{"data":{"id":"us-ky/krs-217.065","jurisdiction":"us-ky","citation":"KRS 217.065","heading":"When drug or device deemed misbranded.","body":"Except for violations of KRS 218A.350, a drug or device shall be deemed to be\nmisbranded:\n(1) If its labeling is false or misleading in any particular;\n(2) If in package form unless it bears a label containing:\n(a) The name and place of business of the man ufacturer, packer, or distributor,\nexcept that, in the case of a prescription drug, it shall bear the name and place\nof business of the manufacturer, and the name and place of business of the\npacker, or distributor, if other than the manufacturer; and\n(b) An accurate statement of the quantity of the contents in terms of weight,\nmeasure, or numerical count; provided that reasonable variations shall be\npermitted, and exemptions as to small packages shall be established, by\nregulations prescribed by the secretary;\n(3) If any word, statement, or other information required by or under authority of KRS\n217.005 to 217.215 to appear on the label or labeling is not prominently placed\nthereon with such conspicuousness (as compared with other words, statements,\ndesigns or devices, in the labeling) and in such terms as to render it likely to be read\nand understood by the ordinary individual under customary conditions of purchase\nand use;\n(4) If it is for use by man and contains any quantity of the narcotic or hypnotic\nsubstance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal,\nchloral, coca, cocaine, codeine, heroin, marijuana, synthetic drugs, salvia, morphine,\nopium, paraldehyde, peyote, or sulfonmethane, or any chemical derivative of such\nsubstance, which derivative has been by the secretary after investigation, found to\nbe, and by regulations under KRS 217.005 to 217.215 designated as, habit forming;\nunless its label bears the name and quantity or proportion of such substance or\nderivative and in juxtaposition therewith the statement \"Warning -- May be habit -\nforming\";\n(5) If it is a drug and is not designated solely by a name recognized in an official\ncompendium unless its label bears:\n(a) The common or usual name of the drug, if such there be; and\n(b) In case it is fabricated from two (2) or more ingredients, the common or usual\nname of each active ingredient, including the kind and quantity or proportion\nof any alcohol, and also including whether active or not the name and quantity\nor proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin,\namidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis,\ndigitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or\nany derivative or preparation of any such substances, contained therein;\nprovided that to the extent that compliance with this subsection is\nimpracticable, exemptions shall be established by regulations promulgated by\nthe secretary;\n(6) Unless its labeling bears:\n(a) Adequate directions for use; and\n(b) Such adequate warnings against use in those pathological conditions or by\nchildren where its use may be dangerous to health, or against unsafe dosage or\nmethods or duration of administration or application, in such manner and\nform, as are n ecessary for the protection of users; provided that where any\nrequirement of subsection (a) of this subsection, as applied to any drug or\ndevice, is not necessary for the protection of the public health, the secretary\nshall promulgate regulations exempting  such drug or device from such\nrequirements;\n(7) If it purports to be a drug the name of which is recognized in an official\ncompendium, unless it is packaged and labeled as prescribed therein; provided that\nthe method of packing may be modified with a consent of the cabinet. Whenever a\ndrug is recognized  in both the United States Pharmacopoeia and the Homeopathic\nPharmacopoeia of the United States, it shall be subject to the requirements of the\nUnited States Pharmacopoeia with respect to packaging and labeling unless it is\nlabeled and offered for sale as a homeopathic drug, in which case it shall be subject\nto the provisions of the Homeopathic Pharmacopoeia of the United States, and not\nto those of the United States Pharmacopoeia;\n(8) If it has been found by the cabinet to be a drug liable to deterioration , unless it is\npackaged in such form and manner, and its label bears a statement of such\nprecautions, as the secretary shall by administrative regulations require as necessary\nfor the protection of public health. No such administrative regulation shall be\nestablished for any drug recognized in an official compendium until the secretary\nshall have informed the appropriate body charged with the revision of such\ncompendium of the need for such packaging or labeling requirements and such body\nshall have failed within a reasonable time to prescribe such requirements;\n(9) (a) If it is a drug and its container is so made, formed, or filled as to be\nmisleading; or\n(b) If it is an imitation of another drug; or\n(c) If it is offered for sale under the name of another drug;\n(10) If it is dangerous to health when used in the dosage, or with the frequency or\nduration prescribed, recommended, or suggested in the labeling thereof;\n(11) If:\n(a) It is a drug intended for use by man which is a habit forming drug to which\nsubsection (4) of this section applies; or because of its toxicity or other\npotentiality for harmful effect, or the method of its use, or the collateral\nmeasures necessary to its use is not safe for use except under the supervision\nof a practitioner, and is not dispensed upon a prescription unless prior to\ndispensing its label bears the statement \"Caution: Federal law prohibits\ndispensing without prescription\"; or\n(b) It is a drug or device and its label (as originally packed) directs that it is to be\ndispensed o r sold only on prescription, unless it is dispensed or sold on a\nprescription of an authorized practitioner and its label (as dispensed) bears the\nname and place of business of the dispenser or seller, the serial number and\ndate of such prescription, and t he name of such licensed practitioner. Such\nprescriptions shall not be refilled except on the specific authorization of the\nprescribing practitioner; provided that where any requirement of this\nsubsection, as applied to any drug or device, is not necessary for the protection\nof the public health, the secretary shall promulgate regulations exempting such\ndrug or device from such requirement;\n(12) A drug sold on a prescription of a practitioner (except a drug sold in the course of\nthe conduct of a business of  selling drugs pursuant to diagnosis by mail) shall be\nexempt from the requirements of this section if:\n(a) Such practitioner is licensed by law to administer such drug; and\n(b) Such drug bears a label containing the name and place of business of the\nseller, the serial number and date of such prescription, and the name of such\npractitioner.\n(13) It is not the intention of subsection (2)(a) of this section as amended herein to\nrequire the name and place of business of the wholesaler to appear upon the label of\nthe package unless otherwise required by this section.","path":["KRS Chapter 217"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=40025","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:24Z","sha256":"9ce45409e7587468de05b9d839aa4ac08fb3fe8ba8433335e7fe7ab806328893","source_id":"us-ky","stale":false,"prev":"us-ky/krs-217.060","next":"us-ky/krs-217.070"},"notice":"GroundRules: Original legal text. Not legal advice."}