Title XVIII, Public Health

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 performa…

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

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

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.

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,…

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…

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 ano…

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…

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-…

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…

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…

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 di…

(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 fou…

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 customar…

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 bu…

(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, appendiciti…

(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, givi…

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…

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.

(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: 1. Sewage is standing in the foo…

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 rev…

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 a…

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…

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…

(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 min…

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 cert…

(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 plan…

(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,…

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 ar…

(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 dis…

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…

(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 elec…

(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 Clas…

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; (c) A practitioner; (d) The administrator in charge of a hospital, but only…

(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 Of…

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 t…

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 u…

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 r…

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 …

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 c…

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.

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 lawf…

(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 w…

(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, …

(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 mess…

(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, …

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 …

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.…

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 organizatio…

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 …