratom product to such a degree that it may injure a consumer;

(b) Contains a poisonous or otherwise harmful nonkratom ingredient, including but not limited to any controlled substance as defined in KRS Chapter 218A;

(c) Contains a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than two percent (2%) of the overall alkaloid composition of the product;

(d) Contains any synthetic alkaloid, including synthetic mitragynine, synthetic 7- hydroxymitragynine, or any other synthetically derived compound of the plant Mitragyna speciosa;

(e) Contains levels of residual solvents higher than those permitted under the United States Pharmacopeia Chapter 467; or

(f) Does not meet the labeling requirements established pursuant to KRS 217.2203 or any administrative regulation promulgated thereunder.

Effective: July 15, 2024

History: Created 2024 Ky. Acts ch. 44, sec. 2, effective July 15, 2024.

217.2202 Kratom processors and retailers -- Prohibitions. (Effective July 1, 2027)

A kratom processor or kratom retailer shall not:

(1) Distribute, dispense, sell, or make available for sale any kratom, kratom extract, or kratom product; or

(2) Prepare, manufacture, distribute, dispense, sell, or make available for sale any kratom, kratom extract, or kratom product.

Effective: July 1, 2027

History: Amended 2026 Ky. Acts ch. 161, sec. 114, effective July 1, 2027. -- Created 2024 Ky. Acts ch. 44, sec. 2, effective July 15, 2024.

217.2203 Repealed, 2026.

[Repealed]

217.2205 Repealed, 2026.

[Repealed]

217.2207 Civil penalties. (Effective until July 1, 2027)

A kratom processor or kratom retailer who violates KRS 217.2202 or 217.2203 or any administrative regulation promulgated thereunder shall be subject to a civil penalty of not more than five hundred dollars ($500) for a first offense and not more than one thousand dollars ($1,000) for a second or subsequent offense.

Effective: July 15, 2024

History: Created 2024 Ky. Acts ch. 44, sec. 5, effective July 15, 2024.

217.2207 Civil penalties. (Effective July 1, 2027)

A kratom processor or kratom retailer who violates KRS 217.2202 shall be subject to a civil penalty of not more than five thousand dollars ($5,000) for a first offense and not more than ten thousand dollars ($10,000) for a second or subsequent offense.

Effective: July 1, 2027

History: Amended 2026 Ky. Acts ch. 161, sec. 115, effective July 1, 2027. -- Created 2024 Ky. Acts ch. 44, sec. 5, effective July 15, 2024.

217.2209 Repealed, 2026.

[Repealed]

217.230 Repealed, 1956.

[Repealed]

217.240 Repealed, 1956.

[Repealed]

217.241 Repealed, 1972.

[Repealed]

217.243 Repealed, 1972.

[Repealed]

217.247 Repealed, 1972.

[Repealed]

217.250 Repealed, 1956.

[Repealed]

217.251 Repealed, 1972.

[Repealed]

217.253 Repealed, 1972.

[Repealed]

217.257 Repealed, 1972.

[Repealed]

217.260 Repealed, 1960.

[Repealed]

217.270 Repealed, 1960.

[Repealed]

217.271 Repealed, 1960.

[Repealed]

217.272 Repealed, 1960.

[Repealed]

217.273 Repealed, 1960.

[Repealed]

217.274 Repealed, 1960.

[Repealed]

Food Establishments Food Establishments

217.280 Food establishments to be sanitary.

Every building, room, inclosure or premises occupied, used or maintained for the preparation, manufacture, packing, storage, sale or distribution of any food intended for sale shall be properly and adequately lighted, drained, plumbed and ventilated, and shall be conducted with strict regard to the influence of such conditions upon the health of those employed therein, and upon the purity and wholesomeness of the food produced, prepared, manufactured, packed, stored, sold or distributed therein.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-1.

217.285 Display of choke-saving techniques posters.

(1) Each food service establishment, having an on-premises seating capacity of twenty- five (25) persons or more, shall post inside the establishment, in a location conspicuous to employees, a choke-saving techniques poster meeting the following requirements.

(2) The choke-saving techniques poster shall meet the following specifications:

(a) The poster shall depict through illustration and description procedures for the removal of food which is lodged in a person's throat; and

(b) The techniques illustrated and described shall include, but need not be limited to, the procedures whereby the choking person is grasped around the lower chest and upper abdomen and given a quick jerk, thus putting increased interabdominal pressure on the lungs and expelling the foreign matter.

(3) The Cabinet for Health and Family Services shall produce or requisition the production of the choke-saving techniques poster as provided in this section and shall supply the posters to the local health departments for distribution without cost to food establishments.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 515, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 459, effective July 15, 1998. -- Created 1990 Ky. Acts ch. 458, sec. 6.

217.290 Buildings and equipment to be kept clean, healthful and sanitary -- Protection from contamination -- Removal of waste.

The floors, side walls, ceilings, furniture, receptacles, implements and machinery of every establishment or place where food intended for sale is produced, prepared, manufactured, packed, stored, sold or distributed, and all vehicles used in the transportation of such food, shall not be kept or permitted to remain in an unclean, unhealthy or unsanitary condition. An unclean, unhealthful and unsanitary condition shall be deemed to exist if food in the process of production, preparation, manufacture, packing, storing, sale, distribution or transportation is not securely protected from flies, dust and dirt, and as far as may be necessary by all reasonable means from all other foreign or injurious contamination; or if the refuse, dirt or waste products subject to decomposition and fermentation incident to the manufacture, preparation, packing, storing, selling, distributing or transportation of food is not removed daily; or if all machinery, equipment and utensils are not thoroughly cleaned daily, or if the clothing of persons therein employed is unclean.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-2.

217.300 Construction requirements of walls, ceilings and floors.

The side walls and ceilings of every bakery, confectionery, creamery and cheese factory, and hotel or restaurant kitchen, shall be so constructed that they can easily be kept clean. Every building, room or inclosure occupied or used for the preparation, manufacture, packing, storage, sale or distribution of food shall have an impermeable floor made of cement or tile laid in cement, brick, wood or other suitable material that can be flushed and washed clean with water.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-3.

217.310 Doors and screens.

All such places containing food shall be provided with proper doors and screens adequate to prevent contamination of the food from flies.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-4.

217.320 Toilets and lavatories.

Every place of the kind mentioned in KRS 217.280 shall have adequate and convenient toilet rooms and lavatories. The toilet rooms shall be separate and apart from any room where the process of preparation, manufacture, packing, storing, selling or distributing is conducted. The floors of the toilet rooms shall be of cement, tile, wood, brick or other nonabsorbent material, and shall be washed and scoured daily. Each toilet shall be furnished with separate ventilating flues and pipes discharging into soil pipes, or shall be outside of and well removed from the building. Lavatories and washrooms shall be adjacent to toilet rooms, or when the toilet is outside of the building the washroom shall be near the exit to the toilet, and shall be supplied with soap, running water and towels and maintained in a sanitary condition.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-5.

217.330 Conditions deemed a nuisance.

If any place of the kind mentioned in KRS 217.280 or any thing mentioned in KRS 217.290 to 217.320 is constructed, kept, maintained or permitted to remain in a condition contrary to any of the provisions of KRS 217.280 to 217.320, the same is declared a nuisance. No person shall unlawfully maintain or allow or permit to exist a nuisance as defined in this section.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-6.

217.340 Repealed, 1972.

[Repealed]

217.350 Spitting in food establishment -- Employees to wash hands.

No person shall expectorate on the food or utensils in, or on the floor or wall of, any place of the kind mentioned in KRS 217.280. All persons who handle the food shall, before beginning work and after visiting the toilet, wash their hands thoroughly in clean water.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-8.

217.360 Sleeping in food establishment prohibited.

No person shall sleep, or permit any other person to sleep, in any place where food is prepared for sale, served or sold, unless all foods therein handled are at all times in hermetically sealed packages.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-9.

217.370 Repealed, 1990.

[Repealed]

217.375 Sale of grocery items -- Limited exemptions for food service establishments.

(1) Legally permitted food service establishments shall be exempt from any state or local laws and administrative regulations that prohibit the sale of grocery items such as bread, milk, and other grocery staples to any customer.

(2) Sales permitted under subsection (1) of this section shall be limited to no more than twenty-five percent (25%) of the food service establishment's gross annual sales for the federal tax year.

(3) Notwithstanding KRS 217.125, no additional permit or permit fee shall be required for the sale of grocery items by legally permitted food service establishments unless the food service establishment violates subsection (2) of this section.

Effective:March 18, 2021

History: Created 2021 Ky. Acts ch. 42, sec. 1, effective March 18, 2021.

217.380 Enforcement of food establishment law -- Abatement of unlawful conditions.

(1) The officials in charge of the enforcement of the pure food laws of this state, the secretary for health and family services, the local health officers, and the duly appointed agents of all such, shall enforce the provisions of KRS 217.280 to 217.390. For this purpose such officers shall have full power at all times to enter every building, room, inclosure or premises occupied or used or suspected of being occupied or used for the preparation or manufacture for sale, or the storage, sale, distribution, or transportation, of such food, and to inspect the premises and all utensils, fixtures, furniture and machinery used therein.

(2) If upon inspection there is found any violation of any of the provisions of KRS 217.280 to 217.390, or if the preparation, manufacture, packing, storage, sale, distribution or transportation of such food is being conducted in a manner detrimental to the health of the employees or to the character or quality of the food, the officer or inspector making the inspection shall report the conditions and violations to the chief pure food official, or to the secretary for health and family services, or to the chief local health officer, as the case may be.

(3) The officer to whom the report is made shall thereupon issue a written order to the person responsible for the violation or condition to abate the condition or violation or to make the changes or improvements necessary to abate them, within a reasonable time as fixed in the order. Notice of the order may be served by delivering a copy to the person, or by sending a copy by certified mail, return receipt requested in which case the post office receipt shall be prima facie evidence that the notice was received. The person shall have the right to appear in person or by attorney before the officer issuing the notice or the person appointed by him for that purpose, within the time limited in the order, and shall be given an opportunity to be heard and to show why the order or instructions should not be obeyed. The hearing shall be under rules and regulations prescribed by the secretary for health and family services. If after the hearing it appears that the provisions of KRS 217.280 to 217.390 have not been violated, the order shall be rescinded. If it appears that the provisions of KRS 217.280 to 217.390 are being violated, and that the person notified is responsible therefor, the previous order shall be confirmed or amended, as the facts warrant, and shall thereupon be final, but such additional time as is necessary may be granted within which to comply with the final order. If the person is not present or represented when the final order is made, notice thereof shall be given as above provided. If the person fails to comply with the first order within the time prescribed, when no hearing is demanded, or fails to comply with the final order within the time specified, the facts shall be certified to the Commonwealth's, county or city attorney in whose jurisdiction the violation occurred, and such attorney shall proceed against the person for the applicable fines and penalties, and for abatement of the nuisance. The proceedings prescribed in this section for abatement of the nuisance shall not relieve the violator from prosecution in the first instance for every violation, nor from the penalties prescribed for such violation.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 516, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 460, effective July 15, 1998. -- Amended 1980 Ky. Acts ch. 114, sec. 43, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1); and ch. 315, sec. 30. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-11.

217.390 Adulterated food found in food establishment to be tagged -- Disposition.

(1) When any duly authorized officer mentioned in KRS 217.380 finds any article of food that is adulterated, or any other article or substance that is detrimental to public health, the article shall be tagged or otherwise properly marked, giving notice that the product is suspected of being adulterated or detrimental to public health and has been quarantined, and warning all persons not to remove it until given permission by the officer or the courts.

(2) No person shall remove or otherwise dispose of such article in violation of this section.

(3) The officer shall then petition the judge of the District Court in the judicial circuit in which the article is found, for the condemnation and destruction of the article. The owner or defender of the article shall be given the right to a hearing, first before the officer, if desired, and before the court. The notice of a hearing before the officer shall state the length of time within which the hearing may be had.

(4) If the finding of the court is with the officer, the article shall be destroyed at the expense of the owner, or by the owner under the supervision of the officer. The costs shall be taxed against the owner or defender of the property, if he appears. If no one appears, the costs shall be collected against the owner or agent properly ascertained.

Effective: January 2, 1978

History: Amended 1976 (1st Extra. Sess.) Ky. Acts ch. 14, sec. 207, effective January 2, 1978 -- Amended 1976 Ky. Acts ch. 62, sec. 102. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2060b-12.

Poisons Generally Poisons Generally

217.400 Poison defined -- Sale restricted -- Register to be kept.

(1) A poison is any drug, chemical or preparation that, according to standard works on medicine or medica, is liable to be destructive to adult human life in quantities of sixty (60) grains or less.

(2) Except as provided in subsection (4) of this section, no person shall sell or retail any poison without affixing to the package containing it a label printed or plainly written containing the name of the article, the word "poison," and the name and place of business of the seller, with the common name of two (2) or more readily accessible antidotes, nor shall he deliver poison to any person without satisfying himself that the poison is to be used for legitimate purposes. Any person selling or dispensing any poison that is known to be destructive to adult human life in quantities of five (5) grains or less shall, before delivering it, enter in a book kept for that purpose the name of the seller, the name and residence of the buyer, the name of the article, the quantity sold or disposed of, and the purpose for which it is said to be intended. The book of registry shall be preserved for at least two (2) years after the date of the last entry, and shall at all times be open to the inspection of the coroner of the county in which it is kept, and the members or authorized inspectors of the Kentucky Board of Pharmacy.

(3) The emmenagogues or abortives known as tansy, pennyroyal, rue, savin, ergot, cotton root and their preparations, patent or otherwise, shall be sold at retail or dispensed only upon the original written prescription of a legally qualified physician. The prescription shall be filled but once and no copy shall be taken by any person.

(4) The provisions of this section shall not apply to the dispensing of poisons in not unusual quantities or doses, on physicians' prescriptions, nor to the sale to agriculturists or horticulturists of articles commonly used by them as insecticides.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2630.

Legislative Research Commission Note. KRS 217.640 provides for the repeal of the provisions of KRS 217.400 covering economic poisons subject to KRS 217.542 to 217.640.

217.410 Repealed, 1954.

[Repealed]

217.420 Methyl (wood) alcohol for human use -- Sale or other disposition prohibited.

No person shall sell, offer for sale, give away, deal in or supply, or have in his possession for that purpose, any article of food or drink or any medicinal or toilet preparation intended for human use internally or externally that contains any methyl alcohol, otherwise known as wood alcohol or wood naphtha, either crude or refined, or that contains denatured alcohol containing methyl or wood alcohol.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2635b-1.

217.430 Labeling of wood alcohol.

No person shall sell, offer for sale, give away, deal in or supply, or have in his possession for that purpose, any methyl alcohol, otherwise known as wood alcohol or wood naphtha, either crude or refined, unless the container bears the following conspicuously printed, stenciled or typewritten notice: "Skull and crossbones -- Poison -- Wood alcohol or wood naphtha -- Warning. Wood alcohol is poisonous, and when inhaled or swallowed may cause blindness or death. It is unlawful to use this fluid in any way either internally or externally for the human body."

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2635b-2.

217.440 Labeling of denatured alcohol.

No person shall sell, offer for sale, give away, deal in or supply, or have in his possession for that purpose, any denatured alcohol that contains methyl or wood alcohol, unless the container bears the following conspicuously printed, stenciled or typewritten notice: "Skull and crossbones -- Poison -- Denatured alcohol -- Warning. This fluid contains wood alcohol, and if inhaled or swallowed may cause blindness or death. It is unlawful to use this fluid in any way either internally or externally for the human body."

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 2635b-3.

217.450 Poisonous drug not to be sold to infant.

No person shall sell or deliver to any person under the age of fifteen (15) years, except with the consent of his parent or guardian or upon the written prescription of a physician, any poisonous drug or medicine.

Effective: October 1, 1942

History: Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 1276.

217.460 Repealed, 1958.

[Repealed]

217.461 Repealed, 1968.

[Repealed]

217.462 Repealed, 1968.

[Repealed]

217.470 Repealed, 1958.

[Repealed]

217.471 Repealed, 1968.

[Repealed]

217.480 Repealed, 1958.

[Repealed]

217.481 Repealed, 1968.

[Repealed]

217.490 Repealed, 1958.

[Repealed]

217.491 Repealed, 1968.

[Repealed]

217.500 Repealed, 1958.

[Repealed]

217.501 Repealed, 1968.

[Repealed]

217.510 Repealed, 1958.

[Repealed]

217.511 Repealed, 1968.

[Repealed]

217.520 Repealed, 1958.

[Repealed]

217.521 Repealed, 1968.

[Repealed]

217.530 Repealed, 1958.

[Repealed]

217.531 Repealed, 1968.

[Repealed]

217.533 Repealed, 1968.

[Repealed]

217.535 Repealed, 1968.

[Repealed]

217.540 Repealed, 1974.

[Repealed]

Experimental Treatments for Terminal Illnesses Experimental Treatments for Terminal Illnesses

217.5401 Definitions for KRS 217.5401 to 217.5408.

As used in KRS 217.5401 to 217.5408:

(1) "Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, protein other than a chemically synthesized polypeptide, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings;

(2) "Device" has the same meaning as in KRS 217.015;

(3) "Drug" has the same meaning as in KRS 217.015;

(4) "Eligible patient" means an individual who meets the requirements of KRS 217.5403;

(5) "Health care provider" means a licensed physician, a licensed advanced practice registered nurse, or a licensed physician assistant;

(6) "Health facility" has the same meaning as in KRS 216B.015;

(7) "Investigational drug, biological product, or device" means a drug, biological product, or device that:

(a) Has successfully completed Phase I of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration; and

(b) Remains under investigation in a United States Food and Drug Administration-approved clinical trial;

(8) "Terminal illness" means a progressive disease or a medical or surgical condition that:

(a) Entails significant functional impairment;

(b) Is not considered by a treating health care provider to be reversible even with administration of a treatment currently approved by the United States Food and Drug Administration; and

(9) "Written informed consent" means a written document that meets the requirements of KRS 217.5404.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 1, effective June 29, 2017.

217.5402 Manufacturer of investigational drug, biological product, or device may make it available to a requesting patient eligible under KRS 217.5401 to 217.5408.

(1) A manufacturer of an investigational drug, biological product, or device may make the investigational drug, biological product, or device available to an eligible patient who has requested it pursuant to KRS 217.5401 to 217.5408.

(2) The manufacturer may:

(a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or

(b) Require an eligible patient to pay the costs of or the costs associated with the manufacture of the investigational drug, biological product, or device.

(3) A manufacturer shall not be required to make an investigational drug, biological product, or device available to an eligible patient.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 2, effective June 29, 2017. Formerly codified as KRS 217.5403.

217.5403 Eligibility requirements for treatment with investigational drug, biological product, or device.

A patient shall be eligible for treatment with an investigational drug, biological product, or device if the patient has:

(1) A terminal illness that is attested to by the patient's treating health care provider;

(2) Considered all other treatment options currently approved by the United States Food and Drug Administration;

(3) Received a recommendation from the patient's treating health care provider for an investigational drug, biological product, or device;

(4) Given written informed consent for the use of the investigational drug, biological product, or device; and

(5) Documentation from the treating health care provider that the patient meets the requirements of this section.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 3, effective June 29, 2017. Formerly codified as KRS 217.5405.

217.5403 Renumbered as KRS 217.5402.

[Renumbered as KRS 217.5402.]

217.5404 Written informed consent required for treatment with investigational drug, biological product, or device.

(1) A patient or a patient's legal guardian shall provide written informed consent for treatment with an investigational drug, biological product, or device.

(2) At a minimum, the written informed consent shall include:

(a) An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;

(b) An attestation that the patient concurs with the treating health care provider's belief that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;

(c) Clear identification of the specific investigational drug, biological product, or device that the patient is seeking to use;

(d) A description of the potentially best and worst outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome;

(e) A statement that the patient's health plan or third-party administrator and provider shall not be obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device unless they are specifically required to do so by law or contract; and

(f) A statement that the patient understands that the patient shall be liable for all expenses related to the use of the investigational drug, biological product, or device and that the liability for expenses extends to the patient's estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.

(3) The description of potential outcomes required under subsection (2)(d) of this section shall:

(a) Include the possibility that new, unanticipated, different, or worse symptoms may result and that the proposed treatment may hasten death; and

(b) Be based on the treating health care provider's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition.

(4) The written informed consent shall be:

(a) Signed by:

The patient;
A parent or legal guardian, if the patient is a minor; or
A legal guardian, if a guardian has been appointed for the patient; and

(b) Attested to by the patient's treating health care provider and a witness.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 4, effective June 29, 2017. Formerly codified as KRS 217.5407.

217.5405 Limitations on impact KRS 217.5401 to 217.5408 may have on insurance coverage or health facility services -- Coverage permitted -- Approval of health facility for use.

(1) KRS 217.5401 to 217.5408 shall not:

(a) Expand the coverage required of an insurer;

(b) Affect the requirements for insurance coverage of routine patient costs for patients involved in approved cancer clinical trials;

(c) Require a health plan, third-party administrator, or governmental agency to pay costs associated with the use, care, or treatment of an eligible patient with an investigational drug, biological product, or device; or

(d) Require a hospital or health facility to provide new or additional services.

(2) A health plan, third-party administrator, or governmental agency may provide coverage for the cost of an investigational drug, biological product, or device or the cost of services related to the use of an investigational drug, biological product, or device under KRS 217.5401 to 217.5408.

(3) A hospital or health facility may approve the use of an investigational drug, biological product, or device in the hospital or health facility.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 5, effective June 29, 2017. Formerly codified as KRS 217.5409.

217.5405 Renumbered as KRS 217.5403.

[Renumbered as KRS 217.5403.]

217.5406 Death of patient receiving experimental treatment absolves heirs of liability for resulting debt.

If an eligible patient dies while being treated with an investigational drug, biological product, or device, the patient's heirs are not liable for any outstanding debt related to the treatment or to a lack of insurance as a result of the treatment.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 6, effective June 29, 2017. Formerly codified as KRS 217.5411.

217.5407 Health care provider held harmless for recommendation that a patient have access to experimental treatment.

(1) A licensing board shall not revoke, fail to renew, suspend, or take any action against a licensed health care provider based solely on the health care provider's recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device.

(2) The Cabinet for Health and Family Services shall not take action against a health care provider's Medicare or Medicaid certification based solely on the health care provider's recommendation that a patient have access to an investigational drug, biological product, or device.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 7, effective June 29, 2017. Formerly codified as KRS 217.5413.

217.5407 Renumbered as KRS 217.5404.

[Renumbered as KRS 217.5404.]

217.5408 Prohibition against blocking or attempting to block access by eligible patient to experimental treatment.

(1) An official, employee, or agent of the Commonwealth of Kentucky shall not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device.

(2) Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider shall not be considered a violation of this section.

Effective: June 29, 2017

History: Created 2017 Ky. Acts ch. 65, sec. 8, effective June 29, 2017. Formerly codified as KRS 217.5415.

217.5409 Renumbered as KRS 217.5405.

[Renumbered as KRS 217.5405.]

Pesticide Control Pesticide Control

217.541 Short title.

KRS 217.542 to 217.630 and 217.998 may be cited as the "Kentucky Pesticide Control Act of 1974."

History: Created 1974 Ky. Acts ch. 200, sec. 1.

217.5411 Renumbered as KRS 217.5406.

[Renumbered as KRS 217.5406.]

217.5413 Renumbered as KRS 217.5407.

[Renumbered as KRS 217.5407.]

217.5415 Renumbered as KRS 217.5408.

[Renumbered as KRS 217.5408.]

217.542 Administration of pesticide control statutes.

KRS 217.542 to 217.630 shall be administered by the Department of Agriculture, hereinafter referred to as the "department."

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 48, effective July 15, 1980. -- Created 1974 Ky. Acts ch. 200, sec. 2.

217.544 Definitions for chapter.

As used in this chapter, unless the context requires otherwise:

(1) "Active ingredient" means any ingredient which will prevent, destroy, repel, control, or mitigate pests, or which will act as a plant regulator, defoliant, or desiccant, or as a functioning agent in a spray adjuvant;

(2) "Adulterated" shall apply to any pesticide if its strength or purity falls below the professed standard or quality as expressed on its labeling or under which it is sold, or if any substance has been substituted wholly or in part for the pesticide, or if any valuable constituent of the pesticide has been wholly or in part abstracted;

(3) "Animal" means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and shellfish;

(4) "Antidote" means the most practical immediate treatment in case of poisoning and includes first-aid treatment;

(5) "Board" means the Pesticide Advisory Board;

(6) "Defoliant" means any substance or mixture of substances intended to cause the leaves or foliage to drop from a plant, with or without causing abscission;

(7) "Desiccant" means any substance or mixture of substances intended to artificially accelerate the drying of plant tissue;

(8) "Device" means any instrument or contrivance other than a firearm which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life other than man and other bacteria, virus, or other microorganisms on or in living man or other living animals; but not including equipment used for the application of pesticides when sold separately therefrom;

(9) "Distribute" means to offer for sale, hold for sale, sell, barter, ship, deliver for shipment, or receive and, having received, deliver, or offer to deliver pesticides in this state;

(10) "Environment" includes water, air, land, and all plants and man and other animals living therein and the interrelationships which exist among these;

(11) "EPA" means the United States Environmental Protection Agency;

(12) "FIFRA" means the Federal Insecticide, Fungicide and Rodenticide Act as amended, and any regulations promulgated thereunder;

(13) "Fungi" means all nonchlorophyll-bearing thallophytes; that is, all nonchlorophyll- bearing plants of a lower order than mosses and liverworts, as for example, rusts, smuts, mildews, molds, yeasts, bacteria, and viruses, except those on or in living man or other living animals, and except those in or on processed food, beverages, or pharmaceuticals;

(14) "Highly toxic pesticide" means any pesticide determined to be highly toxic under the authority of sec. 25(c)(2) of FIFRA or by the department under this chapter;

(15) "Imminent hazard" means a situation which exists when the continued use of a pesticide would likely result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered by the secretary of the United States Department of Interior under Pub. L. 91-135 of the United States Congress;

(16) "Inert ingredient" means an ingredient which is not an active ingredient;

(17) "Ingredient statement" means a statement of the name and percentage of each active ingredient together with the total percentage of the inert ingredients in the pesticide and, when the pesticide contains arsenic in any form, a statement of the percentage of total and water-soluble arsenic, each stated as elemental arsenic;

(18) "Insect" means any of the numerous small invertebrate animals generally having the body more or less obviously segmented, for the most part belonging to the class insecta, comprising six (6) legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six (6) legs, as, for example, spiders, mites, ticks, centipedes, and wood lice, also nematodes and other invertebrates which are destructive, constitute a liability, and may be classed as pests;

(19) "Label" means the written, printed, or graphic matter on, or attached to, the pesticide or device, or to any of its containers or wrappers;

(20) "Labeling" means the label and other written, printed, or graphic matter:

(a) On the pesticide or device, or any of its containers or wrappers;

(b) Accompanying the pesticide or device at any time or referring to it in any other media used to disseminate information to the public; and

(c) To which reference is made on the label or in the literature accompanying the pesticide or device, except when accurate nonmisleading reference is made to current official publications of the United States Environmental Protection Agency, the Departments of Agriculture and Interior, the Department of Health, Education and Welfare, and other similar federal institutions, the College of Agriculture, University of Kentucky, Kentucky Agricultural Experiment Station, Cabinet for Health and Family Services, Energy and Environment Cabinet, or other agencies of this state or other states when such agencies are authorized by law to conduct research in the field of pesticides;

(21) "Land" means all land and water areas, including air space and all plants, animals, structures, buildings, contrivances, and machinery appurtenant thereto, or situated thereon, fixed or mobile, including any used for transportation;

(22) "Livestock" means cattle, sheep, swine, goats, horses, alpacas, llamas, buffaloes, and any other animals of the bovine, ovine, porcine, caprine, equine, or camelid species;

(23) "Misbranded" means a pesticide is misbranded if:

(a) Its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular;

(b) It is an imitation of or is distributed under the name of another pesticide;

(c) The labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and, if complied with, together with any requirements imposed under section 3(d) of FIFRA are adequate to protect health and the environment;

(d) The labeling does not contain a statement of the use classification under which the product is registered by EPA;

(e) The label does not contain a warning or caution statement required under section 3(d) of FIFRA;

(f) The label does not bear an ingredient statement on that part of the immediate container, and on the outside container or wrapper, if there be one, through which the ingredient statement on the immediate container cannot be clearly read, of the retail package which is presented or displayed under customary conditions of the purchase; provided, that the ingredient statement may appear prominently on another part of the container pursuant to section 2(q) 2(A) (i)

(ii) of FIFRA if the size and form of the container makes it impractical to place it on that part of the retail package which is presented or displayed under customary conditions of purchase;

(g) Any word, statement, or other information required by KRS 217.542 to 217.630 or FIFRA to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared to other words, statements, designs, or graphic matter in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(h) The label does not bear the name, brand, or trademark under which the pesticide is distributed;

(i) The label does not bear the net weight or measure of the content;

(j) The label does not bear the name and address of the manufacturer, registrant, or person for whom manufactured; and

(k) The label does not bear the EPA registration number assigned to each establishment in which the product is produced and the EPA number assigned to the pesticide, if required by regulation under FIFRA;

(24) "Nematode" means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmented round worms with elongated, fusiform, or sac-like bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts; may also be called nemas or eelworms;

(25) "Person" means any individual, partnership, association, or any organized group of persons whether incorporated or not;

(26) "Pest" means any insect, snail, slug, rodent, nematode, fungus, weed, and any other form of plant or animal life, or virus, bacteria, or other microorganism, except viruses, bacteria, or other microorganisms on or in living man or other living animals, which is normally considered to be a pest, or which the department may declare to be a pest;

(27) "Pesticide" means any substance or mixture of substances intended to prevent, destroy, control, repel, attract, or mitigate any pest; any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant; and any substance or mixture of substances intended to be used as a spray adjuvant;

(28) "Plant regulator" means any substance or mixture of substances, intended through physiological actions, to accelerate or retard the rate of growth or maturation, or to otherwise alter the behavior of plants, but shall not include substances insofar as they are intended to be used as plant nutrients, trace elements, nutritional chemicals, plant inoculants, or soil amendments;

(29) "Protect health and the environment" means protection against any unreasonable adverse effects on the environment;

(30) "Registrant" means a person who has registered any pesticide pursuant to the provisions of KRS 217.542 to 217.630;

(31) "Restricted-use pesticide" means any pesticide classified for restricted use by the administrator, EPA, or by regulation of the department;

(32) "Spray adjuvant" means any wetting agent, spreading agent, sticker, deposit builder, adhesive, emulsifying agent, deflocculating agent, water modifier, or similar agent intended to be used with any other pesticide as an aid to the application or to the effect thereof, and which is in a package or container separate from that of the other pesticide with which it is to be used;

(33) "Unreasonable adverse effects on the environment" means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide;

(34) "Weed" means any plant which grows where not wanted; and

(35) "Wildlife" means all living things that are neither human, domesticated, nor as defined in KRS 217.542 to 217.630, pests, including but not limited to mammals, birds, and aquatic life.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 11, sec. 2, effective July 15, 2026. -- Amended 2017 Ky. Acts ch. 129, sec. 12, effective June 29, 2017. -- Amended 2010 Ky. Acts ch. 24, sec. 323, effective July 15, 2010. -- Amended 2005 Ky. Acts ch. 99, sec. 517, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 461, effective July 15, 1998. -- Amended 1980 Ky. Acts ch. 295, sec. 49, effective July 15, 1980. -- Created 1974 Ky. Acts ch. 200, sec. 3.

217.550 Prohibitions relating to distribution of pesticides.

It shall be unlawful for any person to distribute within this state the following:

(1) Any pesticide which is not registered pursuant to the provisions of KRS 217.542 to 217.630, and to the provisions of FIFRA;

(2) Any pesticide if any of the claims made for it or any of the directions for its use differ from the representations made in connection with its registration, or if the composition of a pesticide differs from its composition as represented in connection with its registration; provided, that in the discretion of the department, a change in the labeling or formulation of a pesticide may be made, within a registration period, without requiring reregistration of the product if the name is not changed and if the registration is amended to reflect such change and if such change will not violate any provisions of FIFRA;

(3) Any pesticide, unless it is in the registrant's or the manufacturer's unbroken immediate container, and there is affixed to such container, and to the outside container or wrapper of the retail package, if there is one through which the required information on the immediate container cannot be clearly read, a label bearing:

(a) The brand name and address of the manufacturer, registrant or person for whom manufactured;

(b) The name, brand or trademark under which the article is sold;

(d) Any pesticide in containers which are unsafe due to damage.

(4) Any pesticide which contains any substance or substances in quantities highly toxic to man, determined as provided in KRS 217.542 to 217.630, unless the label bears, in addition to any other matter required by KRS 217.542 to 217.630:

(a) The skull and crossbones;

(b) The word "poison" in red prominently displayed on a background of distinctly contrasting color; and

(5) The pesticides commonly known as lead arsenate, basic lead arsenate, calcium arsenate, magnesium arsenate, zinc arsenate, zinc arsenite, sodium fluoride, sodium fluosilicate, and barium fluosilicate unless they are distinctly colored or discolored as provided by regulations, or any other white powder pesticide which the department, after investigation of and after public hearing on the necessity for such action for the protection of human life and the environment and the feasibility of such coloration or discoloration, shall by regulation, require to be distinctly colored or discolored unless it has been so colored or discolored;

(6) Any pesticide which is adulterated or misbranded, or any device which is misbranded.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 50, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 4. -- Created 1956 Ky. Acts ch. 218, sec. 2, effective July 1, 1956.

217.556 Repealed, 1974.

[Repealed]

217.558 Repealed, 1974.

[Repealed]

217.560 Unlawful practices.

It shall be unlawful:

(1) For any person to detach, alter, deface, or destroy, in whole or in part, any label or labeling provided for in KRS 217.542 to 217.630 or the regulations adopted hereunder, or to add any substance to, or take any substance from a pesticide in a manner that may defeat the purposes of KRS 217.542 to 217.630 or the regulations adopted hereunder;

(2) For any person to use for his own advantage or to reveal, other than to the department, or proper officials or employees of the state or officials or employees of EPA, or other federal agencies, or to the courts in response to a subpoena, or to physicians, or in emergencies to pharmacists and other qualified persons for use in the preparation of antidotes, in accordance with such directions as the department may prescribe, any information relative to formulas of products, or trade secrets or other confidential information obtained under authority of KRS 217.542 to 217.630;

(3) For any person to oppose or interfere in any way with the department or its duly authorized agents in carrying out the duties imposed by KRS 217.542 to 217.630 or any regulations adopted hereunder;

(4) For any person to handle, transport, store, display or distribute pesticides in such a manner as to endanger man and his environment, or to endanger food, feed, or any other products that may be transported, stored, displayed or distributed with such pesticides; and

(5) For any person to dispose of, discard, or store any pesticides or pesticide containers in such a manner as to cause injury to humans, vegetation, crops or livestock, wildlife, beneficial insects, or to pollute any water supply or waterway.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 51, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 5. -- Created 1956 Ky. Acts ch. 218, sec. 3, effective July 1, 1956.

217.565 Registered pesticide with EPA-approved master label -- When warning deemed sufficient for purposes of duty to warn or label action -- Exception.

(1) Any pesticide registered for use with the Department of Agriculture, pursuant to KRS 217.570, or the United States Environmental Protection Agency (EPA) pursuant to the FIFRA as defined in KRS 217.544, and any regulations promulgated thereunder, including but not limited to 40 C.F.R. pt. 156, that displays a label that has been approved by the EPA in registering the pesticide or is consistent with the most recent human health risk assessment performed under the FIFRA shall be deemed a sufficient warning label for the purposes of an action commenced under any provision of state law concerning the duty to warn or label, or any other common law duty to warn.

(2) This section shall only apply to any pesticide for which the EPA has approved a master label that includes an Agricultural Use Requirements label in accordance with 40 C.F.R. pt. 156.

(3) The provisions of this section shall not:

(a) Apply when a determination has been made by the EPA that a manufacturer knowingly withheld, concealed, misrepresented, or destroyed material information regarding the human health risks of such pesticide in order to obtain or maintain approval of its label by the EPA; or

(b) Be interpreted to prohibit a cause of action based on any other provision or doctrine of state law.

Effective: July 15, 2026

History: Created 2026 Ky. Acts ch. 11, sec. 1, effective July 15, 2026.

217.570 Registration of pesticides -- Annual inspection fee -- Renewal.

(1) (a) Except as provided by paragraph (b) of this subsection, every pesticide distributed within the state or delivered for transportation or transported in intrastate commerce or between points within the state through points outside the state shall be registered with the department.

(b) Registration is not required if:

A pesticide is shipped from one (1) plant or warehouse to another plant or warehouse operated by the same person and used solely at the plant or warehouse as a constituent part to make a pesticide which is registered under the provisions of KRS 217.542 to 217.630; or
If the pesticide is distributed under the provisions of an experimental use permit issued under the provisions of KRS 217.542 to 217.630 or an experimental use permit issued by EPA.

(2) The applicant for registration shall file with the department, a statement containing:

(a) The name and address of the applicant and the name and address of the person whose name will appear on the label, if other than the applicant's;

(b) The name of the pesticide and its EPA registration number;

(c) A complete copy of the labeling accompanying the pesticide and a statement of all claims made or to be made for it including directions for use and a request that the pesticide be classified for nonrestricted use, for restricted use, or for both as provided for in FIFRA. In the case of renewal of registration, a statement shall be required only with respect to information which is different from that furnished when the pesticide was registered or last reregistered, unless the department requests a copy of the labeling; and

(d) Other necessary information as specified by the department on the application for registration form.

(3) The department may require a full description of the tests made and results of the tests upon which the claims are based on any pesticide not registered in accordance with Section 3 of FIFRA, or on any pesticide on which restrictions are being considered.

(4) (a) The applicant desiring to register a pesticide in this state shall make application on forms furnished by the department, and, for the purposes identified in paragraph (b) of this subsection, shall pay to the department an annual fee of two hundred fifty dollars ($250) for each and every brand or grade to be offered for sale in this state. There shall be issued to the registrant by the department a license entitling the registrant to sell all duly registered brands in this state until the expiration of the license.

(b) The annual fees received by the department shall be used to fund:

The Kentucky Agriculture and Environment in the Classroom program, a program administered by the department;
The farm chemical and container disposal program, a program administered by the department;
The cost-sharing program through the department and the Energy and Environment Cabinet, Division of Conservation, for the use of farmers in implementing agricultural production practices that protect the quality of soil and water resources; and
Expenses incurred in the enforcement of KRS 217.542 to 217.630.

(5) The department, when necessary in the administration of KRS 217.542 to 247.630, may require the submission of the complete formula of any pesticide, including the active and inert ingredients.

(6) The department may refuse to register, or to cancel the registration of, any brand of pesticide upon satisfactory proof that the registrant has been guilty of fraudulent and deceptive practices in evasions or attempted evasions of the provisions of KRS 217.542 to 217.630 or any administrative regulations promulgated under KRS 217.542 to 217.630. No registration shall be revoked or refused until the registrant has been given a hearing by the department.

(7) Registrants desiring to renew registrations shall file with the department an application for renewal prior to January 1. Any registration in effect on the thirty- first day of December and for which a renewal application has been made and the proper fee paid shall continue in full force and effect until the department has notified the applicant that the registration has been renewed, or denied.

(8) If the renewal of a pesticide registration is not filed prior to January 15 of any year, or if a new product is sold or offered for sale prior to registration, an additional fee of ten dollars ($10) shall be assessed and added to the original fee before the registration of that pesticide is renewed or a new registration is accepted. The additional fee shall not apply if the applicant furnishes an affidavit certifying that he did not distribute any unregistered pesticides during the period of nonregistration. The payment of the additional fee is not a bar to any prosecution for doing business without proper registry.

(9) Upon certification by the administrator of EPA to register pesticides in accordance with Section 24(c) of FIFRA, the department may register the pesticides if it determines that:

(a) Its composition warrants the proposed claims for it;

(b) Its labeling and other material required to be submitted meet with the requirements of KRS 217.542 to 217.630;

(c) It will perform its intended function, and when used in accordance with widespread and commonly recognized practice, will not cause unreasonable adverse effects on the environment; and

(d) The registration is not disapproved by the administrator of EPA.

Effective: July 15, 2010

History: Amended 2010 Ky. Acts ch. 24, sec. 324, effective July 15, 2010. -- Amended 2009 Ky. Acts ch. 81, sec. 1, effective June 25, 2009. -- Amended 1994 Ky. Acts ch. 141, sec. 1, effective July 15, 1994. -- Amended 1980 Ky. Acts ch. 295, sec. 52, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 6. -- Created 1956 Ky. Acts ch. 218, sec. 5, effective July 1, 1956. 2026-2028 Budget Reference. See State/Executive Branch Budget, 2026 Ky. Acts ch. 168, Pt. I, A, 21, (1) at 2059.

217.572 Registration refusal, cancellation, suspension, and legal recourse -- Appeal of order -- Notice to EPA.

(1) Upon certification pursuant to Section 24(c) of FIFRA by the administrator of EPA to register pesticides formulated to meet special local needs, the department shall consider the following for refusal to register, for cancellation, for suspension and for legal recourse for applicable pesticides:

(a) If it does not appear to the department that the pesticide is such as to warrant the proposed claims for it or if the pesticide and its labeling and other material required to be submitted do not comply with the provisions of KRS 217.542 to 217.630 or administrative regulations promulgated thereunder, the department shall notify the applicant of the manner in which the pesticide, labeling, or other material required to be submitted fails to comply with the provisions of KRS 217.542 to 217.630 so as to afford the applicant an opportunity to make the necessary corrections. If, upon receipt of this notice, the applicant does not make the required changes, the department may refuse to register the pesticide.

(b) When the department determines that a pesticide or its labeling does not comply with the provisions of KRS 217.542 to 217.630 or the administrative regulations promulgated thereunder, the registration of a pesticide may be cancelled after a hearing that shall be conducted in accordance with KRS Chapter 13B.

(c) When the department determines that there is an imminent hazard, it may suspend the registration of a pesticide by issuing an emergency order pursuant to KRS 13B.125.

(d) Any person who will be adversely affected by a final order or emergency order issued under this section may obtain judicial review by filing a petition in the Franklin Circuit Court in accordance with KRS Chapter 13B.

(2) If the department determines that the federally-registered pesticide with respect to the use of a pesticide subject to this section within this state does not warrant the proposed claims for it, or if the pesticide and its labeling and other material required to be submitted do not comply with the provisions of FIFRA or the regulations promulgated thereunder, EPA shall be notified of the manner in which the pesticide, labeling, or other material required to be submitted fail to comply with the provisions of FIFRA and suggest necessary corrections.

Effective: July 15, 1996

History: Amended 1996 Ky. Acts ch. 318, sec. 124, effective July 15, 1996. -- Amended 1980 Ky. Acts ch. 295, sec. 53, effective July 15, 1980. -- Created 1974 Ky. Acts ch. 200, sec. 7.

217.574 Experimental use permits.

Upon authorization of the state by the administrator of EPA to issue experimental use permits, the department may:

(1) Issue an experimental use permit to any person applying for such permit if the applicant needs such permit in order to accumulate information to register a pesticide. Application for an experimental use permit may be filed at the time of, or before or after an application for registration is filed.

(2) Prescribe terms, conditions and period of time, for experimental use permit which shall be under the supervision of such person as may be designated on the permit.

(3) Revoke any experimental use permit at any time, upon finding that its terms or conditions are being violated, or that its terms and conditions are inadequate to avoid unreasonable adverse effect on the environment.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 54, effective July 15, 1980. -- Created 1974 Ky. Acts ch. 200, sec. 8.

217.580 Authority of department.

(1) The department may, after due notice and an opportunity for a hearing:

(a) Declare as a pest any form of plant or animal life or virus, except virus, bacteria, or other micro-organisms on or in living man or other living animals, which is injurious to plants, animals, or the environment;

(b) Determine whether pesticides registered under the authority of Section 24(c) of FIFRA are highly toxic to man. The definition of highly toxic, as defined in Title 40, Code of Federal Regulations 162.8 as issued or hereafter amended, shall govern the department in this determination;

(c) Determine standards of coloring or discoloring for pesticides and to subject pesticides to the requirements for coloration or discoloration if the department determines such requirements are necessary for the protection of health and the environment;

(d) Determine pesticides, and quantities of substances contained in pesticides, which are injurious to the environment and shall be guided by EPA regulations in this determination.

(2) The department may:

(a) Effect the collection and examination of samples of pesticides and devices to determine compliance with the requirements of KRS 217.542 to 217.630, and may at all reasonable hours enter any car, warehouse, store, building, boat, vessel or other place supposed to contain pesticides or devices for the purpose of inspection or sampling and to procure samples for analysis or examination from any lot, package or parcel of pesticides or device;

(b) Publish from time to time, in such form as it may deem proper, reports of the results of the analyses of official samples of pesticides distributed within the state;

(c) After a public hearing, make appropriate regulations relating to the sale and distribution of pesticides as may be necessary for carrying out the meaning of KRS 217.542 to 217.630, including but not limited to:

The safe handling, transportation, storage, display, distribution and disposal of pesticides and their containers;
Labeling requirements of all pesticides required to be registered under KRS 217.542 to 217.630; provided, that such regulations shall not impose any requirements for federally registered labels in addition to or different from those required pursuant to FIFRA; and
Specify classes of devices which shall be subject to the provisions of KRS 217.542 to 217.630.

(d) Cooperate with, and enter into agreements with, any other agency of this state, the United States Environmental Protection Agency, and any other state or agency thereof for the purpose of carrying out the provisions of KRS 217.542 to 217.630.

(3) For the purpose of uniformity of requirements between states and the federal government the department may, after a public hearing, adopt regulations in conformity with the primary pesticide standards, particularly as to the labeling, registration requirements and "restricted use pesticides" as established by EPA or other federal or state agencies.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 55, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 9. -- Created 1956 Ky. Acts ch. 218, sec. 6, effective July 1, 1956.

217.590 Repealed, 1974.

[Repealed]

217.600 When penalties not applicable.

The penalties provided for violations of KRS 217.542 to 217.630 shall not apply to:

(1) Any carrier while lawfully engaged in transporting a pesticide within this state, if such carrier shall, upon request, permit the department or its designated agent to copy all records showing the transactions in and movements of the pesticides or devices;

(2) Public officials of this state and of the federal government while engaged in the performance of their official duties in administering state or federal laws or regulations, or while engaged in pesticide research;

(3) The manufacturer or shipper of a pesticide for experimental use only by or under the supervision of an agency of this state or of the federal government authorized by law to conduct research in the field of pesticides; provided, that such manufacturer or shipper hold a valid experimental permit as provided for in KRS 217.542 to 217.630 or by EPA;

(4) Any person who ships a substance or mixture of substances being put through tests in which the purpose is only to determine its value for pesticide purposes or to determine its toxicity or other properties and from which the user does not expect to receive any benefit in pest control from its use.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 56, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 10. -- Created 1956 Ky. Acts ch. 218, sec. 8, effective July 1, 1956.

217.610 Department to issue "stop sale, use or removal" order -- Appeal.

The department shall issue and enforce a written or printed "stop sale, use or removal" order to the owner or custodian of any lot of pesticide and to hold it at a designated place when it finds said pesticide is being offered or exposed for sale in violation of the provisions of KRS 217.542 to 217.630 until the law has been complied with and said pesticide is released in writing or said violation has been otherwise legally disposed of by written authority; provided, that the owner or custodian of such pesticide shall have the right to appeal from such order to a court of competent jurisdiction in the county where the said pesticide or pesticides are found, praying for a judgment as to the justification of said order, and for the discharge of such pesticide from the order prohibiting the sale in accordance with the findings of the court; and, provided further, that the provisions of this paragraph shall not be construed as limiting the right of the enforcement officer to proceed as authorized by other provisions of KRS 217.542 to 217.630. The department shall release the pesticide so withdrawn when the requirements of the provisions of KRS 217.542 to 217.630 have been complied with and upon payment of all costs and expenses incurred in connection with the withdrawal.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 57, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 11. -- Created 1956 Ky. Acts ch. 218, sec. 9, effective July 1, 1956.

217.620 Seizure of pesticide.

Any lot of pesticide not in compliance with the provisions of KRS 217.542 to 217.630 shall be subject to seizure on complaint of the department to a court of competent jurisdiction in the county in which said pesticide is located. In the event the court finds the said pesticide to be in violation of KRS 217.542 to 217.630 and orders the condemnation of said pesticide it shall be disposed of in any manner consistent with the quality of the pesticide and the laws of the state; provided, that in no instance shall the disposition of said pesticide be ordered by the court without first giving the claimant an opportunity to apply to the court for release of said pesticide for permission to reprocess or relabel said product to bring it into compliance with KRS 217.542 to 217.630.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 58, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 12. -- Created 1956 Ky. Acts ch. 218, sec. 10, effective July 1, 1956.

217.625 Pesticide Advisory Board.

The Commissioner of Agriculture may appoint a Pesticide Advisory Board to advise in the promulgation of regulations and the administration of this chapter.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 59, effective July 15, 1980. -- Created 1974 Ky. Acts ch. 200, sec. 13.

217.630 Authority vested in department may be executed by employees of department.

All authority vested in the department by virtue of the provisions of KRS 217.542 to 217.630 may, with like force and effect, be executed by employees of the department.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 295, sec. 60, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 200, sec. 14. -- Created 1956 Ky. Acts ch. 218, sec. 11, effective July 1, 1956.

217.640 Jurisdiction vested in department -- Repealing clause.

Jurisdiction in all matters pertaining to the distribution, sale and transportation of pesticides is by KRS 217.542 to 217.640 vested exclusively in the department and all acts and parts of acts inconsistent with KRS 217.542 to 217.640 are hereby expressly repealed including the provisions of KRS 217.400 which cover economic poisons subject to KRS 217.542 to 217.640.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 188, sec. 217, effective July 15, 1980; and ch. 295, sec. 61, effective July 15, 1980. -- Amended 1978 Ky. Acts ch. 384, sec. 68, effective June 17, 1978. -- Amended 1974 Ky. Acts ch. 200, sec. 1 -- Created 1956 Ky. Acts ch. 218, sec. 13, effective July 1, 1956.

Legislative Research Commission Note. This section was amended by two 1980 acts which do not appear to be in conflict and have been compiled together.

Labeling Hazardous Substances Labeling Hazardous Substances

217.650 Citation of KRS 217.650 to 217.710.

KRS 217.650 to 217.710 may be cited as the "Kentucky Hazardous Substances Labeling Act."

Effective: June 16, 1960.

History: Created 1960 Ky. Acts ch. 244, sec. 1, effective June 16, 1960.

217.660 Definitions for KRS 217.650 to 217.710.

As used in KRS 217.650 to 217.710 unless the context indicates otherwise:

(1) "Secretary" means the secretary for health and family services;

(2) "Cabinet" means the Cabinet for Health and Family Services;

(3) "Person" includes any individual, partnership, corporation, firm, or association;

(4) "Hazardous substance" means any substance or mixture of substances which is:

(a) "Toxic" and has the inherent capacity to produce bodily injury to man through ingestion, inhalation, or absorption through any body surface, including toxic substances which are poisonous;

(b) "Corrosive" on contact with living tissue causing substantial destruction of tissue by chemical action, but does not refer to action on inanimate surfaces;

(c) "Irritant" and not corrosive within the meaning of paragraph (b), which on immediate, prolonged, or repeated contact with normal living tissue will induce a local inflammatory reaction;

(d) "Strong sensitizer" and will cause on normal living tissue through an allergic or photodynamic process a hypersensitivity which becomes evident on reapplication of the same substance and which is designated as such by the secretary;

(e) "Flammable" with a flashpoint of eighty (80) degrees Fahrenheit or below;

(f) "Radioactive" as a result of disintegration of unstable atomic nuclei and emits energy;

(g) Capable of generating pressure through decomposition, heat, or other means;

(h) Capable of causing substantial personal injury or illness during any customary or reasonably anticipated handling or use; and

(5) "Label" means a display of written, printed, or graphic matter upon the immediate container of any substance, or that is easily legible through the outside container or wrapper.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 518, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 462, effective July 15, 1998. -- Amended 1974 Ky. Acts ch. 74, Art VI, sec. 107(1), (10) and (11). -- Created 1960 Ky. Acts ch. 244, sec. 2, effective June 16, 1960.

217.670 Construction of term "misbranded."

A hazardous substance is hereby declared to be misbranded when intended for household use if it fails to bear a label:

(1) Which states conspicuously:

(a) The name and place of business of the manufacturer, packer, or distributor;

(b) The common or usual name, or the chemical name (if there be no common or usual name), or the recognized generic name (not trade name only) of the hazardous substance or of each component which contributes substantially to its hazard;

(d) When necessary, an affirmative statement of the principal hazard or hazards such as "flammable," "vapor harmful," "causes burns," "absorbed through skin," or similar wording descriptive of the hazard;

(e) Precautionary measures describing the action to be followed or avoided;

(f) Instructions, when necessary, for the first-aid treatment in case of contact or exposure if the substance is hazardous through contact or exposure;

(g) The word "poison" for any toxic substance which is defined as poisonous by the rules and regulations of the secretary under the provisions of KRS 217.650 to 217.710;

(h) Instructions for handling and storage of packages which require special care in handling or storage; and

(i) The statement "Keep out of reach of children" or its practical equivalent;

(2) On which any statements required under subsection (1) are not located prominently and are not in English in legible type in contrast by typography, layout, or color, with other printed matter on the label; provided, however, that the secretary may by regulations provide for minimum information which shall appear on the labels for small packages, which labels need not include all of the information required by this section; provided further, that the secretary may provide for less than the foregoing statement of the hazard or precautionary measures for labels of hazardous substances presenting only minor hazards; and a package shall not be deemed misbranded under the provisions of KRS 217.650 to 217.710 if it is a substance subject to the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163, 7 U.S.C. secs. 135 et seq.); the Federal Food, Drug and Cosmetic Act (52 Stat. 1040 et seq., 21 U.S.C. secs. 301 et seq.); the Kentucky Pesticide Act (KRS 217.542 to 217.640); KRS 217.005 to 217.215, or to packages or substances intended for use in agriculture or horticulture for industrial or related uses.

Effective: July 15, 1980

History: Amended 1980 Ky. Acts ch. 188, sec. 218, effective July 15, 1980. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 244, sec. 3, effective June 16, 1960.

217.680 Prohibited sales.

No person shall sell, offer for sale, distribute or transport for sale within this state in a package or container intended for general home and household use a hazardous substance which is misbranded.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 244, sec. 4, effective June 16, 1960.

217.690 Regulations.

The secretary shall adopt rules and regulations for the proper administration and enforcement of KRS 217.650 to 217.710. The secretary may in his discretion adopt tests and standards for determination of toxic, poisonous, corrosive, irritant, flammable, and radioactive properties of any hazardous substance.

History: Amended 1974 Ky. Acts ch. 74, Art.VI, sec. 107(22). -- Created 1960 Ky. Acts ch. 244, sec. 5, effective June 16, 1960.

217.700 Duty of cabinet as to misbranded hazardous substance -- Procedure -- Costs -- Bond.

(1) Whenever a duly authorized agent of the cabinet finds or has probable cause to believe that any hazardous substance is misbranded, within the meaning of KRS 217.650 to 217.710, or is dangerous to public health he shall affix to such article a tag or other appropriate marking, giving notice that such article is, or is suspected of being, misbranded or dangerous to public health and has been detained or quarantined and warning all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by such agent or the court. It shall be unlawful for any person to remove or dispose of such detained or quarantined article by sale or otherwise without such permission.

(2) When an article detained or quarantined under subsection (1) has been found by such agent to be misbranded or dangerous to public health, he shall petition the judge of the District Court in whose jurisdiction the article is detained or quarantined for an order for condemnation of such article; provided, however, that nothing in this section shall require that the cabinet or its agent shall go to court if destruction of the quarantined article is accomplished by agreement made in writing with the owner of the property. When such agent has found that an article so detained or quarantined is not misbranded or dangerous to public health, he shall remove the tag or other marking.

(3) If the court finds that a detained or quarantined article is misbranded or dangerous to public health, such article shall, after entry of the order, be destroyed at the expense of the claimant thereof under the supervision of such agent, and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of such article or his agent; provided, however, that if the quarantining of the article is due only to misbranding which can be corrected by proper labeling of the article, the court, after entry of the order and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that such article shall be so labeled has been executed, may by order direct that such article be delivered to the claimant thereof for such labeling under the supervision of an agent of the cabinet. The expense of such supervision shall be paid by the claimant. Such bond shall be returned to the claimant of the article on representation to the court by the cabinet that the article is no longer in violation of KRS 217.650 to 217.710, and that the expenses of such supervision have been paid.

Effective: January 2, 1978

History: Amended 1976 (1st Extra. Sess.) Ky. Acts ch. 14, sec. 208, effective January 2, 1978. -- Created 1960 Ky. Acts ch. 244, sec. 6, effective June 16, 1960.

217.710 Notice may be given of intended criminal proceeding.

Before any violation of KRS 217.650 to 217.710 is reported to the Commonwealth's, county or city attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated may be given appropriate notice and an opportunity to present his views to the cabinet, either orally or in writing, with regard to such contemplated proceeding. Nothing in KRS 217.650 to 217.710 shall be construed as requiring the cabinet to report for prosecution minor violations of KRS 217.650 to 217.710 whenever it believes that the public interest will be best served by a suitable notice of warning in writing.

Effective: June 16, 1960

History: Created 1960 Ky. Acts ch. 244, sec. 7, effective June 16, 1960.

217.720 Repealed, 1968.

[Repealed]

217.721 Repealed, 1972.

[Repealed]

217.725 Repealed, 1972.

[Repealed]

217.730 Repealed, 1968.

[Repealed]

217.731 Repealed, 1972.

[Repealed]

217.735 Repealed, 1972.

[Repealed]

217.740 Repealed, 1968.

[Repealed]

217.741 Repealed, 1972.

[Repealed]

217.745 Repealed, 1972.

[Repealed]

217.750 Repealed, 1968.

[Repealed]

217.751 Repealed, 1972.

[Repealed]

217.755 Repealed, 1972.

[Repealed]

217.760 Repealed, 1968.

[Repealed]

217.761 Repealed, 1972.

[Repealed]

217.765 Repealed, 1972.

[Repealed]

217.770 Repealed, 1968.

[Repealed]

217.771 Repealed, 1972.

[Repealed]

217.775 Repealed, 1972.

[Repealed]

217.780 Repealed, 1968.

[Repealed]

217.781 Repealed, 1972.

[Repealed]

217.785 Repealed, 1972.

[Repealed]

217.790 Repealed, 1968.

[Repealed]

217.800 Repealed, 1972.

[Repealed]

Lead-Based Paint Lead-Based Paint

217.801 Restrictions on sale and use of paint containing lead -- Labeling.

(1) Paint manufactured after July 1, 1972, containing more than one-half of one percent (.5%) lead by weight of the nonvolatile content shall not be sold, or used on any toys, children's furniture, interior surface of any dwelling, or any other surface easily accessible to children under the age of seven (7) years. Such paints shall not be manufactured, sold, or used for any other purpose which would ultimately result in exposure to children under the age of seven (7) years unless proper application and documentation is made to the Cabinet for Health and Family Services and the cabinet determines that no health hazard or danger to children exists from the intended use.

(2) All paints manufactured in this state after July 1, 1972, which will be used in this state will be clearly labeled as to use and hazard when containing more than one- half of one percent (.5%) lead by weight of the total nonvolatile content.

(3) The above provisions of subsections (1) and (2) of this section shall apply to all paints containing more than six one-hundredths of one percent (.06%) lead by weight of the total nonvolatile content after January 1, 1974.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 519, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 463, effective July 15, 1998. -- Amended 1974, Ky. Acts ch. 74, Art. VI, sec. 107(1), (11). -- Created 1972 Ky. Acts ch. 356, paras. (1), (2) and (4).

217.803 Repealed, 1972.

[Repealed]

217.807 Repealed, 1972.

[Repealed]

Food Vending Machines Food Vending Machines

217.808 Definitions for KRS 217.808 to 217.812.

The following terms shall have the meanings set forth below:

(1) "Vending machine" means any self-service or semi-self-service device which upon insertion of a coin, coins or tokens or by other similar means dispenses unit servings of food either in bulk or in packaged form.

(2) "Vending machine commissary" means any place operated by a vending machine company in which food or beverage is prepared for service to vending machines.

(3) "Vending machine company" means any individual, partnership, corporation, firm or association who by contract, agreement, or ownership, takes responsibility for furnishing, installing, servicing, operating, or maintaining one (1) or more vending machines.

History: Created 1972 Ky. Acts ch. 365, sec. 1.

217.809 Permits for vending machine companies -- Expiration date -- Regulations.

No person shall operate a vending machine company without having first obtained a permit to operate from the Cabinet for Health and Family Services as provided in the regulations of the Cabinet for Health and Family Services. All such permits shall expire on June 30 following the date of issue. The Cabinet for Health and Family Services shall adopt regulations relating to vending machines. KRS 217.808 to 217.812 do not apply to blind persons who operate vending machines as part of a program established by federal or state law.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 520, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 464, effective July 15, 1998. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (3) and (11). -- Created 1972 Ky. Acts ch. 365, sec. 2.

217.810 Repealed, 1972.

[Repealed]

217.811 Application and fee for permit -- Exemptions.

(1) The cabinet shall promulgate administrative regulations to establish a fee that:

(a) Shall be the total of the operational and administrative costs of the programs to the cabinet and to agencies as defined in KRS 211.185;

(b) Beginning on March 17, 2020, until December 31, 2020, shall not increase more than twenty-five percent (25%) of the fee amount on March 17, 2020; and

(2) The fee shall be paid with each application for permit to operate a vending machine company for each vending machine commissary plus a fee for the total number of vending machines operated by the applicant.

(3) Vending machines dispensing only bottled or canned soft drinks; prepackaged nonpotentially hazardous food; chewing gum, nuts, and/or candies shall be exempt from the permit and fee requirements of KRS 217.808 to 217.812.

Effective: March 17, 2020

History: Amended 2020 Ky. Acts ch. 21, sec. 9, effective March 17, 2020. -- Amended 2018 Ky. Acts ch. 136, sec. 13, effective July 1, 2019. -- Amended 1982 Ky. Acts ch. 247, sec. 12, effective July 15, 1982. -- Created 1972 Ky. Acts ch. 365, sec. 3.

217.812 Fees credited to trust and agency fund -- Use of funds.

All fees collected by the Cabinet for Health and Family Services under the provisions of KRS 217.808 to 217.812 shall be paid into the State Treasury and credited to a trust and agency fund to be used by the cabinet in defraying the costs and expenses of the cabinet in the administration of KRS 217.808 to 217.812. Such funds may be expended for training of state and local sanitation personnel. The balance of this fund shall revert to the general fund of the Commonwealth at the end of each biennium.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 521, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 465, effective July 15, 1998. -- Amended 1982 Ky. Acts ch. 247, sec. 13, effective July 15, 1982. -- Amended 1974 Ky. Acts ch. 74, Art. VI, sec. 107(1), (11). -- Created 1972 Ky. Acts ch. 365, sec. 4.

217.813 Repealed, 1972.

[Repealed]

Generic Drugs Generic Drugs

217.814 Definitions for KRS 217.815 to 217.826.

The following words and phrases, as used in KRS 217.815 to 217.826, shall have the following meanings, unless the context requires otherwise:

(1) "Biological product" has the same meaning as in 42 U.S.C. sec. 262;

(2) "Board" means the Kentucky Board of Pharmacy;

(3) "Brand name" means the name that a manufacturer of a drug or pharmaceutical places on the container thereof at the time of packaging;

(4) "Dosage formulation" shall include but not be limited to those specific dosage forms which, by the nature of their physical manufacture, are deemed to be nonequivalent to other similar formulations such as controlled-release tablets, aerosol-nebulizer drug delivery systems, and enteric-coated oral dosage forms;

(5) "Equivalent drug product" means a product with the same generic name, active ingredients, strength, quantity, and dosage form as the drug product identified in a prescription;

(6) "Generic name" means the chemical or established name of a drug or pharmaceutical;

(7) "Interchangeable biological product" means:

(a) A biological product that the United States Food and Drug Administration has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. sec. 262(k)(4); or

(b) A biological product that the United States Food and Drug Administration has determined is therapeutically equivalent as set forth in the latest edition or supplement to the federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations;

(8) "Nonequivalent drug product formulary" means a formulary of drugs, drug products, and dosage formulations for which there are no equivalent drugs, drug products, or dosage formulations and which have been determined to be noninterchangeable or to have actual or potential bioequivalency problems by the United States Food and Drug Administration and are contained in a drug bioequivalence problems list as published in the United States Food and Drug Administration publication entitled "Approved prescription drug products with therapeutic equivalence evaluations" with supplements;

(9) "Pharmacist" has the same meaning as in KRS 315.010; and

(10) "Practitioner" has the same meaning as in KRS 217.015.

Effective: July 15, 2016

History: Amended 2016 Ky. Acts ch. 73, sec. 1, effective July 15, 2016. -- Amended 2003 Ky. Acts ch. 51, sec. 2, effective June 24, 2003. -- Amended 1982 Ky. Acts ch. 399, sec. 1. -- Created 1972 Ky. Acts ch. 126, sec. 1.

217.815 Practitioner may express professional opinion to patient.

Nothing in KRS 217.814 to 217.826 shall be construed to prevent a practitioner from informing a patient of his professional opinion as to the capabilities, effectiveness and acceptability of any drug.

History: Created 1972 Ky. Acts ch. 126, sec. 2.

217.816 Label for prescriptions -- Exception.

Every prescription dispensed by a pharmacist in this Commonwealth after July 1, 1972, shall bear upon the label the name of the medication in the container unless the practitioner indicates in the manner of his choice on the prescription "Do Not Label."

History: Created 1972 Ky. Acts ch. 126, sec. 3.

217.817 Repealed, 1972.

[Repealed]

217.818 Repealed, 1982.

[Repealed]

217.819 Nonequivalent drug product formulary -- Distribution and revision.

(1) The board shall prepare by regulation a nonequivalent drug product formulary of drugs with their generic names for which there are no equivalent drug products, and which should not be interchanged by pharmacists. The nonequivalent drug product formulary shall list all drugs, drug products, and dosage formulations that the United States Food and Drug Administration has determined to be therapeutically nonequivalent.

(2) The board shall provide for annual distribution of copies of such formulary and revisions and additions thereto among pharmacies licensed within the Commonwealth and shall supply a copy to any person on request upon payment of the price established by the board. Such formulary shall be revised and distributed as often as new and pertinent information on drugs, drug products, and dosage formulations becomes available from the United States Food and Drug Administration.

Effective: July 15, 1982

History: Amended 1982 Ky. Acts ch. 399, sec. 2, effective July 15, 1982. -- Created 1972 Ky. Acts ch. 126, sec. 6.

217.820 Repealed, 1972.

[Repealed]

217.821 Judicial review.

Any person or party in interest aggrieved by the publication of the nonequivalent drug product formulary of the Board of Pharmacy shall be entitled to a judicial review in Franklin County Circuit Court.

Effective: July 15, 1982

History: Amended 1982 Ky. Acts ch. 399, sec. 3, effective July 15, 1982. -- Created 1972 Ky. Acts ch. 126, sec. 7.

217.822 Substitution of equivalent drug or interchangeable biological product -- Substitute must be lower in price than prescribed drug or biological product -- Selection by pharmacist not practice of medicine -- Liability of pharmacist -- Pharmacist to communicate to prescribing practitioner the specific biological product dispensed.

(1) When a pharmacist receives a prescription for a brand name drug which is not listed by generic name in the nonequivalent drug product formulary prepared by the board, the pharmacist shall select a lower-priced therapeutically equivalent drug which the pharmacist has in stock, unless otherwise instructed by the patient at the point of purchase or by the patient's practitioner. If a lower-priced selection is made, the label on the container of the drug shall show the name of the drug dispensed.

(2) When a pharmacist receives a prescription for a brand name biological product which is not listed by name in the nonequivalent drug product formulary prepared by the board, the pharmacist shall dispense a lower-priced interchangeable biological product, if there is one in stock, unless otherwise instructed by the patient at the point of purchase or by the patient's prescribing practitioner. If an interchangeable product is selected, the label on the container shall show the name of the biological product dispensed.

(3) When an equivalent drug product or interchangeable biological product is dispensed in lieu of a brand name drug prescribed, the price of the equivalent drug or interchangeable biological product dispensed shall be lower in price to the purchaser than the drug product prescribed.

(4) If, in the opinion of a practitioner, it is to the best interest of the practitioner's patient that an equivalent drug or interchangeable biological product should not be dispensed, the practitioner may indicate in the manner of his or her choice on the prescription "Do Not Substitute," except that the indication shall not be preprinted on a prescription.

(5) The selection of any drug or interchangeable biological product by a pharmacist under the provisions of this section shall not constitute the practice of medicine.

(6) A pharmacist who selects an equivalent drug product or interchangeable biological product pursuant to KRS 217.815 to 217.826 assumes no greater liability for selecting the dispensed drug product than would be incurred in dispensing a prescription for a drug product or biological product prescribed by its generic, nonbrand, or proper name.

(7) When a pharmacist receives a generically written prescription for a multiple source drug product, he or she shall dispense an equivalent drug product in accordance with the provisions of KRS 217.815 to 217.826.

(8) When a pharmacist receives a prescription for a biological product written by nonbrand or proper name, he or she shall dispense an interchangeable biological product in accordance with the provisions of KRS 217.814 to 217.826, provided that the interchangeable product has been deemed by the United States Food and Drug Administration to be interchangeable with that specific reference product as identified by the nonbrand or proper name.

(9) A pharmacist shall not substitute a biological product for a prescribed biological product unless the substituted product is an interchangeable biological product for the prescribed biological product.

(10) (a) Within five (5) business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescribing practitioner the specific product provided to the patient, including the name of the product and the manufacturer.

(b) Communication shall be conveyed by making an entry that is electronically accessible to the prescribing practitioner through:

An interoperable electronic medical records system;
An electronic prescribing technology;
A pharmacy benefit management system; or
A pharmacy record.

(c) Communication entries into an electronic records system as described in this subsection are presumed to provide notice to the prescribing practitioner. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescribing practitioner using facsimile, telephone, electronic transmission, or other prevailing means. Communication to the prescribing practitioner, or the prescribing practitioner's office personnel, using facsimile, telephone, electronic transmission, or other prevailing means shall be presumed to provide notice to the prescribing practitioner.

(d) Communication shall not be required where:

There is no United States Food and Drug Administration-approved interchangeable biological product for the product prescribed;
A refill prescription is not changed from the product dispensed on the prior filling of the prescription; or
The prescribing practitioner indicates "Do Not Substitute" on the prescription.

(e) Communication received by the prescribing practitioner from the dispensing pharmacist or the pharmacist's designee shall be treated in accordance with the standards of acceptable and prevailing practice of the prescribing practitioner within the Commonwealth of Kentucky and the following as they relate to patient records:

The principles of ethics of the American Medical Association;
The code of ethics of the American Osteopathic Association;
The principles of ethics and code of professional conduct of the American Dental Association;
The code of ethics of the American Chiropractic Association;
The principles of veterinary medical ethics of the American Veterinary Medical Association;
The code of ethics of the American Optometric Association; or
The code of ethics for nurses of the American Nurses Association.

Effective: July 15, 2016

History: Amended 2016 Ky. Acts ch. 73, sec. 2, effective July 15, 2016. -- Amended 1982 Ky. Acts ch. 399, sec. 4, effective July 15, 1982. -- Amended 1976 Ky. Acts ch. 274, sec. 2. -- Created 1972 Ky. Acts ch. 126, sec. 8.

217.823 Repealed, 1972.

[Repealed]

217.824 Repealed, 1982.

[Repealed]

217.825 Legislative intent.

It is the intent of the General Assembly that all citizens of Kentucky may be assured of high quality medicine at a reasonable cost.

History: Created 1972 Ky. Acts ch. 126, sec. 11.

217.826 Basis for reimbursement when substitution forbidden.

Whenever a drug has been prescribed with the indication "Do Not Substitute" for a patient who has a contract whereunder he is reimbursed for the costs of health care, then the party that has contracted to reimburse the patient shall make the reimbursement on the basis of the brand name price and not on the basis of the generic drug price.

History: Created 1972 Ky. Acts ch. 126, sec. 13.

217.827 Repealed, 1972.

[Repealed]

217.830 Pharmacy required to post sign concerning dispensing of lowest priced generic drug.

Every pharmacy shall post a sign in a location easily seen by patrons at the counter where prescriptions are dispensed stating that: "This pharmacy is required to dispense the lowest priced generic drug in stock which is therapeutically equivalent to the one prescribed for you by your doctor unless you or your doctor do not approve. Ask your pharmacist." The printing on the sign shall be in letters not less than one (1) inch in height.

Effective: July 15, 1986.

History: Created 1986 Ky. Acts ch. 433, sec. 5, effective July 15, 1986. History for former KRS 217.830: Repealed 1972 Ky. Acts ch. 110, sec. 1. -- Created 1968 Ky. Acts ch. 205, sec. 10.

217.833 Repealed, 1972.

[Repealed]

217.837 Repealed, 1972.

[Repealed]

217.840 Repealed, 1972.

[Repealed]

217.843 Repealed, 1972.

[Repealed]

217.847 Repealed, 1972.

[Repealed]

217.850 Repealed, 1972.

[Repealed]

217.853 Repealed, 1972.

[Repealed]

217.857 Repealed, 1972.

[Repealed]

217.860 Repealed, 1972.

[Repealed]

217.863 Repealed, 1972.

[Repealed]

217.867 Repealed, 1972.

[Repealed]

217.870 Repealed, 1972.

[Repealed]

217.873 Repealed, 1972.

[Repealed]

217.877 Repealed, 1972.

[Repealed]

217.880 Repealed, 1972.

[Repealed]

217.883 Repealed, 1972.

[Repealed]

217.887 Repealed, 1972

[Repealed]

217.890 Repealed, 1972.

[Repealed]

217.893 Repealed, 1972.

[Repealed]

217.894 Repealed, 1982.

[Repealed]

217.895 Inspections -- Records of pharmacy.

(1) Routine inspections of pharmacies for compliance with KRS 217.815 to 217.826 shall be undertaken by the Kentucky Board of Pharmacy.

(2) Every pharmacy shall retain for a period of two (2) years from July 15, 1982, a pharmacy record of all prescribed drug and biological products dispensed. The pharmacy record shall be retained for the purpose of providing valid data for bona fide research and reporting to the General Assembly as to the effectiveness of KRS 217.815 to 217.826. The pharmacy record shall include:

(a) The brand name of the drug or biological product, when applicable.

(b) The name of the manufacturer or the supplier of the drug or biological product, if the drug or biological product has no brand name.

(d) The quantity dispensed, when applicable.

(e) The serial number of the prescription.

(f) The date the prescription was originally dispensed and refilled.

(g) The name of prescribing practitioner.

(h) The name of patient for whom the drug or biological product was prescribed.

(i) The price for which the drug or biological product was sold to the purchaser.

(j) A notation if the practitioner indicated "Do not substitute" or the purchaser refused the product selected.

Effective: July 15, 2016

History: Amended 2016 Ky. Acts ch. 73, sec. 4, effective July 15, 2016. -- Created 1982 Ky. Acts ch. 399, sec. 5, effective July 15, 1982.

217.896 Distribution of explanatory pamphlet for citizens of Commonwealth.

The Office of Consumer Protection in the Office of the Attorney General shall develop and distribute to licensed pharmacies without charge a pamphlet for citizens of the Commonwealth which explains the provisions of KRS 217.815 to 217.826 and 217.895. Pharmacists shall display such distributed pamphlets in a prominent place and make them available without charge. Pharmacies shall maintain a sufficient stock of the distributed pamphlets to assure that the supply will not become exhausted for any lengthy time.

Effective: April 5, 2024

History: Amended 2024 Ky. Acts ch. 112, sec. 11, effective April 5, 2024. -- Created 1982 Ky. Acts ch. 399, sec. 6, effective July 15, 1982.

Volatile Substances Volatile Substances

217.900 Volatile substance defined -- Inhalation unlawful.

(1) As used in this section, "volatile substance" means any glue, cement, or paint or other substance containing a solvent or chemical having the property of releasing toxic vapors or fumes which when inhaled may cause a condition of intoxication, inebriation, stupefaction, dulling of the brain or nervous system, or distortion or disturbance of the auditory, visual, or mental processes.

(2) It shall be unlawful for any person to intentionally smell or inhale the fumes of any volatile substance, or to induce any other person to do so for the purpose of inducing a condition described in subsection (1) of this section.

(3) No person shall intentionally sell or offer for sale, deliver or give any volatile substance to any person for purposes of inhalation in violation of subsection (2) of this section.

Effective: July 15, 1980

History: Created 1980 Ky. Acts ch. 138, sec. 1, effective July 15, 1980.

217.902 Repackaging volatile substances.

When any person removes any volatile substance from the container in which it is delivered to him and repackages it into containers not used in the ordinary course of business for the purpose of packaging such volatile substances and for the purpose of sale, a rebuttable presumption will be created that he intends to sell such substances for purposes prohibited by KRS 217.900.

Effective: July 15, 1980

History: Created 1980 Ky. Acts ch. 138, sec. 3, effective July 15, 1980.

Legend Drugs Legend Drugs

217.905 Definitions.

As used in KRS 217.907 to 217.917:

(1) "Legend drug" means any drug defined by the Federal Food, Drug and Cosmetic Act, as amended, and under which definition its label is required to bear the statement "Caution: Federal law prohibits dispensing without prescription."

(2) "Distributor" means any person, corporation, or other entity which distributes for resale a legend drug under its own label even though it is not the actual manufacturer of the legend drug.

(3) "Solid dosage form" means capsules, tablets, or similar legend drug products intended for oral administration.

(4) "Board" means the Kentucky Board of Pharmacy.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 1, effective July 15, 1982.

217.907 Legend drugs to be imprinted with identifying symbol.

No legend drug in finished solid dosage form may be manufactured or distributed within the Commonwealth unless it has clearly and prominently marked or imprinted on it an individual symbol, number, company name, words, letters, marking, National Drug Code, or any combination thereof, identifying the drug product and the manufacturer or distributor of the drug product.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 2, effective July 15, 1982.

217.909 Descriptive material identifying imprints to be available to board.

Manufacturers or distributors shall make available to the board, upon the board's request, descriptive material which will identify each current imprint used by the manufacturer or distributor on legend drugs in solid dosage form.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 3, effective July 15, 1982.

217.911 Exemption of drugs because of size or unique characteristics.

The board may exempt a particular drug product from the requirements of KRS 217.907, upon application of a manufacturer or distributor showing that the drug product's size, texture, or other unique characteristics render imprinting impractical or impossible.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 4, effective July 15, 1982.

217.913 Exemption of drugs compounded in a pharmacy.

The provisions of KRS 217.907 to 217.917 shall not apply to drug products compounded by a pharmacist licensed pursuant to KRS Chapter 315, in a pharmacy operating under a permit as required by KRS 315.035.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 5, effective July 15, 1982.

217.915 Seizure and forfeiture of drugs not properly imprinted.

All legend drugs in solid dosage form that are possessed, distributed, sold or offered for sale in violation of the provisions of KRS 217.907 to 217.917 shall be deemed contraband and shall be seized by the board and forfeited to the state.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 6, effective July 15, 1982.

217.917 Regulations.

The board shall promulgate regulations implementing the provisions of KRS 217.907 to 217.915.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 7, effective July 15, 1982.

217.919 Applicability of KRS 217.907 to 217.917 and 217.990(12).

The provisions of KRS 217.907 to 217.917 and 217.990(12) shall not apply to drug products manufactured prior to July 1, 1983.

Effective: July 15, 1982

History: Created 1982 Ky. Acts ch. 5, sec. 9, effective July 15, 1982.

Tanning Tanning

217.920 Definitions for KRS 217.920 to 217.928.

As used in KRS 217.920 to 217.928, unless the context requires otherwise:

(1) "Cabinet" means the Cabinet for Health and Family Services;

(2) "Tanning device" means any equipment that emits radiation used for tanning of the skin, such as a sun lamp, tanning booth, or tanning bed, and includes any accompanying equipment, such as protective eyewear, timers, and handrails; and

(3) "Tanning facility" means any place where a tanning device is used for a fee, membership dues, or other compensation.

Effective: July 12, 2006

History: Created 2006 Ky. Acts ch. 103, sec. 1, effective July 12, 2006.

217.922 Consent required for minor using tanning device or facility.

(1) Before any person who has reached his or her fourteenth birthday and has not passed his or her eighteenth birthday uses a tanning device, he or she shall give the tanning facility a statement, signed by his or her parent or legal guardian, stating that the parent or legal guardian has read and understood the warnings given by the tanning facility, and that they consent to the minor's use of the tanning device and agree that the minor will use protective eyewear. This parental consent is valid for one (1) calendar year.

(2) A person under the age of fourteen (14) shall be accompanied by a parent or legal guardian when using a tanning device.

Effective: July 12, 2006

History: Created 2006 Ky. Acts ch. 103, sec. 2, effective July 12, 2006.

217.924 Requirements for tanning facilities.

(1) A tanning facility shall give each customer a written statement pursuant to 21 C.F.R. 1040.20. The written statement shall include warnings stating that:

(a) Failure to use eye protection provided to the customer by the tanning facility may result in damage to the eyes;

(b) Overexposure to ultraviolet light causes burns;

(d) Abnormal skin sensitivity or burning may be caused by reactions of the following to ultraviolet light:

Food;
Cosmetics; or
Medications, including but not limited to:

a. Tranquilizers;

b. Diuretics;

c. Antibiotics;

d. High blood pressure medicines; or

e. Birth control pills;

(e) Any person taking a prescription or over-the-counter drug should consult a physician before using a tanning device.

(2) Each tanning facility shall:

(a) Maintain the written or electronic consent forms of the parents or guardians for a period of not less than two (2) years, and make the forms available to cabinet personnel for inspection upon request; and

(b) Make written or electronic records showing the dates and duration of use of a tanning device at the tanning facility by children fourteen (14) years of age to eighteen (18) years of age, maintain those records for a period of not less than two (2) years, and make the records available for cabinet or health department personnel for inspection upon request.

(3) All indoor tanning facilities shall register with the local health department in the district or county in which the facility is operating. Registration shall be valid for one (1) year and applicants shall pay a fee that shall not exceed administrative costs of the program, to the district or county health department.

Effective: July 1, 2019

History: Amended 2018 Ky. Acts ch. 136, sec. 14, effective July 1, 2019. -- Created 2006 Ky. Acts ch. 103, sec. 3, effective July 12, 2006.

217.926 Cabinet to promulgate administrative regulations governing KRS 217.920 to 217.928.

The cabinet shall promulgate administrative regulations as follows:

(1) Develop a strategy to monitor compliance with 21 C.F.R. 1040.20;

(2) Develop forms to assist tanning facilities with recordkeeping regarding parental consent, frequency of use by children fourteen (14) to eighteen (18) years of age, and other forms as needed to implement KRS 217.920 to 217.928; and

(3) Create penalties for violating provisions of KRS 217.920 to 217.928.

Effective: July 12, 2006

History: Created 2006 Ky. Acts ch. 103, sec. 4, effective July 12, 2006.

217.928 Administrative hearings conducted under KRS 217.920 to 217.928.

Any administrative hearing conducted under KRS 217.920 to 217.928 shall be conducted in accordance with KRS Chapter 13B.

Effective: July 12, 2006

History: Created 2006 Ky. Acts ch. 103, sec. 5, effective July 12, 2006.

Hyperbaric Oxygen Therapy Hyperbaric Oxygen Therapy

217.930 Definitions for KRS 217.930 to 217.942.

As used in KRS 217.930 to 217.942:

(1) "Eligible patient" means a veteran who meets the requirements of KRS 217.934;

(2) "Health care provider" means a licensed physician, a licensed advanced practice registered nurse, or a licensed physician assistant;

(3) "Health facility" has the same meaning as in KRS 216B.015;

(4) "Hyperbaric oxygen therapy" or "HBOT" means inhalation of one hundred percent (100%) oxygen in a total body chamber, where atmospheric pressure is increased and controlled, applicable to the prevention, treatment, or cure of a disease or condition of human beings;

(5) "Post-traumatic stress disorder" means a mental health condition caused by an extremely stressful or terrifying event that is diagnosed by a qualified mental health care provider using criteria as set out in the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders;

(6) "Traumatic brain injury" has the same meaning as in KRS 211.470;

(7) "Veteran" has the same meaning as in KRS 40.010; and

(8) "Written informed consent" means a written document that meets the requirements of KRS 217.936.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 110, sec. 1, effective July 15, 2026. -- Created 2018 Ky. Acts ch. 14, sec. 1, effective July 14, 2018.

Legislative Research Commission Note (7/14/2018). 2018 Ky. Acts ch. 14, sec. 8, provides that 2018 Ky. Acts ch. 14 may be known as the "Colonel Ron Ray Veterans Traumatic Brain Injury Treatment Act." This statute was created in Section 1 of that Act.

217.932 Health care provider or health facility to provide hyperbaric oxygen therapy to eligible patients upon request.

(1) A health care provider or health facility shall make hyperbaric oxygen therapy available to an eligible patient who has requested it pursuant to KRS 217.930 to 217.942.

(2) The health care provider or health facility may:

(a) Provide hyperbaric oxygen therapy without receiving compensation; or

(b) Require an eligible patient to pay the costs of or the costs associated with hyperbaric oxygen therapy.

Effective: July 14, 2018

History: Created 2018 Ky. Acts ch. 14, sec. 2, effective July 14, 2018.

217.934 Veterans are eligible patients -- Criteria.

A veteran shall be an eligible patient for hyperbaric oxygen therapy if he or she has:

(1) A diagnosis of traumatic brain injury or post-traumatic stress disorder that is attested to by the patient's treating health care provider;

(2) A prescription for hyperbaric oxygen therapy written by his or her treating health care provider; and

(3) Given written informed consent for the use of HBOT in accordance with KRS 217.936.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 110, sec. 2, effective July 15, 2026. -- Created 2018 Ky. Acts ch. 14, sec. 3, effective July 14, 2018.

217.936 Written informed consent required for hyperbaric oxygen therapy treatment.

(1) A veteran or a veteran's legal guardian shall provide written informed consent for treatment with hyperbaric oxygen therapy in order to receive HBOT to treat traumatic brain injury or post-traumatic stress disorder.

(2) At a minimum, the written informed consent shall include:

(a) An explanation of the currently approved products and treatments for the traumatic brain injury or post-traumatic stress disorder from which the veteran suffers;

(b) A description of the potentially best and worst outcomes of using hyperbaric oxygen therapy and a realistic description of the most likely outcome;

(c) A statement that the veteran's health plan or third-party administrator and provider shall not be obligated to pay for any care or treatments consequent to the use of hyperbaric oxygen therapy unless they are specifically required to do so by law or contract; and

(d) A statement that the veteran understands that the patient shall be liable for all expenses related to the use of hyperbaric oxygen therapy.

(3) The description of potential outcomes required under subsection (2)(b) of this section shall:

(a) Include the possibility that new, unanticipated, different, or worse symptoms may result and that the proposed treatment may hasten death; and

(b) Be based on the treating health care provider's knowledge of the proposed treatment in conjunction with an awareness of the veteran's condition.

(4) The written informed consent shall be:

(a) Signed by:

The veteran; or
A legal guardian, if a guardian has been appointed for the veteran; and

(b) Attested to by the veteran's treating health care provider and a witness.

Effective: July 15, 2026

History: Amended 2026 Ky. Acts ch. 110, sec. 3, effective July 15, 2026. -- Created 2018 Ky. Acts ch. 14, sec. 4, effective July 14, 2018.

217.938 Insurance coverage for hyperbaric oxygen therapy.

(1) KRS 217.930 to 217.942 shall not:

(a) Expand the coverage required of an insurer;

(b) Affect the requirements for insurance coverage of routine patient costs for veterans involved in hyperbaric oxygen therapy;

(c) Require a health plan, third-party administrator, or governmental agency to pay costs associated with the use of hyperbaric oxygen therapy; or

(d) Require a hospital or health facility to provide new or additional services.

(2) A health plan, third-party administrator, or governmental agency may provide coverage for the cost of hyperbaric oxygen therapy under KRS 217.930 to 217.942.

(3) A hospital or health facility may approve the use of hyperbaric oxygen therapy in the hospital or health facility.

Effective: July 14, 2018

History: Created 2018 Ky. Acts ch. 14, sec. 5, effective July 14, 2018.

217.940 Actions prohibited to be taken against health care provider regarding hyperbaric oxygen therapy.

(2) The Cabinet for Health and Family Services shall not take action against a health care provider's Medicare or Medicaid certification based solely on the health care provider's recommendation that an eligible patient have access to hyperbaric oxygen therapy.

Effective: July 14, 2018

History: Created 2018 Ky. Acts ch. 14, sec. 6, effective July 14, 2018.

217.942 State official, employee, or agent prohibited from blocking access to hyperbaric oxygen therapy.

(1) An official, employee, or agent of the Commonwealth of Kentucky shall not block or attempt to block an eligible patient's access to hyperbaric oxygen therapy.

(2) Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider shall not be considered a violation of subsection (1) of this section.

Effective: July 14, 2018

History: Created 2018 Ky. Acts ch. 14, sec. 7, effective July 14, 2018.

217.950 Repealed, 2017.

[Repealed]

217.952 Repealed, 2017.

[Repealed]

Penalties Penalties

217.990 Penalties.

(1) Any person who violates any of the provisions of KRS 217.350 shall be fined not more than twenty-five dollars ($25).

(2) Any person who violates any of the provisions of subsection (2) of KRS 217.390 shall be fined not less than ten dollars ($10) nor more than one hundred dollars ($100), or imprisoned for not more than fifty (50) days, or both.

(3) Except as provided in subsections (1) and (2) of this section, any person who violates any of the provisions of KRS 217.280 to 217.390 or who refuses to comply with any lawful order or requirement duly made in writing as provided in KRS 217.380, shall, for the first offense, be fined not less than ten dollars ($10) nor more than one hundred dollars ($100), or imprisoned for not more than thirty (30) days, or both, and for any subsequent offense shall be fined not less than fifty dollars ($50) nor more than two hundred dollars ($200), or imprisoned for not more than ninety (90) days, or both. Each day after the expiration of the time limit for abating unsanitary conditions and completing improvements to abate such conditions, as ordered under KRS 217.380, shall be a separate offense.

(4) Any person who violates any of the provisions of KRS 217.400 shall be fined not less than ten dollars ($10) nor more than one hundred dollars ($100).

(5) Any person who violates any of the provisions of KRS 217.420 to 217.440 shall be fined not less than two hundred dollars ($200) nor more than one thousand dollars ($1,000), or imprisoned in the county jail for not more than one (1) year, or both.

(6) Any person who violates any of the provisions of KRS 217.450 shall be fined one hundred dollars ($100).

(7) Any person who violates any provision of KRS 217.801 shall be fined not less than fifty dollars ($50) nor more than five hundred dollars ($500) or imprisoned for not less than thirty (30) days nor more than six (6) months, or both.

(8) Any person who violates any of the provisions of KRS 217.808 to 217.812, or any rule or regulation adopted thereunder, or who operates a vending machine company or vending machine commissary without a permit as prescribed in KRS 217.808 to 217.812, or who fails to comply with any order of the cabinet or of any local health department issued pursuant thereto shall be fined not less than twenty-five dollars ($25) nor more than one hundred dollars ($100). Each day of violation or noncompliance shall constitute a separate offense.

(9) Willful noncompliance with KRS 217.816 shall constitute a violation and shall subject the violator to a fine of not over fifty dollars ($50) for the first offense and not over two hundred dollars ($200) for a subsequent offense.

(10) Any person who willfully fails to comply with the provisions of KRS 217.816 to 217.826 shall be guilty of a violation and shall be subject to a fine of not less than one hundred dollars ($100) nor more than five hundred dollars ($500) for each violation.

(11) Any person who violates any of the provisions of KRS 217.177 shall be fined not less than twenty-five dollars ($25) nor more than five hundred dollars ($500) or be imprisoned in the county jail for not less than five (5) nor more than thirty (30) days, or both.

(12) Any manufacturer or distributor who dispenses, sells, or otherwise provides to any other person any legend drug in solid dosage form that fails to comply with the requirements of KRS 217.907 to 217.915 shall be fined not less than one hundred dollars ($100) nor more than five hundred dollars ($500) for each offense.

Effective: July 15, 1982

History: Amended 1982 Ky. Acts ch. 5, sec. 8. effective July 15, 1982; and ch. 399, sec. 13, effective July 15, 1982. -- Amended 1974 Ky. Acts ch. 404, sec. 2. -- Amended 1972 Ky. Acts ch. 126, secs. 4 and 9; ch. 356, para. (3), sec. 1; and ch. 365, sec. 5. -- Amended 1968 Ky. Acts ch. 54, sec. 1. -- Amended 1960 Ky. Acts ch. 247, sec. 24. -- Amended 1958 Ky. Acts ch. 98, sec. 13; and ch. 126, sec. 28. -- Amended 1954 Ky. Acts ch. 158, sec. 2. -- Amended 1950 Ky. Acts ch. 65, sec. 10. - - Amended 1944 Ky. Acts ch. 153, sec. 6. -- Recodified 1942 Ky. Acts ch. 208, sec. 1, effective October 1, 1942, from Ky. Stat. sec. 1276, 1282, 1283a-3, 1905a-60-6, 1905a-60c, 1905a-68, 2060, 2060b-8, 2060b-12, 2060b-13, 2630, 2635a-1, 2635b-5.

Legislative Research Commission Note. This section was amended by two 1982 Acts which do not appear to be in conflict and have been compiled together.

217.991 Repealed, 1968.

[Repealed]

217.992 Penalties for violation of KRS 217.005 to 217.215.

(1) Any person who violates any of the provisions of KRS 217.175 shall be guilty of a misdemeanor and shall on conviction thereof be subject to a fine of not less than one hundred dollars ($100) nor more than five hundred dollars ($500), or by imprisonment for not more than thirty (30) days, or both; but if the violation is committed after a conviction of the person under this section has become final, the person shall be subject to a fine of not less than five hundred dollars ($500) nor more than one thousand dollars ($1,000) or by imprisonment for not more than ninety (90) days, or both.

(2) No person shall be subject to the penalties of subsection (1) of this section, for having violated KRS 217.175(1) or (3) if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of KRS 217.005 to 217.215, designating KRS 217.005 to 217.215.

(3) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by him of the false advertisement, unless he has refused, on the request of the cabinet to furnish the cabinet the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the United States who causes him to disseminate the advertisement.

(4) Any person who operates a retail food establishment, food processing establishment, food storage warehouse, salvage distributor, or salvage processing plant, without a permit as provided in KRS 217.005 to 217.215 or who fails to comply with any regulation adopted thereto shall be guilty of a misdemeanor and shall on conviction be subject to a fine of not less than one hundred dollars ($100) nor more than five hundred dollars ($500), or by imprisonment for not more than thirty (30) days, or both, but if the violation is committed after a conviction of the person under this section has become final, the person shall be subject to a fine of not less than five hundred dollars ($500) nor more than one thousand dollars ($1,000), or by imprisonment for not more than ninety (90) days, or both.

(5) Any person who violates any provision of KRS 217.005 to 217.215, for which a specific penalty is not otherwise provided, or any regulation adopted under the provision of KRS 217.005 to 217.215, or who fails to comply with an order of the cabinet issued pursuant thereto, shall be fined not less than one hundred dollars ($100) nor more than five hundred dollars ($500). Each day of violation or noncompliance shall constitute a separate offense.

Effective: July 15, 1998

History: Amended 1998 Ky. Acts ch. 297, sec. 3, effective July 15, 1998. -- Amended 1990 Ky. Acts ch. 458, sec. 8, effective July 13, 1990. -- Created 1960 Ky. Acts ch. 247, sec. 23, effective June 16, 1960.

217.993 Penalties.

(1) Any person violating any provisions of KRS 217.650 to 217.710 shall be guilty of a violation. Each day of violation shall constitute a separate offense.

(2) Any person violating any provisions of KRS 217.900(2) shall upon conviction be guilty of a Class B misdemeanor.

(3) Any person found guilty of inhaling a volatile substance in violation of KRS 217.900(2) may be ordered to a facility designated by the secretary of the Cabinet for Health and Family Services, where a program of education, treatment, and rehabilitation not to exceed ninety (90) days in duration shall be prescribed. The person ordered to the facility shall present himself for registration and initiation of a treatment program within five (5) days of the date of sentencing. If, without good cause, the person fails to appear at the designated facility within the specified time, or if, any time during the program of treatment prescribed, the authorized clinical director of the facility finds that the person is unwilling to participate in his treatment and rehabilitation, the director shall notify the sentencing court. Upon receipt of notification, the court shall cause the person to be brought before it and may continue the order of treatment or may order the person subject to the fine or imprisonment, or both, for a Class B misdemeanor. Upon discharge of the person from the facility by the clinical director or his designee prior to the expiration of the ninety (90) day period or upon satisfactory completion of ninety (90) days of treatment, the person shall be deemed finally discharged from sentence. The clinical director or his designee shall notify the sentencing court of the date of such discharge from the facility.

(4) The secretary of the Cabinet for Health and Family Services or his designee shall inform each court of the identity and location of the facility to which a person may be ordered under this section.

(5) The sentencing court shall immediately notify the designated facility of the sentence and its effective date.

(6) Responsibility for payment for treatment services rendered to persons pursuant to this section shall be as under the statutes pertaining to payment by patients and others for services rendered by the Cabinet for Health and Family Services unless the facility shall arrange otherwise.

(7) None of the provisions of this section shall be deemed to preclude the court from exercising its usual discretion with regard to ordering probation or conditional discharge.

(8) Any person violating any provision of KRS 217.900(3) shall upon conviction be guilty of a Class D felony.

Effective: June 20, 2005

History: Amended 2005 Ky. Acts ch. 99, sec. 523, effective June 20, 2005. -- Amended 1998 Ky. Acts ch. 426, sec. 467, effective July 15, 1998. -- Amended 1992 Ky. Acts ch. 463, sec. 24, effective July 14, 1992. -- Amended 1980 Ky. Acts ch. 138, sec. 2, effective July 15, 1980. -- Created 1960 Ky. Acts ch. 244, sec. 8, effective June 16, 1960.

217.994 Repealed, 1968.

[Repealed]

217.995 Repealed, 1972.

[Repealed]

217.996 Repealed, 1972.

[Repealed]

217.997 Repealed, 1972.

[Repealed]

217.998 Penalties for violation of KRS 217.542 to 217.630.

(1) Any person who violates any of the provisions of KRS 217.542 to 217.630 or who fails to perform any duties imposed by those sections, or who violates any determination or order of the department promulgated pursuant thereto, shall be liable to a civil penalty of not to exceed the sum of one thousand dollars ($1,000) for said violation, and an additional civil penalty of not to exceed one thousand dollars ($1,000) for each day during which such violation continues, and in addition, may be enjoined from continuing such violations as hereinafter provided in this section. Such penalties shall be recoverable in an action brought in the name of the Commonwealth of Kentucky by the Attorney General.

(2) It shall be the duty of the Attorney General, upon the request of the department, to bring an action for the recovery of the penalties hereinabove provided for, and to bring an action for an injunction against any person violating or threatening to violate any provision of KRS 217.542 to 217.630, or violating or threatening to violate any order or determination of the department promulgated pursuant thereto. In any such action any finding of the department shall be prima facie evidence of the fact or facts found therein.

(3) Any person who shall willfully violate any of the provisions of KRS 217.542 to 217.630 or any determination or order of the department promulgated pursuant to those sections which have become final shall be guilty of a misdemeanor and upon conviction thereof shall be punished by a fine of not less than one hundred dollars ($100) nor more than one thousand dollars ($1,000) or by imprisonment for a term of not more than one (1) year, or by both fine and imprisonment for each separate violation. Each day upon which such violation occurs shall constitute a separate violation.

History: Created 1974 Ky. Acts ch. 200, sec. 15.