217.015 Definitions for KRS 217.005 to 217.215

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. Nothing in this paragraph shall 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;

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

the body of man or other animals; and

ed 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;

(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, 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

er 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 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;

(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 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

t 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;

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;

nd 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 non-potentially 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;

home, produces or

processes non-potentially 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.