KRS 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 ac t. 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 cosmeti c, 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 contriva nces, 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 o fficial 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;

(c) Articles, other than food, intended to affect the structure or any function of the

body of man or other animals; and

(d) Articles intended for use as a component of any article specified in this

subsection but does not include devices or their components, parts, or

accessories;

(12) "Enriched," as applied to flour, mea ns 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 Envi ronmental

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 purpos es 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 i n 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, t o 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

(c) Articles used for components of any such article;

(19) "Food additive" means any substance the intended use of which results or may be

reasonably expected to result, directly or indirectly, in its becoming a component or

otherwise affecting the characteristics of any food, including any substance

intended for use in pro ducing, 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 scient ific 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 us e 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;

(c) A color additive; or

(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 cafe s; 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; caterin g 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 sin gle 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 compo sition 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 s ubstances, 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 I nspection 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 pract icing 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 t erms 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 p ractice 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 con forms 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 whic h 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 f oods 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 excee d 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 inv olving 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 p rocessor, 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, fr uit 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 h orticultural 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 memb er 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.